WorldWideScience

Sample records for complex medical devices

  1. Challenges to validation of a complex nonsterile medical device tray.

    Science.gov (United States)

    Prince, Daniel; Mastej, Jozef; Hoverman, Isabel; Chatterjee, Raja; Easton, Diana; Behzad, Daniela

    2014-01-01

    Validation by steam sterilization of reusable medical devices requires careful attention to many parameters that directly influence whether or not complete sterilization occurs. Complex implant/instrument tray systems have a variety of configurations and components. Geobacillus stearothermophilus biological indicators (BIs) are used in overkill cycles to to simulate worst case conditions and are intended to provide substantial sterilization assurance. Survival of G. stearothermophilus spores was linked to steam access and size of load in the chamber. By a small and reproducible margin, it was determined that placement of the trays in a rigid container into minimally loaded chambers were more difficult to completely sterilize than maximally loaded chambers.

  2. Medical Devices

    NARCIS (Netherlands)

    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,

  3. 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

  4. Cybersecurity vulnerabilities in medical devices: a complex environment and multifaceted problem.

    Science.gov (United States)

    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.

  5. Cybersecurity vulnerabilities in medical devices: a complex environment and multifaceted problem

    Science.gov (United States)

    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

  6. Medical Device Safety

    Science.gov (United States)

    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 ...

  7. Implantable electronic medical devices

    CERN Document Server

    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

  8. Implantable Medical Devices

    Science.gov (United States)

    ... 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 ...

  9. Medical device development.

    Science.gov (United States)

    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.

  10. MDR (Medical Device Reporting)

    Data.gov (United States)

    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...

  11. A lossless multichannel bio-signal compression based on low-complexity joint coding scheme for portable medical devices.

    Science.gov (United States)

    Kim, Dong-Sun; Kwon, Jin-San

    2014-09-18

    Research on real-time health systems have received great attention during recent years and the needs of high-quality personal multichannel medical signal compression for personal medical product applications are increasing. The international MPEG-4 audio lossless coding (ALS) standard supports a joint channel-coding scheme for improving compression performance of multichannel signals and it is very efficient compression method for multi-channel biosignals. However, the computational complexity of such a multichannel coding scheme is significantly greater than that of other lossless audio encoders. In this paper, we present a multichannel hardware encoder based on a low-complexity joint-coding technique and shared multiplier scheme for portable devices. A joint-coding decision method and a reference channel selection scheme are modified for a low-complexity joint coder. The proposed joint coding decision method determines the optimized joint-coding operation based on the relationship between the cross correlation of residual signals and the compression ratio. The reference channel selection is designed to select a channel for the entropy coding of the joint coding. The hardware encoder operates at a 40 MHz clock frequency and supports two-channel parallel encoding for the multichannel monitoring system. Experimental results show that the compression ratio increases by 0.06%, whereas the computational complexity decreases by 20.72% compared to the MPEG-4 ALS reference software encoder. In addition, the compression ratio increases by about 11.92%, compared to the single channel based bio-signal lossless data compressor.

  12. A Medical Delivery Device

    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...

  13. [Medical Devices Law for pain therapists].

    Science.gov (United States)

    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.

  14. Preventing medical device recalls

    CERN Document Server

    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

  15. Case outsourcing medical device reprocessing.

    Science.gov (United States)

    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.

  16. Medical devices; immunology and microbiology devices; classification of nucleic acid-based devices for the detection of Mycobacterium tuberculosis complex and the genetic mutations associated with antibiotic resistance. Final order.

    Science.gov (United States)

    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.

  17. 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

  18. Surgical tools and medical devices

    CERN Document Server

    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...

  19. Mobile medical device connectivity: real world solutions.

    Science.gov (United States)

    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

  20. Body Implanted Medical Device Communications

    Science.gov (United States)

    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.

  1. Medical device market in China.

    Science.gov (United States)

    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.

  2. Medical devices and human engineering

    CERN Document Server

    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

  3. 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

  4. Assurance Cases for Medical Devices

    Science.gov (United States)

    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

  5. MEDIC: medical embedded device for individualized care.

    Science.gov (United States)

    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.

  6. [Consideration of Mobile Medical Device Regulation].

    Science.gov (United States)

    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.

  7. Medical devices regulations, standards and practices

    CERN Document Server

    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

  8. 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...

  9. Metrological Reliability of Medical Devices

    Science.gov (United States)

    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.

  10. Medical device software: defining key terms.

    Science.gov (United States)

    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.

  11. 21 CFR 892.2040 - Medical image hardcopy device.

    Science.gov (United States)

    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...

  12. 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.

  13. 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...

  14. Class 1 devices case studies in medical devices design

    CERN Document Server

    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...

  15. Anti-malware software and medical devices.

    Science.gov (United States)

    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.

  16. 77 FR 72924 - Taxable Medical Devices

    Science.gov (United States)

    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...

  17. 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.

  18. Contextual inquiry for medical device design

    CERN Document Server

    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

  19. Home Healthcare Medical Devices: A Checklist

    Science.gov (United States)

    ... 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 ...

  20. BIOANALYTICAL STANDARDIZING FOR SEROLOGICAL DIAGNOSTIC MEDICAL DEVICES

    OpenAIRE

    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...

  1. 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

  2. Use of mobile devices for medical imaging.

    Science.gov (United States)

    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.

  3. Medical simulator with injection device

    NARCIS (Netherlands)

    2011-01-01

    medical simulator 611 comprises a vessel 609 representing a simulated blood vessel. The vessel comprises a simulated vessel wall capable of being punctured by an electrically conductive injection needle 503. The vessel wall comprises a first electrically conductive layer for closing an electric

  4. Handheld Diagnostic Device Delivers Quick Medical Readings

    Science.gov (United States)

    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.

  5. 78 FR 18233 - Medical Devices; Technical Amendment

    Science.gov (United States)

    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...

  6. Medical ice slurry production device

    Science.gov (United States)

    Kasza, Kenneth E [Palos Park, IL; Oras, John [Des Plaines, IL; Son, HyunJin [Naperville, IL

    2008-06-24

    The present invention relates to an apparatus for producing sterile ice slurries for medical cooling applications. The apparatus is capable of producing highly loaded slurries suitable for delivery to targeted internal organs of a patient, such as the brain, heart, lungs, stomach, kidneys, pancreas, and others, through medical size diameter tubing. The ice slurry production apparatus includes a slurry production reservoir adapted to contain a volume of a saline solution. A flexible membrane crystallization surface is provided within the slurry production reservoir. The crystallization surface is chilled to a temperature below a freezing point of the saline solution within the reservoir such that ice particles form on the crystallization surface. A deflector in the form of a reciprocating member is provided for periodically distorting the crystallization surface and dislodging the ice particles which form on the crystallization surface. Using reservoir mixing the slurry is conditioned for easy pumping directly out of the production reservoir via medical tubing or delivery through other means such as squeeze bottles, squeeze bags, hypodermic syringes, manual hand delivery, and the like.

  7. 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.

  8. Medical instruments and devices principles and practices

    CERN Document Server

    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...

  9. 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

  10. Regulatory affairs for biomaterials and medical devices

    CERN Document Server

    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

  11. Design considerations for medical devices in the home environment.

    Science.gov (United States)

    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.

  12. Low power signal processing electronics for wearable medical devices.

    Science.gov (United States)

    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.

  13. Modelling degradation of bioresorbable polymeric medical devices

    CERN Document Server

    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.

  14. Medical applications for pharmacists using mobile devices.

    Science.gov (United States)

    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.

  15. 77 FR 6028 - Taxable Medical Devices

    Science.gov (United States)

    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...

  16. Electronic medical devices: a primer for pathologists.

    Science.gov (United States)

    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.

  17. 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

  18. Value-based purchasing of medical devices.

    Science.gov (United States)

    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.

  19. [Design and application of implantable medical device information management system].

    Science.gov (United States)

    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.

  20. 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.

  1. 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.

  2. Open-source hardware for medical devices.

    Science.gov (United States)

    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.

  3. 78 FR 68853 - International Medical Device Regulators Forum; Medical Device Single Audit Program International...

    Science.gov (United States)

    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...

  4. Implantable Medical Devices; Networking Security Survey

    OpenAIRE

    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...

  5. 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

  6. Stretchable bioelectronics for medical devices and systems

    CERN Document Server

    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.

  7. 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.)

  8. 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.

  9. Lithography requirements in complex VLSI device fabrication

    International Nuclear Information System (INIS)

    Wilson, A.D.

    1985-01-01

    Fabrication of complex very large scale integration (VLSI) circuits requires continual advances in lithography to satisfy: decreasing minimum linewidths, larger chip sizes, tighter linewidth and overlay control, increasing topography to linewidth ratios, higher yield demands, increased throughput, harsher device processing, lower lithography cost, and a larger part number set with quick turn-around time. Where optical, electron beam, x-ray, and ion beam lithography can be applied to judiciously satisfy the complex VLSI circuit fabrication requirements is discussed and those areas that are in need of major further advances are addressed. Emphasis will be placed on advanced electron beam and storage ring x-ray lithography

  10. Complex cellular logic computation using ribocomputing devices.

    Science.gov (United States)

    Green, Alexander A; Kim, Jongmin; Ma, Duo; Silver, Pamela A; Collins, James J; Yin, Peng

    2017-08-03

    Synthetic biology aims to develop engineering-driven approaches to the programming of cellular functions that could yield transformative technologies. Synthetic gene circuits that combine DNA, protein, and RNA components have demonstrated a range of functions such as bistability, oscillation, feedback, and logic capabilities. However, it remains challenging to scale up these circuits owing to the limited number of designable, orthogonal, high-performance parts, the empirical and often tedious composition rules, and the requirements for substantial resources for encoding and operation. Here, we report a strategy for constructing RNA-only nanodevices to evaluate complex logic in living cells. Our 'ribocomputing' systems are composed of de-novo-designed parts and operate through predictable and designable base-pairing rules, allowing the effective in silico design of computing devices with prescribed configurations and functions in complex cellular environments. These devices operate at the post-transcriptional level and use an extended RNA transcript to co-localize all circuit sensing, computation, signal transduction, and output elements in the same self-assembled molecular complex, which reduces diffusion-mediated signal losses, lowers metabolic cost, and improves circuit reliability. We demonstrate that ribocomputing devices in Escherichia coli can evaluate two-input logic with a dynamic range up to 900-fold and scale them to four-input AND, six-input OR, and a complex 12-input expression (A1 AND A2 AND NOT A1*) OR (B1 AND B2 AND NOT B2*) OR (C1 AND C2) OR (D1 AND D2) OR (E1 AND E2). Successful operation of ribocomputing devices based on programmable RNA interactions suggests that systems employing the same design principles could be implemented in other host organisms or in extracellular settings.

  11. Lessons learned: mobile device encryption in the academic medical center.

    Science.gov (United States)

    Kusche, Kristopher P

    2009-01-01

    The academic medical center is faced with the unique challenge of meeting the multi-faceted needs of both a modern healthcare organization and an academic institution, The need for security to protect patient information must be balanced by the academic freedoms expected in the college setting. The Albany Medical Center, consisting of the Albany Medical College and the Albany Medical Center Hospital, was challenged with implementing a solution that would preserve the availability, integrity and confidentiality of business, patient and research data stored on mobile devices. To solve this problem, Albany Medical Center implemented a mobile encryption suite across the enterprise. Such an implementation comes with complexities, from performance across multiple generations of computers and operating systems, to diversity of application use mode and end user adoption, all of which requires thoughtful policy and standards creation, understanding of regulations, and a willingness and ability to work through such diverse needs.

  12. 78 FR 21129 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    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...

  13. Hacking medical devices a review - biomed 2013.

    Science.gov (United States)

    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.

  14. 76 FR 7220 - Medical Device Innovation Initiative; Request for Comments

    Science.gov (United States)

    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...

  15. Medical applications of superconducting quantum interference devices

    International Nuclear Information System (INIS)

    Uehara, Gen

    2011-01-01

    SQUIDs (Superconducting Quantum Interference Devices) are applied to clinical areas and basic medical science fields because of their potential for measuring a minute magnetic signal from the human body. Magnetoencephalography, one of their applications, is used for the functional mapping of the brain cortex before surgery and the localization of focus of epilepsy. Recently, their applications to the early-stage detection of dementia and the localization of brain ischemia are suggested. Another application of SQUIDs is magnetospinography, which detects the conduction block in spinal cord signal propagation. (author)

  16. Design controls for the medical device industry

    CERN Document Server

    Teixeira, Marie B

    2013-01-01

    The second edition of a bestseller, Design Controls for the Medical Device Industry provides a comprehensive review of the latest design control requirements, as well as proven tools and techniques to ensure your company's design control program evolves in accordance with current industry practice. The text assists in the development of an effective design control program that not only satisfies the US FDA Quality System Regulation (QSR) and ISO 9001 and 13485 standards, but also meets today's third-party auditor/investigator expectations and saves you valuable time and money.The author's cont

  17. Practical design control implementation for medical devices

    CERN Document Server

    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

  18. Analytical Chemistry in the Regulatory Science of Medical Devices.

    Science.gov (United States)

    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.

  19. 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.

  20. 77 FR 18829 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    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...

  1. 76 FR 71983 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    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...

  2. 75 FR 57968 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    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...

  3. 78 FR 26786 - Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    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...

  4. 76 FR 48871 - Immunology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    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...

  5. 76 FR 55398 - Immunology Devices Panel of the Medical Devices Advisory Committee: Notice of Postponement of...

    Science.gov (United States)

    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...

  6. Security and privacy for implantable medical devices

    CERN Document Server

    Carrara, Sandro

    2014-01-01

     This book presents a systematic approach to analyzing the challenging engineering problems posed by the need for security and privacy in implantable medical devices (IMD).  It describes in detail new issues termed as lightweight security, due to the associated constraints on metrics such as available power, energy, computing ability, area, execution time, and memory requirements. Coverage includes vulnerabilities and defense across multiple levels, with basic abstractions of cryptographic services and primitives such as public key cryptography, block ciphers and digital signatures. Experts from engineering introduce to some IMD systems that have  recently been proposed and developed. Experts from Computer Security and Cryptography present new research, which shows vulnerabilities in existing IMDs and proposes solutions. Experts from Privacy Technology and Policy will discuss the societal, legal and ethical challenges surrounding IMD security as well as technological solutions that build on the latest in C...

  7. 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....

  8. Value-based procurement of medical devices: Application to devices for mechanical thrombectomy in ischemic stroke.

    Science.gov (United States)

    Trippoli, Sabrina; Caccese, Erminia; Marinai, Claudio; Messori, Andrea

    2018-03-01

    In the acute ischemic stroke, endovascular devices have shown promising clinical results and are also likely to represent value for money, as several modeling studies have shown. Pharmacoeconomic evaluations in this field, however, have little impact on the procurement of these devices. The present study explored how complex pharmacoeconomic models that evaluate effectiveness and cost can be incorporated into the in-hospital procurement of thrombectomy devices. As regards clinical modeling, we extracted outcomes at three months from randomized trials conducted for four thrombectomy devices, and we projected long-term results using standard Markov modeling. In estimating QALYs, the same model was run for the four devices. As regards economic modeling, we firstly estimated for each device the net monetary benefit (NMB) per patient (threshold = $60,000 per QALY); then, we simulated a competitive tender across the four products by determining the tender-based score (on a 0-to-100 scale). Prices of individual devices were obtained from manufacturers. Extensive sensitivity testing was applied to our analyses. For the four devices (Solitaire, Trevo, Penumbra, Solumbra), QALYs were 1.86, 1.52, 1,79, 1.35, NMB was $101,824, $83,546, $101,923, $69,440, and tender-based scores were 99.70, 43.43, 100, 0, respectively. Sensitivity analysis confirmed findings from base-case. Our results indicate that, in the field of thrombectomy devices, incorporating the typical tools of cost-effectiveness into the processes of tenders and procurement is feasible. Bridging the methodology of cost-effectiveness with the every-day practice of in-hospital procurement can contribute to maximizing the health returns that are generated by in-hospital expenditures for medical devices. Copyright © 2018 Elsevier B.V. All rights reserved.

  9. 78 FR 68714 - Medical Devices; Ophthalmic Devices; Classification of the Scleral Plug

    Science.gov (United States)

    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...

  10. Medical device integration: CIOs must bridge the digital divide between devices and electronic medical records.

    Science.gov (United States)

    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.

  11. Improvised explosive devices: pathophysiology, injury profiles and current medical management.

    Science.gov (United States)

    Ramasamy, A; Hill, A M; Clasper, J C

    2009-12-01

    The improvised explosive device (IED), in all its forms, has become the most significant threat to troops operating in Afghanistan and Iraq. These devices range from rudimentary home made explosives to sophisticated weapon systems containing high-grade explosives. Within this broad definition they may be classified as roadside explosives and blast mines, explosive formed pojectile (EFP) devices and suicide bombings. Each of these groups causeinjury through a number of different mechanisms and can result in vastly different injury profiles. The "Global War on Terror" has meant that incidents which were previously exclusively seen in conflict areas, can occur anywhere, and clinicians who are involved in emergency trauma care may be required to manage casualties from similar terrorist attacks. An understanding of the types of devices and their pathophysiological effects is necessary to allow proper planning of mass casualty events and to allow appropriate management of the complex poly-trauma casualties they invariably cause. The aim of this review article is to firstly describe the physics and injury profile from these different devices and secondly to present the current clinical evidence that underpins their medical management.

  12. Legislative aspects of the development of medical devices.

    Science.gov (United States)

    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.

  13. 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)

  14. An update on mobile phones interference with medical devices.

    Science.gov (United States)

    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.

  15. A microfluidic dialysis device for complex biological mixture SERS analysis

    KAUST Repository

    Perozziello, Gerardo; Candeloro, Patrizio; Gentile, Francesco T.; Coluccio, Maria Laura; Tallerico, Marco; De Grazia, Antonio; Nicastri, Annalisa; Perri, Angela Mena; Parrotta, Elvira; Pardeo, Francesca; Catalano, Rossella; Cuda, Giovanni; Di Fabrizio, Enzo M.

    2015-01-01

    In this paper, we present a microfluidic device fabricated with a simple and inexpensive process allowing rapid filtering of peptides from a complex mixture. The polymer microfluidic device can be used for sample preparation in biological

  16. 78 FR 15878 - Taxable Medical Devices; Correction

    Science.gov (United States)

    2013-03-13

    ...--MANUFATURERS AND RETAILERS EXCISE TAXES 0 Paragraph 1. The authority citation for part 48 continues to read in... device. * * * * * (b) * * * (2) * * * A device will be considered to be of a type that is generally..., the mobile x-ray systems are not devices that are of a type that are generally purchased by the...

  17. 77 FR 69488 - Medical Devices; Custom Devices; Request for Comments

    Science.gov (United States)

    2012-11-19

    ... strategy and policy for the custom device exemption criteria in the FD&C Act amended by FDASIA. FDA is... States in finished form through labeling or advertising by the manufacturer, importer, or distributor for...

  18. Cybersecurity and the Medical Device Product Development Lifecycle.

    Science.gov (United States)

    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.

  19. 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...

  20. ISO 13485 a complete guide to quality management in the medical device industry

    CERN Document Server

    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

  1. Towards sustainable design for single-use medical devices.

    Science.gov (United States)

    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.

  2. Model-based engineering for medical-device software.

    Science.gov (United States)

    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.

  3. Cybersecurity and medical devices: A practical guide for cardiac electrophysiologists

    Science.gov (United States)

    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

  4. Medical Device Integration Model Based on the Internet of Things

    Science.gov (United States)

    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

  5. 78 FR 12329 - Distinguishing Medical Device Recalls From Product Enhancements; Reporting Requirements; Draft...

    Science.gov (United States)

    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...

  6. Product-based Safety Certification for Medical Devices Embedded Software.

    Science.gov (United States)

    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).

  7. Practice of Regulatory Science (Development of Medical Devices).

    Science.gov (United States)

    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.

  8. 75 FR 68200 - Medical Devices; Radiology Devices; Reclassification of Full-Field Digital Mammography System

    Science.gov (United States)

    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...

  9. 77 FR 14272 - Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus Serological...

    Science.gov (United States)

    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...

  10. Medical Devices Assess, Treat Balance Disorders

    Science.gov (United States)

    2009-01-01

    You may have heard the phrase as difficult as walking and chewing gum as a joking way of referring to something that is not difficult at all. Just walking, however, is not all that simple physiologically speaking. Even standing upright is an undertaking requiring the complex cooperation of multiple motor and sensory systems including vision, the inner ear, somatosensation (sensation from the skin), and proprioception (the sense of the body s parts in relation to each other). The compromised performance of any of these elements can lead to a balance disorder, which in some form affects nearly half of Americans at least once in their lifetimes, from the elderly, to those with neurological or vestibular (inner ear) dysfunction, to athletes with musculoskeletal injuries, to astronauts returning from space. Readjusting to Earth s gravity has a significant impact on an astronaut s ability to balance, a result of the brain switching to a different "model" for interpreting sensory input in normal gravity versus weightlessness. While acclimating, astronauts can experience headaches, motion sickness, and problems with perception. To help ease the transition and study the effects of weightlessness on the body, NASA has conducted many investigations into post-flight balance control, realizing this research can help treat patients with balance disorders on Earth as well. In the 1960s, the NASA-sponsored Man Vehicle Laboratory at the Massachusetts Institute of Technology (MIT) studied the effects of prolonged space flight on astronauts. The lab s work intrigued MIT doctoral candidate Lewis Nashner, who began conducting NASA-funded research on human movement and balance under the supervision of Dr. Larry Young in the MIT Department of Aeronautics and Astronautics. In 1982, Nashner s work resulted in a noninvasive clinical technique for assessing the cooperative systems that allow the body to balance, commonly referred to as computerized dynamic posturography (CDP). CDP employs a

  11. A concept ideation framework for medical device design.

    Science.gov (United States)

    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.

  12. Making Medical Devices Safer at Home

    Science.gov (United States)

    ... things found in a home environment, such as pet hair, well water or temperature variations. Other challenges include the user's and the caregiver's physical and emotional health. People taking medications that affect their alertness or ...

  13. #DDOD Use Case: Consolidated reporting of medical device recalls

    Data.gov (United States)

    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...

  14. [Ethic review on clinical experiments of medical devices in medical institutions].

    Science.gov (United States)

    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.

  15. 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.

  16. 21 CFR 892.2010 - Medical image storage device.

    Science.gov (United States)

    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...

  17. Sterilization and reprocessing of materials and medical devices--reusability.

    Science.gov (United States)

    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.

  18. OR.NET: a service-oriented architecture for safe and dynamic medical device interoperability.

    Science.gov (United States)

    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.

  19. Medical device integration using mobile telecommunications infrastructure.

    Science.gov (United States)

    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.

  20. New IEEE 11073 Standards for interoperable, networked Point-of-Care Medical Devices.

    Science.gov (United States)

    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.

  1. Medical device problem reporting for the betterment of healthcare.

    Science.gov (United States)

    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.

  2. 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.

  3. Implantable photonic devices for improved medical treatments

    Science.gov (United States)

    Sheinman, Victor; Rudnitsky, Arkady; Toichuev, Rakhmanbek; Eshiev, Abdyrakhman; Abdullaeva, Svetlana; Egemkulov, Talantbek; Zalevsky, Zeev

    2014-10-01

    An evolving area of biomedical research is related to the creation of implantable units that provide various possibilities for imaging, measurement, and the monitoring of a wide range of diseases and intrabody phototherapy. The units can be autonomic or built-in in some kind of clinically applicable implants. Because of specific working conditions in the live body, such implants must have a number of features requiring further development. This topic can cause wide interest among developers of optical, mechanical, and electronic solutions in biomedicine. We introduce preliminary clinical trials obtained with an implantable pill and devices that we have developed. The pill and devices are capable of applying in-body phototherapy, low-level laser therapy, blue light (450 nm) for sterilization, and controlled injection of chemicals. The pill is also capable of communicating with an external control box, including the transmission of images from inside the patient's body. In this work, our pill was utilized for illumination of the sinus-carotid zone in dog and red light influence on arterial pressure and heart rate was demonstrated. Intrabody liver tissue laser ablation and nanoparticle-assisted laser ablation was investigated. Sterilization effect of intrabody blue light illumination was applied during a maxillofacial phlegmon treatment.

  4. The medical physics of ventricular assist devices

    International Nuclear Information System (INIS)

    Wood, Houston G; Throckmorton, Amy L; Untaroiu, Alexandrina; Song Xinwei

    2005-01-01

    Millions of patients, from infants to adults, are diagnosed with congestive heart failure each year all over the world. A limited number of donor hearts available for these patients results in a tremendous demand for alternative, supplemental circulatory support in the form of artificial heart pumps or ventricular assist devices (VADs). The development procedure for such a device requires careful consideration of biophysical factors, such as biocompatibility, haemolysis, thrombosis, implantability, physiologic control feasibility and pump performance. Conventional pump design equations based on Newton's law and computational fluid dynamics (CFD) are readily used for the initial design of VADs. In particular, CFD can be employed to predict the pressure-flow performance, hydraulic efficiencies, flow profile through the pump, stress levels and biophysical factors, such as possible blood cell damage. These computational flow simulations may involve comprehensive steady and transient flow analyses. The transient simulations involve time-varying boundary conditions and virtual modelling of the impeller rotation in the blood pumps. After prototype manufacture, laser flow measurements with sophisticated optics and mock circulatory flow loop testing assist with validation of pump design and identification of irregular flow patterns for optimization. Additionally, acute and chronic animal implants illustrate the blood pump's ability to support life physiologically. These extensive design techniques, coupled with fundamental principles of physics, ensure a reliable and effective VAD for thousands of heart failure patients each year

  5. The new medical-industrial complex.

    Science.gov (United States)

    Relman, A S

    1980-10-23

    The most important health-care development of the day is the recent, relatively unheralded rise of a huge new industry that supplies health-care services for profit. Proprietary hospitals and nursing homes, diagnostic laboratories, home-care and emergency-room services, hemodialysis, and a wide variety of other services produced a gross income to this industry last year of about $35 billion to +40 billion. This new "medical-industrial complex" may be more efficient than its nonprofit competition, but it creates the problems of overuse and fragmentation of services, overemphasis on technology, and "cream-skimming," and it may also exercise undue influence on national health policy. In this medical market, physicians must act as discerning purchasing agents for their patients and therefore should have no conflicting financial interests. Closer attention from the public and the profession, and careful study, are necessary to ensure that the "medical-industrial complex" puts the interest of the public before those of its stockholders.

  6. 75 FR 61507 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...

    Science.gov (United States)

    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...

  7. Medical device development: managing conflicts of interest encountered by physicians.

    Science.gov (United States)

    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

  8. Security Belt for Wireless Implantable Medical Devices.

    Science.gov (United States)

    Kulaç, Selman

    2017-09-19

    In this study, a new protective design compatible with existing non-secure systems was proposed, since it is focused on the secure communication of wireless IMD systems in all transmissions. This new protector is an external wearable device and appears to be a belt fitted around for the patients IMD implanted. However, in order to provide effective full duplex transmissions and physical layer security, some sophisticated transceiver antennas have been placed on the belt. In this approach, beam-focused multi-antennas in optimal positions on the belt are randomly switched when transmissions to the IMD are performed and multi-jammer switching with MRC combining or majority-rule based receiving techniques are applied when transmissions from the IMD are carried out. This approach can also reduce the power consumption of the IMDs and contribute to the prolongation of the IMD's battery life.

  9. Medical device for applying therapeutic radiation

    International Nuclear Information System (INIS)

    Tokita, K.M.; Haller, B.L.

    1986-01-01

    A device is described for applying therapeutic radiation from a preselected radiation source to a predetermined portion of a body comprising, in combination: a body member having: an external peripheral surface; a first end surface; and a second end surface spaced from the first end surface; the body member further comprising: at least first internal walls defining a first radiation source receiving channel means spaced a preselected distance from the peripheral surface, and having: a first portion extending from the second end surface to regions adjacent the first end surface; and a second portion extending from the first portion at the first end surface to the second end surface; and, the channel means communicating with regions external the body member at the second surface whereby the radiation source of a preselected intensity inserted at least along a preselected portion of the channel means is applied to the predetermined area of the body requiring therapeutic radiation treatment

  10. 76 FR 14414 - Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    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...

  11. 76 FR 22322 - Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass...

    Science.gov (United States)

    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...

  12. 77 FR 19534 - Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus Serological...

    Science.gov (United States)

    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...

  13. 76 FR 16292 - Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass...

    Science.gov (United States)

    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...

  14. 75 FR 70112 - Medical Devices; General and Plastic Surgery Devices; Classification of Non-Powered Suction...

    Science.gov (United States)

    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

  15. 75 FR 68972 - Medical Devices; General and Plastic Surgery Devices; Classification of Tissue Adhesive With...

    Science.gov (United States)

    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...

  16. Counterfeit drugs and medical devices in developing countries

    Directory of Open Access Journals (Sweden)

    Glass BD

    2014-03-01

    Full Text Available Beverley D GlassSchool of Pharmacy and Molecular Sciences, James Cook University, Townsville, QLD, AustraliaAbstract: The World Health Organization has reported that counterfeit medicines potentially make up more than 50% of the global drug market, with a significant proportion of these fake products being encountered in developing countries. This occurrence is attributed to a lack of effective regulation and a weak enforcement capacity existing in these countries, with an increase in this trade resulting from the growing size and sophistication of drug counterfeiters. In addition, due to both cost and lack of availability of medicines, consumers in developing countries are more likely to seek out these inexpensive options. The World Health Organization is mindful of the impact of counterfeit drugs on consumer confidence in health care systems, health professionals, the supply chain, and genuine suppliers of medicines and medical devices. Antibiotics, antituberculosis drugs, and antimalarial and antiretroviral drugs are frequently targeted, with reports of 60% of the anti-infective drugs in Asia and Africa containing active pharmaceutical ingredients outside their pharmacopoeial limits. This has obvious public health implications of increasing drug resistance and negating all the efforts that have already gone into the provision of medicines to treat these life threatening conditions in the developing world. This review, while focusing on counterfeit medicines and medical devices in developing countries, will present information on their impact and how these issues can be addressed by regulation and control of the supply chain using technology appropriate to the developing world. The complexity of the problem will also be highlighted in terms of the definition of counterfeit and substandard medicines, including gray pharmaceuticals. Although this issue presents as a global public health problem, outcomes in developing countries where counterfeit

  17. Transmitting patient and device data via GSM--central management for decentral mobile medical devices.

    Science.gov (United States)

    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.

  18. Stakeholder challenges in purchasing medical devices for patient safety.

    Science.gov (United States)

    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.

  19. Developing medical device software in compliance with regulations.

    Science.gov (United States)

    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.

  20. Pricing and reimbursement of drugs and medical devices in Hungary.

    Science.gov (United States)

    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.

  1. Current status of the regulation for medical devices

    OpenAIRE

    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 ...

  2. Care maps for children with medical complexity.

    Science.gov (United States)

    Adams, Sherri; Nicholas, David; Mahant, Sanjay; Weiser, Natalie; Kanani, Ronik; Boydell, Katherine; Cohen, Eyal

    2017-12-01

    Children with medical complexity require multiple providers and services to keep them well and at home. A care map is a patient/family-created diagram that pictorially maps out this complex web of services. This study explored what care maps mean for families and healthcare providers to inform potential for clinical use. Parents (n=15) created care maps (hand drawn n=10 and computer-generated n=5) and participated in semi-structured interviews about the process of developing care maps and their perceived impact. Healthcare providers (n=30) reviewed the parent-created care maps and participated in semi-structured interviews. Data were analysed for themes and emerging theory using a grounded theory analytical approach. Data analysis revealed 13 overarching themes that were further categorized into three domains: features (characteristics of care maps), functions (what care maps do), and emerging outcomes (benefits of care map use). These domains further informed a definition and a theoretical model of how care maps work. Our findings suggest that care maps may be a way of supporting patient- and family-centred care by graphically identifying and integrating experiences of the family as well as priorities for moving forward. Care maps were endorsed as a useful tool by families and providers. They help healthcare providers better understand parental priorities for care. Parents can create care maps to demonstrate the complex burden of care. They are a unique visual way to incorporate narrative medicine into practice. © 2017 Mac Keith Press.

  3. [Industry regulation and its relationship to the rapid marketing of medical devices].

    Science.gov (United States)

    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").

  4. 78 FR 16684 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    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...

  5. 77 FR 20642 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    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...

  6. 75 FR 47606 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    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...

  7. 76 FR 14415 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    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...

  8. 76 FR 62419 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    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...

  9. 75 FR 49940 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    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...

  10. 78 FR 30928 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    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...

  11. 76 FR 39882 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    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...

  12. 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

  13. 76 FR 71982 - Advancing Regulatory Science for Highly Multiplexed Microbiology/Medical Countermeasure Devices...

    Science.gov (United States)

    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...

  14. Optical tests for using smartphones inside medical devices

    Science.gov (United States)

    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.

  15. Medical devices of the head, neck, and spine.

    Science.gov (United States)

    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

  16. 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

  17. Regulatory Science in Practice (Pharmaceuticals and Medical Devices Agency).

    Science.gov (United States)

    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.

  18. Biomaterials and medical devices a perspective from an emerging country

    CERN Document Server

    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...

  19. Image Quality Characteristics of Handheld Display Devices for Medical Imaging

    Science.gov (United States)

    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

  20. Wearable Devices in Medical Internet of Things: Scientific Research and Commercially Available Devices.

    Science.gov (United States)

    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.

  1. Feasibility of energy harvesting techniques for wearable medical devices.

    Science.gov (United States)

    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.

  2. 31 CFR 594.515 - In-kind donations of medicine, medical devices, and medical services.

    Science.gov (United States)

    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...

  3. 31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.

    Science.gov (United States)

    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...

  4. 31 CFR 597.511 - In-kind donations of medicine, medical devices, and medical services.

    Science.gov (United States)

    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...

  5. Solid state photosensitive devices which employ isolated photosynthetic complexes

    Science.gov (United States)

    Peumans, Peter; Forrest, Stephen R.

    2009-09-22

    Solid state photosensitive devices including photovoltaic devices are provided which comprise a first electrode and a second electrode in superposed relation; and at least one isolated Light Harvesting Complex (LHC) between the electrodes. Preferred photosensitive devices comprise an electron transport layer formed of a first photoconductive organic semiconductor material, adjacent to the LHC, disposed between the first electrode and the LHC; and a hole transport layer formed of a second photoconductive organic semiconductor material, adjacent to the LHC, disposed between the second electrode and the LHC. Solid state photosensitive devices of the present invention may comprise at least one additional layer of photoconductive organic semiconductor material disposed between the first electrode and the electron transport layer; and at least one additional layer of photoconductive organic semiconductor material, disposed between the second electrode and the hole transport layer. Methods of generating photocurrent are provided which comprise exposing a photovoltaic device of the present invention to light. Electronic devices are provided which comprise a solid state photosensitive device of the present invention.

  6. 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

  7. A model of user engagement in medical device development.

    Science.gov (United States)

    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.

  8. [Radiotherapy and implantable medical device: example of infusion pumps].

    Science.gov (United States)

    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.

  9. Management information system of medical equipment using mobile devices

    Science.gov (United States)

    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.

  10. Additive Manufacturing for Robust and Affordable Medical Devices

    OpenAIRE

    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...

  11. A microfluidic dialysis device for complex biological mixture SERS analysis

    KAUST Repository

    Perozziello, Gerardo

    2015-08-01

    In this paper, we present a microfluidic device fabricated with a simple and inexpensive process allowing rapid filtering of peptides from a complex mixture. The polymer microfluidic device can be used for sample preparation in biological applications. The device is fabricated by micromilling and solvent assisted bonding, in which a microdialysis membrane (cut-off of 12-14 kDa) is sandwiched in between an upper and a bottom microfluidic chamber. An external frame connects the microfluidic device to external tubes, microvalves and syringe pumps. Bonding strength and interface sealing are pneumatically tested. Microfluidic protocols are also described by using the presented device to filter a sample composed of specific peptides (MW 1553.73 Da, at a concentration of 1.0 ng/μl) derived from the BRCA1 protein, a tumor-suppressor molecule which plays a pivotal role in the development of breast cancer, and albumin (MW 66.5 kDa, at a concentration of 35 μg/μl), the most represented protein in human plasma. The filtered samples coming out from the microfluidic device were subsequently deposited on a SERS (surface enhanced Raman scattering) substrate for further analysis by Raman spectroscopy. By using this approach, we were able to sort the small peptides from the bigger and highly concentrated protein albumin and to detect them by using a label-free technique at a resolution down to 1.0 ng/μl.

  12. 76 FR 65200 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee: Notice of...

    Science.gov (United States)

    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...

  13. Wireless energy transfer platform for medical sensors and implantable devices.

    Science.gov (United States)

    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.

  14. Towards automated assistance for operating home medical devices.

    Science.gov (United States)

    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%.

  15. 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.

  16. Innovating transformative medical devices and growing the local medical device manufacturing sector

    CSIR Research Space (South Africa)

    Bunn, Tony

    2017-01-01

    Full Text Available . The 4IR is marked by emerging technology breakthroughs in a number of fields, including robotics, genomics, biosensors and wearables, AI, the internet of things, quantum computing, big data predictive analytics, 3D printing/additive manufacturing... of personalized prosthetics and products • Personalized devices and technologies for precision medicine Secure Airway Clamp for safer Anaesthesia MANDIBULAR IMPLANTS PATIENT 2 PATIENT 1 PATIENT 3 PATIENT CT SCAN 3D PRINTED TITANIUM IMPLANT PROPOSED...

  17. 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.

  18. 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)

  19. Integrated circuit devices in control systems of coal mining complexes

    Energy Technology Data Exchange (ETDEWEB)

    1983-01-01

    Systems of automatic monitoring and control of coal mining complexes developed in the 1960's used electromagnetic relays, thyristors, and flip-flops on transistors of varying conductivity. The circuits' designers, devoted much attention to ensuring spark safety, lowering power consumption, and raising noise immunity and repairability of functional devices. The fast development of integrated circuitry led to the use of microelectronic components in most devices of mine automation. An analysis of specifications and experimental research into integrated circuits (IMS) shows that the series K 176 IMS components made by CMOS technology best meet mine conditions of operation. The use of IMS devices under mine conditions has demonstrated their high reliability. Further development of integrated circuitry involve using microprocessors and microcomputers. (SC)

  20. The Complexities of Developing Accessible Web Content for Mobile Devices

    Science.gov (United States)

    Hancock, Richard

    This paper is concerned with the development of accessible mobile content and the complexities that arise during this process. The paper gives an overview of the popularity and advantages of mobile devices before tackling the issues surrounding content development, particularly within an educational context. The paper concludes with an overview of an application that was developed for higher education students within a UK college that had a mobile counterpart, allowing the artefact to transcend the typical desktop environment.

  1. Monitoring of Vital Signs with Flexible and Wearable Medical Devices.

    Science.gov (United States)

    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.

  2. Strategy on biological evaluation for biodegradable/absorbable materials and medical devices.

    Science.gov (United States)

    Liu, Chenghu; Luo, Hongyu; Wan, Min; Hou, Li; Wang, Xin; Shi, Yanping

    2018-01-01

    During the last two decades, biodegradable/absorbable materials which have many benefits over conventional implants are being sought in clinical practices. However, to date, it still remains obscure for us to perform full physic-chemical characterization and biological risk assessment for these materials and related devices due to their complex design and coherent processing. In this review, based on the art of knowledge for biodegradable/absorbable materials and biological risk assessment, we demonstrated some promising strategies to establish and improve the current biological evaluation systems for these biodegradable/absorbable materials and related medical devices.

  3. 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.

  4. The effects of cosmic radiation on implantable medical devices

    International Nuclear Information System (INIS)

    Bradley, P.

    1996-01-01

    Metal oxide semiconductor (MOS) integrated circuits, with the benefits of low power consumption, represent the state of the art technology for implantable medical devices. Three significant sources of radiation are classified as having the ability to damage or alter the behavior of implantable electronics; Secondary neutron cosmic radiation, alpha particle radiation from the device packaging and therapeutic doses(up to 70 Gγ) of high energy radiation used in radiation oncology. The effects of alpha particle radiation from the packaging may be eliminated by the use of polyimide or silicone rubber die coatings. The relatively low incidence of therapeutic radiation incident on an implantable device and the use of die coating leaves cosmic radiation induced secondary neutron single event upset (SEU) as the main pervasive ionising radiation threat to the reliability of implantable devices. A theoretical model which predicts the susceptibility of a RAM cell to secondary neutron cosmic radiation induced SEU is presented. The model correlates well within the statistical uncertainty associated with both the theoretical and field estimate. The predicted Soft Error Rate (SER) is 4.8 x l0 -12 upsets/(bit hr) compared to an observed upset rate of 8.5 x 10 -12 upsets/(bit hr) from 20 upsets collected over a total of 284672 device days. The predicted upset rate may increase by up to 20% when consideration is given to patients flying in aircraft The upset rate is also consistent with the expected geographical variations of the secondary cosmic ray neutron flux, although insufficient upsets precluded a statistically significant test. This is the first clinical data set obtained indicating the effects of cosmic radiation on implantable devices. Importantly, it may be used to predict the susceptibility of future to the implantable device designs to the effects of cosmic radiation

  5. Medical devices made into weapons by prisoners: an unrecognized risk.

    Science.gov (United States)

    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.

  6. 78 FR 66941 - Design Considerations for Pivotal Clinical Investigations for Medical Devices; Guidance for...

    Science.gov (United States)

    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...

  7. 78 FR 35940 - Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; Draft...

    Science.gov (United States)

    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...

  8. Home Healthcare Medical Devices: Infusion Therapy - Getting the Most Out of Your Pump

    Science.gov (United States)

    ... 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? ...

  9. A service protocol for post-processing of medical images on the mobile device

    Science.gov (United States)

    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.

  10. Effects of Sterilization Cycles on PEEK for Medical Device Application

    Science.gov (United States)

    Yap, Wai Teng; Foo, Soo Leong; Lee, Teck Kheng

    2018-01-01

    The effects of the sterilization process have been studied on medical grade thermoplastic polyetheretherketone (PEEK). For a reusable medical device, material reliability is an important parameter to decide its lifetime, as it will be subjected to the continuous steam sterilization process. A spring nature, clip component was selected out of a newly designed medical device (patented) to perform this reliability study. This clip component was sterilized for a predetermined number of cycles (2, 4, 6, 8, 10, 20…100) at 121 °C for 30 min. A significant decrease of ~20% in the compression force of the spring was observed after 30 cycles, and a ~6% decrease in the lateral dimension of the clip was observed after 50 cycles. No further significant change in the compression force or dimension was observed for the subsequent sterilization cycles. Vickers hardness and differential scanning calorimetry (DSC) techniques were used to characterize the effects of sterilization. DSC results exhibited no significant change in the degree of cure and melting behavior of PEEK before and after the sterilization. Hardness measurement exhibited an increase of ~49% in hardness after just 20 cycles. When an unsterilized sample was heated for repetitive cycles without the presence of moisture (121 °C, 10 and 20 cycles), only ~7% of the maximum change in hardness was observed. PMID:29466289

  11. Effects of Sterilization Cycles on PEEK for Medical Device Application.

    Science.gov (United States)

    Kumar, Amit; Yap, Wai Teng; Foo, Soo Leong; Lee, Teck Kheng

    2018-02-21

    The effects of the sterilization process have been studied on medical grade thermoplastic polyetheretherketone (PEEK). For a reusable medical device, material reliability is an important parameter to decide its lifetime, as it will be subjected to the continuous steam sterilization process. A spring nature, clip component was selected out of a newly designed medical device (patented) to perform this reliability study. This clip component was sterilized for a predetermined number of cycles (2, 4, 6, 8, 10, 20…100) at 121 °C for 30 min. A significant decrease of ~20% in the compression force of the spring was observed after 30 cycles, and a ~6% decrease in the lateral dimension of the clip was observed after 50 cycles. No further significant change in the compression force or dimension was observed for the subsequent sterilization cycles. Vickers hardness and differential scanning calorimetry (DSC) techniques were used to characterize the effects of sterilization. DSC results exhibited no significant change in the degree of cure and melting behavior of PEEK before and after the sterilization. Hardness measurement exhibited an increase of ~49% in hardness after just 20 cycles. When an unsterilized sample was heated for repetitive cycles without the presence of moisture (121 °C, 10 and 20 cycles), only ~7% of the maximum change in hardness was observed.

  12. Growing pains: medical device interoperability. Regulators and new standards are helping to bring about the convergence of medical devices and information management systems on IT networks.

    Science.gov (United States)

    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.

  13. Navigating conflicts of interest for the medical device entrepreneur.

    Science.gov (United States)

    Donovan, Aine; Kaplan, Aaron V

    2012-01-01

    The past fifty years has witnessed dramatic progress in the understanding and treatment of patients suffering from cardiovascular disease leading to symptomatic relief and impressive increases in longevity. These advances have been due in large part to the development, study and implementation of new technology. Within interventional cardiology in particular, these advances have been driven by the availability of new technology in the form of medical devices. Successful device development efforts require close collaboration among basic scientist, clinician-inventors/entrepreneurs, clinician-investigators and corporations. Though the role of the clinician is central to this process, these activities present important conflicts-of-interest (COIs). The purpose of this paper is to 1) characterize these conflicts, 2) provide a context from which to approach their management and 3) recommend management strategies. Copyright © 2012 Elsevier Inc. All rights reserved.

  14. 78 FR 33849 - Battery-Powered Medical Devices Workshop: Challenges and Opportunities; Public Workshop; Request...

    Science.gov (United States)

    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...

  15. Evaluating and Predicting Patient Safety for Medical Devices With Integral Information Technology

    Science.gov (United States)

    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

  16. 77 FR 8260 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device...

    Science.gov (United States)

    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...

  17. 42 CFR 410.36 - Medical supplies, appliances, and devices: Scope.

    Science.gov (United States)

    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...

  18. Establishment Of Dose Correlation During Dose Mapping On Medical Devices

    International Nuclear Information System (INIS)

    Ruzalina Baharin; Hasan Sham; Ahsanulkhaliqin Abdul Wahab

    2014-01-01

    This paper explains the work done during product dose mapping in order to get the correlation between doses at MINTec-Sinagama plant. Product used was medical devices in aluminium tubes packaged in cardboard kegs packaging with average weight of 12 kg per carton. 12 cartons were loaded in every one tote to give 0.2 g/ cm 3 of density. Ceric cerous dosimeters were placed at specific locations as indicated in SP14: Product Dose Mapping, QMS of MINTec-Sinagama around three planes. Three processes were made at different days as a three replicates to show the reproducibility of measurements. (author)

  19. How can cardiothoracic and vascular medical devices stay in the market?

    Science.gov (United States)

    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.

  20. Development of bacterially resistant polyurethane for coating medical devices

    International Nuclear Information System (INIS)

    Roohpour, Nima; Moshaverinia, Alireza; Wasikiewicz, Jaroslaw M; Paul, Deepen; Vadgama, Pankaj; Wilks, Mark; Millar, Michael

    2012-01-01

    Polyurethanes have been widely used in medicine for coating and packaging implantable and other medical devices. Polyether-urethanes, in particular, have superior mechanical properties and are biocompatible, but in common with other medical materials they are susceptible to microbial film formation. In this study, polyether-urethane was end-capped with silver lactate and silver sulfadiazine functional groups to produce a bacterially resistant polymer without sacrificing the useful mechanical properties of the polyether-polyurethane. The silver ions were covalently incorporated into the polymer during chain extension of the prepolymer. The functionalized polymers were structurally characterized by light scattering, electron microscopy, NMR, FTIR and Raman spectroscopy. Mechanical properties, hydrophilicity, in vitro stability and antibacterial action of polymers were also investigated. Results indicate that both silver salts were successfully incorporated into the polymer structure without significant effect on mechanical properties, whilst conferring acceptable bacterial resistance.

  1. Home Use Devices: How to Prepare for and Handle Power Outages for Medical Devices That Require Electricity

    Science.gov (United States)

    ... 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 ...

  2. The future of the pharmaceutical, biological and medical device industry

    Directory of Open Access Journals (Sweden)

    Burgess LJ

    2011-09-01

    Full Text Available Lesley J Burgess, Marli TerblancheTREAD Research/Cardiology Unit, Department of Internal Medicine, Tygerberg Hospital and University of Stellenbosch, Parow, South AfricaAbstract: Numerous factors contribute to the declining pharmaceutical industry on the one hand and the rapidly growing generic industry together with the growing importance of medical devices and biologicals on the other. It is clear that the pharmaceutical industry is going to undergo a change in the next decade in order to meet the current challenges facing it and ultimately sustain its profitability and growth. This paper aims to identify a number of fairly obvious trends that are likely to have a significant impact on the product development pipeline in the next decade. It is more than clear that the current production pipeline for pharmaceutical, biotechnology and medical device industries is no longer sustainable and that urgent interventions are required in order to maintain its current level of profitability.Keywords: pharmaceutical industry, personalized medicine, trends, generics, biotechnology

  3. Reducing hospital noise: a review of medical device alarm management.

    Science.gov (United States)

    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.

  4. Sprayed films of europium complexes toward light conversion devices

    Energy Technology Data Exchange (ETDEWEB)

    Camacho, Sabrina A.; Aoki, Pedro H.B.; Constantino, Carlos J.L.; Pires, Ana Maria, E-mail: anapires@fct.unesp.br

    2014-09-15

    Rare-earth complexes have become subject of intensive research due to the high quantum efficiency of their emission, very narrow bands, and excellent fluorescence monochromaticity. The chemical design and characterization of Eu complexes based on β-diketone ligands hexafluoroacetylacetate (hfac) and dibenzoylmetanate (dbm) is reported here. K[Eu(dbm){sub 4}] and K[Eu(hfac){sub 4}] complexes were immobilized as thin films by using the spray technique, a promising methodology for practical applications. The latter provides not only a faster layer deposition but also larger coated areas compared to conventional methods, such as layer-by-layer (LbL) and Langmuir–Blodgett (LB). The growth of the sprayed films was monitored through microbalance (QCM) and ultraviolet–visible (UV–Vis) absorption spectroscopy, which reveal a higher mass and absorbance per deposited layer of K[Eu(dbm){sub 4}] film. Micro-Raman images display a more homogeneous spatial distribution of the K[Eu(dbm){sub 4}] complex throughout the film, when compared to K[Eu(hfac){sub 4}] film. At nanometer scale, atomic force microscopy (AFM) images indicate that the roughness of the K[Eu(hfac){sub 4}] film is approximately one order of magnitude higher than that for the K[Eu(dbm){sub 4}] film, which pattern is kept at micrometer scale according to micro-Raman measurements. The photoluminescence data show that the complexes remain as pure red emitters upon spray immobilization. Besides, the quantum efficiency for the sprayed films are found equivalent to the values achieved for the powders, highlighting the potential of the films for application in light conversion devices. - Highlights: • Rare earth complexes thin films based on β-diketone ligands. • Spraying procedures to fabricate layer-by-layer (LbL) luminescent thin films. • Chemical design of Eu complexes based on hfac and dbm β-diketones ligands immobilized as sprayed films. • Pure red emitters upon spray immobilization. • Sprayed

  5. Cost effectiveness of medical devices to diagnose pre-eclampsia in low-resource settings

    Directory of Open Access Journals (Sweden)

    Zoë M. McLaren

    Full Text Available Background: Maternal mortality remains a major health challenge facing developing countries, with pre-eclampsia accounting for up to 17% of maternal deaths. Diagnosis requires skilled health providers and devices that are appropriate for low-resource settings. This study presents the first cost-effectiveness analysis of multiple medical devices used to diagnose pre-eclampsia in low- and middle-income countries (LMICs. Methods: Blood pressure and proteinuria measurement devices, identified from compendia for LMICs, were included. We developed a decision tree framework to assess the cost-effectiveness of each device using parameter values that reflect the general standard of care based on a survey of relevant literature and expert opinion. We examined the sensitivity of our results using one-way and second-order probabilistic multivariate analyses. Results: Because the disability-adjusted life years (DALYs averted for each device were very similar, the results were influenced by the per-use cost ranking. The most cost-effective device combination was a semi-automatic blood pressure measurement device and visually read urine strip test with the lowest combined per-use cost of $0.2004 and an incremental cost effectiveness ratio of $93.6 per DALY gained relative to a baseline with no access to diagnostic devices. When access to treatment is limited, it is more cost-effective to improve access to treatment than to increase testing rates or diagnostic device sensitivity. Conclusions: Our findings were not sensitive to changes in device sensitivity, however they were sensitive to changes in the testing rate and treatment rate. Furthermore, our results suggest that simple devices are more cost-effective than complex devices. The results underscore the desirability of two design features for LMICs: ease of use and accuracy without calibration. Our findings have important implications for policy makers, health economists, health care providers and

  6. 75 FR 1395 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...

    Science.gov (United States)

    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...

  7. 76 FR 42713 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...

    Science.gov (United States)

    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...

  8. [Study on the reform and improvement of the medical device registration system in China].

    Science.gov (United States)

    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.

  9. Medically Complex Home Care and Caregiver Strain

    Science.gov (United States)

    Moorman, Sara M.; Macdonald, Cameron

    2013-01-01

    Purpose of the study: To examine (a) whether the content of caregiving tasks (i.e., nursing vs. personal care) contributes to variation in caregivers' strain and (b) whether the level of complexity of nursing tasks contributes to variation in strain among caregivers providing help with such tasks. Design and methods: The data came from the Cash…

  10. Quantifying the complexity of medical research.

    Science.gov (United States)

    Rodriguez-Esteban, Raul; Loging, William T

    2013-11-15

    A crucial phenomenon of our times is the diminishing marginal returns of investments in pharmaceutical research and development. A potential reason is that research into diseases is becoming increasingly complex, and thus more burdensome, for humans to handle. We sought to investigate whether we could measure research complexity by analyzing the published literature. Through the text mining of the publication record of multiple diseases, we have found that the complexity and novelty of disease research has been increasing over the years. Surprisingly, we have also found that research on diseases with higher publication rate does not possess greater complexity or novelty than that on less-studied diseases. We have also shown that the research produced about a disease can be seen as a differentiated area of knowledge within the wider biomedical research. For our analysis, we have conceptualized disease research as a parallel multi-agent search in which each scientific agent (a scientist) follows a search path based on a model of a disease. We have looked at trends in facts published for diseases, measured their diversity and turnover using the entropy measure and found similar patterns across disease areas. raul.rodriguez-esteban@roche.com.

  11. 3D printing for health & wealth: Fabrication of custom-made medical devices through additive manufacturing

    Science.gov (United States)

    Colpani, Alessandro; Fiorentino, Antonio; Ceretti, Elisabetta

    2018-05-01

    Additive Manufacturing (AM) differs from traditional manufacturing technologies by its ability to handle complex shapes with great design flexibility. These features make the technique suitable to fabricate customized components, particularly answering specific custom needs. Although AM mainly referred to prototyping, nowadays the interest in direct manufacturing of actual parts is growing. This article shows the application of AM within the project 3DP-4H&W (3D Printing for Health & Wealth) which involves engineers and physicians for developing pediatric custom-made medical devices to enhance the fulfilling of the patients specific needs. In the project, two types of devices made of a two-component biocompatible silicone are considered. The first application (dental field) consists in a device for cleft lip and palate. The second one (audiological field) consists in an acoustic prosthesis. The geometries of the devices are based on the anatomy of the patient that is obtained through a 3D body scan process. For both devices, two different approaches were planned, namely direct AM and indirect Rapid Tooling (RT). In particular, direct AM consists in the FDM processing of silicone, while RT consists in molds FDM fabrication followed by silicone casting. This paper presents the results of the RT method that is articulated in different phases: the acquisition of the geometry to be realized, the design of the molds taking into account the casting feasibility (as casting channel, vents, part extraction), the realization of molds produced through AM, molds surface chemical finishing, pouring and curing of the silicone. The fabricated devices were evaluated by the physicians team that confirmed the effectiveness of the proposed procedure in fabricating the desired devices. Moreover, the procedure can be used as a general method to extend the range of applications to any custom-made device for anatomic districts, especially where complex shapes are present (as tracheal or

  12. Advertising of medical devices: foreign experience and Ukrainian practice.

    Science.gov (United States)

    Pashkov, Vitalii; Harkusha, Andrii; Bytiak, Oleksii

    Chosen European foreign policy vector for Ukraine establishes its obligation to enforce the process of adaptation of the EU law regulations in the internal legal policy. The approximation of Ukrainian law to the European Union (EU) "acquis communautaire" is not only the instrument for deepening our economic cooperation with the European Union, but also the important measure to enhance further development of Ukraine in general. National legislation, which regulate advertising and promotion of medical devices (MD), is not an exception. Some key points on legal regulation of abovementioned sphere is a base of this study. Ukrainian legislation, European Union`s Law Acts, EU's member-states law, WHO Acts and Recommendations, European Medical Technology Industry Association (EUCOMED) Acts. Article is based on dialectical, comparative, analytic, synthetic and comprehensive research methods. In accordance with Ukrainian legislation, there is no special law that concerns advertising on MD in Ukraine, this sphere is regulated by general law that named ≪About advertisement≫, but it doesn't take into account even main characteristics of such a special object as medical devices (MD). Moreover, the law ≪About advertisement≫ contain discrepancies in terms that are used, these contradictions, in our opinion, must be eliminated by appropriate law reforms. The advertising and promotion of MD in EU is regulated by a combination of EU and national legislation of EU Member States, national advertising and promotion of MD are not harmonized with the EU MDD for now, resulting in a fragmented legal landscape that differs from one EU Member State to the other. Practice of adopting different codes and guides that regulate advertising, including advertising of MD, is widespread in EU and EU Member States and thus must be used in Ukraine with appropriate reformation of national law.

  13. The current situation and development of medical device testing institutes in China.

    Science.gov (United States)

    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.

  14. Extended device profiles and testing procedures for the approval process of integrated medical devices using the IEEE 11073 communication standard.

    Science.gov (United States)

    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.

  15. Study on 3D printer production of auxiliary device for upper limb for medical imaging test

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Hyeong Gyun [Dept. of Radiological Science, Far East University, Eumsung (Korea, Republic of); Yoon, Jae Ho [Jukwang Precision Co., Ltd., Gumi (Korea, Republic of); Choi, Seong Dae [Dept. of Mechanical system engineering, Kumoh Institute of Technology, Gumi (Korea, Republic of)

    2015-12-15

    There is a progressive development in the medical imaging technology, especially of descriptive capability for anatomical structure of human body thanks to advancement of information technology and medical devices. But however maintenance of correct posture is essential for the medical imaging checkup on the shoulder joint requiring rotation of the upper limb due to the complexity of human body. In the cases of MRI examination, long duration and fixed posture are critical, as failure to comply with them leads to minimal possibility of reproducibility only with the efforts of the examiner and will of the patient. Thus, this study aimed to develop an auxiliary device that enables rotation of the upper limb as well as fixing it at quantitative angles for medical imaging examination capable of providing diagnostic values. An auxiliary device has been developed based on the results of precedent studies, by designing a 3D model with the CATIA software, an engineering application, and producing it with the 3D printer. The printer is Objet350 Connex from Stratasys, and acrylonitrile- butadiene-styrene(ABS) is used as the material of the device. Dimensions are 120 X 150 X 190 mm, with the inner diameter of the handle being 125.9 mm. The auxiliary device has 4 components including the body (outside), handle (inside), fixture terminal and the connection part. The body and handle have the gap of 2.1 mm for smooth rotation, while the 360 degree of scales have been etched on the handle so that the angle required for observation may be recorded per patient for traceability and dual examination.

  16. Study on 3D printer production of auxiliary device for upper limb for medical imaging test

    International Nuclear Information System (INIS)

    Kim, Hyeong Gyun; Yoon, Jae Ho; Choi, Seong Dae

    2015-01-01

    There is a progressive development in the medical imaging technology, especially of descriptive capability for anatomical structure of human body thanks to advancement of information technology and medical devices. But however maintenance of correct posture is essential for the medical imaging checkup on the shoulder joint requiring rotation of the upper limb due to the complexity of human body. In the cases of MRI examination, long duration and fixed posture are critical, as failure to comply with them leads to minimal possibility of reproducibility only with the efforts of the examiner and will of the patient. Thus, this study aimed to develop an auxiliary device that enables rotation of the upper limb as well as fixing it at quantitative angles for medical imaging examination capable of providing diagnostic values. An auxiliary device has been developed based on the results of precedent studies, by designing a 3D model with the CATIA software, an engineering application, and producing it with the 3D printer. The printer is Objet350 Connex from Stratasys, and acrylonitrile- butadiene-styrene(ABS) is used as the material of the device. Dimensions are 120 X 150 X 190 mm, with the inner diameter of the handle being 125.9 mm. The auxiliary device has 4 components including the body (outside), handle (inside), fixture terminal and the connection part. The body and handle have the gap of 2.1 mm for smooth rotation, while the 360 degree of scales have been etched on the handle so that the angle required for observation may be recorded per patient for traceability and dual examination

  17. Biomaterials in medical devices: an interview with Jörg Vienken of Fresenius Medical Care, Germany.

    Science.gov (United States)

    Vienken, Jörg

    2012-06-01

    Biomaterial and biopolymer research have significant impact on the development as well as application of biotechnology. Biotechnology Journal recently attended the "Nanomaterials for Biomedical Technologies 2012" conference. We were privileged to have the opportunity to ask Prof. Dr. Jörg Vienken, VP of BioSciences at Fresenius Medical Care, a few questions relating to medical devices, the importance of publishing for industry, and also his advice for young scientists/engineers looking for a career in industry. Copyright © 2012 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  18. Measurement complexity of adherence to medication

    Directory of Open Access Journals (Sweden)

    Galato D

    2012-04-01

    Full Text Available Dayani Galato, Fabiana Schuelter-Trevisol, Anna Paula PiovezanMaster Program in Health Sciences, University of Southern Santa Catarina (Unisul Tubarão, Santa Catarina, BrazilAdherence to pharmacologic therapy is a major challenge for the rational use of medicines, particularly when it comes to antiretroviral drugs that require adherence to at least 95% of prescribed doses.1 Studies in this area are always important and contribute to medication adherence understanding, even though there is no reference test for measuring this. Recently, an article was published in this journal that proposes the determination of lamivudine plasma concentration to validate patient self-reported adherence to antiretroviral treatment.2 In that study, serum levels obtained after 3 hours of ingestion of the last dose of the drug were compared with patient reports that were classified into different levels of adherence, based on their recall of missed doses in the previous 7 days.It was hypothesized by the authors that the use of a biological marker for drug adherence was extremely important, given the relevance of the topic. However, we would like to draw attention to some points that may determine the success of the use of similar methods for this purpose. The formation of groups with similar anthropometric characteristics is relevant since the dose of lamivudine may have to be changed, depending, for example, on sex, weight, and age.3 Even information considered important by the authors of that study was not provided. There is a need for greater clarity on the eligibility criteria, especially with regard to the clinical stage of the disease, CD4 counts and viral load, associated diseases, and comorbidity, as well as the evaluation of kidney function and other medications used that can affect lamivudine pharmacokinetics.3View original paper by Minzi and colleagues

  19. 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.)

  20. System theory in medical diagnostic devices: an overview.

    Science.gov (United States)

    Baura, Gail D

    2006-01-01

    Medical diagnostics refers to testing conducted either in vitro or in vivo to provide critical health care information for risk assessment, early diagnosis, treatment, or disease management. Typical in vivo diagnostic tests include the computed tomography scan, magnetic resonance imaging, and blood pressure screening. Typical in vitro diagnostic tests include cholesterol, Papanicolaou smear, and conventional glucose monitoring tests. Historically, devices associated with both types of diagnostics have used heuristic curve fitting during signal analysis. However, since the early 1990s, a few enterprising engineers and physicians have used system theory to improve their core processing for feature detection and system identification. Current applications include automated Pap smear screening for detection of cervical cancer and diagnosis of Alzheimer's disease. Future applications, such as disease prediction before symptom onset and drug treatment customization, have been catalyzed by the Human Genome Project.

  1. Energy efficiency improvement of medical electric tools and devices

    Directory of Open Access Journals (Sweden)

    Meshkov Aleksandr S.

    2014-01-01

    Full Text Available With the ever-increasing volume of applications of various kinds of electric drives in all spheres of human activity, the issues in improving the efficiency of the electromechanical converters of electric energy, one of the most important components of the electric drive (ED, are becoming increasingly important. Such issues include reducing their weight and size, improving the functional characteristics of these devices to increase their operational life and reducing the cost of manufacture. Taking full advantage of these opportunities relates to the AC and DC single-phase commutator motor (SCM, which is widely used in regulated and high-speed motor drives in medical electric hand tools. The SCM is used in machinery where the load torque has a hyperbolic dependence on the rotational speed and the need to work with a large motor overload due to the “soft” mechanical characteristics of such motors.

  2. [New medical device hospital assessment: what kind of clinical data?].

    Science.gov (United States)

    Beaussier, H; Junot, H; Lancrenon, S; Faure, P

    2012-01-01

    Since 2003, the AP-HP medical devices committee (CODIMS) assess the therapeutic relevance of innovated medical device (MD) for the French AP-HP hospitals' group. To accomplish this task, the CODIMS asks manufacturers to bring out clinical arguments to justify the use of their MD in hospital. This work analyses retrospectively after 8years, all assessed MD until March 2011 and the scientific quality of the clinical data submitted by manufacturers to the CODIMS to purchase their MD. All MD were classed according to their certification's level (I, IIa, IIb, III, DMIA). The quality of available clinical studies (CS) provided by manufacturers for each case was assessed and classed according to five clinical relevance levels based on the evidence-based medecine standards (1-2: high methodology; 3-5: low methodology). One hundred and three MD files (80 % of class IIb and III MD) were analysed by the CODIMS (630CS). Our results highlight the lack of relevance of files that are provided to assess innovated MD: 29 files without any CS; concerning class IIb (32DMS, 221CS) and III (50, 342CS) MD, only 6 % of CS presented a correct clinical relevance level. And the situation did not get better during this assessment period. The CODIMS deplore the poor clinical relevance of files provided to assess MD (wrong comparator, inappropriate ends-points, insufficient follow-up to assess long-term security, small population studied). Future legislative developments for MD assessment are expected to improve this situation. Copyright © 2011 Elsevier Masson SAS. All rights reserved.

  3. Improving risk assessment of color additives in medical device polymers.

    Science.gov (United States)

    Chandrasekar, Vaishnavi; Janes, Dustin W; Forrey, Christopher; Saylor, David M; Bajaj, Akhil; Duncan, Timothy V; Zheng, Jiwen; Riaz Ahmed, Kausar B; Casey, Brendan J

    2018-01-01

    Many polymeric medical device materials contain color additives which could lead to adverse health effects. The potential health risk of color additives may be assessed by comparing the amount of color additive released over time to levels deemed to be safe based on available toxicity data. We propose a conservative model for exposure that requires only the diffusion coefficient of the additive in the polymer matrix, D, to be specified. The model is applied here using a model polymer (poly(ether-block-amide), PEBAX 2533) and color additive (quinizarin blue) system. Sorption experiments performed in an aqueous dispersion of quinizarin blue (QB) into neat PEBAX yielded a diffusivity D = 4.8 × 10 -10 cm 2  s -1 , and solubility S = 0.32 wt %. On the basis of these measurements, we validated the model by comparing predictions to the leaching profile of QB from a PEBAX matrix into physiologically representative media. Toxicity data are not available to estimate a safe level of exposure to QB, as a result, we used a Threshold of Toxicological Concern (TTC) value for QB of 90 µg/adult/day. Because only 30% of the QB is released in the first day of leaching for our film thickness and calculated D, we demonstrate that a device may contain significantly more color additive than the TTC value without giving rise to a toxicological concern. The findings suggest that an initial screening-level risk assessment of color additives and other potentially toxic compounds found in device polymers can be improved. © 2017 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 106B: 310-319, 2018. © 2017 Wiley Periodicals, Inc.

  4. 21 CFR 801.122 - Medical devices for processing, repacking, or manufacturing.

    Science.gov (United States)

    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...

  5. 78 FR 27971 - Dental Products Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    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...

  6. Just a piece of equipment? The importance of medical device education.

    Science.gov (United States)

    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.

  7. 21 CFR 801.16 - Medical devices; Spanish-language version of certain required statements.

    Science.gov (United States)

    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...

  8. Using activity theory to study cultural complexity in medical education

    NARCIS (Netherlands)

    Frambach, J.M.; Driessen, E.W.; Vleuten, C.P.M. van der

    2014-01-01

    There is a growing need for research on culture, cultural differences and cultural effects of globalization in medical education, but these are complex phenomena to investigate. Socio-cultural activity theory seems a useful framework to study cultural complexity, because it matches current views on

  9. Using activity theory to study cultural complexity in medical education

    NARCIS (Netherlands)

    Frambach, Janneke M; Driessen, Erik W; van der Vleuten, Cees P M

    There is a growing need for research on culture, cultural differences and cultural effects of globalization in medical education, but these are complex phenomena to investigate. Socio-cultural activity theory seems a useful framework to study cultural complexity, because it matches current views on

  10. Sodium Hypochlorite Treatment and Nitinol Performance for Medical Devices

    Science.gov (United States)

    Weaver, J. D.; Gutierrez, E. J.; Nagaraja, S.; Stafford, P. R.; Sivan, S.; Di Prima, M.

    2017-09-01

    Processing of nitinol medical devices has evolved over the years as manufacturers have identified methods of reducing surface defects such as inclusions. One recent method proposes to soak nitinol medical devices in a 6% sodium hypochlorite (NaClO) solution as a means of identifying surface inclusions. Devices with surface inclusions could in theory then be removed from production because inclusions would interact with NaClO to form a visible black material on the nitinol surface. To understand the effects of an NaClO soak on performance, we compared as-received and NaClO-soaked nitinol wires with two different surface finishes (black oxide and electropolished). Pitting corrosion susceptibility was equivalent between the as-received and NaClO-soaked groups for both surface finishes. Nickel ion release increased in the NaClO-soaked group for black oxide nitinol, but was equivalent for electropolished nitinol. Fatigue testing revealed a lower fatigue life for NaClO-soaked black oxide nitinol at all alternating strains. With the exception of 0.83% alternating strain, NaClO-soaked and as-received electropolished nitinol had similar average fatigue life, but the NaClO-soaked group showed higher variability. NaClO-soaked electropolished nitinol had specimens with the lowest number of cycles to fracture for all alternating strains tested with the exception of the highest alternating strain 1.2%. The NaClO treatment identified only one specimen with surface inclusions and caused readily identifiable surface damage to the black oxide nitinol. Damage from the NaClO soak to electropolished nitinol surface also appears to have occurred and is likely the cause of the increased variability of the fatigue results. Overall, the NaClO soak appears to not lead to an improvement in nitinol performance and seems to be damaging to the nitinol surface in ways that may not be detectable with a simple visual inspection for black material on the nitinol surface.

  11. 77 FR 4252 - Additional Spectrum for the Medical Device Radiocommunication Service

    Science.gov (United States)

    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...

  12. Modification of the surfaces of medical devices to prevent microbial adhesion and biofilm formation.

    Science.gov (United States)

    Desrousseaux, C; Sautou, V; Descamps, S; Traoré, O

    2013-10-01

    The development of devices with surfaces that have an effect against microbial adhesion or viability is a promising approach to the prevention of device-related infections. To review the strategies used to design devices with surfaces able to limit microbial adhesion and/or growth. A PubMed search of the published literature. One strategy is to design medical devices with a biocidal agent. Biocides can be incorporated into the materials or coated or covalently bonded, resulting either in release of the biocide or in contact killing without release of the biocide. The use of biocides in medical devices is debated because of the risk of bacterial resistance and potential toxicity. Another strategy is to modify the chemical or physical surface properties of the materials to prevent microbial adhesion, a complex phenomenon that also depends directly on microbial biological structure and the environment. Anti-adhesive chemical surface modifications mostly target the hydrophobicity features of the materials. Topographical modifications are focused on roughness and nanostructures, whose size and spatial organization are controlled. The most effective physical parameters to reduce bacterial adhesion remain to be determined and could depend on shape and other bacterial characteristics. A prevention strategy based on reducing microbial attachment rather than on releasing a biocide is promising. Evidence of the clinical efficacy of these surface-modified devices is lacking. Additional studies are needed to determine which physical features have the greatest potential for reducing adhesion and to assess the usefulness of antimicrobial coatings other than antibiotics. Copyright © 2013 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.

  13. 77 FR 32644 - Medical Devices; Exemption From Premarket Notification: Wheelchair Elevator

    Science.gov (United States)

    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...

  14. 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...

  15. 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.

  16. [Thoughts on the Witnessed Audit in Medical Device Single Audit Program].

    Science.gov (United States)

    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.

  17. Predictive Analytics In Healthcare: Medications as a Predictor of Medical Complexity.

    Science.gov (United States)

    Higdon, Roger; Stewart, Elizabeth; Roach, Jared C; Dombrowski, Caroline; Stanberry, Larissa; Clifton, Holly; Kolker, Natali; van Belle, Gerald; Del Beccaro, Mark A; Kolker, Eugene

    2013-12-01

    Children with special healthcare needs (CSHCN) require health and related services that exceed those required by most hospitalized children. A small but growing and important subset of the CSHCN group includes medically complex children (MCCs). MCCs typically have comorbidities and disproportionately consume healthcare resources. To enable strategic planning for the needs of MCCs, simple screens to identify potential MCCs rapidly in a hospital setting are needed. We assessed whether the number of medications used and the class of those medications correlated with MCC status. Retrospective analysis of medication data from the inpatients at Seattle Children's Hospital found that the numbers of inpatient and outpatient medications significantly correlated with MCC status. Numerous variables based on counts of medications, use of individual medications, and use of combinations of medications were considered, resulting in a simple model based on three different counts of medications: outpatient and inpatient drug classes and individual inpatient drug names. The combined model was used to rank the patient population for medical complexity. As a result, simple, objective admission screens for predicting the complexity of patients based on the number and type of medications were implemented.

  18. 75 FR 18219 - Drug and Medical Device Forum on Food and Drug Administration Drug and Device Requirements and...

    Science.gov (United States)

    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...

  19. 77 FR 38177 - TRICARE; Off-Label Uses of Devices; Partial List of Examples of Unproven Drugs, Devices, Medical...

    Science.gov (United States)

    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...

  20. ISO 13485: a complete guide to quality management in the medical device industry

    National Research Council Canada - National Science Library

    Abuhav, Itay

    2012-01-01

    .... Written by an experienced industry professional, this practical book provides a complete guide to the ISO 13485 standard certification for medical device manufacturing in terms of quality control...

  1. Instructions included? Make safety training part of medical device procurement process.

    Science.gov (United States)

    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.

  2. "Joint Workshop on High Confidence Medical Devices, Software, and Systems (HCMDSS) and Medical Device Plug-and-Play (MD PnP) Interoperability"

    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...

  3. Artificial intelligence (AI) systems for interpreting complex medical datasets.

    Science.gov (United States)

    Altman, R B

    2017-05-01

    Advances in machine intelligence have created powerful capabilities in algorithms that find hidden patterns in data, classify objects based on their measured characteristics, and associate similar patients/diseases/drugs based on common features. However, artificial intelligence (AI) applications in medical data have several technical challenges: complex and heterogeneous datasets, noisy medical datasets, and explaining their output to users. There are also social challenges related to intellectual property, data provenance, regulatory issues, economics, and liability. © 2017 ASCPT.

  4. Optimised design and development of a bio-medical healthcare device through quality function deployment (QFD).

    Science.gov (United States)

    Sharma, Jitendra

    2012-01-01

    Technology is major stimulus for change and is imbibed in various forms; especially in the field of medical devices and bio-medical instruments used in life and death situations. Cardiotocograph (CTG), a foetal heart rate and uterine contraction monitoring and measurement machine, is a valuable tool in the process of childbirth. The Quality Function Deployment (QFD) is an engineering technique with the number one priority being to satisfy the customer. The aim of using QFD in this paper is to highlight the limitations and complexities of the present instrument. The paper attempts to first discuss out the operational details of the instrument along with a brief review of the relevant literature. Following this, its functional analysis is carried out through QFD - a TQM tool. The resultant outcome enlists CTG functions with their Raw Weight and Priority Score. A detailed theoretical analysis of results pinpoints basic functional limitation of exiting machine.

  5. Optimize Use of Space Research and Technology for Medical Devices

    Science.gov (United States)

    Minnifield, Nona K.

    2012-01-01

    systems, and cutting-edge component technologies to conduct a wide range of scientific observations and measurements. These technologies are also considered for practical applications that benefit society in remarkable ways. At NASA Goddard, the technology transfer initiative promotes matching technologies from Earth and space science needs to targeted industry sectors. This requires clear knowledge of industry needs and priorities and social demands. The process entails matching mature technologies where there are known innovation challenges and good opportunities for matching technology needs. This requires creative thinking and takes commitment of time and resources. Additionally, we also look at applications for known hot industry or societal needs. Doing so has given us occasion to host discussions with representatives from industry, academia, government organizations, and societal special interest groups about the application of NASA Goddard technologies for devices used in medical monitoring and detection tools. As a result, partnerships have been established. Innovation transpired when new products were enabled because of NASA Goddard research and technology programs.

  6. 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.

  7. Scouting For Approval: Lessons on Medical Device Regulation in an Era of Crowdfunding from Scanadu's "Scout".

    Science.gov (United States)

    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.

  8. The potential of medical device industry in technological and economical context.

    Science.gov (United States)

    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.

  9. Medication regimen complexity in ambulatory older adults with heart failure

    Directory of Open Access Journals (Sweden)

    Cobretti MR

    2017-04-01

    Full Text Available Michael R Cobretti,1 Robert L Page II,2 Sunny A Linnebur,2 Kimberly M Deininger,1 Amrut V Ambardekar,3 JoAnn Lindenfeld,4 Christina L Aquilante1 1Department of Pharmaceutical Sciences, 2Department of Clinical Pharmacy, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado, Aurora, CO, 3Division of Cardiology, School of Medicine, University of Colorado, Aurora, CO, 4Advanced Heart Failure and Cardiac Transplant Program, Vanderbilt Heart and Vascular Institute, Nashville, TN, USA Purpose: Heart failure prevalence is increasing in older adults, and polypharmacy is a major problem in this population. We compared medication regimen complexity using the validated patient-level Medication Regimen Complexity Index (pMRCI tool in “young-old” (60–74 years versus “old-old” (75–89 years patients with heart failure. We also compared pMRCI between patients with ischemic cardiomyopathy (ISCM versus nonischemic cardiomyopathy (NISCM.Patients and methods: Medication lists were retrospectively abstracted from the electronic medical records of ambulatory patients aged 60–89 years with heart failure. Medications were categorized into three types – heart failure prescription medications, other prescription medications, and over-the-counter (OTC medications – and scored using the pMRCI tool.Results: The study evaluated 145 patients (n=80 young-old, n=65 old-old, n=85 ISCM, n=60 NISCM, mean age 73±7 years, 64% men, 81% Caucasian. Mean total pMRCI scores (32.1±14.4, range 3–84 and total medication counts (13.3±4.8, range 2–30 were high for the entire cohort, of which 72% of patients were taking eleven or more total medications. Total and subtype pMRCI scores and medication counts did not differ significantly between the young-old and old-old groups, with the exception of OTC medication pMRCI score (6.2±4 young-old versus 7.8±5.8 old-old, P=0.04. With regard to heart failure etiology, total pMRCI scores and medication

  10. Safety problems with the use of medical equipment/devices

    NARCIS (Netherlands)

    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

  11. Identification of Bodies by Unique Serial Numbers on Implanted Medical Devices.

    Science.gov (United States)

    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.

  12. Inhaled medication for asthma management: evaluation of how asthma patients, medical students, and doctors use the different devices

    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.

  13. Human resource management practices in a medical complex in the ...

    African Journals Online (AJOL)

    staff, accountability, general HR efficiency, occupation-specific dispensation adjustments and performance management and development system efficiency, and availability of HR staff. All these characteristics were judged to be poor. Conclusion. HRM practices in this Eastern Cape medical complex were inadequate and a ...

  14. Methodological considerations in observational comparative effectiveness research for implantable medical devices: an epidemiologic perspective.

    Science.gov (United States)

    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.

  15. Fiber bundle probes for interconnecting miniaturized medical imaging devices

    Science.gov (United States)

    Zamora, Vanessa; Hofmann, Jens; Marx, Sebastian; Herter, Jonas; Nguyen, Dennis; Arndt-Staufenbiel, Norbert; Schröder, Henning

    2017-02-01

    Miniaturization of medical imaging devices will significantly improve the workflow of physicians in hospitals. Photonic integrated circuit (PIC) technologies offer a high level of miniaturization. However, they need fiber optic interconnection solutions for their functional integration. As part of European funded project (InSPECT) we investigate fiber bundle probes (FBPs) to be used as multi-mode (MM) to single-mode (SM) interconnections for PIC modules. The FBP consists of a set of four or seven SM fibers hexagonally distributed and assembled into a holder that defines a multicore connection. Such a connection can be used to connect MM fibers, while each SM fiber is attached to the PIC module. The manufacturing of these probes is explored by using well-established fiber fusion, epoxy adhesive, innovative adhesive and polishing techniques in order to achieve reliable, low-cost and reproducible samples. An innovative hydrofluoric acid-free fiber etching technology has been recently investigated. The preliminary results show that the reduction of the fiber diameter shows a linear behavior as a function of etching time. Different etch rate values from 0.55 μm/min to 2.3 μm/min were found. Several FBPs with three different type of fibers have been optically interrogated at wavelengths of 630nm and 1550nm. Optical losses are found of approx. 35dB at 1550nm for FBPs composed by 80μm fibers. Although FBPs present moderate optical losses, they might be integrated using different optical fibers, covering a broad spectral range required for imaging applications. Finally, we show the use of FBPs as promising MM-to-SM interconnects for real-world interfacing to PIC's.

  16. 21 CFR 801.125 - Medical devices for use in teaching, law enforcement, research, and analysis.

    Science.gov (United States)

    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...

  17. 76 FR 18227 - Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2011-04-01

    ...] Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of Meeting... comment period for the notice announcing a meeting of the Molecular and Clinical Genetics Panel (the panel... Clinical Genetics Panel of the Medical Devices Advisory Committee, and the opening of a public docket to...

  18. Medical device registration, agreements on mutual recognition - a step forward to global harmonization?

    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)

  19. 77 FR 32642 - Medical Devices; Exemption From Premarket Notification: Powered Patient Transport

    Science.gov (United States)

    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...

  20. Compiling a Medical Device File and a Proposal for an International Standard for Rehabilitation Robots

    NARCIS (Netherlands)

    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

  1. 78 FR 56719 - Challenging Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of...

    Science.gov (United States)

    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...

  2. An extended protocol for usability validation of medical devices : Research design and reference model

    NARCIS (Netherlands)

    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

  3. Dental implants in medically complex patients-a retrospective study.

    Science.gov (United States)

    Manor, Yifat; Simon, Roy; Haim, Doron; Garfunkel, Adi; Moses, Ofer

    2017-03-01

    Dental implant insertion for oral rehabilitation is a worldwide procedure for healthy and medically compromised patients. The impact of systemic disease risks on the outcome of implant therapy is unclear, since there are few if any published randomized controlled trials (RCTs). The objective of this study is to investigate the rate of complications and failures following dental implantation in medically compromised patients in order to elucidate risk factors and prevent them. A retrospective cohort study was conducted from patient files treated with dental implantation between the years 2008-2014. The study group consisted of medically complex patients while the control group consisted of healthy patients. Preoperative, intraoperative, and post operative clinical details were retrieved from patients' files. The survival rate and the success rate of the dental implants were evaluated clinically and radiographically. A total of 204 patients (1003 dental implants) were included in the research, in the study group, 93 patients with 528 dental implants and in the control group, 111 patients with 475 dental implants. No significant differences were found between the groups regarding implant failures or complications. The failure rate of dental implants among the patients was 11.8 % in the study group and 16.2 % in the control group (P = 0.04). It was found that patients with a higher number of implants (mean 6.8) had failures compared with patients with a lower number of implants (mean 4.2) regardless of their health status (P dental implantation in medically complex patients and in healthy patients. Medically complex patients can undergo dental implantation. There are similar rates of complications and failures of dental implants in medically complex patients and in healthy patients.

  4. Medical Devices; General Hospital and Personal Use Devices; Classification of the Ultraviolet Radiation Chamber Disinfection Device. Final order.

    Science.gov (United States)

    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.

  5. 77 FR 3781 - Pediatric Medical Devices; Public Workshop; Reopening of Comment Period

    Science.gov (United States)

    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...

  6. Mobile Devices, Learning and Clinical Workplaces: Medical Student Use of Smartphones in Parisian Hospitals

    Science.gov (United States)

    Phelps, Megan; Scott, Karen M.; Chauffeté-Manillier, Martine; Lenne, Frédéric; Le Jeunne, Claire

    2017-01-01

    Mobile devices are ubiquitous worldwide, including in hospitals. "Just in time" learning provided by these devices is important for students. We investigated current use of, and learning with, smartphones and other mobile devices by medical students in Parisian hospitals. A survey with quantitative and qualitative items previously used…

  7. Medical Device Plug-and-Play Interoperability Standards and Technology Leadership

    Science.gov (United States)

    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

  8. 76 FR 36548 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-06-22

    ... information related to the humanitarian device exemption for the Berlin Heart EXCOR Pediatric Ventricular Assist Device (VAD) sponsored by Berlin Heart, Inc. The Berlin Heart EXCOR Pediatric VAD device is a..., please contact AnnMarie Williams, Conference Management Staff, at 301-796-5966, at least 7 days in...

  9. The Development of 1Balance: A Connected Medical Device for Measuring Human Balance

    Directory of Open Access Journals (Sweden)

    Heikki Sjöman

    2018-05-01

    Full Text Available Prototyping (iterative loops of design–build–test is a proven method of efficiently developing new products. Developing products not only quickly, but that are also fit for purpose, implies engaging the end users and iterating the technology at hand. However, there is currently little research on how engineering design can approach developing connected devices. The purpose of this paper is to distinguish and discuss design approaches that are suitable for connected devices. Internet of Things devices consist of both the physical products themselves and the data that is coming out of the products, which we define as the external and internal data, respectively. They both can be prototyped separately, but since the data acquired can influence the design of the device and vice versa, we propose to link these two together in the product development process. This issue becomes more apparent when designing networks of sensors, e.g., for complex artificial intelligence (AI databases. We explain the principle by describing the development of 1Balance through six different prototypes for human balance measurement. Technologically quantifying balance is an underused approach for objectively evaluating the state of a human’s performance. The authors have developed a mobile application for monitoring balance as a physiological signal (amount of sway via a compact wireless inertial measurement unit (IMU sensor strapped to the body of the subject for the duration of the measurement. We describe the design process for developing this connected medical device, as well as how the acquired data was used to improve the design of the product. In conclusion, we propose conceptually connecting the external and internal data prototyping loops.

  10. MedMon: securing medical devices through wireless monitoring and anomaly detection.

    Science.gov (United States)

    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.

  11. Using activity theory to study cultural complexity in medical education.

    Science.gov (United States)

    Frambach, Janneke M; Driessen, Erik W; van der Vleuten, Cees P M

    2014-06-01

    There is a growing need for research on culture, cultural differences and cultural effects of globalization in medical education, but these are complex phenomena to investigate. Socio-cultural activity theory seems a useful framework to study cultural complexity, because it matches current views on culture as a dynamic process situated in a social context, and has been valued in diverse fields for yielding rich understandings of complex issues and key factors involved. This paper explains how activity theory can be used in (cross-)cultural medical education research. We discuss activity theory's theoretical background and principles, and we show how these can be applied to the cultural research practice by discussing the steps involved in a cross-cultural study that we conducted, from formulating research questions to drawing conclusions. We describe how the activity system, the unit of analysis in activity theory, can serve as an organizing principle to grasp cultural complexity. We end with reflections on the theoretical and practical use of activity theory for cultural research and note that it is not a shortcut to capture cultural complexity: it is a challenge for researchers to determine the boundaries of their study and to analyze and interpret the dynamics of the activity system.

  12. Post market surveillance in the german medical device sector - current state and future perspectives.

    Science.gov (United States)

    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.

  13. Automated touch screen device for recording complex rodent behaviors

    Science.gov (United States)

    Mabrouk, O.S.; Dripps, I.J.; Ramani, S.; Chang, C.; Han, J.L.; Rice, KC; Jutkiewicz, E.M.

    2016-01-01

    Background Monitoring mouse behavior is a critical step in the development of modern pharmacotherapies. New Method Here we describe the application of a novel method that utilizes a touch display computer (tablet) and software to detect, record, and report fine motor behaviors. A consumer-grade tablet device is placed in the bottom of a specially made acrylic cage allowing the animal to walk on the device (MouseTrapp). We describe its application in open field (for general locomotor studies) which measures step lengths and velocity. The device can perform light-dark (anxiety) tests by illuminating half of the screen and keeping the other half darkened. A divider is built into the lid of the device allowing the animal free access to either side. Results Treating mice with amphetamine and the delta opioid peptide receptor agonist SNC80 stimulated locomotor activity on the device. Amphetamine increased step velocity but not step length during its peak effect (40–70 min after treatment), thus indicating detection of subtle amphetamine-induced effects. Animals showed a preference (74% of time spent) for the darkened half compared to the illuminated side. Comparison with Existing Method Animals were videotaped within the chamber to compare quadrant crosses to detected motion on the device. The slope, duration and magnitude of quadrant crosses tightly correlated with overall locomotor activity as detected by Mousetrapp. Conclusions We suggest that modern touch display devices such as MouseTrapp will be an important step toward automation of behavioral analyses for characterizing phenotypes and drug effects. PMID:24952323

  14. [Impact of an automated dispensing system for medical devices in cardiac surgery department].

    Science.gov (United States)

    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.

  15. Drugs and Medical Devices: Adverse Events and the Impact on Women's Health.

    Science.gov (United States)

    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.

  16. Current challenges for clinical trials of cardiovascular medical devices.

    Science.gov (United States)

    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.

  17. Use-related risk analysis for medical devices based on improved FMEA.

    Science.gov (United States)

    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.

  18. Monitoring of biofilm formation on different material surfaces of medical devices using hyperspectral imaging method

    Science.gov (United States)

    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.

  19. Safety evaluation in the development of medical devices and combination products

    CERN Document Server

    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

  20. Adverse Events Involving Radiation Oncology Medical Devices: Comprehensive Analysis of US Food and Drug Administration Data, 1991 to 2015

    International Nuclear Information System (INIS)

    Connor, Michael J.; Marshall, Deborah C.; Moiseenko, Vitali; Moore, Kevin; Cervino, Laura; Atwood, Todd; Sanghvi, Parag; Mundt, Arno J.; Pawlicki, Todd; Recht, Abram; Hattangadi-Gluth, Jona A.

    2017-01-01

    Purpose: Radiation oncology relies on rapidly evolving technology and highly complex processes. The US Food and Drug Administration collects reports of adverse events related to medical devices. We sought to characterize all events involving radiation oncology devices (RODs) from the US Food and Drug Administration's postmarket surveillance Manufacturer and User Facility Device Experience (MAUDE) database, comparing these with non–radiation oncology devices. Methods and Materials: MAUDE data on RODs from 1991 to 2015 were sorted into 4 product categories (external beam, brachytherapy, planning systems, and simulation systems) and 5 device problem categories (software, mechanical, electrical, user error, and dose delivery impact). Outcomes included whether the device was evaluated by the manufacturer, adverse event type, remedial action, problem code, device age, and time since 510(k) approval. Descriptive statistics were performed with linear regression of time-series data. Results for RODs were compared with those for other devices by the Pearson χ"2 test for categorical data and 2-sample Kolmogorov-Smirnov test for distributions. Results: There were 4234 ROD and 4,985,698 other device adverse event reports. Adverse event reports increased over time, and events involving RODs peaked in 2011. Most ROD reports involved external beam therapy (50.8%), followed by brachytherapy (24.9%) and treatment planning systems (21.6%). The top problem types were software (30.4%), mechanical (20.9%), and user error (20.4%). RODs differed significantly from other devices in each outcome (P<.001). RODs were more likely to be evaluated by the manufacturer after an event (46.9% vs 33.0%) but less likely to be recalled (10.5% vs 37.9%) (P<.001). Device age and time since 510(k) approval were shorter among RODs (P<.001). Conclusions: Compared with other devices, RODs may experience adverse events sooner after manufacture and market approval. Close postmarket surveillance, improved

  1. Adverse Events Involving Radiation Oncology Medical Devices: Comprehensive Analysis of US Food and Drug Administration Data, 1991 to 2015

    Energy Technology Data Exchange (ETDEWEB)

    Connor, Michael J. [Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California (United States); Department of Radiation Oncology, University of California Irvine School of Medicine, Irvine, California (United States); Marshall, Deborah C.; Moiseenko, Vitali; Moore, Kevin; Cervino, Laura; Atwood, Todd; Sanghvi, Parag; Mundt, Arno J.; Pawlicki, Todd [Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California (United States); Recht, Abram [Department of Radiation Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts (United States); Hattangadi-Gluth, Jona A., E-mail: jhattangadi@ucsd.edu [Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California (United States)

    2017-01-01

    Purpose: Radiation oncology relies on rapidly evolving technology and highly complex processes. The US Food and Drug Administration collects reports of adverse events related to medical devices. We sought to characterize all events involving radiation oncology devices (RODs) from the US Food and Drug Administration's postmarket surveillance Manufacturer and User Facility Device Experience (MAUDE) database, comparing these with non–radiation oncology devices. Methods and Materials: MAUDE data on RODs from 1991 to 2015 were sorted into 4 product categories (external beam, brachytherapy, planning systems, and simulation systems) and 5 device problem categories (software, mechanical, electrical, user error, and dose delivery impact). Outcomes included whether the device was evaluated by the manufacturer, adverse event type, remedial action, problem code, device age, and time since 510(k) approval. Descriptive statistics were performed with linear regression of time-series data. Results for RODs were compared with those for other devices by the Pearson χ{sup 2} test for categorical data and 2-sample Kolmogorov-Smirnov test for distributions. Results: There were 4234 ROD and 4,985,698 other device adverse event reports. Adverse event reports increased over time, and events involving RODs peaked in 2011. Most ROD reports involved external beam therapy (50.8%), followed by brachytherapy (24.9%) and treatment planning systems (21.6%). The top problem types were software (30.4%), mechanical (20.9%), and user error (20.4%). RODs differed significantly from other devices in each outcome (P<.001). RODs were more likely to be evaluated by the manufacturer after an event (46.9% vs 33.0%) but less likely to be recalled (10.5% vs 37.9%) (P<.001). Device age and time since 510(k) approval were shorter among RODs (P<.001). Conclusions: Compared with other devices, RODs may experience adverse events sooner after manufacture and market approval. Close postmarket surveillance

  2. Medical devices; neurological devices; classification of the transcutaneous electrical nerve stimulator to treat headache. Final order.

    Science.gov (United States)

    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.

  3. Medical devices; neurological devices; classification of the transcranial magnetic stimulator for headache. Final order.

    Science.gov (United States)

    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.

  4. Light insensitive silver(I) cyanoximates as antimicrobial agents for indwelling medical devices.

    Science.gov (United States)

    Gerasimchuk, Nikolay; Gamian, Andrzej; Glover, Garrett; Szponar, Bogumila

    2010-11-01

    Ten silver(I) cyanoximates of AgL composition (L = NC-C(NO)-R, where R is electron withdrawing groups: -CN, -C(O)NR(2), -C(O)R' (alkyl), -C(O)OEt, 2-heteroaryl fragments such as 2-pyridyl, 2-benzimidazolyl, 2-benzoxazolyl, 2-benzthiazolyl) were synthesized and characterized using spectroscopic methods and X-ray analysis. Crystal structures of four complexes were determined and revealed the formation of two-dimensional (2D) coordination polymers of different complexity in which anions exhibit bridging or combined chelate and bridging binding modes. In these compounds, anions are in the nitroso form. All studied AgL complexes are sparingly soluble in water and are thermally stable to 150 °C. Synthesized compounds demonstrated remarkable insensitivity toward visible light and UV-radiation, which was explained based on their polymeric structures with multiple covalent bonds between bridging cyanoxime ligands and Ag(I) centers. All 10 silver(I) cyanoximates were tested in vitro on the subject of their antimicrobial activity against both Gram-positive and Gram-negative microorganisms such as Escherichia coli, Klebsiella pneumoniae, Proteus sp., Pseudomonas aeruginosa, Enterococcus hirae, Streptococcus mutans, Staphylococcus aureus, and Mycobacterium fortuitum as well as against Candida albicans in solutions, and in the solid state as pressed pellets and dried filter paper disks presoaked with solutions of AgL in DMF. Results showed pronounced antimicrobial activity for all investigated complexes. A combination of five factors: (1) light insensitivity, (2) poor water solubility, (3) high thermal stability, (4) lack of toxicity of organic ligands, and (5) in vitro antimicrobial activity allows development of silver(I) cyanoximates for medical applications. These include antimicrobial additives to acrylate glue, cured by UV-radiation, used in introduction of prosthetic joints and dental implants, and prevention of biofilm formation on several types of indwelling medical

  5. Medical Devices; Neurological Devices; Classification of the External Vagal Nerve Stimulator for Headache. Final order.

    Science.gov (United States)

    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.

  6. Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Organophosphate Test System. Final order.

    Science.gov (United States)

    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.

  7. Medical Devices; Obstetrical and Gynecological Devices; Classification of the Fetal Head Elevator. Final order.

    Science.gov (United States)

    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.

  8. Medical Devices; Hematology and Pathology Devices; Classification of a Cervical Intraepithelial Neoplasia Test System. Final order.

    Science.gov (United States)

    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.

  9. What do you mean you can't sterilize it? The reusable medical device matrix.

    Science.gov (United States)

    Stephens, Anne; Assang, AnnMarie

    2010-12-01

    begins with proper cleaning and processing of the surgical instruments. Surgical site infections can increase the length of stay and the cost of the patients' hospitalization, as well as increased risk, morbidity and even mortality. 1 Today's patients are far more informed than they were in the past. They can gather information from the internet as well as from television, radio, and print media. This knowledge empowers the patient to expect that their healthcare providers are practicing due diligence. It is the ethical duty and responsibility of nurses to provide safe, competent care while protecting the rights of the patient and being accountable to the professional governing bodies. In other words, we are advocates for both our patients and the healthcare system.2 Using both new and innovative instruments in the OR was, in the past, as simple as a surgeon requesting an instrument, the perioperative nurse ordering the instrument and CPD processing it for use in the OR. That is no longer the case. With a wide range of more complex instrumentation and an increasing focus on sterilization strategies, healthcare facilities have had to adopt a more rigorous approach. There are many challenges in the world of sterile processing. A common one, faced on a regular basis, is the provision of vague, inaccurate reprocessing recommendations from the medical device manufacturer. Canadian centres are not able to meet European standards for reprocessing. European cycles, often referred to as "Fractionated Steam Cycles", are different than the pre-vacuum steam cycles run in Canada.

  10. 76 FR 34845 - Medical Devices; Ear, Nose, and Throat Devices; Classification of the Wireless Air-Conduction...

    Science.gov (United States)

    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...

  11. Third-year medical students' knowledge of privacy and security issues concerning mobile devices.

    Science.gov (United States)

    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.

  12. 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

  13. 78 FR 49272 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-08-13

    ... into two types: (1) Devices that provide automatic chest compressions at a fixed compression rate and... circuit is comprised of multiple device types, including, but not limited to, an oxygenator, blood pump... submit a brief statement of the general nature of the evidence or arguments they wish to present, the...

  14. 76 FR 44489 - Medical Devices; Neurological Devices; Classification of Repetitive Transcranial Magnetic...

    Science.gov (United States)

    2011-07-26

    ... is an external device that delivers transcranial repetitive pulsed magnetic fields of sufficient... premarket notification, prior to marketing the device, which contains information about the rTMS system they... significant effect on the human environment. Thus, neither an environmental assessment nor an environmental...

  15. 78 FR 14013 - Medical Devices; Exemption From Premarket Notification; Class II Devices; Wheelchair Elevator

    Science.gov (United States)

    2013-03-04

    ... Elevator AGENCY: Food and Drug Administration, HHS. ACTION: Final order. SUMMARY: The Food and Drug... requirements for wheelchair elevator devices commonly known as inclined platform lifts and vertical platform... wheelchair elevators, class II devices, from premarket notification and establishes conditions for exemption...

  16. Medical devices; exemption from premarket notification; class II devices; wheelchair elevator. Final order.

    Science.gov (United States)

    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).

  17. Medical devices; immunology and microbiology devices; classification of John Cunningham Virus serological reagents. Final order.

    Science.gov (United States)

    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.

  18. 76 FR 21237 - Medical Devices; Obstetrical and Gynecological Devices; Classification of the Hemorrhoid...

    Science.gov (United States)

    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...

  19. 76 FR 43119 - Medical Devices; General and Plastic Surgery Devices; Classification of the Focused Ultrasound...

    Science.gov (United States)

    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...

  20. Payments by US pharmaceutical and medical device manufacturers to US medical journal editors: retrospective observational study

    Science.gov (United States)

    Bell, Chaim M; Matelski, John J; Detsky, Allan S; Cram, Peter

    2017-01-01

    Objective To estimate financial payments from industry to US journal editors. Design Retrospective observational study. Setting 52 influential (high impact factor for their specialty) US medical journals from 26 specialties and US Open Payments database, 2014. Participants 713 editors at the associate level and above identified from each journal’s online masthead. Main outcome measures All general payments (eg, personal income) and research related payments from pharmaceutical and medical device manufacturers to eligible physicians in 2014. Percentages of editors receiving payments and the magnitude of such payments were compared across journals and by specialty. Journal websites were also reviewed to determine if conflict of interest policies for editors were readily accessible. Results Of 713 eligible editors, 361 (50.6%) received some (>$0) general payments in 2014, and 139 (19.5%) received research payments. The median general payment was $11 (£8; €9) (interquartile range $0-2923) and the median research payment was $0 ($0-0). The mean general payment was $28 136 (SD $415 045), and the mean research payment was $37 963 (SD $175 239). The highest median general payments were received by journal editors from endocrinology ($7207, $0-85 816), cardiology ($2664, $0-12 912), gastroenterology ($696, $0-20 002), rheumatology ($515, $0-14 280), and urology ($480, $90-669). For high impact general medicine journals, median payments were $0 ($0-14). A review of the 52 journal websites revealed that editor conflict of interest policies were readily accessible (ie, within five minutes) for 17/52 (32.7%) of journals. Conclusions Industry payments to journal editors are common and often large, particularly for certain subspecialties. Journals should consider the potential impact of such payments on public trust in published research. PMID:29074628

  1. Helping Older Adults Improve Their Medication Experience (HOME) by Addressing Medication Regimen Complexity in Home Healthcare.

    Science.gov (United States)

    Sheehan, Orla C; Kharrazi, Hadi; Carl, Kimberly J; Leff, Bruce; Wolff, Jennifer L; Roth, David L; Gabbard, Jennifer; Boyd, Cynthia M

    In skilled home healthcare (SHHC), communication between nurses and physicians is often inadequate for medication reconciliation and needed changes to the medication regimens are rarely made. Fragmentation of electronic health record (EHR) systems, transitions of care, lack of physician-nurse in-person contact, and poor understanding of medications by patients and their families put patients at risk for serious adverse outcomes. The aim of this study was to develop and test the HOME tool, an informatics tool to improve communication about medication regimens, share the insights of home care nurses with physicians, and highlight to physicians and nurses the complexity of medication schedules. We used human computer interaction design and evaluation principles, automated extraction from standardized forms, and modification of existing EHR fields to highlight key medication-related insights that had arisen during the SHHC visit. Separate versions of the tool were developed for physicians/nurses and patients/caregivers. A pilot of the tool was conducted using 20 SHHC encounters. Home care nurses and physicians found the tool useful for communication. Home care nurses were able to implement the HOME tool into their clinical workflow and reported improved communication with physicians about medications. This simple and largely automated tool improves understanding and communication around medications in SHHC.

  2. Recent advances in medical device triage technologies for chemical, biological, radiological, and nuclear events.

    Science.gov (United States)

    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.

  3. Biofilm eradication and prevention: a pharmaceutical approach to medical device infections

    National Research Council Canada - National Science Library

    Shunmugaperumal, Tamilvanan

    2010-01-01

    "Biofilm Eradication and Preventions presents the basics of biofilm formation on medical devices, diseases related to this formation, and approaches pharmaceutical researchers need to take to limit this problem...

  4. [Precautions of physical performance requirements and test methods during product standard drafting process of medical devices].

    Science.gov (United States)

    Song, Jin-Zi; Wan, Min; Xu, Hui; Yao, Xiu-Jun; Zhang, Bo; Wang, Jin-Hong

    2009-09-01

    The major idea of this article is to discuss standardization and normalization for the product standard of medical devices. Analyze the problem related to the physical performance requirements and test methods during product standard drafting process and make corresponding suggestions.

  5. 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

  6. 77 FR 125 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Device Classification...

    Science.gov (United States)

    2012-01-03

    ... organization. These 16 Panels have largely been the driving force for CDRH's internal organizational structure...). The draft guidance, when finalized, will represent the Agency's current thinking on medical device...

  7. 78 FR 21612 - Medical Device Classification Product Codes; Guidance for Industry and Food and Drug...

    Science.gov (United States)

    2013-04-11

    ... driving force for CDRH's internal organizational structure as well. These Panels were established with the... guidance represents the Agency's current thinking on medical device classification product codes. It does...

  8. 75 FR 20854 - Medical Device Use in the Home Environment: Implications for the Safe and Effective Use of...

    Science.gov (United States)

    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...

  9. Medical Device Plug-and-Play Interoperability Standards and Technology Leadership

    Science.gov (United States)

    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

  10. Efficient organic light-emitting devices with platinum-complex emissive layer

    KAUST Repository

    Yang, Xiaohui

    2011-01-18

    We report efficient organic light-emitting devices having a platinum-complex emissive layer with the peak external quantum efficiency of 17.5% and power efficiency of 45 lm W−1. Variation in the device performance with platinum-complex layer thickness can be attributed to the interplay between carrier recombination and intermolecular interactions in the layer. Efficient white devices using double platinum-complex layers show the external quantum efficiency of 10%, the Commission Internationale d’Énclairage coordinates of (0.42, 0.41), and color rendering index of 84 at 1000 cd m−2.

  11. Efficient organic light-emitting devices with platinum-complex emissive layer

    KAUST Repository

    Yang, Xiaohui; Wu, Fang-Iy; Haverinen, Hanna; Li, Jian; Cheng, Chien-Hong; Jabbour, Ghassan E.

    2011-01-01

    We report efficient organic light-emitting devices having a platinum-complex emissive layer with the peak external quantum efficiency of 17.5% and power efficiency of 45 lm W−1. Variation in the device performance with platinum-complex layer thickness can be attributed to the interplay between carrier recombination and intermolecular interactions in the layer. Efficient white devices using double platinum-complex layers show the external quantum efficiency of 10%, the Commission Internationale d’Énclairage coordinates of (0.42, 0.41), and color rendering index of 84 at 1000 cd m−2.

  12. Electromagnetic compatibility of WLAN adapters with life-supporting medical devices.

    Science.gov (United States)

    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.

  13. BioInnovate Ireland--fostering entrepreneurial activity through medical device innovation training.

    Science.gov (United States)

    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.

  14. 75 FR 17143 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Science.gov (United States)

    2010-04-05

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0495] Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Documents; Availability AGENCY: Food and Drug Administration, HHS. ACTION...

  15. 75 FR 44267 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Science.gov (United States)

    2010-07-28

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0495] Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening of Comment Period AGENCY: Food and Drug...

  16. Virtual worlds are an innovative tool for medical device training in a simulated environment.

    Science.gov (United States)

    Patel, Vishal; Lee, Henry; Taylor, Dave; Aggarwal, Rajesh; Kinross, James; Darzi, Ara

    2012-01-01

    Medical infusion devices are an integral component within the delivery of healthcare management. The aim of this study was to develop a training simulation in the virtual world of Second Life for the management of adverse events associated with infusion devices. Forty nurses were subsequently recruited to participate within the simulation and assess its feasibility.

  17. 77 FR 26769 - Educational Forum on Medical Device Reporting, Complaint Files, and Recalls, Corrections, and...

    Science.gov (United States)

    2012-05-07

    ... Device Quality Systems Regulation (QSR) to the regulated industry, particularly small businesses. DATES... registration fee will be used to offset expenses of hosting the event including continental breakfast, lunch... interest in the topics discussed from small medical device manufacturers in the Dallas District area. This...

  18. 76 FR 20840 - Medical Devices; General and Plastic Surgery Devices; Classification of the Low Level Laser...

    Science.gov (United States)

    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...

  19. 78 FR 25747 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2013-05-02

    ... Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD... as catheters, cannulae or hollow needles. Chronic hemodialysis catheters are soft, blunt-tipped...

  20. Wearable Devices in Medical Internet of Things: Scientific Research and Commercially Available Devices

    OpenAIRE

    Haghi, Mostafa; Thurow, Kerstin; Stoll, Regina

    2017-01-01

    Objectives 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 a...

  1. A Sensor Middleware for integration of heterogeneous medical devices.

    Science.gov (United States)

    Brito, M; Vale, L; Carvalho, P; Henriques, J

    2010-01-01

    In this paper, the architecture of a modular, service-oriented, Sensor Middleware for data acquisition and processing is presented. The described solution was developed with the purpose of solving two increasingly relevant problems in the context of modern pHealth systems: i) to aggregate a number of heterogeneous, off-the-shelf, devices from which clinical measurements can be acquired and ii) to provide access and integration with an 802.15.4 network of wearable sensors. The modular nature of the Middleware provides the means to easily integrate pre-processing algorithms into processing pipelines, as well as new drivers for adding support for new sensor devices or communication technologies. Tests performed with both real and artificially generated data streams show that the presented solution is suitable for use both in a Windows PC or a Windows Mobile PDA with minimal overhead.

  2. Enabling Medical Device Interoperability for the Integrated Clinical Environment

    Science.gov (United States)

    2016-12-01

    context. For instance, part of the data logger demo at NIH included a scenario in which the patient received an overdose from a PCA pump . The device...data shows the patient’s physiologic response, the log from a PCA pump would show that the dose request button was pressed, but only the video could...databases including Microsoft Access  vcd (IEEE-1364) – Value Change Dump – a waveform storage format defined by the Institute of Electrical and

  3. Implantable Glucose BioFuel Cells for Medical Devices

    International Nuclear Information System (INIS)

    Cinquin, P; Martin, D K; Cosnier, S; Belgacem, N; Cosnier, M L; Dal Molin, R

    2013-01-01

    An Implantable BioFuel Cell (IBFC) is a device that produces power only from the chemicals that are naturally occurring inside the body. We have been working on two approaches to creating an IBFC. The first approach is to use chemicals such as glucose and oxygen to provide the fuel for an enzymatic IBFC. The second approach is to use electrolytes such as sodium to provide the fuel for a biomimetic IBFC

  4. Medical devices and the Middle East: market, regulation, and reimbursement in Gulf Cooperation Council states

    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 

  5. Efficient light-emitting devices based on platinum-complexes-anchored polyhedral oligomeric silsesquioxane materials

    KAUST Repository

    Yang, Xiaohui

    2010-08-24

    The synthesis, photophysical, and electrochemical characterization of macromolecules, consisting of an emissive platinum complex and carbazole moieties covalently attached to a polyhedral oligomeric silsesquioxane (POSS) core, is reported. Organic light-emitting devices based on these POSS materials exhibit a peak external quantum efficiency of ca. 8%, which is significantly higher than that of the analogous devices with a physical blend of the platinum complexes and a polymer matrix, and they represent noticeable improvement in the device efficiency of solution-processable phosphorescent excimer devices. Furthermore, the ratio of monomer and excimer/aggregate electroluminescent emission intensity, as well as the device efficiency, increases as the platinum complex moiety presence on the POSS macromolecules decreases. © 2010 American Chemical Society.

  6. 78 FR 950 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    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...

  7. Commercial viability of medical devices using Headroom and return on investment calculation

    NARCIS (Netherlands)

    Markiewicz, Katarzyna; van Til, Janine Astrid; Steuten, Lotte Maria Gertruda; IJzerman, Maarten Joost

    2016-01-01

    The market success of a medical product depends on its commercial viability, yet this may be hard to predict during the development process of medical devices. This paper aims to determine if applying the Headroom method combined with return on investment (ROI) analysis allows for estimation of the

  8. 77 FR 52742 - Public Meeting-Strengthening the National Medical Device Postmarket Surveillance System; Request...

    Science.gov (United States)

    2012-08-30

    ... Contact Person) no later than September 5, 2012. No commercial or promotional material will be permitted... develop and implement a comprehensive medical device postmarket surveillance strategy to collect, analyze... implementing this strategy, FDA is holding a public meeting to discuss the current and future state of medical...

  9. 21 CFR 610.42 - Restrictions on use for further manufacture of medical devices.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Restrictions on use for further manufacture of medical devices. 610.42 Section 610.42 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... for Communicable Disease Agents § 610.42 Restrictions on use for further manufacture of medical...

  10. Design and Functional Validation of a Complex Impedance Measurement Device for Characterization of Ultrasonic Transducers

    International Nuclear Information System (INIS)

    De-Cock, Wouter; Cools, Jan; Leroux, Paul

    2013-06-01

    This paper presents the design and practical implementation of a complex impedance measurement device capable of characterization of ultrasonic transducers. The device works in the frequency range used by industrial ultrasonic transducers which is below the measurement range of modern high end network analyzers. The device uses the Goertzel algorithm instead of the more common FFT algorithm to calculate the magnitude and phase component of the impedance under test. A theoretical overview is given followed by a practical approach and measurement results. (authors)

  11. On-line integration of computer controlled diagnostic devices and medical information systems in undergraduate medical physics education for physicians.

    Science.gov (United States)

    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.

  12. Payments by US pharmaceutical and medical device manufacturers to US medical journal editors: retrospective observational study.

    Science.gov (United States)

    Liu, Jessica J; Bell, Chaim M; Matelski, John J; Detsky, Allan S; Cram, Peter

    2017-10-26

    Objective  To estimate financial payments from industry to US journal editors. Design  Retrospective observational study. Setting  52 influential (high impact factor for their specialty) US medical journals from 26 specialties and US Open Payments database, 2014. Participants  713 editors at the associate level and above identified from each journal's online masthead. Main outcome measures  All general payments (eg, personal income) and research related payments from pharmaceutical and medical device manufacturers to eligible physicians in 2014. Percentages of editors receiving payments and the magnitude of such payments were compared across journals and by specialty. Journal websites were also reviewed to determine if conflict of interest policies for editors were readily accessible. Results  Of 713 eligible editors, 361 (50.6%) received some (>$0) general payments in 2014, and 139 (19.5%) received research payments. The median general payment was $11 (£8; €9) (interquartile range $0-2923) and the median research payment was $0 ($0-0). The mean general payment was $28 136 (SD $415 045), and the mean research payment was $37 963 (SD $175 239). The highest median general payments were received by journal editors from endocrinology ($7207, $0-85 816), cardiology ($2664, $0-12 912), gastroenterology ($696, $0-20 002), rheumatology ($515, $0-14 280), and urology ($480, $90-669). For high impact general medicine journals, median payments were $0 ($0-14). A review of the 52 journal websites revealed that editor conflict of interest policies were readily accessible (ie, within five minutes) for 17/52 (32.7%) of journals. Conclusions  Industry payments to journal editors are common and often large, particularly for certain subspecialties. Journals should consider the potential impact of such payments on public trust in published research. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a

  13. The medical-industrial complex, professional medical associations, and continuing medical education.

    Science.gov (United States)

    Schofferman, Jerome

    2011-12-01

    Financial relationships among the biomedical industries, physicians, and professional medical associations (PMAs) can be professional, ethical, mutually beneficial, and, most importantly, can lead to improved medical care. However, such relationships, by their very nature, present conflicts of interest (COIs). One of the greatest concerns regarding COI is continuing medical education (CME), especially because currently industry funds 40-60% of CME. COIs have the potential to bias physicians in practice, educators, and those in leadership positions of PMAs and well as the staff of a PMA. These conflicts lead to the potential to bias the content and type of CME presentations and thereby influence physicians' practice patterns and patient care. Physicians are generally aware of the potential for bias when industry contributes funding for CME, but they are most often unable to detect the bias. This may because it is very subtle and/or the educators themselves may not realize that they have been influenced by their relationships with industry. Following Accreditation Council for Continuing Medical Education guidelines and mandating disclosure that is transparent and complete have become the fallback positions to manage COIs, but such disclosure does not really mitigate the conflict. The eventual and best solutions to ensure evidence-based education are complete divestment by educators and leaders of PMAs, minimal and highly controlled industry funding of PMAs, blind pooling of any industry contributions to PMAs and CME, strict verification of disclosures, clear separation of marketing from education at CME events, and strict oversight of presentations for the presence of bias. Wiley Periodicals, Inc.

  14. An information model to support user-centered design of medical devices.

    Science.gov (United States)

    Hagedorn, Thomas J; Krishnamurty, Sundar; Grosse, Ian R

    2016-08-01

    The process of engineering design requires the product development team to balance the needs and limitations of many stakeholders, including those of the user, regulatory organizations, and the designing institution. This is particularly true in medical device design, where additional consideration must be given for a much more complex user-base that can only be accessed on a limited basis. Given this inherent challenge, few projects exist that consider design domain concepts, such as aspects of a detailed design, a detailed view of various stakeholders and their capabilities, along with the user-needs simultaneously. In this paper, we present a novel information model approach that combines a detailed model of design elements with a model of the design itself, customer requirements, and of the capabilities of the customer themselves. The information model is used to facilitate knowledge capture and automated reasoning across domains with a minimal set of rules by adopting a terminology that treats customer and design specific factors identically, thus enabling straightforward assessments. A uniqueness of this approach is that it systematically provides an integrated perspective on the key usability information that drive design decisions towards more universal or effective outcomes with the very design information impacted by the usability information. This can lead to cost-efficient optimal designs based on a direct inclusion of the needs of customers alongside those of business, marketing, and engineering requirements. Two case studies are presented to show the method's potential as a more effective knowledge management tool with built-in automated inferences that provide design insight, as well as its overall effectiveness as a platform to develop and execute medical device design from a holistic perspective. Copyright © 2016 Elsevier Inc. All rights reserved.

  15. Guarantee of reliability of devices complexes for plastic tube welding

    International Nuclear Information System (INIS)

    Voskresenskij, L.A.; Zajtsev, A.I.; Nelyubov, V.I.; Fedorov, M.A.

    1988-01-01

    Results of calculations and experimental studies on providing reliability of complex for plastic tube welding are presented. Choice of reliability indeces and standards is based. Reliability levels of components are determined. The most waded details are calculated. It is shown that they meet the reqrurements of strength and reliability. Service life tests supported the correct choice of springs. Recommendations on elevating reliability are given. Directions of further developments are shown. 8 refs.; 2 figs.; 1 tab

  16. Protective device for organs exposed to medical X-radiation

    International Nuclear Information System (INIS)

    Zimmer, K.

    1978-01-01

    The protective device for male or female gonads consists of a protective screen made of hard lead coated with silicon caoutchouc, a flexible supporting arm, and a base plate on which the supporting arm for the protective screen is monted. The protective screen has got the shape of a dish resp. a pear-shaped contour for male resp. female persons. The base may be arranged on a Bucky table between the legs of the person to be examined by means of suction cups. (DG) [de

  17. Medical device innovation and the value analysis process.

    Science.gov (United States)

    Krantz, Heidi; Strain, Barbara; Torzewski, Jane

    2017-09-01

    Heidi A. Krantz, RN, BSN is the Director of Value Analysis at Johns Hopkins Bayview Medical Center in the Johns Hopkins Health System. Barbara Strain, MA, CVAHP is the Director of Value Management at the University of Virginia Health System. Jane Torzewski RN, MAN, MBA is a Senior Category Manager for the Mayo Clinic Physician Preference Contracting team. She previously was a Senior Clinical Value Analyst on the Mayo Clinic Value Analysis team. Copyright © 2018. Published by Elsevier Inc.

  18. EXPERIENCES IN THE AIR SPINNING TO MANUFACTURE MEDICAL DEVICES

    Directory of Open Access Journals (Sweden)

    MARSAL Feliu

    2015-05-01

    Full Text Available The work aims to determine, with scientific rigor, differences in key parameters of the yarns produced by conventional ring spinning systems, open-end and air spinning and its interrelation with the main parameters of those products that are intended for medical-sanitary sector. The experiences have been made in a Spanish company from short fibers sector that has three spinning systems, with tradition and prestige in world market, validating the results in Innotex Center laboratories of the Polytechnic University of Catalonia. Considering the results, it shows that the technology of manufacture of yarns by air is suitable for yarn, woven fabrics and knitting, structures to textile medical-sanitary application, by specific properties as well as enhanced competitiveness, due to the high production rate and shortened spinning process. The viscose yarns manufactured by air mass are more mass regular. The new DR parameter clearly indicates a better look of the finished fabric when we work with yarns produced by air technology.The significant reduction of the hairiness means less formation of loose fibres by friction, very important in the application of these yarns in the manufacture of textile structures for medical-sanitary use. Also no-table increase of about 15% in the absorption capacity of the fluids, especially water, from the yarns made by air. In the functionalization of fabrics obtained from spun yarn by air will need to apply a permanent smoothing.

  19. High-risk medical devices, children and the FDA: regulatory challenges facing pediatric mechanical circulatory support devices.

    Science.gov (United States)

    Almond, Christopher S D; Chen, Eric A; Berman, Michael R; Less, Joanne R; Baldwin, J Timothy; Linde-Feucht, Sarah R; Hoke, Tracey R; Pearson, Gail D; Jenkins, Kathy; Duncan, Brian W; Zuckerman, Bram D

    2007-01-01

    Pediatric mechanical circulatory support is a critical unmet need in the United States. Infant- and child-sized ventricular assist devices are currently being developed largely through federal contracts and grants through the National Heart, Lung, and Blood Institute (NHLBI). Human testing and marketing of high-risk devices for children raises epidemiologic and regulatory issues that will need to be addressed. Leaders from the US Food and Drug Administration (FDA), NHLBI, academic pediatric community, and industry convened in January 2006 for the first FDA Workshop on the Regulatory Process for Pediatric Mechanical Circulatory Support Devices. The purpose was to provide the pediatric community with an overview of the federal regulatory process for high-risk medical devices and to review the challenges specific to the development and regulation of pediatric mechanical circulatory support devices. Pediatric mechanical circulatory support present significant epidemiologic, logistic, and financial challenges to industry, federal regulators, and the pediatric community. Early interactions with the FDA, shared appreciation of challenges, and careful planning will be critical to avoid unnecessary delays in making potentially life-saving devices available for children. Collaborative efforts to address these challenges are warranted.

  20. Protecting computer-based medical devices: defending against viruses and other threats.

    Science.gov (United States)

    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.

  1. Children with medical complexity: the change in the pediatric epidemiology

    Directory of Open Access Journals (Sweden)

    Rino Agostiniani

    2014-06-01

    Full Text Available In the last years, epidemiological landscape of pediatric illness is changed; we are facing a progressive raising of the number of children affected by chronic illness (children with special health care needs [CSHCN], mainly due to the amelioration in surviving and in care. These patients have become the majority of the inpatients in some specialist hospitals, like the Meyer Children’s Hospital (Florence, Italy, in 2012. One important group of CSHCN is represented by the children who are most medically fragile and have the most intensive health care needs (children with medical complexity [CMC]. In these patients, the complexity of the pathological framework frequently results in a plenty of visits and tests, with high risk of redundant and expensive cares. They also need outside support networks such as advocacy and accommodations at school, at home, in social life. The CMC needs specific skill and new strategies that could involve pediatricians in hospital as in home care. The professional competencies are ready but a clear and shared strategy is lacking. Proceedings of the 10th International Workshop on Neonatology · Cagliari (Italy · October 22nd-25th, 2014 · The last ten years, the next ten years in Neonatology Guest Editors: Vassilios Fanos, Michele Mussap, Gavino Faa, Apostolos Papageorgiou

  2. Integration of human factors and ergonomics during medical device design and development: it's all about communication.

    Science.gov (United States)

    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.

  3. Laser direct writing of micro- and nano-scale medical devices

    Science.gov (United States)

    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

  4. Nanolithography for oxide nanoarrays and their application in medical devices

    NARCIS (Netherlands)

    Luttge, R.; Teherani, F.H.; Look, D.C.; Litton, C.W.; Rogers, D.J.

    2010-01-01

    Using lithographic patterning techniques, normally we aim for the integration of structural elements into a more complex apparatus, which can be at various length scales, for example hand-held equipment. Nanoscale fabricated pillars, holes or wires have shown unique properties already and ordering

  5. [Regulatory Program for Medical Devices in Cuba: experiences and current challenges].

    Science.gov (United States)

    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.

  6. Comparison of Transplant Waitlist Outcomes for Pediatric Candidates Supported by Ventricular Assist Devices Versus Medical Therapy.

    Science.gov (United States)

    Law, Sabrina P; Oron, Assaf P; Kemna, Mariska S; Albers, Erin L; McMullan, D Michael; Chen, Jonathan M; Law, Yuk M

    2018-05-01

    Ventricular assist devices have gained popularity in the management of refractory heart failure in children listed for heart transplantation. Our primary aim was to compare the composite endpoint of all-cause pretransplant mortality and loss of transplant eligibility in children who were treated with a ventricular assist device versus a medically managed cohort. This was a retrospective cohort analysis. Data were obtained from the Scientific Registry of Transplant Recipients. The at-risk population (n = 1,380) was less than 18 years old, either on a ventricular assist device (605 cases) or an equivalent-severity, intensively medically treated group (referred to as MED, 775 cases). None. The impact of ventricular assist devices was estimated via Cox proportional hazards regression (hazard ratio), dichotomizing 1-year outcomes to "poor" (22%: 193 deaths, 114 too sick) versus all others (940 successful transplants, 41 too healthy, 90 censored), while adjusting for conventional risk factors. Among children 0-12 months old, ventricular assist device was associated with a higher risk of poor outcomes (hazard ratio, 2.1; 95% CI, 1.5-3.0; p comparative study of ventricular assist devices versus medical therapy in children. Age is a significant modulator of waitlist outcomes for children with end-stage heart failure supported by ventricular assist device, with the impact of ventricular assist devices being more beneficial in adolescents.

  7. Left to their own devices: medical learners' use of mobile technologies.

    Science.gov (United States)

    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.

  8. 78 FR 28733 - Medical Devices; General Hospital and Personal Use Monitoring Devices; Classification of the...

    Science.gov (United States)

    2013-05-16

    ... through intrabody communication to an external recorder which records the date and time of ingestion as... prior to marketing the device, which contains information about the ingestible event marker they intend... environment. Therefore, neither an environmental assessment nor an environmental impact statement is required...

  9. 76 FR 6551 - Medical Devices; General and Plastic Surgery Devices; Classification of Contact Cooling System...

    Science.gov (United States)

    2011-02-07

    ... (classes) of devices, depending on the regulatory controls needed to provide reasonable assurance of their... addressed by adequate bench testing demonstrating that the feedback controls for temperature/ cooling are functional and do maintain target temperature within the stated value. Proper function of mechanical controls...

  10. 77 FR 16925 - Medical Devices; Neurological Devices; Classification of the Near Infrared Brain Hematoma Detector

    Science.gov (United States)

    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...

  11. 77 FR 8117 - Medical Devices; Cardiovascular Devices; Classification of the Endovascular Suturing System

    Science.gov (United States)

    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...

  12. Communication during pediatric asthma visits and child asthma medication device technique 1 month later.

    Science.gov (United States)

    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.

  13. Views of patients and professionals about electronic multicompartment medication devices: a qualitative study.

    Science.gov (United States)

    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

  14. System Testability Analysis for Complex Electronic Devices Based on Multisignal Model

    International Nuclear Information System (INIS)

    Long, B; Tian, S L; Huang, J G

    2006-01-01

    It is necessary to consider the system testability problems for electronic devices during their early design phase because modern electronic devices become smaller and more compositive while their function and structure are more complex. Multisignal model, combining advantage of structure model and dependency model, is used to describe the fault dependency relationship for the complex electronic devices, and the main testability indexes (including optimal test program, fault detection rate, fault isolation rate, etc.) to evaluate testability and corresponding algorithms are given. The system testability analysis process is illustrated for USB-GPIB interface circuit with TEAMS toolbox. The experiment results show that the modelling method is simple, the computation speed is rapid and this method has important significance to improve diagnostic capability for complex electronic devices

  15. OR.NET RT: how service-oriented medical device architecture meets real-time communication.

    Science.gov (United States)

    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).

  16. Value driven innovation in medical device design: a process for balancing stakeholder voices.

    Science.gov (United States)

    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.

  17. Microbiological Load Of Ethylene Oxide Sterilized Medical Devices And Its Elimination By Cobalt 60 Source

    International Nuclear Information System (INIS)

    Bashir, R.; Afroze, B.; Zulfiqar, H. F.; Saleem, R.; Saleem, F.; Aslam, F.; Naz, S.

    2016-01-01

    Objective: To determine the residing microbial flora of ethylene oxide (EtO) sterilized medical devices and optimization of safe dose of gamma radiation (Cobalt 60 source) for the complete elimination of microbial load. Study Design: Experimental study. Place and Duration of Study: Department of Biotechnology, Lahore College for Women University, Lahore, Pakistan from September 2014 to June 2015. Methodology: Thirty-six samples of EtO sterilized medical devices of same batch of three different companies were collected for this study. Isolation and enumeration of microbes were done by using different selective and differential media. Gram staining and biochemically characterization by API 20 (Bio Merieux, France) kit was done for identification of the microorganisms. The medical devices having high microbial load were sent to Pakistan Radiation Services (PARAS) for gamma irradiations at 3 different selected doses (20 KGy, 25 KGy, and 30 KGy). Result: Different types of Gram positive bacteria (Staphylococcus epidermidis, Staphylococcus aureus and Bacillus subtilis) were isolated from the EtO sterilized samples. Gram negative bacteria and fungi were not detected on these medical devices. Gamma irradiations Result showed that 30 KGy was optimized dose for complete elimination of microbial flora on endotracheal, Nelaton, and tracheostomy tubes. Conclusion: Gamma radiations (Co 60 source) effectively decontaminate the microbial flora on the equipment previously sterilized by the ethylene oxide gas; and 30 KGy is the optimized dose for all these medical devices. (author)

  18. Framework conditions and requirements to ensure the technical functional safety of reprocessed medical devices.

    Science.gov (United States)

    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.

  19. Distribution of microorganisms in medical devices and their inactivation effects by gamma-irradiation

    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)

  20. Medical Device Regulation: A Comparison of the United States and the European Union.

    Science.gov (United States)

    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.

  1. 77 FR 7589 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-02-13

    ... ongoing randomized clinical trial, ``Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis'' (SAMMPRIS), published in the New England Journal of Medicine (2011;365...-0923. FDA intends to make background material available to the public no later than 2 business days...

  2. 76 FR 63928 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-10-14

    ..., releasing the Sensor. Electronics Unit (Interrogator) and database--The Electronics Unit contains hardware... transmitted from the electronics unit, and presents the data for review by medical professionals. FDA intends... person on or before November 30, 2011. Oral presentations from the public will be scheduled between...

  3. Dual-tree complex wavelet for medical image watermarking

    International Nuclear Information System (INIS)

    Mavudila, K.R.; Ndaye, B.M.; Masmoudi, L.; Hassanain, N.; Cherkaoui, M.

    2010-01-01

    In order to transmit medical data between hospitals, we insert the information for each patient in the image and its diagnosis, the watermarking consist to insert a message in the image and try to find it with the maximum possible fidelity. This paper presents a blind watermarking scheme in wavelet transform domain dual tree (DTT), who increasing the robustness and preserves the image quality. This system is transparent to the user and allows image integrity control. In addition, it provides information on the location of potential alterations and an evaluation of image modifications which is of major importance in a medico-legal framework. An example using head magnetic resonance and mammography imaging illustrates the overall method. Wavelet techniques can be successfully applied in various image processing methods, namely in image de noising, segmentation, classification, watermarking and others. In this paper we discussed the application of dual tree complex wavelet transform (D T-CWT), which has significant advantages over classic discrete wavelet transform (DWT), for certain image processing problems. The D T-CWT is a form of discreet wavelet transform which generates complex coefficients by using a dual tree of wavelet filters to obtain their real and imaginary parts. The main part of the paper is devoted to profit the exceptional quality for D T-CWT, compared to classical DWT, for a blind medical image watermarking, our schemes are using for the performance bivariate shrinkage with local variance estimation and are robust of attacks and favourably preserves the visual quality. Experimental results show that embedded watermarks using CWT give good image quality and are robust in comparison with the classical DWT.

  4. 47 CFR 95.1119 - Specific requirements for wireless medical telemetry devices operating in the 608-614 MHz band.

    Science.gov (United States)

    2010-10-01

    ... devices operating in the 608-614 MHz band. For a wireless medical telemetry device operating within the... 47 Telecommunication 5 2010-10-01 2010-10-01 false Specific requirements for wireless medical telemetry devices operating in the 608-614 MHz band. 95.1119 Section 95.1119 Telecommunication FEDERAL...

  5. Synthetic diamond devices for medical dosimetry applied to radiotherapy

    International Nuclear Information System (INIS)

    Descamps, C.

    2007-06-01

    The aim of this thesis, lead in the framework of an integrated European project entitled M.A.E.S.T.R.O. for ' Methods and Advanced Equipment for Simulation and Treatment in Radio Oncology', was to develop and test synthetic diamond detector in clinical environment for new modalities used in radiotherapy. Diamond is a good candidate for the detection of high energy beams in medical fields. It can be used for passive dosimetry, as thermoluminescent dosimeters or for active dosimetry as ionisation chambers. These two applications are presented here. Concerning the thermoluminescence, several impurities or dopants (boron, phosphorus, and nitrogen) have been incorporated in the diamond films during growth, in order to modify the material dosimetric properties and a detailed study of nitrogen-containing films is proposed. The second part presents the results obtained in active dosimetry. Two guide lines were followed: the measurement set-up optimisation and the material modification. The first dosimetric studies under radiotherapy beams concerning nitrogen-containing polycrystalline diamond as well as high purity single crystal diamond are conclusive. The detectors behaviours are in agreement with the recommendations of the International Atomic Energy Agency (IAEA). (author)

  6. Limited Awareness of the Essences of Certification or Compliance Markings on Medical Devices.

    Science.gov (United States)

    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.

  7. A prospective window into medical device-related pressure ulcers in intensive care.

    Science.gov (United States)

    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.

  8. Medical Device Integrated Vital Signs Monitoring Application with Real-Time Clinical Decision Support.

    Science.gov (United States)

    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.

  9. Wireless communication with implanted medical devices using the conductive properties of the body.

    Science.gov (United States)

    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.

  10. Near-infrared electroluminescence from double-emission-layers devices based on Ytterbium (III) complexes

    International Nuclear Information System (INIS)

    Li Zhefeng; Zhang Hongjie; Yu Jiangbo

    2012-01-01

    We investigated near-infrared electroluminescence properties of two lanthanide complexes Yb(PMBP) 3 Bath [PMBP = tris(1-phenyl-3-methyl-4-(4-tert-butylbenzacyl)-5-pyrazolone); Bath = bathophenanthroline] and Yb(PMIP) 3 TP 2 [PMIP = tris(1-phenyl-3-methyl-4-isobutyryl-5-pyrazolone); TP = triphenyl phosphine oxide] by fabricated the double-emission-layers devices. From the device characteristics, it is known that holes are easier to transport in Yb(PMIP) 3 TP 2 layer and electrons are easier to transport in Yb(PMBP) 3 Bath layer, at the same time, both of the two complexes can be acted as emission layers in the device. The recombination region of carriers has been confined in the interface of Yb(PMIP) 3 TP 2 /Yb(PMBP) 3 Bath, and pure Yb 3+ ion characteristic emission centered at 980 nm has been obtained. The device shows the maximum near-infrared irradiance as 14.7 mW/m 2 at the applied voltage of 17.8 V. - Highlights: ► Near-infrared electroluminescent devices with Yb(III) complexes as emission layers. ► Double-emission layer device structure introduced to balance carriers. ► Improved performance of double-emission layer device.

  11. Rapid and Low-cost Prototyping of Medical Devices Using 3D Printed Molds for Liquid Injection Molding

    Science.gov (United States)

    Chung, Philip; Heller, J. Alex; Etemadi, Mozziyar; Ottoson, Paige E.; Liu, Jonathan A.; Rand, Larry; Roy, Shuvo

    2014-01-01

    Biologically inert elastomers such as silicone are favorable materials for medical device fabrication, but forming and curing these elastomers using traditional liquid injection molding processes can be an expensive process due to tooling and equipment costs. As a result, it has traditionally been impractical to use liquid injection molding for low-cost, rapid prototyping applications. We have devised a method for rapid and low-cost production of liquid elastomer injection molded devices that utilizes fused deposition modeling 3D printers for mold design and a modified desiccator as an injection system. Low costs and rapid turnaround time in this technique lower the barrier to iteratively designing and prototyping complex elastomer devices. Furthermore, CAD models developed in this process can be later adapted for metal mold tooling design, enabling an easy transition to a traditional injection molding process. We have used this technique to manufacture intravaginal probes involving complex geometries, as well as overmolding over metal parts, using tools commonly available within an academic research laboratory. However, this technique can be easily adapted to create liquid injection molded devices for many other applications. PMID:24998993

  12. Efficient red organic electroluminescent devices based on trivalent europium complex obtained by designing the device structure with stepwise energy levels

    Energy Technology Data Exchange (ETDEWEB)

    Zhou, Liang; Jiang, Yunlong; Cui, Rongzhen; Li, Yanan; Zhao, Xuesen; Deng, Ruiping; Zhang, Hongjie, E-mail: hongjie@ciac.ac.cn

    2016-02-15

    In this study, we aim to further enhance the electroluminescence (EL) performances of trivalent europium complex Eu(TTA){sub 3}phen (TTA=thenoyltrifluoroacetone and phen=1,10-phenanthroline) by designing the device structure with stepwise energy levels. The widely used bipolar material 2,6-bis(3-(9H-carbazol-9-yl)phenyl)pyridine (26DCzPPy) was chosen as host material, while the doping concentration of Eu(TTA){sub 3}phen was optimized to be 4%. To facilitate the injection and transport of holes, MoO{sub 3} anode modification layer and 4,4′,4′′-Tris(carbazole-9-yl)triphenylamine (TcTa) hole transport layer were inserted in sequence. Efficient pure red emission with suppressed efficiency roll-off was obtained attributed to the reduction of accumulation holes, the broadening of recombination zone, and the improved balance of holes and electrons on Eu(TTA){sub 3}phen molecules. Finally, the device with 3 nm MoO{sub 3} and 5 nm TcTa obtained the highest brightness of 3278 cd/m{sup 2}, current efficiency of 12.45 cd/A, power efficiency of 11.50 lm/W, and external quantum efficiency of 6.60%. Such a device design strategy helps to improve the EL performances of emitters with low-lying energy levels and provides a chance to simplify device fabrication processes. - Highlights: • Electroluminescent performances of europium complex were further improved. • Device structure with stepwise energy levels was designed. • Better carriers' balance was realized by improving the injection and transport of holes. • The selection of bipolar host caused the broadening of recombination zone.

  13. Design for Additive Bio-Manufacturing: From Patient-Specific Medical Devices to Rationally Designed Meta-Biomaterials.

    Science.gov (United States)

    Zadpoor, Amir A

    2017-07-25

    Recent advances in additive manufacturing (AM) techniques in terms of accuracy, reliability, the range of processable materials, and commercial availability have made them promising candidates for production of functional parts including those used in the biomedical industry. The complexity-for-free feature offered by AM means that very complex designs become feasible to manufacture, while batch-size-indifference enables fabrication of fully patient-specific medical devices. Design for AM (DfAM) approaches aim to fully utilize those features for development of medical devices with substantially enhanced performance and biomaterials with unprecedented combinations of favorable properties that originate from complex geometrical designs at the micro-scale. This paper reviews the most important approaches in DfAM particularly those applicable to additive bio-manufacturing including image-based design pipelines, parametric and non-parametric designs, metamaterials, rational and computationally enabled design, topology optimization, and bio-inspired design. Areas with limited research have been identified and suggestions have been made for future research. The paper concludes with a brief discussion on the practical aspects of DfAM and the potential of combining AM with subtractive and formative manufacturing processes in so-called hybrid manufacturing processes.

  14. Design for Additive Bio-Manufacturing: From Patient-Specific Medical Devices to Rationally Designed Meta-Biomaterials

    Directory of Open Access Journals (Sweden)

    Amir A. Zadpoor

    2017-07-01

    Full Text Available Recent advances in additive manufacturing (AM techniques in terms of accuracy, reliability, the range of processable materials, and commercial availability have made them promising candidates for production of functional parts including those used in the biomedical industry. The complexity-for-free feature offered by AM means that very complex designs become feasible to manufacture, while batch-size-indifference enables fabrication of fully patient-specific medical devices. Design for AM (DfAM approaches aim to fully utilize those features for development of medical devices with substantially enhanced performance and biomaterials with unprecedented combinations of favorable properties that originate from complex geometrical designs at the micro-scale. This paper reviews the most important approaches in DfAM particularly those applicable to additive bio-manufacturing including image-based design pipelines, parametric and non-parametric designs, metamaterials, rational and computationally enabled design, topology optimization, and bio-inspired design. Areas with limited research have been identified and suggestions have been made for future research. The paper concludes with a brief discussion on the practical aspects of DfAM and the potential of combining AM with subtractive and formative manufacturing processes in so-called hybrid manufacturing processes.

  15. Medical Device Innovation in the Era of the Affordable Care Act: The End of Sexy.

    Science.gov (United States)

    Mattke, Soeren; Liu, Hangsheng; Orr, Patrick

    2016-06-20

    In this article, the authors explore why medical device innovation has traditionally been geared so thoroughly toward improving performance, with little regard to cost. They argue that the changing incentives in the health care sector and the move to value-based payment models, accelerated by the implementation of the Affordable Care Act, will force device manufacturers to redirect investments from the spectacular toward the prudent, which they dub "the end of sexy." The authors explore consequences for manufacturers, investors, and policymakers.

  16. 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.

  17. [Study on restriction factors and countermeasures of influence of China medical devices competitiveness].

    Science.gov (United States)

    Zhang, Zhijun

    2012-07-01

    Recent years, China medical devices industry has been a sunrise industry with widely-ranged products, high-tech innovation, and booming market demands. But with the globalization of market economy, China industry is still in the inferior position of competition. How to promote the industrial structure transition, increase scientific and technological level, speed up the updating of products, enhance the international competitiveness is one of the major tasks to maintain the healthy development of industry. This article makes a study on current situation of China medical devices industry, analyses the new opportunities, challenges and restriction factors, provides the countermeasures of strengthening industry competitiveness as well.

  18. 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.)

  19. Closed-loop approach for situation awareness of medical devices and operating room infrastructure

    Directory of Open Access Journals (Sweden)

    Rockstroh Max

    2015-09-01

    Full Text Available In recent years, approaches for information and control integration in the digital operating room have emerged. A major step towards an intelligent operating room and a cooperative technical environment would be autonomous adaptation of medical devices and systems to the surgical workflow. The OR staff should be freed from information seeking and maintenance tasks. We propose a closed-loop concept integrating workflow monitoring, processing and (semi-automatic interaction to bridge the gap between OR integration of medical devices and workflow-related information management.

  20. Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey.

    Science.gov (United States)

    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.

  1. Hydrophilic Polymer Embolism: Implications for Manufacturing, Regulation, and Postmarket Surveillance of Coated Intravascular Medical Devices.

    Science.gov (United States)

    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.

  2. Medical devices and the Middle East: market, regulation, and reimbursement in Gulf Cooperation Council states.

    Science.gov (United States)

    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.

  3. [Hospital-based health technology assessment in France: how to proceed to evaluate innovative medical devices?].

    Science.gov (United States)

    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.

  4. Characterization of Bacterial Etiologic Agents of Biofilm Formation in Medical Devices in Critical Care Setup

    Directory of Open Access Journals (Sweden)

    Sangita Revdiwala

    2012-01-01

    Full Text Available Background. Biofilms contaminate catheters, ventilators, and medical implants; they act as a source of disease for humans, animals, and plants. Aim. Critical care units of any healthcare institute follow various interventional strategies with use of medical devices for the management of critical cases. Bacteria contaminate medical devices and form biofilms. Material and Methods. The study was carried out on 100 positive bacteriological cultures of medical devices which were inserted in hospitalized patients. The bacterial isolates were processed as per microtitre plate. All the isolates were subjected to antibiotic susceptibility testing by VITEK 2 compact automated systems. Results. Out of the total 100 bacterial isolates tested, 88 of them were biofilm formers. A 16–20-hour incubation period was found to be optimum for biofilm development. 85% isolates were multidrug resistants and different mechanisms of bacterial drug resistance like ESBL, carbapenemase, and MRSA were found among isolates. Conclusion. Availability of nutrition in the form of glucose enhances the biofilm formation by bacteria. Time and availability of glucose are important factors for assessment of biofilm progress. It is an alarm for those who are associated with invasive procedures and indwelling medical devices especially in patients with low immunity.

  5. Effects of Medical Device Regulations on the Development of Stand-Alone Medical Software: A Pilot Study.

    Science.gov (United States)

    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.

  6. Sustained prevention of biofilm formation on a novel silicone matrix suitable for medical devices

    DEFF Research Database (Denmark)

    Steffensen, Søren Langer; Merete H., Vestergaard,; Jensen, Minna Grønning

    2015-01-01

    Bacterial colonization and biofilm formation on medical devices constitute major challenges in clinical long-term use of e.g. catheters due to the risk of (re)infection of patients, which would result in additional use of antibiotics risking bacterial resistance development. The aim of the present...... in the range of 1–20 mg/mL. Devices containing 25% (w/w) hydrogel and loaded with ciprofloxacin displayed a strong antibacterial effect against Staphylococcus aureus bacterial colonization and subsequent biofilm formation on the device material was inhibited for 29 days. In conclusion, the hydrogel...

  7. Pediatric medical device development by surgeons via capstone engineering design programs.

    Science.gov (United States)

    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.

  8. Medical Device Plug-and-Play Interoperability Standards and Technology Leadership

    Science.gov (United States)

    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

  9. Security and Privacy Qualities of Medical Devices: An Analysis of FDA Postmarket Surveillance

    OpenAIRE

    Ransford, Benjamin; Molina-Markham, Andres; Stewart, Quinn; Fu, Kevin; Kramer, Daniel Bruce; Baker, Matthew Charles; Reynolds, Matthew R.

    2012-01-01

    Background: Medical devices increasingly depend on computing functions such as wireless communication and Internet connectivity for software-based control of therapies and network-based transmission of patients’ stored medical information. These computing capabilities introduce security and privacy risks, yet little is known about the prevalence of such risks within the clinical setting. Methods: We used three comprehensive, publicly available databases maintained by the Food and Drug Admini...

  10. Application of complex programmable logic devices in memory radiation effects test system

    International Nuclear Information System (INIS)

    Li Yonghong; He Chaohui; Yang Hailiang; He Baoping

    2005-01-01

    The application of the complex programmable logic device (CPLD) in electronics is emphatically discussed. The method of using software MAX + plus II and CPLD are introduced. A new test system for memory radiation effects is established by using CPLD devices-EPM7128C84-15. The old test system's function are realized and, moreover, a number of small scale integrated circuits are reduced and the test system's reliability is improved. (authors)

  11. Care coordination, medical complexity, and unmet need for prescription medications among children with special health care needs.

    Science.gov (United States)

    Aboneh, Ephrem A; Chui, Michelle A

    Children with special health care needs (CSHCN) have multiple unmet health care needs including that of prescription medications. The objectives of this study were twofold: 1) to quantify and compare unmet needs for prescription medications for subgroups of CSHCN without and with medical complexity (CMC)-those who have multiple, chronic, and complex medical conditions associated with severe functional limitations and high utilization of health care resources, and 2) to describe its association with receipt of effective care coordination services and level of medical complexity. A secondary data analysis of the 2009/2010 National Survey of CSHCN, a nationally representative telephone survey of parents of CSHCN, was conducted. Logistic regression models were constructed to determine associations between unmet need for prescription medications and medical complexity and care coordination for families of CSHCN, while controlling for demographic variables such as race, insurance, education level, and household income. Analyses accounted for the complex survey design and sampling weights. CMC represented about 3% of CSHCN. CMC parents reported significantly more unmet need for prescription medications and care coordination (4%, 68%), compared to Non-CMC parents (2%, 40%). Greater unmet need for prescription medications was associated with unmet care coordination (adjusted OR 3.81; 95% CI: 2.70-5.40) and greater medical complexity (adjusted OR 2.01; 95% CI: 1.00-4.03). Traditional care coordination is primarily facilitated by nurses and nurse practitioners with little formal training in medication management. However, pharmacists are rarely part of the CSHCN care coordination model. As care delivery models for these children evolve, and given the complexity of and numerous transitions of care for these patients, pharmacists can play an integral role to improve unmet needs for prescription medications. Copyright © 2016 Elsevier Inc. All rights reserved.

  12. Soluble dendrimers europium(III) β-diketonate complex for organic memory devices

    International Nuclear Information System (INIS)

    Wang Binbin; Fang Junfeng; Li Bin; You Han; Ma Dongge; Hong Ziruo; Li Wenlian; Su Zhongmin

    2008-01-01

    We report the synthesis of a soluble dendrimers europium(III) complex, tris(dibenzoylmethanato)(1,3,5-tris[2-(2'-pyridyl) benzimidazoly]methylbenzene)-europium(III), and its application in organic electrical bistable memory device. Excellent stability that ensured more than 10 6 write-read-erase-reread cycles has been performed in ambient conditions without current-induced degradation. High-density, low-cost memory, good film-firming property, fascinating thermal and morphological stability allow the application of the dendrimers europium(III) complex as an active medium in non-volatile memory devices

  13. Early-stage valuation of medical devices: the role of developmental uncertainty.

    Science.gov (United States)

    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.

  14. Taking transition into account: designing with pre-users of medical devices

    DEFF Research Database (Denmark)

    Kelly, Janet; Matthews, Ben

    2010-01-01

    of the product. We present a case study that documents how we worked with pre-users of two different types of medical technologies: hearing aids and insulin injection devices. Pre-users are people who do not currently use these products, but who are in a life situation for which these technologies may...

  15. 75 FR 6401 - Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of...

    Science.gov (United States)

    2010-02-09

    ... Biologics Evaluation and Research (HFM-17), Food and Drug Administration, suite 200N, 1401 Rockville Pike... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-M-0513] Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Summaries...

  16. 76 FR 45826 - Medical Device User Fee Rates for Fiscal Year 2012

    Science.gov (United States)

    2011-08-01

    ... paper check: All paper checks must be in U.S. currency from a U.S. bank and made payable to the Food and... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0542] Medical Device User Fee Rates for Fiscal Year 2012 AGENCY: Food and Drug Administration, HHS. ACTION...

  17. 75 FR 15439 - Food and Drug Administration/Xavier University Global Medical Device Conference

    Science.gov (United States)

    2010-03-29

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Food and Drug Administration/Xavier University Global Medical Device Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. SUMMARY: The Food and Drug Administration (FDA...

  18. 78 FR 15957 - Food and Drug Administration/Xavier University Global Medical Device Conference

    Science.gov (United States)

    2013-03-13

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Food and Drug Administration/Xavier University Global Medical Device Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. SUMMARY: The Food and Drug Administration (FDA...

  19. 77 FR 10537 - Food and Drug Administration/Xavier University Global Medical Device Conference

    Science.gov (United States)

    2012-02-22

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Food and Drug Administration/Xavier University Global Medical Device Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. SUMMARY: The Food and Drug Administration (FDA...

  20. 78 FR 41069 - Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Food and Drug...

    Science.gov (United States)

    2013-07-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0743] Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  1. 76 FR 47210 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    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...

  2. 75 FR 391 - Medical Device Quality System Regulation Educational Forum on Risk Management Through the Product...

    Science.gov (United States)

    2010-01-05

    ...] Medical Device Quality System Regulation Educational Forum on Risk Management Through the Product Life... on Risk Management through the Product Life Cycle.'' This public workshop is intended to provide... discussed at the workshop: (1) Standards and guidance, (2) risk management in design, (3) risk management in...

  3. 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)

  4. 78 FR 17415 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    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...

  5. 77 FR 60704 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    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...

  6. 76 FR 7222 - Medical Device Innovation Initiative; Public Meeting; Request for Comments

    Science.gov (United States)

    2011-02-09

    ... public meeting will be provided on a space-available basis beginning at 7 a.m. Non-U.S. citizens are... The United States is the global leader in medical device innovation and CDRH is committed to assuring... public health. CDRH is responsible for advancing public health and facilitating innovation to help bring...

  7. 76 FR 14028 - Center for Devices and Radiological Health 510(k) Implementation: Online Repository of Medical...

    Science.gov (United States)

    2011-03-15

    ... could facilitate patient access to information on what types of devices are available for their medical... input from the public on what they would want and need in labeling and how they would want to access it. CDRH is also interested in learning more about how patients, consumers, and caregivers acquire and use...

  8. Early assessment of medical devices in development for company decision making : An exploration of best practices

    NARCIS (Netherlands)

    Markiewicz, Katarzyna; Van Til, Janine; IJzerman, Maarten

    2017-01-01

    To improve successful development and clinical use of medical technologies, it is suggested that manufacturers should start collecting evidence on devices effectiveness and eficiency early in their development. The aim of this study was to explore whether and how Dutch manufacturers perform an early

  9. OpenICE medical device interoperability platform overview and requirement analysis.

    Science.gov (United States)

    Arney, David; Plourde, Jeffrey; Goldman, Julian M

    2018-02-23

    We give an overview of OpenICE, an open source implementation of the ASTM standard F2761 for the Integrated Clinical Environment (ICE) that leverages medical device interoperability, together with an analysis of the clinical and non-functional requirements and community process that inspired its design.

  10. [Introduction of Quality Management System Audit in Medical Device Single Audit Program].

    Science.gov (United States)

    Wen, Jing; Xiao, Jiangyi; Wang, Aijun

    2018-01-30

    The audit of the quality management system in the medical device single audit program covers the requirements of several national regulatory authorities, which has a very important reference value. This paper briefly described the procedures and contents of this audit. Some enlightenment on supervision and inspection are discussed in China, for reference by the regulatory authorities and auditing organizations.

  11. Application of Dielectric, Ferroelectric and Piezoelectric Thin Film Devices in Mobile Communication and Medical Systems

    NARCIS (Netherlands)

    Klee, M.; Beelen, D.; Keurl, W.; Kiewitt, R.; Kumar, B.; Mauczok, R.; Reimann, K.; Renders, Ch.; Roest, A.; Roozeboom, F.; Steeneken, P.G.; Tiggelman, M.P.J.; Vanhelmont, F.; Wunnicke, O.; Lok, P.; Neumann, K.; Fraser, J.; Schmitz, G.

    2007-01-01

    Dielectric, ferroelectric and piezoelectric thin films are getting more and more attention for next generation mobile communication and medical systems. Thin film technologies based on dielectric, ferroelectric and piezoelectric thin films enable System-in-Package (SiP) devices, resulting in optimal

  12. 31 CFR 560.533 - Brokering sales of agricultural commodities, medicine, and medical devices.

    Science.gov (United States)

    2010-07-01

    ... technical data, software, or information) that are subject to license application requirements of another... IRANIAN TRANSACTIONS REGULATIONS Licenses, Authorizations and Statements of Licensing Policy § 560.533 Brokering sales of agricultural commodities, medicine, and medical devices. (a) General license for...

  13. The Challenges of Balancing Safety and Security in Implantable Medical Devices.

    Science.gov (United States)

    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.

  14. Linking the Regulatory and Reimbursement Processes for Medical Devices : The Need for Integrated Assessments

    NARCIS (Netherlands)

    Ciani, Oriana; Wilcher, Britni; van Giessen, Anoukh; Taylor, Rod S.

    2017-01-01

    Much criticism has been directed at the licencing requirements for medical devices (MDs) as they often result in a lack of robust evidence to inform health technology assessment (HTA) decisions. To better understand the current international decisional framework on MD technologies, we undertook

  15. [The SWOT analysis and strategic considerations for the present medical devices' procurement].

    Science.gov (United States)

    Li, Bin; He, Meng-qiao; Cao, Jian-wen

    2006-05-01

    In this paper, the SWOT analysis method is used to find out the internal strength, weakness, exterior opportunities and threats of the present medical devices' procurements in hospitals and some strategic considerations are suggested as "one direction, two expansions, three changes and four countermeasures".

  16. Antimicrobial treatment of polymeric medical devices by silver nanomaterials and related technology

    Czech Academy of Sciences Publication Activity Database

    Polívková, A.; Hubáček, Tomáš; Staszek, M.; Švorčík, V.; Siegel, J.

    2017-01-01

    Roč. 18, č. 2 (2017), č. článku 419. E-ISSN 1422-0067 Institutional support: RVO:60077344 Keywords : antimicrobials * medical devices * nanostructures * polymers * modification Subject RIV: JJ - Other Materials OBOR OECD: Materials engineering Impact factor: 3.226, year: 2016

  17. 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...

  18. 75 FR 51829 - Public Workshop on Medical Devices and Nanotechnology: Manufacturing, Characterization, and...

    Science.gov (United States)

    2010-08-23

    ... hotel at 301-977-8900 or refer to their Web page at: www.gaithersburg.hilton.com . Contact Person: Daya... provide public comments, time permitting. If you need special accommodations due to a disability, please... refer to the meeting registration Web page at http://www.fda.gov/MedicalDevices/NewsEvents/Workshops...

  19. 76 FR 67463 - Pediatric Medical Devices; Public Workshop; Request for Comments

    Science.gov (United States)

    2011-11-01

    ... use, existing scientific research data to determine pediatric effectiveness based on a similar course... research data, and C. The methods to overcome the pitfalls and data gaps, including statistical approaches... announcing a public workshop entitled ``Using Scientific Research Data to Support Pediatric Medical Device...

  20. 78 FR 69694 - Changing Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of Obesity...

    Science.gov (United States)

    2013-11-20

    ...] Changing Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of Obesity and... Administration (FDA) is announcing a public workshop entitled ``Changing Regulatory and Reimbursement Paradigms... information on the AGA Web site. If you need special accommodations due to a disability, please contact...

  1. High-Confidence Medical Devices: Cyber-Physical Systems for 21st Century Health Care

    Data.gov (United States)

    Networking and Information Technology Research and Development, Executive Office of the President — The U.S. market for medical devices is the largest in the world. At an estimated $83 billion in 2006, this market represents nearly half the global total and is...

  2. CSIR research, development and innovation initiatives for the medical device and diagnostic industry

    CSIR Research Space (South Africa)

    Vilakazi, Busisiwe

    2017-10-01

    Full Text Available This presentation is focused on development and innovation initiatives in the medical device and diagnostic industry. It is presented by Dr Busisiwe Vilakasi at The 6th CSIR Conference: Ideas that work for industrial development, 5-6 October 2017...

  3. Relative risk analysis in regulating the use of radiation-emitting medical devices. A preliminary application

    Energy Technology Data Exchange (ETDEWEB)

    Jones, E.D.; Banks, W.W.; Altenbach, T.J.; Fischer, L.E. [Lawrence Livermore National Lab., CA (United States)

    1995-09-01

    This report describes a preliminary application of an analysis approach for assessing relative risks in the use of radiation- emitting medical devices. Results are presented on human-initiated actions and failure modes that are most likely to occur in the use of the Gamma Knife, a gamma irradiation therapy device. This effort represents an initial step in a US Nuclear Regulatory Commission (NRC) plan to evaluate the potential role of risk analysis in regulating the use of nuclear medical devices. For this preliminary application of risk assessment, the focus was to develop a basic process using existing techniques for identifying the most likely risk contributors and their relative importance. The approach taken developed relative risk rankings and profiles that incorporated the type and quality of data available and could present results in an easily understood form. This work was performed by the Lawrence Livermore National Laboratory for the NRC.

  4. Relative risk analysis in regulating the use of radiation-emitting medical devices. A preliminary application

    International Nuclear Information System (INIS)

    Jones, E.D.; Banks, W.W.; Altenbach, T.J.; Fischer, L.E.

    1995-09-01

    This report describes a preliminary application of an analysis approach for assessing relative risks in the use of radiation- emitting medical devices. Results are presented on human-initiated actions and failure modes that are most likely to occur in the use of the Gamma Knife, a gamma irradiation therapy device. This effort represents an initial step in a US Nuclear Regulatory Commission (NRC) plan to evaluate the potential role of risk analysis in regulating the use of nuclear medical devices. For this preliminary application of risk assessment, the focus was to develop a basic process using existing techniques for identifying the most likely risk contributors and their relative importance. The approach taken developed relative risk rankings and profiles that incorporated the type and quality of data available and could present results in an easily understood form. This work was performed by the Lawrence Livermore National Laboratory for the NRC

  5. Simulation of leakage current measurement on medical devices using helmholtz coil configuration with different current flow

    Science.gov (United States)

    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.

  6. Simulation of leakage current measurement on medical devices using helmholtz coil configuration with different current flow

    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)

  7. Best practices in early phase medical device development: Engineering, prototyping, and the beginnings of a quality management system.

    Science.gov (United States)

    Fearis, Kristy; Petrie, Aidan

    2017-03-01

    Kristy Fearis is the founder and president of KPConsulting. She has held various positions in the medical device and research industry. She has led programs for medical industry leaders Medtronic, Edward Lifesciences, and Kimberly-Clark Healthcare to develop and commercialize Class II and III devices. Although a true quality management systems specialist at heart, Kristy has a passion for effectively and efficiently applying quality systems principles to early stage development to maximize benefit while minimizing impact on resources and time to market. Kristy works with both precommercial and commercial companies to build and implement quality systems that are "right sized" and support both an effective business model and high product quality. Aidan Petrie is the cofounder and chief innovation officer of Ximedica. Aidan drives innovation in Ximedica's core markets of medical device development and consumer healthcare. With a focus on human-centered design, usability, technical innovation and industrial design, Aidan has helped bring hundreds of products to market. Ranging from simple drug compliance aids to wearable therapeutics, home monitoring products, and complex surgical systems, Aidan challenges his teams to rethink the role design plays in the success of each product. Covering topics around usability, sensor and wearable technology, and current trends in medical design and development, Aidan is a sought-after industry speaker and widely published author. In addition to his role at Ximedica, Aidan advises multiple startups in the healthcare space and has interests in a number of related companies. He sits on the Board of MassArt and teaches and lectures at the Rhode Island School of Design, Massachusetts Institute of Technology, the Harvard iLab, and others. Aidan holds an undergraduate degree from Central St Martins in product design/engineering and a Masters in industrial design from the Rhode Island School of Design. Copyright © 2016 Elsevier Inc. All

  8. Potential negative consequences of non-consented switch of inhaled medications and devices in asthma patients.

    Science.gov (United States)

    Björnsdóttir, U S; Gizurarson, S; Sabale, U

    2013-09-01

    Asthma requires individually tailored and careful management to control and prevent symptoms and exacerbations. Selection of the most appropriate treatment is dependent on both the choice of drugs and inhaler device; however, financial pressures may result in patients being switched to alternative medications and devices in an attempt to reduce costs. This review aimed to examine the published literature in order to ascertain whether switching a patient's asthma medications or device negatively impacts clinical and economic outcomes. A literature search of MEDLINE (2001-13 September 2011) was conducted to identify English-language articles focused on the direct impact of switching medications and inhaler devices and switching from fixed-dose combination to monocomponent therapy via separate inhalers in patients with asthma; the indirect impacts of switching were also assessed. Evidence showed that non-consented switching of medications and inhalers in patients with asthma can be associated with a range of negative outcomes, at both individual and organisational levels. Factors that reduce adherence may lead to compromised symptom control resulting in increased healthcare resource utilisation and poorer patient quality of life. The consequences of a non-consented switch should be weighed carefully against arguments supporting an inhaler switch without the patient's consent for non-medical/budgetary reasons, such as potential reductions in initial acquisition costs, which may be associated with subsequent additional healthcare needs. Given the increasing pressure for reduced costs and efficient allocation of limited healthcare resources, an additional investment in ensuring high medication adherence may lead to greater savings due to a potentially decreased demand for healthcare services. In contrast, savings achieved in acquisition costs may result in a greater net loss due to increased healthcare consumption caused by decreased asthma control. © 2013 The Authors

  9. Field Safety Notes in Product Problems of Medical Devices for Use in Pulmonology.

    Science.gov (United States)

    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

  10. FOTOSAN DEVICE IMPLEMENTATION IN COMPLEX TREATMENT OF ORAL AND LABIAL MUSCOSA DISEASES

    Directory of Open Access Journals (Sweden)

    T. S. Chizhikova

    2015-01-01

    Full Text Available The article presents data about Fotosan device and its implementation in complex treatment of oral and labial muscosa diseases. The obtained results evidence that 84% of observed patients had significant reduction of pain, swellings and regeneration acceleration in 1.5 – 2 times

  11. Current disparities in the prices of medical materials between Japan and the United States: further investigation of cardiovascular medical devices.

    Science.gov (United States)

    Yasunaga, Hideo; Ide, Hiroo; Imamura, Tomoaki

    2007-02-01

    Prices of medical devices in Japan were previously reported to be 2 to 4 times higher than those in the United States in 1996 and 1997. However, such data are out of date. We previously compared the market prices in early 2005 between Japan and the US for 16 items in 10 categories of medical materials, and showed that price differences still existed for all these items. However, the number of items investigated was small for each category, and generalization of the results might have been limited. The present study conducted a further investigation into price information for multiple items for each category, focusing on 5 cardiovascular devices. The US market price information was obtained from interviews of a healthcare provider network and 2 different group-purchasing organizations. We could obtain price information on 19 items in 5 categories. We substituted the Japanese reimbursement prices for the Japanese market prices. The price ratio (Japanese reimbursement price / US market price)was 2.0-3.5 for coronary stents, 5.9-6.8 for percutaneous transluminal coronary angioplasty catheters, 2.2-3.5 for pacemakers, 1.6-2.5 for mechanical valves, and 3.4-4.7 for oxygenators. The price disparities for cardiovascular devices between Japan and the US were reconfirmed. Japan's healthcare system should establish group-purchasing organizations, promote centers of clinical excellence, and abolish regulation of parallel imports and protectionism under the Japanese Pharmaceutical Affairs Law.

  12. The technology level of modular devices in outfitting an oil and gas complex in Western Siberia

    Energy Technology Data Exchange (ETDEWEB)

    Berezin, V.L.; Permikin, Yu.N.; Sannikov, Yu.V.; Telegin, L.G.

    1984-01-01

    The status of the problem of ensuring the technology level of modular devices (BKU) is analyzed. It is shown that insufficient consideration in design of the specific production, transport and assembly and operational specifications on the technology level is the cause for creation of irrational designs for modular devices and additional expenditures on their realization. A methodology for controlling the technology level of modular devices being designed is described, which increases the effectiveness of their use (in outfitting petroleum pumping stations (NPS), one of the most important elements of the oil and gas complex). A numerical method for designing the technological structures of the modular devices and an algorithm which ensures practical realization of the method on a computer (EVM) are examined.

  13. Real-time volume rendering of digital medical images on an iOS device

    Science.gov (United States)

    Noon, Christian; Holub, Joseph; Winer, Eliot

    2013-03-01

    Performing high quality 3D visualizations on mobile devices, while tantalizingly close in many areas, is still a quite difficult task. This is especially true for 3D volume rendering of digital medical images. Allowing this would empower medical personnel a powerful tool to diagnose and treat patients and train the next generation of physicians. This research focuses on performing real time volume rendering of digital medical images on iOS devices using custom developed GPU shaders for orthogonal texture slicing. An interactive volume renderer was designed and developed with several new features including dynamic modification of render resolutions, an incremental render loop, a shader-based clipping algorithm to support OpenGL ES 2.0, and an internal backface culling algorithm for properly sorting rendered geometry with alpha blending. The application was developed using several application programming interfaces (APIs) such as OpenSceneGraph (OSG) as the primary graphics renderer coupled with iOS Cocoa Touch for user interaction, and DCMTK for DICOM I/O. The developed application rendered volume datasets over 450 slices up to 50-60 frames per second, depending on the specific model of the iOS device. All rendering is done locally on the device so no Internet connection is required.

  14. Influence of Mobile Phones on the Quality of ECG Signal Acquired by Medical Devices

    Science.gov (United States)

    Buczkowski, T.; Janusek, D.; Zavala-Fernandez, H.; Skrok, M.; Kania, M.; Liebert, A.

    2013-10-01

    Health aspects of the use of radiating devices, like mobile phones, are still a public concern. Stand-alone electrocardiographic systems and those built-in, more sophisticated, medical devices have become a standard tool used in everyday medical practice. GSM mobile phones might be a potential source of electromagnetic interference (EMI) which may affect reliability of medical appliances. Risk of such event is particularly high in places remote from GSM base stations in which the signal received by GSM mobile phone is weak. In such locations an increase in power of transmitted radio signal is necessary to enhance quality of the communication. In consequence, the risk of interference of electronic devices increases because of the high level of EMI. In the present paper the spatial, temporal, and spectral characteristics of the interference have been examined. The influence of GSM mobile phone on multilead ECG recordings was studied. It was observed that the electrocardiographic system was vulnerable to the interference generated by the GSM mobile phone working with maximum transmit power and in DTX mode when the device was placed in a distance shorter than 7.5 cm from the ECG electrode located on the surface of the chest. Negligible EMI was encountered at any longer distance.

  15. Development of ultraviolet LED devices containing europium (III) complexes in fluorescence layer

    International Nuclear Information System (INIS)

    Iwanaga, Hiroki; Amano, Akio; Aiga, Fumihiko; Harada, Kohichi; Oguchi, Masayuki

    2006-01-01

    Relations between molecular structures of europium complexes and their luminescent properties were investigated. Europium complex with β-diketones and two different phosphine oxides 8 was highly soluble in fluorinated medium, and realized largest fluorescence intensities. The luminous intensity of ultraviolet light emitting diodes devices (LEDs) whose fluorescence layer consists of fluorinated polymer and 8 was over 200 mcd (20 mA). Fluorescence compounds of this type are promising for application in next-generation white LEDs. Moreover, we proposed a novel molecular design of europium complex with asymmetric diphosphine dioxide

  16. Integrating the results of user research into medical device development: insights from a case study.

    Science.gov (United States)

    Martin, Jennifer L; Barnett, Julie

    2012-07-19

    It is well established that considering users is an important aspect of medical device development. However it is also well established that there are numerous barriers to successfully conducting user research and integrating the results into product development. It is not sufficient to simply conduct user research, it must also be effectively integrated into product development. A case study of the development of a new medical imaging device was conducted to examine in detail how users were involved in a medical device development project. Two user research studies were conducted: a requirements elicitation interview study and an early prototype evaluation using contextual inquiry. A descriptive in situ approach was taken to investigate how these studies contributed to the product development process and how the results of this work influenced the development of the technology. Data was collected qualitatively through interviews with the development team, participant observation at development meetings and document analysis. The focus was on investigating the barriers that exist to prevent user data from being integrated into product development. A number of individual, organisational and system barriers were identified that functioned to prevent the results of the user research being fully integrated into development. The user and technological aspects of development were seen as separate work streams during development. The expectations of the developers were that user research would collect requirements for the appearance of the device, rather than challenge its fundamental concept. The manner that the user data was communicated to the development team was not effective in conveying the significance or breadth of the findings. There are a range of informal and formal organisational processes that can affect the uptake of user data during medical device development. Adopting formal decision making processes may assist manufacturers to take a more integrated and

  17. Integrating the results of user research into medical device development: insights from a case study

    Directory of Open Access Journals (Sweden)

    Martin Jennifer L

    2012-07-01

    Full Text Available Abstract Background It is well established that considering users is an important aspect of medical device development. However it is also well established that there are numerous barriers to successfully conducting user research and integrating the results into product development. It is not sufficient to simply conduct user research, it must also be effectively integrated into product development. Methods A case study of the development of a new medical imaging device was conducted to examine in detail how users were involved in a medical device development project. Two user research studies were conducted: a requirements elicitation interview study and an early prototype evaluation using contextual inquiry. A descriptive in situ approach was taken to investigate how these studies contributed to the product development process and how the results of this work influenced the development of the technology. Data was collected qualitatively through interviews with the development team, participant observation at development meetings and document analysis. The focus was on investigating the barriers that exist to prevent user data from being integrated into product development. Results A number of individual, organisational and system barriers were identified that functioned to prevent the results of the user research being fully integrated into development. The user and technological aspects of development were seen as separate work streams during development. The expectations of the developers were that user research would collect requirements for the appearance of the device, rather than challenge its fundamental concept. The manner that the user data was communicated to the development team was not effective in conveying the significance or breadth of the findings. Conclusion There are a range of informal and formal organisational processes that can affect the uptake of user data during medical device development. Adopting formal decision

  18. A flexible super-capacitive solid-state power supply for miniature implantable medical devices.

    Science.gov (United States)

    Meng, Chuizhou; Gall, Oren Z; Irazoqui, Pedro P

    2013-12-01

    We present a high-energy local power supply based on a flexible and solid-state supercapacitor for miniature wireless implantable medical devices. Wireless radio-frequency (RF) powering recharges the supercapacitor through an antenna with an RF rectifier. A power management circuit for the super-capacitive system includes a boost converter to increase the breakdown voltage required for powering device circuits, and a parallel conventional capacitor as an intermediate power source to deliver current spikes during high current transients (e.g., wireless data transmission). The supercapacitor has an extremely high area capacitance of ~1.3 mF/mm(2), and is in the novel form of a 100 μm-thick thin film with the merit of mechanical flexibility and a tailorable size down to 1 mm(2) to meet various clinical dimension requirements. We experimentally demonstrate that after fully recharging the capacitor with an external RF powering source, the supercapacitor-based local power supply runs a full system for electromyogram (EMG) recording that consumes ~670 μW with wireless-data-transmission functionality for a period of ~1 s in the absence of additional RF powering. Since the quality of wireless powering for implantable devices is sensitive to the position of those devices within the RF electromagnetic field, this high-energy local power supply plays a crucial role in providing continuous and reliable power for medical device operations.

  19. 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

  20. 76 FR 6623 - Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-02-07

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0066] Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Molecular and Clinical Genetics Panel of the Medical Devices Advisory...

  1. 47 CFR 95.1121 - Specific requirements for wireless medical telemetry devices operating in the 1395-1400 and 1427...

    Science.gov (United States)

    2010-10-01

    ... wireless medical telemetry devices operating in the 1395-1400 and 1427-1432 MHz bands. Due to the critical... 47 Telecommunication 5 2010-10-01 2010-10-01 false Specific requirements for wireless medical telemetry devices operating in the 1395-1400 and 1427-1432 MHz bands. 95.1121 Section 95.1121...

  2. 21 CFR 801.128 - Exceptions or alternatives to labeling requirements for medical devices held by the Strategic...

    Science.gov (United States)

    2010-04-01

    ... requirements for medical devices held by the Strategic National Stockpile. 801.128 Section 801.128 Food and... requirements for medical devices held by the Strategic National Stockpile. (a) The appropriate FDA Center... Strategic National Stockpile. (b)(1)(i) A Strategic National Stockpile official or any entity that...

  3. 21 CFR 801.1 - Medical devices; name and place of business of manufacturer, packer or distributor.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices; name and place of business of manufacturer, packer or distributor. 801.1 Section 801.1 Food and Drugs FOOD AND DRUG ADMINISTRATION... § 801.1 Medical devices; name and place of business of manufacturer, packer or distributor. (a) The...

  4. How does the knowledge environment shape procurement practices for orthopaedic medical devices in Mexico?

    Science.gov (United States)

    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

  5. A color display device recording X ray spectra, especially intended for medical radiography

    International Nuclear Information System (INIS)

    Boulch, J.-M.

    1975-01-01

    Said invention relates to a color display recording device for X ray spectra intended for medical radiography. The video signal of the X ray camera receiving the radiation having passed through the patient is amplified and transformed into a color coding according to the energy spectrum received by the camera. In a first version, the energy spectrum from the camera gives directly an image on the color tube. In a second version the energy spectrum, after having been transformed into digital signals, is first sent into a memory, then into a computer used as a spectrum analyzer, and finally into the color display device [fr

  6. Three-Dimensional Printed PCL-Based Implantable Prototypes of Medical Devices for Controlled Drug Delivery

    DEFF Research Database (Denmark)

    Hollander, Jenny; Genina, Natalja; Jukarainen, Harri

    2016-01-01

    The goal of the present study was to fabricate drug-containing T-shaped prototypes of intrauterine system (IUS) with the drug incorporated within the entire backbone of the medical device using 3-dimensional (3D) printing technique, based on fused deposition modeling (FDM™). Indomethacin was used...... prototypes were dependent on the amount of drug loading. The drug release profiles from the printed devices were faster than from the corresponding filaments due to a lower degree of the drug crystallinity in IUS in addition to the differences in the external/internal structure and geometry between...

  7. PRE-MARKET CLINICAL EVALUATIONS OF INNOVATIVE HIGH-RISK MEDICAL DEVICES IN EUROPE

    DEFF Research Database (Denmark)

    Hulstaert, F.; Neyt, M.; Vinck, I.

    2012-01-01

    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. Methods: The literature and regulatory documents were checked. Representatives from industry, Competent Authorities, Notified...... 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. Conclusions: For innovative high-risk devices, new EU legislation should...

  8. Approval of devices and facilities using ionizing radiations for medical purposes

    International Nuclear Information System (INIS)

    1977-01-01

    This Order made by the Ministers of Health and Social Security, Agriculture and Labour amends a previous Decree of 23 April 1969 in particular concerning the classification of medical or dental radiodiagnostic devices subject to approval. The technical conditions to be complied with for such devices and facilities have also been amended. Finally, it is provided that, as regards facilities with heavy equipment subject to licensing (Act of 31 December 1970), approval is subject to compliance with the licensing conditions and is requested together with the application for a licence. (NEA) [fr

  9. Analysis of liquid medication dose errors made by patients and caregivers using alternative measuring devices.

    Science.gov (United States)

    Ryu, Gyeong Suk; Lee, Yu Jeung

    2012-01-01

    Patients use several types of devices to measure liquid medication. Using a criterion ranging from a 10% to 40% variation from a target 5 mL for a teaspoon dose, previous studies have found that a considerable proportion of patients or caregivers make errors when dosing liquid medication with measuring devices. To determine the rate and magnitude of liquid medication dose errors that occur with patient/caregiver use of various measuring devices in a community pharmacy. Liquid medication measurements by patients or caregivers were observed in a convenience sample of community pharmacy patrons in Korea during a 2-week period in March 2011. Participants included all patients or caregivers (N = 300) who came to the pharmacy to buy over-the-counter liquid medication or to have a liquid medication prescription filled during the study period. The participants were instructed by an investigator who was also a pharmacist to select their preferred measuring devices from 6 alternatives (etched-calibration dosing cup, printed-calibration dosing cup, dosing spoon, syringe, dispensing bottle, or spoon with a bottle adapter) and measure a 5 mL dose of Coben (chlorpheniramine maleate/phenylephrine HCl, Daewoo Pharm. Co., Ltd) syrup using the device of their choice. The investigator used an ISOLAB graduated cylinder (Germany, blue grad, 10 mL) to measure the amount of syrup dispensed by the study participants. Participant characteristics were recorded including gender, age, education level, and relationship to the person for whom the medication was intended. Of the 300 participants, 257 (85.7%) were female; 286 (95.3%) had at least a high school education; and 282 (94.0%) were caregivers (parent or grandparent) for the patient. The mean (SD) measured dose was 4.949 (0.378) mL for the 300 participants. In analysis of variance of the 6 measuring devices, the greatest difference from the 5 mL target was a mean 5.552 mL for 17 subjects who used the regular (etched) dosing cup and 4

  10. 78 FR 951 - Accessible Medical Device Labeling in a Standard Content and Format Public Workshop; Request for...

    Science.gov (United States)

    2013-01-07

    ... format so that patients, caregivers, and healthcare providers may access and utilize device labeling as... labeling, and what they would want in a standard version of device labeling. Key findings from the survey... survey with the National Family Caregivers Association (NFCA) on medical device labeling to elicit home...

  11. FDA (Food and Drug Administration) Compliance Program Guidance Manual (FY 88). Section 4. Medical and radiological devices

    International Nuclear Information System (INIS)

    1988-01-01

    The FDA Compliance Program Guidance Manual provides a system for issuing and filing program plans and instructions directed to Food and Drug Administration Field operations for project implementation. Section IV provides those chapters of the Compliance Program Guidance Manual which pertain to the areas of medical and radiological devices. Some of the areas of coverage include laser and sunlamp standards inspections, compliance testing of various radiation-emitting products such as television receivers and microwave ovens, emergency response planning and policy, premarket approval and device manufacturers inspections, device problem reporting, sterilization of devices, and consumer education programs on medical and radiological devices

  12. Linking Engineering and Medical Training: A USC program seeks to introduce medical and engineering students to medical device development.

    Science.gov (United States)

    Tolomiczenko, George; Sanger, Terry

    2015-01-01

    Medical students are attracted by the prospect of a meaningful addition to their clinical work. Engineering students are excited by a unique opportunity to learn directly alongside their medical student peers. For both, as well as the scientific community at large, the boutique program at the University of Southern California (USC) linking engineering and medical training at the graduate level is instructive of a new way of approaching engineering education that can potentially provide benefits to both students and society. Students who have grown up in an era of ?mass customization? in the retail and service industries can enjoy that same degree of flexibility also in the realm of education. At the same time, society gains engineers who have developed an increased empathy and awareness of the clinical contexts in which their innovations will be implemented.

  13. Real-time signal processing of accelerometer data for wearable medical patient monitoring devices.

    Science.gov (United States)

    Van Wieringen, Matt; Eklund, J

    2008-01-01

    Elderly and other people who live at home but required some physical assistance to do so are often more susceptible injury causing falls in and around their place of residence. In the event that a fall does occur, as a direct result of a previous medical condition or the fall itself, these people are typically less likely to be able to seek timely medical help without assistance. The goal of this research is to develop a wearable sensor device that uses an accelerometer for monitoring the movement of the person to detect falls after they have occurred in order to enable timely medical assistance. The data coming from the accelerometer is processed in real-time in the device and sent to a remote monitoring station where operators can attempt to make contact with the person and/or notify medical personnel of the situation. The ADXL330 accelerometer is contained within a Nintendo WiiMote controller, which forms the basis of the wearable medical sensor. The accelerometer data can then be sent via Bluetooth connection and processed by a local gateway processor. If a fall is detected, the gateway will then contact a remote monitoring station, on a cellular network, for example, via satellite, and/or through a hardwired phone or Internet connection. To detect the occurrence of ta fall, the accelerometer data is passed through a matched filter and the data is compared to benchmark analysis data that will define the conditions that represents the occurrence of a fall.

  14. A flexible mobile-device biosensing instrumentation platform for point-of-care medical diagnostics applications

    DEFF Research Database (Denmark)

    Patou, François; Pfreundt, Andrea; Zulfiqar, Azeem

    2014-01-01

    helping to address this challenge. Specifically, Lab-on-Chip (LoC) devices have a key role to play in the advent of Point-of-Care (PoC) medical applications, driving a shift of the medical diagnostics paradigm and the transition from a centralized, technical, high-throughput biological sample analysis...... programmable electrical readout from LoCs potentially comprehending varied transducers addressing different targeted biological markers. A smart-phone/tablet docking-station embeds the hardware interface necessary for the implementation of a smart-phone digital lock-in amplifier. The platform is tested...

  15. Medical diagnostics with mobile devices: Comparison of intrinsic and extrinsic sensing.

    Science.gov (United States)

    Kwon, L; Long, K D; Wan, Y; Yu, H; Cunningham, B T

    2016-01-01

    We review the recent development of mobile detection instruments used for medical diagnostics, and consider the relative advantages of approaches that utilize the internal sensing capabilities of commercially available mobile communication devices (such as smartphones and tablet computers) compared to those that utilize a custom external sensor module. In this review, we focus specifically upon mobile medical diagnostic platforms that are being developed to serve the need in global health, personalized medicine, and point-of-care diagnostics. Copyright © 2016 Elsevier Inc. All rights reserved.

  16. [Software as medical devices/medical apps : Tasks, requirements, and experiences from the point of view of a competent authority].

    Science.gov (United States)

    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.

  17. The Role of Healthcare Technology Management in Facilitating Medical Device Cybersecurity.

    Science.gov (United States)

    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.

  18. Definition of information technology architectures for continuous data management and medical device integration in diabetes.

    Science.gov (United States)

    Hernando, M Elena; Pascual, Mario; Salvador, Carlos H; García-Sáez, Gema; Rodríguez-Herrero, Agustín; Martínez-Sarriegui, Iñaki; Gómez, Enrique J

    2008-09-01

    The growing availability of continuous data from medical devices in diabetes management makes it crucial to define novel information technology architectures for efficient data storage, data transmission, and data visualization. The new paradigm of care demands the sharing of information in interoperable systems as the only way to support patient care in a continuum of care scenario. The technological platforms should support all the services required by the actors involved in the care process, located in different scenarios and managing diverse information for different purposes. This article presents basic criteria for defining flexible and adaptive architectures that are capable of interoperating with external systems, and integrating medical devices and decision support tools to extract all the relevant knowledge to support diabetes care.

  19. METHOD OF PHYSIOTHERAPY MEDICAL PROCEDURES FOR THERMAL IMPACT ON SELECTED AREAS WITH HUMAN HANDS THERMOELECTRIC DEVICES

    Directory of Open Access Journals (Sweden)

    A. B. Sulin

    2015-01-01

    Full Text Available The device for thermal impact on separate zones of a hand of the person executed on the basis of thermoelectric converters of energy is considered. The advantages consisting in high environmental friendliness, noiselessness, reliability, functionality, universality are noted it. The technique of carrying out medical (preventive physiotherapeutic procedures, the hands of the person consisting in contrast thermal impact on a site with various level of heating and cooling, and also lasting expositions is described.

  20. Moving Up the Value Chain : A Study of Malaysia's Solar and Medical Device Industries

    OpenAIRE

    World Bank

    2011-01-01

    This report responds to a request by the Government of Malaysia to examine how Malaysia can move up the value chain in the solar and medical device industries. Through the lens of long-term development, the overall growth performance of the Malaysian economy has been a resounding success story. The Commission on growth and development listed Malaysia as one of only 13 countries that regist...

  1. Preparation and Characterization of an Advanced Medical Device for Bone Regeneration

    OpenAIRE

    Dorati, Rossella; Colonna, Claudia; Genta, Ida; Bruni, Giovanna; Visai, Livia; Conti, Bice

    2013-01-01

    Tridimensional scaffolds can promote bone regeneration as a framework supporting the migration of cells from the surrounding tissue into the damaged tissue and as delivery systems for the controlled or prolonged release of cells, genes, and growth factors. The goal of the work was to obtain an advanced medical device for bone regeneration through coating a decellularized and deproteinized bone matrix of bovine origin with a biodegradable, biocompatible polymer, to improve the cell engraftment...

  2. Security and privacy issues in implantable medical devices: A comprehensive survey.

    Science.gov (United States)

    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.

  3. Radiological Medical Device Innovation: Approvals via the Premarket Approval Pathway From 2000 to 2015.

    Science.gov (United States)

    Ghobadi, Comeron W; Hayman, Emily L; Finkle, Joshua H; Walter, Jessica R; Xu, Shuai

    2017-01-01

    The aim of this study was to critically assess the clinical evidence leading to radiologic medical device approvals via the premarket approval pathway from 2000 to 2015. This study used the publically available FDA premarket database for radiologic device approvals over the past 15 years (September 1, 2000, to August 31, 2015). Approval characteristics were collected for each device, and statistical analysis was performed on the data for each pivotal trial. Additionally, methodological quality of the pivotal trial was determined using the Quality Assessment of Diagnostic Accuracy Studies tool. Twenty-three class III radiologic device approvals were identified, with breast imaging accounting for 16 (70%) and computer-aided detection software accounting for 9 (39%) approvals. The median premarket approval time was 475 days (range, 180-1,116). Twenty-one devices were approved on the basis of multireader, multicenter studies, one on the basis of a randomized controlled trial, and one on the basis of a preclinical technical equivalence trial. The median number of patients per pivotal trial was 201 (range, 25-3,946). Twenty-six of the 34 pivotal trials (76%) had at least one methodologic bias. Breast imaging devices had a greater number of patients per pivotal trial (P = .009) and more prospective studies. With regard to all modalities, increased time to device approval correlated with weaker trial quality (r = 0.600, P assessing diagnostic technologies. Given that radiologic devices play a key role in modern medicine, further efforts should be made to increase transparency of clinical data leading to approval. Copyright © 2016 American College of Radiology. Published by Elsevier Inc. All rights reserved.

  4. Outsourcing versus in-house maintenance of medical devices: a longitudinal, empirical study

    Directory of Open Access Journals (Sweden)

    Antonio Miguel-Cruz

    2014-03-01

    Full Text Available OBJECTIVE: To determine what factors have a significant influence on the performance of medical device maintenance outsourcing, and to determine how the performance of external governance structures differs depending on whether a hospital is private or public. METHODS: This was a longitudinal study of 590 maintenance transactions at 20 hospitals in Bogotá, Colombia, involving 764 medical devices and 72 maintenance service providers. Maintenance performance data (i.e., turn-around time in hours; TAT for the service providers (either in-house or outsourced were primarily collected over a 20-month period, from December 2009-August 2011, by means of a monitoring procedure; then, a hazards model was run. RESULTS: The availability of specific repair parts, in-stock, in the city in which the medical devices were located, had a positive impact on the performance of both internal and external governance structures. Online service also had a positive impact on both, with a stronger positive impact on the performance of internal governance than on that of external governance. For transactions governed by external structures, better performance was seen in private hospitals than in public ones. In public health institutions, internal governance showed better performance than external governance. Both internal and external governance structures showed better performance in private healthcare institutions than in public ones. CONCLUSIONS: In public health institutions, internal governance shows better performance than external governance; this suggests that healthcare managers should reconsider the trend to eliminate in-house maintenance service staff in public healthcare institutions.

  5. Outsourcing versus in-house maintenance of medical devices: a longitudinal, empirical study.

    Science.gov (United States)

    Miguel-Cruz, Antonio; Rios-Rincón, Adriana; Haugan, Gregory L

    2014-03-01

    To determine what factors have a significant influence on the performance of medical device maintenance outsourcing, and to determine how the performance of external governance structures differs depending on whether a hospital is private or public. This was a longitudinal study of 590 maintenance transactions at 20 hospitals in Bogotá, Colombia, involving 764 medical devices and 72 maintenance service providers. Maintenance performance data (i.e., turn-around time in hours; TAT) for the service providers (either in-house or outsourced) were primarily collected over a 20-month period, from December 2009-August 2011, by means of a monitoring procedure; then, a hazards model was run. The availability of specific repair parts, in-stock, in the city in which the medical devices were located, had a positive impact on the performance of both internal and external governance structures. Online service also had a positive impact on both, with a stronger positive impact on the performance of internal governance than on that of external governance. For transactions governed by external structures, better performance was seen in private hospitals than in public ones. In public health institutions, internal governance showed better performance than external governance. Both internal and external governance structures showed better performance in private healthcare institutions than in public ones. In public health institutions, internal governance shows better performance than external governance; this suggests that healthcare managers should reconsider the trend to eliminate in-house maintenance service staff in public healthcare institutions.

  6. Utilizing national and international registries to enhance pre-market medical device regulatory evaluation.

    Science.gov (United States)

    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.

  7. Security and privacy qualities of medical devices: an analysis of FDA postmarket surveillance.

    Science.gov (United States)

    Kramer, Daniel B; Baker, Matthew; Ransford, Benjamin; Molina-Markham, Andres; Stewart, Quinn; Fu, Kevin; Reynolds, Matthew R

    2012-01-01

    Medical devices increasingly depend on computing functions such as wireless communication and Internet connectivity for software-based control of therapies and network-based transmission of patients' stored medical information. These computing capabilities introduce security and privacy risks, yet little is known about the prevalence of such risks within the clinical setting. We used three comprehensive, publicly available databases maintained by the Food and Drug Administration (FDA) to evaluate recalls and adverse events related to security and privacy risks of medical devices. Review of weekly enforcement reports identified 1,845 recalls; 605 (32.8%) of these included computers, 35 (1.9%) stored patient data, and 31 (1.7%) were capable of wireless communication. Searches of databases specific to recalls and adverse events identified only one event with a specific connection to security or privacy. Software-related recalls were relatively common, and most (81.8%) mentioned the possibility of upgrades, though only half of these provided specific instructions for the update mechanism. Our review of recalls and adverse events from federal government databases reveals sharp inconsistencies with databases at individual providers with respect to security and privacy risks. Recalls related to software may increase security risks because of unprotected update and correction mechanisms. To detect signals of security and privacy problems that adversely affect public health, federal postmarket surveillance strategies should rethink how to effectively and efficiently collect data on security and privacy problems in devices that increasingly depend on computing systems susceptible to malware.

  8. An extended protocol for usability validation of medical devices: Research design and reference model.

    Science.gov (United States)

    Schmettow, Martin; Schnittker, Raphaela; Schraagen, Jan Maarten

    2017-05-01

    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 and derive performance measures. Secondly, a prevailing focus on cross-sectional validation studies, ignoring the issues of learnability and training. The U.S. Federal Drug and Food Administration's recent proposal for a validation testing protocol for medical devices is then extended to address these shortcomings: (1) a novel process measure 'normative path deviations' is introduced that is useful for both quantitative and qualitative usability studies and (2) a longitudinal, completely within-subject study design is presented that assesses learnability, training effects and allows analysis of diversity of users. A reference regression model is introduced to analyze data from this and similar studies, drawing upon generalized linear mixed-effects models and a Bayesian estimation approach. The extended protocol is implemented and demonstrated in a study comparing a novel syringe infusion pump prototype to an existing design with a sample of 25 healthcare professionals. Strong performance differences between designs were observed with a variety of usability measures, as well as varying training-on-the-job effects. We discuss our findings with regard to validation testing guidelines, reflect on the extensions and discuss the perspectives they add to the validation process. Copyright © 2017 Elsevier Inc. All rights reserved.

  9. Analysis of medical device materials with the local electrode atom probe

    International Nuclear Information System (INIS)

    Goodman, S.L.; Mengelt, T.J.; Ali, M.; Ulfig, R.M.; Martens, R.M.; Kelly, T.F.; Kostrna, S.L.P.; Kostrna, M.S.; Carmichael, W.J.

    2004-01-01

    Full text: As medical technology advances towards microsurgical and minimally invasive techniques, there is a drive to produce ever-smaller devices that demand higher material performance and hence enhanced nano and micro-scale control of material structure. These devices are made from stainless steel alloys, Nitinol, titanium, CoCrMo, and non-metals such as pyrolytic carbon and silicon. These applications are made possible due to suitable physical and mechanical properties, good corrosion resistance in biological environments, reasonable biocompatibility, and good manufacturability. With respect to the metals, the nano-structure and composition of the material surface, typically an oxide, is especially critical since biological responses and corrosion occur at the material-environment interface. Thus, there is an increasing need to understand the 3-D structure and composition of metallic biomaterials at the atomic scale. Three-dimensional atom probe microscopy can uniquely provide such atomic-level structural information. In the present study several of these medical device materials were examined. These include a 316L stainless steel alloy which is widely used in implanted spinal fixation devices, bone screws, cardiovascular and neurological stents, a cast CoCrMo acetabular hip cup of a Cormet metal-on-metal Hip Resurfacing System (Corin Group, Cirencester, England) that was rejected for clinical use, Nitinol wires specimens such as are used for stents and guide wires, and low temperature pyrolytic carbon as used in clinical heart valve prosthetics. (author)

  10. Challenges in the Assessment of Medical Devices: The MedtecHTA Project.

    Science.gov (United States)

    Tarricone, Rosanna; Torbica, Aleksandra; Drummond, Michael

    2017-02-01

    Assessing medical devices (MDs) raises challenges which require us to reflect on whether current methods are adequate. Major features of devices are: (i) device-operator interaction can generate learning curve effects; (ii) incremental nature of innovation needs to be addressed by careful identification of the alternatives for comparative and incremental cost-effectiveness analysis; and (iii) broader organizational impact in terms of training and infrastructure, coupled with dynamic pricing, requires a more flexible approach to costing. The objective of the MedtecHTA project was to investigate improvements in HTA methods to allow for more comprehensive evaluation of MDs. It consisted of several work packages concerning (i) the available evidence on the currently adopted approaches for regulation and HTA of medical devices; (ii) the geographical variation in access to MDs; (iii) the development of methodological frameworks for conducting comparative effectiveness research and economic evaluation of MDs; and (iv) the organizational impact of MDs. This introductory paper summarizes the main results of the project and draws out the main overarching themes. This supplement represents a comprehensive report of all the main findings of the MedtecHTA project, and it is intended to be the main source for researchers and policy makers wanting information on the project. © 2017 The Authors. Health Economics published by John Wiley & Sons, Ltd. © 2017 The Authors. Health Economics Published by John Wiley & Sons, Ltd.

  11. Identification of proteins involved in the adhesionof Candida species to different medical devices.

    Science.gov (United States)

    Núñez-Beltrán, Arianna; López-Romero, Everardo; Cuéllar-Cruz, Mayra

    2017-06-01

    Adhesion is the first step for Candida species to form biofilms on medical devices implanted in the human host. Both the physicochemical nature of the biomaterial and cell wall proteins (CWP) of the pathogen play a determinant role in the process. While it is true that some CWP have been identified in vitro, little is known about the CWP of pathogenic species of Candida involved in adhesion. On this background, we considered it important to investigate the potential role of CWP of C. albicans, C. glabrata, C. krusei and C. parapsilosis in adhesion to different medical devices. Our results indicate that the four species strongly adher to polyvinyl chloride (PVC) devices, followed by polyurethane and finally by silicone. It was interesting to identify fructose-bisphosphate aldolase (Fba1) and enolase 1 (Eno1) as the CWP involved in adhesion of C. albicans, C. glabrata and C. krusei to PVC devices whereas phosphoglycerate kinase (Pgk) and Eno1 allow C. parapsilosis to adher to silicone-made implants. Results presented here suggest that these CWP participate in the initial event of adhesion and are probably followed by other proteins that covalently bind to the biomaterial thus providing conditions for biofilm formation and eventually the onset of infection. Copyright © 2017 Elsevier Ltd. All rights reserved.

  12. Power Factor Improvement Using Automatic Power Factor Compensation (APFC Device for Medical Industries in Malaysia

    Directory of Open Access Journals (Sweden)

    Zaidi Maryam Nabihah

    2018-01-01

    Full Text Available This paper present the project designed to correcting power factor for medical industries in Malaysia automatically. Which with hope to make the cost and energy usage efficient, because the energy source are depleting due to increase in population. Power factor is the ratio of real power and apparent power. This definition is mathematically represented as kW/kVA where kW is active power and kVA is apparent power (active + reactive. Reactive power is the non-working power generated by the magnetic and inductive load to generate magnetic flux. The increase in reactive power increase the apparent power so the power factor will decrease. Low pF will cause the industry to meet high demand thus making it less efficient. The main aim of this project is to increasing the current power factor of medical industries from 0.85 to 0.90. Power factor compensation contribute to reduction in current-dependent losses and increase energy efficiency while expanding the reliability of planning for future energy network. As technology develops, the gradual cost and efficiency penalty should reduce. Therefore, automatic power factor compensation device should become cost-effective and smaller device over time. That is the reason this project is using programmable device as it is a miniature architecture device.

  13. Polymer coating embolism from intravascular medical devices - a clinical literature review.

    Science.gov (United States)

    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.

  14. A thermal technique for local ultrasound intensity measurement: part 2. Application to exposimetry on a medical diagnostic device

    International Nuclear Information System (INIS)

    Wilkens, V

    2010-01-01

    Acoustic output measurements on medical ultrasound equipment are usually performed using radiation force balances to determine the output power and using hydrophones to determine pressure and intensity parameters. The local temporal-average ultrasound intensity can be measured alternatively by thermal sensors. The technique was described and prototype sensors were characterized in a preceding paper. Here, the application of such a thermal intensity sensor to the output beam characterization of a typical medical diagnostic device is described. Two transducers, a 7.5 MHz linear array and a 3.5 MHz convex array were investigated in different operating modes. For comparison, hydrophone measurements were also performed. If the spatial averaging effect is taken into account, good agreement is found between both measurement methods. The maximum deviations of the spatial-peak temporal-average intensities I SPTA obtained with the thermal sensor from the corresponding hydrophone-based results were below 12%. The simple thermal technique offers advantages for intensity measurements especially in the case of scanning and combined modes of the diagnostic device, where the synchronization between hydrophone measurements and the complex pulse emission pattern can be difficult

  15. Advancing medical device innovation through collaboration and coordination of structured data capture pilots: Report from the Medical Device Epidemiology Network (MDEpiNet) Specific, Measurable, Achievable, Results-Oriented, Time Bound (SMART) Think Tank.

    Science.gov (United States)

    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.

  16. Design of point-of-care (POC) microfluidic medical diagnostic devices

    Science.gov (United States)

    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.

  17. Pre-market approval and post-market direct-to-consumer advertising of medical devices in Australia: a case study of breast cancer screening and diagnostic devices.

    Science.gov (United States)

    Vreugdenburg, T D; Willis, C D; Mundy, L; Hiller, J E

    2013-01-01

    While research investigating direct-to-consumer advertising of therapeutic goods in Australia has historically focused on prescription medicines, recent action taken by regulators against companies promoting medical devices has placed the industry into the spotlight. Despite the need to effectively regulate direct-to-consumer advertising of medical devices due to its potential harms, inadequacies in the current regulatory system have been noted. Under the present system, devices with a questionable evidence base may enter the Australian marketplace without an evaluation of their effectiveness, and regulators are reliant on industry self-regulation and consumer complaints to draw attention to cases of advertising misconduct. Although some successes in the present system have been observed, we argue that the outlined inadequacies continue to enable the promotion of medical devices to consumers without thorough or sufficient examination of evidence. © 2011 The Authors; Internal Medicine Journal © 2011 Royal Australasian College of Physicians.

  18. Complex programmable logic device based alarm sequencer for nuclear power plants

    International Nuclear Information System (INIS)

    Khedkar, Ravindra; Solomon, J. Selva; KrishnaKumar, B.

    2001-01-01

    Complex Programmable Logic Device based Alarm Sequencer is an instrument, which detects alarms, memorizes them and displays the sequences of occurrence of alarms. It caters to sixteen alarm signals and distinguishes the sequence among any two alarms with a time resolution of 1 ms. The system described has been designed for continuous operation in process plants, nuclear power plants etc. The system has been tested and found to be working satisfactorily. (author)

  19. Pre-market clinical evaluations of innovative high-risk medical devices in Europe.

    Science.gov (United States)

    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.

  20. Implementation of a low-cost mobile devices to support medical diagnosis.

    Science.gov (United States)

    García Sánchez, Carlos; Botella Juan, Guillermo; Ayuso Márquez, Fermín; González Rodríguez, Diego; Prieto-Matías, Manuel; Tirado Fernández, Francisco

    2013-01-01

    Medical imaging has become an absolutely essential diagnostic tool for clinical practices; at present, pathologies can be detected with an earliness never before known. Its use has not only been relegated to the field of radiology but also, increasingly, to computer-based imaging processes prior to surgery. Motion analysis, in particular, plays an important role in analyzing activities or behaviors of live objects in medicine. This short paper presents several low-cost hardware implementation approaches for the new generation of tablets and/or smartphones for estimating motion compensation and segmentation in medical images. These systems have been optimized for breast cancer diagnosis using magnetic resonance imaging technology with several advantages over traditional X-ray mammography, for example, obtaining patient information during a short period. This paper also addresses the challenge of offering a medical tool that runs on widespread portable devices, both on tablets and/or smartphones to aid in patient diagnostics.

  1. Implementation of a Low-Cost Mobile Devices to Support Medical Diagnosis

    Directory of Open Access Journals (Sweden)

    Carlos García Sánchez

    2013-01-01

    Full Text Available Medical imaging has become an absolutely essential diagnostic tool for clinical practices; at present, pathologies can be detected with an earliness never before known. Its use has not only been relegated to the field of radiology but also, increasingly, to computer-based imaging processes prior to surgery. Motion analysis, in particular, plays an important role in analyzing activities or behaviors of live objects in medicine. This short paper presents several low-cost hardware implementation approaches for the new generation of tablets and/or smartphones for estimating motion compensation and segmentation in medical images. These systems have been optimized for breast cancer diagnosis using magnetic resonance imaging technology with several advantages over traditional X-ray mammography, for example, obtaining patient information during a short period. This paper also addresses the challenge of offering a medical tool that runs on widespread portable devices, both on tablets and/or smartphones to aid in patient diagnostics.

  2. MEMS- and NEMS-based complex adaptive smart devices and systems

    Science.gov (United States)

    Varadan, Vijay K.

    2001-10-01

    The microelectronics industry has seen explosive growth during the last thirty years. Extremely large markets for logic and memory devices have driven the development of new materials, and technologies for the fabrication of even more complex devices with feature sizes now down at the sub micron and nanometer level. Recent interest has arisen in employing these materials, tools and technologies for the fabrication of miniature sensors and actuators and their integration with electronic circuits to produce smart devices and systems. This effort offers the promise of: 1) increasing the performance and manufacturability of both sensors and actuators by exploiting new batch fabrication processes developed including micro stereo lithographic and micro molding techniques; 2) developing novel classes of materials and mechanical structures not possible previously, such as diamond like carbon, silicon carbide and carbon nanotubes, micro-turbines and micro-engines; 3) development of technologies for the system level and wafer level integration of micro components at the nanometer precision, such as self-assembly techniques and robotic manipulation; 4) development of control and communication systems for MEMS devices, such as optical and RF wireless, and power delivery systems, etc. A novel composite structure can be tailored by functionalizing carbon nanotubes and chemically bonding them with the polymer matrix e.g. block or graft copolymer, or even cross-linked copolymer, to impart exceptional structural, electronic and surface properties. Bio- and mechanical-MEMS devices derived from this hybrid composite provide a new avenue for future smart systems.

  3. Personal medical electronic devices and walk-through metal detector security systems: assessing electromagnetic interference effects.

    Science.gov (United States)

    Guag, Joshua; Addissie, Bisrat; Witters, Donald

    2017-03-20

    There have been concerns that Electromagnetic security systems such as walk-through metal detectors (WTMDs) can potentially cause electromagnetic interference (EMI) in certain active medical devices including implantable cardiac pacemakers and implantable neurostimulators. Incidents of EMI between WTMDs and active medical devices also known as personal medical electronic devices (PMED) continue to be reported. This paper reports on emission measurements of sample WTMDs and testing of 20 PMEDs in a WTMD simulation system. Magnetic fields from sample WTMD systems were characterized for emissions and exposure of certain PMEDs. A WTMD simulator system designed and evaluated by FDA in previous studies was used to mimic the PMED exposures to the waveform from sample WTMDs. The simulation system allows for controlled PMED exposure enabling careful study with adjustable magnetic field strengths and exposure duration, and provides flexibility for PMED exposure at elevated levels in order to study EMI effects on the PMED. The PMED samples consisted of six implantable cardiac pacemakers, six implantable cardioverter defibrillators (ICD), five implantable neurostimulators, and three insulin pumps. Each PMED was exposed in the simulator to the sample WTMD waveforms using methods based on appropriate consensus test standards for each of the device type. Testing the sample PMEDs using the WTMD simulator revealed EMI effects on two implantable pacemakers and one implantable neurostimulator for exposure field strength comparable to actual WTMD field strength. The observed effects were transient and the PMEDs returned to pre-exposure operation within a few seconds after removal from the simulated WTMD exposure fields. No EMI was observed for the sample ICDs or insulin pumps. The findings are consistent with earlier studies where certain sample PMEDs exhibited EMI effects. Clinical implications were not addressed in this study. Additional studies are needed to evaluate potential PMED

  4. PS-022 Complex automated medication systems reduce medication administration error rates in an acute medical ward

    DEFF Research Database (Denmark)

    Risør, Bettina Wulff; Lisby, Marianne; Sørensen, Jan

    2017-01-01

    Background Medication errors have received extensive attention in recent decades and are of significant concern to healthcare organisations globally. Medication errors occur frequently, and adverse events associated with medications are one of the largest causes of harm to hospitalised patients...... cabinet, automated dispensing and barcode medication administration; (2) non-patient specific automated dispensing and barcode medication administration. The occurrence of administration errors was observed in three 3 week periods. The error rates were calculated by dividing the number of doses with one...

  5. Process evaluation of complex interventions: Medical Research Council guidance

    OpenAIRE

    Moore, G.F.; Audrey, S.; Barker, M.; Bond, L.; Bonell, C.; Hardeman, W.; Moore, L.; O'Cathain, A.; Tinati, T.; Wight, D.; Baird, J.

    2015-01-01

    Attempts to tackle problems such as smoking and obesity increasingly use complex interventions. These are commonly defined as interventions that comprise multiple interacting components, although additional dimensions of complexity include the difficulty of their implementation and the number of organisational levels they target.1 Randomised controlled trials are regarded as the gold standard for establishing the effectiveness of interventions, when randomisation is feasible. However, effect ...

  6. The tablet device in hospital neurology and in neurology graduate medical education: a preliminary study.

    Science.gov (United States)

    George, Pravin; Newey, Christopher R; Bhimraj, Adarsh

    2015-01-01

    There is limited literature on tablet devices for neurohospitalists and in neurological graduate medical education. This study evaluated utilization, benefits, and limitations of customized tablets on inpatient neurology practice and resident education. The hypothesis was the perception of the tablet would be positive, given their portability, convenience to accessing point-of-care reference, and accessibility to the electronic medical record. Second-generation iPads with neurology-specific applications and literature were provided to our in-hospital general, stroke, and consult neurology teams. After 1 year, residents on these teams were surveyed on demographic data, familiarity, and utilization of the iPad and their perceptions of the device. All 27 residents responded to the survey. Most participants (23 of 27) used a tablet while on inpatient service. Twelve regularly utilized the neurology-specific apps and/or accessed scientific articles. Technologically savvy residents felt significantly more comfortable using tablets and were more quickly acquainted with the features. Thirteen respondents wanted a formal orientation on the advanced features of the tablet independent of their familiarity with the device or level of technological comfort. Overall, the perception was that the tablet was beneficial for inpatient clinical care and as an educational reference. Participants became easily familiarized with the device features quickly, regardless of whether they owned one previously or not. Most physicians indicated interest in advanced features of tablets; however, a formal orientation may be beneficial for optimal utilization. A reliable network connection is essential to in-hospital use of tablet devices. Additional research pertaining to patient outcomes, objective educational benefit, and cost-effectiveness is necessary.

  7. Use of technical skills and medical devices among new registered nurses: A questionnaire study.

    Science.gov (United States)

    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.

  8. [Discussion on Quality Evaluation Method of Medical Device During Life-Cycle in Operation Based on the Analytic Hierarchy Process].

    Science.gov (United States)

    Zheng, Caixian; Zheng, Kun; Shen, Yunming; Wu, Yunyun

    2016-01-01

    The content related to the quality during life-cycle in operation of medical device includes daily use, repair volume, preventive maintenance, quality control and adverse event monitoring. In view of this, the article aims at discussion on the quality evaluation method of medical devices during their life cycle in operation based on the Analytic Hierarchy Process (AHP). The presented method is proved to be effective by evaluating patient monitors as example. The method presented in can promote and guide the device quality control work, and it can provide valuable inputs to decisions about purchase of new device.

  9. Quantum transport through complex networks - from light-harvesting proteins to semiconductor devices

    Energy Technology Data Exchange (ETDEWEB)

    Kreisbeck, Christoph

    2012-06-18

    Electron transport through small systems in semiconductor devices plays an essential role for many applications in micro-electronics. One focus of current research lies on establishing conceptually new devices based on ballistic transport in high mobility AlGaAs/AlGa samples. In the ballistic regime, the transport characteristics are determined by coherent interference effects. In order to guide experimentalists to an improved device design, the characterization and understanding of intrinsic device properties is crucial. We develop a time-dependent approach that allows us to simulate experimentally fabricated, complex devicegeometries with an extension of up to a few micrometers. Particularly, we explore the physical origin of unexpected effects that have been detected in recent experiments on transport through Aharonov-Bohm waveguide-interferometers. Such interferometers can be configured as detectors for transfer properties of embedded quantum systems. We demonstrate that a four-terminal waveguide-ring is a suitable setup for measuring the transmission phase of a harmonic quantum dot. Quantum effects are not restricted exclusively to artificial devices but have been found in biological systems as well. Pioneering experiments reveal quantum effects in light-harvesting complexes, the building blocks of photosynthesis. We discuss the Fenna-Matthews-Olson complex, which is a network of coupled bacteriochlorophylls. It acts as an energy wire in the photosynthetic apparatus of green sulfur bacteria. Recent experimental findings suggest that energy transfer takes place in the form of coherent wave-like motion, rather than through classical hopping from one bacteriochlorophyll to the next. However, the question of why and how coherent transfer emerges in light-harvesting complexes is still open. The challenge is to merge seemingly contradictory features that are observed in experiments on two-dimensional spectroscopy into a consistent theory. Here, we provide such a

  10. Potentials and challenges of integration for complex metal oxides in CMOS devices and beyond

    International Nuclear Information System (INIS)

    Kim, Y; Pham, C; Chang, J P

    2015-01-01

    This review focuses on recent accomplishments on complex metal oxide based multifunctional materials and the potential they hold in advancing integrated circuits. It begins with metal oxide based high-κ materials to highlight the success of their integration since 45 nm complementary metal–oxide–semiconductor (CMOS) devices. By simultaneously offering a higher dielectric constant for improved capacitance as well as providing a thicker physical layer to prevent the quantum mechanical tunnelling of electrons, high-κ materials have enabled the continued down-scaling of CMOS based devices. The most recent technology driver has been the demand to lower device power consumption, which requires the design and synthesis of novel materials, such as complex metal oxides that exhibit remarkable tunability in their ferromagnetic, ferroelectric and multiferroic properties. These properties make them suitable for a wide variety of applications such as magnetoelectric random access memory, radio frequency band pass filters, antennae and magnetic sensors. Single-phase multiferroics, while rare, offer unique functionalities which have motivated much scientific and technological research to ascertain the origins of their multiferroicity and their applicability to potential devices. However, due to the weak magnetoelectric coupling for single-phase multiferroics, engineered multiferroic composites based on magnetostrictive ferromagnets interfacing piezoelectrics or ferroelectrics have shown enhanced multiferroic behaviour from effective strain coupling at the interface. In addition, nanostructuring of the ferroic phases has demonstrated further improvement in the coupling effect. Therefore, single-phase and engineered composite multiferroics consisting of complex metal oxides are reviewed in terms of magnetoelectric coupling effects and voltage controlled ferromagnetic properties, followed by a review on the integration challenges that need to be overcome to realize the

  11. Effects of sterilization on the mechanical properties of poly(methyl methacrylate) based personalized medical devices.

    Science.gov (United States)

    Münker, T J A G; van de Vijfeijken, S E C M; Mulder, C S; Vespasiano, V; Becking, A G; Kleverlaan, C J; Becking, A G; Dubois, L; Karssemakers, L H E; Milstein, D M J; van de Vijfeijken, S E C M; Depauw, P R A M; Hoefnagels, F W A; Vandertop, W P; Kleverlaan, C J; Münker, T J A G; Maal, T J J; Nout, E; Riool, M; Zaat, S A J

    2018-05-01

    Nowadays, personalized medical devices are frequently used for patients. Due to the manufacturing procedure sterilization is required. How different sterilization methods affect the mechanical behavior of these devices is largely unknown. Three poly(methyl methacrylate) (PMMA) based materials (Vertex Self-Curing, Palacos R+G, and NextDent C&B MFH) were sterilized with different sterilization methods: ethylene oxide, hydrogen peroxide gas plasma, autoclavation, and γ-irradiation. Mechanical properties were determined by testing the flexural strength, flexural modulus, fracture toughness, and impact strength. The flexural strength of all materials was significantly higher after γ-irradiation compared to the control and other sterilization methods, as tested in a wet environment. NextDent C&B MFH showed the highest flexural and impact strength, Palacos R+G showed the highest maximum stress intensity factor and total fracture work. Autoclave sterilization is not suitable for the sterilization of PMMA-based materials. Ethylene oxide, hydrogen peroxide gas plasma, and γ-irradiation appear to be suitable techniques to sterilize PMMA-based personalized medical devices. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

  12. Security Mechanism Based on Hospital Authentication Server for Secure Application of Implantable Medical Devices

    Science.gov (United States)

    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

  13. Security Mechanism Based on Hospital Authentication Server for Secure Application of Implantable Medical Devices

    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.

  14. Security mechanism based on Hospital Authentication Server for secure application of implantable medical devices.

    Science.gov (United States)

    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.

  15. Health economic evaluations of medical devices in the People's Republic of China: A systematic literature review.

    Science.gov (United States)

    Zhang, Rongrong; Modaresi, Farhang; Borisenko, Oleg

    2015-01-01

    The objective of this study is to identify and review the methodological quality of health economic evaluations of medical devices performed in the People's Republic of China. To our knowledge, no such investigations have been performed to date. A systematic literature review involving searches of Medline, Medline In-Process, the National Health Service Economic Evaluation Database, the Cost-Effectiveness Analysis Registry of the Tufts Medical Center, and the Wanfang Database was performed. The search spanned the period from 1990 to 2013. Studies on health economic evaluations of medical devices, in-vitro diagnostics, procedures, and the use of medical devices in Chinese health care settings were included. Full-text articles and conference abstracts in English and Chinese were included. Fifty-seven publications were included, 26 (46%) of which were in English and 31 (54%) of which were in Chinese. The included publications covered a wide range of clinical areas, such as surgery (n=23, 40%), screening (n=9, 16%), imaging use (n=6, 11%), kidney intervention (n=4, 7%), and nine other technological areas. Most of the studies (n=31, 54%) were cost analyses. Among the others, 13 (50%) studies used modeling, and another 13 (50%) were within-trial evaluations. Among studies that used modeling, eleven (85%) conducted sensitivity analyses, six of which had one-way sensitivity analysis, whereas one conducted both one-way and two-way sensitivity analyses; four of these eleven modeling-based analyses included probabilistic sensitivity analyses. The incremental cost-effectiveness ratio was reported in ten (18%) studies, eight of which were screening studies. The remaining two modeling studies were in areas of imaging and oncology. This study indicates that there are major limitations and deficiencies in the health economic evaluations on medical devices performed in the People's Republic of China. Further efforts are required from different stakeholders - academic, governmental

  16. 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

  17. BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES – BRIEF REVIEW ON SOME DENTISTRY PRODUCTS.

    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.

  18. Guide to preemption of state-law claims against Class III PMA medical devices.

    Science.gov (United States)

    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.

  19. Mobile devices in medicine: a survey of how medical students, residents, and faculty use smartphones and other mobile devices to find information*

    Science.gov (United States)

    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

  20. Mobile devices in medicine: a survey of how medical students, residents, and faculty use smartphones and other mobile devices to find information.

    Science.gov (United States)

    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.