Sample records for medical device safety
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Evaluating and Predicting Patient Safety for Medical Devices With Integral Information Technology
2005-01-01
323 Evaluating and Predicting Patient Safety for Medical Devices with Integral Information Technology Jiajie Zhang, Vimla L. Patel, Todd R...errors are due to inappropriate designs for user interactions, rather than mechanical failures. Evaluating and predicting patient safety in medical ...the users on the identified trouble spots in the devices. We developed two methods for evaluating and predicting patient safety in medical devices
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A medical device is any product used to diagnose, cure, or treat a condition, or to prevent disease. They ... may need one in a hospital. To use medical devices safely Know how your device works. Keep ...
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Safety evaluation in the development of medical devices and combination products
Gad, Shayne C
2008-01-01
Capturing the growth of the global medical device market in recent years, this practical new guide is essential for all who are responsible for ensuring safety in the use and manufacture of medical devices. It has been extensively updated to reflect significant advances, incorporating combination products and helpful case examples of current real-life problems in the field.The Third Edition explores these key current trends:global device marketscontinually advancing technologythe increasing harmonization of device safety regulation worldwideEach aspect of safety evaluation is considered in ter
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Product-based Safety Certification for Medical Devices Embedded Software.
Neto, José Augusto; Figueiredo Damásio, Jemerson; Monthaler, Paul; Morais, Misael
2015-01-01
Worldwide medical device embedded software certification practices are currently focused on manufacturing best practices. In Brazil, the national regulatory agency does not hold a local certification process for software-intensive medical devices and admits international certification (e.g. FDA and CE) from local and international industry to operate in the Brazilian health care market. We present here a product-based certification process as a candidate process to support the Brazilian regulatory agency ANVISA in medical device software regulation. Center of Strategic Technology for Healthcare (NUTES) medical device embedded software certification is based on a solid safety quality model and has been tested with reasonable success against the Class I risk device Generic Infusion Pump (GIP).
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Kraft, Marc
2008-09-03
Testing and restoring technical-functional safety is an essential part of medical device reprocessing. Technical functional tests have to be carried out on the medical device in the course of the validation of reprocessing procedures. These ensure (in addition to the hygiene tests) that the reprocessing procedure is suitable for the medical device. Functional tests are, however, also a part of reprocessing procedures. As a stage in the reprocessing, they ensure for the individual medical device that no damage or other changes limit the performance. When determining which technical-functional tests are to be carried out, the current technological standard has to be taken into account in the form of product-specific and process-oriented norms. Product-specific norms primarily define safety-relevant requirements. The risk management method described in DIN EN ISO 14971 is the basis for recognising hazards; the likelihood of such hazards arising can be minimised through additional technical-functional tests, which may not yet have been standardised. Risk management is part of a quality management system, which must be bindingly certified for manufacturers and processors of critical medical devices with particularly high processing demands by a body accredited by the competent authority.
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Stakeholder challenges in purchasing medical devices for patient safety.
Hinrichs, Saba; Dickerson, Terry; Clarkson, John
2013-03-01
This study identifies the stakeholders who have a role in medical device purchasing within the wider system of health-care delivery and reports on their particular challenges to promote patient safety during purchasing decisions. Data was collected through observational work, participatory workshops, and semi-structured qualitative interviews, which were analyzed and coded. The study takes a systems-based and engineering design approach to the study. Five hospitals took part in this study, and the participants included maintenance, training, clinical end-users, finance, and risk departments. The main stakeholders for purchasing were identified to be staff from clinical engineering (Maintenance), device users (Clinical), device trainers (Training), and clinical governance for analyzing incidents involving devices (Risk). These stakeholders display varied characteristics in terms of interpretation of their own roles, competencies for selecting devices, awareness and use of resources for purchasing devices, and attitudes toward the purchasing process. The role of "clinical engineering" is seen by these stakeholders to be critical in mediating between training, technical, and financial stakeholders but not always recognized in practice. The findings show that many device purchasing decisions are tackled in isolation, which is not optimal for decisions requiring knowledge that is currently distributed among different people within different departments. The challenges expressed relate to the wider system of care and equipment management, calling for a more systemic view of purchasing for medical devices.
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Risk assessment of medical devices: evaluation of microbiological and toxicological safety
International Nuclear Information System (INIS)
Dorpema, J.W.
1995-01-01
Safety assessment of medical devices includes sterilization and biological evaluation or biocompatability testing. Sterilization by ETO gas is criticised for their carcinogenic potency or even banned. Mutual acceptance of biological evaluation test results is promoted by a laboratory accreditation and qualification program. (Author)
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2012-10-04
... regulations provide that FDA publish a quarterly list of available safety and effectiveness summaries of PMA...-0638] Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval... Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This...
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The Challenges of Balancing Safety and Security in Implantable Medical Devices.
Katzis, Konstantinos; Jones, Richard W; Despotou, George
2016-01-01
Modern Implantable Medical Devices (IMDs), implement capabilities that have contributed significantly to patient outcomes, as well as quality of life. The ever increasing connectivity of IMD's does raise security concerns though there are instances where implemented security measures might impact on patient safety. The paper discusses challenges of addressing both of these attributes in parallel.
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2013-03-21
... its decision. The regulations provide that FDA publish a quarterly list of available safety and..., FDA-2012-M-1183, and FDA-2012-M-1184] Medical Devices; Availability of Safety and Effectiveness.... SUMMARY: The Food and Drug Administration (FDA) is publishing a list of premarket approval applications...
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Field Safety Notes in Product Problems of Medical Devices for Use in Pulmonology.
Hannig, Jürgen; Siekmeier, Rüdiger
2015-01-01
The current European system for medical devices is governed by three EC directives: the Medical Device Directive 93/42/EEC, the In-Vitro Diagnostic Directive 98/79/EC and the Active Implantable Medical Device Directive 90/385/EEC and regulates marketing and post-market surveillance of medical devices in the European Economic Area. In cases of incidents and field safety corrective actions (FSCA) manufacturers have to inform the responsible Competent Authority, which is the Federal Institute for Drugs and Medical Devices (BfArM) and the public by field safety notices (FSN). In this study we analyzed FSN of medical devices exclusively serving for diagnostics or treatment in pulmonology (e.g. nebulizers, oxygen concentrators, pulse oximeters, lung function analyzers, and non-active devices for treatment). FSCA and FSN publicized by BfArM in 2005-2013 were analyzed in respect to the MEDDEV 2.12-1 rev 8. In total 41 FSCA were publicized for the included products. German and English FSN were found in 36/35 cases, respectively. FSN were clearly characterized as FSN in 22/20 cases and declaration of the type of action was found in 27/26 cases, respectively. Product names were provided in all cases. Lot numbers or other information for product characterization were available in 7/8 and 26/24 cases, respectively. Detailed information regarding FSCA and product malfunction were found in 27/33 and 36/35 cases, respectively. Information on product related risks with previous use of the affected product was provided in 24/23 cases. In 34/34 cases manufacturers provided information to mitigate product related risks. Requests to pass FSN to persons needing awareness were found in 10/14 cases. Contact data were provided in 30/30 cases. Confirmation that the Competent Authority was informed was found in 12/14 cases and in 19/18 cases a customer confirmation was included. The obtained data suggest that there is an increasing annual number of FSCA and most FSN fulfill the criteria of
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[Ethic review on clinical experiments of medical devices in medical institutions].
Shuai, Wanjun; Chao, Yong; Wang, Ning; Xu, Shining
2011-07-01
Clinical experiments are always used to evaluate the safety and validity of medical devices. The experiments have two types of clinical trying and testing. Ethic review must be done by the ethics committee of the medical department with the qualification of clinical research, and the approval must be made before the experiments. In order to ensure the safety and validity of clinical experiments of medical devices in medical institutions, the contents, process and approval criterions of the ethic review were analyzed and discussed.
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[Industry regulation and its relationship to the rapid marketing of medical devices].
Matsuoka, Atsuko
2012-01-01
In the market of medical devices, non-Japanese products hold a large part even in Japan. To overcome this situation, the Japanese government has been announcing policies to encourage the medical devices industry, such as the 5-year strategy for medical innovation (June 6, 2012). The Division of Medical Devices has been contributing to rapid marketing of medical devices by working out the standards for approval review and accreditation of medical devices, guidances on evaluation of medical devices with emerging technology, and test methods for biological safety evaluation of medical devices, as a part of practice in the field of regulatory science. The recent outcomes are 822 standards of accreditation for Class II medical devices, 14 guidances on safety evaluation of medical devices with emerging technology, and the revised test methods for biological safety evaluation (MHLW Notification by Director, OMDE, Yakushokuki-hatsu 0301 No. 20 "Basic Principles of Biological Safety Evaluation Required for Application for Approval to Market Medical Devices").
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Model-based engineering for medical-device software.
Ray, Arnab; Jetley, Raoul; Jones, Paul L; Zhang, Yi
2010-01-01
This paper demonstrates the benefits of adopting model-based design techniques for engineering medical device software. By using a patient-controlled analgesic (PCA) infusion pump as a candidate medical device, the authors show how using models to capture design information allows for i) fast and efficient construction of executable device prototypes ii) creation of a standard, reusable baseline software architecture for a particular device family, iii) formal verification of the design against safety requirements, and iv) creation of a safety framework that reduces verification costs for future versions of the device software. 1.
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Preventing medical device recalls
Raheja, Dev
2014-01-01
Introduction to Medical Device RequirementsIntroductionThe ChallengesSources of ErrorsUnderstanding the Science of Safety Overview of FDA Quality System Regulation Overview of Risk Management Standard ISO 14971 Overview of FDA Device Approval Process Overview of Regulatory Requirements for Clinical TrialsSummaryReferencesPreventing Recalls during Specification WritingIntroductionConduct Requirements Analysis to Identify Missing RequirementsSpecifications for Safety, Durability, and
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BIOANALYTICAL STANDARDIZING FOR SEROLOGICAL DIAGNOSTIC MEDICAL DEVICES
A. Yu. Galkin; A. G. Komar; A. A. Grigorenko
2015-01-01
In article we analyzed national and international regulations concerning the quality and safety of medical devices for in vitro diagnostics. We discussed the possibility of a partial application of the recommendations of the State Pharmacopoeia of Ukraine to this type of product. The main guiding regulatory documents establishing requirements for quality and safety tools for the serological diagnosis products are The technical regulation on medical devices for the diagnosis in vitro, DSTU ISO...
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Surgical tools and medical devices
Jackson, Mark
2016-01-01
This new edition presents information and knowledge on the field of biomedical devices and surgical tools. The authors look at the interactions between nanotechnology, nanomaterials, design, modeling, and tools for surgical and dental applications, as well as how nanostructured surfaces can be created for the purposes of improving cell adhesion between medical devices and the human body. Each original chapter is revised in this second edition and describes developments in coatings for heart valves, stents, hip and knee joints, cardiovascular devices, orthodontic applications, and regenerative materials such as bone substitutes. There are also 8 new chapters that address: Microvascular anastomoses Inhaler devices used for pulmonary delivery of medical aerosols Surface modification of interference screws Biomechanics of the mandible (a detailed case study) Safety and medical devices The synthesis of nanostructured material Delivery of anticancer molecules using carbon nanotubes Nano and micro coatings for medic...
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Practice of Regulatory Science (Development of Medical Devices).
Niimi, Shingo
2017-01-01
Prototypes of medical devices are made in accordance with the needs of clinical practice, and for systems required during the initial process of medical device development for new surgical practices. Verification of whether these prototypes produce the intended performance specifications is conducted using basic tests such as mechanical and animal tests. The prototypes are then improved and modified until satisfactory results are obtained. After a prototype passes through a clinical trial process similar to that for new drugs, application for approval is made. In the approval application process, medical devices are divided into new, improved, and generic types. Reviewers judge the validity of intended use, indications, operation procedures, and precautions, and in addition evaluate the balance between risk and benefit in terms of efficacy and safety. Other characteristics of medical devices are the need for the user to attain proficiency in usage techniques to ensure efficacy and safety, and the existence of a variety of medical devices for which assessment strategies differ, including differences in impact on the body in cases in which a physical burden to the body or failure of a medical device develops. Regulatory science of medical devices involves prediction, judgment, and evaluation of efficacy, safety, and quality, from which data result which can become indices in the development stages from design to application for approval. A reduction in the number of animals used for testing, improvement in efficiency, reduction of the necessity for clinical trials, etc. are expected through rational setting of evaluation items.
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78 FR 68714 - Medical Devices; Ophthalmic Devices; Classification of the Scleral Plug
2013-11-15
... amendments), as ``preamendments devices.'' FDA classifies these devices after the Agency takes the following.... FDA-2012-N-1238] Medical Devices; Ophthalmic Devices; Classification of the Scleral Plug AGENCY: Food... scleral plugs in order to provide a reasonable assurance of safety and effectiveness of the device. The...
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Arney, David; Goldman, Julian M.; Whitehead, Susan F.; Lee, Insup
When a x-ray image is needed during surgery, clinicians may stop the anesthesia machine ventilator while the exposure is made. If the ventilator is not restarted promptly, the patient may experience severe complications. This paper explores the interconnection of a ventilator and simulated x-ray into a prototype plug-and-play medical device system. This work assists ongoing interoperability framework development standards efforts to develop functional and non-functional requirements and illustrates the potential patient safety benefits of interoperable medical device systems by implementing a solution to a clinical use case requiring interoperability.
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Instructions included? Make safety training part of medical device procurement process.
Keller, James P
2010-04-01
Before hospitals embrace new technologies, it's important that medical personnel agree on how best to use them. Likewise, hospitals must provide the support to operate these sophisticated devices safely. With this in mind, it's wise for hospitals to include medical device training in the procurement process. Moreover, purchasing professionals can play a key role in helping to increase the amount of user training for medical devices and systems. What steps should you take to help ensure that new medical devices are implemented safely? Here are some tips.
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Medical device risk management and its economic impact
Directory of Open Access Journals (Sweden)
Katerina Krsteva Jakimovska
2013-10-01
Full Text Available The importance of medical devices in everyday users/patients lives is imensse. This is the reason why emphasis must be put on safety during their use. Satisfactory safety level can be achived by implementation of quality and risk management standards. Medical device manufacturers must learn to deal with the potential risks by using theoretical and practical examples and measures in order to protect their users/patients and themselves from suffering huge losses arising from adverse events or recall of their products. The best moment for implementation of risk management methods and analysis begins from the device design and development through manufacturing, sales and distribution. These way medical device manufacturers will succseed in protecting their users/patients from serious adverse events and at the same time protect their brand and society status, while minimizing economic losses.
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An update on mobile phones interference with medical devices.
Mahmoud Pashazadeh, Ali; Aghajani, Mahdi; Nabipour, Iraj; Assadi, Majid
2013-10-01
Mobile phones' electromagnetic interference with medical devices is an important issue for the medical safety of patients who are using life-supporting medical devices. This review mainly focuses on mobile phones' interference with implanted medical devices and with medical equipment located in critical areas of hospitals. A close look at the findings reveals that mobile phones may adversely affect the functioning of medical devices, and the specific effect and the degree of interference depend on the applied technology and the separation distance. According to the studies' findings and the authors' recommendations, besides mitigating interference, using mobile phones at a reasonable distance from medical devices and developing technology standards can lead to their effective use in hospital communication systems.
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An update on mobile phones interference with medical devices
International Nuclear Information System (INIS)
Pashazadeh, A. M.; Aghajani, M.; Nabipour, I.; Assadi, M.
2013-01-01
Mobile phones' electromagnetic interference with medical devices is an important issue for the medical safety of patients who are using life-supporting medical devices. This review mainly focuses on mobile phones' interference with implanted medical devices and with medical equipment located in critical areas of hospitals. A close look at the findings reveals that mobile phones may adversely affect the functioning of medical devices, and the specific effect and the degree of interference depend on the applied technology and the separation distance. According to the studies' findings and the authors' recommendations, besides mitigating interference, using mobile phones at a reasonable distance from medical devices and developing technology standards can lead to their effective use in hospital communication systems. (authors)
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Cybersecurity and the Medical Device Product Development Lifecycle.
Jones, Richard W; Katzis, Konstantinos
2017-01-01
Protecting connected medical devices from evolving cyber related threats, requires a continuous lifecycle approach whereby cybersecurity is integrated within the product development lifecycle and both complements and re-enforces the safety risk management processes therein. This contribution reviews the guidance relating to medical device cybersecurity within the product development lifecycle.
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Monitoring Device Safety in Interventional Cardiology
Matheny, Michael E.; Ohno-Machado, Lucila; Resnic, Frederic S.
2006-01-01
Objective: A variety of postmarketing surveillance strategies to monitor the safety of medical devices have been supported by the U.S. Food and Drug Administration, but there are few systems to automate surveillance. Our objective was to develop a system to perform real-time monitoring of safety data using a variety of process control techniques.
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Directory of Open Access Journals (Sweden)
Faunce Thomas
2006-03-01
Full Text Available Abstract • Expert evaluations of the safety, efficacy and cost-effectiveness of pharmaceutical and medical devices, prior to marketing approval or reimbursement listing, collectively represent a globally important public good. The scientific processes involved play a major role in protecting the public from product risks such as unintended or adverse events, sub-standard production and unnecessary burdens on individual and governmental healthcare budgets. • Most States now have an increasing policy interest in this area, though institutional arrangements, particularly in the area of cost-effectiveness analysis of medical devices, are not uniformly advanced and are fragile in the face of opposing multinational industry pressure to recoup investment and maintain profit margins. • This paper examines the possibility, in this context, of States commencing negotiations toward bilateral trade agreement provisions, and ultimately perhaps a multilateral Treaty, on safety, efficacy and cost-effectiveness analysis of pharmaceuticals and medical devices. Such obligations may robustly facilitate a conceptually interlinked, but endangered, global public good, without compromising the capacity of intellectual property laws to facilitate local product innovations.
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Body Implanted Medical Device Communications
Yazdandoost, Kamya Yekeh; Kohno, Ryuji
The medical care day by day and more and more is associated with and reliant upon concepts and advances of electronics and electromagnetics. Numerous medical devices are implanted in the body for medical use. Tissue implanted devices are of great interest for wireless medical applications due to the promising of different clinical usage to promote a patient independence. It can be used in hospitals, health care facilities and home to transmit patient measurement data, such as pulse and respiration rates to a nearby receiver, permitting greater patient mobility and increased comfort. As this service permits remote monitoring of several patients simultaneously it could also potentially decrease health care costs. Advancement in radio frequency communications and miniaturization of bioelectronics are supporting medical implant applications. A central component of wireless implanted device is an antenna and there are several issues to consider when designing an in-body antenna, including power consumption, size, frequency, biocompatibility and the unique RF transmission challenges posed by the human body. The radiation characteristics of such devices are important in terms of both safety and performance. The implanted antenna and human body as a medium for wireless communication are discussed over Medical Implant Communications Service (MICS) band in the frequency range of 402-405MHz.
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Analytical Chemistry in the Regulatory Science of Medical Devices.
Wang, Yi; Guan, Allan; Wickramasekara, Samanthi; Phillips, K Scott
2018-06-12
In the United States, regulatory science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all Food and Drug Administration-regulated products. Good regulatory science facilitates consumer access to innovative medical devices that are safe and effective throughout the Total Product Life Cycle (TPLC). Because the need to measure things is fundamental to the regulatory science of medical devices, analytical chemistry plays an important role, contributing to medical device technology in two ways: It can be an integral part of an innovative medical device (e.g., diagnostic devices), and it can be used to support medical device development throughout the TPLC. In this review, we focus on analytical chemistry as a tool for the regulatory science of medical devices. We highlight recent progress in companion diagnostics, medical devices on chips for preclinical testing, mass spectrometry for postmarket monitoring, and detection/characterization of bacterial biofilm to prevent infections.
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Home Healthcare Medical Devices: A Checklist
... not using it. Contact your doctor and home healthcare team often to review your health condition. * Check ... assurance of their safety and effectiveness. A home healthcare medical device is any product or equipment used ...
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Mitchell, A H; Parker, G B; Kanamori, H; Rutala, W A; Weber, D J
2017-06-01
The United States Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens Standard as amended by the Needlestick Safety and Prevention Act requiring the use of safety-engineered medical devices to prevent needlesticks and sharps injuries has been in place since 2001. Injury changes over time include differences between those from non-safety compared with safety-engineered medical devices. This research compares two US occupational incident surveillance systems to determine whether these data can be generalized to other facilities and other countries either with legislation in place or considering developing national policies for the prevention of sharps injuries among healthcare personnel. Copyright © 2017 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.
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Design of Hack-Resistant Diabetes Devices and Disclosure of Their Cyber Safety.
Sackner-Bernstein, Jonathan
2017-03-01
The focus of the medical device industry and regulatory bodies on cyber security parallels that in other industries, primarily on risk assessment and user education as well as the recognition and response to infiltration. However, transparency of the safety of marketed devices is lacking and developers are not embracing optimal design practices with new devices. Achieving cyber safe diabetes devices: To improve understanding of cyber safety by clinicians and patients, and inform decision making on use practices of medical devices requires disclosure by device manufacturers of the results of their cyber security testing. Furthermore, developers should immediately shift their design processes to deliver better cyber safety, exemplified by use of state of the art encryption, secure operating systems, and memory protections from malware.
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Assurance Cases for Medical Devices
2011-04-28
the patient, and the hospital setting. Some pumps allow the patient to control part of the injection process (e.g. to inject more painkiller ...overdose, incorrect therapy, etc. Design and development decisions that bear on safety and effectiveness http://www.fda.gov/MedicalDevices
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Regulatory Science in Practice (Pharmaceuticals and Medical Devices Agency).
Hojo, Taisuke
2017-01-01
Review, safety, and relief services of the Pharmaceuticals and Medical Devices Agency are primarily focused on scientifically evaluating pharmaceuticals, medical devices, and cellular and tissue-based products referring to their quality, efficacy, and safety, which requires a variety of scientific knowledge and methods. Pharmaceutical regulation should be established based on the most advanced scientific expertise at all times. In order to evaluate products that use cutting-edge technology such as induced pluripotent stem cells and information and communication technology adequately, since fiscal year 2012 the Science Committee has been established as a platform to exchange opinions among members from top-ranking domestic and international academia and to enhance personnel exchanges through the Initiative to Facilitate Development of Innovative Drugs. In addition, the Regulatory Science Center will be established in 2018 to increase the integrity of our services for product reviews and safety measures. In particular, requiring electronic data submissions for clinical trial applications followed by an advanced approach to analysis should not only enhance the quality of reviews of individual products but should also support the development of pharmaceuticals and medical devices by providing pharmaceutical affairs consultations on research and development strategies with various guidelines based on new insights resulting from product-bridging data analysis. Moreover, a database including electronic health records with comprehensive medical information collected mainly from 10 cooperating medical institutions will be developed with the aim of developing safety measures in a more timely manner using methods of pharmacoepidemiological analysis.
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Medical Device Plug-and-Play Interoperability Standards and Technology Leadership
2017-10-01
Award Number: W81XWH-09-1-0705 TITLE: “Medical Device Plug-and-Play Interoperability Standards and Technology Leadership” PRINCIPAL INVESTIGATOR...Sept 2016 – 20 Sept 2017 4. TITLE AND SUBTITLE “Medical Device Plug-and-Play Interoperability 5a. CONTRACT NUMBER Standards and Technology ...efficiency through interoperable medical technologies . We played a leadership role on interoperability safety standards (AAMI, AAMI/UL Joint
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BIOANALYTICAL STANDARDIZING FOR SEROLOGICAL DIAGNOSTIC MEDICAL DEVICES
Directory of Open Access Journals (Sweden)
A. Yu. Galkin
2015-04-01
Full Text Available In article we analyzed national and international regulations concerning the quality and safety of medical devices for in vitro diagnostics. We discussed the possibility of a partial application of the recommendations of the State Pharmacopoeia of Ukraine to this type of product. The main guiding regulatory documents establishing requirements for quality and safety tools for the serological diagnosis products are The technical regulation on medical devices for the diagnosis in vitro, DSTU ISO 13485 “Medical devices. Quality management system. Regulatory requirements”, and DSTU ISO/IEC 17025 “General requirements for the competence of testing and calibration laboratories”. Similar requirements of the State Pharmacopoeia of Ukraine which are used for drug standardization can not be directly applied to the medical devises for in vitro diagnostics due to a number of features, namely, the serological diagnosis products pre-designed to determine the unknown concentration of a particular analyte in a biological material, the diagnostic kits has to include the control samples (internal standard systems that need to be calibrated. It was determined following parameters of bioanalytical standardization and validation characterization for of qualitative (semi quantitative test-kits for serological diagnosis: precision (convergence, intralaboratory precision and reproducibility, diagnostic and analytical specificity, diagnostic sensitivity. It’s necessary to inspect additional parameters for quantitative test-kits such as accuracy (precision, linearity, analytical sensitivity and range.
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77 FR 32642 - Medical Devices; Exemption From Premarket Notification: Powered Patient Transport
2012-06-01
...] Medical Devices; Exemption From Premarket Notification: Powered Patient Transport AGENCY: Food and Drug... received a petition requesting exemption from the premarket notification requirements for powered patient... necessary to provide a reasonable assurance of safety and effectiveness. Under the Medical Device Amendments...
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Medical instruments and devices principles and practices
Schreiner, Steven; Peterson, Donald R
2015-01-01
Medical Instruments and Devices: Principles and Practices originates from the medical instruments and devices section of The Biomedical Engineering Handbook, Fourth Edition. Top experts in the field provide material that spans this wide field. The text examines how biopotential amplifiers help regulate the quality and content of measured signals. It includes instruments and devices that span a range of physiological systems and the physiological scale: molecular, cellular, organ, and system. The book chronicles the evolution of pacemakers and their system operation and discusses oscillometry, cardiac output measurement, and the direct and indirect methods of measuring cardiac output. The authors also expound on the mechanics and safety of defibrillators and cover implantable stimulators, respiration, and the structure and function of mechanical ventilators. In addition, this text covers in depth: Anesthesia Delivery Electrosurgical Units and Devices Biomedical Lasers Measuring Cellular Traction Forces Blood G...
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The current situation and development of medical device testing institutes in China.
Yang, Xiaofang; Mu, Ruihong; Fan, Yubo; Wang, Chunren; Li, Deyu
2017-04-01
This article analyses the current situation and development of Chinese medical device testing institutes from the perspectives of the two most important functions - testing functions and medical device standardization functions. Areas Covered: The objective of the Chinese government regulations for medical device industry is to ensure the safety and effectiveness of medical devices for Chinese patients. To support the regulation system, the Chinese government has established medical device testing institutes at different levels for example, the national, provincial, and municipal levels. These testing institutes also play an important role in technical support during medical device premarket registration and post market surveillance, they are also the vital practitioners of Chinese medical device standardization. Expert Commentary: Chinese medical device testing institutes are technical departments established by government, and serve the regulatory functions of government agency. In recent years, with the rapid development of medical device industry as well as constantly increasing international and domestic medical device market, the importance of medical device testing institute is more prominent, However, there are still some problems unsolved, such as their overall capacity remains to be improved, construction of standardization is to be strengthened, etc.
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Mobile medical device connectivity: real world solutions.
Pettus, Dan
2004-01-01
Mobile medical devices, such as infusion pumps, provide an important therapeutic function. They are also valuable sources of information about treatment patterns at the point of care. However, these mobile devices have been independent islands of valuable information, unable to share the data they gather with other hospital information resources on a real time basis. Although data from these devices can provide significant improvements for medical safety and vital information needed for clinical best practice development, gathering that data poses significant challenges when interfacing with hospital information systems. Mobile medical devices move from place to place as independent actors, raising a series of security and identification issues when they need to be disconnected and reconnected using traditional tethered cable connections. The continuing lack of accepted communications protocol standards, in spite of the concentrated efforts of organizations like the IEEE and the Medical Information Bus (IEEE 1073) to establish them, has made integration into the hospital information system a complex and non-standard task. The rapid spread in availability and adoption of high-speed 802.11 wireless systems in hospitals offers a realistic connectivity solution for mobile medical devices. Inspite of this, the 802.11 standard is still evolving, and current security methods designed for user-based products like PDAs and laptop computers are not ideal for unmanned mobile medical devices because they assume the availability of a human operator to authenticate a wireless session. In the absence of accepted standards, manufacturers have created practical and innovative solutions to support the collection of clinical data from mobile medical devices and the integration of that data with hospital information systems. This paper will explore the potential benefits of integrating mobile medical devices into the hospital information system, and describe the challenges in
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Medical devices for the anesthetist: current perspectives
Directory of Open Access Journals (Sweden)
Ingrande J
2014-03-01
Full Text Available Jerry Ingrande, Hendrikus JM LemmensDepartment of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, CA, USAAbstract: Anesthesiologists are unique among most physicians in that they routinely use technology and medical devices to carry out their daily activities. Recently, there have been significant advances in medical technology. These advances have increased the number and utility of medical devices available to the anesthesiologist. There is little doubt that these new tools have improved the practice of anesthesia. Monitoring has become more comprehensive and less invasive, airway management has become easier, and placement of central venous catheters and regional nerve blockade has become faster and safer. This review focuses on key medical devices such as cardiovascular monitors, airway equipment, neuromonitoring tools, ultrasound, and target controlled drug delivery software and hardware. This review demonstrates how advances in these areas have improved the safety and efficacy of anesthesia and facilitate its administration. When applicable, indications and contraindications to the use of these novel devices will be explored as well as the controversies surrounding their use.Keywords: catheters, echocardiography, ultrasound, fiberoptic bronchoscope, laryngeal mask airway, closed-loop anesthesia
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Jalbert, Jessica J; Ritchey, Mary Elizabeth; Mi, Xiaojuan; Chen, Chih-Ying; Hammill, Bradley G; Curtis, Lesley H; Setoguchi, Soko
2014-11-01
Medical devices play a vital role in diagnosing, treating, and preventing diseases and are an integral part of the health-care system. Many devices, including implantable medical devices, enter the market through a regulatory pathway that was not designed to assure safety and effectiveness. Several recent studies and high-profile device recalls have demonstrated the need for well-designed, valid postmarketing studies of medical devices. Medical device epidemiology is a relatively new field compared with pharmacoepidemiology, which for decades has been developed to assess the safety and effectiveness of medications. Many methodological considerations in pharmacoepidemiology apply to medical device epidemiology. Fundamental differences in mechanisms of action and use and in how exposure data are captured mean that comparative effectiveness studies of medical devices often necessitate additional and different considerations. In this paper, we discuss some of the most salient issues encountered in conducting comparative effectiveness research on implantable devices. We discuss special methodological considerations regarding the use of data sources, exposure and outcome definitions, timing of exposure, and sources of bias. © The Author 2014. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.
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The Role of Patient Safety in the Device Purchasing Process
National Research Council Canada - National Science Library
Johnson, Todd R; Zhang, Jiajie; Patel, Vimla L; Keselman, Alla; Tang, Xiaozhou; Brixey, Juliana J; Paige, Danielle; Turley, James P
2005-01-01
To examine how patient safety considerations are incorporated into medical device purchase decisions, individuals involved in recent infusion pump purchasing decisions at three different health care...
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MedWatch Safety Alerts for Human Medical Products
U.S. Department of Health & Human Services — MedWatch alerts provide timely new safety information on human drugs, medical devices, vaccines and other biologics, dietary supplements, and cosmetics. The alerts...
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Blagec, Kathrin; Jungwirth, David; Haluza, Daniela; Samwald, Matthias
2018-01-01
Medical device regulations which aim to ensure safety standards do not only apply to hardware devices but also to standalone medical software, e.g. mobile apps. To explore the effects of these regulations on the development and distribution of medical standalone software. We invited a convenience sample of 130 domain experts to participate in an online survey about the impact of current regulations on the development and distribution of medical standalone software. 21 respondents completed the questionnaire. Participants reported slight positive effects on usability, reliability, and data security of their products, whereas the ability to modify already deployed software and customization by end users were negatively impacted. The additional time and costs needed to go through the regulatory process were perceived as the greatest obstacles in developing and distributing medical software. Further research is needed to compare positive effects on software quality with negative impacts on market access and innovation. Strategies for avoiding over-regulation while still ensuring safety standards need to be devised.
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Implantable electronic medical devices
Fitzpatrick, Dennis
2014-01-01
Implantable Electronic Medical Devices provides a thorough review of the application of implantable devices, illustrating the techniques currently being used together with overviews of the latest commercially available medical devices. This book provides an overview of the design of medical devices and is a reference on existing medical devices. The book groups devices with similar functionality into distinct chapters, looking at the latest design ideas and techniques in each area, including retinal implants, glucose biosensors, cochlear implants, pacemakers, electrical stimulation t
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... Artery Disease Venous Thromboembolism Aortic Aneurysm More Implantable Medical Devices Updated:Sep 16,2016 For Rhythm Control ... a Heart Attack Introduction Medications Surgical Procedures Implantable Medical Devices • Life After a Heart Attack • Heart Attack ...
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Raths, David
2009-02-01
To get funding approved for medical device integration, ClOs suggest focusing on specific patient safety or staff efficiency pain points. Organizations that make clinical engineering part of their IT team report fewer chain-of-command issues. It also helps IT people understand the clinical goals because the engineering people have been working closely with clinicians for years. A new organization has formed to work on collaboration between clinical engineers and IT professionals. For more information, go to www.ceitcollaboration.org. ECRI Institute has written a guide to handling the convergence of medical technology and hospital networks. Its "Medical Technology for the IT Professional: An Essential Guide for Working in Today's Healthcare Setting" also details how IT professionals can assist hospital technology planning and acquisition, and provide ongoing support for IT-based medical technologies. For more information, visit www.ecri.org/ITresource.
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Bohnet-Joschko, Sabine; Zippel, Claus; Siebert, Hartmut
2015-01-01
The use and organisation of medical technology has an important role to play for patient and user safety in anaesthesia. Specification of the recommendations of the German Coalition for Patient Safety (APS) for users and operators of anaesthesia equipment, explore opportunities and challenges for the safe use and organisation of anaesthesia devices. We conducted a literature search in Medline/PubMed for studies dealing with the APS recommendations for the prevention of medical device-related risks in the context of anaesthesia. In addition, we performed an internet search for reports and recommendations focusing on the use and organisation of medical devices in anaesthesia. Identified studies were grouped and assigned to the recommendations. The division into users and operators was maintained. Instruction and training in anaesthesia machines is sometimes of minor importance. Failure to perform functional testing seems to be a common cause of critical incidents in anaesthesia. There is a potential for reporting to the federal authority. Starting points for the safe operation of anaesthetic devices can be identified, in particular, at the interface of staff, organisation, and (anaesthesia) technology. The APS recommendations provide valuable information on promoting the safe use of medical devices and organisation in anaesthesia. The focus will be on risks relating to the application as well as on principles and materials for the safe operation of anaesthesia equipment. Copyright © 2015. Published by Elsevier GmbH.
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The Biological Responses to Magnesium-Based Biodegradable Medical Devices
Directory of Open Access Journals (Sweden)
Lumei Liu
2017-11-01
Full Text Available The biocompatibility of Magnesium-based materials (MBMs is critical to the safety of biodegradable medical devices. As a promising metallic biomaterial for medical devices, the issue of greatest concern is devices’ safety as degrading products are possibly interacting with local tissue during complete degradation. The aim of this review is to summarize the biological responses to MBMs at the cellular/molecular level, including cell adhesion, transportation signaling, immune response, and tissue growth during the complex degradation process. We review the influence of MBMs on gene/protein biosynthesis and expression at the site of implantation, as well as throughout the body. This paper provides a systematic review of the cellular/molecular behavior of local tissue on the response to Mg degradation, which may facilitate a better prediction of long-term degradation and the safe use of magnesium-based implants through metal innovation.
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Risk evaluation of medical and industrial radiation devices
International Nuclear Information System (INIS)
Jones, E.D.; Cunningham, R.E.; Rathbun, P.A.
1994-03-01
In 1991, the NRC, Division of Industrial and Medical Nuclear Safety, began a program to evaluate the use of probabilistic risk assessment (PRA) in regulating medical devices. This program represents an initial step in an overall plant to evaluate the use of PRA in regulating the use of nuclear by-product materials. The NRC envisioned that the use of risk analysis techniques could assist staff in ensuring that the regulatory approach was standardized, understandable, and effective. Traditional methods of assessing risk in nuclear power plants may be inappropriate to use in assessing the use of by-product devices. The approaches used in assessing nuclear reactor risks are equipment-oriented. Secondary attention is paid to the human component, for the most part after critical system failure events have been identified. This paper describes the risk methodology developed by Lawrence Livermore National Laboratory (LLNL), initially intended to assess risks associated with the use of the Gamma Knife, a gamma stereotactic radiosurgical device. For relatively new medical devices such as the Gamma Knife, the challenge is to perform a risk analysis with very little quantitative data but with an important human factor component. The method described below provides a basic approach for identifying the most likely risk contributors and evaluating their relative importance. The risk analysis approach developed for the Gamma Knife and described in this paper should be applicable to a broader class of devices in which the human interaction with the device is a prominent factor. In this sense, the method could be a prototypical model of nuclear medical or industrial device risk analysis
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New IEEE 11073 Standards for interoperable, networked Point-of-Care Medical Devices.
Kasparick, Martin; Schlichting, Stefan; Golatowski, Frank; Timmermann, Dirk
2015-08-01
Surgical procedures become more and more complex and the number of medical devices in an operating room (OR) increases continuously. Today's vendor-dependent solutions for integrated ORs are not able to handle this complexity. They can only form isolated solutions. Furthermore, high costs are a result of vendor-dependent approaches. Thus we present a service-oriented device communication for distributed medical systems that enables the integration and interconnection between medical devices among each other and to (medical) information systems, including plug-and-play functionality. This system will improve patient's safety by making technical complexity of a comprehensive integration manageable. It will be available as open standards that are part of the IEEE 11073 family of standards. The solution consists of a service-oriented communication technology, the so called Medical Devices Profile for Web Services (MDPWS), a Domain Information & Service Model, and a binding between the first two mechanisms. A proof of this concept has been done with demonstrators of real world OR devices.
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International Nuclear Information System (INIS)
Murakami, Kiyonobu; Kurosaki, Akira.
1988-01-01
Purpose: To rapidly insert safety rods for a criticality experiment device into a reactor core container to stop the criticality reaction thereby prevent reactivity accidents. Constitution: A cylinder device having a safety rod as a cylinder rod attached with a piston at one end is constituted. The piston is elevated by pressurized air and attracted and fixed by an electromagnet which is a stationary device disposed at the upper portion of the cylinder. If the current supply to the electromagnet is disconnected, the safety rod constituting the cylinder rod is fallen together with the piston to the lower portion of the cylinder. Since the cylinder rod driving device has neither electrical motor nor driving screw as in the conventional device, necessary space can be reduced and the weight is decreased. In addition, since the inside of the nuclear reactor can easily be shielded completely from the external atmosphere, leakage of radioactive materials can be prevented. (Horiuchi, T.)
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Safety of mechanical devices. Safety of automation systems
International Nuclear Information System (INIS)
Pahl, G.; Schweizer, G.; Kapp, K.
1985-01-01
The paper deals with the classic procedures of safety engineering in the sectors mechanical engineering, electrical and energy engineering, construction and transport, medicine technology and process technology. Particular stress is laid on the safety of automation systems, control technology, protection of mechanical devices, reactor safety, mechanical constructions, transport systems, railway signalling devices, road traffic and protection at work in chemical plans. (DG) [de
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Drugs and Medical Devices: Adverse Events and the Impact on Women's Health.
Carey, Jennifer L; Nader, Nathalie; Chai, Peter R; Carreiro, Stephanie; Griswold, Matthew K; Boyle, Katherine L
2017-01-01
A large number of medications and medical devices removed from the market by the US Food and Drug Administration over the past 4 decades specifically posed greater health risks to women. This article reviews the historical background of sex and gender in clinical research policy and describes several approved drugs and devices targeted for use in women that have caused major morbidity and mortality. The intended population for the medications and devices, population affected, approval process, and the basic and legal actions taken against the medication/drug company are also discussed. It is recognized that women are still at risk for harm from unsafe medications and devices, and continued improvements in legislation that promotes inclusion of sex and gender into the design and analysis of research will improve safety for both men and women. Copyright © 2017 Elsevier HS Journals, Inc. All rights reserved.
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Safety lock for radiography exposure device
International Nuclear Information System (INIS)
Gaines, T.M.
1982-01-01
A safety lock for securing a radiation source in a radiography exposure device is disclosed. The safety lock prevents the inadvertent extension of the radiation source from the exposure device. The exposure devices are used extensively in industry for nondestructive testing of metal materials for defect. Unnecessary exposure of the radiographer or operator occurs not infrequently due to operator's error in believing that the radiation source is secured in the exposure device when, in fact, it is not. The present invention solves this problem of unnecessary exposure by releasingly trapping the radiation source in the shield of the radiography exposure device each time the source is retracted therein so that it is not inadvertently extended therefrom without the operator resetting the safety lock, thereby releasing the radiation source. Further, the safety lock includes an indicator which indicates when the source is trapped in the exposure device and also when it is untrapped. The safety lock is so designed that it does not prevent the return of the source to the trapped, shielded position in the exposure device. Further the safety lock includes a key means for locking the radiation source in the trapped position. The key means cannot be actuated until said radiation source is in said trapped position to further insure the safety lock cannot be inadvertently locked with the source untrapped and thus still extendable from the exposure device
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How can cardiothoracic and vascular medical devices stay in the market?
Wong, Kathie A; Hodgson, Luke; Garas, George; Malietzis, George; Markar, Sheraz; Rao, Christopher; von Segesser, Ludwig K; Athanasiou, Thanos
2016-12-01
Surgeons, as the consumers, must engage in commercial activity regarding medical devices since it directly has impacts on surgical practice and patient outcomes. Unique features defy traditional economic convention in this specific market partly because consumers do not usually pay directly. Greater involvement with commercial activity means better post-market surveillance of medical devices which leads to improved patient safety. The medical device industry has exhibited astonishing levels of growth and profitability reaching $398 billion on a global scale with new product development focusing on unmet clinical need. The industry has rapidly emerged within the context of an ageing population and a global surge in healthcare spending. But the market remains fragmented. The split of consumer, purchaser and payer leads to clinical need driving demand for new product development. This demand contributes to potentially large profit margins mainly contained by regulatory burden and liability issues. Demographic trends, prevalence of diseases and a huge capacity to absorb technology have sustained near unparalleled growth. To stay in the market, incremental development over the short term is essentially aided by responsiveness to demand. Disruptive product development is now more likely to come from multinational companies, in an increasingly expensive, regulated industry. Understanding healthcare organization can help explain the highly complex process of diffusion of innovations in healthcare that include medical devices. The time has come for surgeons to become actively involved with all aspects of the medical device life cycle including commercial activity and post-market surveillance. This is vital for improving patient care and ensuring patient safety. © The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.
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Class 1 devices case studies in medical devices design
Ogrodnik, Peter J
2014-01-01
The Case Studies in Medical Devices Design series consists of practical, applied case studies relating to medical device design in industry. These titles complement Ogrodnik's Medical Device Design and will assist engineers with applying the theory in practice. The case studies presented directly relate to Class I, Class IIa, Class IIb and Class III medical devices. Designers and companies who wish to extend their knowledge in a specific discipline related to their respective class of operation will find any or all of these titles a great addition to their library. Class 1 Devices is a companion text to Medical Devices Design: Innovation from Concept to Market. The intention of this book, and its sister books in the series, is to support the concepts presented in Medical Devices Design through case studies. In the context of this book the case studies consider Class I (EU) and 510(k) exempt (FDA) . This book covers classifications, the conceptual and embodiment phase, plus design from idea to PDS. These title...
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2013-06-12
... summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2013-M-0036... Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY...
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2011-06-02
... summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2011-M-0034... Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY...
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2011-06-15
... control by other users with a similar medical device. Exposure to non-ionizing radiation Wireless... relating to EMC and wireless technology and human exposure to non-ionizing radiation. Therefore, on March... electro magnetic compatibility (EMC) and safety of exposure to non-ionizing radiation; (2) Design...
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Case outsourcing medical device reprocessing.
Haley, Deborah
2004-04-01
IN THE INTEREST OF SAVING MONEY, many hospitals are considering extending the life of some single-use medical devices by using medical device reprocessing programs. FACILITIES OFTEN LACK the resources required to meet the US Food and Drug Administration's tough quality assurance standards. BY OUTSOURCING, hospitals can reap the benefits of medical device reprocessing without assuming additional staffing and compliance burdens. OUTSOURCING enables hospitals to implement a medical device reprocessing program quickly, with no capital investment and minimal effort.
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Reed, Terrie L; Drozda, Joseph P; Baskin, Kevin M; Tcheng, James; Conway, Karen; Wilson, Natalia; Marinac-Dabic, Danica; Heise, Theodore; Krucoff, Mitchell W
2017-12-01
The Medical Device Epidemiology Network (MDEpiNet) is a public private partnership (PPP) that provides a platform for collaboration on medical device evaluation and depth of expertise for supporting pilots to capture, exchange and use device information for improving device safety and protecting public health. The MDEpiNet SMART Think Tank, held in February, 2013, sought to engage expert stakeholders who were committed to improving the capture of device data, including Unique Device Identification (UDI), in key electronic health information. Prior to the Think Tank there was limited collaboration among stakeholders beyond a few single health care organizations engaged in electronic capture and exchange of device data. The Think Tank resulted in what has become two sustainable multi-stakeholder device data capture initiatives, BUILD and VANGUARD. These initiatives continue to mature within the MDEpiNet PPP structure and are well aligned with the goals outlined in recent FDA-initiated National Medical Device Planning Board and Medical Device Registry Task Force white papers as well as the vision for the National Evaluation System for health Technology.%. Published by Elsevier Inc.
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Medical device-related pressure ulcers
Directory of Open Access Journals (Sweden)
Black JM
2016-08-01
Full Text Available Joyce M Black,1 Peggy Kalowes2 1Adult Health and Illness Department, College of Nursing, University of Nebraska Medical Center, Omaha, NE, 2Nursing Research and Innovation, Long Beach Memorial Miller Children’s & Women’s Hospital, Long Beach, CA, USA Abstract: Pressure ulcers from medical devices are common and can cause significant morbidity in patients of all ages. These pressure ulcers appear in the shape of the device and are most often found from the use of oxygen delivery devices. A hospital program designed to reduce the number of pressure ulcers from medical devices was successful. The program involved the development of a team that focused on skin, the results were then published for the staff to track their performance, and it was found that using foam dressings helped reduce the pressure from the device. The incidence of ulcers from medical devices has remained at zero at this hospital since this program was implemented. Keywords: pressure ulcer, medical device related
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Human Factors and Medical Devices
International Nuclear Information System (INIS)
Dick Sawyer
1998-01-01
Medical device hardware- and software-driven user interfaces should be designed to minimize the likelihood of use-related errors and their consequences. The role of design-induced errors in medical device incidents is attracting widespread attention. The U.S. Food and Drug Administration (FDA) is fully cognizant that human factors engineering is critical to the design of safe medical devices, and user interface design is receiving substantial attention by the agency. Companies are paying more attention to the impact of device design, including user instructions, upon the performance of those health professionals and lay users who operate medical devices. Concurrently, the FDA is monitoring human factors issues in its site inspections, premarket device approvals, and postmarket incident evaluations. Overall, the outlook for improved designs and safer device operation is bright
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Campaign to gather medical devices containing radium: results
International Nuclear Information System (INIS)
Pierre, J.P.; Vidal, J.P.; Martin, J.C.; Pasquier, J.L.
2002-01-01
Campaign to gather medical devices containing radium: results. On December 1, 1999, at the request of the French Health Ministry, OPRI and ANDRA launched a campaign to gather medical devices containing radium, formerly used in brachytherapy. This campaign addressed a public health issue because of the risks actually involved in a careless handling of these objects. Moreover the growing number of reported scattered radium medical devices in the last few years reinforced the necessity of the campaign. The gathering was initiated by a call of the owners (hospitals, caring centers, retired doctors or their heirs) to a toll free number. OPRI or ANDRA then appreciated the situation urgency. Priority was given to private people because most of them did not have suitable storage facilities. OPRI teams operated according a strict protocol guaranteeing their own safety, proper procedures and compliance with transport regulations for radioactive materials. 517 objects amounting to an activity of 1.32 x 10 11 Bq have been gathered in 90 operations. Properly packaged they were transported to and safely stored at the CEA Saclay site before their permanent storage in the ANDRA facilities. (author)
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[Medical Devices Law for pain therapists].
Regner, M; Sabatowski, R
2016-08-01
Medical Devices Law is a relatively new legal system, which has replaced the Medical Devices Regulations still well-known in Germany. German Medical Devices Law is based on European directives, which are, in turn, incorporated into national law by the Medical Devices Act. The Medical Devices Act is a framework law and covers a number of regulations that address specific topics within Medical Devices Law. In turn, in individual regulations, reference is made to guidelines, recommendations, etc. from other sources that provide detailed technical information on specific topics. Medical Devices Law is a very complex legal system, which needs to be permanently observed due to constant updating and adjustment. In the current article, the design and the structure of the system will be described, but special emphasis will be laid on important problem areas that need to be considered when applying and operating medical products, in this case by pain therapists in particular.
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[Regulatory Program for Medical Devices in Cuba: experiences and current challenges].
Pereira, Dulce María Martínez; Rodríguez, Yadira Álvarez; Valdés, Yamila Cedeño; Ribas, Silvia Delgado
2016-05-01
Regulatory control of medical devices in Cuba is conducted through a system based on the Regulatory Program for Medical Devices as a way to ensure the safety, efficacy, and effectiveness of these technologies, which are in use by the National Health System. This program was launched in 1992, when the Regulations for State Evaluation and Registration of Medical Devices were approved. Its successive stages and the merging of regulatory activities for drugs and medical equipment have meant progress toward stronger, more transparent strategies and greater control of industry and the National Health System. Throughout its course the Cuban program has met with challenges and difficulties that it has addressed by drawing on its own experiences. During the new period, the greatest challenges revolve around ensuring that regulatory systems incorporate scientific evaluation, risk levels, maximum rigor through the use of technical standards, and the implementation of international recommendations, together with the application of the ISO 13485 certification scheme, enhanced market monitoring, and classification of medical devices in accordance with their relevance to the country's national health policies. From the regional standpoint, the greatest challenge lies in working toward regulatory convergence. The Collaborating Centre for the Regulation of Health Technologies will support the proposed regulatory strategy and established regional priorities, in particular in connection with the implementation of actions involving medical devices.
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Medical Device Plug-and-Play Interoperability Standards and Technology Leadership
2016-10-01
death,” The Boston Globe, April 3 2010. 27. Arney D, Pajic M, Goldman JM, Lee I, Mangharam R, Sokolsky O, “Toward Patient Safety in Closed - Loop Medical ...becoming increasingly clear. We have been providing medical device interoperability domain expertise to assist the Veterans Administration in a...15. Wallroth C, Goldman J, Manigel J, Osborn D, Roellike T, Weininger S, Westenskow D, “Development of a Standard for Physiologic Closed Loop
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Safety and effectiveness considerations for clinical studies of visual prosthetic devices
Cohen, Ethan D.
2007-03-01
With the advent of new designs of visual prostheses for the blind, FDA is faced with developing guidance for evaluating their engineering, safety and patient performance. Visual prostheses are considered significant risk medical devices, and their use in human clinical trials must be approved by FDA under an investigation device exemption (IDE). This paper contains a series of test topics and design issues that sponsors should consider in order to assess the safety and efficacy of their device. The IDE application includes a series of pre-clinical and clinical data sections. The pre-clinical section documents laboratory, animal and bench top performance tests of visual prostheses safety and reliability to support a human clinical trial. The materials used in constructing the implant should be biocompatible, sterile, corrosion resistant, and able to withstand any forces exerted on it during normal patient use. The clinical data section is composed of items related to patient-related evaluation of device performance. This section documents the implantation procedure, trial design, statistical analysis and how visual performance is assessed. Similar to cochlear implants, a visual prosthesis is expected to last in the body for many years, and good pre-clinical and clinical testing will help ensure its safety, durability and effectiveness.
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Radiation as a microbiological contamination control of drugs, cosmetics and medical devices
International Nuclear Information System (INIS)
Ishizeki, Chuichi
1985-01-01
This paper deals with current status of radiation sterilization or disinfection of drugs, cosmetics, their materials, and medical devices, and with quality control as a tool for securing microbiological safety, especially current status of sterilization tests. Ointment containing tetracyclin, steroid hormones, gelatin, and enzymes are presented as drug samples to be irradiated, and explanations for radiation sterilization of these drugs are provided. An outline of the application of radiation in cosmetics and medical devices is given. Issues are also provided from the viewpoint of safey and effectiveness of radiation sterilization. (Namekawa, K.)
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Ronquillo, Jay G; Zuckerman, Diana M
2017-09-01
Policy Points: Medical software has become an increasingly critical component of health care, yet the regulation of these devices is inconsistent and controversial. No studies of medical devices and software assess the impact on patient safety of the FDA's current regulatory safeguards and new legislative changes to those standards. Our analysis quantifies the impact of software problems in regulated medical devices and indicates that current regulations are necessary but not sufficient for ensuring patient safety by identifying and eliminating dangerous defects in software currently on the market. New legislative changes will further deregulate health IT, reducing safeguards that facilitate the reporting and timely recall of flawed medical software that could harm patients. Medical software has become an increasingly critical component of health care, yet the regulatory landscape for digital health is inconsistent and controversial. To understand which policies might best protect patients, we examined the impact of the US Food and Drug Administration's (FDA's) regulatory safeguards on software-related technologies in recent years and the implications for newly passed legislative changes in regulatory policy. Using FDA databases, we identified all medical devices that were recalled from 2011 through 2015 primarily because of software defects. We counted all software-related recalls for each FDA risk category and evaluated each high-risk and moderate-risk recall of electronic medical records to determine the manufacturer, device classification, submission type, number of units, and product details. A total of 627 software devices (1.4 million units) were subject to recalls, with 12 of these devices (190,596 units) subject to the highest-risk recalls. Eleven of the devices recalled as high risk had entered the market through the FDA review process that does not require evidence of safety or effectiveness, and one device was completely exempt from regulatory review
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Vincent, Christopher James; Li, Yunqiu; Blandford, Ann
2014-05-01
Manufacturers of interactive medical devices, such as infusion pumps, need to ensure that devices minimise the risk of unintended harm during use. However, development teams face challenges in incorporating Human Factors. The aim of the research reported here was to better understand the constraints under which medical device design and development take place. We report the results of a qualitative study based on 19 semi-structured interviews with professionals involved in the design, development and deployment of interactive medical devices. A thematic analysis was conducted. Multiple barriers to designing for safety and usability were identified. In particular, we identified barriers to communication both between the development organisation and the intended users and between different teams within the development organisation. We propose the use of mediating representations. Artefacts such as personas and scenarios, known to provide integration across multiple perspectives, are an essential component of designing for safety and usability. Copyright © 2013 Elsevier Ltd and The Ergonomics Society. All rights reserved.
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Permitting product liability litigation for FDA-approved drugs and devices promotes patient safety.
Kesselheim, A S
2010-06-01
In 2008 and 2009, the Supreme Court reviewed the question of whether patients injured by dangerous prescription drugs or medical devices can bring tort lawsuits against pharmaceutical and device manufacturers. The Court ruled that claims against device manufacturers were preempted while claims against pharmaceutical manufacturers were not. The threat of product liability lawsuits promotes patient safety by encouraging manufacturers to take greater responsibility in providing clear warnings about known adverse effects of their products.
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Advancing medication infusion safety through the clinical integration of technology.
Gerhart, Donald; O'Shea, Kristen; Muller, Sharon
2013-01-01
Adverse drug events resulting from errors in prescribing or administering medications are preventable. Within a hospital system, numerous technologies are employed to address the common sources of medication error, including the use of electronic medical records, physician order entry, smart infusion pumps, and barcode medication administration systems. Infusion safety is inherently risky because of the high-risk medications administered and the lack of integration among the stand-alone systems in most institutions. Intravenous clinical integration (IVCI) is a technology that connects electronic medical records, physician order entry, smart infusion pumps, and barcode medication administration systems. It combines the safety features of an automatically programmed infusion pump (drug, concentration, infusion rate, and patient weight, all auto-programmed into the device) with software that provides visibility to real-time clinical infusion data. Our article describes the characteristics of IVCI at WellSpan Health and its impact on patient safety. The integrated infusion system has the capability of reducing medication errors, improving patient care, reducing in-facility costs, and supporting asset management. It can enhance continuous quality improvement efforts and efficiency of clinical work flow. After implementing IVCI, the institution realized a safer patient environment and a more streamlined work flow for pharmacy and nursing.
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Medical device software: defining key terms.
Pashkov, Vitalii; Gutorova, Nataliya; Harkusha, Andrii
one of the areas of significant growth in medical devices has been the role of software - as an integral component of a medical device, as a standalone device and more recently as applications on mobile devices. The risk related to a malfunction of the standalone software used within healthcare is in itself not a criterion for its qualification or not as a medical device. It is therefore, necessary to clarify some criteria for the qualification of stand-alone software as medical devices Materials and methods: Ukrainian, European Union, United States of America legislation, Guidelines developed by European Commission and Food and Drug Administration's, recommendations represented by international voluntary group and scientific works. This article is based on dialectical, comparative, analytic, synthetic and comprehensive research methods. the legal regulation of software which is used for medical purpose in Ukraine limited to one definition. In European Union and United States of America were developed and applying special guidelines that help developers, manufactures and end users to difference software on types standing on medical purpose criteria. Software becomes more and more incorporated into medical devices. Developers and manufacturers may not have initially appreciated potential risks to patients and users such situation could have dangerous results for patients or users. It is necessary to develop and adopt the legislation that will intend to define the criteria for the qualification of medical device software and the application of the classification criteria to such software, provide some illustrative examples and step by step recommendations to qualify software as medical device.
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[Implementation of safety devices: biological accident prevention].
Catalán Gómez, M Teresa; Sol Vidiella, Josep; Castellà Castellà, Manel; Castells Bo, Carolina; Losada Pla, Nuria; Espuny, Javier Lluís
2010-04-01
Accidental exposures to blood and biological material were the most frequent and potentially serious accidents in healthcare workers, reported in the Prevention of Occupational Risks Unit within 2002. Evaluate the biological percutaneous accidents decrease after a progressive introduction of safety devices. Biological accidents produced between 2.002 and 2.006 were analyzed and reported by the injured healthcare workers to the Level 2b Hospital Prevention of Occupational Risk Unit with 238 beds and 750 employees. The key of the study was the safety devices (peripheral i.v. catheter, needleless i.v. access device and capillary blood collection lancet). Within 2002, 54 percutaneous biological accidents were registered and 19 in 2006, that represents a 64.8% decreased. There has been no safety devices accident reported involving these material. Accidents registered during the implantation period occurred because safety devices were not used at that time. Safety devices have proven to be effective in reducing needle stick percutaneous accidents, so that they are a good choice in the primary prevention of biological accidents contact.
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Mehta, Rashi I; Mehta, Rupal I
2018-03-19
Hydrophilic polymers are ubiquitously applied as surface coatings on catheters and intravascular medical technologies. Recent clinical literature has heightened awareness on the complication of hydrophilic polymer embolism, the phenomenon wherein polymer coating layers separate from catheter and device surfaces, and may be affiliated with a range of unanticipated adverse reactions. Significant system barriers have limited and delayed reporting on this iatrogenic complication, the full effects of which remain underrecognized by healthcare providers and manufacturers of various branded devices. In 2015, the United States Food and Drug Administration acknowledged rising clinical concerns and stated that the agency would work with stakeholders to further evaluate gaps that exist in current national and international device standards for coated intravascular medical technologies. The present article reviews current knowledge on this complication as well as factors that played a role in delaying detection and dissemination of information and new knowledge once hazards and clinical risks were identified. Furthermore, organ-specific effects and adverse reaction patterns are summarized, along with implications for device manufacturing, safety assurance, and regulation. Qualitative and quantitative particulate testing are needed to optimize coated intravascular device technologies. Moreover, general enhanced processes for medical device surveillance are required for timely adverse event management and to ensure patient safety.
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Medical devices regulations, standards and practices
Ramakrishna, Seeram; Wang, Charlene
2015-01-01
Medical Devices and Regulations: Standards and Practices will shed light on the importance of regulations and standards among all stakeholders, bioengineering designers, biomaterial scientists and researchers to enable development of future medical devices. Based on the authors' practical experience, this book provides a concise, practical guide on key issues and processes in developing new medical devices to meet international regulatory requirements and standards. Provides readers with a global perspective on medical device regulationsConcise and comprehensive information on how to desig
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21 CFR 892.2040 - Medical image hardcopy device.
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical image hardcopy device. 892.2040 Section... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device. (a) Identification. A medical image hardcopy device is a device that produces a visible printed record of a medical...
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[Consideration of Mobile Medical Device Regulation].
Peng, Liang; Yang, Pengfei; He, Weigang
2015-07-01
The regulation of mobile medical devices is one of the hot topics in the industry now. The definition, regulation scope and requirements, potential risks of mobile medical devices were analyzed and discussed based on mobile computing techniques and the FDA guidance of mobile medical applications. The regulation work of mobile medical devices in China needs to adopt the risk-based method.
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Cybersecurity vulnerabilities in medical devices: a complex environment and multifaceted problem
Directory of Open Access Journals (Sweden)
Williams PAH
2015-07-01
Full Text Available Patricia AH Williams, Andrew J Woodward eHealth Research Group and Security Research Institute, Edith Cowan University, Perth, WA, Australia Abstract: The increased connectivity to existing computer networks has exposed medical devices to cybersecurity vulnerabilities from which they were previously shielded. For the prevention of cybersecurity incidents, it is important to recognize the complexity of the operational environment as well as to catalog the technical vulnerabilities. Cybersecurity protection is not just a technical issue; it is a richer and more intricate problem to solve. A review of the factors that contribute to such a potentially insecure environment, together with the identification of the vulnerabilities, is important for understanding why these vulnerabilities persist and what the solution space should look like. This multifaceted problem must be viewed from a systemic perspective if adequate protection is to be put in place and patient safety concerns addressed. This requires technical controls, governance, resilience measures, consolidated reporting, context expertise, regulation, and standards. It is evident that a coordinated, proactive approach to address this complex challenge is essential. In the interim, patient safety is under threat. Keywords: cybersecurity, security, safety, wireless, risk, medical devices
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Panescu, Dorin
2009-01-01
The development of a successful medical product requires not only engineering design efforts, but also clinical, regulatory, marketing and business expertise. This paper reviews items related to the process of designing medical devices. It discusses the steps required to take a medical product idea from concept, through development, verification and validation, regulatory approvals and market release.
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Regulation E 69-14. Monitoring requirements for medical devices
International Nuclear Information System (INIS)
2015-01-01
In the 'Regulations for the State Evaluation and Registration of Medical Equipment' force (Hereinafter Rules) set forth in Chapter VII, Articles 79 and 86, the monitoring activity as one of the programs necessary for evaluating the safety and effectiveness of medical monitoring equipment. In the years 2008 and 2011 were approved and implemented by the Center for State Control of Medical Equipment (CCEEM) Regulations and -1.1 ER and ER-1 that support and regulatory requirements 'Control and monitoring of pacemakers and implantable defibrillators' and 'Assessment, recording and control after market surgical silicone implants,' which are specific to these products and have provided a useful result for the performance of the activity. Given the number and diversity of high-risk medical devices as implantable or sustain human life that are brought into our National Health System (SNS), a regulation establishing control over the behavior becomes necessary safety and effectiveness of this equipment during use, which provide inputs to risk management. The objective of this regulation is to establish the regulatory requirements for tracking medical equipment introduced in the NHS. The provisions of this Regulation is aimed at health institutions, to CECMED as manufacturers, suppliers, distributors and importers of medical equipment.
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30 CFR 250.511 - Traveling-block safety device.
2010-07-01
... 30 Mineral Resources 2 2010-07-01 2010-07-01 false Traveling-block safety device. 250.511 Section... Traveling-block safety device. All units being used for well-completion operations that have both a traveling block and a crown block must be equipped with a safety device that is designed to prevent the...
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Medical social consequences of the safety problems of oncological radiology
International Nuclear Information System (INIS)
Pilipenko, M.Yi.; Stadnik, L.L.; Shal'opa, O.Yu.; Rigan, M.M.; Skalets'kij, Yu.M.
2015-01-01
Actuality of the problem of patient safety in oncoradiology in Ukraine is grounded. The results of international audit TLD (IAEA/WHO) quality during dosimetry procedures cobalt-telegamma vehicles in Ukraine are investigated, as well as legal and regulatory framework providing for the safety of radiotherapy care, scientific publications on patient safety. Methods: statistical, analytical, bibliographical, systematic approach. On the example of radiation therapy using the results of the international program of the IAEA/WHO TLD audit quality dosimetry calibration devices for remote gamma therapy in Ukraine from 1998 to 2014 the attempt to assess the extent of medical and social consequences of underestimating of medical errors in oncoradiology is made. The problems of regulatory nature of medical errors in oncoradiology are preliminary identified. The problem of medical errors in the treatment of cancer radiation methods in Ukraine is extremely important. Usually the problems of errors in oncoradiology are considered in organizational, technical, personnel and technical aspects, while medical and social consequences of problem are not covered. About 10 thousand of cancer patients in year may suffer from errors related only to dose calculation according to the optimistic variant, while the number of patients for the same period on the pessimistic case can reach 15 thousand. There are a number of legal character problems in oncoradiology related to patient safety that require clarification. The first priority for improving the safety of patients in oncoradiology is the recording and analysis of radiation therapy defects and their consequences
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2013-01-07
..., FDA- 2012-M-0965, FDA-2012-M-0968, FDA-2012-M-1011, and FDA-2012-M-1013] Medical Devices; Availability.... Glucose Monitoring System (TGMS). P000008/S017, FDA-2012-M-1013.. Allergan, Inc..... LAP-BAND \\TM\\ February 16, 2011. Adjustable Gastric Banding System. P100049, FDA-2012-M-0893....... Torax Medical, Inc...
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30 CFR 250.611 - Traveling-block safety device.
2010-07-01
... 30 Mineral Resources 2 2010-07-01 2010-07-01 false Traveling-block safety device. 250.611 Section... Traveling-block safety device. After May 31, 1989, all units being used for well-workover operations which have both a traveling block and a crown block shall be equipped with a safety device which is designed...
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International Nuclear Information System (INIS)
2010-01-01
As some dysfunctions and events had been reported in 2007 and 2008 in field of radiotherapy, this report aims at clarifying the articulation between the different European regulations concerning medical devices emitting ionizing radiations and radiation protection. The authors report a survey with device manufacturers, and analyze the content of the different regulations and recommendations. Then, the authors recommend and propose a set of actions related to the IAEA requirements and recommendations, to CE marking requirements, and to new radiation protection and safety requirements present in the Euratom directive
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International Standards for Radiation Sterilization of Medical Devices
International Nuclear Information System (INIS)
Miller, A.
2007-01-01
For a terminally sterilized medical device to be designated '' STERILE '', probability of finding the viable micro-organisms in the device shall be equal to or less than 1 x 10 -6 (EN 556-1:2001: Sterilization of medical devices - Requirements for medical devices to be designated '' STERILE '' - Part 1: Requirements for terminally sterilized medical devices). Author presents the main legal aspects of the international standards for radiation sterilization of medical devices
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Halo and spillover effect illustrations for selected beneficial medical devices and drugs
Directory of Open Access Journals (Sweden)
Brent D. Kerger
2016-09-01
Full Text Available Abstract Background Negative news media reports regarding potential health hazards of implanted medical devices and pharmaceuticals can lead to a ‘negative halo effect,’ a phenomenon whereby judgments about a product or product type can be unconsciously altered even though the scientific support is tenuous. To determine how a ‘negative halo effect’ may impact the rates of use and/or explantation of medical products, we analyzed the occurrence of such an effect on three implanted medical devices and one drug: 1 intrauterine contraceptive devices (IUDs; 2 silicone gel-filled breast implants (SGBI; 3 metal-on-metal hip implants (MoM; and 4 the drug Tysabri. Methods Data on IUD use from 1965 to 2008 were gathered from the Department of Health and Human Services Vital and Health Statistics and peer-reviewed publications. Data regarding SGBI implant and explantation rates from 1989 to 2012 were obtained from the Institute of Medicine and the American Society of Plastic Surgeons. MoM implant and explantation data were extracted from the England and Wales National Joint Registry and peer-reviewed publications. Tysabri patient data were reported by Elan Corporation or Biogen Idec Inc. Data trends for all products were compared with historical recall or withdrawal events and discussed in the context of public perceptions following such events. Results We found that common factors altered public risk perceptions and patterns of continued use. First, a negative halo effect may be driven by continuing patient anxiety despite positive clinical outcomes. Second, negative reports about one product can spill over to affect the use of dissimilar products in the same category. Third, a negative halo effect on an entire category of medical devices can be sustained regardless of the scientific findings pertaining to safety. Fourth, recovery of a product’s safety reputation and prevalent use may take decades in the U.S., even while these products may
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Safety device for nuclear reactor
International Nuclear Information System (INIS)
Jacquelin, Roland.
1977-01-01
This invention relates to a safety device for a nuclear reactor, particularly a liquid metal (generally sodium) cooled fast reactor. This safety device includes an absorbing element with a support head connected by a disconnectable connector formed by the armature of an electromagnet at the end of an axially mobile vertical control rod. This connection is so designed that in the event of it becoming disconnected, the absorbing element gravity slides in a passage through the reactor core into an open container [fr
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Zippel, Claus; Bohnet-Joschko, Sabine
2017-08-01
Medical devices play a central role in the diagnosis and treatment of diseases but also bring the potential for adverse events, hazards or malfunction with serious consequences for patients and users. Medical device manufacturers are therefore required by law to monitor the performance of medical devices that have been approved by the competent authorities (post market surveillance). Conducting a nationwide online-survey in the German medical device sector in Q2/2014 in order to explore the current status of the use of post market instruments we obtained a total of 118 complete data sets, for a return rate of 36%. The survey included manufacturers of different sizes, producing medical devices of all risk classes. The post market instruments most frequently reported covered the fields of production monitoring and quality management as well as literature observation, regulatory vigilance systems, customer knowledge management and market observation while Post Market Clinical Follow-up and health services research were being used less for product monitoring. We found significant differences between the different risk classes of medical devices produced and the intensity of use of post market instruments. Differences between company size and the intensity of instruments used were hardly detected. Results may well contribute to the development of device monitoring which is a crucial element of the policy and regulatory system to identify device-related safety issues. Copyright © 2017 Elsevier B.V. All rights reserved.
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An evaluation of sharp safety blood evacuation devices.
Ford, Joanna; Phillips, Peter
This article describes an evaluation of three sharp safety blood evacuation devices in seven Welsh NHS boards and the Welsh Blood Service. Products consisted of two phlebotomy needles possessing safety shields and one phlebotomy device with wings, tubing and a retractable needle. The device companies provided the devices and appropriate training. Participating healthcare workers used the safety device instead of the conventional device to sample blood during the evaluation period and each type of device was evaluated in random order. Participants filled in a questionnaire for each type of device and then a further questionnaire comparing the two shielded evacuation needles with each other Results showed that responses to all three products were fairly positive, although each device was not liked by everyone who used it. When the two shielded evacuation devices were compared with each other, most users preferred the device with the shield positioned directly above the needle to the device with the shield at the side. However, in laboratory tests, the preferred device produced more fluid splatter than the other shielded device on activation.
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Pre-market clinical evaluations of innovative high-risk medical devices in Europe.
Hulstaert, Frank; Neyt, Mattias; Vinck, Imgard; Stordeur, Sabine; Huić, Mirjana; Sauerland, Stefan; Kuijpers, Marja R; Abrishami, Payam; Vondeling, Hindrik; Flamion, Bruno; Garattini, Silvio; Pavlovic, Mira; van Brabandt, Hans
2012-07-01
High-quality clinical evidence is most often lacking when novel high-risk devices enter the European market. At the same time, a randomized controlled trial (RCT) is often initiated as a requirement for obtaining market access in the US. Should coverage in Europe be postponed until RCT data are available? We studied the premarket clinical evaluation of innovative high-risk medical devices in Europe compared with the US, and with medicines, where appropriate. The literature and regulatory documents were checked. Representatives from industry, Competent Authorities, Notified Bodies, Ethics Committees, and HTA agencies were consulted. We also discuss patient safety and the transparency of information. In contrast to the US, there is no requirement in Europe to demonstrate the clinical efficacy of high-risk devices in the premarket phase. Patients in Europe can thus have earlier access to a potentially lifesaving device, but at the risk of insufficiently documented efficacy and safety. Variations in the stringency of clinical reviews, both at the level of Notified Bodies and Competent Authorities, do not guarantee patient safety. We tried to document the design of premarket trials in Europe and number of patients exposed, but failed as this information is not made public. Furthermore, the Helsinki Declaration is not followed with respect to the registration and publication of premarket trials. For innovative high-risk devices, new EU legislation should require the premarket demonstration of clinical efficacy and safety, using an RCT if possible, and a transparent clinical review, preferably centralized.
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Smith, Colleen
2015-01-01
Internet crowdfunding, a new and increasingly popular method of raising capital to develop products and businesses, has recently come into conflict with the Food and Drug Administration's (FDA's) regulation of medical devices. This Article examines the issues that arise when companies pre-sell medical devices via crowdfunding campaigns before gaining FDA approval of the devices. Because Internet crowdfunding has only been in use for a few years, little has been written about it academically, particularly about its interaction with FDA regulations. The rising interest in crowdfunding, coupled with the downturn in investment in the American medical device industry, make this a salient issue that is ripe for FDA review. This Article uses the crowdfunding campaign Scanadu, a medical device company, conducted in 2013 to raise money to develop its in-home diagnostic device, the "Scout," as a starting point for this analysis. Because it is extremely costly to develop a device and obtain FDA approval, medical device companies should be able to utilize crowdfunding to raise the necessary capital. However, because of the possible dangers medical devices pose, FDA needs to review the risks created by allowing companies to crowdfund medical devices and should issue guidance to help companies comply with FDA regulations while still allowing them to take advantage of the benefits of crowdfunding. This guidance should ensure the continued commitment to consumer safety that is at the core of FDA regulation.
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Safety syringes and anti-needlestick devices in orthopaedic surgery.
Sibbitt, Wilmer L; Band, Philip A; Kettwich, Lawrence G; Sibbitt, Cristina R; Sibbitt, Lori J; Bankhurst, Arthur D
2011-09-07
The American Academy of Orthopaedic Surgery (AAOS), The Joint Commission, the Occupational Safety and Health Administration (OSHA), and the Needlestick Safety and Prevention Act encourage the integration of safety-engineered devices to prevent needlestick injuries to health-care workers and patients. We hypothesized that safety syringes and needles could be used in outpatient orthopaedic injection and aspiration procedures. The study investigated the orthopaedic uses and procedural idiosyncrasies of safety-engineered devices, including (1) four safety needles (Eclipse, SafetyGlide, SurGuard, and Magellan), (2) a mechanical safety syringe (RPD), (3) two automatic retractable syringes (Integra, VanishPoint), (4) three manual retractable syringes (Procedur-SF, Baksnap, Invirosnap), and (5) three shielded syringes (Safety-Lok, Monoject, and Digitally Activated Shielded [DAS] Syringe). The devices were first tested ex vivo, and then 1300 devices were used for 425 subjects undergoing outpatient arthrocentesis, intra-articular injections, local anesthesia, aspiration biopsy, and ultrasound-guided procedures. During the clinical observation, there were no accidental needlesticks (0 needlesticks per 1300 devices). Safety needles could be successfully used on a Luer syringe but were limited to ≤1.5 in (≤3.81 cm) in length and the shield could interfere with sonography. The mechanical safety syringes functioned well in all orthopaedic procedures. Automatic retractable syringes were too small for arthrocentesis of the knee, and the plunger blew out and prematurely collapsed with high-pressure injections. The manual retractable syringes and shielded syringes could be used with conventional needles for most orthopaedic procedures. The most effective and reliable safety devices for orthopaedic syringe procedures are shielded safety needles, mechanical syringes, manual retractable syringes, and shielded syringes, but not automatic retractable syringes. Even when adopting
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Verkerke, Gijsbertus Jacob; Mahieu, H.F.; Geertsema, A.A.; Hermann, I.F.; van Horn, J.R.; Hummel, J. Marjan; van Loon, J.P.; Mihaylov, D.; van der Plaats, A.; Schraffordt Koops, H.; Schutte, H.K.; Veth, R.P.H.; de Vries, M.P.; Rakhorst, G.; Shi, Donglu
2004-01-01
The development of new medical devices is a very time-consuming and costly process. Besides the time between the initial idea and the time that manufacturing and testing of prototypes takes place, the time needed for the development of production facilities, production of test series, marketing,
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Classification and evaluation of medical devices
Directory of Open Access Journals (Sweden)
Edina Vranić
2003-05-01
Full Text Available Medical devices and medical disposables contribute significantly to the quality and effectiveness of the health care system. It is necessary to commit scientifically sound regulatory environment that will provide consumers with the best medical care. This includes continued services to small manufacturers, readily available guidance on FDA requirements, predictable and reasonable response times on applications for marketing, and equitable enforcement. But in the public interest, this commitment to the industry must be coupled with a reciprocal commitment: that medical device firms will meet high standards in the design, manufacture, and evaluation of their products. The protections afforded our consumer, and the benefits provided the medical device industry, cannot be underestimated.
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Safety status system for operating room devices.
Guédon, Annetje C P; Wauben, Linda S G L; Overvelde, Marlies; Blok, Joleen H; van der Elst, Maarten; Dankelman, Jenny; van den Dobbelsteen, John J
2014-01-01
Since the increase of the number of technological aids in the operating room (OR), equipment-related incidents have come to be a common kind of adverse events. This underlines the importance of adequate equipment management to improve the safety in the OR. A system was developed to monitor the safety status (periodic maintenance and registered malfunctions) of OR devices and to facilitate the notification of malfunctions. The objective was to assess whether the system is suitable for use in an busy OR setting and to analyse its effect on the notification of malfunctions. The system checks automatically the safety status of OR devices through constant communication with the technical facility management system, informs the OR staff real-time and facilitates notification of malfunctions. The system was tested for a pilot period of six months in four ORs of a Dutch teaching hospital and 17 users were interviewed on the usability of the system. The users provided positive feedback on the usability. For 86.6% of total time, the localisation of OR devices was accurate. 62 malfunctions of OR devices were reported, an increase of 12 notifications compared to the previous year. The safety status system was suitable for an OR complex, both from a usability and technical point of view, and an increase of reported malfunctions was observed. The system eases monitoring the safety status of equipment and is a promising tool to improve the safety related to OR devices.
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Safety in Cryogenics – Safety device sizing
CERN. Geneva
2016-01-01
The calculation is separated in three operations: o The estimation of the loads arriving on the component to protect, o The calculation of the mass flow to evacuate, o And the sizing of the safety device.
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Yue, Lilly Q; Campbell, Gregory; Lu, Nelson; Xu, Yunling; Zuckerman, Bram
2016-01-01
Regulatory decisions are made based on the assessment of risk and benefit of medical devices at the time of pre-market approval and subsequently, when post-market risk-benefit balance needs reevaluation. Such assessments depend on scientific evidence obtained from pre-market studies, post-approval studies, post-market surveillance studies, patient perspective information, as well as other real world data such as national and international registries. Such registries provide real world evidence and are playing a more and more important role in enhancing the safety and effectiveness evaluation of medical devices. While these registries provide large quantities of data reflecting real world practice and can potentially reduce the cost of clinical trials, challenges arise concerning (1) data quality adequate for regulatory decision-making, (2) bias introduced at every stage and aspect of study, (3) scientific validity of study designs, and (4) reliability and interpretability of study results. This article will discuss related statistical and regulatory challenges and opportunities with examples encountered in medical device regulatory reviews.
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Do we have to Include HCI Issues in Clinical Trials of Medical Devices?
DEFF Research Database (Denmark)
Nielsen, Lene; Christensen, Lars Rune; Sabers, Anne
2017-01-01
Digital devices play an important role in medical treatment and will in the future play a larger role in connection to cures of health-related issues. Traditionally medicine has been tested by clinical double blind, randomized trials to document the efficacy and safety profile. When it comes to t...
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Contextual inquiry for medical device design
Privitera, Mary Beth
2015-01-01
Contextual Inquiry for Medical Device Design helps users understand the everyday use of medical devices and the way their usage supports the development of better products and increased market acceptance. The text explains the concept of contextual inquiry using real-life examples to illustrate its application. Case studies provide a frame of reference on how contextual inquiry is successfully used during product design, ultimately producing safer, improved medical devices. Presents the ways contextual inquiry can be used to inform the evaluation and business case of technologyHelps users
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Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey.
Ross, Joseph S; Blount, Katrina L; Ritchie, Jessica D; Hodshon, Beth; Krumholz, Harlan M
2015-01-01
In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA) to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA's pre-market approval (PMA) pathway. We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%), nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives.
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Seltzer, Jonathan H; Heise, Ted; Carson, Peter; Canos, Daniel; Hiatt, Jo Carol; Vranckx, Pascal; Christen, Thomas; Cutlip, Donald E
2017-08-01
This white paper provides a summary of presentations, discussions and conclusions of a Thinktank entitled "The Role of Endpoint Adjudication in Medical Device Clinical Trials". The think tank was cosponsored by the Cardiac Safety Research Committee, MDEpiNet and the US Food and Drug Administration (FDA) and was convened at the FDA's White Oak headquarters on March 11, 2016. Attention was focused on tailoring best practices for evaluation of endpoints in medical device clinical trials, practical issues in endpoint adjudication of therapeutic, diagnostic, biomarker and drug-device combinations, and the role of adjudication in regulatory and reimbursement issues throughout the device lifecycle. Attendees included representatives from medical device companies, the FDA, Centers for Medicare and Medicaid Services (CMS), end point adjudication specialist groups, clinical research organizations, and active, academically based adjudicators. The manuscript presents recommendations from the think tank regarding (1) rationale for when adjudication is appropriate, (2) best practices establishment and operation of a medical device adjudication committee and (3) the role of endpoint adjudication for post market evaluation in the emerging era of real world evidence. Copyright © 2017. Published by Elsevier Inc.
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Hannig, Jürgen; Siekmeier, Rüdiger
2015-01-01
The current European system governed by the three EC directives 93/42/EEC (Medical Device Directive), 98/79/EC (In-Vitro Diagnostic Directive) and 90/385/EEC (Active Implantable Medical Device Directive) regulates marketing and post-market surveillance of medical devices in the European Economic Area (EEA). In cases of incidents raising the field safety corrective actions (FSCA), manufacturers have to inform the responsible Competent Authority (CA; in Germany this is the Federal Institute for Drugs and Medical Devices, BfArM) and the public by field safety notices (FSN). In this study we analyzed FSN of respirators and consumables directly required for their function, whereas devices for anesthesia and gas delivery were excluded. FSCA and FSN of 2005-2013 publicized by BfArM for the included products were analyzed with respect to the MEDDEV 2.12-1 rev. 8. In total, 60 FSCA were publicized. German and English FSN were found in 59/53 cases, respectively. FSN were clearly characterized as FSN in 44/38 cases and declaration of the type of action in 45/44 cases, respectively. Product names were provided in all cases. Lot numbers or other information for product characterization were available in 7/7 and 43/40 cases, respectively. Detailed information regarding FSCA and product malfunction was found in all cases. Information on product related risks with previous use of affected devices was provided in 42/38 cases. In 53/53 cases manufacturers provided information to mitigate product related risks. Requests to pass FSN to persons needing awareness in the organization were found in 27/24 cases. Contact data were provided in 53/48 cases, respectively. Confirmation that a CA was informed was found in 28/26 cases and in 19/15 cases a customer confirmation was included. The identified risks were: total loss of function (19/16), short circuit (1/1) and burn (3/3), and inhalation of foreign particles (1/1) which might cause severe risk to patients and users. The most frequent
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Medical device market in China.
Boyer, Philip; Morshed, Bashir I; Mussivand, Tofy
2015-06-01
With China's growing old-age population and economic presence on the international stage, it has become important to evaluate its domestic and foreign market contribution to medical devices. Medical devices are instruments or apparatuses used in the prevention, rehabilitation, treatment, or knowledge generation with respect to disease or other abnormal conditions. This article provides information drawn from recent publications to describe the current state of the Chinese domestic market for medical devices and to define opportunities for foreign investment potential therein. Recent healthcare reforms implemented to meet rising demand due to an aging and migrating population are having a positive effect on market growth-a global market with a projected growth of 15% per year over the next decade. Copyright © 2015 International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.
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Auxetic foam for snowsport safety devices
Allen, Tom; Duncan, Olly; Foster, Leon; Senior, Terry; Zampieri, Davide; Edeh, Victor; Alderson, Andrew
2017-01-01
Skiing and snowboarding are popular snow-sports with inherent risk of injury. There is potential to reduce the prevalence of injuries by improving and implementing snow-sport safety devices with the application of advanced materials. This paper investigates the application of auxetic foam to snow-sport safety devices. Composite pads - consisting of foam covered with a semi-rigid shell - were investigated as a simple model of body armour and a large 70 x 355 x 355 mm auxetic foam sample was fa...
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International Nuclear Information System (INIS)
Timmermans, Francis; Vandervorst, Jean.
1981-01-01
Safety device for longitudinally leak proofing the shaft of a pump in the event of the fracture of the dynamic seal separating the pump fluid high pressure chamber from the low pressure chamber. It is designed for fitting to the primary pumps of nuclear reactors. It includes a hollow cyclindrical piston located coaxially around the pump shaft and normally housed in a chamber provided for this purpose in the fixed housing of the dynamic seal, and means for moving this piston coaxially so as to compress a safety O ring between the shaft and the piston in the event of the dynamic seal failing [fr
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Sutanto, E.; Chandra, F.; Dinata, R.
2017-05-01
Leakage current measurement which can follow IEC standard for medical device is one of many challenges to be answered. The IEC 60601-1 has defined that the limit for a leakage current for Medical Device can be as low as 10 µA and as high as 500 µA, depending on which type of contact (applied part) connected to the patient. Most people are using ELCB (Earth-leakage circuit breaker) for safety purpose as this is the most common and available safety device in market. One type of ELCB devices is RCD (Residual Current Device) and this RCD type can measure the leakage current directly. This work will show the possibility on how Helmholtz Coil Configuration can be made to be like the RCD. The possibility is explored by comparing the magnetic field formula from each device, then it proceeds with a simulation using software EJS (Easy Java Simulation). The simulation will make sure the concept of magnetic field current cancellation follows the RCD concept. Finally, the possibility of increasing the measurement’s sensitivity is also analyzed. The sensitivity is needed to see the possibility on reaching the minimum leakage current limit defined by IEC, 0.01mA.
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International Nuclear Information System (INIS)
Sutanto, E; Chandra, F; Dinata, R
2017-01-01
Leakage current measurement which can follow IEC standard for medical device is one of many challenges to be answered. The IEC 60601-1 has defined that the limit for a leakage current for Medical Device can be as low as 10 µA and as high as 500 µA, depending on which type of contact (applied part) connected to the patient. Most people are using ELCB (Earth-leakage circuit breaker) for safety purpose as this is the most common and available safety device in market. One type of ELCB devices is RCD (Residual Current Device) and this RCD type can measure the leakage current directly. This work will show the possibility on how Helmholtz Coil Configuration can be made to be like the RCD. The possibility is explored by comparing the magnetic field formula from each device, then it proceeds with a simulation using software EJS (Easy Java Simulation). The simulation will make sure the concept of magnetic field current cancellation follows the RCD concept. Finally, the possibility of increasing the measurement’s sensitivity is also analyzed. The sensitivity is needed to see the possibility on reaching the minimum leakage current limit defined by IEC, 0.01mA. (paper)
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Nurses' perceptions and problems in the usability of a medication safety app.
Ankem, Kalyani; Cho, Sookyung; Simpson, Diana
2017-10-16
The majority of medication apps support medication adherence. Equally, if not more important, is medication safety. Few apps report on medication safety, and fewer studies have been conducted with these apps. The usability of a medication safety app was tested with nurses to reveal their perceptions of the graphical user interface and to discover problems they encountered in using the app. Usability testing of the app was conducted with RN-BSN students and informatics students (n = 18). Perceptions of the graphical components were gathered in pretest and posttest questionnaires, and video recordings of the usability testing were transcribed. The significance of the difference in mean performance time for 8 tasks was tested, and qualitative analysis was deployed to identify problems encountered and to rate the severity of each problem. While all participants perceived the graphical user interface as easy to understand, nurses took significantly more time to complete certain tasks. More nurses found the medication app to be lacking in intuitiveness of user interface design, in capability to match real-world data, and in providing optimal information architecture. To successfully integrate mobile devices in healthcare, developers must address the problems that nurses encountered in use of the app.
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Legislative aspects of the development of medical devices.
Marešová, Petra; Klímová, Blanka; Krejcar, Ondřej; Kuča, Kamil
2015-09-01
European industry of medical device technologies represents 30% of all worlds sales. New health technologies bring effective treatment approaches, help shorten stays in hospital1),bring better treatment results and accelerate rehabilitation which leads to the earlier patients recovery.Legislative aspects are one of the key areas influencing the speed of development of medical devices and their launching. The aim of this article is to specify current state of legislation in the development of medical devices in the European Union in comparison with the market leaders such as China, Japan and USA.The best established market of medical devices is in the USA. Both Japan and China follow the USA model. However, a non-professional code of ethics in China in some respect contributes to the decrease of quality of medical devices, while Japan as well as the EU countries try really hard to conform to all the regulations imposed on the manufacturing of medical devices.
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33 CFR 159.131 - Safety: Incinerating device.
2010-07-01
... (CONTINUED) POLLUTION MARINE SANITATION DEVICES Design, Construction, and Testing § 159.131 Safety.... Unitized incineration devices must completely burn to a dry, inert ash, a simultaneous defecation and...
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The Role of Healthcare Technology Management in Facilitating Medical Device Cybersecurity.
Busdicker, Mike; Upendra, Priyanka
2017-09-02
This article discusses the role of healthcare technology management (HTM) in medical device cybersecurity and outlines concepts that are applicable to HTM professionals at a healthcare delivery organization or at an integrated delivery network, regardless of size. It provides direction for HTM professionals who are unfamiliar with the security aspects of managing healthcare technologies but are familiar with standards from The Joint Commission (TJC). It provides a useful set of recommendations, including relevant references for incorporating good security practices into HTM practice. Recommendations for policies, procedures, and processes referencing TJC standards are easily applicable to HTM departments with limited resources and to those with no resource concerns. The authors outline processes from their organization as well as best practices learned through information sharing at AAMI, National Health Information Sharing and Analysis Center (NH-ISAC), and Medical Device Innovation, Safety, and Security Consortium (MDISS) conferences and workshops.
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Medical devices and human engineering
Bronzino, Joseph D
2014-01-01
Known as the bible of biomedical engineering, The Biomedical Engineering Handbook, Fourth Edition, sets the standard against which all other references of this nature are measured. As such, it has served as a major resource for both skilled professionals and novices to biomedical engineering.Medical Devices and Human Engineering, the second volume of the handbook, presents material from respected scientists with diverse backgrounds in biomedical sensors, medical instrumentation and devices, human performance engineering, rehabilitation engineering, and clinical engineering.More than three doze
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Medical device reliability and associated areas
National Research Council Canada - National Science Library
Dhillon, Balbir S
2000-01-01
.... Although the history of reliability engineering can be traced back to World War II, the application of reliability engineering concepts to medical devices is a fairly recent idea that goes back to the latter part of the 1960s when many publications on medical device reliability emerged. Today, a large number of books on general reliability have been...
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Optimizing medication safety in the home.
LeBlanc, Raeanne Genevieve; Choi, Jeungok
2015-06-01
Medication safety among community-dwelling older adults in the United States is an ongoing health issue impacting health outcomes, chronic disease management, and aging in place at home. This article describes a medication safety improvement project that aimed to: (1) Increase the ability of participants to manage medications, (2) Identify and make necessary medication changes, (3) Create an accurate up-to-date medication list to be available in the home, and (4) Provide communication between the primary care provider, participant, and case manager. An in-home medication assessment was completed for 25 participants using an evidence-based medication management software system. This process was used to review medications; identify medication-related problems; create a shared medication list; and convey this information to the primary care provider, case manager, and client while addressing needed medication changes. Educational interventions on management and understanding of medications were provided to participants to emphasize the correct use of medications and use of a personal medication record. Outcome improvements included provision of an accurate medication list, early identification of medication-related problems, identification of drug duplication, and identification of medication self-management challenges that can be useful for optimizing medication safety-related home healthcare and inform future interventions.
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2011-08-04
... placed on the Internet. Section 10.33(b) provides that FDA may, for good cause, extend this 30-day period.......... Chestnut Medical Pipeline embolization device.... April 6, 2011. Technologies, Inc. P100034 FDA-2011-M-0295... Scientific Corp ION paclitaxel-eluting coronary April 22, 2011. stent system (monorail and over- the-wire...
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Comparative cardiovascular safety of dementia medications
DEFF Research Database (Denmark)
Fosbøl, Emil L; Peterson, Eric D; Holm, Ellen
2012-01-01
To compare the cardiovascular safety of currently marketed dementia medications in new users in the United States and Denmark.......To compare the cardiovascular safety of currently marketed dementia medications in new users in the United States and Denmark....
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A concept ideation framework for medical device design.
Hagedorn, Thomas J; Grosse, Ian R; Krishnamurty, Sundar
2015-06-01
Medical device design is a challenging process, often requiring collaboration between medical and engineering domain experts. This collaboration can be best institutionalized through systematic knowledge transfer between the two domains coupled with effective knowledge management throughout the design innovation process. Toward this goal, we present the development of a semantic framework for medical device design that unifies a large medical ontology with detailed engineering functional models along with the repository of design innovation information contained in the US Patent Database. As part of our development, existing medical, engineering, and patent document ontologies were modified and interlinked to create a comprehensive medical device innovation and design tool with appropriate properties and semantic relations to facilitate knowledge capture, enrich existing knowledge, and enable effective knowledge reuse for different scenarios. The result is a Concept Ideation Framework for Medical Device Design (CIFMeDD). Key features of the resulting framework include function-based searching and automated inter-domain reasoning to uniquely enable identification of functionally similar procedures, tools, and inventions from multiple domains based on simple semantic searches. The significance and usefulness of the resulting framework for aiding in conceptual design and innovation in the medical realm are explored via two case studies examining medical device design problems. Copyright © 2015 Elsevier Inc. All rights reserved.
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Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey
Directory of Open Access Journals (Sweden)
Ross JS
2015-05-01
Full Text Available Joseph S Ross, Katrina L Blount, Jessica D Ritchie, Beth Hodshon, Harlan M Krumholz Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA Background: In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA's pre-market approval (PMA pathway. Methods and results: We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%, nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Conclusion: Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives. Keywords: FDA, PMA pathway, post-market surveillance
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Power Approaches for Implantable Medical Devices
Directory of Open Access Journals (Sweden)
Achraf Ben Amar
2015-11-01
Full Text Available Implantable medical devices have been implemented to provide treatment and to assess in vivo physiological information in humans as well as animal models for medical diagnosis and prognosis, therapeutic applications and biological science studies. The advances of micro/nanotechnology dovetailed with novel biomaterials have further enhanced biocompatibility, sensitivity, longevity and reliability in newly-emerged low-cost and compact devices. Close-loop systems with both sensing and treatment functions have also been developed to provide point-of-care and personalized medicine. Nevertheless, one of the remaining challenges is whether power can be supplied sufficiently and continuously for the operation of the entire system. This issue is becoming more and more critical to the increasing need of power for wireless communication in implanted devices towards the future healthcare infrastructure, namely mobile health (m-Health. In this review paper, methodologies to transfer and harvest energy in implantable medical devices are introduced and discussed to highlight the uses and significances of various potential power sources.
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Safety device of thermonuclear device
International Nuclear Information System (INIS)
Aoki, Isao; Ueda, Shuzo; Seki, Yasushi; Sakurai, Akiko; Kasahara, Fumio; Obara, Atsushi; Yamauchi, Michinori.
1997-01-01
The present invention provides a safety device against an event of intrusion of coolants in a vacuum vessel. Namely, a coolant supply system comprises cooling tubes for supplying coolants to main reactor structure components including a vacuum vessel. A detection means detects leakage of coolants in the vacuum vessel. A coolant supply control means controls the supply of coolants to the main reactor structural components based on the leakage detection signals of the detection means. A stagnated material discharging means discharges stagnated materials in the main reactor structural components caused by the leakage of coolants. The leakage of coolants (for example, water) in the vacuum vessel can thus be detected by the water detection device in the vacuum vessel. A control value of a coolant supply means is closed by the leakage detection signals. The supply of coolants to the main reactor structural components is restricted to suppress the leakage. The stagnated materials are discharged to a tank by way of a water draining valve. (I.S.)
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Medical devices made into weapons by prisoners: an unrecognized risk.
Hayden, J W; Laney, C; Kellermann, A L
1995-12-01
The alteration of a knee immobilizer into a sharp weapon by a prisoner prompted us to survey neighboring penal institutions to determine the frequency of such events. We mailed a nine-item survey to all detention facilities in Tennessee, Arkansas, and Mississippi. A second survey was sent to nonresponding institutions 6 weeks after the initial mailing. The Regional Medical Center at Memphis, the designated facility for evaluation and treatment of prisoners from the county jail and state penitentiary. Survey respondents included 25 state penitentiaries, 31 county jails, 1 state minimum-security facility, 1 state maximum-security facility, 1 work-release center, 1 county detention center for drunken-driving offenders, and 1 federal penitentiary. Of the 81 institutions surveyed, 77% responded to one of the two mailings. Forty percent responded in the affirmative when asked whether stolen or unauthorized medical equipment from outside their institutions had been discovered among inmates. When respondents were questioned as to whether medical equipment, prescribed or not, had been used or altered in a criminal manner, 34% responded "yes." Medications and medical appliances were listed in the responses. A survey of 81 local and neighboring penal institutions in a three-state area revealed that the illicit use of medicine and medical devices by prisoners is a legitimate safety concern of prison personnel and health care workers when medical care for inmates must be sought outside the security of their institutions. The modification of medical equipment into weapons by incarcerated patients, although clearly recognized as a security and safety problem by police authorities, appears to be unappreciated by health care workers providing episodic care to inmates.
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Using Contemporary Leadership Skills in Medication Safety Programs.
Hertig, John B; Hultgren, Kyle E; Weber, Robert J
2016-04-01
The discipline of studying medication errors and implementing medication safety programs in hospitals dates to the 1970s. These initial programs to prevent errors focused only on pharmacy operation changes - and not the broad medication use system. In the late 1990s, research showed that faulty systems, and not faulty people, are responsible for errors and require a multidisciplinary approach. The 2013 ASHP Statement on the Role of the Medication Safety Leader recommended that medication safety leaders be integrated team members rather than a single point of contact. Successful medication safety programs must employ a new approach - one that embraces the skills of all health care team members and positions many leaders to improve safety. This approach requires a new set of leadership skills based on contemporary management principles, including followership, team-building, tracking and assessing progress, storytelling and communication, and cultivating innovation, all of which promote transformational change. The application of these skills in developing or changing a medication safety program is reviewed in this article.
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Towards sustainable design for single-use medical devices.
Hanson, Jacob J; Hitchcock, Robert W
2009-01-01
Despite their sophistication and value, single-use medical devices have become commodity items in the developed world. Cheap raw materials along with large scale manufacturing and distribution processes have combined to make many medical devices more expensive to resterilize, package and restock than to simply discard. This practice is not sustainable or scalable on a global basis. As the petrochemicals that provide raw materials become more expensive and the global reach of these devices continues into rapidly developing economies, there is a need for device designs that take into account the total life-cycle of these products, minimize the amount of non-renewable materials consumed and consider alternative hybrid reusable / disposable approaches. In this paper, we describe a methodology to perform life cycle and functional analyses to create additional design requirements for medical devices. These types of sustainable approaches can move the medical device industry even closer to the "triple bottom line"--people, planet, profit.
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2013-04-09
... radiofrequency band ranging between 13 megahertz to 27.12 megahertz and is intended for the treatment of medical...] Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices...
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Anti-malware software and medical devices.
2010-10-01
Just as much as healthcare information systems, medical devices need protection against cybersecurity threats. Anti-malware software can help safeguard the devices in your facility-but it has limitations and even risks. Find out what steps you can take to manage anti-malware applications in your devices.
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Energy Technology Data Exchange (ETDEWEB)
NONE
2000-09-01
This paper is the material distributed in the medical and welfare device session held under the auspices of NEDO in September 2000. Diversification of needs in the medical and welfare areas and handling of age advancement are the growing issue. NEDO is putting efforts toward enhancement of quality of life (QOL) and realization of the nation with great life by providing high-quality and high-efficiency medical and welfare services. The NEDO's efforts cover the areas of treating adult diseases such as cancers and cardiac diseases whose seriousness is growing, early diagnoses of diseases, medical treatment with low invasion, elderly people helping, reduction of helpers' burden, reduction of handicaps to elderly people and mentally and physically handicapped persons, and assistance to participation in the society. To achieve these goals, NEDO is implementing the following four projects: research and development of medical and welfare device technologies, researches of medical science and engineering collaboration type, and promotion of developing welfare techno-systems and practical application of welfare appliances. Developments are being made toward practical application of medical and welfare devices with excellent safety and convenience, of low cost and high performance. The session gave the keynote addresses related to medical treatment and prevention of brain diseases; brain, the universe and MRI (the world of mind as seen in images), and high-tech medical treatments to protect brain (challenge to brain that starts now). (NEDO)
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MDR (Medical Device Reporting)
U.S. Department of Health & Human Services — This database allows you to search the CDRH's database information on medical devices which may have malfunctioned or caused a death or serious injury during the...
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Safety considerations in the design of the fusion engineering device
International Nuclear Information System (INIS)
Barrett, R.J.
1983-01-01
Safety considerations play a significant role in the design of a near-term Fusion Engineering Device (FED). For the safety of the general public and the plant workers, the radiation environment caused by the reacting plasma and the potential release of tritium fuel are the dominant considerations. The U.S. Department of Energy (DOE) regulations and guidelines for radiation protection have been reviewed and are being applied to the device design. Direct radiation protection is provided by the device shield and the reactor building walls. Radiation from the activated device components and the tritium fuel is to be controlled with shielding, contamination control, and ventilation. The potential release of tritium from the plant has influenced the selection of reactor building and plant designs and specifications. The safety of the plant workers is affected primarily by the radiation from the activated device components and from plasma chamber debris. The highly activated device components make it necessary to design many of the maintenance activities in the reactor building for totally remote operation. The hot cell facility has evolved as a totally remote maintenance facility due to the high radiation levels of the device components. Safety considerations have had substantial impacts on the design of FED. Several examples of safety-related design impacts are discussed in the paper. Feasible solutions have been identified for all outstanding safety-related items, and additional optimization of these solutions is anticipated in future design studies
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Use of mobile devices for medical imaging.
Hirschorn, David S; Choudhri, Asim F; Shih, George; Kim, Woojin
2014-12-01
Mobile devices have fundamentally changed personal computing, with many people forgoing the desktop and even laptop computer altogether in favor of a smaller, lighter, and cheaper device with a touch screen. Doctors and patients are beginning to expect medical images to be available on these devices for consultative viewing, if not actual diagnosis. However, this raises serious concerns with regard to the ability of existing mobile devices and networks to quickly and securely move these images. Medical images often come in large sets, which can bog down a network if not conveyed in an intelligent manner, and downloaded data on a mobile device are highly vulnerable to a breach of patient confidentiality should that device become lost or stolen. Some degree of regulation is needed to ensure that the software used to view these images allows all relevant medical information to be visible and manipulated in a clinically acceptable manner. There also needs to be a quality control mechanism to ensure that a device's display accurately conveys the image content without loss of contrast detail. Furthermore, not all mobile displays are appropriate for all types of images. The smaller displays of smart phones, for example, are not well suited for viewing entire chest radiographs, no matter how small and numerous the pixels of the display may be. All of these factors should be taken into account when deciding where, when, and how to use mobile devices for the display of medical images. Copyright © 2014 American College of Radiology. Published by Elsevier Inc. All rights reserved.
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77 FR 72924 - Taxable Medical Devices
2012-12-07
... in hospitals, doctors offices and other medical institutions, such as x-ray machines, magnetic... the medical device context include sales to hospitals and other medical service providers. Although... of a taxable article to charity constitutes a taxable use under section 4218. However, the IRS and...
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MO-E-213-00: What Is Medical Physics Without Radiation Safety?
International Nuclear Information System (INIS)
2015-01-01
The focus of work of medical physicists in 1980’s was on quality control and quality assurance. Radiation safety was important but was dominated by occupational radiation protection. A series of over exposures of patients in radiotherapy, nuclear medicine and observation of skin injuries among patients undergoing interventional procedures in 1990’s started creating the need for focus on patient protection. It gave medical physicists new directions to develop expertise in patient dosimetry and dose management. Publications creating awareness on cancer risks from CT in early part of the current century and over exposures in CT in 2008 brought radiation risks in public domain and created challenging situations for medical physicists. Increasing multiple exposures of individual patient and patient doses of few tens of mSv or exceeding 100 mSv are increasing the role of medical physicists. Expansion of usage of fluoroscopy in the hands of clinical professionals with hardly any training in radiation protection shall require further role for medical physicists. The increasing publications in journals, recent changes in Safety Standards, California law, all increase responsibilities of medical physicists in patient protection. Newer technological developments in dose efficiency and protective devices increase percentage of time devoted by medical physicists on radiation protection activities. Without radiation protection, the roles, responsibilities and day-to-day involvement of medical physicists in diagnostic radiology becomes questionable. In coming years either medical radiation protection may emerge as a specialty or medical physicists will have to keep major part of day-to-day work on radiation protection. Learning Objectives: To understand how radiation protection has been increasing its role in day-to-day activities of medical physicist To be aware about international safety Standards, national and State regulations that require higher attention to radiation
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MO-E-213-00: What Is Medical Physics Without Radiation Safety?
Energy Technology Data Exchange (ETDEWEB)
NONE
2015-06-15
The focus of work of medical physicists in 1980’s was on quality control and quality assurance. Radiation safety was important but was dominated by occupational radiation protection. A series of over exposures of patients in radiotherapy, nuclear medicine and observation of skin injuries among patients undergoing interventional procedures in 1990’s started creating the need for focus on patient protection. It gave medical physicists new directions to develop expertise in patient dosimetry and dose management. Publications creating awareness on cancer risks from CT in early part of the current century and over exposures in CT in 2008 brought radiation risks in public domain and created challenging situations for medical physicists. Increasing multiple exposures of individual patient and patient doses of few tens of mSv or exceeding 100 mSv are increasing the role of medical physicists. Expansion of usage of fluoroscopy in the hands of clinical professionals with hardly any training in radiation protection shall require further role for medical physicists. The increasing publications in journals, recent changes in Safety Standards, California law, all increase responsibilities of medical physicists in patient protection. Newer technological developments in dose efficiency and protective devices increase percentage of time devoted by medical physicists on radiation protection activities. Without radiation protection, the roles, responsibilities and day-to-day involvement of medical physicists in diagnostic radiology becomes questionable. In coming years either medical radiation protection may emerge as a specialty or medical physicists will have to keep major part of day-to-day work on radiation protection. Learning Objectives: To understand how radiation protection has been increasing its role in day-to-day activities of medical physicist To be aware about international safety Standards, national and State regulations that require higher attention to radiation
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Development of Implantable Medical Devices: From an Engineering Perspective
Directory of Open Access Journals (Sweden)
Yeun-Ho Joung
2013-09-01
Full Text Available From the first pacemaker implant in 1958, numerous engineering and medical activities for implantable medical device development have faced challenges in materials, battery power, functionality, electrical power consumption, size shrinkage, system delivery, and wireless communication. With explosive advances in scientific and engineering technology, many implantable medical devices such as the pacemaker, cochlear implant, and real-time blood pressure sensors have been developed and improved. This trend of progress in medical devices will continue because of the coming super-aged society, which will result in more consumers for the devices. The inner body is a special space filled with electrical, chemical, mechanical, and marine-salted reactions. Therefore, electrical connectivity and communication, corrosion, robustness, and hermeticity are key factors to be considered during the development stage. The main participants in the development stage are the user, the medical staff, and the engineer or technician. Thus, there are three different viewpoints in the development of implantable devices. In this review paper, considerations in the development of implantable medical devices will be presented from the viewpoint of an engineering mind.
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Push Off 2000 : new oilfield safety device catching on
Energy Technology Data Exchange (ETDEWEB)
Mowers, J.
2006-12-15
Fuel gas scrubbers use production gas to operate oil batteries, well separators, dehydrators, compressors, and pneumatic and pressure controls. Once an internal float gets stuck, production is stopped. The Push Off 2000 is a new safety device for fuel gas scrubbers which allows operators to easily dislodge a stuck internal float by activating the tool, which is mounted on top of the vessel. The device was developed after an operator suffered burns from a flash explosion that occurred after using a hammer to strike the fuel gas scrubber. The hammer method is the usual method of dealing with stuck internal floats, and can also jeopardize the integrity of the vessel, releasing gas or liquid hydrocarbons into the environment. The Push Off 2000 is expected to reduce costly facility downtime and increase revenue generating production time. Over 50 oil and gas companies have the Push Off 2000 device installed on fuel gas scrubber units at their facilities, and have recognized the safety and economic merits of the tool. The patented device has been approved by the Alberta Boilers Safety Association, the British Columbia Boiler and Elevator Safety Branch, and the Saskatchewan Boiler and Pressure Vessel Safety Unit. 1 fig.
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2013-05-08
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Microbiology Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To...
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76 FR 48871 - Immunology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
2011-08-09
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Immunology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Immunology Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To...
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Functionality of road safety devices – identification and analysis of factors
Directory of Open Access Journals (Sweden)
Jeliński Łukasz
2017-01-01
Full Text Available Road safety devices are designed to protect road users from the risk of injury or death. The principal type of restraint is the safety barrier. Deployed on sites with the highest risk of run-off-road accidents, safety barriers are mostly found on bridges, flyovers, central reservations, and on road edges which have fixed obstacles next to them. If properly designed and installed, safety barriers just as other road safety devices, should meet a number of functional features. This report analyses factors which may deteriorate functionality, ways to prevent this from happening and the thresholds for loss of road safety device functionality.
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On the impact of medical device regulations on software architecture
DEFF Research Database (Denmark)
Hansen, Klaus Marius; Manikas, Konstantinos
2016-01-01
Compliance to regulations and regulatory approval are requirements for many medical device software systems. In this paper, we investigate the implications of medical device software regulations to the design of software systems. We do so by focusing on the American and European regulatory author...... of the device. Moreover, we review software modularity in the implementation of software medical device and propose a set of preliminary principles for architectural design of software medical device based on a set of constrains identified from the reviewed regulations....
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Medical Device Regulation: A Comparison of the United States and the European Union.
Maak, Travis G; Wylie, James D
2016-08-01
Medical device regulation is a controversial topic in both the United States and the European Union. Many physicians and innovators in the United States cite a restrictive US FDA regulatory process as the reason for earlier and more rapid clinical advances in Europe. The FDA approval process mandates that a device be proved efficacious compared with a control or be substantially equivalent to a predicate device, whereas the European Union approval process mandates that the device perform its intended function. Stringent, peer-reviewed safety data have not been reported. However, after recent high-profile device failures, political pressure in both the United States and the European Union has favored more restrictive approval processes. Substantial reforms of the European Union process within the next 5 to 10 years will result in a more stringent approach to device regulation, similar to that of the FDA. Changes in the FDA regulatory process have been suggested but are not imminent.
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Use of technical skills and medical devices among new registered nurses: A questionnaire study.
Ewertsson, Mona; Gustafsson, Margareta; Blomberg, Karin; Holmström, Inger K; Allvin, Renée
2015-12-01
One comprehensive part of nursing practice is performing technical skills and handling of medical equipment. This might be challenging for new registered nurses (RNs) to do in patient-safe way. The aim of this study was to describe and compare the extent to which new RNs perform various technical skills and handle medical devices in different settings, and to investigate their possibility for continued learning in this respect. A further aim was to describe their perceptions of incident reporting related to technical skills and medical devices. A cross-sectional study with descriptive and comparative design. RNs who recently graduated from a nursing programme at three Swedish universities and had worked as a RN for up to 1 year were included in the study (n=113, response rate 57%). Data were collected by means of a postal questionnaire. Half of the RNs reported that they performed several of the listed tasks every day or every week, regardless of workplace. These tasks were most frequently performed in surgical departments. The majority of the participants (76%) stated a need of continued practical training. However, less than half of them (48%) had access to a training environment. Several participants (43%) had been involved in incidents related to technical skills or medical devices, which were not always reported. Nearly a third of the participants (31%) did not use the existing guidelines when performing technical skills, and reflection on performance was uncommon. This study highlights the importance of shared responsibilities between nurse educators and health care employers to provide learning opportunities for new RNs in technical skills, to maintain patient safety. To increase the safety culture where nursing students and new RNs understand the importance of using evidence-based guidelines and taking a reflective approach in the performance of technical tasks is needed. Copyright © 2015 Elsevier Ltd. All rights reserved.
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76 FR 7220 - Medical Device Innovation Initiative; Request for Comments
2011-02-09
... medical device innovation. 6. Other actions CDRH should take to facilitate the development, assessment...] Medical Device Innovation Initiative; Request for Comments AGENCY: Food and Drug Administration, HHS... availability of a document for public comment entitled ``Medical Device Innovation Initiative'' (the report...
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2013-11-15
... its inaugural meeting in Singapore in 2012, identified a Work Group (WG) to develop specific documents... Assessment Method for the Recognition and Monitoring of Medical Device Auditing Organizations;'' and IMDRF...
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2013-02-13
...] Global Quality Systems--An Integrated Approach To Improving Medical Product Safety; Public Workshop... (AFDO), is announcing a public workshop entitled ``Global Quality Systems--An Integrated Approach to... topics concerning FDA requirements related to the production and marketing of drugs and/or devices...
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Reducing hospital noise: a review of medical device alarm management.
Konkani, Avinash; Oakley, Barbara; Bauld, Thomas J
2012-01-01
Increasing noise in hospital environments, especially in intensive care units (ICUs) and operating rooms (ORs), has created a formidable challenge for both patients and hospital staff. A major contributing factor for the increasing noise levels in these environments is the number of false alarms generated by medical devices. This study focuses on discovering best practices for reducing the number of false clinical alarms in order to increase patient safety and provide a quiet environment for both work and healing. The researchers reviewed Pub Med, Web of Knowledge and Google Scholar sources to obtain original journal research and review articles published through January 2012. This review includes 27 critically important journal articles that address different aspects of medical device alarms management, including the audibility, identification, urgency mapping, and response time of nursing staff and different solutions to such problems. With current technology, the easiest and most direct method for reducing false alarms is to individualize alarm settings for each patient's condition. Promoting an institutional culture change that emphasizes the importance of individualization of alarms is therefore an important goal. Future research should also focus on the development of smart alarms.
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2012-03-28
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory...
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2011-11-21
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory...
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Investigation of radiation safety and safety culture of medical sanitation vocation in Suzhou
International Nuclear Information System (INIS)
Tang Bo; Tu Yu; Zhang Yin
2009-01-01
Objective: To investigate the construction of radiation safety and safety culture of medical sanitation vocation in Suzhou. Methods: All medical units registered in administration center of Suzhou were included. The above selected medical units were completely investigated, district and county under the same condition of quality control. Results: The radiation safety and safety culture are existing differences among different property and grade hospitals of medicai sanitation vocation in Suzhou. Conclusion: The construction of radiation safety and safety culture is generally occupying in good level in suhzou, but there are obvious differences among different property and grade hospitals. The main reason for the differences in the importance attached to by the hospital decision-making and department management officials as well as the staff personal. (authors)
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Polymer coating embolism from intravascular medical devices - a clinical literature review.
Chopra, Amitabh M; Mehta, Monik; Bismuth, Jean; Shapiro, Maksim; Fishbein, Michael C; Bridges, Alina G; Vinters, Harry V
Over the past three decades, lubricious (hydrophobic and/or hydrophilic) polymer-coated devices have been increasingly adopted by interventional physicians and vascular surgeons to access and treat a wider range of clinical presentations. Recent clinical literature highlights the presence of polymer coating emboli within the anatomy - a result of coating separation from an intravascular device - and associates it with a range of adverse clinical sequelae. The 2015 U.S. Food and Drug Administration safety communication titled "Lubricious Coating Separation from Intravascular Medical Devices" acknowledges these concerns and concludes that it will work with stakeholders to develop nonclinical test methodologies, establish performance criteria, and identify gaps in current national and international device standards for coating integrity performance. Despite this communication and multiple case reports from interventional physicians, pathologists, dermatologists and other involved physician specialties, polymer coating embolism remains clinically underrecognized. This article consolidates the available literature on polymer coating embolism (1986-2016) and highlights the following relevant information for the physician: (a) the history and elusive nature of polymer coating embolism; (b) potential incidence rates of this phenomenon; (c) reported histologic findings and clinical effects of polymer emboli in the anatomy; (d) the importance of the collaborative clinician-pathologist partnership to report polymer embolism findings; and (e) the importance to study particulate release from intravascular devices so as to further understand and potentially evolve coated interventional technologies. Preliminary research on coatings highlights the potential of using iterations of coatings on medical devices that attain the desired therapeutic result and mitigate or eliminate particulates altogether. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.
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42 CFR 410.36 - Medical supplies, appliances, and devices: Scope.
2010-10-01
... 42 Public Health 2 2010-10-01 2010-10-01 false Medical supplies, appliances, and devices: Scope... Services § 410.36 Medical supplies, appliances, and devices: Scope. (a) Medicare Part B pays for the following medical supplies, appliances and devices: (1) Surgical dressings, and splints, casts, and other...
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Security and privacy issues in implantable medical devices: A comprehensive survey.
Camara, Carmen; Peris-Lopez, Pedro; Tapiador, Juan E
2015-06-01
Bioengineering is a field in expansion. New technologies are appearing to provide a more efficient treatment of diseases or human deficiencies. Implantable Medical Devices (IMDs) constitute one example, these being devices with more computing, decision making and communication capabilities. Several research works in the computer security field have identified serious security and privacy risks in IMDs that could compromise the implant and even the health of the patient who carries it. This article surveys the main security goals for the next generation of IMDs and analyzes the most relevant protection mechanisms proposed so far. On the one hand, the security proposals must have into consideration the inherent constraints of these small and implanted devices: energy, storage and computing power. On the other hand, proposed solutions must achieve an adequate balance between the safety of the patient and the security level offered, with the battery lifetime being another critical parameter in the design phase. Copyright © 2015 Elsevier Inc. All rights reserved.
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2010-09-23
...] Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory... committee will discuss, make recommendations, and vote on information related to the PMA for the LAP-BAND...
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2011-09-07
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Immunology Devices Panel of the Medical Devices Advisory Committee: Notice of Postponement of Meeting AGENCY... postponing the meeting of the Immunology Devices Panel of the Medical Devices Advisory Committee scheduled...
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DEFF Research Database (Denmark)
2010-01-01
The present invention relates to a medical delivery device comprising at least two membrane electrode assembly units each of which comprises three layers: an upper and a lower electrode and a selective ionic conductive membrane provided there-between. At least one of the three layers are shared...
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Medical Device Integration Model Based on the Internet of Things
Hao, Aiyu; Wang, Ling
2015-01-01
At present, hospitals in our country have basically established the HIS system, which manages registration, treatment, and charge, among many others, of patients. During treatment, patients need to use medical devices repeatedly to acquire all sorts of inspection data. Currently, the output data of the medical devices are often manually input into information system, which is easy to get wrong or easy to cause mismatches between inspection reports and patients. For some small hospitals of which information construction is still relatively weak, the information generated by the devices is still presented in the form of paper reports. When doctors or patients want to have access to the data at a given time again, they can only look at the paper files. Data integration between medical devices has long been a difficult problem for the medical information system, because the data from medical devices are lack of mandatory unified global standards and have outstanding heterogeneity of devices. In order to protect their own interests, manufacturers use special protocols, etc., thus causing medical decices to still be the "lonely island" of hospital information system. Besides, unfocused application of the data will lead to failure to achieve a reasonable distribution of medical resources. With the deepening of IT construction in hospitals, medical information systems will be bound to develop towards mobile applications, intelligent analysis, and interconnection and interworking, on the premise that there is an effective medical device integration (MDI) technology. To this end, this paper presents a MDI model based on the Internet of Things (IoT). Through abstract classification, this model is able to extract the common characteristics of the devices, resolve the heterogeneous differences between them, and employ a unified protocol to integrate data between devices. And by the IoT technology, it realizes interconnection network of devices and conducts associate matching
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Safety problems with the use of medical equipment/devices
Rademakers, C.
2009-01-01
In the past decennia medical technology has rapidly developed. Nowadays it plays an important role in all medical fields. It introduced technologic solutions for many medical problems and it definitely increased the possibilities in the medical field to increase the quality of life. However with
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Medication safety programs in primary care: a scoping review.
Khalil, Hanan; Shahid, Monica; Roughead, Libby
2017-10-01
Medication safety plays an essential role in all healthcare organizations; improving this area is paramount to quality and safety of any wider healthcare program. While several medication safety programs in the hospital setting have been described and the associated impact on patient safety evaluated, no systematic reviews have described the impact of medication safety programs in the primary care setting. A preliminary search of the literature demonstrated that no systematic reviews, meta-analysis or scoping reviews have reported on medication safety programs in primary care; instead they have focused on specific interventions such as medication reconciliation or computerized physician order entry. This scoping review sought to map the current medication safety programs used in primary care. The current scoping review sought to examine the characteristics of medication safety programs in the primary care setting and to map evidence on the outcome measures used to assess the effectiveness of medication safety programs in improving patient safety. The current review considered participants of any age and any condition using care obtained from any primary care services. We considered studies that focussed on the characteristics of medication safety programs and the outcome measures used to measure the effectiveness of these programs on patient safety in the primary care setting. The context of this review was primary care settings, primary healthcare organizations, general practitioner clinics, outpatient clinics and any other clinics that do not classify patients as inpatients. We considered all quantitative studied published in English. A three-step search strategy was utilized in this review. Data were extracted from the included studies to address the review question. The data extracted included type of medication safety program, author, country of origin, aims and purpose of the study, study population, method, comparator, context, main findings and outcome
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Handbook of materials for medical devices
National Research Council Canada - National Science Library
Davis, J. R
2003-01-01
... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii Introduction Chapter 1 Overview of Biomaterials and Their Use in Medical Devices . . . . . . . . . . . . . . . . 1 Uses for Biomaterials...
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CFD Analysis of the Safety Injection Tank and Fluidic Device
Energy Technology Data Exchange (ETDEWEB)
Cho, Jai Oan; Nietiadi, Yohanes Setiawan; Lee, Jeong Ik [KAIST, Daejeon (Korea, Republic of); Addad, Yacine [KUSTAR, Abu Dhabi (United Arab Emirates)
2016-05-15
One of the most important components in the ECCS is the safety injection tank (SIT). Inside the SIT, a fluidic device is installed, which passively controls the mass flow of the safety injection and eliminates the need for low pressure safety injection pumps. As more passive safety mechanisms are being pursued, it has become more important to understand flow structure and the loss mechanism within the fluidic device. Current computational fluid dynamics (CFD) calculations have had limited success in predicting the fluid flow accurately. This study proposes to find a more exact result using CFD and more realistic modeling to predict the performance during accident scenarios more accurately. The safety injection tank with fluidic device was analyzed thoroughly using CFD. The preliminary calculation used 60,000 meshes for the initial test calculation. The results fit the experimental results surprisingly despite its coarse grid. Nonetheless, the mesh resolution was increased to capture the vortex in the fluidic device precisely. Once a detailed CFD computation is finished, a small-scale experiment will be conducted for the given conditions. Using the experimental results and the CFD model, physical models can be improved to fit the results more accurately.
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Rantanen, Pekka; Parkkari, Timo; Leikola, Saija; Airaksinen, Marja; Lyles, Alan
2017-05-01
We examined the safety profile and usability of an integrated advanced robotic device and telecare system to promote medication adherence for elderly home-care patients. There were two phases. Phase I aimed to verify under controlled conditions in a single nursing home (n = 17 patients) that no robotic malfunctions would hinder the device's safe use. Phase II involved home-care patients from 3 sites (n = 27) who were on long-term medication. On-time dispensing and missed doses were recorded by the robotic system. Patients' and nurses' experiences were assessed with structured interviews. The 17 nursing home patients had 457 total days using the device (Phase I; mean, 26.9 per patient). On-time sachet retrieval occurred with 97.7% of the alerts, and no medication doses were missed. At baseline, Phase II home-dwelling patients reported difficulty remembering to take their medicines (23%), and 18% missed at least 2 doses per week. Most Phase II patients (78%) lived alone. The device delivered and patients retrieved medicine sachets for 99% of the alerts. All patients and 96% of nurses reported the device was easy to use. This trial demonstrated the safety profile and usability of an in-home advanced robotic device and telecare system and its acceptability to patients and nurses. It supports individualized patient dosing schedules, patient-provider communications, and on-time, in-home medication delivery to promote adherence. Real time dose-by-dose monitoring and communication with providers if a dose is missed provide oversight generally not seen in home care. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.
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2010-10-05
...] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice... announcing an amendment to the notice of meeting of the General and Plastic Surgery Devices Panel of the..., FDA announced that a meeting of the General and Plastic Surgery Devices Panel of the Medical Devices...
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Safety and feasibility research of CIPT-Ⅱ irradiation device
International Nuclear Information System (INIS)
Zhang Zhihua; Mi Xiangmiao; Li Rundong
2014-01-01
CITP-Ⅱ irradiation device, which is specially designed for fusion tritium breeder research, works in a thermal neutron reactor. With lithium orthosilicate as the breeder, the safety analysis was done to work out the device's influence on physical parameters of the reactor and get the breeder's temperature distribution and thermo-technical features in the n-γ field. The stiffness and strength were checked, and also the safety characters of the device were assessed. The feasibility of gap gas regulating the temperature and gas refueling the breeder was demonstrated. The calculation and analysis results provide data for comprehensive performance assessment. (authors)
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2011-04-15
... type of device must submit to FDA a premarket notification, prior to marketing the device, which... directs agencies to assess all costs and benefits of available regulatory alternatives and, when... economic, environmental, public health and safety, and other advantages; distributive impacts; and equity...
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Medication Safety Systems and the Important Role of Pharmacists.
Mansur, Jeannell M
2016-03-01
Preventable medication-related adverse events continue to occur in the healthcare setting. While the Institute of Medicine's To Err is Human, published in 2000, highlighted the prevalence of medical and medication-related errors in patient morbidity and mortality, there has not been significant documented progress in addressing system contributors to medication errors. The lack of progress may be related to the myriad of pharmaceutical options now available and the nuances of optimizing drug therapy to achieve desired outcomes and prevent undesirable outcomes. However, on a broader scale, there may be opportunities to focus on the design and performance of the many processes that are part of the medication system. Errors may occur in the storage, prescribing, transcription, preparation and dispensing, or administration and monitoring of medications. Each of these nodes of the medication system, with its many components, is prone to failure, resulting in harm to patients. The pharmacist is uniquely trained to be able to impact medication safety at the individual patient level through medication management skills that are part of the clinical pharmacist's role, but also to analyze the performance of medication processes and to lead redesign efforts to mitigate drug-related outcomes that may cause harm. One population that can benefit from a focus on medication safety through clinical pharmacy services and medication safety programs is the elderly, who are at risk for adverse drug events due to their many co-morbidities and the number of medications often used. This article describes the medication safety systems and provides a blueprint for creating a foundation for medication safety programs within healthcare organizations. The specific role of pharmacists and clinical pharmacy services in medication safety is also discussed here and in other articles in this Theme Issue.
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2010-08-06
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of... General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee scheduled for August...
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[Design and application of implantable medical device information management system].
Cao, Shaoping; Yin, Chunguang; Zhao, Zhenying
2013-03-01
Through the establishment of implantable medical device information management system, with the aid of the regional joint sharing of resources, we further enhance the implantable medical device traceability management level, strengthen quality management, control of medical risk.
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Liao, Joshua M; Etchegaray, Jason M; Williams, S Tyler; Berger, David H; Bell, Sigall K; Thomas, Eric J
2014-02-01
To develop and test the psychometric properties of a survey to measure students' perceptions about patient safety as observed on clinical rotations. In 2012, the authors surveyed 367 graduating fourth-year medical students at three U.S. MD-granting medical schools. They assessed the survey's reliability and construct and concurrent validity. They examined correlations between students' perceptions of organizational cultural factors, organizational patient safety measures, and students' intended safety behaviors. They also calculated percent positive scores for cultural factors. Two hundred twenty-eight students (62%) responded. Analyses identified five cultural factors (teamwork culture, safety culture, error disclosure culture, experiences with professionalism, and comfort expressing professional concerns) that had construct validity, concurrent validity, and good reliability (Cronbach alphas > 0.70). Across schools, percent positive scores for safety culture ranged from 28% (95% confidence interval [CI], 13%-43%) to 64% (30%-98%), while those for teamwork culture ranged from 47% (32%-62%) to 74% (66%-81%). They were low for error disclosure culture (range: 10% [0%-20%] to 27% [20%-35%]), experiences with professionalism (range: 7% [0%-15%] to 23% [16%-30%]), and comfort expressing professional concerns (range: 17% [5%-29%] to 38% [8%-69%]). Each cultural factor correlated positively with perceptions of overall patient safety as observed in clinical rotations (r = 0.37-0.69, P safety behavioral intent item. This study provided initial evidence for the survey's reliability and validity and illustrated its applicability for determining whether students' clinical experiences exemplify positive patient safety environments.
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2013-03-18
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...
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2012-04-05
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...
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2011-03-16
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...
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2011-10-07
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...
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2010-08-16
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...
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2013-05-23
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...
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2011-07-07
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0478] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...
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Design considerations for medical devices in the home environment.
Kaufman-Rivi, Diana; Collins-Mitchell, Janette; Jetley, Raoul
2010-01-01
Patient demographics, economic forces, and technological advancements contribute to the rise in home care services. Advanced medical devices and equipment originally designed for use by trained personnel in hospitals and clinics are increasingly migrating into the home. Unlike the clinical setting, the home is an uncontrolled environment with additional hazards. The compatibility of the device with the recipient's knowledge, abilities, lifestyle, and home environment plays a significant role in their therapy and rehabilitation. The advent of new device technologies such as wireless devices and interoperability of systems lends a new and complex perspective for medical device use in the home that must also be addressed. Adequately assessing and matching the patient and their caregiver with the appropriate device technology while considering the suitability of the home environment for device operation and maintenance is a challenge that relies on good human factors principles. There is a need to address these challenges in the growing home care sector In this article, the authors take a look at some important considerations and design issues for medical devices used in the home care environment.
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McKim, James M; Keller, Donald J; Gorski, Joel R
2012-12-01
Chemical sensitization is a serious condition caused by small reactive molecules and is characterized by a delayed type hypersensitivity known as allergic contact dermatitis (ACD). Contact with these molecules via dermal exposure represent a significant concern for chemical manufacturers. Recent legislation in the EU has created the need to develop non-animal alternative methods for many routine safety studies including sensitization. Although most of the alternative research has focused on pure chemicals that possess reasonable solubility properties, it is important for any successful in vitro method to have the ability to test compounds with low aqueous solubility. This is especially true for the medical device industry where device extracts must be prepared in both polar and non-polar vehicles in order to evaluate chemical sensitization. The aim of this research was to demonstrate the functionality and applicability of the human reconstituted skin models (MatTek Epiderm(®) and SkinEthic RHE) as a test system for the evaluation of chemical sensitization and its potential use for medical device testing. In addition, the development of the human 3D skin model should allow the in vitro sensitization assay to be used for finished product testing in the personal care, cosmetics, and pharmaceutical industries. This approach combines solubility, chemical reactivity, cytotoxicity, and activation of the Nrf2/ARE expression pathway to identify and categorize chemical sensitizers. Known chemical sensitizers representing extreme/strong-, moderate-, weak-, and non-sensitizing potency categories were first evaluated in the skin models at six exposure concentrations ranging from 0.1 to 2500 µM for 24 h. The expression of eight Nrf2/ARE, one AhR/XRE and two Nrf1/MRE controlled gene were measured by qRT-PCR. The fold-induction at each exposure concentration was combined with reactivity and cytotoxicity data to determine the sensitization potential. The results demonstrated that
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Implantable Medical Devices; Networking Security Survey
Directory of Open Access Journals (Sweden)
Siamak Aram
2016-08-01
Full Text Available The industry of implantable medical devices (IMDs is constantly evolving, which is dictated by the pressing need to comprehensively address new challenges in the healthcare field. Accordingly, IMDs are becoming more and more sophisticated. Not long ago, the range of IMDs’ technical capacities was expanded, making it possible to establish Internet connection in case of necessity and/or emergency situation for the patient. At the same time, while the web connectivity of today’s implantable devices is rather advanced, the issue of equipping the IMDs with sufficiently strong security system remains unresolved. In fact, IMDs have relatively weak security mechanisms which render them vulnerable to cyber-attacks that compromise the quality of IMDs’ functionalities. This study revolves around the security deficiencies inherent to three types of sensor-based medical devices; biosensors, insulin pump systems and implantable cardioverter defibrillators. Manufacturers of these devices should take into consideration that security and effectiveness of the functionality of implants is highly dependent on the design. In this paper, we present a comprehensive study of IMDs’ architecture and specifically investigate their vulnerabilities at networking interface.
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MedMon: securing medical devices through wireless monitoring and anomaly detection.
Zhang, Meng; Raghunathan, Anand; Jha, Niraj K
2013-12-01
Rapid advances in personal healthcare systems based on implantable and wearable medical devices promise to greatly improve the quality of diagnosis and treatment for a range of medical conditions. However, the increasing programmability and wireless connectivity of medical devices also open up opportunities for malicious attackers. Unfortunately, implantable/wearable medical devices come with extreme size and power constraints, and unique usage models, making it infeasible to simply borrow conventional security solutions such as cryptography. We propose a general framework for securing medical devices based on wireless channel monitoring and anomaly detection. Our proposal is based on a medical security monitor (MedMon) that snoops on all the radio-frequency wireless communications to/from medical devices and uses multi-layered anomaly detection to identify potentially malicious transactions. Upon detection of a malicious transaction, MedMon takes appropriate response actions, which could range from passive (notifying the user) to active (jamming the packets so that they do not reach the medical device). A key benefit of MedMon is that it is applicable to existing medical devices that are in use by patients, with no hardware or software modifications to them. Consequently, it also leads to zero power overheads on these devices. We demonstrate the feasibility of our proposal by developing a prototype implementation for an insulin delivery system using off-the-shelf components (USRP software-defined radio). We evaluate its effectiveness under several attack scenarios. Our results show that MedMon can detect virtually all naive attacks and a large fraction of more sophisticated attacks, suggesting that it is an effective approach to enhancing the security of medical devices.
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A study of RFID application impacts on medical safety.
Chang, She-I; Ou, Chin-Shyh; Ku, Cheng-Yuan; Yang, Morris
2008-01-01
With the international reform in medical management systems gaining ground worldwide, hospital management has gradually begun to shift its focus from providing expensive medical treatment to improving medical service quality and patient safety. In this study, we discuss the application of Radio Frequency Identification (RFID) and data integrating technology with the medical service, and examine whether or not this technology can enhance medical safety. We also discuss the possible benefits following the application of the RFID system. The findings show that the application of RFID to hospitals can actually generate benefits, which can be further divided into operational structure benefits, users' structure benefits, and organisational and environmental benefits. However, not all these benefits can achieve medical safety. Among them, only the operator and environmental benefits can play such roles. Nevertheless, the application of RFID can bring hospitals towards the integration of technology benefits and improved medical safety.
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2015-11-20
The Food and Drug Administration (FDA or the Agency) is classifying the ultraviolet (UV) radiation chamber disinfection device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the UV radiation chamber disinfection device classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
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Value-based purchasing of medical devices.
Obremskey, William T; Dail, Teresa; Jahangir, A Alex
2012-04-01
Health care in the United States is known for its continued innovation and production of new devices and techniques. While the intention of these devices is to improve the delivery and outcome of patient care, they do not always achieve this goal. As new technologies enter the market, hospitals and physicians must determine which of these new devices to incorporate into practice, and it is important these devices bring value to patient care. We provide a model of a physician-engaged process to decrease cost and increase review of physician preference items. We describe the challenges, implementation, and outcomes of cost reduction and product stabilization of a value-based process for purchasing medical devices at a major academic medical center. We implemented a physician-driven committee that standardized and utilized evidence-based, clinically sound, and financially responsible methods for introducing or consolidating new supplies, devices, and technology for patient care. This committee worked with institutional finance and administrative leaders to accomplish its goals. Utilizing this physician-driven committee, we provided access to new products, standardized some products, decreased costs of physician preference items 11% to 26% across service lines, and achieved savings of greater than $8 million per year. The implementation of a facility-based technology assessment committee that critically evaluates new technology can decrease hospital costs on implants and standardize some product lines.
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Kulkarni, Vaman; Kanchan, Tanuj; Palanivel, C; Papanna, M K; Kumar, Nithin; Unnikrishnan, B
2013-05-01
The UN general assembly has declared 2011-2020 as the "Decade of Action for Road Safety". The declaration holds significance because road traffic accidents (RTAs) have become a major cause of morbidity and mortality, especially among the adults and middle aged individuals who constitute economically most productive age groups of society. The importance of knowledge and practice of road safety measures needs to be emphasized in the prevention of RTAs. The present study is aimed to assess the knowledge and practice of road safety measures among the students of a medical college in coastal, South India. A total of 260 medical students were included in this cross-sectional study. A semi-structured questionnaire was used to collect the relevant information from the participants. The data collected was analyzed using SPSS version 11.5. Out of the 260 participants, 149 (57.3%) were females and 111 (42.7%) were males. The overall awareness on road safety measures was slightly higher among females (20.6%) than males (19.9%). The participants had significantly low awareness with regard to alcohol and driving (4.2%), use of seat belts (20%) and use of mobile phones without hands free device (6.1%). The participants had a better knowledge about traffic signs and more than half of them identified all the signs correctly. With regard to the road safety practices, 25% were involved in drunken driving in the past one year. The practice of using mobile phones with hands free devices while driving was admitted by 20% of them. Nearly two-third participants (68%) admitted to have crossed speed limits on multiple occasions. Observations of the study emphasize on the need to generate awareness among medical students through training and IEC activities to curb the epidemic of RTAs. Copyright © 2012 Elsevier Ltd and Faculty of Forensic and Legal Medicine. All rights reserved.
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Fujiwara, Yasuhiro; Fujioka, Hitoshi; Watanabe, Tomoko; Sekiguchi, Maiko; Murakami, Ryuji
2017-09-01
Confirmation of the magnetic resonance (MR) compatibility of implanted medical devices (IMDs) is mandatory before conducting magnetic resonance imaging (MRI) examinations. In Japan, few such confirmation methods are in use, and they are time-consuming. This study aimed to develop a Web-based searchable MR safety information system to confirm IMD compatibility and to evaluate the usefulness of the system. First, MR safety information for intravascular stents and stent grafts sold in Japan was gathered by interviewing 20 manufacturers. These IMDs were categorized based on the descriptions available on medical package inserts as: "MR Safe," "MR Conditional," "MR Unsafe," "Unknown," and "No Medical Package Insert Available". An MR safety information database for implants was created based on previously proposed item lists. Finally, a Web-based searchable system was developed using this database. A questionnaire was given to health-care personnel in Japan to evaluate the usefulness of this system. Seventy-nine datasets were collected using information provided by 12 manufacturers and by investigating the medical packaging of the IMDs. Although the datasets must be updated by collecting data from other manufacturers, this system facilitates the easy and rapid acquisition of MR safety information for IMDs, thereby improving the safety of MRI examinations.
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The potential of medical device industry in technological and economical context.
Maresova, Petra; Penhaker, Marek; Selamat, Ali; Kuca, Kamil
2015-01-01
The high quality of public health improves not only healthy life expectancy, but also the productivity of labor. The most important part of the health care sector is the medical technology industry. The aim of this study is to analyze the current situation in the medical device industry in Europe, its potential strengths and weaknesses in the context of topical economic and demographic development. The contribution specifies an analysis of the economic state of the medical device industry in the context of demographic development of European Union's macroeconomic indicators and views of experts in the field of medical device development, concerning the opportunities for entities involved in the medical device market. There is fierce competition on the European market. The innovative activity is stable and well regulated by responsible authorities. Worldwide, the medical device market is expected to grow.
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2012-03-09
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2012-N-0165] Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus... AND MICROBIOLOGY DEVICES 0 1. The authority citation for 21 CFR part 866 continues to read as follows...
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A safety control device for detecting undesirable conditions
Energy Technology Data Exchange (ETDEWEB)
1974-09-26
The invention relates to safety control devices. It deals with a device adapted to transmit a warning signal and to the detection of an undesirable condition in an associated apparatus, said device comprising switching means comprising transistors mounted in a reaction path, feeding means for opening the switching means whenever an undesirable condition has been detected by sensors, whereby an oscillator is caused to stop oscillating, and an outlet device controlled by the oscillator stoppage. This can be applied to the supervision of nuclear reactor.
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Regulatory affairs for biomaterials and medical devices
Amato, Stephen F; Amato, B
2015-01-01
All biomaterials and medical devices are subject to a long list of regulatory practises and policies which must be adhered to in order to receive clearance. This book provides readers with information on the systems in place in the USA and the rest of the world. Chapters focus on a series of procedures and policies including topics such as commercialization, clinical development, general good practise manufacturing and post market surveillance.Addresses global regulations and regulatory issues surrounding biomaterials and medical devicesEspecially useful for smaller co
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Four Medication Safety Tips for Older Adults
... Products For Consumers Home For Consumers Consumer Updates 4 Medication Safety Tips for Older Adults Share Tweet ... you are experiencing could be due to medications. 4. Review Medications with Your Health Care Provider Ideally, ...
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INTERFACE ELECTRONIC MEDICAL CARD ON MOBILE DEVICE
Directory of Open Access Journals (Sweden)
Y. L. Nechyporenko
2013-05-01
Full Text Available The concept designed by electronic medical card for heterogeneous environment of medical information systems at various levels. Appropriate model and technical solution. Done evaluating operating systems for mobile devices. Designed and produced by the project mobile application on Android OS as an electronic medical record on a Tablet PC Acer.
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Degaspari, John
2011-07-01
Both provider organizations and medical device vendors have made significant, if slow-going, progress over the last several years to network their digitally-enabled medical devices. Recent strides in both the regulatory and standards arenas have provided renewed impetus on the part of both stakeholder groups to bring more interoperability to disparate medical devices, resulting in better security and quality of patient data.
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Current challenges for clinical trials of cardiovascular medical devices.
Zannad, Faiez; Stough, Wendy Gattis; Piña, Ileana L; Mehran, Roxana; Abraham, William T; Anker, Stefan D; De Ferrari, Gaetano M; Farb, Andrew; Geller, Nancy L; Kieval, Robert S; Linde, Cecilia; Redberg, Rita F; Stein, Kenneth; Vincent, Alphons; Woehrle, Holger; Pocock, Stuart J
2014-07-15
Several features of cardiovascular devices raise considerations for clinical trial conduct. Prospective, randomized, controlled trials remain the highest quality evidence for safety and effectiveness assessments, but, for instance, blinding may be challenging. In order to avoid bias and not confound data interpretation, the use of objective endpoints and blinding patients, study staff, core labs, and clinical endpoint committees to treatment assignment are helpful approaches. Anticipation of potential bias should be considered and planned for prospectively in a cardiovascular device trial. Prospective, single-arm studies (often referred to as registry studies) can provide additional data in some cases. They are subject to selection bias even when carefully designed; thus, they are generally not acceptable as the sole basis for pre-market approval of high risk cardiovascular devices. However, they complement the evidence base and fill the gaps unanswered by randomized trials. Registry studies present device safety and effectiveness in day-to-day clinical practice settings and detect rare adverse events in the post-market period. No single research design will be appropriate for every cardiovascular device or target patient population. The type of trial, appropriate control group, and optimal length of follow-up will depend on the specific device, its potential clinical benefits, the target patient population and the existence (or lack) of effective therapies, and its anticipated risks. Continued efforts on the part of investigators, the device industry, and government regulators are needed to reach the optimal approach for evaluating the safety and performance of innovative devices for the treatment of cardiovascular disease. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.
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78 FR 18233 - Medical Devices; Technical Amendment
2013-03-26
... human environment. Therefore, neither an environmental assessment nor an environmental impact statement..., Confidential business information, Medical devices, Medical research, Reporting and recordkeeping requirements... revising the second sentence in paragraph (a) to read as follows: Sec. 870.3600 External pacemaker pulse...
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A root cause analysis project in a medication safety course.
Schafer, Jason J
2012-08-10
To develop, implement, and evaluate team-based root cause analysis projects as part of a required medication safety course for second-year pharmacy students. Lectures, in-class activities, and out-of-class reading assignments were used to develop students' medication safety skills and introduce them to the culture of medication safety. Students applied these skills within teams by evaluating cases of medication errors using root cause analyses. Teams also developed error prevention strategies and formally presented their findings. Student performance was assessed using a medication errors evaluation rubric. Of the 211 students who completed the course, the majority performed well on root cause analysis assignments and rated them favorably on course evaluations. Medication error evaluation and prevention was successfully introduced in a medication safety course using team-based root cause analysis projects.
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DEFF Research Database (Denmark)
Zawadzki, Antoni; Johnson, Louis Banka; Bohe, Måns
2017-01-01
PURPOSE: It has been proposed that biological/chemical substances in the intestine might play a role in the occurrence and deterioration of perianal fistulas. Elimination of such unidentified factors from the lower gastrointestinal tract might offer a new strategy for the management of anal...... fistulas. The aim of this study was to evaluate the clinical effects on non-Crohn's disease perianal fistula healing, and the safety and tolerability of a new medical device that applies high-purity, high-activity granular activated carbon locally into the rectum twice daily of patients with perianal...... fistulas without any concomitant medication. METHODS: An open, single-arm, prospective study with active treatment for 8 weeks and an optional follow-up until week 24 ( ClinicalTrial.gov identifier NCT01462747) among patients with chronic, uncomplicated perianal fistulas scheduled for surgery was conducted...
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2011-10-20
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee: Notice of... Administration (FDA) is postponing the meeting of the General and Plastic Surgery Devices Panel of the Medical...
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2014-01-01
After two recent security attacks against implantable medical devices (IMDs) have been reported, the privacy and security risks of IMDs have been widely recognized in the medical device market and research community, since the malfunctioning of IMDs might endanger the patient's life. During the last few years, a lot of researches have been carried out to address the security-related issues of IMDs, including privacy, safety, and accessibility issues. A physician accesses IMD through an external device called a programmer, for diagnosis and treatment. Hence, cryptographic key management between IMD and programmer is important to enforce a strict access control. In this paper, a new security architecture for the security of IMDs is proposed, based on a 3-Tier security model, where the programmer interacts with a Hospital Authentication Server, to get permissions to access IMDs. The proposed security architecture greatly simplifies the key management between IMDs and programmers. Also proposed is a security mechanism to guarantee the authenticity of the patient data collected from IMD and the nonrepudiation of the physician's treatment based on it. The proposed architecture and mechanism are analyzed and compared with several previous works, in terms of security and performance. PMID:25276797
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Park, Chang-Seop
2014-01-01
After two recent security attacks against implantable medical devices (IMDs) have been reported, the privacy and security risks of IMDs have been widely recognized in the medical device market and research community, since the malfunctioning of IMDs might endanger the patient's life. During the last few years, a lot of researches have been carried out to address the security-related issues of IMDs, including privacy, safety, and accessibility issues. A physician accesses IMD through an external device called a programmer, for diagnosis and treatment. Hence, cryptographic key management between IMD and programmer is important to enforce a strict access control. In this paper, a new security architecture for the security of IMDs is proposed, based on a 3-Tier security model, where the programmer interacts with a Hospital Authentication Server, to get permissions to access IMDs. The proposed security architecture greatly simplifies the key management between IMDs and programmers. Also proposed is a security mechanism to guarantee the authenticity of the patient data collected from IMD and the nonrepudiation of the physician's treatment based on it. The proposed architecture and mechanism are analyzed and compared with several previous works, in terms of security and performance.
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Use of digital computing devices in systems important to safety
International Nuclear Information System (INIS)
1986-01-01
The incorporation of digital computing devices in systems important to safety now is progressing fast in several countries, including Canada, France, Federal Republic of Germany, Japan, USA. There are now reactors with microprocessors in some trip systems. The major functions of those systems are: reactor trip initiation, display, monitoring, testing, re-calibration of detectors. The benefits of moving to a fully computerized shut-down system should be improved reliability, greater flexibility, better man-machine interface, improved testing, higher reactor output and lower overall cost. With the introduction of computer devices in systems important to safety, plant availability and safety are improved because disturbances are treated before they lead to safety action, in this way helping the operator to avoid errors. The Meeting presentations were divided into sessions devoted to the following topics: Needs for the use of digital devices (DCD) in safety important systems (SIS) (5 papers); Problems raised by the integration SIS in the NPP control (7 papers); Description and presentation of DCD of SIS (6 papers); Results of experiences in engineering, manufacture, qualification operation of DCD hardware and software (5 papers). A separate abstract was prepared for each of these papers
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Prospects of radiation sterilization of medical devices
International Nuclear Information System (INIS)
Hosobuchi, Kazunari
1992-01-01
Since radiation sterilization was first introduced in the United States in 1956 in the field of disposable medical devices, it has become an indispensable technique for sterilization because of the following reasons: (1) introduction into dialyzers, (2) introduction in medical device makers, (3) development of disposable medical devices associated with developing both high molecular chemistry and cool sterilization, (4) rationality of sterilization process, and (5) problems of sterilization with ethylene oxide gas. To promote the further development of radiation sterilization, the following items are considered necessary: (1) an increase in the number of facilities for radiation sterilization, (2) recommendation of the international standardization of sterilization method, (3) decrease in radiation doses associated with sterilization, (4) development of electron accelerators and bremsstrahlung equipments for radiation sources, and (5) simplification of sterilization process management. Factors precluding the development of radiation sterilization are: (1) development of other methods than radiation sterilization, (2) development of technique for sterile products, (3) high facility cost, (4) high irradiation cost, (5) benefits and limits of sterilization markets, and (6) influences of materials. (N.K.)
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Electronic medical devices: a primer for pathologists.
Weitzman, James B
2003-07-01
Electronic medical devices (EMDs) with downloadable memories, such as implantable cardiac pacemakers, defibrillators, drug pumps, insulin pumps, and glucose monitors, are now an integral part of routine medical practice in the United States, and functional organ replacements, such as the artificial heart, pancreas, and retina, will most likely become commonplace in the near future. Often, EMDs end up in the hands of the pathologist as a surgical specimen or at autopsy. No established guidelines for systematic examination and reporting or comprehensive reviews of EMDs currently exist for the pathologist. To provide pathologists with a general overview of EMDs, including a brief history; epidemiology; essential technical aspects, indications, contraindications, and complications of selected devices; potential applications in pathology; relevant government regulations; and suggested examination and reporting guidelines. Articles indexed on PubMed of the National Library of Medicine, various medical and history of medicine textbooks, US Food and Drug Administration publications and product information, and specifications provided by device manufacturers. Studies were selected on the basis of relevance to the study objectives. Descriptive data were selected by the author. Suggested examination and reporting guidelines for EMDs received as surgical specimens and retrieved at autopsy. Electronic medical devices received as surgical specimens and retrieved at autopsy are increasing in number and level of sophistication. They should be systematically examined and reported, should have electronic memories downloaded when indicated, will help pathologists answer more questions with greater certainty, and should become an integral part of the formal knowledge base, research focus, training, and practice of pathology.
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Haghi, Mostafa; Thurow, Kerstin; Stoll, Regina
2017-01-01
Wearable devices are currently at the heart of just about every discussion related to the Internet of Things. The requirement for self-health monitoring and preventive medicine is increasing due to the projected dramatic increase in the number of elderly people until 2020. Developed technologies are truly able to reduce the overall costs for prevention and monitoring. This is possible by constantly monitoring health indicators in various areas, and in particular, wearable devices are considered to carry this task out. These wearable devices and mobile apps now have been integrated with telemedicine and telehealth efficiently, to structure the medical Internet of Things. This paper reviews wearable health care devices both in scientific papers and commercial efforts. MIoT is demonstrated through a defined architecture design, including hardware and software dealing with wearable devices, sensors, smart phones, medical application, and medical station analyzers for further diagnosis and data storage. Wearables, with the help of improved technology have been developed greatly and are considered reliable tools for long-term health monitoring systems. These are applied in the observation of a large variety of health monitoring indicators in the environment, vital signs, and fitness. Wearable devices are now used for a wide range of healthcare observation. One of the most important elements essential in data collection is the sensor. During recent years with improvement in semiconductor technology, sensors have made investigation of a full range of parameters closer to realization.
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The Style Evolution of Glasses: Acknowledging Well-being for Wearable Medical Device
Directory of Open Access Journals (Sweden)
Lydia Royeen
2015-10-01
Full Text Available The focus of Peta Bush’s work is to create wearable medical devices that address all qualities of the individual, including physical, mental, emotional, and psychosocial aspects. Peta is completing a practice-based research PhD titled “Therapeutic jewelry: The craft of people-centric devices for wellbeing.” Her passion for creating wearable medical devices that are multi-dimensional stems from her personal experiences, as she has Ehlers-Danlos syndrome. In addition, she uses her knowledge of well-being and the biopsychosocial model when creating her wearable medical devices. Peta currently uses technology, such as 3D printing, as one method to fabricate her collection. Her aspirations are for this concept of wearable medical devices to become mainstream, similar to glasses, and to remove the stigma associated with wearable medical devices.
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2013-02-22
... medical devices to take timely action to correct violative devices or remove them from the marketplace...] Distinguishing Medical Device Recalls From Product Enhancements; Reporting Requirements; Draft Guidance for... draft guidance entitled ``Distinguishing Medical Device Recalls From Product Enhancements; Reporting...
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International Nuclear Information System (INIS)
Ghosh, Dilip; Skinner, Margot; Ferguson, Lynnette R.
2006-01-01
Currently, the regulation of complementary and alternative medicines and related health claims in Australia and New Zealand is managed in a number of ways. Complementary medicines, including herbal, minerals, nutritional/dietary supplements, aromatherapy oils and homeopathic medicines are regulated under therapeutic goods/products legislation. The Therapeutic Goods Administration (TGA), a division of the Commonwealth Department of Health and Ageing is responsible for administering the provisions of the legislation in Australia. The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) administers the provision of legislation in New Zealand. In December 2003 the Australian and New Zealand governments signed a Treaty to establish a single, bi-national agency to regulate therapeutic products, including medical devices prescription, over-the-counter and complementary medicines. A single agency will replace the Australian TGA and the New Zealand Medsafe. The role of the new agency will be to safeguard public health through regulation of the quality, safety and efficacy or performance of therapeutic products in both Australia and New Zealand. The major activities of the new joint Australia New Zealand therapeutic products agency are in product licensing, specifying labelling standards and setting the advertising scheme, together with determining the risk classes of medicines and creating an expanded list of ingredients permitted in Class I medicines. A new, expanded definition of complementary medicines is proposed and this definition is currently under consultation. Related Australian and New Zealand legislation is being developed to implement the joint scheme. Once this legislation is passed, the Treaty will come into force and the new joint regulatory scheme will begin. The agency is expected to commence operation no later than 1 July 2006 and will result in a single agency to regulate complementary and alternative medicines
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[Thoughts on the Witnessed Audit in Medical Device Single Audit Program].
Wen, Jing; Xiao, Jiangyi; Wang, Aijun
2018-02-08
Medical Device Single Audit Program is one of the key projects in International Medical Device Regulators Forum, which has much experience to be used for reference. This paper briefly describes the procedures and contents of the Witnessed Audit in Medical Device Single Audit Program. Some revelations about the work of Witnessed Audit have been discussed, for reference by the Regulatory Authorities and the Auditing Organizations.
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Radiation sterilization and volatile matter used for medical devices touching to blood
Energy Technology Data Exchange (ETDEWEB)
Nakamura, Akitada; Sato, Michio; Igarashi, Yoshiaki; Yagami, Takeshi [National Inst. of Health Sciences, Tokyo (Japan); Yoshii, Fumio
1998-02-01
In this study, it was conducted by using chemical analysis and cell toxic test if any volatile matter actually on radiation, if any matter could be detected when its generating, if it stayed to a safe volume range, and so forth. Objective materials of this study focus the elements used for medical devices always touching blood having large effect on human bodies. In this fiscal year, because of many cases of sterilization after filling water and necessary gas-liquid equilibrium for quantitative method using a head space when actually using the materials for dialyzer, irradiation was conducted after filling water into the material, comparison of gas volume and evaluation of safety with those of conventional experiments. As a result, by {gamma}-ray irradiation, various matters are formed, and some volatile matters less than some ng level in present volume could be detected. However, from a standpoint of safety data and forming volume of the cell toxic test results, there were no matter anxious to safety. Furthermore, the present dialyzer and others are washed before using chemically, and its safety seems to be fully held. (G.K.)
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Radiation sterilization and volatile matter used for medical devices touching to blood
International Nuclear Information System (INIS)
Nakamura, Akitada; Sato, Michio; Igarashi, Yoshiaki; Yagami, Takeshi; Yoshii, Fumio
1998-01-01
In this study, it was conducted by using chemical analysis and cell toxic test if any volatile matter actually on radiation, if any matter could be detected when its generating, if it stayed to a safe volume range, and so forth. Objective materials of this study focus the elements used for medical devices always touching blood having large effect on human bodies. In this fiscal year, because of many cases of sterilization after filling water and necessary gas-liquid equilibrium for quantitative method using a head space when actually using the materials for dialyzer, irradiation was conducted after filling water into the material, comparison of gas volume and evaluation of safety with those of conventional experiments. As a result, by γ-ray irradiation, various matters are formed, and some volatile matters less than some ng level in present volume could be detected. However, from a standpoint of safety data and forming volume of the cell toxic test results, there were no matter anxious to safety. Furthermore, the present dialyzer and others are washed before using chemically, and its safety seems to be fully held. (G.K.)
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Safety Features of Material and Personnel Movement Devices. Module SH-25. Safety and Health.
Center for Occupational Research and Development, Inc., Waco, TX.
This student module on safety features of material and personnel movement devices is one of 50 modules concerned with job safety and health. This module covers safe conditions and operating practices for conveyors, elevators, escalators, moving walks, manlifts, forklifts, and motorized hand trucks. Following the introduction, 10 objectives (each…
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Medical device development: managing conflicts of interest encountered by physicians.
Baim, Donald S; Donovan, Aine; Smith, John J; Briefs, Nancy; Geoffrion, Richard; Feigal, David; Kaplan, Aaron V
2007-04-01
New technologies introduced over the past three decades have transformed medical diagnosis and treatment, and significantly improved patient outcomes. These changes have been mediated by the introduction of new medical devices, particularly for the treatment of cardiovascular, orthopedic, and ophthalmic disorders. These devices, in turn, have created large markets and spawned a burgeoning medical device industry, including six Fortune 500 companies whose combined market capitalization now exceeds 400 billion dollars. This success story, which has unquestionably benefited patients and society alike, has been dependent upon an intense collaboration among industry, clinicians, and regulatory authorities. However, when physicians actively involved in patient care participate in such collaborations, they are increasingly vulnerable to creating potential conflicts between these two (clinical and device development) roles. Such conflicts, which may ultimately erode public trust, have important consequences not only for the individual physicians, but also for their parent institutions, their patients, sponsoring companies, and the entire clinical research enterprise that makes the development and introduction of new devices possible. The third Dartmouth Device Development Symposium held in October 2005 brought together thought leaders within the medical device community, including academicians, clinical investigators, regulators from the Food and Drug Administration and Centers for Medicare and Medicaid Services (CMS), large and small device manufacturers and the financial (venture capital and investment banks) community. The Symposium examined the conflicts of interest encountered during the early development and commercialization of a medical device. The goal of these discussions was to (1) identify and characterize the conflicts that arise and (2) provide strategies to address these conflicts. This manuscript was prepared by a writing committee to provide a summary
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FAST and SAFE Passive Safety Devices for Sodium-cooled Fast Reactor
Energy Technology Data Exchange (ETDEWEB)
Hartanto, Donny; Kim, Chihyung; Kim, In-Hyung; Kim, Yonghee [KAIST, Daejeon (Korea, Republic of)
2015-05-15
The major factor is the impact of the neutron spectral hardening. The second factor that affects the CVR is reduced capture by the coolant when the coolant voiding occurs. To improve the CVR, many ideas and concepts have been proposed, which include introduction of an internal blanket, spectrum softening, or increasing the neutron leakage. These ideas may reduce the CVR, but they deteriorate the neutron economy. Another potential solution is to adopt a passive safety injection device such as the ARC (autonomous reactivity control) system, which is still under development. In this paper, two new concepts of passive safety devices are proposed. The devices are called FAST (Floating Absorber for Safety at Transient) and SAFE (Static Absorber Feedback Equipment). Their purpose is to enhance the negative reactivity feedback originating from the coolant in fast reactors. SAFE is derived to balance the positive reactivity feedback due to sodium coolant temperature increases. It has been demonstrated that SAFE allows a low-leakage SFR to achieve a self-shutdown and self-controllability even though the generic coolant temperature coefficient is quite positive and the coolant void reactivity can be largely managed by the new FAST device. It is concluded that both FAST and SAFE devices will improve substantially the fast reactor safety and they deserve more detailed investigations.
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Cybersecurity vulnerabilities in medical devices: a complex environment and multifaceted problem.
Williams, Patricia Ah; Woodward, Andrew J
2015-01-01
The increased connectivity to existing computer networks has exposed medical devices to cybersecurity vulnerabilities from which they were previously shielded. For the prevention of cybersecurity incidents, it is important to recognize the complexity of the operational environment as well as to catalog the technical vulnerabilities. Cybersecurity protection is not just a technical issue; it is a richer and more intricate problem to solve. A review of the factors that contribute to such a potentially insecure environment, together with the identification of the vulnerabilities, is important for understanding why these vulnerabilities persist and what the solution space should look like. This multifaceted problem must be viewed from a systemic perspective if adequate protection is to be put in place and patient safety concerns addressed. This requires technical controls, governance, resilience measures, consolidated reporting, context expertise, regulation, and standards. It is evident that a coordinated, proactive approach to address this complex challenge is essential. In the interim, patient safety is under threat.
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Cybersecurity vulnerabilities in medical devices: a complex environment and multifaceted problem
Williams, Patricia AH; Woodward, Andrew J
2015-01-01
The increased connectivity to existing computer networks has exposed medical devices to cybersecurity vulnerabilities from which they were previously shielded. For the prevention of cybersecurity incidents, it is important to recognize the complexity of the operational environment as well as to catalog the technical vulnerabilities. Cybersecurity protection is not just a technical issue; it is a richer and more intricate problem to solve. A review of the factors that contribute to such a potentially insecure environment, together with the identification of the vulnerabilities, is important for understanding why these vulnerabilities persist and what the solution space should look like. This multifaceted problem must be viewed from a systemic perspective if adequate protection is to be put in place and patient safety concerns addressed. This requires technical controls, governance, resilience measures, consolidated reporting, context expertise, regulation, and standards. It is evident that a coordinated, proactive approach to address this complex challenge is essential. In the interim, patient safety is under threat. PMID:26229513
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2010-11-05
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 892 [Docket No. FDA-2008-N-0273] Medical Devices; Radiology Devices; Reclassification of Full- Field Digital... and Drugs, 21 CFR part 892 is amended as follows: PART 892--RADIOLOGY DEVICES 0 1. The authority...
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Identification of Bodies by Unique Serial Numbers on Implanted Medical Devices.
Blessing, Melissa M; Lin, Peter T
2018-05-01
Visual identification is the most common identification method used by medical examiners but is not always possible. Alternative methods include X-ray, fingerprint, or DNA comparison, but these methods require additional resources. Comparison of serial numbers on implanted medical devices is a rapid and definitive method of identification. To assess the practicality of using this method, we reviewed 608 consecutive forensic autopsies performed at a regional medical examiner office. Of these, 56 cases required an alternative method of identification due to decomposition (n = 35), gunshot wound (n = 9), blunt trauma (n = 6), or charring (n = 6). Of these 56 cases, eight (14.3%) were known to have an implanted medical device. Of these eight cases, five (63%) could be positively identified by comparing serial numbers. If an implanted medical device is known to be present, and medical records are available, identification by medical device serial number should be a first-line method. © 2017 American Academy of Forensic Sciences.
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MEDIC: medical embedded device for individualized care.
Wu, Winston H; Bui, Alex A T; Batalin, Maxim A; Au, Lawrence K; Binney, Jonathan D; Kaiser, William J
2008-02-01
Presented work highlights the development and initial validation of a medical embedded device for individualized care (MEDIC), which is based on a novel software architecture, enabling sensor management and disease prediction capabilities, and commercially available microelectronic components, sensors and conventional personal digital assistant (PDA) (or a cell phone). In this paper, we present a general architecture for a wearable sensor system that can be customized to an individual patient's needs. This architecture is based on embedded artificial intelligence that permits autonomous operation, sensor management and inference, and may be applied to a general purpose wearable medical diagnostics. A prototype of the system has been developed based on a standard PDA and wireless sensor nodes equipped with commercially available Bluetooth radio components, permitting real-time streaming of high-bandwidth data from various physiological and contextual sensors. We also present the results of abnormal gait diagnosis using the complete system from our evaluation, and illustrate how the wearable system and its operation can be remotely configured and managed by either enterprise systems or medical personnel at centralized locations. By using commercially available hardware components and software architecture presented in this paper, the MEDIC system can be rapidly configured, providing medical researchers with broadband sensor data from remote patients and platform access to best adapt operation for diagnostic operation objectives.
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Medical applications for pharmacists using mobile devices.
Aungst, Timothy Dy
2013-01-01
Mobile devices (eg, smartphones, tablet computers) have become ubiquitous and subsequently there has been a growth in mobile applications (apps). Concurrently, mobile devices have been integrated into health care practice due to the availability and quality of medical apps. These mobile medical apps offer increased access to clinical references and point-of-care tools. However, there has been little identification of mobile medical apps suitable for the practice of pharmacy. To address the shortage of recommendations of mobile medical apps for pharmacists in daily practice. Mobile medical apps were identified via the iTunes and Google Play Stores via the "Medical" app categories and key word searches (eg, drug information, medical calculators). In addition, reviews provided by professional mobile medical app review websites were used to identify apps. Mobile medical apps were included if they had been updated in the previous 3 months, were available in the US, used evidence-based information or literature support, had dedicated app support, and demonstrated stability. Exclusion criteria included apps that were not available in English, had advertisement bias, used nonreferenced sources, were available only via an institution-only subscription, and were web-based portals. Twenty-seven mobile apps were identified and reviewed that involved general pharmacy practice, including apps that involved drug references, clinical references, medical calculators, laboratory references, news and continuing medical education, and productivity. Mobile medical apps have a variety of features that are beneficial to pharmacy practice. Individual clinicians should consider several characteristics of these apps to determine which are suitable to incorporate into their daily practice.
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Developing medical device software in compliance with regulations.
Zema, M; Rosati, S; Gioia, V; Knaflitz, M; Balestra, G
2015-08-01
In the last decade, the use of information technology (IT) in healthcare has taken a growing role. In fact, the adoption of an increasing number of computer tools has led to several benefits related to the process of patient care and allowed easier access to social and health care resources. At the same time this trend gave rise to new challenges related to the implementation of these new technologies. Software used in healthcare can be classified as medical devices depending on the way they are used and on their functional characteristics. If they are classified as medical devices they must satisfy specific regulations. The aim of this work is to present a software development framework that can allow the production of safe and high quality medical device software and to highlight the correspondence between each software development phase and the appropriate standard and/or regulation.
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21 CFR 801.122 - Medical devices for processing, repacking, or manufacturing.
2010-04-01
....122 Medical devices for processing, repacking, or manufacturing. A device intended for processing... act if its label bears the statement “Caution: For manufacturing, processing, or repacking”. ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices for processing, repacking, or...
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Handheld Diagnostic Device Delivers Quick Medical Readings
2014-01-01
To monitor astronauts' health remotely, Glenn Research Center awarded SBIR funding to Cambridge, Massachusetts-based DNA Medical Institute, which developed a device capable of analyzing blood cell counts and a variety of medical biomarkers. The technology will prove especially useful in rural areas without easy access to labs.
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Taylor, Natalie; Bamford, Thomas; Haindl, Cornelia; Cracknell, Alison
2016-04-01
Significant deficiencies exist in the knowledge and skills of medical students and residents around health care quality and safety. The theory and practice of quality and safety should be embedded into undergraduate medical practice so that health care professionals are capable of developing interventions and innovations to effectively anticipate and mitigate errors. Since 2011, Leeds Medical School in the United Kingdom has used case study examples of nasogastric (NG) tube patient safety incidents within the undergraduate patient safety curriculum. In 2012, a medical undergraduate student approached a clinician with an innovative idea after undertaking an NG tubes root cause analysis case study. Simultaneously, a separate local project demonstrated low compliance (11.6%) with the United Kingdom's National Patient Safety Agency NG tubes guideline for use of the correct method to check tube position. These separate endeavors led to interdisciplinary collaboration between a medical student, health care professionals, researchers, and industry to develop the Initial Placement Nasogastric Tube Safety Pack. Human factors engineering was used to inform pack design to allow guideline recommendations to be accessible and easy to follow. A timeline of product development, mapped against key human factors and medical device design principles used throughout the process, is presented. The safety pack has since been launched in five UK National Health Service (NHS) hospitals, and the pack has been introduced into health care professional staff training for NG tubes. A mixed-methods evaluation is currently under way in five NHS organizations.
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Medical device problem reporting for the betterment of healthcare.
1998-08-01
Given that there are nearly 5,000 individual classes of medical devices, tens of thousands of medical device suppliers, and millions of healthcare providers around the world, device-related problems are bound to happen. But effective problem reporting can help reduce or eliminate many of these problems--not only within an institution, but also potentially around the world. In this article, we trace the problem reporting process from its beginnings in the hospital to its global impact in making critical information available throughout the healthcare community.
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Radiation sterilization of medical devices
International Nuclear Information System (INIS)
Kaluska, I.; Stuglik, Z.
1996-01-01
Overview of sterilization methods of medical devices has been given, with the special stress put on radiation sterilization. A typical validation program for radiation sterilization has been shown and also a comparison of European and ISO standards concerning radiation sterilization has been discussed. (author). 13 refs, 1 fig., 2 tabs
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2012-04-02
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2012-N-0165] Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus Serological Reagents; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; correction...
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Drozda, Joseph P; Roach, James; Forsyth, Thomas; Helmering, Paul; Dummitt, Benjamin; Tcheng, James E
2018-02-01
The US Food and Drug Administration (FDA) has recognized the need to improve the tracking of medical device safety and performance, with implementation of Unique Device Identifiers (UDIs) in electronic health information as a key strategy. The FDA funded a demonstration by Mercy Health wherein prototype UDIs were incorporated into its electronic information systems. This report describes the demonstration's informatics architecture. Prototype UDIs for coronary stents were created and implemented across a series of information systems, resulting in UDI-associated data flow from manufacture through point of use to long-term follow-up, with barcode scanning linking clinical data with UDI-associated device attributes. A reference database containing device attributes and the UDI Research and Surveillance Database (UDIR) containing the linked clinical and device information were created, enabling longitudinal assessment of device performance. The demonstration included many stakeholders: multiple Mercy departments, manufacturers, health system partners, the FDA, professional societies, the National Cardiovascular Data Registry, and information system vendors. The resulting system of systems is described in detail, including entities, functions, linkage between the UDIR and proprietary systems using UDIs as the index key, data flow, roles and responsibilities of actors, and the UDIR data model. The demonstration provided proof of concept that UDIs can be incorporated into provider and enterprise electronic information systems and used as the index key to combine device and clinical data in a database useful for device evaluation. Keys to success and challenges to achieving this goal were identified. Fundamental informatics principles were central to accomplishing the system of systems model. © The Author 2017. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com
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Hasan, Reema; Ghanbari, Hamid; Feldman, Dustin; Menesses, Daniel; Rivas, Daniel; Zakhem, Nicole C; Duarte, Carlos; Machado, Christian
2011-06-01
Patients in underdeveloped nations have limited access to life-saving medical technology including cardiac rhythm management (CRM) devices. We evaluated alternative means to provide such technology to this patient population while assessing the safety and efficacy of such a practice. Patients in the United States with clinical indications for extraction of CRM devices were consented. Antemortem CRM devices were cleaned and sterilized following a protocol established at our institution. Surveillance in vitro cultures were performed for quality assurance. The functional status of pulse generators was tested with a pacing system analyzer to confirm at least 70% battery life. Most generators were transported, in person, to an implanting institution in Nicaragua. Recipients with a Class I indication for CRM implantation, and meeting economical criteria set forth, were consented for implantation of a recycled device. Between 2003 and 2009, implantation was performed in 17 patients with an average age of 42.1 ± 20.3 years. Of the 17 patients, nine were male and eight were female. Mean follow-up was 68 ± 38 months. Device evaluation occurred prior to discharge, 4 weeks post implantation, and every 6 months thereafter. There were three deaths during the follow-up period secondary to myocardial infarction, stroke, and heart failure. Hematoma formation occurred in one patient. No infections, early battery depletion, or device malfunction were identified during follow-up. Our case series is the longest follow-up of recipients of recycled antemortem CRM devices. Our findings support the feasibility and safety of this alternative acquisition of life-saving technology. ©2011, The Authors. Journal compilation ©2011 Wiley Periodicals, Inc.
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... for Mental Illnesses Clinical Trials Outreach Outreach Home Stakeholder Engagement Outreach Partnership Program Alliance for Research Progress ... public health by ensuring the safety, efficacy and security of drugs (medications), biological products, medical devices, our ...
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Directory of Open Access Journals (Sweden)
Ross JS
2017-08-01
Full Text Available Joseph S Ross,1–4 Jonathan Bates,4 Craig S Parzynski,4 Joseph G Akar,4,5 Jeptha P Curtis,4,5 Nihar R Desai,4,5 James V Freeman,4,5 Ginger M Gamble,4 Richard Kuntz,6 Shu-Xia Li,4 Danica Marinac-Dabic,7 Frederick A Masoudi,8 Sharon-Lise T Normand,9,10 Isuru Ranasinghe,11 Richard E Shaw,12 Harlan M Krumholz2–5 1Section of General Medicine, Department of Medicine, 2Robert Wood Johnson Foundation Clinical Scholars Program, Yale School of Medicine, 3Department of Health Policy and Management, Yale School of Public Health, 4Center for Outcomes Research and Evaluation, Yale–New Haven Hospital, 5Section of Cardiovascular Medicine, Department of Medicine, Yale School of Medicine, New Haven, CT, 6Medtronic Inc, Minneapolis, MN, 7Division of Epidemiology, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD, 8Division of Cardiology, Department of Medicine, University of Colorado, Aurora, CO, 9Department of Health Care Policy, Harvard Medical School, 10Department of Biostatistics, Harvard TH Chan School of Public Health, Boston, MA, USA; 11Discipline of Medicine, University of Adelaide, Adelaide, SA, Australia; 12Department of Clinical Informatics, California Pacific Medical Center, San Francisco, CA, USA Background: Machine learning methods may complement traditional analytic methods for medical device surveillance.Methods and results: Using data from the National Cardiovascular Data Registry for implantable cardioverter–defibrillators (ICDs linked to Medicare administrative claims for longitudinal follow-up, we applied three statistical approaches to safety-signal detection for commonly used dual-chamber ICDs that used two propensity score (PS models: one specified by subject-matter experts (PS-SME, and the other one by machine learning-based selection (PS-ML. The first approach used PS-SME and cumulative incidence (time-to-event, the second approach used PS-SME and cumulative risk (Data Extraction and
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Liability for damage caused by shortage and failure to use necessary medical devices
Directory of Open Access Journals (Sweden)
Cvetković Mihajlo
2014-01-01
Full Text Available In order to provide for successful, safe and high quality medical services, health care institutions need to be equipped with adequate medical devices. For this reason, every medical institution is legally obliged to have relevant medical devices. In case a patient has been deprived of some medical service for the lack of necessary medical devices (which the institution has been obliged to provide, the medical institution is responsible for the damage and harm sustained by the patient. The responsibility implies non-contractual liability (in tort law or pre-contractual liability (in contract law. In both cases, the liability is based on the presumed culpability. In order to be excluded from liability, the medical institution has to prove that the patient has been deprived of medical service (or that the institution has refused to enter into a medical service provider agreement on justifiable grounds, i.e. due to the lack of necessary medical devices. On the other hand, in case the medial institutions fail to provide needed care or violate their obligation to use medical devices when necessary, it is regarded as medical negligence (professional error. In most cases, it implies the liability of medical institutions for damage, injury or harm caused to the patient by medical services provided without applying a relevant medical device, whose use has been medically indicated. The liability is even more substantial in cases where the medical device has been available but the medical institutions has not applied it in medial treatment (even though its use has been medically indicated; such conduct is qualified as gross negligence.
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2011-07-20
... type of device must submit to FDA a premarket notification, prior to marketing the device, which... Orders 12866 and 13563 direct Agencies to assess all costs and benefits of available regulatory... (including potential economic, environmental, public health and safety, and other advantages; distributive...
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Closed medical negligence claims can drive patient safety and reduce litigation.
Pegalis, Steven E; Bal, B Sonny
2012-05-01
Medical liability reform is viewed by many physician groups as a means of reducing medical malpractice litigation and lowering healthcare costs. However, alternative approaches such as closed medical negligence claims data may also achieve these goals. We asked whether information gleaned from closed claims related to medical negligence could promote patient safety and reduce costs related to medical liability. Specifically, we investigated whether physician groups have examined such data to identify error patterns and to then institute specific patient treatment protocols. We searched for medical societies that have systematically examined closed medical negligence claims in their specialty to develop specific standards of physician conduct. We then searched the medical literature for published evidence of the efficacy, if any, related to the patient safety measures thus developed. Anesthesia and obstetric physician societies have successfully targeted costs and related concerns arising from medical malpractice lawsuits by using data from closed claims to develop patient safety and treatment guidelines. In both specialties, after institution of safety measures derived from closed medical negligence claims, the incidence and costs related to medical malpractice decreased and physician satisfaction improved. Tort reform, in the form of legislatively prescribed limits on damages arising from lawsuits, is not the only means of addressing the incidence and costs related to medical malpractice litigation. As the experience of anesthesia and obstetric physicians has demonstrated, safety guidelines derived from analyzing past medical malpractice litigation can achieve the same goals while also promoting patient safety.
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Evaluation of Patient and Family Engagement Strategies to Improve Medication Safety.
Kim, Julia M; Suarez-Cuervo, Catalina; Berger, Zackary; Lee, Joy; Gayleard, Jessica; Rosenberg, Carol; Nagy, Natalia; Weeks, Kristina; Dy, Sydney
2018-04-01
Patient and family engagement (PFE) is critical for patient safety. We systematically reviewed types of PFE strategies implemented and their impact on medication safety. We searched MEDLINE, EMBASE, reference lists and websites to August 2016. Two investigators independently reviewed all abstracts and articles, and articles were additionally reviewed by two senior investigators for selection. One investigator abstracted data and two investigators reviewed the data for accuracy. Study quality was determined by consensus. Investigators developed a framework for defining the level of patient engagement: informing patients about medications (Level 1), informing about engagement with health care providers (Level 2), empowering patients with communication tools and skills (Level 3), partnering with patients in their care (Level 4), and integrating patients as full care team members (Level 5). We included 19 studies that mostly targeted older adults taking multiple medications. The median level of engagement was 2, ranging from 2-4. We identified no level 5 studies. Key themes for patient engagement strategies impacting medication safety were patient education and medication reconciliation, with a subtheme of patient portals. Most studies (84%) reported implementation outcomes. The most commonly reported medication safety outcomes were medication errors, including near misses and discrepancies (47%), and medication safety knowledge (37%). Most studies (63%) were of medium to low quality, and risk of bias was generally moderate. Among the 11 studies with control groups, 55% (n = 6) reported statistically significant improvement on at least one medication safety outcome. Further synthesis of medication safety measures was limited due to intervention and outcome heterogeneity. Key strategies for engaging patients in medication safety are education and medication reconciliation. Patient engagement levels were generally low, as defined by a novel framework for determining
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2014-07-08
The Food and Drug Administration (FDA) is classifying the transcranial magnetic stimulator for headache into class II (special controls). The special controls that will apply to the device are identified in this order, and will be part of the codified language for the transcranial magnetic stimulator for headache classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
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Effect of electronic device use on pedestrian safety : a literature review.
2016-04-01
This literature review on the effect of electronic device use on pedestrian safety is part of a research project sponsored by the Office of Behavioral Safety Research in the National Highway Traffic Safety Administration (NHTSA). An extensive literat...
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Bachmor, T; Schöchlin, J; Bolz, A
2002-01-01
Equipping medical devices with long range telemetry opens completely new possibilities for emergency response, home care and remote diagnosis. Mobile communications nowadays seem to be a generally accepted part of our modern world, but bridging the gap between new (consumer-) technologies and medical devices still is a challenge today. Providing a telemetry link (GSM) is just the trivial part--ensuring security, reliability and service management are the more critical tasks that need to be addressed. Therefore, a complete system concept consists of an automatic fleet management (e.g. periodic device-initiated service calls) as well as customer relationship management (CRM), including technical service and a trouble-ticket system.
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On safety enhancements for medical robots
International Nuclear Information System (INIS)
Ng, W.S.; Tan, C.K.
1996-01-01
Both software and hardware methods to enhance safety are discussed for active medical robots applied to, among others, neurosurgery, orthopaedic surgery and prostatectomy. This paper advocates that while it is practically difficult, if not impossible, for software reliability to be 100%, there are positive measures by which a medical robot system can be made adequately or inherently safe. Such measures avoid the problems of software reliability but turn to mathematical logic directly to build a safer system. Examples in a newly developed prototype, known as surgeon assistant robot for selected urological disorders (SARUD), are given to illustrate the concept. Although software measures to promote reliability of a system is less preferred compared to hardware measures, as it can never escape from operating on a hardware platform, it is suggested that a complementary/ hybrid approach can be a good solution for achieving a safe and flexible (by being reprogrammable) system. A totally independent safety monitor is being built. It can arrest a servo runaway and detect out-of-safe-boundary conditions, using encoder pulses as input. This dedicated system can resolve some major safety concerns of a medical robot such as SARUD
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Energy Technology Data Exchange (ETDEWEB)
Lee, Seung Youl; Kim, Jae Ryang; Lee, Jun Ho; Park, Chang Won [Division of Medical Device Research, National Institute of Food and Drug Safety Evaluation, Mnistry of Food and Drug Safety (Korea, Republic of)
2016-12-15
Due to recent population aging, the number of check-up for senior citizens has increased steadily. According to this trend, the market size of dental X-ray equipment and the number of approval and review for these devices have simultaneously increased. The technical document of medical device is required for approval and review for medical device, and medical device companies needs to have work comprehension and expertise, as the document needs to include the overall contents such as performances, test criteria, etc.. Yet, since most of domestic manufacturers or importers of medical devices are small businesses, it is difficult for them to recruit professional manpower for approval of medical devices, and submission of inaccurate technical documents has increased. These problems lead to delay of the approval process and to difficulties in quick entering into the market. Especially, the Ministry of Food and Drug safety (MFDS) standards of a dental extra-oral X-ray equipment, a dental intra-oral X-ray equipment, an arm-type computed tomography, and a portable X-ray system have been recently enacted or not. this guideline of dental X-ray equipment adjusting revised standards was developed to help relative companies and reviewers. For this study, first, the methods to write technical document have been reviewed with revised international and domestic regulations and system. Second, the domestic and foreign market status of each item has been surveyed and analyzed. Third, the contents of technical documents already approved by MFDS have been analyzed to select the correct example, test items, criteria, and methods. Finally, the guideline has been developed based on international and domestic regulation, through close review of a consultative body composed of academic, industrial, research institute and government experts.
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International Nuclear Information System (INIS)
Lee, Seung Youl; Kim, Jae Ryang; Lee, Jun Ho; Park, Chang Won
2016-01-01
Due to recent population aging, the number of check-up for senior citizens has increased steadily. According to this trend, the market size of dental X-ray equipment and the number of approval and review for these devices have simultaneously increased. The technical document of medical device is required for approval and review for medical device, and medical device companies needs to have work comprehension and expertise, as the document needs to include the overall contents such as performances, test criteria, etc.. Yet, since most of domestic manufacturers or importers of medical devices are small businesses, it is difficult for them to recruit professional manpower for approval of medical devices, and submission of inaccurate technical documents has increased. These problems lead to delay of the approval process and to difficulties in quick entering into the market. Especially, the Ministry of Food and Drug safety (MFDS) standards of a dental extra-oral X-ray equipment, a dental intra-oral X-ray equipment, an arm-type computed tomography, and a portable X-ray system have been recently enacted or not. this guideline of dental X-ray equipment adjusting revised standards was developed to help relative companies and reviewers. For this study, first, the methods to write technical document have been reviewed with revised international and domestic regulations and system. Second, the domestic and foreign market status of each item has been surveyed and analyzed. Third, the contents of technical documents already approved by MFDS have been analyzed to select the correct example, test items, criteria, and methods. Finally, the guideline has been developed based on international and domestic regulation, through close review of a consultative body composed of academic, industrial, research institute and government experts
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The ‘Medication Safety Minute’− Microlearning in Medicine
LENUS (Irish Health Repository)
Relihan, Eileen
2018-04-06
Summary of an initiative of St. James’s Hospital (SJH) medication safety programme to highlighting prescribing safety issues. The project the ‘Medication Safety Minute\\' was based on the concept of ‘bite-sized learning’. The aim was to deliver a message which could be which could be read and understood in one minute or less. The project was selected for the HSE excellence awards showcase.
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Cybersecurity and medical devices: A practical guide for cardiac electrophysiologists
Kramer, Daniel B.; Foo Kune, Denis; Auto de Medeiros, Julio; Yan, Chen; Xu, Wenyuan; Crawford, Thomas; Fu, Kevin
2017-01-01
Abstract Medical devices increasingly depend on software. While this expands the ability of devices to perform key therapeutic and diagnostic functions, reliance on software inevitably causes exposure to hazards of security vulnerabilities. This article uses a recent high‐profile case example to outline a proactive approach to security awareness that incorporates a scientific, risk‐based analysis of security concerns that supports ongoing discussions with patients about their medical devices. PMID:28512774
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Radiation safety and regulatory aspects in Medical Facilities
International Nuclear Information System (INIS)
Banerjee, Sharmila
2017-01-01
Radiation safety and regulatory aspect of medical facilities are relevant in the context where radiation is used in providing healthcare to human patients. These include facilities, which carry out radiological procedures in diagnostic radiology, including dentistry, image-guided interventional procedures, nuclear medicine, and radiation therapy. The safety regulations provide recommendations and guidance on meeting the requirements for the safe use of radiation in medicine. The different safety aspects which come under its purview are the personnel involved in medical facilities where radiological procedures are performed which include the medical practitioners, radiation technologists, medical physicists, radiopharmacists, radiation protection and over and above all the patients. Regulatory aspects cover the guidelines provided by ethics committees, which regulate the administration of radioactive formulation in human patients. Nuclear medicine is a modality that utilizes radiopharmaceuticals either for diagnosis of physiological disorders related to anatomy, physiology and patho-physiology and for diagnosis and treatment of cancer
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Energy Technology Data Exchange (ETDEWEB)
Hassan, Moinuddin, E-mail: moinuddin.hassan@fda.hhs.gov; Ilev, Ilko [Optical Therapeutics and Medical Nanophotonics Laboratory, Division of Biomedical Physics, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland 20993 (United States)
2014-10-15
Contamination of medical devices has become a critical and prevalent public health safety concern since medical devices are being increasingly used in clinical practices for diagnostics, therapeutics and medical implants. The development of effective sensing methods for real-time detection of pathogenic contamination is needed to prevent and reduce the spread of infections to patients and the healthcare community. In this study, a hollow-core fiber-optic Fourier transform infrared spectroscopy methodology employing a grazing incidence angle based sensing approach (FO-FTIR-GIA) was developed for detection of various biochemical contaminants on medical device surfaces. We demonstrated the sensitivity of FO-FTIR-GIA sensing approach for non-contact and label-free detection of contaminants such as lipopolysaccharide from various surface materials relevant to medical device. The proposed sensing system can detect at a minimum loading concentration of approximately 0.7 μg/cm{sup 2}. The FO-FTIR-GIA has the potential for the detection of unwanted pathogen in real time.
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2014-01-23
The Food and Drug Administration (FDA) is classifying John Cunningham Virus (JCV) serological reagents into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
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2013-05-20
... NUCLEAR REGULATORY COMMISSION [NRC-2013-0098] Embedded Digital Devices in Safety-Related Systems, Systems Important to Safety, and Items Relied on for Safety AGENCY: Nuclear Regulatory Commission. ACTION... (NRC) is issuing for public comment Draft Regulatory Issue Summary (RIS) 2013-XX, ``Embedded Digital...
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Directory of Open Access Journals (Sweden)
Chang-Seop Park
2014-01-01
Full Text Available After two recent security attacks against implantable medical devices (IMDs have been reported, the privacy and security risks of IMDs have been widely recognized in the medical device market and research community, since the malfunctioning of IMDs might endanger the patient’s life. During the last few years, a lot of researches have been carried out to address the security-related issues of IMDs, including privacy, safety, and accessibility issues. A physician accesses IMD through an external device called a programmer, for diagnosis and treatment. Hence, cryptographic key management between IMD and programmer is important to enforce a strict access control. In this paper, a new security architecture for the security of IMDs is proposed, based on a 3-Tier security model, where the programmer interacts with a Hospital Authentication Server, to get permissions to access IMDs. The proposed security architecture greatly simplifies the key management between IMDs and programmers. Also proposed is a security mechanism to guarantee the authenticity of the patient data collected from IMD and the nonrepudiation of the physician’s treatment based on it. The proposed architecture and mechanism are analyzed and compared with several previous works, in terms of security and performance.
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International Nuclear Information System (INIS)
Eidenberger, R.Reiner
2000-01-01
The purpose of this article is to give a short overview of some different regulations in Europe and the United States with regard to the clearance of medical devices and to give an outlook of what the Agreements on Mutual Recognition will bring in terms of Global Harmonization. Recent European legislation, the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (Medical Device Directive, MDD), requires that all medical devices placed on the European market bear the CE marking. From 14 June 1998, medical devices fall under the scope of this European Medical Device Directive and there is a harmonization within the European market. Similar to this, but for another market, are the USA FDA requirements, Premarket Approval (PMA) and Premarket notification (510(k)). The same medical device, the same goal - a safe product - but different legislation and thus duplication of registration procedures. The European Commission is presently discussing a series of agreements with third countries, Australia, New Zealand, USA, Canada, Japan and Eastern European countries wishing to join the EU, concerning the mutual acceptance of inspection bodies and, ultimately, proof of conformity (for example reports on examination, certificates, licenses and marks of conformity) in connection with medical devices. Meanwhile agreements with Australia, New Zealand, USA and Canada came into force. (author)
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Health physics, safety and medical services report for 1989
International Nuclear Information System (INIS)
Burt, A.K.; Bird, R.W.
1990-09-01
The Health Physics, Safety and Medical Services Report for Harwell Laboratory for 1989 includes data on the monitoring of the working environment, personnel monitoring, radiological incidents, disposal of radioactive waste and protection of the public. Work on emergency planning, non-radiological health and safety, occupational hygiene, operations support is also discussed. Finally the medical services available and the medical examinations performed are described. (UK)
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The potential of medical device industry in technological and economical context
Directory of Open Access Journals (Sweden)
Maresova P
2015-10-01
Full Text Available Petra Maresova,1 Marek Penhaker,1,2 Ali Selamat,1,3 Kamil Kuca1,41Faculty of Informatics and Management, University of Hradec Králové, Hradec Králové, Czech Republic; 2Department of Cybernetics and Biomedical Engineering, Faculty of Electrical Engineering and Computer Science, Technical University of Ostrava, Poruba, Czech Republic; 3Faculty of Computing, Universiti Teknologi Malaysia, Johor Bahru, Johor, Malaysia; 4Center for Biomedical Research, University Hospital Hradec Králové, Hradec Králové, Czech RepublicAbstract: The high quality of public health improves not only healthy life expectancy, but also the productivity of labor. The most important part of the health care sector is the medical technology industry. The aim of this study is to analyze the current situation in the medical device industry in Europe, its potential strengths and weaknesses in the context of topical economic and demographic development. The contribution specifies an analysis of the economic state of the medical device industry in the context of demographic development of European Union’s macroeconomic indicators and views of experts in the field of medical device development, concerning the opportunities for entities involved in the medical device market. There is fierce competition on the European market. The innovative activity is stable and well regulated by responsible authorities. Worldwide, the medical device market is expected to grow.Keywords: technology context, medical device, Europe, expenditure, review
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Theodorou, Mamas; Georgiou, Marina; Nikolentzos, Athanasios; Bellali, Thalia
2015-04-19
Hospital procurement is a crucial field for any health care system, not only for economic reasons but also for reasons related to the quality and safety of the services provided. That is why the process of procurement is, in most countries, governed by a strict legal framework and policy mechanisms. This study investigates the problems and inefficiencies associated with the procurement of medical devices in public hospitals in Cyprus and formulates empirically documented proposals for improvement. Using the Delphi method, a group of 38 experts approach the procurement system in Cyprus from different angles, achieving high rates of consensus on 35 different statements on the weaknesses and problems of the current medical device procurement system, as well as presenting proposals and recommendations for improvement. The findings are highly valuable for future policy initiatives in Cyprus in the light of the economic crisis and the expected implementation of the new General Health Insurance System (GeSY), which the Government of the Republic of Cyprus and the Troika has agreed.
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Wu, Wei; Fang, Qiang
2011-01-01
Printed Spiral Coil (PSC) is a coil antenna for near-field wireless power transmission to the next generation implant medical devices. PSC for implant medical device should be power efficient and low electromagnetic radiation to human tissues. We utilized a physical model of printed spiral coil and applied our algorithm to design PSC operating at 13.56 MHz. Numerical and electromagnetic simulation of power transfer efficiency of PSC in air medium is 77.5% and 71.1%, respectively. The simulation results show that the printed spiral coil which is optimized for air will keep 15.2% power transfer efficiency in human subcutaneous tissues. In addition, the Specific Absorption Ratio (SAR) for this coil antenna in subcutaneous at 13.56 MHz is below 1.6 W/Kg, which suggests this coil is implantable safe based on IEEE C95.1 safety guideline.
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Badía, Xavier; Guyver, Alice; Magaz, Sol; Bigorra, Juan
2002-06-01
The implementation of health outcomes research as a healthcare decision-making tool has expanded rapidly in the last decade. Drugs and medical devices are increasingly being required to demonstrate not only their efficacy and safety characteristics, but also their performance in at least three core dimensions of health outcomes research: clinical effectiveness, patient-reported outcomes and economic outcomes. However, the current integration of health outcomes research lacks coordination and communication and as a result, money and time is being spent on the generation of health outcomes research data which can be both insufficient and fail to satisfy the information demands of all the relevant stakeholders. In response to this, a new paradigm is evolving which involves the implementation of health outcomes research strategies that encompass the development, pre- and postmarketing stages of a drug or medical device.
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77 FR 4252 - Additional Spectrum for the Medical Device Radiocommunication Service
2012-01-27
... licensed users in these frequency bands to continue providing service. Medical Micro-Power Networks (MMNs...). Under this approach, medical devices would operate in the band on a shared, non-exclusive basis with...Radio Service rules for devices operating in the 413-457 MHz band. These definitions were for a Medical...
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Economic benefits of safety-engineered sharp devices in Belgium - a budget impact model.
Hanmore, Emma; Maclaine, Grant; Garin, Fiona; Alonso, Alexander; Leroy, Nicolas; Ruff, Lewis
2013-11-25
Measures to protect healthcare workers where there is risk of injury or infection from medical sharps became mandatory in the European Union (EU) from May 2013. Our research objective was to estimate the net budget impact of introducing safety-engineered devices (SEDs) for prevention of needlestick injuries (NSIs) in a Belgian hospital. A 5-year incidence-based budget impact model was developed from the hospital inpatient perspective, comparing costs and outcomes with SEDs and prior-used conventional (non-safety) devices. The model accounts for device acquisition costs and costs of NSI management in 4 areas of application where SEDs are currently used: blood collection, infusion, injection and diabetes insulin administration. Model input data were sourced from the Institut National d'Assurance Maladie-Invalidité, published studies, clinical guidelines and market research. Costs are discounted at 3%. For a 420-bed hospital, 100% substitution of conventional devices by SEDs is estimated to decrease the cumulative 5-year incidence of NSIs from 310 to 75, and those associated with exposure to blood-borne viral diseases from 60 to 15. Cost savings from managing fewer NSIs more than offset increased device acquisition costs, yielding estimated 5-year overall savings of €51,710. The direction of these results is robust to a range of sensitivity and model scenario analyses. The model was most sensitive to variation in the acquisition costs of SEDs, rates of NSI associated with conventional devices, and the acquisition costs of conventional devices. NSIs are a significant potential risk with the use of sharp devices. The incidence of NSIs and the costs associated with their management can be reduced through the adoption of safer work practices, including investment in SEDs. For a Belgian hospital, the budget impact model reports that the incremental acquisition costs of SEDs are offset by the savings from fewer NSIs. The availability of more robust data for NSI reduction
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Optical tests for using smartphones inside medical devices
Bernat, Amir S.; Acobas, Jennifer K.; Phang, Ye Shang; Hassan, David; Bolton, Frank J.; Levitz, David
2018-02-01
Smartphones are currently used in many medical applications and are more frequently being integrated into medical imaging devices. The regulatory requirements in existence today however, particularly the standardization of smartphone imaging through validation and verification testing, only partially cover imaging characteristics with a smartphone. Specifically, it has been shown that smartphone camera specifications are of sufficient quality for medical imaging, and there are devices which comply with the FDA's regulatory requirements for a medical device such as a device's field of view, direction of viewing and optical resolution and optical distortion. However, these regulatory requirements do not call specifically for color testing. Images of the same object using automatic settings or different light sources can show different color composition. Experimental results showing such differences are presented. Under some circumstances, such differences in color composition could potentially lead to incorrect diagnoses. It is therefore critical to control the smartphone camera and illumination parameters properly. This paper examines different smartphone camera settings that affect image quality and color composition. To test and select the correct settings, a test methodology is proposed. It aims at evaluating and testing image color correctness and white balance settings for mobile phones and LED light sources. Emphasis is placed on color consistency and deviation from gray values, specifically by evaluating the ΔC values based on the CIEL*a*b* color space. Results show that such standardization minimizes differences in color composition and thus could reduce the risk of a wrong diagnosis.
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Laser direct writing of micro- and nano-scale medical devices
Gittard, Shaun D; Narayan, Roger J
2010-01-01
Laser-based direct writing of materials has undergone significant development in recent years. The ability to modify a variety of materials at small length scales and using short production times provides laser direct writing with unique capabilities for fabrication of medical devices. In many laser-based rapid prototyping methods, microscale and submicroscale structuring of materials is controlled by computer-generated models. Various laser-based direct write methods, including selective laser sintering/melting, laser machining, matrix-assisted pulsed-laser evaporation direct write, stereolithography and two-photon polymerization, are described. Their use in fabrication of microstructured and nanostructured medical devices is discussed. Laser direct writing may be used for processing a wide variety of advanced medical devices, including patient-specific prostheses, drug delivery devices, biosensors, stents and tissue-engineering scaffolds. PMID:20420557
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Open-source hardware for medical devices.
Niezen, Gerrit; Eslambolchilar, Parisa; Thimbleby, Harold
2016-04-01
Open-source hardware is hardware whose design is made publicly available so anyone can study, modify, distribute, make and sell the design or the hardware based on that design. Some open-source hardware projects can potentially be used as active medical devices. The open-source approach offers a unique combination of advantages, including reducing costs and faster innovation. This article compares 10 of open-source healthcare projects in terms of how easy it is to obtain the required components and build the device.
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Perceptions of medication safety among patients with inflammatory bowel disease.
LENUS (Irish Health Repository)
Cullen, Garret
2010-09-01
The aim of this study was to assess attitudes towards and knowledge of medication safety in inflammatory bowel disease (IBD). IBD patients frequently require long-term treatment with potentially toxic medications. Techniques are employed to improve patient awareness of medication safety, but there are sparse data on their effectiveness.
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Embedded Control in Wearable Medical Devices: Application to the Artificial Pancreas
Directory of Open Access Journals (Sweden)
Stamatina Zavitsanou
2016-09-01
Full Text Available Significant increases in processing power, coupled with the miniaturization of processing units operating at low power levels, has motivated the embedding of modern control systems into medical devices. The design of such embedded decision-making strategies for medical applications is driven by multiple crucial factors, such as: (i guaranteed safety in the presence of exogenous disturbances and unexpected system failures; (ii constraints on computing resources; (iii portability and longevity in terms of size and power consumption; and (iv constraints on manufacturing and maintenance costs. Embedded control systems are especially compelling in the context of modern artificial pancreas systems (AP used in glucose regulation for patients with type 1 diabetes mellitus (T1DM. Herein, a review of potential embedded control strategies that can be leveraged in a fully-automated and portable AP is presented. Amongst competing controllers, emphasis is provided on model predictive control (MPC, since it has been established as a very promising control strategy for glucose regulation using the AP. Challenges involved in the design, implementation and validation of safety-critical embedded model predictive controllers for the AP application are discussed in detail. Additionally, the computational expenditure inherent to MPC strategies is investigated, and a comparative study of runtime performances and storage requirements among modern quadratic programming solvers is reported for a desktop environment and a prototype hardware platform.
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Modelling degradation of bioresorbable polymeric medical devices
Pan, J
2015-01-01
The use of bioresorbable polymers in stents, fixation devices and tissue engineering is revolutionising medicine. Both industry and academic researchers are interested in using computer modelling to replace some experiments which are costly and time consuming. This book provides readers with a comprehensive review of modelling polymers and polymeric medical devices as an alternative to practical experiments. Chapters in part one provide readers with an overview of the fundamentals of biodegradation. Part two looks at a wide range of degradation theories for bioresorbable polymers and devices.
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2012-02-14
... will be used to evaluate risks associated with medical devices which will enable FDA to take...] Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Reporting... comment in response to the notice. This notice solicits comments on medical device reporting (MDR...
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Martelli, Nicolas; van den Brink, Hélène
2014-07-01
Financing innovative medical devices is an important challenge for national health policy makers, and a crucial issue for hospitals. However, when innovative medical devices are launched on the European market there is generally little clinical evidence regarding both efficacy and safety, both because of the flaws in the European system for regulating such devices, and because they are at an early stage of development. To manage the uncertainty surrounding the reimbursement of innovation, several European countries have set up temporary funding schemes to generate evidence about the effectiveness of devices. This article explores two different French approaches to funding innovative in-hospital devices and collecting supplementary data: the coverage with evidence development (CED) scheme introduced under Article L. 165-1-1 of the French Social Security Code; and national programs for hospital-based research. We discuss pros and cons of both approaches in the light of CED policies in Germany and the UK. The CED policies for devices share common limitations. Thus, transparency of CED processes should be enhanced and decisions need to be made in a timely way. Finally, we think that closer collaboration between manufacturers, health authorities and hospitals is essential to make CED policies more operational. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.
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Kow, A W C; Ang, B L S; Chong, C S; Tan, W B; Menon, K R
2016-11-01
While healthcare outcomes have improved significantly, the complex management of diseases in the hospitals has also escalated the risks in patient safety. Therefore, in the process of training medical students to be proficient in medical knowledge and skills, the importance of patient safety cannot be neglected. A new innovation using mobile apps gaming system (PAtient Safety in Surgical EDucation-PASSED) to teach medical students on patient safety was created. Students were taught concepts of patient safety followed by a gaming session using iPad games created by us. This study aims to evaluate the outcome of patient safety perception using the PASSED games created. An interactive iPad game focusing on patient safety issues was created by the undergraduate education team in the Department of Surgery, Yong Loo Lin School of Medicine at the National University of Singapore. The game employed the unique touched-screen feature with clinical scenarios extracted from the hospital sentinel events. Some of the questions were time sensitive, with extra bonus marks awarded if the student provided the correct answer within 10 s. Students could reattempt the questions if the initial answer was wrong. However, this entailed demerit points. Third-year medical students posted to the Department of Surgery experienced this gaming system in a cohort of 55-60 students. Baseline understanding of the students on patient safety was evaluated using Attitudes to Patient Safety Questionnaire III (APSQ-III) prior to the game. A 20 min talk on concept of patient safety using the WHO Patient Safety Guidelines was conducted. Following this, students downloaded the apps from ITune store and played with the game for 20-30 min. The session ended with the students completing the postintervention questionnaire. A total of 221 3rd year medical students responded to the survey during the PASSED session. Majority of the students felt that the PASSED game had trained them to understand the
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Safety work with MRI devices in medicine
International Nuclear Information System (INIS)
Zivkovic, D.; Hrnjak, M.
1999-01-01
This paper gives the basis of biological effects of physical factors which could affect personnel working on MRI devices and patients, and corresponding protection measures. Medical personnel working with MRI devices and patients could be exposed to static magnetic field, time varying fields and radiofrequency radiation, danger from electric current and chemical matters, and there is a high risk from moving metal objects which could wound the persons near-by. The protection from static magnetic field could be ensured by increasing the distance from the source. If MRI device is put in Faradays cage it could be corresponding protection of radiofrequency radiation. (author)
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Safety of Magnetic Resonance Imaging in Patients with Cardiac Devices.
Nazarian, Saman; Hansford, Rozann; Rahsepar, Amir A; Weltin, Valeria; McVeigh, Diana; Gucuk Ipek, Esra; Kwan, Alan; Berger, Ronald D; Calkins, Hugh; Lardo, Albert C; Kraut, Michael A; Kamel, Ihab R; Zimmerman, Stefan L; Halperin, Henry R
2017-12-28
Patients who have pacemakers or defibrillators are often denied the opportunity to undergo magnetic resonance imaging (MRI) because of safety concerns, unless the devices meet certain criteria specified by the Food and Drug Administration (termed "MRI-conditional" devices). We performed a prospective, nonrandomized study to assess the safety of MRI at a magnetic field strength of 1.5 Tesla in 1509 patients who had a pacemaker (58%) or an implantable cardioverter-defibrillator (42%) that was not considered to be MRI-conditional (termed a "legacy" device). Overall, the patients underwent 2103 thoracic and nonthoracic MRI examinations that were deemed to be clinically necessary. The pacing mode was changed to asynchronous mode for pacing-dependent patients and to demand mode for other patients. Tachyarrhythmia functions were disabled. Outcome assessments included adverse events and changes in the variables that indicate lead and generator function and interaction with surrounding tissue (device parameters). No long-term clinically significant adverse events were reported. In nine MRI examinations (0.4%; 95% confidence interval, 0.2 to 0.7), the patient's device reset to a backup mode. The reset was transient in eight of the nine examinations. In one case, a pacemaker with less than 1 month left of battery life reset to ventricular inhibited pacing and could not be reprogrammed; the device was subsequently replaced. The most common notable change in device parameters (>50% change from baseline) immediately after MRI was a decrease in P-wave amplitude, which occurred in 1% of the patients. At long-term follow-up (results of which were available for 63% of the patients), the most common notable changes from baseline were decreases in P-wave amplitude (in 4% of the patients), increases in atrial capture threshold (4%), increases in right ventricular capture threshold (4%), and increases in left ventricular capture threshold (3%). The observed changes in lead parameters
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2017-12-19
The Food and Drug Administration (FDA or we) is classifying the fetal head elevator into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the fetal head elevator's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
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Use-related risk analysis for medical devices based on improved FMEA.
Liu, Long; Shuai, Ma; Wang, Zhu; Li, Ping
2012-01-01
In order to effectively analyze and control use-related risk of medical devices, quantitative methodologies must be applied. Failure Mode and Effects Analysis (FMEA) is a proactive technique for error detection and risk reduction. In this article, an improved FMEA based on Fuzzy Mathematics and Grey Relational Theory is developed to better carry out user-related risk analysis for medical devices. As an example, the analysis process using this improved FMEA method for a certain medical device (C-arm X-ray machine) is described.
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... to Create a Personal Emergency File My personal emergency file contains: □ Instructions for using the medical device and all device manuals. □ First aid kit □ Medical records □ Insurance cards □ Current home care doctor’s orders □ Plan of treatment □ What a family ...
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NASA safety standard for lifting devices and equipment
1990-09-01
NASA's minimum safety requirements are established for the design, testing, inspection, maintenance, certification, and use of overhead and gantry cranes (including top running monorail, underhung, and jib cranes), mobile cranes, derrick hoists, and special hoist supported personnel lifting devices (these do not include elevators, ground supported personnel lifts, or powered platforms). Minimum requirements are also addressed for the testing, inspection, and use of Hydra-sets, hooks, and slings. Safety standards are thoroughly detailed.
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Autonomous booster device of a safety valve
International Nuclear Information System (INIS)
Namand, H.
1983-01-01
The invention concerns an autonomous booster device of a protection safety valve of a pressure vessel. The valve comprises a hollow structure, a seat connected with a mobile flap forming one piece with a stem and a calibration spring bearing on the stem and on the valve structure to maintain the flap bearing on the seat. The stem of the flap is prolongated in a box forming one piece with the valve structure and receives an added push of a spring. The box acts as a pressure device of which the piston can exercise on the stem a push opposite to and larger than the spring one. The feeding device of the pressure box is finally described in detail [fr
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Directory of Open Access Journals (Sweden)
Ephrem Abebe
2018-02-01
Full Text Available Objective: To describe challenges associated with the medication use process and potential medication safety hazards in an Ethiopian hospital emergency department using a human factors approach. Methods: We conducted a qualitative study employing observations and semi-structured interviews guided by the Systems Engineering Initiative for Patient Safety model of work system as an analytical framework. The study was conducted in the emergency department of a teaching hospital in Ethiopia. Study participants included resident doctors, nurses, and pharmacists. We performed content analysis of the qualitative data using accepted procedures. Results: Organizational barriers included communication failures, limited supervision and support for junior staff contributing to role ambiguity and conflict. Compliance with documentation policy was minimal. Task related barriers included frequent interruptions and work-related stress resulting from job requirements to continuously prioritize the needs of large numbers of patients and family members. Person related barriers included limited training and work experience. Work-related fatigue due to long working hours interfered with staff’s ability to document and review medication orders. Equipment breakdowns were common as were non-calibrated or poorly maintained medical devices contributing to erroneous readings. Key environment related barriers included overcrowding and frequent interruption of staff’s work. Cluttering of the work space compounded the problem by impeding efforts to locate medications, medical supplies or medical charts. Conclusions: Applying a systems based approach allows a context specific understanding of medication safety hazards in EDs from low-income countries. When developing interventions to improve medication and overall patient safety, health leaders should consider the interactions of the different factors. Conflict of Interest We declare no conflicts of interest or
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Janß, Armin; Thorn, Johannes; Schmitz, Malte; Mildner, Alexander; Dell'Anna-Pudlik, Jasmin; Leucker, Martin; Radermacher, Klaus
2018-02-23
Nowadays, only closed and proprietary integrated operating room systems (IORS) from big manufacturers are available on the market. Hence, the interconnection of components from third-party vendors is only possible with increased time and costs. In the context of the German Federal Ministry of Education and Research (BMBF)-funded project OR.NET (2012-2016), the open integration of medical devices from different manufacturers was addressed. An integrated operating theater based on the open communication standard IEEE 11073 shall give clinical operators the opportunity to choose medical devices independently of the manufacturer. This approach would be advantageous especially for hospital operators and small- and medium-sized enterprises (SME) of medical devices. Actual standards and concepts regarding technical feasibility and the approval process do not cope with the requirements for a modular integration of medical devices in the operating room (OR), based on an open communication standard. Therefore, innovative approval strategies and corresponding certification and test procedures, which cover actual legal and normative standards, have to be developed in order to support the future risk management and the usability engineering process of open integrated medical devices in the OR. The use of standardized device and service profiles and a three-step testing procedure, including conformity, interoperability and integration tests are described in this paper and shall support the manufacturers to integrate their medical devices without disclosing the medical devices' risk analysis and related confidential expertise or proprietary information.
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Drug safety: withdrawn medications are only part of the picture.
Rawson, Nigel S B
2016-02-13
In a research article published in BMC Medicine, Onakpoya and colleagues provide a historical review of withdrawals of medications for safety reasons. However, withdrawn medications are only one part of the picture about how regulatory agencies manage drug risks. Moreover, medications introduced before the increased pre-marketing regulations and post-marketing monitoring systems instituted after the thalidomide tragedy have little relevance when considering the present drug safety picture because the circumstances under which they were introduced were completely different. To more fully understand drug safety management and regulatory agency actions, withdrawals should be evaluated within the setting and timeframe in which the medications are approved, which requires information about approvals and safety warnings. Studies are needed that provide a more comprehensive current picture of the identification and evaluation of drug safety risks as well as how regulatory agencies deal with them. Please see related research article: http://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-016-0553-2.
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2011-04-21
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2010-N-0026] Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass Assessment Score Test System; Correction AGENCY: Food and Drug Administration, HHS. ACTION...
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Just a piece of equipment? The importance of medical device education.
Brand, Darren
2012-12-01
The use of medical devices is an increasingly important element of a healthcare professional's role. It is crucial that users receive regular teaching and education to ensure that they are competent in the use of devices. This is particularly relevant in the increasingly litigious society in which we live. This article focuses upon the importance of a medical device education.
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Hassan, Moinuddin; Tan, Xin; Welle, Elissa; Ilev, Ilko
2013-05-01
As a potential major source of biochemical contamination, medical device surfaces are of critical safety concerns in the clinical practice and public health. The development of innovative sensing methods for accurate and real-time detection of medical device surface contamination is essential to protect patients from high risk infection. In this paper, we demonstrate an alternative fiber-optic Fourier Transform Infrared (FTIR) spectroscopy based sensing approach for remote, non-contact, and label-free detection of biochemical contaminants in the mid-infrared (mid-IR) region. The sensing probe is designed using mid-IR hollow fibers and FTIR measurements are carried out in reflection mode. Bovine Serum Albumin (BSA) and bacterial endotoxin of different concentrations under thoroughly dry condition are used to evaluate the detection sensitivity. The devised system can identify ≤0.0025% (≤4 × 1011 molecules) BSA and 0.5% (0.5 EU/ml) endotoxin concentration. The developed sensing approach may be applied to detect various pathogens that pose public health threats.
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Implementing Protocols to Improve Patient Safety in the Medical Imaging Department.
Carrizales, Gwen; Clark, Kevin R
2015-01-01
Patient safety is a focal point in healthcare because of recent changes issued by CMS. Hospital reimbursement rates have fallen, and these reimbursement rates are governed by CMS mandates regarding patient safety procedures. Reimbursement changes are reflected in the National Patient Safety Goals (NPSGs) administered annually by The Joint Commission. Medical imaging departments have multiple areas of patient safety concerns including effective handoff communication, proper patient identification, and safe medication/contrast administration. This literature review examines those areas of patient safety within the medical imaging department and reveals the need for continued protocol and policy changes to keep patients safe.
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Saber, Hamidreza; Rajah, Gary B; Kherallah, Riyad Y; Jadhav, Ashutosh P; Narayanan, Sandra
2017-12-15
Mechanical thrombectomy (MT) is increasingly used for large-vessel occlusions (LVO), but randomized clinical trial (RCT) level data with regard to differences in clinical outcomes of MT devices are limited. We conducted a network meta-analysis (NMA) that enables comparison of modern MT devices (Trevo, Solitaire, Aspiration) and strategies (stent retriever vs aspiration) across trials. Relevant RCTs were identified by a systematic review. The efficacy outcome was 90-day functional independence (modified Rankin Scale (mRS) score 0-2). Safety outcomes were 90-day catastrophic outcome (mRS 5-6) and symptomatic intracranial hemorrhage (sICH). Fixed-effect Bayesian NMA was performed to calculate risk estimates and the rank probabilities. In a NMA of six relevant RCTs (SWIFT, TREVO2, EXTEND-IA, SWIFT-PRIME, REVASCAT, THERAPY; total of 871 patients, 472 Solitaire vs medical-only, 108 Aspiration vs medical-only, 178 Trevo vs Merci, and 113 Solitaire vs Merci) with medical-only arm as the reference, Trevo had the greatest functional independence (OR 4.14, 95% credible interval (CrI) 1.41-11.80; top rank probability 92%) followed by Solitaire (OR 2.55, 95% CrI 1.75-3.74; top rank probability 72%). Solitaire and Aspiration devices had the greatest top rank probability with respect to low sICH and catastrophic outcomes (76% and 91%, respectively), but without significant differences between each other. In a separate network of seven RCTs (MR-CLEAN, ESCAPE, EXTEND-IA, SWIFT-PRIME, REVASCAT, THERAPY, ASTER; 1737 patients), first-line stent retriever was associated with a higher top rank probability of functional independence than aspiration (95% vs 54%), with comparable safety outcomes. These findings suggest that Trevo and Solitaire devices are associated with a greater likelihood of functional independence whereas Solitaire and Aspiration devices appear to be safer. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights
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Lee, Hoo-Yeon; Hahm, Myung-Il; Lee, Sang Gyu
2018-04-04
The purpose of this study was to examine undergraduate medical students' perceptions and intentions regarding patient safety during clinical clerkships. Cross-sectional study administered in face-to-face interviews using modified the Medical Student Safety Attitudes and Professionalism Survey (MSSAPS) from three colleges of medicine in Korea. We assessed medical students' perceptions of the cultures ('safety', 'teamwork', and 'error disclosure'), 'behavioural intentions' concerning patient safety issues and 'overall patient safety'. Confirmatory factor analysis and Spearman's correlation analyses was performed. In total, 194(91.9%) of the 211 third-year undergraduate students participated. 78% of medical students reported that the quality of care received by patients was impacted by teamwork during clinical rotations. Regarding error disclosure, positive scores ranged from 10% to 74%. Except for one question asking whether the disclosure of medical errors was an important component of patient safety (74%), the percentages of positive scores for all the other questions were below 20%. 41.2% of medical students have intention to disclose it when they saw a medical error committed by another team member. Many students had difficulty speaking up about medical errors. Error disclosure guidelines and educational efforts aimed at developing sophisticated communication skills are needed. This study may serve as a reference for other institutions planning patient safety education in their curricula. Assessing student perceptions of safety culture can provide clerkship directors and clinical service chiefs with information that enhances the educational environment and promotes patient safety.
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Challenges to and the future of medication safety in Saudi Arabia: A qualitative study
Aljadhey, Hisham; Mahmoud, Mansour Adam; Hassali, Mohamed Azmi; Alrasheedy, Alian; Alahmad, Amjad; Saleem, Fahad; Sheikh, Aziz; Murray, Michael; Bates, David W.
2013-01-01
Background Medication safety is a global concern among healthcare providers. However, the challenges to and the future of medication safety in Saudi Arabia have not been explored. Objectives We explored the perspectives of healthcare practitioners on current issues about medication safety in hospitals and community settings in Saudi Arabia in order to identify challenges to improving it and explore the future of medication safety practice. Methods A total of 65 physicians, pharmacists, academics and nurses attended a one-day meeting in March 2010, designed especially for the purpose of this study. The participants were divided into nine round-table discussion sessions. Three major themes were explored in these sessions, including: major factors contributing to medication safety problems, challenges to improving medication safety practice, and participants’ suggestions for improving medication safety. The round-table discussion sessions were videotaped and transcribed verbatim and analyzed by two independent researchers. Results The round-table discussions revealed that major factors contributing to medication safety problems included unrestricted public access to medications from various hospitals and community pharmacies, communication gaps between healthcare institutions, limited use of important technologies such as computerized provider order entry, and the lack of medication safety programs in hospitals. Challenges to current medication safety practice identified by participants included underreporting of medication errors and adverse drug reactions, multilingualism and differing backgrounds of healthcare professionals, lack of communication between healthcare providers and patients, and high workloads. Suggestions for improving medication safety practices in Saudi Arabia included continuous education for healthcare professionals and competency assessment focusing on medication safety, development of a culture that encourages medication error and adverse
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Protecting computer-based medical devices: defending against viruses and other threats.
2005-07-01
The increasing integration of computer hardware has exposed medical devices to greater risks than ever before. More and more devices rely on commercial off-the-shelf software and operating systems, which are vulnerable to the increasing proliferation of viruses and other malicious programs that target computers. Therefore, it is necessary for hospitals to take steps such as those outlined in this article to ensure that their computer-based devices are made safe and continue to remain safe in the future. Maintaining the security of medical devices requires planning, careful execution, and a commitment of resources. A team should be created to develop a process for surveying the security status of all computerized devices in the hospital and making sure that patches and other updates are applied as needed. These patches and updates should be approved by the medical system supplier before being implemented. The team should consider using virtual local area networks to isolate susceptible devices on the hospital's network. All security measures should be carefully documented, and the documentation should be kept up-to-date. Above all, care must be taken to ensure that medical device security involves a collaborative, supportive partnership between the hospital's information technology staff and biomedical engineering personnel.
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Transformational leadership in nursing and medication safety education: a discussion paper.
Vaismoradi, Mojtaba; Griffiths, Pauline; Turunen, Hannele; Jordan, Sue
2016-10-01
This paper discusses the application of transformational leadership to the teaching and learning of safe medication management. The prevalence of adverse drug events (ADEs) and medication-related hospitalisations (one hundred thousand each year in the USA) are of concern. This discussion is based on a narrative literature review and scrutiny of international nursing research to synthesise pedagogical strategies for the application of transformational leadership to teaching medication safety. The four elements relating transformational leadership to medication safety education are: 'Idealised influence' or role modelling, both actual and exemplary, 'Inspirational motivation' providing students with commitment to medication safety, 'Intellectual stimulation' encouraging students to value improvement and change, and 'Individualised consideration' of individual students' educational goals, practice development and patient outcomes. The model lends itself to experiential learning and a case-study approach to teaching, offering an opportunity to reduce nursing's theory-practice gap. Transformational leadership for medication safety education is characterised by a focus on the role of nurse educators and mentors in the development of students' abilities, creation of a supportive culture, and enhancement of students' creativity, motivation and ethical behaviour. This will prepare nursing graduates with the competencies necessary to be diligent about medication safety and the prevention of errors. Teaching medication safety through transformational leadership requires the close collaboration of educators, managers and policy makers. Investigation of strategies to reduced medication errors and consequent patient harm should include exploration of the application of transformational leadership to education and its impact on the number and severity of medication errors. © 2016 John Wiley & Sons Ltd.
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21 CFR 892.2010 - Medical image storage device.
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical image storage device. 892.2010 Section 892.2010 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED..., and digital memory. (b) Classification. Class I (general controls). The device is exempt from the...
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[Impact of an automated dispensing system for medical devices in cardiac surgery department].
Clou, E; Dompnier, M; Kably, B; Leplay, C; Poupon, E; Archer, V; Paul, M
2018-01-01
To secure medical devices' management, the implementation of automated dispensing system in surgical service has been realized. The objective of this study was to evaluate security, organizational and economic impact of installing automated dispensing system for medical devices (ASDM). The implementation took place in a cardiac surgery department. Security impact was assessed by comparing traceability rate of implantable medical devices one year before and one year after installation. Questionnaire on nurses' perception and satisfaction completed this survey. Resupplying costs, stocks' evolution and investments for the implementation of ASDM were the subject of cost-benefit study. After one year, traceability rate is excellent (100%). Nursing staffs were satisfied with 87.5% by this new system. The introduction of ASDM allowed a qualitative and quantitative decrease in stocks, with a reduction of 30% for purchased medical devices and 15% for implantable medical devices in deposit-consignment. Cost-benefit analysis shows a rapid return on investment. Real stock decrease (purchased medical devices) is equivalent to 46.6% of investment. Implementation of ASDM allows to secure storage and dispensing of medical devices. This system has also an important economic impact and appreciated by users. Copyright © 2017 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.
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Medical device integration using mobile telecommunications infrastructure.
Moorman, Bridget A; Cockle, Richard A
2013-01-01
Financial pressures, an aging population, and a rising number of patients with chronic diseases, have encouraged the use of remote monitoring technologies. This usually entails at least one physiological parameter measurement for a clinician. Mobile telecommunication technologies lend themselves to this functionality, and in some cases, avoid some of the issues encountered with device integration. Moreover, the inherent characteristics of the mobile telecommunications infrastructure allow a coupling of business and clinical functions that were not possible before. Table I compares and contrasts some key aspect of device integration in and out of a healthcare facility. An HTM professional may be part of the team that acquires and/or manages a system using a mobile telecommunications technology. It is important for HTM professionals to ensure the data is in a standard format so that the interfaces across this system don't become brittle and break easily if one part changes. Moreover, the security and safety considerations of the system and the data should be a primary consideration in and y purchase, with attention given to the proper environmental and encryption mechanisms. Clinical engineers and other HTM professionals are unique in that they understand the patient/clinician/device interface and the need to ensure its safety and effectiveness regardless of geographical environment.
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2011-03-23
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2011-N-0026] Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian... of Food and Drugs, 21 CFR part 866 is amended as follows: PART 866--IMMUNOLOGY AND MICROBIOLOGY...
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The Impact of a Patient Safety Program on Medical Error Reporting
2005-05-01
307 The Impact of a Patient Safety Program on Medical Error Reporting Donald R. Woolever Abstract Background: In response to the occurrence of...a sentinel event—a medical error with serious consequences—Eglin U.S. Air Force (USAF) Regional Hospital developed and implemented a patient safety...communication, teamwork, and reporting. Objective: To determine the impact of a patient safety program on patterns of medical error reporting. Methods: This
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Tseliou, Tasoula
2015-01-01
In 2013, the CJEU ruled on the ‘Lyocentre’ case touching upon an important and contemporary issue in the EU Medical Device regime – the classification issue between medical devices and medicinal products. This problem is connected with the internal market v. protection of health dilemma as well as
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Directory of Open Access Journals (Sweden)
Muniz Janaína Barbosa
2003-01-01
Full Text Available Asthma results from a combination of three essential features: airflow obstruction, hyperresponsiveness of airways to endogenous or exogenous stimuli and inflammation. Inadequacy of the techniques to use different inhalation devices is one of the causes of therapeutic failure. The main purpose of this study was to evaluate how 20 medical students, 36 resident physicians of Internal Medicine/Pediatrics, and 40 asthma patients used three devices for inhalation therapy containing placebo. All patients were followed at the Pulmonary Outpatient Service of Botucatu Medical School and had been using inhaled medication for at least six months. The following devices were evaluated: metered dose inhalers (MDI, dry powder inhalers (DPI, and MDI attached to a spacer device. A single observer applied a protocol containing the main steps necessary to obtain a good inhaler technique to follow and grade the use of different devices. Health care professionals tested all three devices and patients tested only the device being used on their management. MDI was the device best known by doctors and patients. MDI use was associated with errors related to the coordination between inspiration and device activation. Failure to exhale completely before inhalation of the powder was the most frequent error observed with DPI use. In summary, patients did not receive precise instruction on how to use inhaled medication and health care professionals were not well prepared to adequately teach their patients.
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[Study on the reform and improvement of the medical device registration system in China].
Wang, Lanming
2012-11-01
Based on the theories of the Government Regulation and Administrative Licensure, aiming at the current situations of medical device registration system in China, some policy suggestions for future reform and improvement were provided as follows. (1) change the concepts of medical device registration administration. (2) perfect the regulations of medical device registration administration. (3) reform the medical device review organizational system. (4) Optimize the procedure of review and approval. (5) set up and maintain a professional team of review and approval staff. (6) reinforce the post-marketing supervision of medical devices. (7) foster and bring into play of the role of non-government organizations.
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Patient safety education at Japanese medical schools: results of a nationwide survey.
Maeda, Shoichi; Kamishiraki, Etsuko; Starkey, Jay
2012-05-10
Patient safety education, including error prevention strategies and management of adverse events, has become a topic of worldwide concern. The importance of the patient safety is also recognized in Japan following two serious medical accidents in 1999. Furthermore, educational curriculum guideline revisions in 2008 by relevant the Ministry of Education includes patient safety as part of the core medical curriculum. However, little is known about the patient safety education in Japanese medical schools partly because a comprehensive study has not yet been conducted in this field. Therefore, we have conducted a nationwide survey in order to clarify the current status of patient safety education at medical schools in Japan. Response rate was 60.0% (n = 48/80). Ninety-eight-percent of respondents (n = 47/48) reported integration of patient safety education into their curricula. Thirty-nine percent reported devoting less than five hours to the topic. All schools that teach patient safety reported use of lecture based teaching methods while few used alternative methods, such as role-playing or in-hospital training. Topics related to medical error theory and legal ramifications of error are widely taught while practical topics related to error analysis such as root cause analysis are less often covered. Based on responses to our survey, most Japanese medical schools have incorporated the topic of patient safety into their curricula. However, the number of hours devoted to the patient safety education is far from the sufficient level with forty percent of medical schools that devote five hours or less to it. In addition, most medical schools employ only the lecture based learning, lacking diversity in teaching methods. Although most medical schools cover basic error theory, error analysis is taught at fewer schools. We still need to make improvements to our medical safety curricula. We believe that this study has the implications for the rest of the world as a
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Patient safety education at Japanese medical schools: results of a nationwide survey
Directory of Open Access Journals (Sweden)
Maeda Shoichi
2012-05-01
Full Text Available Abstract Background Patient safety education, including error prevention strategies and management of adverse events, has become a topic of worldwide concern. The importance of the patient safety is also recognized in Japan following two serious medical accidents in 1999. Furthermore, educational curriculum guideline revisions in 2008 by relevant the Ministry of Education includes patient safety as part of the core medical curriculum. However, little is known about the patient safety education in Japanese medical schools partly because a comprehensive study has not yet been conducted in this field. Therefore, we have conducted a nationwide survey in order to clarify the current status of patient safety education at medical schools in Japan. Results Response rate was 60.0% (n = 48/80. Ninety-eight-percent of respondents (n = 47/48 reported integration of patient safety education into their curricula. Thirty-nine percent reported devoting less than five hours to the topic. All schools that teach patient safety reported use of lecture based teaching methods while few used alternative methods, such as role-playing or in-hospital training. Topics related to medical error theory and legal ramifications of error are widely taught while practical topics related to error analysis such as root cause analysis are less often covered. Conclusions Based on responses to our survey, most Japanese medical schools have incorporated the topic of patient safety into their curricula. However, the number of hours devoted to the patient safety education is far from the sufficient level with forty percent of medical schools that devote five hours or less to it. In addition, most medical schools employ only the lecture based learning, lacking diversity in teaching methods. Although most medical schools cover basic error theory, error analysis is taught at fewer schools. We still need to make improvements to our medical safety curricula. We believe that this
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What do you mean you can't sterilize it? The reusable medical device matrix.
Stephens, Anne; Assang, AnnMarie
2010-12-01
Health Canada recommends that hospitals should have procedures in place to ensure Reusable Medical Devices (RMD) are cleaned, disinfected and sterilized according to the manufacturer's instructions. For the purpose of this paper, reusable medical devices will be referred to as RMDs and include all instrumentation and devices that the Central Processing Department (CPD) resterilizes for use in the hospital. Patient safety in surgery begins in CPD. Manufacturer recommendations for the decontamination and sterilization of surgical instrumentation are of utmost importance to Operating Room (OR) and CPD staff. With recommendations that are unclear, nonspecific or unattainable there was a need to define what it means institutionally to meet standards and provide safe patient care while continuing to support the advancement of surgical technology. The purpose of this paper is to describe the challenges faced by one multisite organization (The University Health Network) in managing the sterilization of surgical instrumentation. The development of The Guidance Matrix by the network's inter-professional Reusable Medical Device (RMD) Committee, will be discussed along with information about the elements of this tool and an illustration of how it is used. The key benefits of The Guidance Matrix, including how its use has facilitated transparent decision-making, communication and collaboration regarding sterilization issues across the sites, will be described. Sterilization processes in Central Processing Departments (CPD) include chemical indicators, dated load indicators, and tamperproof locks and filters. The lack of an indicator of sterilization can be a frustrating experience for an OR Nurse. But do we really understand the critical importance of all these indicators? The foundation of sterilizing reusable medical devices (RMDs) begins with proper processes, standards and subsequent scientific validation from the vendors. According to AORN, patient safety is vital and it
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TU-AB-204-01: Device Approval Process
International Nuclear Information System (INIS)
Delfino, J.
2016-01-01
The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC
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TU-AB-204-01: Device Approval Process
Energy Technology Data Exchange (ETDEWEB)
Delfino, J. [Food & Drug Administration (United States)
2016-06-15
The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC
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2010-11-17
.... FDA-2010-N-0513] Medical Devices; General and Plastic Surgery Devices; Classification of Non-Powered... risks. Adverse tissue reaction Material degradation Improper function of suction apparatus (e.g., reflux.... Material degradation Section 8. Stability and Shelf Life. [[Page 70113
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2010-10-01
... 47 Telecommunication 5 2010-10-01 2010-10-01 false RF safety. 95.1125 Section 95.1125 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PERSONAL RADIO SERVICES Wireless Medical Telemetry Service (WMTS) General Provisions § 95.1125 RF safety. Portable devices...
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Medical devices, electronic health records and assuring patient safety : Future challenges?
Kalkman, Cor J.
2015-01-01
The patient safety movement was triggered by publications showing that modern health care is more unsafe than road travel and that more patients are killed annually by avoidable adverse events than by breast cancer [1]. As a result, an urgent need to improve patient safety has dominated
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2011-11-21
... Multiplexed Microbiology Devices: Their clinical application and public health/clinical needs; inclusion of...] Advancing Regulatory Science for Highly Multiplexed Microbiology/ Medical Countermeasure Devices; Public... Multiplexed Microbiology/ Medical Countermeasure Devices'' that published in the Federal Register of August 8...
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Electromagnetic compatibility of WLAN adapters with life-supporting medical devices.
Calcagnini, G; Mattei, E; Censi, F; Triventi, M; Lo Sterzo, R; Marchetta, E; Bartolini, P
2011-05-01
This paper investigates the electromagnetic compatibility of 45 critical care medical devices (infusion pumps, defibrillators, monitors, lung ventilators, anesthesia machines and external pacemakers) with various types of wireless local area network (WLAN, IEEE 802.11 b/g, 2.45 GHz, 100 mW) adapters. Interference is evaluated by performing ad-hoc tests according to the ANSI C63.18 recommended practice. The behavior of the devices during the tests was monitored using patient simulators/device testers specific for each device class. Electromagnetic interference cases were observed in three of 45 devices at a maximum distance of 5 cm. In two cases the interference caused malfunctions that may have clinical consequences for the patient. The authors' findings show that the use of these wireless local area network adapters can be considered reasonably safe, although interference may occur if they are operated at very close distance (<10 cm) to the medical devices.
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77 FR 6028 - Taxable Medical Devices
2012-02-07
... sold as part of an x-ray system. Commentators also requested information on the tax treatment of..., mitigation, treatment, or prevention of disease; or intended to affect the structure or any function of the... subject to an IDE is not a ``taxable medical device'' under the proposed regulations. VI. Dental...
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2017-12-27
The Food and Drug Administration (FDA or we) is classifying the external vagal nerve stimulator for headache into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the external vagal nerve stimulator for headache's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
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2013-06-05
... after the public workshop on the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/Workshops..., compact, and mobile, the number of battery-powered medical devices will continue to increase. While many...] Battery-Powered Medical Devices Workshop: Challenges and Opportunities; Public Workshop; Request for...
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Safety Issues Concerning the Medical Use of Cannabis and Cannabinoids
Directory of Open Access Journals (Sweden)
Mark A Ware
2005-01-01
Full Text Available Safety issues are a major barrier to the use of cannabis and cannabinoid medications for clinical purposes. Information on the safety of herbal cannabis may be derived from studies of recreational cannabis use, but cannabis exposure and effects may differ widely between medical and recreational cannabis users. Standardized, quality-controlled cannabinoid products are available in Canada, and safety profiles of approved medications are available through the Canadian formulary. In the present article, the evidence behind major safety issues related to cannabis use is summarized, with the aim of promoting informed dialogue between physicians and patients in whom cannabinoid therapy is being considered. Caution is advised in interpreting these data, because clinical experience with cannabinoid use is in the early stages. There is a need for long-term safety monitoring of patients using cannabinoids for a wide variety of conditions, to further guide therapeutic decisions and public policy.
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Safety device for nuclear reactors
International Nuclear Information System (INIS)
Gruhl, H.
1974-01-01
The safety device is used to capture fragments of the lid of a pressure vessel when this vessel ruptures. It consists of a catcher structure attached to the concrete vessel, which is open at the top, and surrounding the pressure vessel. The catcher structure in this case may be designed as a ring installed very close to the concrete vessel, as a closure plate or may be made of transverse beams arranged parallel to each other. It is anchored either rigidly or elastically to the concrete vessel by means of springs or to the foundation by means of steel stretching members. (DG) [de
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2010-11-10
.... FDA-2010-N-0512] Medical Devices; General and Plastic Surgery Devices; Classification of Tissue... running to unintended areas, etc. B. Wound dehiscence C. Adverse tissue reaction and chemical burns D..., Clinical Studies, Labeling. Adverse tissue reaction and chemical Biocompatibility Animal burns. Testing...
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An interprofessional approach to improving paediatric medication safety
Directory of Open Access Journals (Sweden)
Kennedy Neil
2010-02-01
Full Text Available Abstract Background Safe drug prescribing and administration are essential elements within undergraduate healthcare curricula, but medication errors, especially in paediatric practice, continue to compromise patient safety. In this area of clinical care, collective responsibility, team working and communication between health professionals have been identified as key elements in safe clinical practice. To date, there is limited research evidence as to how best to deliver teaching and learning of these competencies to practitioners of the future. Methods An interprofessional workshop to facilitate learning of knowledge, core competencies, communication and team working skills in paediatric drug prescribing and administration at undergraduate level was developed and evaluated. The practical, ward-based workshop was delivered to 4th year medical and 3rd year nursing students and evaluated using a pre and post workshop questionnaire with open-ended response questions. Results Following the workshop, students reported an increase in their knowledge and awareness of paediatric medication safety and the causes of medication errors (p Conclusion This study has helped bridge the knowledge-skills gap, demonstrating how an interprofessional approach to drug prescribing and administration has the potential to improve quality and safety within healthcare.
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77 FR 32644 - Medical Devices; Exemption From Premarket Notification: Wheelchair Elevator
2012-06-01
...] Medical Devices; Exemption From Premarket Notification: Wheelchair Elevator AGENCY: Food and Drug... elevator devices commonly known as inclined platform lifts and vertical platform lifts. These devices are... behalf of Bruno Independent Living Aids, Inc., for wheelchair elevator devices (commonly known as...
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Medical and Safety Reforms in Boxing
Jordan, Barry D.
1988-01-01
The continued existence of boxing as an accepted sport in civilized society has been long debated. The position of the American Medical Association (AMA) has evolved from promoting increased safety and medical reform to recommending total abolition of both amateur and professional boxing. In response to the AMA opposition to boxing, the boxing community has attempted to increase the safeguards in amateur and professional boxing. The United States of America Amateur Boxing Federation, which is the national regulatory agency for all amateur boxing in the United States, has taken several actions to prevent the occurrence of acute brain injury and is currently conducting epidemiologic studies to assess the long-term neuropsychologic consequences of amateur boxing. In professional boxing, state regulatory agencies such as the New York State Athletic Commission have introduced several medical interventions to prevent and reduce neurologic injury. The lack of a national regulatory agency to govern professional boxing has stimulated the formation of the Association of Boxing Commissions and potential legislation for the federal regulation of professional boxing by a federally chartered organization called the United States Boxing Commission. The AMA's opposition to boxing and the medical and safety reforms implemented by the proponents of boxing are discussed. PMID:3385788
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2013-03-04
The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from premarket notification requirements for wheelchair elevator devices commonly known as inclined platform lifts and vertical platform lifts. These devices are used to provide a means for a person with a mobility impairment caused by injury or other disease to move from one level to another, usually in a wheelchair. This order exempts wheelchair elevators, class II devices, from premarket notification and establishes conditions for exemption for this device that will provide a reasonable assurance of the safety and effectiveness of the device without submission of a premarket notification (510(k)). This exemption from 510(k), subject to these conditions, is immediately in effect for wheelchair elevators. All other devices classified under FDA's wheelchair elevator regulations, including attendant-operated stair climbing devices for wheelchairs and portable platform lifts, continue to require submission of 510(k)s. FDA is publishing this order in accordance with the section of the Food, Drug, and Cosmetic Act (the FD&C Act) permitting the exemption of a device from the requirement to submit a 510(k).
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2012-02-14
... premarket notification, prior to marketing the device, which contains information about the endovascular...), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct..., environmental, public health and safety, and other advantages; distributive impacts; and equity). The Agency...
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Hall, Jill; Bond, Christine; Kinnear, Moira; McKinstry, Brian
2016-10-17
To explore the perceived acceptability, advantages and disadvantages of electronic multicompartment medication devices. Qualitative study using 8 focus groups and 10 individual semistructured interviews. Recordings were transcribed and analysed thematically. Strategies were employed to ensure the findings were credible and trustworthy. Community pharmacists (n=11), general practitioners (n=9), community nurses (n=12) and social care managers (n=8) were recruited from the National Health Service (NHS) and local authority services. Patients (n=15) who were current conventional or electronic multicompartment medication device users or had medication adherence problems were recruited from community pharmacies. 3 informal carers participated. Electronic multicompartment medication devices which prompt the patient to take medication may be beneficial for selected individuals, particularly those with cognitive impairment, but who are not seriously impaired, provided they have a good level of dexterity. They may also assist individuals where it is important that medication is taken at fixed time intervals. These are likely to be people who are being supported to live alone. No single device suited everybody; smaller/lighter devices were preferred but their usefulness was limited by the small number/size of storage compartments. Removing medications was often challenging. Transportability was an important factor for patients and carers. A carer's alert if medication is not taken was problematic with multiple barriers to implementation and no consensus as to who should receive the alert. There was a lack of enthusiasm among professionals, particularly among pharmacists, due to concerns about responsibility and funding for devices as well as ensuring devices met regulatory standards for storage and labelling. This study provides indicators of which patients might benefit from an electronic multicompartment medication device as well as the kinds of features to consider when
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Left to their own devices: medical learners' use of mobile technologies.
Ellaway, Rachel H; Fink, Patricia; Graves, Lisa; Campbell, Alanna
2014-02-01
Although many medical learners and teachers are using mobile technologies within medical education, there has been little evidence presented describing how they use mobile devices across a whole curriculum. The Northern Ontario School of Medicine (NOSM) introduced a new mobile device program in 2010. Incoming undergraduate medical learners received a laptop and an iPad and learners entering year three of the four-year program received a laptop and an iPhone. A survey was sent to all learners to gather information on their use of and attitudes toward these devices. A combination of quantitative and qualitative methods was used to analyze the data and to generate a series of themes that synthesized student behaviors, perceptions and attitudes. Context and learner autonomy were found to be important factors with learners using multiple devices for different purposes and adopting strategic approaches to learning using these devices. The expectation that school-issued devices would be regularly and enthusiastically used to replace more traditional study media was not reflected in practice. Learners' approaches to using mobile devices are heterogeneous as is the extent to which they use them. Learners adapt their use of mobile devices to the learning cultures and contexts they find themselves in.
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Smeulers, Marian; Onderwater, Astrid T; van Zwieten, Myra C B; Vermeulen, Hester
2014-04-01
To explore nurses' experiences with and perspectives on preventing medication administration errors. Insight into nurses' experiences with and perspectives on preventing medication administration errors is important and can be utilised to tailor and implement safety practices. A qualitative interview study of 20 nurses in an academic medical centre was conducted between March and December of 2011. Three themes emerged from this study: (1) nurses' roles and responsibilities in medication safety: aside from safe preparation and administration, the clinical reasoning of nurses is essential for medication safety; (2) nurses' ability to work safely: knowledge of risks and nurses' work circumstances influence their ability to work safely; and (3) nurses' acceptance of safety practices: advantages, feasibility and appropriateness are important incentives for acceptance of a safety practice. Nurses' experiences coincide with the assumption that they are in a pre-eminent position to enable safe medication management; however, their ability to adequately perform this role depends on sufficient knowledge to assess the risks of medication administration and on the circumstances in which they work. Safe medication management requires a learning climate and professional practice environment that enables further development of professional nursing skills and knowledge. © 2014 John Wiley & Sons Ltd.
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International Nuclear Information System (INIS)
1980-02-01
The manual consists of the following chapters: general policies and administration; the Environmental Health and Safety Department; the Medical Services Department: biological hazards; chemical safety; confined space entry; cryogenic safety; electrical safety; emergency plans; engineering and construction; evacuations, trenching, and shoring; fire safety; gases, flammable and compressed; guarding, mechanical; ladders and scaffolds, work surfaces; laser safety; materials handling and storage; noise; personal protective equipment; pressure safety; radiation safety, ionizing and non-ionizing; sanitation; seismic safety; training, environmental health and safety; tools, power and hand-operated; traffic and transportation; and warning signs and devices
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Possibilities of radiation sterilization for re-usage of medical devices in the medical management
International Nuclear Information System (INIS)
Tabei, Masae; Kudo, Hisaaki; Katsumura, Yosuke
2004-01-01
The rule for re-usage of medical single-use devices was established in US in 2000 based on the concept of Managed Care (total management of medicare on cost, quality and patients' satisfaction) and 20-30% of those devices are re-used at present. The re-usage is conducted in not only US but also Canada, Denmark, UK, India, China etc. Standing on the viewpoint, this paper described and discussed the possibility of re-usage of the single-use devices now prohibited in Japan, possible re-sterilization, possible re-usage of hollow fiber-type hemodialyzer following γ-ray sterilization with consideration for D-values against bacteria and viruses, cost estimation of electron beam sterilization for re-usage, and radiation sterilization of waste water and plastic materials. Radiation sterilization for re-usage of medical devices was concluded possible if their materials and records for their usage processes are proper, and should be conducted in a large scale after sufficient examinations by industries/government/academia. (N.I.)
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Third-year medical students' knowledge of privacy and security issues concerning mobile devices.
Whipple, Elizabeth C; Allgood, Kacy L; Larue, Elizabeth M
2012-01-01
The use of mobile devices are ubiquitous in medical-care professional settings, but information on privacy and security concerns of mobile devices for medical students is scarce. To gain baseline information about third-year medical students' mobile device use and knowledge of privacy and security issues concerning mobile devices. We surveyed 67 third-year medical students at a Midwestern university on their use of mobile devices and knowledge of how to protect information available through mobile devices. Students were also presented with clinical scenarios to rate their level of concern in regards to privacy and security of information. The most used features of mobile devices were: voice-to-voice (100%), text messaging (SMS) (94%), Internet (76.9%), and email (69.3%). For locking of one's personal mobile phone, 54.1% never physically lock their phone, and 58% never electronically lock their personal PDA. Scenarios considering definitely privacy concerns include emailing patient information intact (66.7%), and posting de-identified information on YouTube (45.2%) or Facebook (42.2%). As the ease of sharing data increases with the use of mobile devices, students need more education and training on possible privacy and security risks posed with mobile devices.
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International Nuclear Information System (INIS)
Vaz, Pedro
2015-01-01
The use of radiation sources, namely radioactive sealed or unsealed sources and particle accelerators and beams is ubiquitous in the industrial and medical applications of ionizing radiation. Besides radiological protection of the workers, members of the public and patients in routine situations, the use of radiation sources involves several aspects associated to the mitigation of radiological or nuclear accidents and associated emergency situations. On the other hand, during the last decade security issues became burning issues due to the potential malevolent uses of radioactive sources for the perpetration of terrorist acts using RDD (Radiological Dispersal Devices), RED (Radiation Exposure Devices) or IND (Improvised Nuclear Devices). A stringent set of international legally and non-legally binding instruments, regulations, conventions and treaties regulate nowadays the use of radioactive sources. In this paper, a review of the radiological protection issues associated to the use of radiation sources in the industrial and medical applications of ionizing radiation is performed. The associated radiation safety issues and the prevention and mitigation of incidents and accidents are discussed. A comprehensive discussion of the security issues associated to the global use of radiation sources for the aforementioned applications and the inherent radiation detection requirements will be presented. Scientific, technical, legal, ethical, socio-economic issues are put forward and discussed. - Highlights: • The hazards associated to the use of radioactive sources must be taken into account. • Security issues are of paramount importance in the use of radioactive sources. • Radiation sources can be used to perpetrate terrorist acts (RDDs, INDs, REDs). • DSRS and orphan sources trigger radiological protection, safety and security concerns. • Regulatory control, from cradle to grave, of radioactive sources is mandatory.
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Low power signal processing electronics for wearable medical devices.
Casson, Alexander J; Rodriguez-Villegas, Esther
2010-01-01
Custom designed microchips, known as Application Specific Integrated Circuits (ASICs), offer the lowest possible power consumption electronics. However, this comes at the cost of a longer, more complex and more costly design process compared to one using generic, off-the-shelf components. Nevertheless, their use is essential in future truly wearable medical devices that must operate for long periods of time from physically small, energy limited batteries. This presentation will demonstrate the state-of-the-art in ASIC technology for providing online signal processing for use in these wearable medical devices.
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The safety issues of medical robotics
Energy Technology Data Exchange (ETDEWEB)
Fei Baowei; Ng, W.S.; Chauhan, Sunita; Kwoh, Chee Keong
2001-08-01
In this paper, we put forward a systematic method to analyze, control and evaluate the safety issues of medical robotics. We created a safety model that consists of three axes to analyze safety factors. Software and hardware are the two material axes. The third axis is the policy that controls all phases of design, production, testing and application of the robot system. The policy was defined as hazard identification and safety insurance control (HISIC) that includes seven principles: definitions and requirements, hazard identification, safety insurance control, safety critical limits, monitoring and control, verification and validation, system log and documentation. HISIC was implemented in the development of a robot for urological applications that was known as URObot. The URObot is a universal robot with different modules adaptable for 3D ultrasound image-guided interstitial laser coagulation, radiation seed implantation, laser resection, and electrical resection of the prostate. Safety was always the key issue in the building of the robot. The HISIC strategies were adopted for safety enhancement in mechanical, electrical and software design. The initial test on URObot showed that HISIC had the potential ability to improve the safety of the system. Further safety experiments are being conducted in our laboratory.
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The safety issues of medical robotics
International Nuclear Information System (INIS)
Fei Baowei; Ng, W.S.; Chauhan, Sunita; Kwoh, Chee Keong
2001-01-01
In this paper, we put forward a systematic method to analyze, control and evaluate the safety issues of medical robotics. We created a safety model that consists of three axes to analyze safety factors. Software and hardware are the two material axes. The third axis is the policy that controls all phases of design, production, testing and application of the robot system. The policy was defined as hazard identification and safety insurance control (HISIC) that includes seven principles: definitions and requirements, hazard identification, safety insurance control, safety critical limits, monitoring and control, verification and validation, system log and documentation. HISIC was implemented in the development of a robot for urological applications that was known as URObot. The URObot is a universal robot with different modules adaptable for 3D ultrasound image-guided interstitial laser coagulation, radiation seed implantation, laser resection, and electrical resection of the prostate. Safety was always the key issue in the building of the robot. The HISIC strategies were adopted for safety enhancement in mechanical, electrical and software design. The initial test on URObot showed that HISIC had the potential ability to improve the safety of the system. Further safety experiments are being conducted in our laboratory
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Implementation of radiation safety program in a medical institution
International Nuclear Information System (INIS)
Palanca, Elena D.
1999-01-01
A medical institution that utilizes radiation for the diagnosis and treatment of diseases of malignancies develops and implements a radiation safety program to keep occupational exposures of radiation workers and exposures of non-radiation workers and the public to the achievable and a more achievable minimum, to optimize the use of radiation, and to prevent misadministration. The hospital radiation safety program is established by a core medical radiation committee composed of trained radiation safety officers and head of authorized users of radioactive materials and radiation machines from the different departments. The radiation safety program sets up procedural guidelines of the safe use of radioactive material and of radiation equipment. It offers regular training to radiation workers and radiation safety awareness courses to hospital staff. The program has a comprehensive radiation safety information system or radsis that circularizes the radiation safety program in the hospital. The radsis keeps the drafted and updated records of safety guides and policies, radioactive material and equipment inventory, personnel dosimetry reports, administrative, regulatory and licensing activity document, laboratory procedures, emergency procedures, quality assurance and quality control program process, physics and dosimetry procedures and reports, personnel and hospital staff training program. The medical radiation protection committee is tasked to oversee the actual implementation of the radiation safety guidelines in the different radiation facilities in the hospital, to review personnel exposures, incident reports and ALARA actions, operating procedures, facility inspections and audit reports, to evaluate the existing radiation safety procedures, to make necessary changes to these procedures, and make modifications of course content of the training program. The effective implementation of the radiation safety program provides increased confidence that the physician and
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Terhechte, Arno
2018-03-01
Software can be classified as a medical device according to the Medical Device Directive 93/42/EEC. The number of software products and medical apps is continuously increasing and so too is the use in health institutions (e. g., in hospitals and doctors' surgeries) for diagnosis and therapy.Different aspects of standalone software and medical apps from the perspective of the authority responsible are presented. The quality system implemented to establish a risk-based systematic inspection and supervision of manufacturers is discussed. The legal framework, as well as additional standards that are the basis for inspection, are outlined. The article highlights special aspects that occur during inspection like verification of software and interfaces, and the clinical evaluation of software. The Bezirksregierung, as the local government authority responsible in North Rhine-Westphalia, is also in charge of inspection of health institutions. Therefore this article is not limited to the manufacturers placing the software on the market, but in addition it describes the management and use of software as a medical device in hospitals.The future legal framework, the Medical Device Regulation, will strengthen the requirements and engage notified bodies more than today in the conformity assessment of software as a medical device.Manufacturers, health institutions, notified bodies and the authorities responsible are in charge of intensifying their efforts towards software as a medical device. Mutual information, improvement of skills, and inspections will lead to compliance with regulatory requirements.
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2011-02-11
... Organizations: Voluntary Delisting From Community Medical Foundation for Patient Safety AGENCY: Agency for... Medical Foundation for Patient Safety, of its status as a Patient Safety Organization (PSO). The Patient... notification from Community Medical Foundation for Patient Safety, PSO number P0029, to voluntarily relinquish...
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Safety as experienced by patients themselves: a Finnish survey of the most recent period of care.
Sahlström, Merja; Partanen, Pirjo; Turunen, Hannele
2014-06-01
We examined patients' experiences of patient safety and participation in promoting safe care during their most recent care period. A survey of patients (N = 175) revealed that treatment, medication, and device safety were mostly experienced as very good or excellent, but responses varied by age and experience. Patients ages 66-75 were most critical of treatment and medication safety. Device safety was rated the worst aspect of safety. Twenty percent of respondents had experienced errors at some time during their care. Patients who had experienced errors and those who were treated at inpatient wards versus a day surgery unit were most critical towards patient participation. Open and transparent error management involving patients is needed to promote treatment, medication, and especially device safety. © 2014 Wiley Periodicals, Inc.
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Research on dose setting for radiation sterilization of medical device
International Nuclear Information System (INIS)
Zhang Tongcheng; Liu Qingfang; Zhong Hongliang; Mi Zhisu; Wang Chunlei; Jiang Jianping
2002-01-01
Objective: To establish the radiation sterilization dose for medical devices using data of bioburden on the medical device. Methods: Firstly determination of recovery ratio and correction coefficient of the microbiological test method was used according to ISO11737 standard, then determination of bioburden on the products, finally the dose setting was completed based on the Method 1 in ISO11137 standard. Results: Fifteen kinds of medical devices were tested. Bioburden range was from 8.6-97271.2 CFU/device, recovery ration range 54.6%-100%, correction co-efficiency range 1.00-1.83, D 10 distribution from 1.40 to 2.82 kGy, verification dose (dose at SAL = 10 -2 ) range 5.1-17.6 kGy and sterilization dose (dose at SAL 10 -6 ) range 17.5-32.5 kGy. Conclusion: One hundred samples of each kind of product were exposed to the pre-determined verification dose and then the sterility test was performed. Each sterility test showed positive number was not greater than two. This indicated that the sterilization dose established for each kind of product was statistically acceptable
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2011-03-16
... DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. FDA-2011-N-0002] Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Microbiology...
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A performance improvement plan to increase nurse adherence to use of medication safety software.
Gavriloff, Carrie
2012-08-01
Nurses can protect patients receiving intravenous (IV) medication by using medication safety software to program "smart" pumps to administer IV medications. After a patient safety event identified inconsistent use of medication safety software by nurses, a performance improvement team implemented the Deming Cycle performance improvement methodology. The combined use of improved direct care nurse communication, programming strategies, staff education, medication safety champions, adherence monitoring, and technology acquisition resulted in a statistically significant (p < .001) increase in nurse adherence to using medication safety software from 28% to above 85%, exceeding national benchmark adherence rates (Cohen, Cooke, Husch & Woodley, 2007; Carefusion, 2011). Copyright © 2012 Elsevier Inc. All rights reserved.
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MRI with cardiac pacing devices – Safety in clinical practice
Energy Technology Data Exchange (ETDEWEB)
Kaasalainen, Touko, E-mail: touko.kaasalainen@hus.fi [HUS Medical Imaging Center, Helsinki University Central Hospital, POB 340 (Haartmaninkatu 4), 00290 Helsinki (Finland); Department of Physics, University of Helsinki (Finland); Pakarinen, Sami, E-mail: sami.pakarinen@hus.fi [HUS Department of Cardiology, Helsinki University Central Hospital, POB 340 (Haartmaninkatu 4), 00290 Helsinki (Finland); Kivistö, Sari, E-mail: sari.kivisto@hus.fi [HUS Medical Imaging Center, Helsinki University Central Hospital, POB 340 (Haartmaninkatu 4), 00290 Helsinki (Finland); Holmström, Miia, E-mail: miia.holmstrom@hus.fi [HUS Medical Imaging Center, Helsinki University Central Hospital, POB 340 (Haartmaninkatu 4), 00290 Helsinki (Finland); Hänninen, Helena, E-mail: helena.hanninen@hus.fi [HUS Department of Cardiology, Helsinki University Central Hospital, POB 340 (Haartmaninkatu 4), 00290 Helsinki (Finland); Peltonen, Juha, E-mail: juha.peltonen@hus.fi [HUS Medical Imaging Center, Helsinki University Central Hospital, POB 340 (Haartmaninkatu 4), 00290 Helsinki (Finland); Department of Biomedical Engineering and Computational Science, School of Science, Aalto University, Helsinki (Finland); Lauerma, Kirsi, E-mail: kirsi.lauerma@hus.fi [HUS Medical Imaging Center, Helsinki University Central Hospital, POB 340 (Haartmaninkatu 4), 00290 Helsinki (Finland); Sipilä, Outi, E-mail: outi.sipila@hus.fi [HUS Medical Imaging Center, Helsinki University Central Hospital, POB 340 (Haartmaninkatu 4), 00290 Helsinki (Finland)
2014-08-15
Objectives: The aim of this study was to introduce a single centre “real life” experience of performing MRI examinations in clinical practice on patients with cardiac pacemaker systems. Additionally, we aimed to evaluate the safety of using a dedicated safety protocol for these patients. Materials and methods: We used a 1.5 T MRI scanner to conduct 68 MRI scans of different body regions in patients with pacing systems. Of the cardiac devices, 32% were MR-conditional, whereas the remaining 68% were MR-unsafe. We recorded the functional parameters of the devices prior, immediately after, and approximately one month after the MRI scanning, and compared the device parameters to the baseline values. Results: All MRI examinations were completed safely, and each device could be interrogated normally following the MRI. We observed no changes in the programmed parameters of the devices. For most of the participants, the distributions of the immediate and one-month changes in the device parameters were within 20% of the baseline values, although some changes approached clinically important thresholds. Furthermore, we observed no differences in the variable changes between MR-conditional and MR-unsafe pacing systems, or between scans of the thorax area and other scanned areas. Conclusion: MRI in patients with MR-conditional pacing systems and selected MR-unsafe systems could be performed safely under strict conditions in this study.
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Medical Device Plug-and-Play Interoperability Standards and Technology Leadership
2010-10-01
American Telemedicine Association), we demonstrated how continuous monitoring of the patient’s SpO2 and respiratory rate could detect the onset of...designed to monitor sepsis infection sounded its alarm continually, day and night. The device was built with an innovative algorithm to detect sepsis, but...transport Figure 3. This medical device has misread its sensors and inserted false data into patient’s permanent medical record. SPECIal FEaTuRE October
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2014-07-03
The Food and Drug Administration (FDA) is classifying the transcutaneous electrical nerve stimulator to treat headache into class II (special controls). The special controls that will apply to the device are identified in this order, and will be part of the codified language for the transcutaneous electrical nerve stimulator to treat headache classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
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Safety of the medical gas pipeline system
Directory of Open Access Journals (Sweden)
Sushmita Sarangi
2018-01-01
Full Text Available Medical gases are nowadays being used for a number of diverse clinical applications and its piped delivery is a landmark achievement in the field of patient care. Patient safety is of paramount importance in the design, installation, commissioning, and operation of medical gas pipeline systems (MGPS. The system has to be operational round the clock, with practically zero downtime and its failure can be fatal if not restored at the earliest. There is a lack of awareness among the clinicians regarding the medico-legal aspect involved with the MGPS. It is a highly technical field; hence, an in-depth knowledge is a must to ensure safety with the system.
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An examination of safety reports involving electronic flight bags and portable electronic devices
2014-06-01
The purpose of this research was to develop a better understanding of safety considerations with the use of Electronic Flight Bags (EFBs) and Portable Electronic Devices (PEDs) by examining safety reports from Aviation Safety Reporting System (ASRS),...
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Evidence for the safety assurance of the radiation associated equipments for stat-up check
International Nuclear Information System (INIS)
Takahashi, Yasuyuki; Igarashi, Hiroshi; Saito, Kyoko; Kawaharada, Yasuhiro; Hirano, Kunihiro; Murase, Kenya; Mochizuki, Teruhito
2008-01-01
Based on the new amendment of the Medical Service Law and the Pharmaceutical Affairs Law, the safety control for the medical equipments and devices was strengthened; and a radiological technologist should be stipulated as a safety control manager for the medical equipments and devices. Although it is thought that Start-up check is important for the safety assurance, the enforcement situation is not clear until now. In this report, on the occasion of the start-up of the new Law, questionnaire about the start up check (time and a check items) were investigated from 56 hospitals applying the visit interview. Modality by modality check up time was obtained from 261 institutions by the descriptive study paper type. Start-up check and arming up were applied for almost all modalities about 30 minutes before start of the clinical tests. The check up items for the medical equipments and devices depended on each hospital. Therefore, safety assurance should be established, cooperating with the medical equipment distributors, the hospital sharing the checked results for the patients' safety. (author)
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21 CFR 801.16 - Medical devices; Spanish-language version of certain required statements.
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices; Spanish-language version of....16 Medical devices; Spanish-language version of certain required statements. If devices restricted to prescription use only are labeled solely in Spanish for distribution in the Commonwealth of Puerto Rico where...
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Safety considerations in the design of the Fusion Engineering Device
International Nuclear Information System (INIS)
Barrett, R.J.
1983-01-01
The US Department of Energy (DOE) regulations and guidelines for radiation protection have been reviewed and are being applied to the device design. Direct radiation protection is provided by the device shield and the reactor building walls. Radiation from the activated device components and the tritium fuel is to be controlled with shielding, contamination control, and ventilation. The potential release of tritium from the plant has influenced the selection of reactor building and plant designs and specifications. The safety of the plant workers is affected primarily by the radiation from the activated device components and from plasma chamber debris
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Energy Technology Data Exchange (ETDEWEB)
Pooley, R [Mayo Clinic, Jacksonville, FL (United States); Bernstein, M; Shu, Y; Gorny, K; Felmlee, J [Mayo Clinic, Rochester, MN (United States); Panda, A [Mayo Clinic, Arizona, Scottsdale, AZ (United States)
2014-06-15
Clinical diagnostic medical physicists may be responsible for implementing and maintaining a comprehensive MR safety program. Accrediting bodies including the ACR, IAC, Radsite and The Joint Commission each include aspects of MR Safety into their imaging accreditation programs; MIPPA regulations further raise the significance of non-compliance. In addition, The Joint Commission recently announced New and Revised Diagnostic Imaging Standards for accredited health care organizations which include aspects of MR Safety. Hospitals and clinics look to the physicist to understand guidelines, regulations and accreditation requirements related to MR safety. The clinical medical physicist plays a significant role in a clinical practice by understanding the physical basis for the risks and acting as a facilitator to successfully implement a safety program that provides well-planned siting, allows for the safe scanning of certain implanted devices, and helps radiologists manage specific patient exams. The MRI scanning of specific devices will be discussed including cardiac pacemakers and neurostimulators such as deep brain stimulators. Furthermore for sites involved in MR guided interventional procedures, the MR physicist plays an essential role to establish safe practices. Creating a framework for a safe MRI practice includes the review of actual safety incidents or close calls to determine methods for prevention in the future. Learning Objectives: Understand the requirements and recommendations related to MR safety from accrediting bodies and federal regulations. Understand the Medical Physicist's roles to ensure MR Safety. Identify best practices for dealing with implanted devices, including pacemakers and deep brain stimulators. Review aspects of MR safety involved in an MR guided interventional environment. Understand the important MR safety aspects in actual safety incidents or near misses.
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Health Care: Reprocessed Medical Single-Use Devices in DoD
National Research Council Canada - National Science Library
2002-01-01
... for decontamination and resterilization. The emergence of new materials and sterilization methods, and the increasing costs of health care, resulted in the development of medical single-use devices and the practice of reprocessing the devices...
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Motorcycle safety device investigation: A case study on airbags
Indian Academy of Sciences (India)
analysis methods for research evaluation of rider crash protective devices fitted to ... The safety evaluation is then based on simulation of the 200 impact types. ... with recording of ISO 13232 car-front impact tests to evaluate the qualitative.
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Management information system of medical equipment using mobile devices
Núñez, C.; Castro, D.
2011-09-01
The large numbers of technologies currently incorporated into mobile devices transform them into excellent tools for capture and to manage the information, because of the increasing computing power and storage that allow to add many miscellaneous applications. In order to obtain benefits of these technologies, in the biomedical engineering field, it was developed a mobile information system for medical equipment management. The central platform for the system it's a mobile phone, which by a connection with a web server, it's capable to send and receive information relative to any medical equipment. Decoding a type of barcodes, known as QR-Codes, the management process is simplified and improved. These barcodes identified the medical equipments in a database, when these codes are photographed and decoded with the mobile device, you can access to relevant information about the medical equipment in question. This Project in it's actual state is a basic support tool for the maintenance of medical equipment. It is also a modern alternative, competitive and economic in the actual market.
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31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.
2010-07-01
... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false In-kind donations of medicine...-kind donations of medicine, medical devices, and medical services. (a) Effective July 6, 2006, nongovernmental organizations that are U.S. persons are authorized to provide in-kind donations of medicine...
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Pricing and reimbursement of drugs and medical devices in Hungary.
Gulácsi, L; Dávid, T; Dózsa, Cs
2002-01-01
Similarly to other countries of Central and Eastern Europe, Hungary has witnessed massive diffusion of healthcare technology such as drugs and medical devices since 1990. While substantial new pharmaceuticals, medical devices, and procedures have been liberalized, there has been no proper evaluation or training in their use. Healthcare providers have come to find themselves as entrepreneurs in private practice, while patients are acquiring an increasing awareness as customers of healthcare,demanding services in return for their taxes and contributions. This has led to extremely irrational patterns of investment in technology, with most an obvious waste of resources, while leaving basic needs unmet. Both the National Health Insurance Fund and the Ministry of Finance believe that the current pharmaceutical and medical device bill is too high. However, introducing a more transparent and flexible pricing and reimbursement framework may enable a more efficient allocation of the limited resources to be achieved.
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Vaz, Pedro
2015-11-01
The use of radiation sources, namely radioactive sealed or unsealed sources and particle accelerators and beams is ubiquitous in the industrial and medical applications of ionizing radiation. Besides radiological protection of the workers, members of the public and patients in routine situations, the use of radiation sources involves several aspects associated to the mitigation of radiological or nuclear accidents and associated emergency situations. On the other hand, during the last decade security issues became burning issues due to the potential malevolent uses of radioactive sources for the perpetration of terrorist acts using RDD (Radiological Dispersal Devices), RED (Radiation Exposure Devices) or IND (Improvised Nuclear Devices). A stringent set of international legally and non-legally binding instruments, regulations, conventions and treaties regulate nowadays the use of radioactive sources. In this paper, a review of the radiological protection issues associated to the use of radiation sources in the industrial and medical applications of ionizing radiation is performed. The associated radiation safety issues and the prevention and mitigation of incidents and accidents are discussed. A comprehensive discussion of the security issues associated to the global use of radiation sources for the aforementioned applications and the inherent radiation detection requirements will be presented. Scientific, technical, legal, ethical, socio-economic issues are put forward and discussed.
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International Nuclear Information System (INIS)
Roh, Young Hoon; Kim, Jung Min
2015-01-01
Medical electrical equipment - Part 1: General requirement for basic safety and essential performance of MFDS was revised as 3th edition and Medical electrical equipment Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment will be expected to be announced as notification. Therefore this technical report was written to introduce provision of the particular requirements, replacement, addition, amendment. The purpose of this particular requirements is to secure requirements for basic safety and essential performance of X-ray equipment for radiography and radioscopy. X-ray high voltage generator, mechanical protective device, protection against radiation is included in this particular requirements. Medical electrical equipment - Part 1, Part 1-2, Part 1-3 is applied to this particular requirements. If the requirements is announced as notification, It is expected to widen understanding for basic safety and essential performance of X-ray equipment for radiography and radioscopy and play a part to internationalize of medical equipment
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2017-10-18
The Food and Drug Administration (FDA or we) is classifying the organophosphate test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the organophosphate test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
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2018-01-03
The Food and Drug Administration (FDA or we) is classifying the cervical intraepithelial neoplasia (CIN) test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the CIN test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
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2010-01-11
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0606] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice...) is announcing an amendment to the notice of a meeting of the General and Plastic Surgery Devices...
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Pediatric Nurses' Perceptions of Medication Safety and Medication Error: A Mixed Methods Study.
Alomari, Albara; Wilson, Val; Solman, Annette; Bajorek, Beata; Tinsley, Patricia
2017-05-30
This study aims to outline the current workplace culture of medication practice in a pediatric medical ward. The objective is to explore the perceptions of nurses in a pediatric clinical setting as to why medication administration errors occur. As nurses have a central role in the medication process, it is essential to explore nurses' perceptions of the factors influencing the medication process. Without this understanding, it is difficult to develop effective prevention strategies aimed at reducing medication administration errors. Previous studies were limited to exploring a single and specific aspect of medication safety. The methods used in these studies were limited to survey designs which may lead to incomplete or inadequate information being provided. This study is phase 1 on an action research project. Data collection included a direct observation of nurses during medication preparation and administration, audit based on the medication policy, and guidelines and focus groups with nursing staff. A thematic analysis was undertaken by each author independently to analyze the observation notes and focus group transcripts. Simple descriptive statistics were used to analyze the audit data. The study was conducted in a specialized pediatric medical ward. Four key themes were identified from the combined quantitative and qualitative data: (1) understanding medication errors, (2) the busy-ness of nurses, (3) the physical environment, and (4) compliance with medication policy and practice guidelines. Workload, frequent interruptions to process, poor physical environment design, lack of preparation space, and impractical medication policies are identified as barriers to safe medication practice. Overcoming these barriers requires organizations to review medication process policies and engage nurses more in medication safety research and in designing clinical guidelines for their own practice.
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Towards automated assistance for operating home medical devices.
Gao, Zan; Detyniecki, Marcin; Chen, Ming-Yu; Wu, Wen; Hauptmann, Alexander G; Wactlar, Howard D
2010-01-01
To detect errors when subjects operate a home medical device, we observe them with multiple cameras. We then perform action recognition with a robust approach to recognize action information based on explicitly encoding motion information. This algorithm detects interest points and encodes not only their local appearance but also explicitly models local motion. Our goal is to recognize individual human actions in the operations of a home medical device to see if the patient has correctly performed the required actions in the prescribed sequence. Using a specific infusion pump as a test case, requiring 22 operation steps from 6 action classes, our best classifier selects high likelihood action estimates from 4 available cameras, to obtain an average class recognition rate of 69%.
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Perceived medical benefit, peer/partner influence and safety and ...
African Journals Online (AJOL)
Perceived medical benefit, peer/partner influence and safety and cost to access the service: client motivators for voluntary seeking of medical male circumcision in Iganga District Eastern Uganda, a qualitative study.
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Lansdowne, Krystal; Scully, Christopher G; Galeotti, Loriano; Schwartz, Suzanne; Marcozzi, David; Strauss, David G
2015-06-01
In 2010, the US Food and Drug Administration (Silver Spring, Maryland USA) created the Medical Countermeasures Initiative with the mission of development and promoting medical countermeasures that would be needed to protect the nation from identified, high-priority chemical, biological, radiological, or nuclear (CBRN) threats and emerging infectious diseases. The aim of this review was to promote regulatory science research of medical devices and to analyze how the devices can be employed in different CBRN scenarios. Triage in CBRN scenarios presents unique challenges for first responders because the effects of CBRN agents and the clinical presentations of casualties at each triage stage can vary. The uniqueness of a CBRN event can render standard patient monitoring medical device and conventional triage algorithms ineffective. Despite the challenges, there have been recent advances in CBRN triage technology that include: novel technologies; mobile medical applications ("medical apps") for CBRN disasters; electronic triage tags, such as eTriage; diagnostic field devices, such as the Joint Biological Agent Identification System; and decision support systems, such as the Chemical Hazards Emergency Medical Management Intelligent Syndromes Tool (CHEMM-IST). Further research and medical device validation can help to advance prehospital triage technology for CBRN events.
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Bauman, Jordan
2012-01-01
With the Medical Device Amendments of 1976, Congress granted FDA authority to regulate medical devices by implementing a risk-based regulatory framework. Several years prior to this legislation, the Cooper Committee reviewed the medical device regulatory landscape and uncovered weaknesses that could be detrimental to public health. However, only after several high-profile incidents involving unsafe medical devices did Congress respond with strong legislation. Since 1976, additional medical device legislative revisions have been enacted to address deficiencies highlighted by various groups representing Congress, FDA, and industry. A repetitive conclusion from these groups has been that the 510(k) program is incapable of serving as a premarket evaluation of safety and effectiveness under the existing statutory framework. However, these legislative revisions did not change the statutory framework despite these repeated findings. In 2009, CDRH convened separate groups to again review the 510(k) program. While more comprehensive than previous initiatives, the observed deficiencies and the proposed recommendations are remarkably similar to those identified by their predecessors. This cyclical review of the medical device regulatory landscape whereby the same observations and recommendations are repeated yet the output of such review does not yield major legislative revision of the existing statutory framework can be described as the "déjà vu effect." This will continue unless Congress enacts legislation that implements a new statutory framework with a different standard other than substantial equivalence. In the past, Congress has implemented major legislation only after a public health crisis. Hopefully this will not be the driving force in the future.
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31 CFR 594.515 - In-kind donations of medicine, medical devices, and medical services.
2010-07-01
... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false In-kind donations of medicine....515 In-kind donations of medicine, medical devices, and medical services. (a) Effective July 6, 2006, nongovernmental organizations that are U.S. persons are authorized to provide in-kind donations of medicine...
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31 CFR 597.511 - In-kind donations of medicine, medical devices, and medical services.
2010-07-01
... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false In-kind donations of medicine... Licensing Policy § 597.511 In-kind donations of medicine, medical devices, and medical services. (a... incident to the provision by nongovernmental organizations that are U.S. persons of in-kind donations of...
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ANSTO and CSIRO: supporting the medical devices and sensors industry in Australia
International Nuclear Information System (INIS)
Triani, Gerry; Doe, Simon
2005-01-01
The Australian Nuclear Science and Technology Organisation (ANSTO) and the Commonwealth Scientific and Industrial Research Organisation (CSIRO) have provided support to the Medical Devices and Sensors Industry in Australia for many years. In particular the Institute of Materials and Engineering Science at ANSTO and CSIRO Manufacturing and Infrastructure Technology have worked independently and jointly on a number of projects to provide technical services and support to small to medium sized companies. A recent venture to capture their capabilities in the WTIA's Medical Devices and Sensors Industry Sectoral Project, part of the WTIA National Diffusion Networks Project, has produced substantial technical and financial gains for its participants. The aim of this article is to highlight the infrastructure and capabilities that ANSTO and CSIRO can provide to component manufacturers and industry clusters that offer a range of manufacturing processes needed for medical devices and sensors. Several case studies illustrate how ANSTO and CSIRO have provided support to the medical devices industry
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Sterilization and reprocessing of materials and medical devices--reusability.
Jayabalan, M
1995-07-01
Problems associated with reprocessing of disposable medical devices such as hemodialysers with resterilization for reuse and changes in material properties with resterilization of polymeric (PVC, polypropylene, polyester, polycarbonate) materials intended for development of disposable devices are reviewed. Reprocessing of hospital supplies, polystyrene microtiter plate and angiographic catheter for reuse is also discussed.
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Universal Safety Distance Alert Device for Road Vehicles
Directory of Open Access Journals (Sweden)
Matic Virant
2016-04-01
Full Text Available Driving with too short of a safety distance is a common problem in road traffic, often with traffic accidents as a consequence. Research has identified a lack of vehicle-mountable devices for alerting the drivers of trailing vehicles about keeping a sufficient safe distance. The principal requirements for such a device were defined. A conceptual study was performed in order to select the components for the integration of the device. Based on the results of this study, a working prototype of a flexible, self-contained device was designed, built and tested. The device is intended to be mounted on the rear of a vehicle. It uses radar as the primary distance sensor, assisted with a GPS receiver for velocity measurement. A Raspberry Pi single-board computer is used for data acquisition and processing. The alerts are shown on an LED-matrix display mounted on the rear of the host vehicle. The device software is written in Python and provides automatic operation without requiring any user intervention. The tests have shown that the device is usable on almost any motor vehicle and performs reliably in simulated and real traffic. The open issues and possibilities for future improvements are presented in the Discussion.
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International Nuclear Information System (INIS)
2006-01-01
This part of the ISO 11137 standard specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. Although the scope of this part of the ISO 11137 standard is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment. This part of the international standard covers radiation processes employing irradiators using the radionuclide 60 Co or 137 Cs, a beam from an electron generator or a beam from an X-ray generator. This part of the international standard does not: - specify requirements for development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease; - detail specified requirements for designating a medical device as sterile; - specify a quality management system for the control of all stages of production of medical devices; - specify requirements for occupational safety associated with the design and operation of irradiation facilities; - specify requirements for the sterilization of used or reprocessed devices
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Guide to preemption of state-law claims against Class III PMA medical devices.
Whitney, Daniel W
2010-01-01
There is a perception that the express preemption holding of the Supreme Court in Riegel v. Medtronic, 552 U.S. 312(2008), immunizes medical device manufacturers from common law personal injury actions involving Class III devices that received FDA clearance under a premarket approval application (PMA). In the aftermath of Riegel, many lawsuits involving Class III PMA devices have been dismissed by district courts applying the new heightened pleading standard of Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007). Other lawsuits involving Class III PMA devices premised on fraud-on-FDA have been dismissed based on the implied preemption holding of the Supreme Court in Buckman v. Plaintiffs' Legal Comm., 531 U.S. 341 (2001). When these decisions are carefully analyzed together with Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), which found no preemption regarding a Class III device receiving FDA clearance through the 510(k) mechanism, it is apparent that the preemption defense does not apply universally to Class III PMA devices. The overall methodology for framing a non-preempted claim is to first identify conduct which violated the PMA or other specific requirements related to safety or efficacy. If such conduct can also be stated in terms of a breach of a parallel common law duty (e.g, failure to warn under strict liability or negligence, manufacturing defect or breach of warranty), then it would appear the claim is not preempted. Alternatively, regardless of a specific violation, common law remedies are not preempted by general CGMP requirements.
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Do Leadership Style, Unit Climate, and Safety Climate Contribute to Safe Medication Practices?
Farag, Amany; Tullai-McGuinness, Susan; Anthony, Mary K; Burant, Christopher
2017-01-01
This study aims at: examining if leadership style and unit climate predict safety climate; and testing the direct, indirect, and total effect of leadership style, unit climate, and safety climate on nurses' safe medication practices. The Institute of Medicine and nursing scholars propose that safety climate is a prerequisite to safety practices. However, there is limited empirical evidence about factors contributing to the development of safety climate and about the association with nurses' safe medication practices. This cross-sectional study used survey data from 246 RNs working in a Magnet® hospital. Leadership style and unit climate predicted 20% to 50% of variance on all safety climate dimensions. Model testing revealed the indirect impact of leadership style and unit climate on nurses' safe medication practices. Our hypothesized model explained small amount of the variance on nurses' safe medication practices. This finding suggests that nurses' safe medication practices are influenced by multiple contextual and personal factors that should be further examined.
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Home Healthcare Medical Devices: Infusion Therapy - Getting the Most Out of Your Pump
... Medical Procedures Home Health and Consumer Devices Brochure - Home Healthcare Medical Devices: Infusion Therapy - Getting the Most ... if needed. What is the role of your home healthcare provider and supplier in your infusion therapy? ...
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Condition Monitoring and Fault Diagnosis for an Antifalling Safety Device
Directory of Open Access Journals (Sweden)
Guangxiang Yang
2015-01-01
Full Text Available There is a constant need for the safe operation and reliability of antifalling safety device (AFSD of an elevator. This paper reports an experimental study on rotation speed and catching torque monitoring and fault diagnosis of an antifalling safety device in a construction elevator. Denoising the signal using wavelet transform is presented in this paper. Based on the denoising effects for several types of wavelets, the sym8 wavelet basis, which introduces the high order approximation and an adaptive threshold, is employed for denoising the signal. The experimental result shows a maximum data error reduction of 7.5% is obtained and SNRs (signal-to-noise ratio of rotation speed and catching torque are improved for 3.9% and 6.4%, respectively.
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2011-07-19
...] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice... announcing an amendment to the notice of meeting of the General and Plastic Surgery Devices Panel of the... INFORMATION: In the Federal Register of July 7, 2011, FDA announced that a meeting of the General and Plastic...
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OR.NET: a service-oriented architecture for safe and dynamic medical device interoperability.
Kasparick, Martin; Schmitz, Malte; Andersen, Björn; Rockstroh, Max; Franke, Stefan; Schlichting, Stefan; Golatowski, Frank; Timmermann, Dirk
2018-02-23
Modern surgical departments are characterized by a high degree of automation supporting complex procedures. It recently became apparent that integrated operating rooms can improve the quality of care, simplify clinical workflows, and mitigate equipment-related incidents and human errors. Particularly using computer assistance based on data from integrated surgical devices is a promising opportunity. However, the lack of manufacturer-independent interoperability often prevents the deployment of collaborative assistive systems. The German flagship project OR.NET has therefore developed, implemented, validated, and standardized concepts for open medical device interoperability. This paper describes the universal OR.NET interoperability concept enabling a safe and dynamic manufacturer-independent interconnection of point-of-care (PoC) medical devices in the operating room and the whole clinic. It is based on a protocol specifically addressing the requirements of device-to-device communication, yet also provides solutions for connecting the clinical information technology (IT) infrastructure. We present the concept of a service-oriented medical device architecture (SOMDA) as well as an introduction to the technical specification implementing the SOMDA paradigm, currently being standardized within the IEEE 11073 service-oriented device connectivity (SDC) series. In addition, the Session concept is introduced as a key enabler for safe device interconnection in highly dynamic ensembles of networked medical devices; and finally, some security aspects of a SOMDA are discussed.
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Safety in home care: A research protocol for studying medication management
Directory of Open Access Journals (Sweden)
Easty Anthony
2010-06-01
Full Text Available Abstract Background Patient safety is an ongoing global priority, with medication safety considered a prevalent, high-risk area of concern. Yet, we have little understanding of the supports and barriers to safe medication management in the Canadian home care environment. There is a clear need to engage the providers and recipients of care in studying and improving medication safety with collaborative approaches to exploring the nature and safety of medication management in home care. Methods A socio-ecological perspective on health and health systems drives our iterative qualitative study on medication safety with elderly home care clients, family members and other informal caregivers, and home care providers. As we purposively sample across four Canadian provinces: Alberta (AB, Ontario (ON, Quebec (QC and Nova Scotia (NS, we will collect textual and visual data through home-based interviews, participant-led photo walkabouts of the home, and photo elicitation sessions at clients' kitchen tables. Using successive rounds of interpretive description and human factors engineering analyses, we will generate robust descriptions of managing medication at home within each provincial sample and across the four-province group. We will validate our initial interpretations through photo elicitation focus groups with home care providers in each province to develop a refined description of the phenomenon that can inform future decision-making, quality improvement efforts, and research. Discussion The application of interpretive and human factors lenses to the visual and textual data is expected to yield findings that advance our understanding of the issues, challenges, and risk-mitigating strategies related to medication safety in home care. The images are powerful knowledge translation tools for sharing what we learn with participants, decision makers, other healthcare audiences, and the public. In addition, participants engage in knowledge exchange
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El Centro de Cardioestimuladores del Uruguay. CCC Medical Devices
Directory of Open Access Journals (Sweden)
Pablo Darscht
2011-05-01
Full Text Available Estudio de caso del Centro de Cardioestimuladores del Uruguay - CCC Medical Devices preparado a solicitud de Ingenio en el marco del proyecto financiado por la Iniciativa para Incubadoras de InfoDev - Grupo Banco Mundial. Este estudio detalla los pasos seguidos por una empresa nacional con un fuerte factor de innovación y los cambios producidos en el entorno de los negocios de la empresa. El comienzo de una pequeña empresa de marcapasos que tras pasar por diferentes etapas hoy gana mercados en el área de ingeniería para dispositivos médicos para diferentes empresas de investigación biomédica a nivel internacional.AbstractCase study of the Centro de Cardioestimuladores del Uruguay - CCC Medical Devices prepared on behalf of Ingenio within the project financed by de Incubator Initiative of InfoDev-World Bank Group. This study refers to the steps followed by a highly innovative local company and to the changes in its business environment. The start up of a small pacemakers company that after going through different stages is presently increasing its market share in the area of engineering of medical devices for biomedic research companies worldwide.
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Lee, Eunjoo
2016-09-01
This study compared registered nurses' perceptions of safety climate and attitude toward medication error reporting before and after completing a hospital accreditation program. Medication errors are the most prevalent adverse events threatening patient safety; reducing underreporting of medication errors significantly improves patient safety. Safety climate in hospitals may affect medication error reporting. This study employed a longitudinal, descriptive design. Data were collected using questionnaires. A tertiary acute hospital in South Korea undergoing a hospital accreditation program. Nurses, pre- and post-accreditation (217 and 373); response rate: 58% and 87%, respectively. Hospital accreditation program. Perceived safety climate and attitude toward medication error reporting. The level of safety climate and attitude toward medication error reporting increased significantly following accreditation; however, measures of institutional leadership and management did not improve significantly. Participants' perception of safety climate was positively correlated with their attitude toward medication error reporting; this correlation strengthened following completion of the program. Improving hospitals' safety climate increased nurses' medication error reporting; interventions that help hospital administration and managers to provide more supportive leadership may facilitate safety climate improvement. Hospitals and their units should develop more friendly and intimate working environments that remove nurses' fear of penalties. Administration and managers should support nurses who report their own errors. © The Author 2016. Published by Oxford University Press in association with the International Society for Quality in Health Care. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.
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Current status of the regulation for medical devices
Shah Anuja; Goyal R
2008-01-01
In the light of escalating use of medical devices, stringent regulatory standards are required to ensure that the devices are safe, well studied and have least adverse reactions. Recently introduced guidelines and the amendment in the law will provide adequate guidance for both the manufacturers and competent authorities to manage cases efficiently and appropriately. India has emerged as one of the leaders in pharmaceutical industry. Like many other amendments in Drugs and Cosmetics Act that ...
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[A Medical Devices Management Information System Supporting Full Life-Cycle Process Management].
Tang, Guoping; Hu, Liang
2015-07-01
Medical equipments are essential supplies to carry out medical work. How to ensure the safety and reliability of the medical equipments in diagnosis, and reduce procurement and maintenance costs is a topic of concern to everyone. In this paper, product lifecycle management (PLM) and enterprise resource planning (ERP) are cited to establish a lifecycle management information system. Through integrative and analysis of the various stages of the relevant data in life-cycle, it can ensure safety and reliability of medical equipments in the operation and provide the convincing data for meticulous management.
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TU-AB-204-02: Device Adverse Events and Compliance
International Nuclear Information System (INIS)
Gonzales, S.
2016-01-01
The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC
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TU-AB-204-02: Device Adverse Events and Compliance
Energy Technology Data Exchange (ETDEWEB)
Gonzales, S. [Food & Drug Administration (United States)
2016-06-15
The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC
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Image Quality Characteristics of Handheld Display Devices for Medical Imaging
Yamazaki, Asumi; Liu, Peter; Cheng, Wei-Chung; Badano, Aldo
2013-01-01
Handheld devices such as mobile phones and tablet computers have become widespread with thousands of available software applications. Recently, handhelds are being proposed as part of medical imaging solutions, especially in emergency medicine, where immediate consultation is required. However, handheld devices differ significantly from medical workstation displays in terms of display characteristics. Moreover, the characteristics vary significantly among device types. We investigate the image quality characteristics of various handheld devices with respect to luminance response, spatial resolution, spatial noise, and reflectance. We show that the luminance characteristics of the handheld displays are different from those of workstation displays complying with grayscale standard target response suggesting that luminance calibration might be needed. Our results also demonstrate that the spatial characteristics of handhelds can surpass those of medical workstation displays particularly for recent generation devices. While a 5 mega-pixel monochrome workstation display has horizontal and vertical modulation transfer factors of 0.52 and 0.47 at the Nyquist frequency, the handheld displays released after 2011 can have values higher than 0.63 at the respective Nyquist frequencies. The noise power spectra for workstation displays are higher than 1.2×10−5 mm2 at 1 mm−1, while handheld displays have values lower than 3.7×10−6 mm2. Reflectance measurements on some of the handheld displays are consistent with measurements for workstation displays with, in some cases, low specular and diffuse reflectance coefficients. The variability of the characterization results among devices due to the different technological features indicates that image quality varies greatly among handheld display devices. PMID:24236113
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Medical cyber-physical systems: A survey.
Dey, Nilanjan; Ashour, Amira S; Shi, Fuqian; Fong, Simon James; Tavares, João Manuel R S
2018-03-10
Medical cyber-physical systems (MCPS) are healthcare critical integration of a network of medical devices. These systems are progressively used in hospitals to achieve a continuous high-quality healthcare. The MCPS design faces numerous challenges, including inoperability, security/privacy, and high assurance in the system software. In the current work, the infrastructure of the cyber-physical systems (CPS) are reviewed and discussed. This article enriched the researches of the networked Medical Device (MD) systems to increase the efficiency and safety of the healthcare. It also can assist the specialists of medical device to overcome crucial issues related to medical devices, and the challenges facing the design of the medical device's network. The concept of the social networking and its security along with the concept of the wireless sensor networks (WSNs) are addressed. Afterward, the CPS systems and platforms have been established, where more focus was directed toward CPS-based healthcare. The big data framework of CPSs is also included.
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National Research Council Canada - National Science Library
Goldman, Julian M
2008-01-01
Partial support was requested from TATRC, with joint funding from NSF, for a joint workshop to bring together the synergistic efforts and communities of the High Confidence Medical Devices, Software, and Systems (HCMDSS...
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Value driven innovation in medical device design: a process for balancing stakeholder voices.
de Ana, F J; Umstead, K A; Phillips, G J; Conner, C P
2013-09-01
The innovation process has often been represented as a linear process which funnels customer needs through various business and process filters. This method may be appropriate for some consumer products, but in the medical device industry there are some inherent limitations to the traditional innovation funnel approach. In the medical device industry, there are a number of stakeholders who need to have their voices heard throughout the innovation process. Each stakeholder has diverse and unique needs relating to the medical device, the needs of one may highly affect the needs of another, and the relationships between stakeholders may be tenuous. This paper describes the application of a spiral innovation process to the development of a medical device which considers three distinct stakeholder voices: the Voice of the Customer, the Voice of the Business and the Voice of the Technology. The process is presented as a case study focusing on the front-end redesign of a class III medical device for an orthopedics company. Starting from project initiation and scope alignment, the process describes four phases, Discover, Envision, Create, and Refine, and concludes with value assessment of the final design features.
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ISO 13485 a complete guide to quality management in the medical device industry
Abuhav, Itay
2011-01-01
Although complex and lengthy, the process of certification for the ISO 13485 can be easily mastered using the simple method outlined in ISO 13485: A Complete Guide to Quality Management in the Medical Device Industry. Written by an experienced industry professional, this practical book provides a complete guide to the ISO 13485 Standard certification for medical device manufacturing. Filled with examples drawn from the author's experience and spanning different sectors and fields of the medical device industry, the book translates the extra ordinary requirements and objectives of the standard
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The Perception of Patient Safety in Medical Students
Directory of Open Access Journals (Sweden)
Unal Demirtas
2014-08-01
CONCLUSION:It is seen that effects that increase the awareness such as more intense clinical studies, having knowledge about the subject, getting harmed from malpractice increase the perception of malpractice. Particularly the practices and studies of patient safety done in university hospitals have some benefits on the approach and point of views of medical school students, taking these benefits into account, we consider that taking active role in these studies for students and including patient safety classes into the medical school programs would be useful in increasing the awareness and in being more cautious against malpractice [TAF Prev Med Bull 2014; 13(4.000: 315-320
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Stretchable bioelectronics for medical devices and systems
Ghaffari, Roozbeh; Kim, Dae-Hyeong
2016-01-01
This book highlights recent advances in soft and stretchable biointegrated electronics. A renowned group of authors address key ideas in the materials, processes, mechanics, and devices of soft and stretchable electronics; the wearable electronics systems; and bioinspired and implantable biomedical electronics. Among the topics discussed are liquid metals, stretchable and flexible energy sources, skin-like devices, in vitro neural recording, and more. Special focus is given to recent advances in extremely soft and stretchable bio-inspired electronics with real-world clinical studies that validate the technology. Foundational theoretical and experimental aspects are also covered in relation to the design and application of these biointegrated electronics systems. This is an ideal book for researchers, engineers, and industry professionals involved in developing healthcare devices, medical tools and related instruments relevant to various clinical practices.
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A model of user engagement in medical device development.
Grocott, Patricia; Weir, Heather; Ram, Mala Bridgelal
2007-01-01
The purpose of this paper is to address three topical themes: user involvement in health services research; determining the value of new medical technologies in patient care pathways, furthering knowledge related to quality in health and social care; and knowledge exchange between manufacturers, health service supply chain networks and device users. The model is being validated in a case study in progress. The latter is a "proving ground" study for a translational research company. Medical devices play a pivotal role in the management of chronic diseases, across all care settings. Failure to engage users in device development inevitably affects the quality of clinical outcomes. A model of user engagement is presented, turning unmet needs for medical devices into viable commercial propositions. A case study investigating the perceptions of individuals with Epidermolysis Bullosa (EB), their lay and professional carers into unmet needs. EB is an inherited condition affecting the skin and mucosal linings that leads to blistering and wounds. Qualitative data are being collected to generate understanding of unmet needs and wound care products. These needs are being translated into new design concepts and prototypes. Prototypes will be evaluated in an n = 1 experimental design, generating quantitative outcomes data. There are generalisations from the case study, and the model outlined. New products for managing EB wounds can logically benefit other groups. The model is transferable to other clinical problems, which can benefit from research and technological advances that are integral to clinical needs and care.
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Patient safety culture among medical students in Singapore and Hong Kong.
Leung, Gilberto Ka Kit; Ang, Sophia Bee Leng; Lau, Tang Ching; Neo, Hong Jye; Patil, Nivritti Gajanan; Ti, Lian Kah
2013-09-01
Undergraduate education in medical schools plays an important role in promoting patient safety. Medical students from different backgrounds may have different perceptions and attitudes toward issues concerning safety. This study aimed to investigate whether patient safety cultures differed between students from two Asian countries, and if they did, to find out how they differed. This study also aimed to identify the educational needs of these students. A voluntary, cross-sectional and self-administered questionnaire survey was conducted on 259 students from two medical schools - one in Hong Kong and the other in Singapore. None of the students had received any formal teaching on patient safety. We used a validated survey instrument, the Attitudes to Patient Safety Questionnaire III (APSQ-III), which was designed specifically for students and covered nine key factors of patient safety culture. Of the 259 students, 81 (31.3%) were from Hong Kong and 178 (68.7%) were from Singapore. The overall response rate was 66.4%. Significant differences between the two groups of students were found for two key factors - 'patient safety training', with Hong Kong students being more likely to report having received more of such training (p = 0.007); and 'error reporting confidence', which Singapore students reported having less of (p working hours and professional incompetence were important causes of medical errors. The importance of patient involvement and team functioning were ranked relatively lower by the students. Students from different countries with no prior teaching on patient safety may differ in their baseline patient safety cultures and educational needs. Our findings serve as a reference for future longitudinal studies on the effects of different teaching and healthcare development programmes.
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Thermal-Responsive Polymers for Enhancing Safety of Electrochemical Storage Devices.
Yang, Hui; Leow, Wan Ru; Chen, Xiaodong
2018-03-01
Thermal runway constitutes the most pressing safety issue in lithium-ion batteries and supercapacitors of large-scale and high-power density due to risks of fire or explosion. However, traditional strategies for averting thermal runaway do not enable the charging-discharging rate to change according to temperature or the original performance to resume when the device is cooled to room temperature. To efficiently control thermal runaway, thermal-responsive polymers provide a feasible and reversible strategy due to their ability to sense and subsequently act according to a predetermined sequence when triggered by heat. Herein, recent research progress on the use of thermal-responsive polymers to enhance the thermal safety of electrochemical storage devices is reviewed. First, a brief discussion is provided on the methods of preventing thermal runaway in electrochemical storage devices. Subsequently, a short review is provided on the different types of thermal-responsive polymers that can efficiently avoid thermal runaway, such as phase change polymers, polymers with sol-gel transitions, and polymers with positive temperature coefficients. The results represent the important development of thermal-responsive polymers toward the prevention of thermal runaway in next-generation smart electrochemical storage devices. © 2018 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.
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Nurses perceptions of the nurse-physician collaboration in relation to medication safety
DEFF Research Database (Denmark)
Sørensen, Ann Lykkegaard; Nielsen, Lars Peter; Poulsen, Birgitte Klindt
to medication safety and medication management. Methods: A qualitative design using a semi-structured interview guide. The interviews took place in two focus groups consisting of psychiatric nurses (Group 1 (n= 9) and group 2 (n=8)) from two bedwards in a Danish University Hospital. The interviews were carried......Background: Medication errors continue to challenge patient safety across health sectors, including psychiatry. Nurses are integral safeguards in the medication process and a growing body of research demonstrates that nurse’s ability to ensure medication safety also depend on organizational factors....... Nurses with somatic experience felt reduced in their professional competencies and perceived the hierarchy in the NPR as profoundly explicit compared to somatic care. Access to discussing specific medication problems with a physician could be difficult due to the type of rounds (an example was group care...
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2013-11-07
.... 66, rm. 2110, Silver Spring, MD 20993-0002, 301- 796-5750. For devices regulated by CBER: Stephen... the best clinical and statistical practices for investigational medical device studies. A medical...
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Software used to size the safety devices
CERN. Geneva
2016-01-01
To avoid mistakes during the calculation, CEA/SBT has decided to write a software that take into account all the situations it is possible to encountered (subcritical state, supercritical state, …). The goal is to permit to the engineer in charge of a cryostat manufacturing to perform this calculation; he is the only person able to do the accidental analysis which is fundamental for the sizing of the safety device. The software performed will be presented.
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Review of Radiation Safety in Medical X-Ray Diagnosis
International Nuclear Information System (INIS)
Koteng, O.A.
2015-01-01
Medical X-Ray machines have been used for more than a century for non-invasive diagnosis of patients for the benefit of mankind. The safety of operators and patients during such practice has improved with time, but, still cases of detrimental effects to Radiation Workers in Kenya including cancer related deaths have been reported in the recent past. An ongoing study is reviewing the safety status of the worker and patients during medical and dental exposures. The study was initiated following complaint of recurrent headaches by a radiographer working in a busy Kenyan hospital. (author)
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2011-04-14
... looking directly at the laser beam and the wearing of appropriate laser safety eyewear by both the user...). The special control for this device is the FDA guidance document entitled ``Guidance for Industry and...
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2017-10-20
The Food and Drug Administration (FDA or we) is classifying the device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid into class II (special controls). The special controls that will apply to the device type are identified in this order and will be part of the codified language for the device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid’s classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
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Factors affecting the utilization of safety devices by commercial ...
African Journals Online (AJOL)
Background: Motorcycle crashes are common causes of morbidity and mortality for both riders and passengers. To prevent and reduce the severity of injuries sustained through road traffic accidents (RTA) many countries enforce the use of safety devices while riding. Certain factors including non-enforcement of the existing ...
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Electromedical devices test laboratories accreditation
International Nuclear Information System (INIS)
Murad, C; Rubio, D; Ponce, S; Alvarez Abri, A; Terron, A; Vicencio, D; Fascioli, E
2007-01-01
In the last years, the technology and equipment at hospitals have been increase in a great way as the risks of their implementation. Safety in medical equipment must be considered an important issue to protect patients and their users. For this reason, test and calibrations laboratories must verify the correct performance of this kind of devices under national and international standards. Is an essential mission for laboratories to develop their measurement activities taking into account a quality management system. In this article, we intend to transmit our experience working to achieve an accredited Test Laboratories for medical devices in National technological University
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Zhu, Ling-Ling; Li, Wei; Song, Ping; Zhou, Quan
2014-01-01
The use of injection devices to administer intravenous or subcutaneous medications is common practice throughout a variety of health care settings. Studies suggest that one-half of all harmful medication errors originate during drug administration; of those errors, about two-thirds involve injectables. Therefore, injection device management is pivotal to safe administration of medications. In this article, the authors summarize the relevant experiences by retrospective analysis of injection device-related near misses and adverse events in the Second Affiliated Hospital of Zhejiang University, School of Medicine, Zhejiang University, People's Republic of China. Injection device-related near misses and adverse events comprised the following: 1) improper selection of needle diameter for subcutaneous injection, material of infusion sets, and pore size of in-line filter; 2) complications associated with vascular access; 3) incidents induced by absence of efficient electronic pump management and infusion tube management; and 4) liquid leakage of chemotherapeutic infusion around the syringe needle. Safe injection drug use was enhanced by multidisciplinary collaboration, especially among pharmacists and nurses; drafting of clinical pathways in selection of vascular access; application of approaches such as root cause analysis using a fishbone diagram; plan-do-check-act and quality control circle; and construction of a culture of spontaneous reporting of near misses and adverse events. Pharmacists must be professional in regards to medication management and use. The depth, breadth, and efficiency of cooperation between nurses and pharmacists are pivotal to injection safety.
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OR.NET RT: how service-oriented medical device architecture meets real-time communication.
Pfeiffer, Jonas H; Kasparick, Martin; Strathen, Benjamin; Dietz, Christian; Dingler, Max E; Lueth, Tim C; Timmermann, Dirk; Radermacher, Klaus; Golatowski, Frank
2018-02-23
Today's landscape of medical devices is dominated by stand-alone systems and proprietary interfaces lacking cross-vendor interoperability. This complicates or even impedes the innovation of novel, intelligent assistance systems relying on the collaboration of medical devices. Emerging approaches use the service-oriented architecture (SOA) paradigm based on Internet protocol (IP) to enable communication between medical devices. While this works well for scenarios with no or only soft timing constraints, the underlying best-effort communication scheme is insufficient for time critical data. Real-time (RT) networks are able to reliably guarantee fixed latency boundaries, for example, by using time division multiple access (TDMA) communication patterns. However, deterministic RT networks come with their own limitations such as tedious, inflexible configuration and a more restricted bandwidth allocation. In this contribution we overcome the drawbacks of both approaches by describing and implementing mechanisms that allow the two networks to interact. We introduce the first implementation of a medical device network that offers hard RT guarantees for control and sensor data and integrates into SOA networks. Based on two application examples we show how the flexibility of SOA networks and the reliability of RT networks can be combined to achieve an open network infrastructure for medical devices in the operating room (OR).
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Personnel Risks in Ensuring Safety of Medical Activity
Directory of Open Access Journals (Sweden)
O. L. Zadvornaya
2017-01-01
Full Text Available Purpose: modern strategies of management of the organization require the formation of special management approaches based on the analysis of the mechanisms and processes of the organization of medical activities related to possible risks in activity of medical personnel. Based on international experience and own research the authors have identified features of a system of management of personnel risk in medical activities, examined approaches showing the sequence and contents of the main practical activities of the formation, maintenance and development of the system of management of personnel risks. Emphasized is the need for further research and implementation of the system of management of personnel risk in health care organizations. Study and assessment of personnel risks affecting the security of medical activities aimed at the development of the system of personnel risk management, development of a system of identification and monitoring of HR risk indicators with a purpose to improve institutional management and increase efficiency of activity of medical organizations. Methods: in the present study, the following methods were used: systemic approach, content analysis, methods of social diagnosis (questionnaires, interviews, comparative analysis, method of expert evaluations, method of statistical processing of information. Results: approaches to predict the occurrence and development of personnel risks have been reviewed and proposed. Conclusions and Relevance: patient safety is a global issue affecting countries at all levels of development. Each year, the WHO identifies a number of systemic and technical aspects and trends in the field of patient safety related to actions of medical workers. Existing imbalances in the staffing of the health system of the Russian Federation increase the probability of potential risks in medical practice. The personnel policy of healthcare of the Russian Federation requires further improvement and
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Barbier, Thérèse; Aissani, Sarra; Weber, Nicolas; Pasquier, Cédric; Felblinger, Jacques
2018-03-30
To evaluate the function of an active implantable medical device (AIMD) during magnetic resonance imaging (MRI) scans. The induced voltages caused by the switching of magnetic field gradients and rectified radio frequency (RF) pulse were measured, along with the AIMD stimulations. An MRI-compatible voltage probe with a bandwidth of 0-40 kHz was designed. Measurements were carried out both on the bench with an overvoltage protection circuit commonly used for AIMD and with a pacemaker during MRI scans on a 1.5 T (64 MHz) MR scanner. The sensor exhibits a measurement range of ± 15 V with an amplitude resolution of 7 mV and a temporal resolution of 10 µs. Rectification was measured on the bench with the overvoltage protection circuit. Linear proportionality was confirmed between the induced voltage and the magnetic field gradient slew rate. The pacemaker pacing was recorded successfully during MRI scans. The characteristics of this low-frequency voltage probe allow its use with extreme RF transmission power and magnetic field gradient positioning for MR safety test of AIMD during MRI scans.
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Design and construction of safety devices utilizing methods of measurement and control engineering
Energy Technology Data Exchange (ETDEWEB)
Greiner, B; Weidlich, S
1982-08-01
This article considers a proposed concept for the design and construction of measurement and control devices for the safety of chemical plants with the aim of preventing danger to persons and the environment and damage. Such measurement and control devices are generally employed when primary measures adopted for plant safety, such as safety valves, collection vessels, etc. are not applicable or insufficient by themselves. The concept regards the new sheet no. 3 of the VDI/VDE code draft 2180 ''Safety of chemical engineering plant'' and proposes a further subdivision of class A into safety classes A0, A1, and A2. Overall, it is possible, on the basis of the measures for raising the availability of measurement and control equipment which are presented in this article, to make selection appropriate to the potential danger involved. The proposed procedure should not, however, be regarded as a rigid scheme but rather as leading to a systematic view and supporting decisions resting on sound operating experience.
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Monitoring of Vital Signs with Flexible and Wearable Medical Devices.
Khan, Yasser; Ostfeld, Aminy E; Lochner, Claire M; Pierre, Adrien; Arias, Ana C
2016-06-01
Advances in wireless technologies, low-power electronics, the internet of things, and in the domain of connected health are driving innovations in wearable medical devices at a tremendous pace. Wearable sensor systems composed of flexible and stretchable materials have the potential to better interface to the human skin, whereas silicon-based electronics are extremely efficient in sensor data processing and transmission. Therefore, flexible and stretchable sensors combined with low-power silicon-based electronics are a viable and efficient approach for medical monitoring. Flexible medical devices designed for monitoring human vital signs, such as body temperature, heart rate, respiration rate, blood pressure, pulse oxygenation, and blood glucose have applications in both fitness monitoring and medical diagnostics. As a review of the latest development in flexible and wearable human vitals sensors, the essential components required for vitals sensors are outlined and discussed here, including the reported sensor systems, sensing mechanisms, sensor fabrication, power, and data processing requirements. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.
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Directory of Open Access Journals (Sweden)
Howard JJ
2014-11-01
Full Text Available Jason J Howard Division of Paediatric Orthopaedics, Department of Surgery, Sidra Medical and Research Center, Doha, Qatar Abstract: With some of the richest economies in the world, the Gulf Cooperation Council (GCC is undergoing rapid growth not only in its population but also in health care expenditure. Despite the GCC's abundance of hydrocarbon-based wealth, the drivers of the medical device industry in the GCC are still in flux, with gains yet to be made in areas of infrastructure, regulation, and reimbursement. However, the regional disease burden, expanding health insurance penetration, increasing privatization, and a desire to attract skilled expatriate health care providers have led to favorable conditions for the medical device market in the GCC. The purpose of this article is to investigate the current state of the GCC medical device industry, with respect to market, regulation, and reimbursement, paying special attention to the three largest medical device markets: Saudi Arabia, the United Arab Emirates, and Qatar. The GCC would seem to represent fertile ground for the development of medical technologies, especially those in line with the regional health priorities of the respective member states. Keywords: medical devices, regulation, reimbursement, Middle East
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2012-03-23
... notification, prior to marketing the device, which contains information about the NIR Brain Hematoma Detector...), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct..., environmental, public health and safety, and other advantages; distributive impacts; and equity). The Agency...
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Relihan, E; Glynn, S; Daly, D; Silke, B; Ryder, S
2009-12-01
To assess the safety culture in an acute medical admissions unit (AMAU) of a teaching hospital in order to benchmark results against international data and guide a unit-based, integrated, risk management strategy. The safety attitudes questionnaire (SAQ), a validated instrument for the measurement of safety culture was applied to an AMAU. All AMAU healthcare staff (n = 92) were surveyed: doctors, nurses, healthcare assistants (HCAs) and allied healthcare professionals (AHPs). Safety attitude scores for the overall unit and individual caregiver types were assessed across six domains of safety culture. When compared against an international benchmark, the AMAU scored significantly higher for four of the six safety domains: p < 0.01 for 'teamwork climate', 'safety climate' and 'stress recognition' and p < 0.05 for 'job satisfaction'. The difference between nurse manager scores and the overall mean for the study group was statistically significant for the domains of 'teamwork climate' (p < 0.05) and 'safety climate' (p < 0.01). HCAs scored significantly lower relative to staff overall with regard to 'working conditions' (p < 0.05) and 'perceptions of management' (p < 0.01). The SAQ was successfully applied to an AMAU setting giving a valuable insight into staff issues of concern across the safety spectrum: employee and environmental safety, clinical risk management and medication safety.
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Organizational safety culture and medical error reporting by Israeli nurses.
Kagan, Ilya; Barnoy, Sivia
2013-09-01
To investigate the association between patient safety culture (PSC) and the incidence and reporting rate of medical errors by Israeli nurses. Self-administered structured questionnaires were distributed to a convenience sample of 247 registered nurses enrolled in training programs at Tel Aviv University (response rate = 91%). The questionnaire's three sections examined the incidence of medication mistakes in clinical practice, the reporting rate for these errors, and the participants' views and perceptions of the safety culture in their workplace at three levels (organizational, departmental, and individual performance). Pearson correlation coefficients, t tests, and multiple regression analysis were used to analyze the data. Most nurses encountered medical errors from a daily to a weekly basis. Six percent of the sample never reported their own errors, while half reported their own errors "rarely or sometimes." The level of PSC was positively and significantly correlated with the error reporting rate. PSC, place of birth, error incidence, and not having an academic nursing degree were significant predictors of error reporting, together explaining 28% of variance. This study confirms the influence of an organizational safety climate on readiness to report errors. Senior healthcare executives and managers can make a major impact on safety culture development by creating and promoting a vision and strategy for quality and safety and fostering their employees' motivation to implement improvement programs at the departmental and individual level. A positive, carefully designed organizational safety culture can encourage error reporting by staff and so improve patient safety. © 2013 Sigma Theta Tau International.
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Boruff, Jill T.; Storie, Dale
2014-01-01
Objectives: The research investigated the extent to which students, residents, and faculty members in Canadian medical faculties use mobile devices, such as smartphones (e.g., iPhone, Android, Blackberry) and tablet computers (e.g., iPad), to answer clinical questions and find medical information. The results of this study will inform how health libraries can effectively support mobile technology and collections. Methods: An electronic survey was distributed by medical librarians at four Canadian universities to medical students, residents, and faculty members via departmental email discussion lists, personal contacts, and relevant websites. It investigated the types of information sought, facilitators to mobile device use in medical information seeking, barriers to access, support needs, familiarity with institutionally licensed resources, and most frequently used resources. Results: The survey of 1,210 respondents indicated widespread use of smartphones and tablets in clinical settings in 4 Canadian universities. Third- and fourth-year undergraduate students (i.e., those in their clinical clerkships) and medical residents, compared to other graduate students and faculty, used their mobile devices more often, used them for a broader range of activities, and purchased more resources for their devices. Conclusions: Technological and intellectual barriers do not seem to prevent medical trainees and faculty from regularly using mobile devices for their medical information searches; however, barriers to access and lack of awareness might keep them from using reliable, library-licensed resources. Implications: Libraries should focus on providing access to a smaller number of highly used mobile resources instead of a huge collection until library-licensed mobile resources have streamlined authentication processes. PMID:24415916
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Boruff, Jill T; Storie, Dale
2014-01-01
The research investigated the extent to which students, residents, and faculty members in Canadian medical faculties use mobile devices, such as smartphones (e.g., iPhone, Android, Blackberry) and tablet computers (e.g., iPad), to answer clinical questions and find medical information. The results of this study will inform how health libraries can effectively support mobile technology and collections. An electronic survey was distributed by medical librarians at four Canadian universities to medical students, residents, and faculty members via departmental email discussion lists, personal contacts, and relevant websites. It investigated the types of information sought, facilitators to mobile device use in medical information seeking, barriers to access, support needs, familiarity with institutionally licensed resources, and most frequently used resources. The survey of 1,210 respondents indicated widespread use of smartphones and tablets in clinical settings in 4 Canadian universities. Third- and fourth-year undergraduate students (i.e., those in their clinical clerkships) and medical residents, compared to other graduate students and faculty, used their mobile devices more often, used them for a broader range of activities, and purchased more resources for their devices. Technological and intellectual barriers do not seem to prevent medical trainees and faculty from regularly using mobile devices for their medical information searches; however, barriers to access and lack of awareness might keep them from using reliable, library-licensed resources. Libraries should focus on providing access to a smaller number of highly used mobile resources instead of a huge collection until library-licensed mobile resources have streamlined authentication processes.
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Implantable Medical Devices; Networking Security Survey
Siamak Aram; Rouzbeh A. Shirvani; Eros G. Pasero; Mohamd F. Chouikha
2016-01-01
The industry of implantable medical devices (IMDs) is constantly evolving, which is dictated by the pressing need to comprehensively address new challenges in the healthcare field. Accordingly, IMDs are becoming more and more sophisticated. Not long ago, the range of IMDs’ technical capacities was expanded, making it possible to establish Internet connection in case of necessity and/or emergency situation for the patient. At the same time, while the web connectivity of today’s implantable dev...
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77 FR 3781 - Pediatric Medical Devices; Public Workshop; Reopening of Comment Period
2012-01-25
... devices. DATES: Submit either electronic or written comments by March 5, 2012. ADDRESSES: Submit.... Designing pediatric medical devices can be challenging; children are often smaller and more active than adults; body structures and functions change throughout childhood, and children may be long-term device...
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A Maturity Grid Assessment Tool for Environmentally Conscious Design in the Medical Device Industry
DEFF Research Database (Denmark)
Moultrie, James; Sutcliffe, Laura Francesca Rose; Maier, Anja
2016-01-01
. This intervention tool provides designers and product marketers with insights on how to improve the design of their medical devices and specifically allows consideration of the complex trade-offs between decisions that influence different life-cycle stages. Through the tool, actionable insight is created......The medical device industry is growing increasingly concerned about environmental impact of products. Whilst there are many tools aiming to support environmentally conscious design, they are typically complex to use, demand substantial data collection and are not tailored to the specific needs...... of the medical device sector. This paper reports on the development of a Maturity Grid to address this gap. This novel design tool was developed iteratively through application in five case studies. The tool captures principles of eco-design for medical devices in a simple form, designed to be used by a team...
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Initiatives in the Australian Medical Devices Industry
International Nuclear Information System (INIS)
Whelan, Luke
2005-01-01
The medical device industry is as diverse as it is specialised and calls on the innovative use of design and components and utilises all facets of precision manufacturing from printed circuit boards, injection-moulded plastics to engineering, using a wide range of materials. It generally requires exacting standards, starting with design, particularly for devices that are invasive or have direct contact with the human body. Of course this brings the further consideration of sterilisation and whether it is for single or multiple use. There is an ever-present need to produce more accurate less invasive and cheaper devices. The driving motivation appears to be meeting clinical needs at a reduced cost. The push to treat people outside the hospital is growing, creating new demands and directions. The advent of the Internet and wireless technology has opened a whole new direction of research and development opportunities
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78 FR 27971 - Dental Products Panel of the Medical Devices Advisory Committee; Notice of Meeting
2013-05-13
...] Dental Products Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Dental Products Panel of the Medical Devices Advisory Committee. General Function of the Committee: To... regulatory classification for dental devices known as Endosseous Dental Implants (Blade-form), one of the...
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A RFID grouping proof protocol for medication safety of inpatient.
Huang, Hsieh-Hong; Ku, Cheng-Yuan
2009-12-01
In order to provide enhanced medication safety for inpatients, the medical mechanism which adopts the modified grouping proof protocol is proposed in this paper. By using the grouping proof protocol, the medical staffs could confirm the authentication and integrity of a group of Radio-Frequency Identification (RFID) tags which are embedded on inpatient bracelets and the containers of drugs. This mechanism is designed to be compatible with EPCglobal Class-1 Generation-2 standard which is the most popular specification of RFID tags. Due to the light-weight computational capacity of passive tags, only the pseudo-random number generator (PRNG) and cyclic redundancy code (CRC) are allowed to be used in the communication protocol. Furthermore, a practical scenario of using this proposed mechanism in hospital to examine the medication safety is also presented.
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Directory of Open Access Journals (Sweden)
Zhu LL
2014-03-01
Full Text Available Ling-ling Zhu,1 Wei Li,2 Ping Song,3 Quan Zhou3 1Geriatric VIP Ward, Division of Nursing, 2Division of Medical Administration, 3Department of Pharmacy, the Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, People's Republic of China Abstract: The use of injection devices to administer intravenous or subcutaneous medications is common practice throughout a variety of health care settings. Studies suggest that one-half of all harmful medication errors originate during drug administration; of those errors, about two-thirds involve injectables. Therefore, injection device management is pivotal to safe administration of medications. In this article, the authors summarize the relevant experiences by retrospective analysis of injection device-related near misses and adverse events in the Second Affiliated Hospital of Zhejiang University, School of Medicine, Zhejiang University, People's Republic of China. Injection device-related near misses and adverse events comprised the following: 1 improper selection of needle diameter for subcutaneous injection, material of infusion sets, and pore size of in-line filter; 2 complications associated with vascular access; 3 incidents induced by absence of efficient electronic pump management and infusion tube management; and 4 liquid leakage of chemotherapeutic infusion around the syringe needle. Safe injection drug use was enhanced by multidisciplinary collaboration, especially among pharmacists and nurses; drafting of clinical pathways in selection of vascular access; application of approaches such as root cause analysis using a fishbone diagram; plan–do–check–act and quality control circle; and construction of a culture of spontaneous reporting of near misses and adverse events. Pharmacists must be professional in regards to medication management and use. The depth, breadth, and efficiency of cooperation between nurses and pharmacists are pivotal to injection safety. Keywords
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Biomaterials and medical devices a perspective from an emerging country
Hermawan, Hendra
2016-01-01
This book presents an introduction to biomaterials with the focus on the current development and future direction of biomaterials and medical devices research and development in Indonesia. It is the first biomaterials book written by selected academic and clinical experts experts on biomaterials and medical devices from various institutions and industries in Indonesia. It serves as a reference source for researchers starting new projects, for companies developing and marketing products and for governments setting new policies. Chapter one covers the fundamentals of biomaterials, types of biomaterials, their structures and properties and the relationship between them. Chapter two discusses unconventional processing of biomaterials including nano-hybrid organic-inorganic biomaterials. Chapter three addresses biocompatibility issues including in vitro cytotoxicity, genotoxicity, in vitro cell models, biocompatibility data and its related failure. Chapter four describes degradable biomaterial for medical implants...
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Additive Manufacturing for Robust and Affordable Medical Devices
Wolozny Gomez Robelo, Daniel Andre
2016-01-01
Additive manufacturing in the form of 3D printing is a revolutionary technology that has developed within the last two decades. Its ability to print an object with accurate features down to the micro scale have made its use in medical devices and research feasible. A range of life-saving technologies can now go from the laboratory and into field with the application of 3D-printing. This technology can be applied to medical diagnosis of patients in at-risk populations. Living biosensors a...
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10 CFR 32.101 - Schedule B-prototype tests for luminous safety devices for use in aircraft.
2010-01-01
....101 Schedule B—prototype tests for luminous safety devices for use in aircraft. An applicant for a... 10 Energy 1 2010-01-01 2010-01-01 false Schedule B-prototype tests for luminous safety devices for use in aircraft. 32.101 Section 32.101 Energy NUCLEAR REGULATORY COMMISSION SPECIFIC DOMESTIC LICENSES...
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Operating room fire prevention: creating an electrosurgical unit fire safety device.
Culp, William C; Kimbrough, Bradly A; Luna, Sarah; Maguddayao, Aris J
2014-08-01
To reduce the incidence of surgical fires. Operating room fires represent a potentially life-threatening hazard and are triggered by the electrosurgical unit (ESU) pencil. Carbon dioxide is a fire suppressant and is a routinely used medical gas. We hypothesize that a shroud of protective carbon dioxide covering the tip of the ESU pencil displaces oxygen, thereby preventing fire ignition. Using 3-dimensional modeling techniques, a polymer sleeve was created and attached to an ESU pencil. This sleeve was connected to a carbon dioxide source and directed the gas through multiple precisely angled ports, generating a cone of fire-suppressive carbon dioxide surrounding the active pencil tip. This device was evaluated in a flammability test chamber containing 21%, 50%, and 100% oxygen with sustained ESU activation. The sleeve was tested with and without carbon dioxide (control) until a fuel was ignited or 30 seconds elapsed. Time to ignition was measured by high-speed videography. Fires were ignited with each control trial (15/15 trials). The control group median ± SD ignition time in 21% oxygen was 3.0 ± 2.4 seconds, in 50% oxygen was 0.1 ± 1.8 seconds, and in 100% oxygen was 0.03 ± 0.1 seconds. No fire was observed when the fire safety device was used in all concentrations of oxygen (0/15 trials; P fire ignition was 76% to 100%. A sleeve creating a cone of protective carbon dioxide gas enshrouding the sparks from an ESU pencil effectively prevents fire in a high-flammability model. Clinical application of this device may reduce the incidence of operating room fires.
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Xu, Jie; Reale, Carrie; Slagle, Jason M; Anders, Shilo; Shotwell, Matthew S; Dresselhaus, Timothy; Weinger, Matthew B
Medication safety presents an ongoing challenge for nurses working in complex, fast-paced, intensive care unit (ICU) environments. Studying ICU nurse's medication management-especially medication-related events (MREs)-provides an approach to analyze and improve medication safety and quality. The goal of this study was to explore the utility of facilitated MRE reporting in identifying system deficiencies and the relationship between MREs and nurses' work in the ICUs. We conducted 124 structured 4-hour observations of nurses in three different ICUs. Each observation included measurement of nurse's moment-to-moment activity and self-reports of workload and negative mood. The observer then obtained MRE reports from the nurse using a structured tool. The MREs were analyzed by three experts. MREs were reported in 35% of observations. The 60 total MREs included four medication errors and seven adverse drug events. Of the 49 remaining MREs, 65% were associated with negative patient impact. Task/process deficiencies were the most common contributory factor for MREs. MRE occurrence was correlated with increased total task volume. MREs also correlated with increased workload, especially during night shifts. Most of these MREs would not be captured by traditional event reporting systems. Facilitated MRE reporting provides a robust information source about potential breakdowns in medication management safety and opportunities for system improvement.
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A cloud medication safety support system using QR code and Web services for elderly outpatients.
Tseng, Ming-Hseng; Wu, Hui-Ching
2014-01-01
Drug is an important part of disease treatment, but medication errors happen frequently and have significant clinical and financial consequences. The prevalence of prescription medication use among the ambulatory adult population increases with advancing age. Because of the global aging society, outpatients need to improve medication safety more than inpatients. The elderly with multiple chronic conditions face the complex task of medication management. To reduce the medication errors for the elder outpatients with chronic diseases, a cloud medication safety supporting system is designed, demonstrated and evaluated. The proposed system is composed of a three-tier architecture: the front-end tier, the mobile tier and the cloud tier. The mobile tier will host the personalized medication safety supporting application on Android platforms that provides some primary functions including reminders for medication, assistance with pill-dispensing, recording of medications, position of medications and notices of forgotten medications for elderly outpatients. Finally, the hybrid technology acceptance model is employed to understand the intention and satisfaction level of the potential users to use this mobile medication safety support application system. The result of the system acceptance testing indicates that this developed system, implementing patient-centered services, is highly accepted by the elderly. This proposed M-health system could assist elderly outpatients' homecare in preventing medication errors and improving their medication safety.
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Schmettow, M.; Schnittker, R.; Schraagen, J.M.
2017-01-01
This paper proposes and demonstrates an extended protocol for usability validation testing of medical devices. A review of currently used methods for the usability evaluation of medical devices revealed two main shortcomings. Firstly, the lack of methods to closely trace the interaction sequences
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Murakami, Madoka; Suzuki, Yuka; Tominaga, Toshiyoshi
2018-02-23
Delays in the introduction to the Japanese market of drug-eluting stents (DES) developed overseas (i.e., "device lag") decreased sharply between 2004 and 2012. The reduction accompanied a shift in clinical development from a succession pattern (initial product development and approval overseas followed by eventual entrance into the Japanese market) to parallel development (employing multiregional clinical trials (MRCTs)). Although resource-intensive in the short-term, MRCTs are proving to be an effective tool in simultaneous global product development. Creative study designs and the absence of significant ethnic differences in Japanese subjects regarding DES safety and efficacy and the pharmacokinetic behavior of their coating drugs propel this process. More general factors such as medical need and industry incentivization also encourage this shift. Physicians' preference for DES over other percutaneous coronary interventions, the expanding global DES market, and streamlined development and approval prospects each motivate industry to continue investing in DES product development. The efforts of various stakeholders were also integral to overcoming practical obstacles, and contributions by 'Harmonization by Doing' and a premarket collaboration initiative between the USA and Japan were particularly effective. Today, USA/Japan regulatory cooperation is routine, and Japan is now integrated into global medical device development. MRCTs including Japanese subjects, sites, and investigators are now commonplace.
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International Nuclear Information System (INIS)
Ito, Hitoshi; Ishigaki, Isao
1986-01-01
Radiation treatment is getting important position for sterilizing medical devices and for packaging films of foods. Recently, survey of bioburden is an important technique for evaluation of sterility doses for medical devices. However, many studies have been done mainly on the irradiation effects of spore-forming bacteria in medical devices. In this study, radiation sensitivity of spore-forming bacteria and fungi were examined after the survey on distribution of microorganisms in several kinds of medical devices. The main contaminant in disposable syringes, needles and conical flasks were consisted of Bacillus, with lesser amount of Micrococcus, Pseudomonas, Peptococcaceae and fungi as positive of 5 - 60 % in the medical devices which cultivated in thioglycolate broth. Bacillus group were identified as B. pumilus, B. sphaericus, B. coagulans, B. megaterium and etc. Fungi were isolated a lesser amounts compared with spore-forming bacteria and identified as Blastomyces, Penicillium, Haplosporangium, Euricoa and Audeobasidium. Peptococaceae were not isolated after irradiation with a dose of 0.1 Mrad even the samples were contaminated with high percentage. The D 10 values of dryed endospores of Bacillus-isolates which attached to the filter paper with pepton-glycerin were obtained to be 0.11 - 0.19 Mrad. The D 10 values of many isolates of fungi in dry condition were obtained below 0.08 Mrad. However, the isolate of Aureobasidium is radiation-resistant, and it's D 10 values was obtained as 0.28 Mrad under aerobic and anaerobic dry condition. (author)
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Research on patient safety: falls and medications.
Boddice, Sandra Dawn; Kogan, Polina
2009-10-01
Below you will find summaries of published research describing investigations into patient safety issues related to falls and medications. The first summary provides details on the incidence of falls associated with the use of walkers and canes. This is followed by a summary of a fall-prevention intervention study that evaluated the effectiveness of widespread dissemination of evidence-based strategies in a community in Connecticut. The third write up provides information on three classes of medications that are associated with a significant number of emergency room visits. The last summary describes a pharmacist-managed medication reconciliation intervention pilot program. For additional details about the study findings and interventions, we encourage readers to review the original articles.
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Medical devices of the head, neck, and spine.
Hunter, Tim B; Yoshino, Mark T; Dzioba, Robert B; Light, Rick A; Berger, William G
2004-01-01
There are many medical devices used for head, neck, and spinal diseases and injuries, and new devices are constantly being introduced. Many of the newest devices are variations on a previous theme. Knowing the specific name of a device is not important. It is important to recognize the presence of a device and to have an understanding of its function as well as to be able to recognize the complications associated with its use. The article discusses the most common and important devices of the head, neck, and spine, including cerebrospinal fluid shunts and the Codman Hakim programmable valve; subdural drainage catheters, subdural electrodes, intracranial electrodes, deep brain stimulators, and cerebellar electrodes; coils, balloons, adhesives, particles, and aneurysm clips; radiation therapy catheters, intracranial balloons for drug installation, and carmustine wafers; hearing aids, cochlear implants, and ossicular reconstruction prostheses; orbital prostheses, intraocular silicone oil, and lacrimal duct stents; anterior and posterior cervical plates, posterior cervical spine wiring, odontoid fracture fixation devices, cervical collars and halo vests; thoracic and lumbar spine implants, anterior and posterior instrumentation for the thoracic and lumbar spine, vertebroplasty, and artificial disks; spinal column stimulators, bone stimulators, intrathecal drug delivery pumps, and sacral stimulators; dental and facial implant devices; gastric and tracheal tubes; vagus nerve stimulators; lumboperitoneal shunts; and temperature- and oxygen-sensing probes. Copyright RSNA, 2004
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Metrological Reliability of Medical Devices
Costa Monteiro, E.; Leon, L. F.
2015-02-01
The prominent development of health technologies of the 20th century triggered demands for metrological reliability of physiological measurements comprising physical, chemical and biological quantities, essential to ensure accurate and comparable results of clinical measurements. In the present work, aspects concerning metrological reliability in premarket and postmarket assessments of medical devices are discussed, pointing out challenges to be overcome. In addition, considering the social relevance of the biomeasurements results, Biometrological Principles to be pursued by research and innovation aimed at biomedical applications are proposed, along with the analysis of their contributions to guarantee the innovative health technologies compliance with the main ethical pillars of Bioethics.
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Early-stage valuation of medical devices: the role of developmental uncertainty.
Girling, Alan; Young, Terry; Brown, Celia; Lilford, Richard
2010-08-01
At the concept stage, many uncertainties surround the commercial viability of a new medical device. These include the ultimate functionality of the device, the cost of producing it and whether, and at what price, it can be sold to a health-care provider (HCP). Simple assessments of value can be made by estimating such unknowns, but the levels of uncertainty may mean that their operational value for investment decisions is unclear. However, many decisions taken at the concept stage are reversible and will be reconsidered later before the product is brought to market. This flexibility can be exploited to enhance early-stage valuations. To develop a framework for valuing a new medical device at the concept stage that balances benefit to the HCP against commercial costs. This is done within a simplified stage-gated model of the development cycle for new products. The approach is intended to complement existing proposals for the evaluation of the commercial headroom available to new medical products. A model based on two decision gates can lead to lower bounds (underestimates) for product value that can serve to support a decision to develop the product. Quantifiable uncertainty that can be resolved before the device is brought to market will generally enhance early-stage valuations of the device, and this remains true even when some components of uncertainty cannot be fully described. Clinical trials and other evidence-gathering activities undertaken as part of the development process can contribute to early-stage estimates of value.
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2010-04-09
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0142] Drug and Medical Device Forum on Food and Drug Administration Drug and Device Requirements and Supplier Controls; Public Educational Forum AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public...
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Design of point-of-care (POC) microfluidic medical diagnostic devices
Leary, James F.
2018-02-01
Design of inexpensive and portable hand-held microfluidic flow/image cytometry devices for initial medical diagnostics at the point of initial patient contact by emergency medical personnel in the field requires careful design in terms of power/weight requirements to allow for realistic portability as a hand-held, point-of-care medical diagnostics device. True portability also requires small micro-pumps for high-throughput capability. Weight/power requirements dictate use of super-bright LEDs and very small silicon photodiodes or nanophotonic sensors that can be powered by batteries. Signal-to-noise characteristics can be greatly improved by appropriately pulsing the LED excitation sources and sampling and subtracting noise in between excitation pulses. The requirements for basic computing, imaging, GPS and basic telecommunications can be simultaneously met by use of smartphone technologies, which become part of the overall device. Software for a user-interface system, limited real-time computing, real-time imaging, and offline data analysis can be accomplished through multi-platform software development systems that are well-suited to a variety of currently available cellphone technologies which already contain all of these capabilities. Microfluidic cytometry requires judicious use of small sample volumes and appropriate statistical sampling by microfluidic cytometry or imaging for adequate statistical significance to permit real-time (typically medical decisions for patients at the physician's office or real-time decision making in the field. One or two drops of blood obtained by pin-prick should be able to provide statistically meaningful results for use in making real-time medical decisions without the need for blood fractionation, which is not realistic in the field.
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Perception and Practice of Road Safety among Medical Students, Mansoura, Egypt.
Helal, Randah; El-Khawaga, Ghada; El-Gilany, Abdel-Hady
2018-01-01
To assess the knowledge and attitude of medical students towards road safety and to determine their driving behavior and its relation to different related factors. This cross-sectional study involved 480 medical students at Mansoura University, Egypt. A self-administered questionnaire was used to collect student personal data, knowledge about road safety, attitude towards road safety, and driving practices. More than 40% of students experienced an injury in the previous year, mainly as a pedestrian (56%), and 15.2% practiced driving, although only 9.6% had a driving licence. Most of the students had correct road safety knowledge except for awareness that the safe time to read maps is when your vehicle is parked (44%), one should drive in the left lane (29.6%), and one should overtake from the right-hand lane only (25.8%). The majority of the students reported that road traffic injuries can be prevented (89.2%). The mean score of the driving practices of the students ranged from 0.66±1.04 to 2.44±6.28 and rural residents showed significantly higher score regarding errors and lapses. Good road safety knowledge and a favorable, low risk attitude, did not translate into improved road traffic behavior and this highlights the importance of stricter implementation of the existing rules and including road safety in medical education programs.
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#DDOD Use Case: Consolidated reporting of medical device recalls
U.S. Department of Health & Human Services — SUMMARY DDOD use case request for consolidated, consistent reporting of medical device recalls. WHAT IS A USE CASE? A “Use Case” is a request that was made by the...
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A service protocol for post-processing of medical images on the mobile device
He, Longjun; Ming, Xing; Xu, Lang; Liu, Qian
2014-03-01
With computing capability and display size growing, the mobile device has been used as a tool to help clinicians view patient information and medical images anywhere and anytime. It is uneasy and time-consuming for transferring medical images with large data size from picture archiving and communication system to mobile client, since the wireless network is unstable and limited by bandwidth. Besides, limited by computing capability, memory and power endurance, it is hard to provide a satisfactory quality of experience for radiologists to handle some complex post-processing of medical images on the mobile device, such as real-time direct interactive three-dimensional visualization. In this work, remote rendering technology is employed to implement the post-processing of medical images instead of local rendering, and a service protocol is developed to standardize the communication between the render server and mobile client. In order to make mobile devices with different platforms be able to access post-processing of medical images, the Extensible Markup Language is taken to describe this protocol, which contains four main parts: user authentication, medical image query/ retrieval, 2D post-processing (e.g. window leveling, pixel values obtained) and 3D post-processing (e.g. maximum intensity projection, multi-planar reconstruction, curved planar reformation and direct volume rendering). And then an instance is implemented to verify the protocol. This instance can support the mobile device access post-processing of medical image services on the render server via a client application or on the web page.
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Act to keep patients safe: device-related adverse event reporting.
Schoem, Scott R; Shah, Udayan K
2010-05-01
Primum non nocere- "Above all do no harm." Since the first year of medical school, we have all heard and spoken this dictum countless times. Translating this dictum into action may present challenges in our daily practice. Every day, clinicians must distinguish between scientific evidence, clinical experience, and marketing claims by industry vendors of improved efficacy and safety regarding medical devices. Adverse event reporting and device failure notification are generally laid out well in hospital practice settings. Reporting beyond the local level takes on a new dimension for most surgeons. Perceived stigma from peers and corporations, lack of confidentiality, and cynicism regarding protective actions for patients should not limit one from "raising the alarm" when concerns arise about device safety or performance. This commentary aims to explain the process for reporting device-related adverse events. Copyright 2010 American Academy of Otolaryngology-Head and Neck Surgery Foundation. Published by Mosby, Inc. All rights reserved.
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Adhikari, Radha; Tocher, Jennifer; Smith, Pam; Corcoran, Janet; MacArthur, Juliet
2014-02-01
Medication management is a complex multi-stage and multi-disciplinary process, involving doctors, pharmacists, nurses and patients. Errors can occur at any stage from prescribing, dispensing and administering, to recording and reporting. There are a number of safety mechanisms built into the medication management system and it is recognised that nurses are the final stage of defence. However, medication error still remains a major challenge to patient safety globally. This paper aims to illustrate two main aspects of medication safety practices that have been elicited from an action research study in a Scottish Health Board and three local Higher Education Institutions: firstly current medication safety practices in two clinical settings; and secondly pre and post-registration nursing education and teaching on medication safety. This paper is based on Phase One and Two of an Action Research project. An ethnography-style observational method, influenced by an Appreciative Inquiry (AI) approach was adapted to study the everyday medication management systems and practices of two hospital wards. This was supplemented by seven in-depth interviews with nursing staff, numerous informal discussions with healthcare professionals, two focus-groups, one peer-interview and two in-depth individual interviews with final year nursing students from three Higher Education Institutions in Scotland. This paper highlights the current positive practical efforts in medication safety practices in the chosen clinical areas. Nursing staff do employ the traditional 'five right' principles - right patient, right medication, right dose, right route and right time - for safe administration. Nursing students are taught these principles in their pre-registration nursing education. However, there are some other challenges remaining: these include the establishment of a complete medication history (reconciliation) when patients come to hospital, the provision of an in-depth training in
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The Efficacy, Safety and Applications of Medical Hypnosis.
Häuser, Winfried; Hagl, Maria; Schmierer, Albrecht; Hansen, Ernil
2016-04-29
The efficacy and safety of hypnotic techniques in somatic medicine, known as medical hypnosis, have not been supported to date by adequate scientific evidence. We systematically reviewed meta-analyses of randomized controlled trials (RCTs) of medical hypnosis. Relevant publications (January 2005 to June 2015) were sought in the Cochrane databases CDSR and DARE, and in PubMed. Meta-analyses involving at least 400 patients were included in the present analysis. Their methodological quality was assessed with AMSTAR (A Measurement Tool to Assess Systematic Reviews). An additional search was carried out in the CENTRAL and PubMed databases for RCTs of waking suggestion (therapeutic suggestion without formal trance induction) in somatic medicine. Out of the 391 publications retrieved, five were reports of metaanalyses that met our inclusion criteria. One of these meta-analyses was of high methodological quality; three were of moderate quality, and one was of poor quality. Hypnosis was superior to controls with respect to the reduction of pain and emotional stress during medical interventions (34 RCTs, 2597 patients) as well as the reduction of irritable bowel symptoms (8 RCTs, 464 patients). Two meta-analyses revealed no differences between hypnosis and control treatment with respect to the side effects and safety of treatment. The effect size of hypnosis on emotional stress during medical interventions was low in one meta-analysis, moderate in one, and high in one. The effect size on pain during medical interventions was low. Five RCTs indicated that waking suggestion is effective in medical procedures. Medical hypnosis is a safe and effective complementary technique for use in medical procedures and in the treatment of irritable bowel syndrome. Waking suggestions can be a component of effective doctor-patient communication in routine clinical situations.
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Martelli, N; van den Brink, H; Denies, F; Dervaux, B; Germe, A F; Prognon, P; Pineau, J
2014-01-01
Innovative medical devices offer solutions to medical problems and greatly improve patients' outcomes. Like National Health Technology Assessment (HTA) agencies, hospitals face numerous requests for innovative and costly medical devices. To help local decision-makers, different approaches of hospital-based HTA (HB-HTA) have been adopted worldwide. The objective of the present paper is to explore HB-HTA models for adopting innovative medical devices in France and elsewhere. Four different models have been conceptualized: "ambassador" model, "mini-HTA" model, "HTA unit" model and "internal committee". Apparently, "HTA unit" and "internal committee" (or a mixture of both models) are the prevailing HB-HTA models in France. Nevertheless, some weaknesses of these models have been pointed out in previous works. Only few examples involving hospital pharmacists have been found abroad, except in France and in Italy. Finally, the harmonization of the assessment of innovative medical devices in France needs a better understanding of HB-HTA practices. Copyright © 2013 Elsevier Masson SAS. All rights reserved.
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2017-07-27
The Food and Drug Administration (FDA, Agency, or we) is classifying the assayed quality control material for clinical microbiology assays into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the assayed quality control material for clinical microbiology assays' classification. The Agency is classifying the device into class II (special controls) to provide a reasonable assurance of safety and effectiveness of the device.
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TU-AB-204-00: CDRH/FDA Regulatory Processes and Device Science Activities
International Nuclear Information System (INIS)
2016-01-01
The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC
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TU-AB-204-00: CDRH/FDA Regulatory Processes and Device Science Activities
Energy Technology Data Exchange (ETDEWEB)
NONE
2016-06-15
The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC
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International Nuclear Information System (INIS)
Ohba, Hisateru; Ogasawara, Katsuhiko; Aburano, Tamio
2005-01-01
In this study, a questionnaire survey was carried out to determine the actual situation of radiation safety management systems in Japanese medical institutions with nuclear medicine facilities. The questionnaire consisted of questions concerning the Radiation Protection Supervisor license, safety management organizations, and problems related to education and training in safety management. Analysis was conducted according to region, type of establishment, and number of beds. The overall response rate was 60%, and no significant difference in response rate was found among regions. Medical institutions that performed nuclear medicine practices without a radiologist participating accounted for 10% of the total. Medical institutions where nurses gave patients intravenous injections of radiopharmaceuticals as part of the nuclear medicine practices accounted for 28% of the total. Of these medical institutions, 59% provided education and training in safety management for nurses. The rate of acquisition of Radiation Protection Supervisor licenses was approximately 70% for radiological technologists and approximately 20% for physicians (regional difference, p=0.02). The rate of medical institutions with safety management organizations was 71% of the total. Among the medical institutions (n=208) without safety management organizations, approximately 56% had 300 beds or fewer. In addition, it became clear that 35% of quasi-public organizations and 44% of private organizations did not provide education and training in safety management (p<0.001, according to establishment). (author)
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Pediatric medical device development by surgeons via capstone engineering design programs.
Sack, Bryan S; Elizondo, Rodolfo A; Huang, Gene O; Janzen, Nicolette; Espinoza, Jimmy; Sanz-Cortes, Magdalena; Dietrich, Jennifer E; Hakim, Julie; Richardson, Eric S; Oden, Maria; Hanks, John; Haridas, Balakrishna; Hury, James F; Koh, Chester J
2018-03-01
There is a need for pediatric medical devices that accommodate the unique physiology and anatomy of pediatric patients that is increasingly receiving more attention. However, there is limited literature on the programs within children's hospitals and academia that can support pediatric device development. We describe our experience with pediatric device design utilizing collaborations between a children's hospital and two engineering schools. Utilizing the academic year as a timeline, unmet pediatric device needs were identified by surgical faculty and matched with an engineering mentor and a team of students within the Capstone Engineering Design programs at two universities. The final prototypes were showcased at the end of the academic year and if appropriate, provisional patent applications were filed. All twelve teams successfully developed device prototypes, and five teams obtained provisional patents. The prototypes that obtained provisional patents included a non-operative ureteral stent removal system, an evacuation device for small kidney stone fragments, a mechanical leech, an anchoring system of the chorio-amniotic membranes during fetal surgery, and a fetal oxygenation monitor during fetoscopic procedures. Capstone Engineering Design programs in partnership with surgical faculty at children's hospitals can play an effective role in the prototype development of novel pediatric medical devices. N/A - No clinical subjects or human testing was performed. Copyright © 2017 Elsevier Inc. All rights reserved.
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Energy Technology Data Exchange (ETDEWEB)
Kim, Y. M.; Lee, H. K.; Park, H. S. [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)
2016-10-15
Conventional I and C(Instrumentation and Control) systems are tend to becoming unavailable and being replaced by smart equipment. These smart equipment is usually called embedded digital devices (EDDs) or industrial digital devices of limited functionality. Usually, some of these devices are found embedded in plant equipment such as sensing instrumentation, motors, pumps, actuators and breakers. They typically have a micro-processor, RAM, communication interface, a power source, etc. The U.S. Nuclear Regulatory Commission (US NRC) is concerning that these EDDs might exist in procured equipment used in safety systems without the devices having been explicitly identified in procurement documentation. This paper addresses the regulatory experiences of KINS of the EDDs for safety I and C systems and the future works for them. In this paper, we showed regulatory experiences of EDDs which used for safety grade equipment. EDDs might exist in safety grade procured equipment without explicit identification. Undetected defects of EDDs might be the potential safety concerns. EDDs should meet certain specific requirements in order to be selected and used in safety I and C system. We have plan to develop technical positions for identification and qualifying them. The technical position will address, but may not be limited to, quality and reliability, CCFs via software errors, EMC, and CGID for EDDs.
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Wireless communication with implanted medical devices using the conductive properties of the body.
Ferguson, John E; Redish, A David
2011-07-01
Many medical devices that are implanted in the body use wires or wireless radiofrequency telemetry to communicate with circuitry outside the body. However, the wires are a common source of surgical complications, including breakage, infection and electrical noise. In addition, radiofrequency telemetry requires large amounts of power and results in low-efficiency transmission through biological tissue. As an alternative, the conductive properties of the body can be used to enable wireless communication with implanted devices. In this article, several methods of intrabody communication are described and compared. In addition to reducing the complications that occur with current implantable medical devices, intrabody communication can enable novel types of miniature devices for research and clinical applications.
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Directory of Open Access Journals (Sweden)
Christopher M. Loftus
2018-06-01
Full Text Available The United States Food and Drug Administration (FDA Center for Devices and Radiological Health (CDRH is charged with ensuring patients in the US have timely access to high-quality, safe, and effective medical devices of public health importance. Within CDRH, the Division of Neurological and Physical Medicine Devices reviews medical technologies that interface with the central and peripheral nervous system (neurotechnologies, including neurointerventional medical devices that are used in the treatment of stroke. Endovascular treatments have demonstrated recent advances in reaching the marketplace and providing more options for patients with acute ischemic stroke and intracranial aneurysms specifically. Depending upon the pathway chosen for regulatory approval, and the evidentiary standard for different regulatory pathways, neurotechnologies can have well-established safety and effectiveness profiles, varying degrees of scientific and clinical uncertainty regarding safety and effectiveness, or when a humanitarian use exists, need only demonstrate a probable benefit and safety to the patient so potentially life-saving treatments can reach the marketplace. Reperfusion therapies have had specific advances in the treatment of stroke patients that originally had limited or no treatment options and for preventative treatments in providing care to patients with intracranial aneurysms to avoid potentially more catastrophic outcomes. Collaboration in multiple forums and environments will be important to continue to foster the neurointerventional technology sector and positively impact clinical medicine, from diagnosing and treating a neurological disorder, to potentially altering the progression of disease, and in many ways, contemporary approved devices have brought a new sense of hope and optimism that serious and otherwise disabling neurological diseases can be treated and in many cases cured with modern therapy. We present here the scope of FDA
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Using Mobile Devices in Nursing Education.
Day-Black, Crystal; Merrill, Earlene B
2015-01-01
The use of mobile device technology in nursing education is growing. These devices are becoming more important in the health care environment with an advantage of providing a compendium of drug, nursing procedures and treatments, and disease information to nursing students. Senior baccalaureate nursing students traditionally are prohibited from medication administration during psychiatric-mental health clinical rotations, but they are required to participate in simulated medication discussions and administration experiences. The incorporation of this mobile device technology to augment clinical learning experiences has advantages including potential reduction of medication errors, and improved patient safety during students' clinical rotation. The purpose of this project is to explain how the mobile device (iPod Touch, 4th generation wireless media player) may be used to enhance and augment comprehensive nursing care in a psychiatric-mental health clinical setting. Thirty-four (34) baccalaureate senior nursing students enrolled in a clinical psychiatric-mental nursing course at a mid-Atlantic public university school of nursing were used. Each student was provided a loaner mobile device with appropriate software and the necessary training. Data were collected on the student's ability to simulate medication administration to a psychiatric-mental health client. Surveys were administered before distribution, at mid-point and at the end of two (2) seven week semesters.
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Regulator Loss Functions and Hierarchical Modeling for Safety Decision Making.
Hatfield, Laura A; Baugh, Christine M; Azzone, Vanessa; Normand, Sharon-Lise T
2017-07-01
Regulators must act to protect the public when evidence indicates safety problems with medical devices. This requires complex tradeoffs among risks and benefits, which conventional safety surveillance methods do not incorporate. To combine explicit regulator loss functions with statistical evidence on medical device safety signals to improve decision making. In the Hospital Cost and Utilization Project National Inpatient Sample, we select pediatric inpatient admissions and identify adverse medical device events (AMDEs). We fit hierarchical Bayesian models to the annual hospital-level AMDE rates, accounting for patient and hospital characteristics. These models produce expected AMDE rates (a safety target), against which we compare the observed rates in a test year to compute a safety signal. We specify a set of loss functions that quantify the costs and benefits of each action as a function of the safety signal. We integrate the loss functions over the posterior distribution of the safety signal to obtain the posterior (Bayes) risk; the preferred action has the smallest Bayes risk. Using simulation and an analysis of AMDE data, we compare our minimum-risk decisions to a conventional Z score approach for classifying safety signals. The 2 rules produced different actions for nearly half of hospitals (45%). In the simulation, decisions that minimize Bayes risk outperform Z score-based decisions, even when the loss functions or hierarchical models are misspecified. Our method is sensitive to the choice of loss functions; eliciting quantitative inputs to the loss functions from regulators is challenging. A decision-theoretic approach to acting on safety signals is potentially promising but requires careful specification of loss functions in consultation with subject matter experts.
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[Training in patient safety in medical and nursing schools].
Mira, J J; Guilabert, M; Vitaller, J; Ignacio, E
2016-01-01
To compare the information on patient safety received by students of medicine and nursing. Cross-sectional study was conducted using a convenience sample of medical and nursing students of 3 Universities. The Latin Patient Safety Student Information and a test of 5 questions with 5 options were used. A sample of 79 students in each group was enrolled to detect differences of .3 units (bilateral estimation), considering 80% statistical power and 95% confidence interval. A total of 144 students replied (74 nursing and 70 medicine students). Nursing students achieved higher scores in the communication with patients factor (3.8 vs 3.2, P<.001) and proactive attitude to identify risks for patient safety (4.3 vs 3.8, P<.001). Medical students were more aware of the inevitability of adverse events (2.3 vs 3.1, P<.001). Ten (7%) students had only one fault in the test, and only one (1%) answered all questions correctly. The training in patient safety should be improved both in nursing and medicine, although nursing students receive more information. Copyright © 2015 SECA. Published by Elsevier Espana. All rights reserved.
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International Nuclear Information System (INIS)
Yoon, Yong Su; Kim, Jung Min; Kim, Ji Hyun; Choi, In Seok; Sung, Dong Wook; Do, Kyung Hyun; Jung, Seung Eun; Kim, Hyung Soo
2013-01-01
There are many concerns about radiation exposure in Korea after Fukushima Nuclear Plant Accident on 2011 in Japan. As some isotope materials are detected in Korea, people get worried about the radioactive material. In addition, the mass media create an air of anxiety that jump on the people’s fear instead of scientific approach. Therefore, for curbing this flow, health, medical institute from the world provide a variety of information about medical radiation safety and hold the campaign which can give people the image that medical radiation is safe. At this, the Korean Food and Drug Administration(KFDA) suggested that make the alliance of medical radiation safety and culture on August, 2011. Seven societies and institutions related medical radiation started to research and advertise the culture of medical radiation safety in Korea. In this report, mainly introduce the activities of the Korean Alliance for Radiation Safety and Culture in Medicine(KARSM) for spreading culture of medical radiation safety from 2011 to 2012
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Energy Technology Data Exchange (ETDEWEB)
Yoon, Yong Su; Kim, Jung Min; Kim, Ji Hyun; Choi, In Seok [Dept. of Radiologic Science, Korea University, Seoul (Korea, Republic of); Sung, Dong Wook [Dept. of Radiology, Kyunghee University Hospital, Seoul (Korea, Republic of); Do, Kyung Hyun [Dept. of Radiology, University of Ulsan College of Medicine, Asan Medical Center, Seoul (Korea, Republic of); Jung, Seung Eun [Dept. of Radiology, College of Medicine, The Catholic University of Korea, Seoul (Korea, Republic of); Kim, Hyung Soo [Dept. of Radiation Safety, National Institute of Food and Drug Safety Evaluation, Korea Food and Drug Administration, Seoul (Korea, Republic of)
2013-09-15
There are many concerns about radiation exposure in Korea after Fukushima Nuclear Plant Accident on 2011 in Japan. As some isotope materials are detected in Korea, people get worried about the radioactive material. In addition, the mass media create an air of anxiety that jump on the people’s fear instead of scientific approach. Therefore, for curbing this flow, health, medical institute from the world provide a variety of information about medical radiation safety and hold the campaign which can give people the image that medical radiation is safe. At this, the Korean Food and Drug Administration(KFDA) suggested that make the alliance of medical radiation safety and culture on August, 2011. Seven societies and institutions related medical radiation started to research and advertise the culture of medical radiation safety in Korea. In this report, mainly introduce the activities of the Korean Alliance for Radiation Safety and Culture in Medicine(KARSM) for spreading culture of medical radiation safety from 2011 to 2012.
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2013-06-14
...] Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; Draft Guidance for... draft guidance entitled ``Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.'' This guidance identifies cybersecurity issues that manufacturers should consider in preparing...
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TU-AB-204-03: Research Activities in Medical Physics
International Nuclear Information System (INIS)
Badano, A.
2016-01-01
The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC
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TU-AB-204-03: Research Activities in Medical Physics
Energy Technology Data Exchange (ETDEWEB)
Badano, A. [Food & Drug Administration (United States)
2016-06-15
The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC
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Safety assessment and quality control of medical x-ray facilities in some hospitals in Ghana
International Nuclear Information System (INIS)
Darko, E.O.; Charles, D.F.
1998-01-01
Safety assessment and quality control measurements of diagnostic x-ray installations were carried out in five hospitals in Ghana. The study was focused on the siting, design and construction of the buildings housing the x-ray units, assessment of safety systems and devices and measurements of the technical performance, and film processing conditions. The location, inadequacies in the design/construction, unavailability of relevant safety systems and devices, violation of basic safety principles and poor performance of some of the x-ray facilities indicate the need to improve quality control programmes, safety culture and enforcement of regulatory standards in diagnostic x-ray examinations in Ghana. (author). 8 refs., 11 tabs., 8 figs
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The safety net medical home initiative: transforming care for vulnerable populations.
Sugarman, Jonathan R; Phillips, Kathryn E; Wagner, Edward H; Coleman, Katie; Abrams, Melinda K
2014-11-01
Despite findings that medical homes may reduce or eliminate health care disparities among underserved and minority populations, most previous medical home pilot and demonstration projects have focused on health care delivery systems serving commercially insured patients and Medicare beneficiaries. To develop a replicable approach to support medical home transformation among diverse practices serving vulnerable and underserved populations. Facilitated by a national program team, convening organizations in 5 states provided coaching and learning community support to safety net practices over a 4-year period. To guide transformation, we developed a framework of change concepts aligned with supporting tools including implementation guides, activity checklists, and measurement instruments. Sixty-five health centers, homeless clinics, private practices, residency training centers, and other safety net practices in Colorado, Idaho, Massachusetts, Oregon, and Pennsylvania. We evaluated implementation of the change concepts using the Patient-Centered Medical Home-Assessment, and conducted a survey of participating practices to assess perceptions of the impact of the technical assistance. All practices implemented key features of the medical home model, and nearly half (47.6%) implemented the 33 identified key changes to a substantial degree as evidenced by level A Patient-Centered Medical Home-Assessment scores. Two thirds of practices that achieved substantial implementation did so only after participating in the initiative for >2 years. By the end of the initiative, 83.1% of sites achieved external recognition as medical homes. Despite resource constraints and high-need populations, safety net clinics made considerable progress toward medical home implementation when provided robust, multimodal support over a 4-year period.
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Protection of the patient in medical exposure - the related IAEA safety guide
International Nuclear Information System (INIS)
Turai, I.
1999-01-01
The Radiation Safety Section of the Agency has recently completed the draft Safety Guide on Radiation Protection in Medical Exposures' for submission to the Publication Committee of the IAEA. The author as served as one of the scientific secretaries responsible for the preparation and review of this document in the last two years. The drafts of this IAEA Safety Guide have undergone a detailed review process by specialists of 14 Member States and the co-sponsoring organizations, the Pan American Health Organization and the World Health Organization (WHO). The last draft is the primary source of this paper. The Safety Guide will be part of the Safety Standards Series. It is addressed to Regulatory Authorities and other National Institutions to provide them with guidance at the national level on the practical implementation of Appendix II (Medical Exposure) of the International Basic Safety Standards for the Protection against Ionizing Radiation and for the Safety of Radiation Sources
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Research Devices Maintenance Programs and Safety Network Infrastructures in Nuclear Malaysia
International Nuclear Information System (INIS)
Zainudin Jaafar; Muhammad Zahidee Taat; Ishak Mansor
2015-01-01
Instrumentation and Automation Center (PIA) is responsible in carrying out maintenance work for building safety infrastructure and area for nuclear scientific and research work. Care cycle and nuclear scientific tools starting from the preparation of specifications until devices disposal- to get the maximum output from devices therefore PIA has introduced Effective and Comprehensive Maintenance Plan under Management/ Trust/ Development/ Science Fund budgets and also user, Asset Management, caring and handling of the devices. This paper also discussed more on case study related to using and handling so that it can be guidance and standard when its involving mishandling, improper maintenance, inadequacy of supervision and others including improvement suggestion programs. (author)
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A Secure ECC-based RFID Mutual Authentication Protocol to Enhance Patient Medication Safety.
Jin, Chunhua; Xu, Chunxiang; Zhang, Xiaojun; Li, Fagen
2016-01-01
Patient medication safety is an important issue in patient medication systems. In order to prevent medication errors, integrating Radio Frequency Identification (RFID) technology into automated patient medication systems is required in hospitals. Based on RFID technology, such systems can provide medical evidence for patients' prescriptions and medicine doses, etc. Due to the mutual authentication between the medication server and the tag, RFID authentication scheme is the best choice for automated patient medication systems. In this paper, we present a RFID mutual authentication scheme based on elliptic curve cryptography (ECC) to enhance patient medication safety. Our scheme can achieve security requirements and overcome various attacks existing in other schemes. In addition, our scheme has better performance in terms of computational cost and communication overhead. Therefore, the proposed scheme is well suitable for patient medication systems.
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Wireless energy transfer platform for medical sensors and implantable devices.
Zhang, Fei; Hackworth, Steven A; Liu, Xiaoyu; Chen, Haiyan; Sclabassi, Robert J; Sun, Mingui
2009-01-01
Witricity is a newly developed technique for wireless energy transfer. This paper presents a frequency adjustable witricity system to power medical sensors and implantable devices. New witricity resonators are designed for both energy transmission and reception. A prototype platform is described, including an RF power source, two resonators with new structures, and inductively coupled input and output stages. In vitro experiments, both in open air and using a human head phantom consisting of simulated tissues, are employed to verify the feasibility of this platform. An animal model is utilized to evaluate in vivo energy transfer within the body of a laboratory pig. Our experiments indicate that witricity is an effective new tool for providing a variety of medical sensors and devices with power.
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Anand, K; Saini, Ks; Chopra, Y; Binod, Sk
2010-07-01
'Medical Devices' include everything from highly sophisticated, computerized, medical equipment, right down to simple wooden tongue depressors. Regulations embody the public expectations for how buildings and facilities are expected to perform and as such represent public policy. Regulators, who develop and enforce regulations, are empowered to act in the public's interest to set this policy and are ultimately responsible to the public in this regard. Standardization contributes to the basic infrastructure that underpins society including health and environment, while promoting sustainability and good regulatory practice. The international organizations that produce International Standards are the International Electrotechnical Commission (IEC), the International Organization for Standardization (ISO), and the International Telecommunication Union (ITU). With the increasing globalization of markets, International Standards (as opposed to regional or national standards) have become critical to the trading process, ensuring a level playing field for exports, and ensuring that imports meet the internationally recognized levels of performance and safety. The development of standards is done in response to sectors and stakeholders that express a clearly established need for them. An industry sector or other stakeholder group typically communicates its requirement for standards to one of the national members. To be accepted for development, a proposed work item must receive a majority support of the participating members, who verify the global relevance of the proposed item. The regulatory authority (RA) should provide a method for the recognition of international voluntary standards and for public notification of such recognition. The process of recognition may vary from country to country. Recognition may occur by periodic publication of lists of standards that a regulatory authority has found will meet the Essential Principles. In conclusion, International standards
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Bepko, Robert J; Moore, John R; Coleman, John R
2009-01-01
This article reports an intervention to improve the quality and safety of hospital patient care by introducing the use of pharmacy robotics into the medication distribution process. Medication safety is vitally important. The integration of pharmacy robotics with computerized practitioner order entry and bedside medication bar coding produces a significant reduction in medication errors. The creation of a safe medication-from initial ordering to bedside administration-provides enormous benefits to patients, to health care providers, and to the organization as well.
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Radiation safety in X-ray facilities
International Nuclear Information System (INIS)
2001-09-01
The guide specifies the radiation safety requirements for structural shielding and other safety arrangements used in X-ray facilities in medical and veterinary X-ray activities and in industry, research and education. The guide is also applicable to premises in which X-ray equipment intended for radiation therapy and operating at a voltage of less than 25 kV is used. The guide applies to new X-ray facilities in which X-ray equipment that has been used elsewhere is transferred. The radiation safety requirements for radiation therapy X-ray devices operating at a voltage exceeding 25 kV, and for the premices in which such devices are used, are set out in Guide ST 2.2
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Radiation safety in X-ray facilities
Energy Technology Data Exchange (ETDEWEB)
NONE
2001-09-01
The guide specifies the radiation safety requirements for structural shielding and other safety arrangements used in X-ray facilities in medical and veterinary X-ray activities and in industry, research and education. The guide is also applicable to premises in which X-ray equipment intended for radiation therapy and operating at a voltage of less than 25 kV is used. The guide applies to new X-ray facilities in which X-ray equipment that has been used elsewhere is transferred. The radiation safety requirements for radiation therapy X-ray devices operating at a voltage exceeding 25 kV, and for the premices in which such devices are used, are set out in Guide ST 2.2.
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Directory of Open Access Journals (Sweden)
Maya Lyapina
2015-02-01
Full Text Available Defining a given product as a medical device and interpretation of the application of the classification rules fall within the competence of the competent authorities of the Member States where the product is on the market. Different interpretations of Community legislation occur, and, can put public health at risk and distort the internal market. Borderline cases are considered to be those cases where it is not clear from the outset whether a given product is a medical device, an in vitro diagnostic medical device, an active implantable medical device or not. Classification cases can be described as those cases where there exists a difficulty in the uniform application of the classification rules as laid down in the Medical Devices Directive (MDD, or where for a given device, depending on interpretation of the rules, different classifications can occur. The aim of the present work is to make a brief review on discussion on classification in the community regulatory framework for medical devices of some dentistry products.
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Elaboration and Validation of the Medication Prescription Safety Checklist 1
Pires, Aline de Oliveira Meireles; Ferreira, Maria Beatriz Guimarães; do Nascimento, Kleiton Gonçalves; Felix, Márcia Marques dos Santos; Pires, Patrícia da Silva; Barbosa, Maria Helena
2017-01-01
ABSTRACT Objective: to elaborate and validate a checklist to identify compliance with the recommendations for the structure of medication prescriptions, based on the Protocol of the Ministry of Health and the Brazilian Health Surveillance Agency. Method: methodological research, conducted through the validation and reliability analysis process, using a sample of 27 electronic prescriptions. Results: the analyses confirmed the content validity and reliability of the tool. The content validity, obtained by expert assessment, was considered satisfactory as it covered items that represent the compliance with the recommendations regarding the structure of the medication prescriptions. The reliability, assessed through interrater agreement, was excellent (ICC=1.00) and showed perfect agreement (K=1.00). Conclusion: the Medication Prescription Safety Checklist showed to be a valid and reliable tool for the group studied. We hope that this study can contribute to the prevention of adverse events, as well as to the improvement of care quality and safety in medication use. PMID:28793128
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Utilization of ocular safety devices among Sawmill workers in Nigeria
African Journals Online (AJOL)
Objective: The study was carried out to assess the use of eye safety devices in sawmill workers in Nigeria. Methods: A cross-sectional study of sawmill workers was carried out using pretested questionnaires. Ocular examination was done on site with a pen torch, portable hand-held slit lamp bio-microscope and direct ...
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Sleath, Betsy; Carpenter, Delesha M; Ayala, Guadalupe X; Williams, Dennis; Davis, Stephanie; Tudor, Gail; Yeatts, Karin; Gillette, Chris
2012-11-01
This study investigated how provider demonstration of and assessment of child use of asthma medication devices and certain aspects of provider-patient communication during medical visits is associated with device technique 1 month later. Two hundred and ninety-six children aged 8-16 years with persistent asthma and their caregivers were recruited at five North Carolina pediatric practices. All of the medical visits were audio-tape recorded. Children were interviewed 1 month later and their device technique was observed and rated. If the provider asked the child to demonstrate metered dose inhaler technique during the medical visit, then the child was significantly more likely to perform a greater percentage of inhaler steps correctly 1 month later. Children with higher asthma management self-efficacy scores were significantly more likely to perform a greater percentage of diskus steps correctly. Additionally, children were significantly more likely to perform a greater percentage of diskus steps correctly if the provider discussed a written action plan during the visit. Children were significantly more likely to perform a greater percentage of turbuhaler steps correctly if they asked more medication questions. Providers should ask children to demonstrate their inhaler technique during medical visits so that they can educate children about proper technique and improve child asthma management self-efficacy. Providers should encourage children to ask questions about asthma medication devices during visits and they should discuss asthma action plans with families.
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French Sizing of Medical Devices is not Fit for Purpose
International Nuclear Information System (INIS)
Kibriya, Nabil; Hall, Rebecca; Powell, Steven; How, Thien; McWilliams, Richard G.
2013-01-01
PurposeThe purpose of the study is to quantify the variation in the metric equivalent of French size in a range of medical devices, from various manufacturers, used in interventional radiology.MethodsThe labelling of a range of catheters, introducers, drains, balloons, stents, and endografts was examined. Products were chosen to achieve a broad range of French sizes from several manufacturers. To assess manufacturing accuracy, eight devices were selected for measurement using a laser micrometer. The external diameters of three specimens of each device were measured at centimeter intervals along the length of the device to ensure uniformity.ResultsA total of 200 labels of interventional radiology equipment were scrutinized. The results demonstrate a wide variation in the metric equivalent of French sizing. Labelled products can vary in diameter across the product range by up to 0.79 mm.The devices selected for measurement with the non-contact laser micrometer demonstrate acceptable manufacturing consistency. The external diameter differed by 0.05 mm on average.ConclusionsOur results demonstrate wide variation in the interpretation of the French scale by different manufacturers of medical devices. This has the potential to lead to problems using coaxial systems especially when the products are from different manufacturers. It is recommended that standard labelling should be employed by all manufacturers conveying specific details of the equipment. Given the wide variation in the interpretation of the French scale, our opinion is that this scale either needs to be abandoned or be strictly defined and followed
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2012-06-27
... drugs, devices, and medical treatments or procedures and adding the TRICARE definition of unlabeled or... labeling. We are now modifying the definition of ``unlabeled or off-label drug'' to ``off-label use of a... reference back to the definition of the term in 199.2. ``Off-label uses of drugs and devices'' includes off...
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2010-04-21
...] Medical Device Use in the Home Environment: Implications for the Safe and Effective Use of Medical Device... related to the safe and effective use of medical device technology in the home environment. The workshop... the home environment. FDA will solicit feedback on: 1. The agency's current working definition of...
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2017-12-28
The Food and Drug Administration (FDA or we) is classifying the pressure wedge for the reduction of cesarean delivery into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the pressure wedge for the reduction of cesarean delivery's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
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Howard, Jason J
2014-01-01
With some of the richest economies in the world, the Gulf Cooperation Council (GCC) is undergoing rapid growth not only in its population but also in health care expenditure. Despite the GCC's abundance of hydrocarbon-based wealth, the drivers of the medical device industry in the GCC are still in flux, with gains yet to be made in areas of infrastructure, regulation, and reimbursement. However, the regional disease burden, expanding health insurance penetration, increasing privatization, and a desire to attract skilled expatriate health care providers have led to favorable conditions for the medical device market in the GCC. The purpose of this article is to investigate the current state of the GCC medical device industry, with respect to market, regulation, and reimbursement, paying special attention to the three largest medical device markets: Saudi Arabia, the United Arab Emirates, and Qatar. The GCC would seem to represent fertile ground for the development of medical technologies, especially those in line with the regional health priorities of the respective member states.
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Passive safety device and internal short tested method for energy storage cells and systems
Keyser, Matthew; Darcy, Eric; Long, Dirk; Pesaran, Ahmad
2015-09-22
A passive safety device for an energy storage cell for positioning between two electrically conductive layers of the energy storage cell. The safety device also comprising a separator and a non-conductive layer. A first electrically conductive material is provided on the non-conductive layer. A first opening is formed through the separator between the first electrically conductive material and one of the electrically conductive layers of the energy storage device. A second electrically conductive material is provided adjacent the first electrically conductive material on the non-conductive layer, wherein a space is formed on the non-conductive layer between the first and second electrically conductive materials. A second opening is formed through the non-conductive layer between the second electrically conductive material and another of the electrically conductive layers of the energy storage device. The first and second electrically conductive materials combine and exit at least partially through the first and second openings to connect the two electrically conductive layers of the energy storage device at a predetermined temperature.
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Medical Device-Associated Candida Infections in a Rural Tertiary Care Teaching Hospital of India
Directory of Open Access Journals (Sweden)
Sachin C. Deorukhkar
2016-01-01
Full Text Available Health care associated infections (HCAIs add incrementally to the morbidity, mortality, and cost expected of the patient’s underlying diseases alone. Approximately, about half all cases of HCAIs are associated with medical devices. As Candida medical device-associated infection is highly drug resistant and can lead to serious life-threatening complications, there is a need of continuous surveillance of these infections to initiate preventive and corrective measures. The present study was conducted at a rural tertiary care hospital of India with an aim to evaluate the rate of medical device-associated Candida infections. Three commonly encountered medical device-associated infections (MDAI, catheter-associated urinary tract infection (CA-UTI, intravascular catheter-related blood stream infections (CR-BSI, and ventilator-associated pneumonia (VAP, were targeted. The overall rate of MDAI in our hospital was 2.1 per 1000 device days. The rate of Candida related CA-UTI and CR-BSI was noted as 1.0 and 0.3, respectively. Untiring efforts taken by team members of Hospital Acquired Infection Control Committee along with maintenance of meticulous hygiene of the hospital and wards may explain the low MDAI rates in our institute. The present surveillance helped us for systematic generation of institutional data regarding MDAI with special reference to role of Candida spp.
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Römer, GertWillem R.B.E.; Stuyt, Harry J.A.
2007-01-01
Medical devices produced by manufacturers are subject to regulatory review by authorities. Usually, medical devices are developed at universities and other research institutes. This implies that regulatory activities are to be carried out by the designer at these organizations also. And as early as
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2013-09-13
...] Challenging Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of Metabolic Diseases... announcing a public workshop entitled ``Changing Regulatory and Reimbursement Paradigms for Medical Devices... registration information on the AGA Web site. If you need special accommodations due to a disability, please...
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Moqeem, Aasia; Baig, Mirza; Gholamhosseini, Hamid; Mirza, Farhaan; Lindén, Maria
2018-01-01
This research involves the design and development of a novel Android smartphone application for real-time vital signs monitoring and decision support. The proposed application integrates market available, wireless and Bluetooth connected medical devices for collecting vital signs. The medical device data collected by the app includes heart rate, oxygen saturation and electrocardiograph (ECG). The collated data is streamed/displayed on the smartphone in real-time. This application was designed by adopting six screens approach (6S) mobile development framework and focused on user-centered approach and considered clinicians-as-a-user. The clinical engagement, consultations, feedback and usability of the application in the everyday practices were considered critical from the initial phase of the design and development. Furthermore, the proposed application is capable to deliver rich clinical decision support in real-time using the integrated medical device data.
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77 FR 38294 - Patient Safety Organizations: Delisting for Cause for Medical Informatics
2012-06-27
... Organizations: Delisting for Cause for Medical Informatics AGENCY: Agency for Healthcare Research and Quality... Safety Organization (PSO) due to its failure to correct a deficiency. The Patient Safety and Quality... organizations whose mission and primary activity is to conduct activities to improve patient safety and the...
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Agility in Development of Safety-Critical Software: A Conceptual Model
DEFF Research Database (Denmark)
Tordrup Heeager, Lise; Nielsen, Peter Axel
2018-01-01
Safety-critical information systems are being used increasingly as we see applications in new areas such as personal medical devices, traffic control and detection of pathogens. A current research debate is whether safety-critical systems must be developed with traditional waterfall processes...
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2014-10-22
The Food and Drug Administration (FDA) is classifying nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex (MTB-complex) and the genetic mutations associated with MTB-complex antibiotic resistance in respiratory specimens devices into class II (special controls). The Agency is classifying the device into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of the device.
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Limited Awareness of the Essences of Certification or Compliance Markings on Medical Devices.
Foo, Jong Yong Abdiel; Tan, Xin Ji Alan
2017-06-01
Medical devices have been long used for odiagnostic, therapeutic or rehabilitation purposes. Currently, they can range from a low-cost portable device that is often used for personal health monitoring to high-end sophisticated equipment that can only be operated by trained professionals. Depending on the functional purposes, there are different certification or compliance markings on the device when it is sold. One common certification marking is the Conformité Européenne affixation but this has a range of certification mark numbering for a variety of functional purposes. While the regulators and medical device manufacturers understand the associated significance and clinical implications, these may not be apparent to the professionals (using or maintaining the device) and the general public. With portable healthcare devices and mobile applications gaining popularity, better awareness of certification marking will be needed. Particularly, there are differences in the allowed functional purposes and the associated cost derivations of devices with a seemingly similar nature. A preferred approach such as an easy-to-understand notation next to any certification marking on a device can aid in differentiation without the need to digest mountainous regulatory details.
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Wang, Chi-Jane; Fetzer, Susan J; Yang, Yi-Ching; Wang, Jing-Jy
2013-01-01
It is a challenge for rural health professionals to promote medication safety among older adults taking multiple medications. A volunteer coaching program to promote medication safety among rural elders with chronic illnesses was designed and evaluated. A community-based interventional study randomly assigned 62 rural elders with at least two chronic illnesses to routine care plus volunteer coaching or routine care alone. The volunteer coaching group received a medication safety program, including a coach and reminders by well-trained volunteers, as well as three home visits and five telephone calls over a two-month period. All the subjects received routine medication safety instructions for their chronic illnesses. The program was evaluated using pre- and post-tests of knowledge, attitude and behaviors with regard to medication safety. Results show the volunteer coaching group improved their knowledge of medication safety, but there was no change in attitude after the two-month study period. Moreover, the group demonstrated three improved medication safety behaviors compared to the routine care group. The volunteer coaching program and instructions with pictorial aids can provide a reference for community health professionals who wish to improve the medication safety of chronically ill elders. Copyright © 2013 Mosby, Inc. All rights reserved.
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Feasibility of energy harvesting techniques for wearable medical devices.
Voss, Thaddaeus J; Subbian, Vignesh; Beyette, Fred R
2014-01-01
Wearable devices are arguably one of the most rapidly growing technologies in the computing and health care industry. These systems provide improved means of monitoring health status of humans in real-time. In order to cope with continuous sensing and transmission of biological and health status data, it is desirable to move towards energy autonomous systems that can charge batteries using passive, ambient energy. This not only ensures uninterrupted data capturing, but could also eliminate the need to frequently remove, replace, and recharge batteries. To this end, energy harvesting is a promising area that can lead to extremely power-efficient portable medical devices. This paper presents an experimental prototype to study the feasibility of harvesting two energy sources, solar and thermoelectric energy, in the context of wearable devices. Preliminary results show that such devices can be powered by transducing ambient energy that constantly surrounds us.
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Dosimetric studies for gamma radiation validation of medical devices
International Nuclear Information System (INIS)
Soliman, Y.S.; Beshir, W.B.; Abdel-Fattah, A.A.; Abdel-Rehim, F.
2013-01-01
The delivery and validation of a specified dose to medical devices are key concerns to operators of gamma radiation facilities. The objective of the present study was to characterize the industrial gamma radiation facility and map the dose distribution inside the product-loading pattern during the validation and routine control of the sterilization process using radiochromic films. Cardboard phantoms were designed to achieve the homogeneity of absorbed doses. The uncertainty of the dose delivered during validation of the sterilization process was assessed. - Highlights: ► Using γ-rays for sterilization of hollow fiber dialyzers and blood tubing sets according to ISO 11137, 2006. ► Dosimetry studies of validations of γ-irradiation facility and sterilized medical devices. ► Places of D min and D max have been determined using FWT-60 films. ► Determining the target minimum doses required to meet the desired SAL of 10 −6 for the two products.
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2010-07-01
... safety devices and follow all safety guidelines? Yes, Federal employees in Government motor vehicles have... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false Do Federal employees in Government motor vehicles have to use all safety devices and follow all safety guidelines? 102-34.250 Section...
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Schraagen, Jan Maarten; Verhoeven, Fenne
2013-02-01
The aims of this study were to investigate how a variety of research methods is commonly employed to study technology and practitioner cognition. User-interface issues with infusion pumps were selected as a case because of its relevance to patient safety. Starting from a Cognitive Systems Engineering perspective, we developed an Impact Flow Diagram showing the relationship of computer technology, cognition, practitioner behavior, and system failure in the area of medical infusion devices. We subsequently conducted a systematic literature review on user-interface issues with infusion pumps, categorized the studies in terms of methods employed, and noted the usability problems found with particular methods. Next, we assigned usability problems and related methods to the levels in the Impact Flow Diagram. Most study methods used to find user interface issues with infusion pumps focused on observable behavior rather than on how artifacts shape cognition and collaboration. A concerted and theory-driven application of these methods when testing infusion pumps is lacking in the literature. Detailed analysis of one case study provided an illustration of how to apply the Impact Flow Diagram, as well as how the scope of analysis may be broadened to include organizational and regulatory factors. Research methods to uncover use problems with technology may be used in many ways, with many different foci. We advocate the adoption of an Impact Flow Diagram perspective rather than merely focusing on usability issues in isolation. Truly advancing patient safety requires the systematic adoption of a systems perspective viewing people and technology as an ensemble, also in the design of medical device technology. Copyright © 2012 Elsevier Inc. All rights reserved.
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2012-06-14
..., battery powered device with a semiconductor sensor. (2) Alcohol Countermeasure Systems Corp., submitted...-0062] Highway Safety Programs; Conforming Products List of Screening Devices To Measure Alcohol in... Screening Devices to Measure Alcohol in Bodily Fluids dated, March 31, 2008 (73 FR 16956). DATES: Effective...
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Seniors managing multiple medications: using mixed methods to view the home care safety lens.
Lang, Ariella; Macdonald, Marilyn; Marck, Patricia; Toon, Lynn; Griffin, Melissa; Easty, Tony; Fraser, Kimberly; MacKinnon, Neil; Mitchell, Jonathan; Lang, Eddy; Goodwin, Sharon
2015-12-12
Patient safety is a national and international priority with medication safety earmarked as both a prevalent and high-risk area of concern. To date, medication safety research has focused overwhelmingly on institutional based care provided by paid healthcare professionals, which often has little applicability to the home care setting. This critical gap in our current understanding of medication safety in the home care sector is particularly evident with the elderly who often manage more than one chronic illness and a complex palette of medications, along with other care needs. This study addresses the medication management issues faced by seniors with chronic illnesses, their family, caregivers, and paid providers within Canadian publicly funded home care programs in Alberta (AB), Ontario (ON), Quebec (QC) and Nova Scotia (NS). Informed by a socio-ecological perspective, this study utilized Interpretive Description (ID) methodology and participatory photographic methods to capture and analyze a range of visual and textual data. Three successive phases of data collection and analysis were conducted in a concurrent, iterative fashion in eight urban and/or rural households in each province. A total of 94 participants (i.e., seniors receiving home care services, their family/caregivers, and paid providers) were interviewed individually. In addition, 69 providers took part in focus groups. Analysis was iterative and concurrent with data collection in that each interview was compared with subsequent interviews for converging as well as diverging patterns. Six patterns were identified that provide a rich portrayal of the complexity of medication management safety in home care: vulnerabilities that impact the safe management and storage of medication, sustaining adequate supports, degrees of shared accountability for care, systems of variable effectiveness, poly-literacy required to navigate the system, and systemic challenges to maintaining medication safety in the home
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Medication Management, Use and Safety in Non- Communicable ...
African Journals Online (AJOL)
... combination of the efforts from government, health professionals and the individual patients. Adequate education of the patients and the public can lead to behavioral change and reduction in NCDs while at the same time improving medication use behaviours. Keywords: NCDs, Drug management, Drug safety, Drug Use, ...
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BioInnovate Ireland--fostering entrepreneurial activity through medical device innovation training.
Bruzzi, M S; Linehan, J H
2013-09-01
In the midst of a rich environment for medical device development and manufacturing, universities can play a critical role by developing relevant training programs to produce entrepreneurs who can be efficient and successful in creating early stage companies by understanding deeply the issues involved in creating a useful device, how to raise money, designing early clinical studies and locating manufacturing partners.
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Hacking medical devices a review - biomed 2013.
Frenger, Paul
2013-01-01
Programmable, implantable and external biomedical devices (such as pacemakers, defibrillators, insulin pumps, pain management pumps, vagus nerve stimulators and others) may be vulnerable to unauthorized access, commonly referred to as hacking. This intrusion may lead to compromise of confidential patient data or loss of control of the device itself, which may be deadly. Risks to health from unauthorized access is in addition to hazards from faulty (buggy) software or circuitry. Historically, this aspect of medical device design has been underemphasized by both manufacturers and regulatory bodies until recently. However, an insulin pump was employed as a murder weapon in 2001 and successful hacking of an implantable defibrillator was demonstrated in 2008. To remedy these problems, professional groups have announced a variety of design standards and the governmental agencies of several countries have enacted device regulations. In turn, manufacturers have developed new software products and hardware circuits to assist biomedical engineering firms to improve their commercial offerings. In this paper the author discusses these issues, reviewing known problems and zero-day threats, with potential solutions. He outlines his approach to secure software and hardware challenges using the Forth language. A plausible scenario is described in which hacking of an implantable defibrillator by terrorists results in a severe national security threat to the United States.
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Kim, Do-Hyun; Kim, Moon S.; Hwang, Jeeseong
2012-03-01
Contamination of the inner surface of indwelling (implanted) medical devices by microbial biofilm is a serious problem. Some microbial bacteria such as Escherichia coli form biofilms that lead to potentially lifethreatening infections. Other types of medical devices such as bronchoscopes and duodenoscopes account for the highest number of reported endoscopic infections where microbial biofilm is one of the major causes for these infections. We applied a hyperspectral imaging method to detect biofilm contamination on the surface of several common materials used for medical devices. Such materials include stainless steel, titanium, and stainless-steeltitanium alloy. Potential uses of hyperspectral imaging technique to monitor biofilm attachment to different material surfaces are discussed.
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Directory of Open Access Journals (Sweden)
Jong-Seok Oh
2017-10-01
Full Text Available Recently, smart fluids have drawn significant attention and growing a great interest in a broad range of engineering applications such as automotive and medical areas. In this article, two smart fluids called electro-rheological (ER fluid and magneto-rheological (MR fluid are reviewed in terms of medical applications. Especially, this article describes the attributes and inherent properties of individual medical and rehabilitation devices. The devices surveyed in this article include multi-degree-of-freedom haptic masters for robot surgery, thin membrane touch panels for braille readers, sponge-like tactile sensors to feel human tissues such as liver, rehabilitation systems such as prosthetic leg, and haptic interfaces for dental implant surgery. The operating principle, inherent characteristics and practical feasibility of each medical device or system are fully discussed in details.
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Practical design control implementation for medical devices
Justiniano, Jose
2003-01-01
Bringing together the concepts of design control and reliability engineering, this book is a must for medical device manufacturers. It helps them meet the challenge of designing and developing products that meet or exceed customer expectations and also meet regulatory requirements. Part One covers motivation for design control and validation, design control requirements, process validation and design transfer, quality system for design control, and measuring design control program effectiveness. Part Two discusses risk analysis and FMEA, designing-in reliability, reliability and design verific
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Remote Access: A Vision for Mobile Medical Devices
Directory of Open Access Journals (Sweden)
Herbert Ernst
2005-11-01
Full Text Available During the Symposium for Remote Engineering and Virtual Instrumentation held at Brasov in early July 2005 an outlook was presented regarding the future potential of remote engineering for mobile medical devices. It is the intention of this article to recapitulate the content of the initiated discussions and to stimulate work in this complex and until now largely neglected field of application.
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Lingg, Myriam; Wyss, Kaspar; Durán-Arenas, Luis
2016-07-08
In organisational theory there is an assumption that knowledge is used effectively in healthcare systems that perform well. Actors in healthcare systems focus on managing knowledge of clinical processes like, for example, clinical decision-making to improve patient care. We know little about connecting that knowledge to administrative processes like high-risk medical device procurement. We analysed knowledge-related factors that influence procurement and clinical procedures for orthopaedic medical devices in Mexico. We based our qualitative study on 48 semi-structured interviews with various stakeholders in Mexico: orthopaedic specialists, government officials, and social security system managers or administrators. We took a knowledge-management related perspective (i) to analyse factors of managing knowledge of clinical procedures, (ii) to assess the role of this knowledge and in relation to procurement of orthopaedic medical devices, and (iii) to determine how to improve the situation. The results of this study are primarily relevant for Mexico but may also give impulsion to other health systems with highly standardized procurement practices. We found that knowledge of clinical procedures in orthopaedics is generated inconsistently and not always efficiently managed. Its support for procuring orthopaedic medical devices is insufficient. Identified deficiencies: leaders who lack guidance and direction and thus use knowledge poorly; failure to share knowledge; insufficiently defined formal structures and processes for collecting information and making it available to actors of health system; lack of strategies to benefit from synergies created by information and knowledge exchange. Many factors are related directly or indirectly to technological aspects, which are insufficiently developed. The content of this manuscript is novel as it analyses knowledge-related factors that influence procurement of orthopaedic medical devices in Mexico. Based on our results we
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21 CFR 801.125 - Medical devices for use in teaching, law enforcement, research, and analysis.
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices for use in teaching, law enforcement, research, and analysis. 801.125 Section 801.125 Food and Drugs FOOD AND DRUG ADMINISTRATION... Directions for Use § 801.125 Medical devices for use in teaching, law enforcement, research, and analysis. A...
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[Radiotherapy and implantable medical device: example of infusion pumps].
Abrous-Anane, S; Benhassine, S; Lopez, S; Cristina, K; Mazeron, J-J
2013-12-01
Indication for radiotherapy is often questioned for patients equipped with implantable medical devices like infusion pumps as the radiation tolerance is poor or not known. We report here on the case of a patient who we treated with pelvic radiotherapy for cervical cancer and who had an infusion pump in iliac fossa. We conducted a series of tests on five identical pumps that insured that the treatment protocol is harmless to the implanted device. Copyright © 2013 Société française de radiothérapie oncologique (SFRO). Published by Elsevier SAS. All rights reserved.
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A prospective window into medical device-related pressure ulcers in intensive care.
Coyer, Fiona M; Stotts, Nancy A; Blackman, Virginia Schmied
2014-12-01
The aim of this study was to determine the prevalence, severity, location, aetiology, treatment and healing of medical device-related pressure ulcers (PUs) in intensive care patients for up to 7 days. A prospective repeated measures study design was used. Patients in six intensive care units of two major medical centres, one each in Australia and the USA, were screened 1 day per month for 6 months. Those with device-related ulcers were followed daily for up to 7 days. The outcome measures were device-related ulcer prevalence, pain, infection, treatment and healing. Fifteen of 483 patients had device-related ulcers and 9 of 15 with 11 ulcers were followed beyond screening. Their mean age was 60·5 years, and most were men, overweight and at increased risk of PU. Endotracheal (ET) and nasogastric (NG) tubes were the cause of most device-related ulcers. Repositioning was the most frequent treatment. Four of 11 ulcers healed within the 7-day observation period. In conclusion, device-related ulcer prevalence was 3·1%, similar to that reported in the limited literature available, indicating an ongoing problem. Systematic assessment and repositioning of devices are the mainstays of care. We recommend continued prevalence determination and that nurses remain vigilant to prevent device-related ulcers, especially in patients with NG and ET tubes. © 2013 The Authors. International Wound Journal © 2013 Medicalhelplines.com Inc and John Wiley & Sons Ltd.
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Hanus, Josef; Nosek, Tomas; Zahora, Jiri; Bezrouk, Ales; Masin, Vladimir
2013-01-01
We designed and evaluated an innovative computer-aided-learning environment based on the on-line integration of computer controlled medical diagnostic devices and a medical information system for use in the preclinical medical physics education of medical students. Our learning system simulates the actual clinical environment in a hospital or primary care unit. It uses a commercial medical information system for on-line storage and processing of clinical type data acquired during physics laboratory classes. Every student adopts two roles, the role of 'patient' and the role of 'physician'. As a 'physician' the student operates the medical devices to clinically assess 'patient' colleagues and records all results in an electronic 'patient' record. We also introduced an innovative approach to the use of supportive education materials, based on the methods of adaptive e-learning. A survey of student feedback is included and statistically evaluated. The results from the student feedback confirm the positive response of the latter to this novel implementation of medical physics and informatics in preclinical education. This approach not only significantly improves learning of medical physics and informatics skills but has the added advantage that it facilitates students' transition from preclinical to clinical subjects. Copyright © 2011 Associazione Italiana di Fisica Medica. Published by Elsevier Ltd. All rights reserved.
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Billaux, Mathilde; Borget, Isabelle; Prognon, Patrice; Pineau, Judith; Martelli, Nicolas
2016-06-01
Objectives Many university hospitals have developed local health technology assessment processes to guide informed decisions about new medical devices. However, little is known about stakeholders' perceptions and assessment of innovative devices. Herein, we investigated the perceptions regarding innovative medical devices of their chief users (physicians and surgeons), as well as those of hospital pharmacists, because they are responsible for the purchase and management of sterile medical devices. We noted the evaluation criteria used to assess and select new medical devices and suggestions for improving local health technology assessment processes indicated by the interviewees. Methods We randomly selected 18 physicians and surgeons (nine each) and 18 hospital pharmacists from 18 French university hospitals. Semistructured interviews were conducted between October 2012 and August 2013. Responses were coded separately by two researchers. Results Physicians and surgeons frequently described innovative medical devices as 'new', 'safe' and 'effective', whereas hospital pharmacists focused more on economic considerations and considered real innovative devices to be those for which no equivalent could be found on the market. No significant difference in evaluation criteria was found between these groups of professionals. Finally, hospital pharmacists considered the management of conflicts of interests in local health technology assessment processes to be an issue, whereas physicians and surgeons did not. Conclusions The present study highlights differences in perceptions related to professional affiliation. The findings suggest several ways in which current practices for local health technology assessment in French university hospitals could be improved and studied. What is known about the topic? Hospitals are faced with ever-growing demands for innovative and costly medical devices. To help hospital management deal with technology acquisition issues, hospital
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AMDIS Case Conference: Intrusive Medication Safety Alerts.
Graham, J; Levick, D; Schreiber, R
2010-01-01
Clinical decision support that provides enhanced patient safety at the point of care frequently encounters significant pushback from clinicians who find the process intrusive or time-consuming. We present a hypothetical medical center's dilemma about its allergy alerting system and discuss similar problems faced by real hospitals. We then share some lessons learned and best practices for institutions who wish to implement these tools themselves.
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AMDIS Case Conference: Intrusive Medication Safety Alerts
Graham, J.; Levick, D.; Schreiber, R.
2010-01-01
Clinical decision support that provides enhanced patient safety at the point of care frequently encounters significant pushback from clinicians who find the process intrusive or time-consuming. We present a hypothetical medical center’s dilemma about its allergy alerting system and discuss similar problems faced by real hospitals. We then share some lessons learned and best practices for institutions who wish to implement these tools themselves.
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Radiation Safety Awareness Among Medical Staff
International Nuclear Information System (INIS)
Szarmach, Arkadiusz; Piskunowicz, Maciej; Świętoń, Dominik; Muc, Adam; Mockałło, Gabor; Dzierżanowski, Jarosław; Szurowska, Edyta
2015-01-01
The common access to imaging methods based on ionizing radiation requires also radiation protection. The knowledge of ionizing radiation exposure risks among the medical staff is essential for planning diagnostic procedures and therapy. Evaluation of the knowledge of radiation safety during diagnostic procedures among the medical staff. The study consisted of a questionnaire survey. The questionnaire consisted of seven closed-ended questions concerning the knowledge of the effects of exposure to ionizing radiation as well as questions related to responder’s profession and work experience. The study group included a total of 150 individuals from four professional groups: nurses, doctors, medical technicians, support staff. The study was carried out in the three largest hospitals in Gdańsk between July and October 2013. The highest rates of correct answers to questions related to the issue of radiation protection were provided by the staff of radiology facilities and emergency departments with 1–5 years of professional experience. The most vulnerable group in terms of the knowledge of these issues consisted of individuals working at surgical wards with 11–15 years of professional experience. Education in the field of radiological protection should be a subject of periodic training of medical personnel regardless of position and length of service
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Radiological protection for medical exposure to ionizing radiation. Safety guide
International Nuclear Information System (INIS)
2002-01-01
radiotherapy owing to an ageing population. In addition, further growth in medical radiology can be expected in developing States, where at present facilities and services are often lacking. The risks associated with these expected increases in medical exposures should be outweighed by the benefits. For the purposes of radiation protection, ionizing radiation exposures are divided into three types: Medical exposure, which is mainly the exposure of patients as part of their diagnosis or treatment (see below); Occupational exposure, which is the exposure of workers incurred in the course of their work, with some specific exclusions; and Public exposure, which comprises all other exposures of members of the public that are susceptible to human control. Medical exposure is defined in the International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources (BSS, the Standards) as: 'Exposure incurred by patients as part of their own medical or dental diagnosis or treatment; by persons, other than those occupationally exposed, knowingly while voluntarily helping in the support and comfort of patients; and by volunteers in a programme of biomedical research involving their exposure.' This Safety Guide covers all of the medical exposures defined above, with emphasis on the radiological protection of patients, but does not cover exposures of workers or the public derived from the application of medical radiation sources. Guidance relating to these exposures can be found in the Safety Guide on Occupational Radiation Protection. In addition to the IAEA, several intergovernmental and international organizations, among them the European Commission, the International Commission on Radiological Protection (ICRP), the Pan American Health Organization (PAHO) and the World Health Organization (WHO), have already published numerous recommendations, guides and codes of practice relevant to this subject area. National authorities should therefore