..., to enact needed regulatory reforms so that medical device manufacturers can bring their safe and...] Medical Device User Fee Act; Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice of... public meeting to discuss proposed recommendations for the reauthorization of the Medical Device User Fee...
... 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...
... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Immunology Devices Panel of the Medical Devices Advisory...). The meeting will be open to the public. Name of Committee: Immunology Devices Panel of the Medical...
... 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...
... manufacturers can bring their safe and effective devices to the American people at an earlier time, and to...] Medical Device User Fee Act; Public Meeting; Request for Comments AGENCY: Food and Drug Administration... (FDA) is announcing a public meeting on the reauthorization of the medical device user fee program. The...
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory...
...] Device Improvements to Reduce Unnecessary Radiation Exposure From Medical Imaging; Public Meeting... Improvements to Reduce Unnecessary Radiation Exposure From Medical Imaging.'' The purpose of this meeting is to... radiation from these medical imaging modalities. The deadline for submitting comments related to this public...
.... The hotel telephone number is 301-977-8900. Contact Person: Jamie Waterhouse, Center for Devices and..., pneumatically, or electrically and (2) devices that aid the emergency medical professional in delivering manual...
... 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...
... 301-977-8900. Contact Person: Natasha Facey, Center for Devices and Radiological Health, Food and Drug... who meet the following criteria: Adults, age 25 years or older. Bare light or no light perception in... perception, the retina must be able to respond to electrical stimulation as evidenced by an electrically...
... 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...
... 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...
... announce the meeting location in a future Federal Register notice. We will also provide the meeting... population (Ref. 3). This peer-reviewed journal article presented the following findings regarding primary Mo... resurfacing). FDA intends to make background material available to the public no later than 2 business days...
... asymptomatic dense- breasted women following a negative screening mammogram. On April 12, 2012, during session... appropriate meeting topic, the names and addresses of proposed participants, and an indication of the...
... (301) 977-8900. Contact Person: Avena Russell, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1535, Silver Spring, MD 20993-0002, Avena...
.... Contact Person: Deborah Falls, Center for Devices and Radiological Health, Food and Drug Administration... premarket approval application for the Deep Brain Stimulation System for Epilepsy sponsored by Medtronic...-onset seizures (affecting only a part of the brain when they begin), with or without secondary...
... HUMAN SERVICES Food and Drug Administration Ear, Nose and Throat Devices Panel of the Medical Devices... Federal Register about last minute modifications that impact a previously announced advisory committee... for the Nucleus Hybrid TM L24 Implant System sponsored by Cochlear Americas. The proposed Indications...
Pfeiffer, Jonas H; Kasparick, Martin; Strathen, Benjamin; Dietz, Christian; Dingler, Max E; Lueth, Tim C; Timmermann, Dirk; Radermacher, Klaus; Golatowski, Frank
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).
... received by FDA concerning the final rule on the classification of dental amalgam, which published in the... adequacy of the risk assessment performed by FDA in classifying dental amalgam in light of a new report on... HUMAN SERVICES Food and Drug Administration Dental Products Panel of the Medical Devices Advisory...
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 ...
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
... regulatory classification for dental devices known as Endosseous Dental Implants (Blade-form), one of the remaining preamendments Class III devices. The Class III blade-form endosseous dental implant is a device... endosseous dental implant into class II (special controls). The committee's discussion will involve making...
..., including name, title, affiliation, address, email, and telephone number. Those without Internet access... after the public workshop on the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/Workshops...) proposed partnership structure and governance; (3) MDEpiNet as a framework for medical device postmarket...
Strisland, Frode; Svagård, Ingrid Storruste; Austad, Hanne Opsahl; Reitan, Jarl
The aim of this case study has been to investigate to what extent user centered design (UCD) methodologies have been applied, how the process and outcomes were perceived by project team members, and what were potential barriers towards meeting end user needs. The case studied was the European Union Framework 7 integrated project d-LIVER (2011-2015), which aimed at developing an integrated care system for chronic liver disease patient management. d-LIVER is an example of a public funded, international, multidisciplinary, collaborative research project where development starts from a low technology readiness level, but where research is motivated by societal needs for better health care solutions. Awareness of central end user needs are therefore crucial. 14 project participants were interviewed. To meet societal and end user needs represent a prominent motivation factor for participants. The project organization with only clinical partners interacting with end users was accepted as a fact of life and not as a project pain point. A summary of observations and recommendations for good practice is given.
Ramakrishna, Seeram; Wang, Charlene
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
Galgon, Richard E
The purpose of this article is to provide a structural and functional understanding of the systems used for the regulation of medical devices in the USA and European Union (EU). Safe and effective anesthesia care depends heavily on medical devices, including simple, low risk devices to complex life-supporting and life-sustaining devices. In the USA and EU, the Food and Drug Administration and European Commission, respectively, provide regulatory oversight to ensure medical devices are reasonably safe and effective when used for their intended purposes. Unfortunately, practicing anesthesiologists generally have little or no understanding of how medical devices are regulated, nor do they have sufficient knowledge of available adverse event reporting systems. The US and EU medical device regulatory systems are similar in many ways, but differ in important ways too, which impacts the afforded level of safety and effectiveness assurance. In both systems, medical devices are classified and regulated on a risk basis, which fundamentally differs from drug regulation, where uniform requirements are imposed. Anesthesia providers must gain knowledge of these systems and be active players in both premarket and postmarket activities, particularly with regard to vigilance and adverse event/device failure reporting.
Boyer, Philip; Morshed, Bashir I; Mussivand, Tofy
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.
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...
...] Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice AGENCY... an amendment to the notice of meeting of the Obstetrics and Gynecology Devices Panel of the Medical... Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee would be held on September...
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
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
Malchesky, P S; Chamberlain, V C; Scott-Conner, C; Salis, B; Wallace, C
Advances in medical science and, in particular, minimally invasive surgical and diagnostic procedures have stimulated the development of new and improved medical devices. This has been made possible because of developments in engineering and material sciences. The design of devices for reusability is particularly important in an effort to provide cost effective healthcare. Concerns and issues include the ability to safely and effectively reprocess the devices, infection prevention and control, safety of the patient and healthcare worker, environmental concerns, and effective use of resources. From an infection prevention point of view, present requirements are based upon the intended use of the devices. Critical devices require sterilization. Semi-critical devices require, as a minimum, high level disinfection. Sterilization is, however, preferred whenever possible. Before sterilization or disinfection, devices should be cleaned adequately. Device designs should be readily amenable to cleaning and sterilization. In the past, design requirements focused primarily on the clinical user and device functionality, with reuse considerations left to the user. In the current market, the customer is redefined and, for reusable medical devices, includes all those associated with the device through the reprocessing procedure. In addition, regulations require that manufacturers give detailed instructions for reprocessing medical devices. The device users have the obligation to follow reprocessing instructions. Many choices exist today in device designs, including disposable or reusable devices. The user needs to balance cost versus convenience and reprocessing requirements for reusables. Current trends are to reuse more devices, including many of which were meant to be disposable. Cost effective designs can best be achieved when the user and manufacturer work together on the design.(ABSTRACT TRUNCATED AT 250 WORDS)
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
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...
...] Advancing Regulatory Science for Highly Multiplexed Microbiology/ Medical Countermeasure Devices; Public... Regulatory Science for Highly Multiplexed Microbiology/Medical Countermeasure Devices.'' The purpose of the public meeting is to discuss performance evaluation of highly multiplexed microbiology/medical...
Sridhar, Radhakrishnan; Pliszka, Damian; Luo, He-Kuan; Chin Lim, Keith Hsiu; Ramakrishna, Seeram
Medical devices form a broad range of appliances from a basic nanoparticle coating or surgical gloves to a complicated laser therapy device. These devices are designed to support patients, surgeons and healthcare personnel in meeting patients' healthcare needs. Regulatory authorities of each country regulate the process of approval, manufacturing and sales of these medical devices so as to ensure safety and quality to patients or users. Recent recalls of medical devices has increased importance of safety, awareness and regulation of the devices. Singapore and India have strong presence and national priorities in medical devices development and use. Herein we capture the rationale of each of these national regulatory bodies and compare them with the medical devices regulatory practices of USA and European nations. Apart from the comparison of various regulatory aspects, this review will specifically throw light on the polymer material based medical devices and their safety.
LoBuglio, R J
The marketing concept says that a firm should focus all of its efforts on satisfying its customers, at a profit. This is really a a new philosophy of business, replacing a production-oriented philosophy which focused on organizing a firm's resources to make products and then selling them. The marketing concept calls for reorienting the firm's ways of doing things. Instead of trying to get customers to buy what the firm has produced, a marketing-oriented firm would try to sell what the customers want. The underlying principle of the marketing concept is that a firm should seek to meet the needs of customers, at a profit, rather than place its main emphasis on its own internal activities and utilization of its resources. These latter factors are also important, of course, but those who believe in the marketing concept feel that customers' needs should be the firm's primary focus and that resources should be organized to satisfy those needs. Give the customer what he needs--this may seem so obvious and logical that it is difficult to understand why the marketing concept is considered such a breakthrough. However, people haven't always done the logical and obvious. In a typical company, production men thought mainly about getting the product out. Accountants were only interested in balancing the books. Financial people were absorbed in the company's cash position. And salesmen were mainly concerned with getting orders. No one was particularly concerned with whether the whole system made sense. As long as the company made a profit, each department went merrily on its independent way, "doing its own thing." Unfortunately, they still do in the majority of companies today. Finding out customer's attitudes can avoid prejudices and stereotypes commonly found in the typical organization. The need for market research to avoid stereotypes can be dramatized by the following results from a large-scale survey of European adults: The average Frenchman uses almost twice as many
Bronzino, Joseph D
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
Kaluska, I.; Stuglik, Z.
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
... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Immunology Devices Panel of the Medical Devices Advisory.... SUMMARY: The Food and Drug Administration (FDA) is postponing the meeting of the Immunology Devices Panel...
R Please use this checklist to use and maintain your medical device safely and effectively in your home. As a homecare medical device user, you ... home monitoring devices. Home Healthcare Medical Devices: A Checklist For additional government sources and information visit: CDRH ...
Teixeira, Marie B
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
Davis, J. R
... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii Introduction Chapter 1 Overview of Biomaterials and Their Use in Medical Devices . . . . . . . . . . . . . . . . 1 Uses for Biomaterials...
Costa Monteiro, E.; Leon, L. F.
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.
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee: Notice of Change of Meeting Schedule AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction...
... generally that the term ``device'' means an instrument, apparatus, implement, machine, contrivance, implant...) whether the device generally must be implanted, inserted, operated, or otherwise administered by a medical... subject to an IDE is not a ``taxable medical device'' under the proposed regulations. VI. Dental...
...) Implementation: Online Repository of Medical Device Labeling, Including Photographs; Public Meeting AGENCY: Food... of an Online Repository of Medical Device Labeling and of Making Device Photographs Available in a... public comment on the following topics: FDA's plans to establish an online public repository of medical...
...The meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee scheduled for August 26, 2010, is postponed. The meeting was announced in the Federal Register of June 24, 2010 (75 FR 36102). The meeting is postponed so that FDA can review and consider additional information that was submitted. A future meeting date will be announced in the Federal Register at a later date.
...The Food and Drug Administration (FDA) is postponing the meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee scheduled for December 1, 2011. The meeting was announced in the Federal Register of Friday, October 7, 2011 (76 FR 62419). The meeting is postponed so that FDA can review and consider additional information that was submitted. A future meeting date will be announced in the Federal Register.
National Aeronautics and Space Administration — A compact microgravity and hypogravity compatible vacuum device is proposed to provide medical suction and containment of extracted fluids. The proposed aspirator...
... 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...
... 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 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food...
... 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 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food...
... 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 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food...
... 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 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food...
... 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 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food...
... 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 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food...
... 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 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food...
...] 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...
... used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of devices... practitioners; and health care and consumer advocacy organizations, including individual physicians and hospital...
Hodges, Brian D; Martimianakis, Maria A; McNaughton, Nancy; Whitehead, Cynthia
There have been repeated calls for the greater use of conceptual frameworks and of theory in medical education. Although it is familiar to few medical educators, Michel Foucault's work is a helpful theoretical and methodological source. This article explores what it means to use a 'Foucauldian approach', presents a sample of Foucault's historical-genealogical studies that are relevant to medical education, and introduces the work of four researchers currently undertaking Foucauldian-inspired medical education research. Although they are not without controversy, Foucauldian approaches are employed by an increasing number of scholars and are helpful in shedding light on what it is possible to think, say and be in medical education. Our hope in sharing this Foucauldian work and perspective is that we might stimulate a dialogue that is forward-looking and optimistic about the possibilities for change in medical education. © 2014 John Wiley & Sons Ltd.
Ogrodnik, Peter J
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...
Dhillon, Balbir S
.... 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...
... in 2011 as a forum to discuss future directions in medical device regulatory harmonization. It is a... auditing and monitoring the manufacturing of medical devices to ensure safe medical devices. The IMDRF, at... addition to regulatory authority inspectorates, allows greater coverage in auditing manufacturers as...
Brown, Colin; Rudkjøbing, Andreas
Medical students of the world have signalled their commitment to health promotion by prohibiting smoking at the semiannual general assembly meetings of the International Federation of Medical Students' Associations (IFMSA). Although initially adopted in 2000, the smoke-free bylaw took 5 years to ...... to come into force. This year finally saw compliance with the bylaw on March 1, 2005, at the IFMSA General Assembly in Antalya, Turkey, when medical students who wanted to smoke had to do so outside....
Brown, Colin; Rudkjøbing, Andreas
Medical students of the world have signalled their commitment to health promotion by prohibiting smoking at the semiannual general assembly meetings of the International Federation of Medical Students' Associations (IFMSA). Although initially adopted in 2000, the smoke-free bylaw took 5 years...... to come into force. This year finally saw compliance with the bylaw on March 1, 2005, at the IFMSA General Assembly in Antalya, Turkey, when medical students who wanted to smoke had to do so outside....
Privitera, Mary Beth
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
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
National Aeronautics and Space Administration — An innovative Microgravity Compatible Medical Suction Device (MCMSD) is proposed for the efficient aspiration and containment of bodily fluids and vomitus in a...
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
Hirschorn, David S; Choudhri, Asim F; Shih, George; Kim, Woojin
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.
... 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...
Kasza, Kenneth E [Palos Park, IL; Oras, John [Des Plaines, IL; Son, HyunJin [Naperville, IL
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.
Integration ” at Society of Critical Care Medicine Annual Congress, San Francisco, CA January 21-22 2014 – Chaired Meetings for US TAG ISO TC 121 on...Award Number: W81XWH-12-C-0154 TITLE: “Enabling Medical Device Interoperability for the Integrated Clinical Environment” PRINCIPAL INVESTIGATOR...Julian M. Goldman, MD CONTRACTING ORGANIZATION: Massachusetts General Hospital Boston, MA 02114 REPORT DATE: December 2016 TYPE OF REPORT : Final
Lee, Phong Ching; Dixon, John
Obesity is a major public health concern that leads to numerous metabolic, mechanical and psychological complications. Although lifestyle interventions are the cornerstone of obesity management, subsequent physiological neurohormonal adaptations limit weight loss, strongly favour weight regain and counteract sustained weight loss. A range of effective therapies are therefore needed to manage this chronic relapsing disease. Bariatric surgery delivers substantial, durable weight loss but limited access to care, perceived high risks and costs restrict uptake. Medical devices are uniquely positioned to bridge the gap between more conservative lifestyle intervention and weight-loss pharmacotherapy and more disruptive bariatric surgery. In this Review, we examine the range of gastrointestinal medical devices that are available in clinical practice to treat obesity, as well as those that are in advanced stages of development. We focus on the mechanisms of action as well as the efficacy and safety profiles of these devices. Many of these devices are placed endoscopically, which provides gastroenterologists with exciting opportunities for treatment.
Kusche, Kristopher P
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.
Amato, Stephen F; Amato, B
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
After much work and research, the Food and Drug Administration is preparing to publish a proposed rule for unique device identifier (UDI) standards for medical devices. The UDI would be used to identify a vast array of medical products and would streamline the hospital supply chain while improving patient safety. For instance, having a UDI in place would assist product recall efforts. But getting hospital supply chain leaders, manufacturers, group purchasing organizations and others to embrace UDI standards won't be easy. Here's a look at what's ahead.
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.
Anand, K; Saini, Sk; Singh, Bk; Veermaram, C
In the medical device field, there are a number of players, having quite different responsibilities and levels of understanding of the processes, but all with one common interest, that of ensuring the availability of sound medical devices to the general public. To assist in this very important process, there is a need for a common method for describing and identifying these medical devices in an unambiguous manner. The Global Medical Device Nomenclature (GMDN) now provides, for the first time, an international tool for identifying all medical devices, at the generic level, in a meaningful manner that can be understood by all users. Prior to the GMDN, many nomenclature systems existed, all built upon different structures, and used locally or nationally for special purposes, with unusual approaches. These diverse systems, although often workable in their own right, have had no impact on improving the overall situation of providing a common platform, whereby, medical devices could be correctly identified and the related data safely exchanged between the involved parties. Work by standard organizations such as, CEN (European Committee for Standardization) and ISO (International Organization for Standardization), from 1993 to 1996, resulted in a standard that specified a structure for a new nomenclature, for medical devices. In this article we are trying to explain GMDN as the prime method to reduce medical device errors, and to understand the concept of GMDN, to regulate the medical device throughout the globe. Here we also make an attempt to explain various aspects of the GMDN system, such as, the process of development of the GMDN-CEN report, purpose, benefits, and their structural considerations. In addition, there will be an explanation of the coding system, role of the GMDN agency, and their utilization in the unique device identification (UDI) System. Finally, the current area of focus and vision for the future are also mentioned.
Medical devices used in the United States must comply with federal regulations established to ensure that specified requirements have been met. The article will focus on 1 of 14 elements of the Quality System Regulation (QSR)-Design Controls. A high-level overview of these design control requirements is provided to increase awareness of the device development process and provide a basis for mutual understanding for continued dialogue with end users. Design control requirements were established by the US Food and Drug Administration (FDA) as an element of the QSR in 1996. Device manufacturers are required to have a quality management system (QMS) to ensure their devices are safe and effective. The QMS is established by writing operating procedures to achieve consistent application of the methods used to control quality and comply with regulatory requirements. The FDA has the responsibility to audit device manufacturers for compliance with the regulation. The requirements of the QSR and the resulting device design control procedures lend themselves to what is commonly known as the waterfall development process. This iterative process results in documented evidence that is defined in the QSR as the Design History File. This record of development is essential for managing the product life cycle. The elements and purpose of the design control process will be presented to illuminate today's development environment. Collaboration between device developers and the practitioner is essential for improving clinical outcomes and reducing time to market of innovative devices.
The United States' medical device color additive regulations are unknown to some, and confusing to many. This article reviews statutory language on color additives in the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended, including the Delaney Clause on carcinogenicity; color additive regulatory language as it relates to medical devices in Title 21 of the Code of Federal Regulations (C.F.R.), Parts 70-82; reports on the Food and Drug Administration's (FDA's) likely current and historical practices in dealing with color additives in medical devices; and speculates on what may have given rise to decades of seemingly ad hoc color additives practices, which may now be difficult to reconstruct and satisfactorily modify. Also addressed is the Center for Devices and Radiological Health's (CDRH's) recent publicly-vetted approach to color additives in Section 7 of its April 2013 draft guidance, Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," which the author concludes is a change in the right direction, but which, at least in its current draft form, is not a fix to the CDRH's color additives dilemma. Lastly, the article suggests what the CDRH might consider in further developing a new approach to color additives. Such an approach would treat color additives as if they were any other potentially toxic group of chemicals, and could be fashioned in such a way that the CDRH could still satisfy the broad aspects of Congressional color additives mandates, and.yet be consistent with ISO 10993. In doing this, the CDRH would need to recommend a more directed use of its Quality System Regulation, 21 C.F.R. Part 820, for material and vendor qualification and validation in general; approach Congress for needed statutory changes; or make administrative changes. In order for any approach to be successful, whether it is a new twist on past practices, or an entirely new path forward, the FDA must, to the best of its
Babušiak, Branko; Borik, Štefan
wireless communication eliminates obtrusive cables associated with wearable sensors and considerably increases patient comfort during measurement and collection of medical data. Wireless communication is very popular in recent years and plays a significant role in telemedicine and homecare applications. Bluetooth technology is one of the most commonly used wireless communication types in medicine. This paper describes the design of a universal wireless communication device with excellent price/performance ratio. The said device is based on the low-cost RN4020 Bluetooth module with Microchip Low-energy Data Profile (MLDP) and due to low-power consumption is especially suitable for the transmission of biological signals (ECG, EMG, PPG, etc.) from wearable medical/personal health devices. A unique USB dongle adaptor was developed for wireless communication via UART interface and power consumption was evaluated under various conditions.
Obremskey, William T; Dail, Teresa; Jahangir, A Alex
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.
Cao, Shaoping; Yin, Chunguang; Zhao, Zhenying
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.
A. Yu. Galkin
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.
ENTERVISION, the Research Training Network in 3D Digital Imaging for Cancer Radiation Therapy, successfully passed its mid-term review held at CERN on 11 January. This multidisciplinary project aims at qualifying experts in medical imaging techniques for improved hadron therapy. ENTERVISION provides training in physics, medicine, electronics, informatics, radiobiology and engineering, as well as a wide range of soft skills, to 16 researchers of different backgrounds and nationalities. The network is funded by the European Commission within the Marie Curie Initial Training Network, and relies on the EU-funded research project ENVISION to provide a training platform for the Marie Curie researchers. The two projects hold their annual meetings jointly, allowing the young researchers to meet senior scientists and to have a full picture of the latest developments in the field beyond their individual research project. ENVISION and ENTERVISION are both co-ordinated by CERN, and the Laboratory hosts t...
Niezen, Gerrit; Eslambolchilar, Parisa; Thimbleby, Harold
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.
Ghaffari, Roozbeh; Kim, Dae-Hyeong
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.
Siamak Aram; Rouzbeh A. Shirvani; Eros G. Pasero; Mohamd F. Chouikha
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...
Ethylene oxide gas is an agent in the sterilization of medical devices due to its effectiveness and compatibility with most materials. The advantages and disadvantages, as well as its recommended uses, are explored in this review article. The variables and their relevance on process optimization are described, the types of processing cycles are detailed and emphasis is given to the design and validation of the sterilization process.
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.
Bertoloni, G; Bertucco, A; Rassu, M; Vezzù, K
The employment of disinfection-sterilisation processes for the re-use of medical devices without negative effects such as the presence of toxic residues, material degradation or other modifications is an important consideration for reducing the costs of surgical and medical procedures. Ethylene oxide is the most commonly used low temperature sterilisation technique in healthcare facilities, but its associated toxicity has reduced interest in this technology for the reprocessing of medical equipment. The aim of this study was to examine the disinfection efficiency of a novel low temperature approach, based on dense carbon dioxide on artificially contaminated catheters. The results obtained demonstrated that this method provided a complete inactivation of all bacteria and yeast strains tested, and that no obvious modifications to the surfaces tested were observed with multiple treatments. Copyright © 2010 The Hospital Infection Society. Published by Elsevier Ltd. All rights reserved.
.... FDA-2011-N-0026] Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian....), as amended by the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L. 94-295), the Safe Medical Devices Act of 1990 (the SMDA) (Pub. L. 101-629), and the Food and Drug Administration...
.... FDA-2012-N-0165] Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus... commercial distribution before May 28, 1976, the date of enactment of the Medical Device Amendments of 1976... ``requirements'' to address each identified risk to health presented by these specific medical devices under 21 U...
... Workshop; Notice of Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration's (FDA) Office of Orphan Products Development is announcing the following workshop: FDA Pediatric Medical Devices Workshop. This meeting is intended to focus on challenges in pediatric device development...
May-Newman, Karen; Cornwall, G Bryan
The design of medical devices requires an understanding of a large number of factors, many of which are difficult to teach in the traditional educational format. This subject benefits from using a challenge-based learning approach, which provides focused design challenges requiring students to understand important factors in the context of a specific device. A course was designed at San Diego State University (CA, USA) that applied challenge-based learning through in-depth design challenges in cardiovascular and orthopedic medicine, and provided an immersive field, needs-finding experience to increase student engagement in the process of knowledge acquisition. The principles of US FDA 'design control' were used to structure the students' problem-solving approach, and provide a format for the design documentation, which was the basis of grading. Students utilized a combination of lecture materials, industry guest expertise, texts and readings, and internet-based searches to develop their understanding of the problem and design their solutions. The course was successful in providing a greatly increased knowledge base and competence of medical device design than students possessed upon entering the course.
Hu, Wei; Gu, Hanqing
To study the USA government's administrative system about medical device standards as well as the standard making. The relevant documents, regulations, website that USA Food and Drug Administration announced were extensively reviewed, knowing the USA medical device standards synthetically. The USA standards system of medical device included regulatory requirements and voluntary consensus standards. This article simply introduced the laws, regulations, performance standards and consensus standards. The USA's administrative system about medical device standards as well as many standards can be referenced.
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.
Liu, Wenbo; Shi, Xinli; Lu, Zhong; Wang, Lanming; Zhang, Kai; Zhang, Xingdong
The 4th US-China Joint Workshop on Regulation, Standards and Innovation of Biomaterials was held during the Annual Meeting of the Society for Biomaterials on April 5, 2017 at Minneapolis, MN. This series of joint workshops have become a unique platform for both the US and China to discuss and update what is new in the field of biomaterials and medical devices in terms of regulation, standards and innovation since 2013. China Food and Drug Administration and its affiliated agencies such as Center for Medical Device Evaluation presented at each of the workshop. With the implementation of Regulations for the Supervision and Administration of Medical Devices (Decree of the State Council of the People's Republic of China, No. 650) since June 1, 2014, the regulatory changes and reform for medical devices in China have been hot topics in the workshops. This report captures the key information presented during the workshops, which includes major changes of the Chinese medical device regulation systems, reform of the review and approval system for medical devices in China, and the special procedures of review and approval for innovative medical devices. The market growth of medical devices along with demands for innovative technologies brings the ongoing regulatory changes and reform in China, which will certainly create positive impact on both the development of the Chinese healthcare system and the innovation of medical devices in China. © 2017 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 2017. © 2017 Wiley Periodicals, Inc.
To Investigate necessity of safety evaluation, research ideas, evaluation methods of DEHP in PVC medical devices. The ideas of The United States, Japan and the European Union on safety evaluation of DEHP in PVC medical devices was reviewed and sorted, regarding to currently requirements for PVC medical devices in our country, the research ideas and methods of DEHP in PVC medical devices was explored. DEHP released from High-risk PVC medical devices may exceed human tolerance intake values and thus potentially be harmful to human health. So it is necessary for production enterprise to assess safety of DEHP in PVC medical device. The assessment can be done by material control and detecting release of DEHP from PVC medical devices. In order to assess safety of DEHP in PVC medical device, production enterprise can firstly assess materials according to national standard. Secondly, production enterprise can detect release of DEHP from PVC medical devices simulating clinical application. By comparing release of DEHP from PVC medical devices and TI, safety of DEHP in PVC medical device can be evaluated.
Zunino, Silvia; Venencia, Daniel; Martinez, Monica; Garrigo, Edgardo
The Marie Curie Foundation in the city of Cordoba in Argentina, has organized the Second Congress of radiochemotherapy and brachytherapy and the Fifth Meeting of Medical Physics in order to collaborate with the scientific growth of radiation oncology and medical physics. The main topics covered were: patient's radioprotection, brachytherapy with iodine, radiation protection regulatory issues in Argentina, risk analysis in radiotherapy, medical radiation therapy, EPID dosimetry (Electronic Portal Image Device), accidents in radiotherapy, among others. [es
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...
Pinedo Herbert, Michael; Kraaijenhagen Roderik, Adriaan; Van Den Berg, Albert
The invention relates to a capsule or chip or sensor comprising a marker/detector and signalling device/method associated with the development of a medical condition/disease and to its use. This In Situ Lab On a Chip Signalling device (ISLOGS device) is used for detecting a medical condition/disease
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.
Dogan, Ülkü Balcı; Dogan, Mehmet Ugur; Ülgen, Yekta; Özkan, Mehmed
In the proposed study, a medical device maintenance management system (MEDEMAS) is designed and implemented which provides a data pool of medical devices, the maintenance protocols and other required information for these devices. The system also contains complete repair and maintenance history of a specific device. MEDEMAS creates optimal maintenance schedule for devices and enables the service technician to carry out and report maintenance/repair processes via remote access. Thus predicted future failures are possible to prevent or minimize. Maintenance and repair is essential for patient safety and proper functioning of the medical devices, as it prevents performance decrease of the devices, deterioration of the equipment, and detrimental effects on the health of a patient, the user or other interacting people. The study aims to make the maintenance process more accurate, more efficient, faster and easier to manage and organize; and much less confusing. The accumulated history of medical devices and maintenance personnel helps efficient facility planning.
Marešová, Petra; Klímová, Blanka; Krejcar, Ondřej; Kuča, Kamil
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.
.... The factors are (i) whether the device generally must be implanted, inserted, operated, or otherwise... with respect to an orthotic or prosthetic device that is not implanted. The final regulations provide a... circumstances test. 6. Dental Devices Several commenters suggested that dental devices that are customized for...
Mahmoud Pashazadeh, Ali; Aghajani, Mahdi; Nabipour, Iraj; Assadi, Majid
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.
Pashazadeh, A. M.; Aghajani, M.; Nabipour, I.; Assadi, M.
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)
Full Text Available for detection of cardiovascular disease (CVD) risk factors implicated in most non- communicable diseases (NCDs) FROM POINT OF APPLICATION POINT OF CARE South Africa-UK Newton Collaborative Research Development Programme in Precision Medicine... contributes to product control 2. Post-market surveillance ensures that medical devices in use continue to be safe and effective. A third element is the representation of the product to the user - Label, Advertising and Education/ Training From Simone...
... (CONTINUED) MEDICAL DEVICES LABELING Labeling Requirements for Over-the-Counter Devices § 801.63 Medical... class I ozone-depleting substances. (a) All over-the-counter devices containing or manufactured with... harms public health and environment by destroying ozone in the upper atmosphere. (2) The alternative...
... Handle Power Outages for Medical Devices that Require Electricity Center for De CDRH vices and Rad lth ... Handle Power Outages for Medical Devices that Require Electricity As a home medical device user, it is ...
... 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...
Bhatti, Khadijah Z; Nguyen, Antoinette T; Stuart, Gretchen S
Medical abortion is a safe, effective, and acceptable option for patients seeking an early nonsurgical abortion. In 2014, medical abortion accounted for nearly one third (31%) of all abortions performed in the United States. State-level attempts to restrict reproductive and sexual health have recently included bills that require physicians to inform women that a medical abortion is reversible. In this commentary, we will review the history, current evidence-based regimen, and regulation of medical abortion. We will then examine current proposed and existing abortion reversal legislation. The objective of this commentary is to ensure physicians are armed with rigorous evidence to inform patients, communities, and policy makers about the safety of medical abortion. Furthermore, given the current paucity of evidence for medical abortion reversal, physicians and policy makers can dispel bad science and misinformation and advocate against medical abortion reversal legislation. Copyright © 2017 Elsevier Inc. All rights reserved.
La Puma, John; Schiedermayer, David; Becker, Jennifer
Little isd known about how meals are chosen for medical meetings. We surveyed the annual meeting planners for 20 major specialty societies. Thirteen (65%) responded; all were currently planning their next meeting. Attendance in 2000 was reported at 113,477 physicians, with 2 million planned meals and snacks. No physician was named as responsible for food choices; the meeting planner and staff were primarily responsible for deciding what food to serve, excluding exhibit halls. Twelve (92%) respondents rated "available budget" as the most important factor. "Nutritional guidelines" were rated "very important" by eight of 13 (63%). However, no specific nutritional guidelines could be identified by any planner. All respondents indicated that members would attend a meeting if "healthy" food were the only option. For 2000, 100% of respondents indicated that for each lunch and for each dinner, a dessert had been included. No annual meeting and no planned 2001 meeting excluded potato chips, snack mixes, or candies at breaks; soda pop was offered at each break. Most respondents (89%) relied on a concluding questionnaire about the meeting facilities to evaluate the food. Respondents reported no difference in charges for "special meals," including vegetarian and kosher meals. Physicians may be unaware that some food served at medical meetings may impair learning, with excessive calorie, fat, and carbohydrate consumption. Small changes can improve the quality of food and beverages selected, without increased cost, and provide choices that conform to national nutritional guidelines. Medical meetings should serve flavorful, healthful food.
Yu, Sicong; Pan, Ying; Yu, Xiping; Zhu, Yinfeng
The article intends to analyze the software safety problems in high-risk medical devices based on the investigation of software R & D Quality control procedures in Shanghai medical device manufacturing enterprises. The idea of improving the software pre-market safety evaluation method in China is also explored through the way of comparing those in U.S. and Europe.
Kuyvenhoven, JD; Lahorte, P; Persyn, K; De Geest, E; van Loon, PW; Jacobs, F; van Rijk, PP; Lemahieu, [No Value; Dierckx, R A
The European Council Directive 93/42/EEC concerning medical devices (14 June 1993) assigns new responsibilities and imposes technical requirements both to the manufacturer and user of medical devices. In this paper the general outlines of the directive are discussed with a particular emphasis on the
Hanson, Jacob J; Hitchcock, Robert W
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.
Ray, Arnab; Jetley, Raoul; Jones, Paul L; Zhang, Yi
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.
Kramer, Daniel B.; Foo Kune, Denis; Auto de Medeiros, Julio; Yan, Chen; Xu, Wenyuan; Crawford, Thomas; Fu, Kevin
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
Hao, Aiyu; Wang, Ling
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
Wang, Yi; Guan, Allan; Wickramasekara, Samanthi; Phillips, K Scott
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. Expected final online publication date for the Annual Review of Analytical Chemistry Volume 11 is June 12, 2018. Please see http://www.annualreviews.org/page/journal/pubdates for revised estimates.
Wang, K; Cheng, Y; Yang, H; Tang, Y H; Jiang, J; Ji, F; Li, L B; Wu, S C
To compare the effectiveness of medicated γ intrauterine device (IUD) and medicated genefix IUD inserted immediately after abortion. A multicenter clinical trail was performed for the study from Mar. 2012 to Jan. 2013. Totally 840 women who volunteered to participate were randomly allocated to γ-group (medicated γ IUD) or genefix-group (medicated genefix IUD) immediately after abortion. While 464 abortion women who had not used IUD or steroids contraceptive methods were chosen as control group. The effectiveness of the IUD were followed up for 1 year. All women were required to record the number of vaginal bleeding days and blood volume of vaginal bleeding within 3 months after abortion. At the 12(th) month, the expulsion was the most common reason for termination. The expulsion rates of genefix-group and γ-group were 2.48/100 women years and 3.12/100 women years, respectively (P>0.05). For the expulsion reasons, IUD moving down could account for more than seventy percent. The removal rate for IUD usage of two IUD groups were almost equal (3.91/100 women years verus 4.35/100 women years), the differences were not statistically significant (P>0.05). At the 90(th) day after abortion, comparing with control group, the bleeding and (or) spotting days of genefix-group and γ-group extended by 3.9 and 2.6 days respectively, the differences had statistical significance between the three groups (P0.05). The insertion of medicated genefix IUD and medicated γ IUD immediately after abortion is safe, feasible, has slight side effects and could be effective contraception.
.... 66, rm. 2460, Silver Spring, MD 20993-0002, 301- 796-6493. SUPPLEMENTARY INFORMATION: I. What is the... functioning of other medical devices; Adverse tissue reaction; Hazards associated with electrical equipment...-clinical analysis and testing. other medical devices. Labeling. Adverse tissue reaction Biocompatibility...
Neugebauer, Edmund A M; Rath, Ana; Antoine, Sunya-Lee; Eikermann, Michaela; Seidel, Doerthe; Koenen, Carsten; Jacobs, Esther; Pieper, Dawid; Laville, Martine; Pitel, Séverine; Martinho, Cecilia; Djurisic, Snezana; Demotes-Mainard, Jacques; Kubiak, Christine; Bertele, Vittorio; Jakobsen, Janus C; Garattini, Silvio; Gluud, Christian
Medical devices play an important role in the diagnosis, prevention, treatment and care of diseases. However, compared to pharmaceuticals, there is no rigorous formal regulation for demonstration of benefits and exclusion of harms to patients. The medical device industry argues that the classical evidence hierarchy cannot be applied for medical devices, as randomised clinical trials are impossible to perform. This article aims to identify the barriers for randomised clinical trials on medical devices. Systematic literature searches without meta-analysis and internal European Clinical Research Infrastructure Network (ECRIN) communications taking place during face-to-face meetings and telephone conferences from 2013 to 2017 within the context of the ECRIN Integrating Activity (ECRIN-IA) project. In addition to the barriers that exist for all trials, we identified three major barriers for randomised clinical trials on medical devices, namely: (1) randomisation, including timing of assessment, acceptability, blinding, choice of the comparator group and considerations on the learning curve; (2) difficulties in determining appropriate outcomes; and (3) the lack of scientific advice, regulations and transparency. The present review offers potential solutions to break down the barriers identified, and argues for applying the randomised clinical trial design when assessing the benefits and harms of medical devices.
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.
.... FDA-2012-N-1238] Medical Devices; Ophthalmic Devices; Classification of the Scleral Plug AGENCY: Food... composed of surgical grade stainless steel (with or without coating in gold, silver, or titanium) from... steps: (1) Receives a recommendation from a device classification panel (an FDA advisory committee); (2...
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee; Notice... be open to the public. Name of Committee: Clinical Chemistry and Clinical Toxicology Devices Panel of...
... provide advice and recommendations regarding Emergency Medical Services (EMS) to the U.S. DOT's NHTSA.... NHTSA-2011-0003] National Emergency Medical Services Advisory Council Teleconference Meeting AGENCY... Emergency Medical Services Advisory Council Teleconference Meeting. ACTION: National Emergency Medical...
Sorenson, Corinna; Drummond, Michael
Recent debates and events have brought into question the effectiveness of existing regulatory frameworks for medical devices in the United States and Europe to ensure their performance, safety, and quality. This article provides a comparative analysis of medical device regulation in the two jurisdictions, explores current reforms to improve the existing systems, and discusses additional actions that should be considered to fully meet this aim. Medical device regulation must be improved to safeguard public health and ensure that high-quality and effective technologies reach patients. We explored and analyzed medical device regulatory systems in the United States and Europe in accordance with the available gray and peer-reviewed literature and legislative documents. The two regulatory systems differ in their mandate and orientation, organization, pre- and postmarket evidence requirements, and transparency of process. Despite these differences, both jurisdictions face similar challenges for ensuring that only safe and effective devices reach the market, monitoring real-world use, and exchanging pertinent information on devices with key users such as clinicians and patients. To address these issues, reforms have recently been introduced or debated in the United States and Europe that are principally focused on strengthening regulatory processes, enhancing postmarket regulation through more robust surveillance systems, and improving the traceability and monitoring of devices. Some changes in premarket requirements for devices are being considered. Although the current reforms address some of the outstanding challenges in device regulation, additional steps are needed to improve existing policy. We examine a number of actions to be considered, such as requiring high-quality evidence of benefit for medium- and high-risk devices; moving toward greater centralization and coordination of regulatory approval in Europe; creating links between device identifier systems and
Großkopf, Volker; Jäkel, Christian
The processing of single-use products is permissible pursuant to medical device law. This is apparent both from the wording of the German Law on Medical Devices and from the purpose and the objectives underpinning the legislative materials. The prerequisite for processing is, however, compliance with the the Joint Recommendation of the Commission for Hospital Hygiene and the Prevention of Infection at the Robert Koch Institute (RKI) and the Federal Institute for Drugs and Medical Products (BfArM). For medical devices in the category “critical C”, the RKI/BfArM-recommendation provides that the processor’s quality management system must be certified by a body accredited by the Central Authority of the Federal States for Health Protection with regard to Medicinal Products and Medical Devices (Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten, ZLG). The certification must be carried out in accordance with EN ISO 13485:2003+AC:2007. On April 4, 2008 the Federal Health Ministry (Bundesministerium für Gesundheit, BMG) presented a progress report on the processing of medical devices. The BMG concludes that the legal framework for the processing of medical devices is sufficient, and that a prohibition on the processing of single-use products is inappropriate. PMID:20204096
Phillips, J Matthew; Mossop, Paula; Bartol, Carolyn; Hodgson, Barbara
Technology and medical equipment devices have become integrated in the delivery of health care. These technologies and devices can introduce new risks, either through user error or malfunction. When these incidents occur, it is important they are reported so that learning and improvements are possible. A just culture encourages reporting of incidents by not blaming individuals, but rather by seeking to understand incidents in relation to how they occurred because of the systems in place. These concepts are explored through a case study in a dialysis unit where a malfunction of a medical equipment device (central venous catheter) was identified. The process for addressing the issue is defined and includes reviewing applicable data, reporting incidents, and evaluating devices that malfunctioned. Finally, the role of the frontline health care professional is identified as an important stakeholder in identifying issues with technology and medical devices, reporting these incidents, and participating in the process that resolves the issues.
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...
... poor usability is among the top 10 health technology hazards of 2012. Examples include users having difficulty ... handle the device in an emergency. Designing Visual Learning Guides, using mostly pictures. The first two guides ... and Players . Language Assistance Available: EspaÃ±ol | ç¹é«ä¸æ | ...
This paper presents an overview of the medical device manufacturing industry in Taiwan. Taiwan’s medical device manufacturers have achieved mature production technology in homecare products. With assistance provided to international giants through Original Equipment Manufacturer and through sales of self-owned brands, they are securing a predominant position on the global market. Contact lenses and glucose meters made in Taiwan have also shown significant growth in production and exports for...
... 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...
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.
Over 10 years ago, the Public Health Agency of Canada released the results of a nation-wide survey of hospitals that demonstrated that the reuse of single-use medical devices was widespread in Canadian healthcare institutions. In this article, the author discusses the reuse and reprocessing of these devices, as well as the risks this practice presents. She then goes on to outline the legal implications of reusing single-use devices. Copyright © 2013 Longwoods Publishing.
Garric, Xavier; Nottelet, Benjamin; Pinese, Coline; Leroy, Adrien; Coudane, Jean
The sector of implantable medical devices is a growing sector of health products especially dynamic in the field of research. To improve the management of patients and to meet clinical requirements, researchers are developing new types of medical devices. They use different families of biomaterials presenting various chemical and physical characteristics in order for providing clinicians with health products optimized for biomedical applications. In this article, we aim to show how, starting from a family of biomaterials (degradable polymers), it is possible to design an implantable medical device for the therapeutic management of the failure of anterior cruciate ligament. The main steps leading to the design of a total ligament reinforcement are detailed. They range from the synthesis and characterization of degradable polymer to the shaping of the knitted implant, through the assessment of the study of the impact of sterilization on mechanical properties and checking cytocompatibility. © 2017 médecine/sciences – Inserm.
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. PMID:24143287
Moorman, Bridget A; Cockle, Richard A
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.
... TRICARE; Off-Label Uses of Devices; Partial List of Examples of Unproven Drugs, Devices, Medical... removes the partial list of examples of unproven drugs, devices, and medical treatments or procedures... partial list of examples of unproven drugs, devices, and medical treatments or procedures proscribed under...
...] 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... Regulatory Science for Highly Multiplexed Microbiology/Medical Countermeasure Devices,'' for FDA's proposed...
Daw, Zamira; Cleaveland, Rance; Vetter, Marcus
Software-based devices have increasingly become an important part of several clinical scenarios. Due to their critical impact on human life, medical devices have very strict safety requirements. It is therefore necessary to apply verification methods to ensure that the safety requirements are met. Verification of software-based devices is commonly limited to the verification of their internal elements without considering the interaction that these elements have with other devices as well as the application environment in which they are used. Medical guidelines define clinical procedures, which contain the necessary information to completely verify medical devices. The objective of this work was to incorporate medical guidelines into the verification process in order to increase the reliability of the software-based medical devices. Medical devices are developed using the model-driven method deterministic models for signal processing of embedded systems (DMOSES). This method uses unified modeling language (UML) models as a basis for the development of medical devices. The UML activity diagram is used to describe medical guidelines as workflows. The functionality of the medical devices is abstracted as a set of actions that is modeled within these workflows. In this paper, the UML models are verified using the UPPAAL model-checker. For this purpose, a formalization approach for the UML models using timed automaton (TA) is presented. A set of requirements is verified by the proposed approach for the navigation-guided biopsy. This shows the capability for identifying errors or optimization points both in the workflow and in the system design of the navigation device. In addition to the above, an open source eclipse plug-in was developed for the automated transformation of UML models into TA models that are automatically verified using UPPAAL. The proposed method enables developers to model medical devices and their clinical environment using clinical workflows as one
Wood, Houston G; Throckmorton, Amy L; Untaroiu, Alexandrina; Song Xinwei
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
Sheinman, Victor; Rudnitsky, Arkady; Toichuev, Rakhmanbek; Eshiev, Abdyrakhman; Abdullaeva, Svetlana; Egemkulov, Talantbek; Zalevsky, Zeev
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.
Wood, Houston G [Mechanical and Aerospace Engineering Department, Virginia Artificial Heart Institute, 122 Engineers Way, University of Virginia, Charlottesville, VA (United States); Throckmorton, Amy L [Biomedical Engineering Department, Virginia Artificial Heart Institute, University of Virginia, Charlottesville, VA (United States); Untaroiu, Alexandrina [Mechanical and Aerospace Engineering Department, Virginia Artificial Heart Institute, 122 Engineers Way, University of Virginia, Charlottesville, VA (United States); Song Xinwei [Mechanical and Aerospace Engineering Department, Virginia Artificial Heart Institute, 122 Engineers Way, University of Virginia, Charlottesville, VA (United States)
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.
Baim, Donald S; Donovan, Aine; Smith, John J; Briefs, Nancy; Geoffrion, Richard; Feigal, David; Kaplan, Aaron V
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
Eberhardt, Alan W.; Johnson, Ophelia L.; Kirkland, William B.; Dobbs, Joel H.; Moradi, Lee G.
There is a global shift in the teaching methodology of science and engineering toward multidisciplinary, team-based processes. To meet the demands of an evolving technical industry and lead the way in engineering education, innovative curricula are essential. This paper describes the development of multidisciplinary, team-based learning environments in undergraduate and graduate engineering curricula focused on medical device design. In these programs, students actively collaborate with clini...
Pashkov, Vitalii; Hutorova, Nataliia; Harkusha, Andrii
In Ukraine differentiated VAT rates is a matter of debate. Today the Cabinet approved a list of medical products that has been changed three times resulting in changed VAT rates for specific products. European Union provides another method of regulation of VAT rates on medical devices. The abovementioned demonstrates the relevance of this study. Comparative analysis of Ukrainian and European Union legislation based on dialectical, comparative, analytic, synthetic and comprehensive research methods were used in this article. In Ukraine general rate of VAT for all business activities is 20 %. But for medical devices, Tax Code of Ukraine provides special rules. VAT rate of 7% for transactions supplies into Ukraine and imported into the customs territory of Ukraine of medical products on the list approved by the Cabinet. The list generated by the medical product name and nomenclature code that does not correspond to European experience and Council Directive 2006/112/EC. In our opinion, reduced VAT rates should to be established for all medical devices that are in a stream of commerce, have all necessary documents, that proved their quality and safety and fall under definition of medical devices.
... validate electromagnetic compatibility (EMC) and safety of exposure to non-ionizing radiation; (2) Design... HUMAN SERVICES Food and Drug Administration 21 CFR Part 886 Medical Devices; Ophthalmic Devices; Classification of the Eyelid Thermal Pulsation System AGENCY: Food and Drug Administration, HHS. ACTION: Final...
... lipids from these cells for noninvasive aesthetic use. (b) Classification. Class II (special controls.... FDA-2011-N-0188] Medical Devices; General and Plastic Surgery Devices; Classification of the Low Level.... DATES: This rule is effective May 16, 2011. The classification was effective on August 24, 2010. FOR...
... 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...
... 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...
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.
Fung, Constance H; Igodan, Uyi; Alessi, Cathy; Martin, Jennifer L; Dzierzewski, Joseph M; Josephson, Karen; Kramer, B Josea
Evidence suggests that medical equipment often fails to accommodate the needs of individuals with disabling conditions. Few studies have focused on the accessibility of home medical devices such as positive airway pressure (PAP), which is a type of home medical equipment prescribed for long-term therapy. The purpose of this study was to explore in detail the types of difficulties experienced by patients with physical/sensory impairments who use PAP devices, as an initial step in designing a questionnaire to survey users about this topic. In this descriptive study, in-depth interviews were conducted with 19 participants (9 patients with physical/sensory impairment and 10 health care providers). Interviews were coded and analyzed for major topics. Participants detailed the numerous ways in which current PAP devices fail to meet the needs of individuals with physical/sensory impairments (e.g., tremor, poor depth perception, paresis), by requiring patients to perform manually difficult tasks, such as inserting PAP parts through small apertures, attaching parts using a twisting motion, and lifting arms overhead to apply PAP headgear. These demands contributed to patients' frustration with and reduced usage of the home medical device. Our findings suggest that home medical devices such as PAP may not be currently designed to meet the needs of some users with physical/sensory impairments. Additional studies are needed to measure the prevalence and impact of impairment-related barriers on PAP adherence for this common medical equipment. Published by Elsevier Inc.
Bachmor, T; Schöchlin, J; Bolz, A
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.
The Food and Drug Administration (FDA or we) is classifying the irrigating wound retractor device 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 irrigating wound retractor device'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.
Hinrichs, Saba; Dickerson, Terry; Clarkson, John
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.
records and will introduce error resistance into networked medical device systems. We are producing a standardization framework consisting of a...We have also begun collecting data on the issue related to device clock time errors and erroneous data time-stamps in preparation for a White House...advances in mind. We also recognize that, as in all technological advances, interoperability poses safety and medico -legal challenges as well. The
Jang, Hye Jung; Choi, Young Deuk; Kim, Nam Hyun
This paper describes an evaluation study on the effectiveness of developing an in-hospital medical device safety information reporting system for managing safety information, including adverse incident data related to medical devices, following the enactment of the Medical Device Act in Korea. Medical device safety information reports were analyzed for 190 cases that took place prior to the application of a medical device safety information reporting system and during a period when the reporting system was used. Also, questionnaires were used to measure the effectiveness of the medical device safety information reporting system. The analysis was based on the questionnaire responses of 15 reporters who submitted reports in both the pre- and post-reporting system periods. Sixty-two reports were submitted in paper form, but after the system was set up, this number more than doubled to 128 reports in electronic form. In terms of itemized reporting, a total of 45 items were reported. Before the system was used, 23 items had been reported, but this increased to 32 items after the system was put to use. All survey variables of satisfaction received a mean of over 3 points, while positive attitude , potential benefits , and positive benefits all exceeded 4 points, each receiving 4.20, 4.20, and 4.13, respectively. Among the variables, time-consuming and decision-making had the lowest mean values, each receiving 3.53. Satisfaction was found to be high for system quality and user satisfaction , but relatively low for time-consuming and decision-making . We were able to verify that effective reporting and monitoring of adverse incidents and the safety of medical devices can be implemented through the establishment of an in-hospital medical device safety information reporting system that can enhance patient safety and medical device risk management.
Full Text Available In applied research for medical devices exists a conflict between effective research and regulations. While researchers need sufficient freedom the regulations require a complex technical documentation for a medical device. One relevant aspect of the regulations is risk management which takes time and therefore is ignored in many research projects. With adoptions to the standard the effort can be reduced: Identifying of risks can be focused on critical risks, measures can be categorised and only some categories need to be implemented. Research teams using this method can provide results which can be transferred into commercial products easier, cheaper and faster.
series of dynamic protocols to isolate and assess balance function deficiencies. The technology was based on Nashner s novel, engineering-inspired concept of balance as an adaptable collaboration between multiple sensory and motor systems. CDP proved useful not only for examining astronauts, but for anyone suffering from balance problems. Today, CDP is the standard medical tool for objectively evaluating balance control.
Full Text Available Standards are produced for many different products and services, and may be created for company, national, regional or global application. In Europe there are three different categories of standard: International standard – a standard adopted by an international standardization organization; European standard – a standard adopted by a European standardization body; National standard – a standard adopted by a national standardization body and made available to the public. Harmonized standards play a special role in the EU. A harmonised standard is a European standard elaborated on the basis of a request from the European Commission to a recognised European Standards Organisation to develop a European standard that provides solutions for compliance with a legal provision. Most standards for dental materials have been harmonized through a so-called cumulative standard (EN 1641:2009 - Dentistry - Medical devices for dentistry - Materials. This European Standard specifies general requirements for materials used in the practice of dentistry for the restoration of the form and function of the dentition and which are medical devices. A multiplicity of laws, standards, and recommendations regulate the marketing of medical devices. The medical doctor and the dentist should be informed about the European and international standards concerning medical devices and use only those for which appropriate information is available. The manufacturer/importer is responsible for its products and is potentially liable for damages.
Vargas, Eric J; Rizk, Monika; Bazerbachi, Fateh; Abu Dayyeh, Barham K
Endoscopic bariatric therapies (EBTs) are effective tools for the management of obesity. By mimicking restrictive and bypass surgery physiology, they provide a safe and effective treatment option with the added capabilities of reaching a broader population. Multiple efficacious medical devices, such as intragastric balloons, endoscopic suturing/plication devices, and bypass liners, at various stages of development are available in the United States. EBTs represent the newest addition to a multidisciplinary approach in obesity management. This article reviews several devices' safety and efficacy for primary care providers in the era of evolving obesity treatment. Copyright © 2017 Elsevier Inc. All rights reserved.
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").
comprising -a medical device for transporting fluids having a lumen and a first connector part, and -at least one light source configured to emit light having bactericidal effect which light source has a corresponding second connector part, and comprises an optical window being transparent for light from...
Kaluska, I.; Stuglik, Z. [Institute of Nuclear Chemistry and Technology, Warsaw (Poland)
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.
... facility best practices. This is part of an ongoing effort to address patient exposure to inadequately... of reusable medical devices. DATES: Submit either electronic or written comments by September 26... the heading of this document, by any of the following methods: Electronic Submissions Submit...
Kibriya, Nabil, E-mail: email@example.com; Hall, Rebecca; Powell, Steven [The Royal Liverpool University Hospital, Radiology Department (United Kingdom); How, Thien [University of Liverpool, Faculty of Health and Life Sciences (United Kingdom); McWilliams, Richard G. [The Royal Liverpool University Hospital, Radiology Department (United Kingdom)
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.
Kibriya, Nabil; Hall, Rebecca; Powell, Steven; How, Thien; McWilliams, Richard G.
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
Haghi, Mostafa; Thurow, Kerstin; Stoll, Regina
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.
Gerson Roberto Luqueta
Full Text Available Abstract Introduction Ozonization is an alternative sterilization process for heat-sensitive medical devices. However, the side effects of this process on packaging materials should be verified. Methods Four types of commercial disposable packaging for medical devices were evaluated after undergoing ozone sterilization: crepe paper sheet, non-woven fabric sheet (SMS, medical grade paper-plastic pouch and Tyvec©-plastic pouch. For each material, the gas penetration through the microbiological barrier was measured. Other packaging properties, such as chemical composition, color, tactile and mechanical resistance, were also evaluated after sterilization, by using characterization techniques, namely microbiological indicators, infrared spectroscopy, tensile test and optical microscopy. Results All commercial disposable packaging showed good ozone penetration. Crepe paper and SMS were chemically and mechanically modified by ozone, while Tyvec© only suffered mechanical modification. Paper-plastic pouch was the packaging material which just experienced an acceptable reduction in tensile resistance, showing no variations on chemical or visual properties. Conclusion The results suggest that medical grade paper-plastic pouch is the most appropriate disposable medical device packaging to be sterilized by ozone when compared to other materials.
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...
Voss, Thaddaeus J; Subbian, Vignesh; Beyette, Fred R
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.
... Committee on the Medical Uses of Isotopes: Meeting AGENCY: U.S. Nuclear Regulatory Commission (NRC). ACTION: Notice of meeting. SUMMARY: NRC will convene a meeting of the Advisory Committee on the Medical Uses of Isotopes (ACMUI) on April 11-12, 2011. This will be a public meeting, and the final agenda is under...
Grocott, Patricia; Weir, Heather; Ram, Mala Bridgelal
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.
Guze, Phyllis A
Medical education is rapidly changing, influenced by many factors including the changing health care environment, the changing role of the physician, altered societal expectations, rapidly changing medical science, and the diversity of pedagogical techniques. Changes in societal expectations put patient safety in the forefront, and raises the ethical issues of learning interactions and procedures on live patients, with the long-standing teaching method of "see one, do one, teach one" no longer acceptable. The educational goals of using technology in medical education include facilitating basic knowledge acquisition, improving decision making, enhancement of perceptual variation, improving skill coordination, practicing for rare or critical events, learning team training, and improving psychomotor skills. Different technologies can address these goals. Technologies such as podcasts and videos with flipped classrooms, mobile devices with apps, video games, simulations (part-time trainers, integrated simulators, virtual reality), and wearable devices (google glass) are some of the techniques available to address the changing educational environment. This article presents how the use of technologies can provide the infrastructure and basis for addressing many of the challenges in providing medical education for the future.
Hindelang, Florine; Zurbach, Raphael; Roggo, Yves
Biomedical device and medicine product manufacturing are long processes facing global competition. As technology evolves with time, the level of quality, safety and reliability increases simultaneously. Micro Computer Tomography (Micro CT) is a tool allowing a deep investigation of products: it can contribute to quality improvement. This article presents the numerous applications of Micro CT for medical device and pharmaceutical packaging analysis. The samples investigated confirmed CT suitability for verification of integrity, measurements and defect detections in a non-destructive manner. Copyright © 2015 Elsevier B.V. All rights reserved.
Popescu-Belis, A.; Boertjes, E.M.; Kilgour, J.; Poller, P.; Castronovo, S.; Wilson, T.; Jaimes, A.; Carletta, J.
The AMIDA Automatic Content Linking Device (ACLD) is a just-in-time document retrieval system for meeting environments. The ACLD listens to a meeting and displays information about the documents from the group's history that are most relevant to what is being said. Participants can view an outline
Craven Michael P
Full Text Available Abstract Background Academic literature and international standards bodies suggest that user involvement, via the incorporation of human factors engineering methods within the medical device design and development (MDDD process, offer many benefits that enable the development of safer and more usable medical devices that are better suited to users' needs. However, little research has been carried out to explore medical device manufacturers' beliefs and attitudes towards user involvement within this process, or indeed what value they believe can be added by doing so. Methods In-depth interviews with representatives from 11 medical device manufacturers are carried out. We ask them to specify who they believe the intended users of the device to be, who they consult to inform the MDDD process, what role they believe the user plays within this process, and what value (if any they believe users add. Thematic analysis is used to analyse the fully transcribed interview data, to gain insight into medical device manufacturers' beliefs and attitudes towards user involvement within the MDDD process. Results A number of high-level themes emerged, relating who the user is perceived to be, the methods used, the perceived value and barriers to user involvement, and the nature of user contributions. The findings reveal that despite standards agencies and academic literature offering strong support for the employment formal methods, manufacturers are still hesitant due to a range of factors including: perceived barriers to obtaining ethical approval; the speed at which such activity may be carried out; the belief that there is no need given the 'all-knowing' nature of senior health care staff and clinical champions; a belief that effective results are achievable by consulting a minimal number of champions. Furthermore, less senior health care practitioners and patients were rarely seen as being able to provide valuable input into the process. Conclusions Medical
Meng, Chuizhou; Gall, Oren Z; Irazoqui, Pedro P
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.
Wolozny Gomez Robelo, Daniel Andre
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...
Mc Hugh, Martin; McCaffery, Fergal; Fitzgerald, Brian; Klass-Jan, Stol; Casey, Valentine; Coady, Garret
peer-reviewed Agile development techniques are becoming increasingly popular in the generic software development industry as they appear to offer solutions to the problems associated with following a plan-driven Software Development Life Cycle (SDLC). However, agile methods may not be suited to all industries or organisations. For agile methods to succeed, an organisation must be structured in a way to accommodate agile methods. Medical device software development organisations are bound b...
Regan, Gilbert; Biro, Miklos; Mc Caffery, Fergal; McDaid, Kevin; Flood, Derek
peer-reviewed Traceability of requirements through the software development lifecycle (including supporting processes such as risk management and change management) is a difficult and expensive task. The implementation of effective traceability allows organizations to leverage its many advantages, such as im-pact analysis, product verification and validation, and facilitation of code maintenance. Traceability is conducive to producing quality software. Within the medical device domain, ...
Bernard A; Vaneau M; Fournel I; Galmiche H; Nony P; Dubernard JM
Alain Bernard,1 Michel Vaneau,2 Isabelle Fournel,3 Hubert Galmiche,2 Patrice Nony,4,5 Jean Michel Dubernard6 1Department of Thoracic Surgery CHU Bocage, Dijon, France; 2Department for Assessment of Medical Devices, HAS (French National Authority of Health), Saint-Denis La Plaine, France; 3Centre of Epidemiology of the Populations, Burgundy University, Dijon, France; 4Department of Clinical Pharmacology, Lyon University CNRS, Lyon, France; 5Laboratory of Biometry and Biology, CNRS, Lyon, Franc...
Trippoli, Sabrina; Caccese, Erminia; Marinai, Claudio; Messori, Andrea
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.
Wang, Yue; Li, Tianping; Liang, Ningxia
A series of laws and regulations are the essential legal requirement in the field of clinical trial of medical device currently in China, especially the Provision for Clinical Trial of Medical Device. On the basis of current situation of medical device clinical trial, systemic analysis on the hot spot topics in the regulations was conducted to explore the way of improving the control system of clinical trial of medical device in China, which will provide the reference for medical device industry and the investigators of the clinical trial of medical device.
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.
Full Text Available A Cardiac Implantable Medical device (IMD is a device, which is surgically implanted into a patient's body, and wirelessly configured using an external programmer by prescribing physicians and doctors. A set of lethal attacks targeting these devices can be conducted due to the use of vulnerable wireless communication and security protocols, and the lack of security protection mechanisms deployed on IMDs. In this paper, we propose a system for postmortem analysis of lethal attack scenarios targeting cardiac IMDs. Such a system reconciles in the same framework conclusions derived by technical investigators and deductions generated by pathologists. An inference system integrating a library of medical rules is used to automatically infer potential medical scenarios that could have led to the death of a patient. A Model Checking based formal technique allowing the reconstruction of potential technical attack scenarios on the IMD, starting from the collected evidence, is also proposed. A correlation between the results obtained by the two techniques allows to prove whether a potential attack scenario is the source of the patient's death.
Pierre, J.P.; Vidal, J.P.; Martin, J.C.; Pasquier, J.L.
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)
Martin Jennifer L
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
Martin, Jennifer L; Barnett, Julie
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
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.
The evolution of smart mobile devices has significantly impacted the way people access and share contents. Existing content sharing schemes require an Internet connection to be always available. However, many places lack Internet connectivity and Internet traffic is also increasing at a rapid speed. Therefore, to alleviate the requirement of having such a persistent connection, this thesis presents novel decentralized content sharing techniques, specifically targeting tourist spot type scenar...
... Cycle; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop...), is announcing a public workshop entitled ``Medical Device Quality System Regulation Educational Forum... information about FDA's Medical Device Quality Systems Regulation (QSR) to the regulated industry...
Full Text Available Utilization of biodegradable polymers for controlled drug delivery has gained immense attention in the pharmaceutical and medical device industry to administer various drugs, proteins and other bio-molecules both systematically and locally to cure several diseases. The efficacy and toxicity of this local therapeutics depends upon drug release kinetics, which will further decide drug deposition, distribution, and retention at the target site. Drug Eluting Stent (DES presently possesses clinical importance as an alternative to Coronary Artery Bypass Grafting due to the ease of the procedure and comparable safety and efficacy. Many models have been developed to describe the drug delivery from polymeric carriers based on the different mechanisms which control the release phenomenon from DES. Advanced characterization techniques facilitate an understanding of the complexities behind design and related drug release behavior of drug eluting stents, which aids in the development of improved future drug eluting systems. This review discusses different drug release mechanisms, engineering principles, mathematical models and current trends that are proposed for drug-polymer coated medical devices such as cardiovascular stents and different analytical methods currently utilized to probe diverse characteristics of drug eluting devices.
Zaidi Maryam Nabihah
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.
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.
Donovan, Aine; Kaplan, Aaron V
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.
... children may be long-term device users--bringing new concerns about device longevity and long- term...] Pediatric Medical Devices; Public Workshop; Request for Comments AGENCY: Food and Drug Administration, HHS... announcing a public workshop entitled ``Using Scientific Research Data to Support Pediatric Medical Device...
Goldman, Julian M
.... The three-day workshop drew 145 participants from academia, industry, government, and health care, including researchers, developers, regulators, users, and manufacturers of medical devices, as well...
... commodities, medicine, and medical devices. 560.533 Section 560.533 Money and Finance: Treasury Regulations... Brokering sales of agricultural commodities, medicine, and medical devices. (a) General license for... agricultural commodities, medicine, and medical devices, provided that the sale and exportation or...
... commodities, medicine, and medical devices. 538.526 Section 538.526 Money and Finance: Treasury Regulations... Brokering sales of agricultural commodities, medicine, and medical devices. (a) General license for... agricultural commodities, medicine, and medical devices to the Government of Sudan, to any individual or entity...
Wagner, Teresa; Lindstadt, Calandra; Jeon, Yongwoog; Mackert, Michael
As more individuals turn to the Internet for health-related information and technology increases the availability and use of implantable medical devices (IMDs), the websites marketing these devices will increase. Healthy People 2020 mandates increased understandability and usability of health-related websites. This project used social cognitive theory (SCT) and health literacy constructs from the Institute of Medicine and National Institutes of Health to analyze eight IMD websites. Despite current recommendations, none of the websites considered for this study offered content of an appropriate reading level in conjunction with the United States average of eighth grade, and 75% of the sites failed to satisfy more than one health literacy construct. Most of the websites lacked many of the SCT constructs. More attention is needed to improve the usability of these and future IMD websites to simultaneously meet the goal of marketing IMDs and the Healthy People 2020 goals to educate patients and promote public health.
Ruzalina Baharin; Hasan Sham; Ahsanulkhaliqin Abdul Wahab
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)
... NUCLEAR REGULATORY COMMISSION Advisory Committee on the Medical Uses of Isotopes: Meeting Notice... teleconference meeting of the Advisory Committee on the Medical Uses of Isotopes (ACMUI) on July 9, 2012. The... contact information below. Purpose: Discuss issues related to 10 CFR Part 35 Medical Use of Byproduct...
... NUCLEAR REGULATORY COMMISSION Advisory Committee on the Medical Uses of Isotopes: Meeting Notice... meeting of the Advisory Committee on the Medical Uses of Isotopes (ACMUI) on May 24-25, 2010. A sample of... administration of iodine 131; (3) updates on the medical isotope shortage; (4) updates on the prostate...
... consumers to provide advice and recommendations regarding Emergency Medical Services (EMS) to the U.S. DOT's.... NHTSA-2010-0155] National Emergency Medical Services Advisory Council Meeting Notice AGENCY: National... Emergency Medical Services Advisory Council (NEMSAC); Notice of Federal Advisory Committee Meeting. SUMMARY...
Roohpour, Nima; Moshaverinia, Alireza; Wasikiewicz, Jaroslaw M; Paul, Deepen; Vadgama, Pankaj; Wilks, Mark; Millar, Michael
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.
Kelly Farrah, MLIS, AHIP
Full Text Available Objective: The study tested the performance of adverse effects search filters when searching for safety information on medical devices, procedures, and diagnostic tests in MEDLINE and Embase. Methods: The sensitivity of 3 filters was determined using a sample of 631 references from 131 rapid reviews related to the safety of health technologies. The references were divided into 2 sets by type of intervention: drugs and nondrug health technologies. Keyword and indexing analysis were performed on references from the nondrug testing set that 1 or more of the filters did not retrieve. Results: For all 3 filters, sensitivity was lower for nondrug health technologies (ranging from 53%– 87% than for drugs (88%–93% in both databases. When tested on the nondrug health technologies set, sensitivity was lower in Embase (ranging from 53%–81% than in MEDLINE (67%–87% for all filters. Of the nondrug records that 1 or more of the filters missed, 39% of the missed MEDLINE records and 18% of the missed Embase records did not contain any indexing terms related to adverse events. Analyzing the titles and abstracts of nondrug records that were missed by any 1 filter, the most commonly used keywords related to adverse effects were: risk, complications, mortality, contamination, hemorrhage, and failure. Conclusions: In this study, adverse effects filters were less effective at finding information about the safety of medical devices, procedures, and tests compared to information about the safety of drugs.
Konkani, Avinash; Oakley, Barbara; Bauld, Thomas J
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.
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.
Aubourg, R; Putzolu, J; Bouche, S; Galmiche, H; Denis, C; d'Andon, A; Maitrot, D; Partensky, C
Surgical hemostatic agents are indicated to improve hemostasis when conventional techniques (compression, sutures or electrocoagulation) are inadequate. The National French Authority for Health (Haute Autorité de santé [HAS]) set out to assess these products (medical devices and agents) to determine their optimal utility. This evaluation included one class of products containing some form of human fibrinogen and thrombin and eight classes of medical devices and automated devices to prepare autologous fibrin. The assessment was based on a systematic review of the literature and expert opinion of health care professionals. The main measures of effectiveness of hemostatic agents were the success rate as expressed in terms of the time necessary to obtain adequate hemostasis, the volume of intra and/or postoperative blood loss, the need for blood transfusions, complication rate, duration of operations and hospital stay. A meta-analysis and 52 controlled randomized studies were selected involving cardiac or vascular surgery (19), ENT surgery (11), gastrointestinal surgery (5), urology (4), orthopedic surgery (4). Approximately half of the studies retained in this analysis evaluated blood derived agents (fibrin sealants) while the other half evaluated medical devices. The working group considered that there is not any evidence that these surgical hemostatic agents decrease the rates of transfusion, complications, reoperation, mortality, duration of operation and/or hospital stay. The working group considered that the use of surgical hemostatic agents to improve the safety of hemostasis in the absence of identified bleeding as an alternative to adequate conventional hemostasis was not justified. Surgical hemostatic agents can be used in ad hoc settings, as a complement to conventional methods to control persistent bleeding after conventional hemostatic techniques, or when abundant bleeding has led to biologic hemostatic disorders. The working group also distinguished
Janß, Armin; Thorn, Johannes; Schmitz, Malte; Mildner, Alexander; Dell'Anna-Pudlik, Jasmin; Leucker, Martin; Radermacher, Klaus
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.
This paper provides an overview of the United States Food and Drug Administration's (FDA) role as a regulatory agency in medical device clinical studies involving human subjects. The FDA's regulations and responsibilities are explained and the device application process discussed. The specific medical device regulatory authorities are described as they apply to the development and clinical study of retinal visual prosthetic devices. The FDA medical device regulations regarding clinical studies of human subjects are intended to safeguard the rights and safety of subjects. The data gathered in pre-approval clinical studies provide a basis of valid scientific evidence in order to demonstrate the safety and effectiveness of a medical device. The importance of a working understanding of applicable medical device regulations from the beginning of the device development project is emphasized particularly for novel, complex products such as implantable visual prosthetic devices.
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.
Sriram Thirumalai; Kingshuk K. Sinha
Medical devices play an increasingly significant role in the delivery of health care today. However, persistent quality problems with medical devices and the associated recalls present potential health risks to patients and personnel using these devices. This study addresses three key issues in this regard. First, it empirically assesses the financial implications of medical device recalls to understand if these consequences are severe enough to deter firms from introducing potentially hazard...
The thirteenth IAEA technical committee meeting on research using small fusion devices are held in Chengdu, P. R. China on 18-20 Oct. , 1999. 41 articles are received and the content includes toroidal systems, helical systems, plasma focus, diagnostic systems, theory and modeling, improving confinement, numerical simulation, innovative concepts and others
Molleman, Eric; Broekhuis, Manda; Stoffels, Renee; Jaspers, Frans
This study examines the consequences for medical specialists of participating in multidisciplinary medical team meetings in terms of perceived clinical autonomy, domain distinctiveness, and professional accountability. These consequences may influence their willingness to cooperate and the quality
Meshkov Aleksandr S.
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.
Nevoux, Jérôme; Coez, Arnaud; Truy, Éric
The management of deafness has become a major public health issue as their lack of detection has a deleterious effect in children and increases the risk factors for aggravation of other pathologies in adults. The detection of deafness remains a real challenge: in the newborn, systematic screening at birth is a good strategy, in adults, much remains to be done. The functional rehabilitation of deafness is based on the use of hearing aids by aerial or bone conduction or of auditory implants. There are three types of auditory implants available: bone anchored hearing implants, middle ear implants and cochlear implants. Many actors, in particular social organizations, can intervene in the financial management of these medical devices. Copyright © 2017 Elsevier Masson SAS. All rights reserved.
Tabei, Masae; Kudo, Hisaaki; Katsumura, Yosuke
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.)
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.
... 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...
... Devices in the Treatment of Obesity and Metabolic Diseases: How To Estimate and Reward True Patient... ``Changing Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of Obesity and... medical devices for the treatment of morbid obesity and other metabolic diseases and evolving approaches...
Beaussier, H; Junot, H; Lancrenon, S; Faure, P
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 Â© 2011 Elsevier Masson SAS. All rights reserved.
Wallace, G G; Higgins, M J; Moulton, S E; Wang, C
The nexus of any bionic device can be found at the electrode-cellular interface. Overall efficiency is determined by our ability to transfer electronic information across that interface. The nanostructure imparted to electrodes plays a critical role in controlling the cascade of events that determines the composition and structure of that interface. With commonly used conductors: metals, carbon and organic conducting polymers, a number of approaches that promote control over structure in the nanodomain have emerged in recent years with subsequent studies revealing a critical dependency between nanostructure and cellular behaviour. As we continue to develop our understanding of how to create and characterise electromaterials in the nanodomain, this is expected to have a profound effect on the development of next generation bionic devices. In this review, we focus on advances in fabricating nanostructured electrodes that present new opportunities in the field of medical bionics. We also briefly evaluate the interactions of living cells with the nanostructured electromaterials, in addition to highlighting emerging tools used for nanofabrication and nanocharacterisation of the electrode-cellular interface.
... NUCLEAR REGULATORY COMMISSION Advisory Committee on the Medical Uses of Isotopes: Meeting Notice AGENCY: U.S. Nuclear Regulatory Commission. ACTION: Notice of meeting. SUMMARY: The U.S. Nuclear... Uses of Isotopes (ACMUI) on June 18, 2013, to discuss the committee's analysis of reported medical...
... NUCLEAR REGULATORY COMMISSION Advisory Committee on the Medical Uses of Isotopes: Meeting Notice... Regulatory Commission will convene a teleconference meeting of the Advisory Committee on the Medical Uses of Isotopes (ACMUI) on December 13, 2010, to discuss: (1) Patient release following iodine-131 therapy; (2...
... NUCLEAR REGULATORY COMMISSION Advisory Committee on the Medical Uses of Isotopes: Meeting Notice... meeting of the Advisory Committee on the Medical Uses of Isotopes (ACMUI) on October 20-21, 2010. A sample... isotope production; (7) updates on 10 CFR part 37 Rule and Guidance; (8) discussion on the draft policy...
...] Medical Imaging Drugs 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: Medical Imaging Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations...
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
Juan Francisco Márquez-Peiró
Full Text Available Objective: To describe the features of computer program to support the activity of the responsible for surveillance of medical devices. To evaluate their use after one year of implementation in a hospital. Method: The stages of the process were: description of the activities of medical devices surveillance and implant registration, definition of functionality and data processing, creation of databases, implementation in a private hospital which manages PS, validation of the program and analysis of their usefulness. Results: SIVIPS was developed using Acces®. Main variables were described for all the activities of the responsible for medical device surveillance (implants, alert, medical device incidents, including for in vitro diagnostics and all the functionalities of the computer program. SIVIPS was introduced in a pharmacy service with one pharmacist for the management of medical devices. One year after its implementation we had registered 564 implants with a description by type of implant, 31 alerts and 6 incidents. SIVIPS allow monitoring of the actions taken in these cases. Conclusions: SIVIPS® is the first tool to support the activity of medical device surveillance. It is an easy tool that allows the registration of alerts and medical device related incidents, and registration of implants performed in the center, which will improve the traceability of the PS.
Márquez-Peiró, Juan Francisco; Gaspar-Carreño, Marisa; Jiménez-Torres, José; Selva-Otaolaurruchi, Juan
To describe the features of computer program to support the activity of the responsible for surveillance of medical devices. To evaluate their use after one year of implementation in a hospital. The stages of the process were: description of the activities of medical devices surveillance and implant registration, definition of functionality and data processing, creation of databases, implementation in a private hospital which manages PS, validation of the program and analysis of their usefulness. SIVIPS was developed using Acces. Main variables were described for all the activities of the responsible for medical device surveillance (implants, alert, medical device incidents, including for in vitro diagnostics) and all the functionalities of the computer program. SIVIPS was introduced in a pharmacy service with one pharmacist for the management of medical devices. One year after its implementation we had registered 564 implants with a description by type of implant, 31 alerts and 6 incidents. SIVIPS allow monitoring of the actions taken in these cases. SIVIPS is the first tool to support the activity of medical device surveillance. It is an easy tool that allows the registration of alerts and medical device related incidents, and registration of implants performed in the center, which will improve the traceability of the PS. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.
...] Medical Devices; Exemption From Premarket Notification: Powered Patient Transport AGENCY: Food and Drug... transport devices commonly known as stairlifts. These devices are used to assist transfers of a mobility... behalf of Bruno Independent Living Aids, Inc., for powered patient transport devices (commonly known as...
...] 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...
Mattei, Eugenio; Censi, Federica; Triventi, Michele; Bartolini, Pietro; Calcagnini, Giovanni
The number and the types of electromagnetic emitters to which patients with active implantable medical devices (AIMD) are exposed to in their daily activities have proliferated over the last decade. Radiofrequency identification (RFID) is an example of wireless technology applied in many fields. The interaction between RFID emitters and AIMD is an important issue for patients, industry and regulators, because of the risks associated with such interactions. The different AIMDs refer to different standards that address the electromagnetic immunity issue in different ways. Indeed, different test setups, immunity levels and rationales are used to guarantee that AIMDs are immune to electromagnetic nonionizing radiation. In this article, the regulatory framework concerning electromagnetic compatibility between RFID systems and AIMDs is analyzed to understand whether and how the application of the current AIMD standards allows for the effective control of the possible risks associated with RFID technology.
... 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...
This meeting has provided an appropriate forum to discuss current issues covering a wide range of technical topics related to the steady state operation issues and also to encourage forecast of the ITER performances. The technical meeting includes invited and contributed papers. The topics that have been dealt with are: 1) Superconducting devices (ITER, KSTAR, Tore-Supra, HT-7U, EAST, LHD, Wendelstein-7-X,...); 2) Long-pulse operation and advanced tokamak physics; 3) steady state fusion technologies; 4) Long pulse heating and current drive; 5) Particle control and power exhaust, and 6) ITER-related research and development issues. This document gathers the abstracts
Forrest, R.; Mengoni, A.
A Technical Meeting on 'Nuclear Data Library for Advanced Systems - Fusion Devices' was held at the IAEA Headquarters in Vienna from 31 October to 2 November 2007. The main objective of the initiative has been to define a proposal and detailed plan of activities for a Co-ordinated Research Project on this subject. Details of the discussions which took place at the meeting, including a review of the current activities in the field, a list of recommendations and a proposed timeline schedule for the CRP are summarized in this report. (author)
... 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; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing an amendment to the notice of...
... 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; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing an amendment to the notice of...
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.
Neugebauer, Edmund A M; Rath, Ana; Antoine, Sunya-Lee
that the classical evidence hierarchy cannot be applied for medical devices, as randomised clinical trials are impossible to perform. This article aims to identify the barriers for randomised clinical trials on medical devices. METHODS: Systematic literature searches without meta-analysis and internal European...... of scientific advice, regulations and transparency. CONCLUSIONS: The present review offers potential solutions to break down the barriers identified, and argues for applying the randomised clinical trial design when assessing the benefits and harms of medical devices....
Eberhardt, Alan W; Johnson, Ophelia L; Kirkland, William B; Dobbs, Joel H; Moradi, Lee G
There is a global shift in the teaching methodology of science and engineering toward multidisciplinary, team-based processes. To meet the demands of an evolving technical industry and lead the way in engineering education, innovative curricula are essential. This paper describes the development of multidisciplinary, team-based learning environments in undergraduate and graduate engineering curricula focused on medical device design. In these programs, students actively collaborate with clinicians, professional engineers, business professionals, and their peers to develop innovative solutions to real-world problems. In the undergraduate senior capstone courses, teams of biomedical engineering (BME) and business students have produced and delivered numerous functional prototypes to satisfied clients. Pursuit of commercialization of devices has led to intellectual property (IP) disclosures and patents. Assessments have indicated high levels of success in attainment of student learning outcomes and student satisfaction with their undergraduate design experience. To advance these projects toward commercialization and further promote innovative team-based learning, a Master of Engineering (MEng) in Design and Commercialization was recently launched. The MEng facilitates teams of graduate students in engineering, life sciences, and business who engage in innovation-commercialization (IC) projects and coursework that take innovative ideas through research and development (R&D) to create marketable devices. The activities are structured with students working together as a "virtual company," with targeted outcomes of commercialization (license agreements and new start-ups), competitive job placement, and/or career advancement.
Eberhardt, Alan W.; Johnson, Ophelia L.; Kirkland, William B.; Dobbs, Joel H.; Moradi, Lee G.
There is a global shift in the teaching methodology of science and engineering toward multidisciplinary, team-based processes. To meet the demands of an evolving technical industry and lead the way in engineering education, innovative curricula are essential. This paper describes the development of multidisciplinary, team-based learning environments in undergraduate and graduate engineering curricula focused on medical device design. In these programs, students actively collaborate with clinicians, professional engineers, business professionals, and their peers to develop innovative solutions to real-world problems. In the undergraduate senior capstone courses, teams of biomedical engineering (BME) and business students have produced and delivered numerous functional prototypes to satisfied clients. Pursuit of commercialization of devices has led to intellectual property (IP) disclosures and patents. Assessments have indicated high levels of success in attainment of student learning outcomes and student satisfaction with their undergraduate design experience. To advance these projects toward commercialization and further promote innovative team-based learning, a Master of Engineering (MEng) in Design and Commercialization was recently launched. The MEng facilitates teams of graduate students in engineering, life sciences, and business who engage in innovation-commercialization (IC) projects and coursework that take innovative ideas through research and development (R&D) to create marketable devices. The activities are structured with students working together as a “virtual company,” with targeted outcomes of commercialization (license agreements and new start-ups), competitive job placement, and/or career advancement. PMID:26902869
Stephens, Anne; Assang, AnnMarie
Health Canada recommends that hospitals should have procedures in place to ensure Reusable Medical Devices (RMD) are cleaned, disinfected and sterilized according to the manufacturer's instructions. For the purpose of this paper, reusable medical devices will be referred to as RMDs and include all instrumentation and devices that the Central Processing Department (CPD) resterilizes for use in the hospital. Patient safety in surgery begins in CPD. Manufacturer recommendations for the decontamination and sterilization of surgical instrumentation are of utmost importance to Operating Room (OR) and CPD staff. With recommendations that are unclear, nonspecific or unattainable there was a need to define what it means institutionally to meet standards and provide safe patient care while continuing to support the advancement of surgical technology. The purpose of this paper is to describe the challenges faced by one multisite organization (The University Health Network) in managing the sterilization of surgical instrumentation. The development of The Guidance Matrix by the network's inter-professional Reusable Medical Device (RMD) Committee, will be discussed along with information about the elements of this tool and an illustration of how it is used. The key benefits of The Guidance Matrix, including how its use has facilitated transparent decision-making, communication and collaboration regarding sterilization issues across the sites, will be described. Sterilization processes in Central Processing Departments (CPD) include chemical indicators, dated load indicators, and tamperproof locks and filters. The lack of an indicator of sterilization can be a frustrating experience for an OR Nurse. But do we really understand the critical importance of all these indicators? The foundation of sterilizing reusable medical devices (RMDs) begins with proper processes, standards and subsequent scientific validation from the vendors. According to AORN, patient safety is vital and it
... or intermittent. While FDA has confidence that medical devices currently being marketed will continue... for open dialogue among stakeholders to share lessons learned and best practices for overcoming...
.... 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...
Zapata, Lauren B; Jatlaoui, Tara C; Marchbanks, Polly A; Curtis, Kathryn M
Potential barriers to intrauterine device (IUD) use include provider concern about difficult insertion, particularly for nulliparous women. This study aims to evaluate the evidence on the effectiveness of medications to ease IUD insertion on provider outcomes (i.e., ease of insertion, need for adjunctive insertion measures, insertion success). We searched the PubMed database for peer-reviewed articles published in any language from database inception through February 2016. We included randomized controlled trials (RCTs) that examined medications to ease interval insertion of levonorgestrel-releasing IUDs and copper T IUDs. From 1855 articles, we identified 15 RCTs that met our inclusion criteria. Most evidence suggested that misoprostol did not improve provider ease of insertion, reduce the need for adjunctive insertion measures or improve insertion success among general samples of women seeking an IUD (evidence Level I, good to fair). However, one RCT found significantly higher insertion success among women receiving misoprostol prior to a second IUD insertion attempt after failed attempt versus placebo (evidence Level I, good). Two RCTs on 2% intracervical lidocaine as a topical gel or injection suggested no positive effect on provider ease of insertion (evidence Level I, good to poor), and one RCT on diclofenac plus 2% intracervical lidocaine as a topical gel suggested no positive effect on provider ease of insertion (evidence Level I, good). Limited evidence from two RCTs on nitric oxide donors, specifically nitroprusside or nitroglycerin gel, suggested no positive effect on provider ease of insertion or need for adjunctive insertion measures (evidence Level I, fair). Overall, most studies found no significant differences between women receiving interventions to ease IUD insertion versus controls. Among women with a recent failed insertion who underwent a second insertion attempt, one RCT found improved insertion success among women using misoprostol versus
Goldman, Julian M
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...
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.
Crouzel, C.; Le Poec, C.; Jarry, E.; Knipper, R.; Comar, D.
The authors describe an irradiation device set up beside a compact medical cyclotron (520.CGR-MeV cyclotron). The variable energy machine can accelerate 3-22 MeV protons, 3-13 MeV deuterons, 6-26 MeV alpha particles and 5-31 MeV helium-3 particles, the currents extracted at the maximum energies reaching 50 μA for 4 He and 3 He, 70 μA for protons and deuterons. The essential characteristics demanded of the apparatus in order to produce a regular and abundant supply of short-lived radioisotopes were as follows: - Flexibility of use or the possibility of fast, completely non-manual target changing. - Simplicity of operation: the target-holder components must be easily interchangeable and the transfer of radioisotopes from the irradiation point to the chemical laboratory must be rapid. - Working safety: the automatic target-holder cooling controls must be duplicated by manual controls. - Target cooling efficiency: these targets, whether gaseous, liquid or solid, must be able to support a high particle current. (Auth.)
... the challenges and risks posed by the proliferation of new sophisticated medical implants and other... deliver treatment and therapy. There has also been an increasing proliferation of devices using... networks to practitioners, caregivers, and patients. These and other products cover a broad range of health...
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.
Bowsher, K.; Civillico, E. F.; Coburn, J.; Collinger, J.; Contreras-Vidal, J. L.; Denison, T.; Donoghue, J.; French, J.; Getzoff, N.; Hochberg, L. R.; Hoffmann, M.; Judy, J.; Kleitman, N.; Knaack, G.; Krauthamer, V.; Ludwig, K.; Moynahan, M.; Pancrazio, J. J.; Peckham, P. H.; Pena, C.; Pinto, V.; Ryan, T.; Saha, D.; Scharen, H.; Shermer, S.; Skodacek, K.; Takmakov, P.; Tyler, D.; Vasudevan, S.; Wachrathit, K.; Weber, D.; Welle, C. G.; Ye, M.
Objective. The Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) believes it is important to help stakeholders (e.g., manufacturers, health-care professionals, patients, patient advocates, academia, and other government agencies) navigate the regulatory landscape for medical devices. For innovative devices involving brain-computer interfaces, this is particularly important. Approach. Towards this goal, on 21 November, 2014, CDRH held an open public workshop on its White Oak, MD campus with the aim of fostering an open discussion on the scientific and clinical considerations associated with the development of brain-computer interface (BCI) devices, defined for the purposes of this workshop as neuroprostheses that interface with the central or peripheral nervous system to restore lost motor or sensory capabilities. Main results. This paper summarizes the presentations and discussions from that workshop. Significance. CDRH plans to use this information to develop regulatory considerations that will promote innovation while maintaining appropriate patient protections. FDA plans to build on advances in regulatory science and input provided in this workshop to develop guidance that provides recommendations for premarket submissions for BCI devices. These proceedings will be a resource for the BCI community during the development of medical devices for consumers.
Maresova, Petra; Penhaker, Marek; Selamat, Ali; Kuca, Kamil
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.
Demiris, George; Marek, Karen D.
Introduction Older adults with multiple chronic conditions face the complex task of medication management involving multiple medications of varying doses at different times. Advances in telehealth technologies have resulted in home-based devices for medication management and health monitoring of older adults. We examined older adults’ perceptions of a telehealth medication dispensing device as part of a clinical trial involving home health care clients, nurse coordination and use of the medication dispensing device. Methods Ninety-six frail older adult participants who used the medication dispensing device for 12 months completed a satisfaction survey related to perceived usefulness and reliability. Results were analyzed and grouped by themes in the following areas: Ease of Use, Reliability, Medication Management Assistance, Routine Task Performance and Acceptability. Results Nearly all participants perceived the medication dispensing device as very easy to use, very reliable and helpful in management of their medications. Eighty-four percent of participants expressed a desire to use the machine in the future. Conclusion The technology-enhanced medication management device in this study is an acceptable tool for older adults to manage medication in collaboration with home care nurses. Improved usability and cost models for medication dispensers are areas for future research. Trial Registration clinicaltrials.gov identifier: NCT01321853 PMID:23323721
Reeder, Blaine; Demiris, George; Marek, Karen D
Older adults with multiple chronic conditions face the complex task of medication management involving multiple medications of varying doses at different times. Advances in telehealth technologies have resulted in home-based devices for medication management and health monitoring of older adults. We examined older adults' perceptions of a telehealth medication dispensing device as part of a clinical trial involving home healthcare clients, nurse coordination and use of the medication dispensing device. Ninety-six frail older adult participants who used the medication dispensing device for 12 months completed a satisfaction survey related to perceived usefulness and reliability. Results were analyzed and grouped by themes in the following areas: Ease of Use, Reliability, Medication Management Assistance, Routine Task Performance and Acceptability. Nearly all participants perceived the medication dispensing device as very easy to use, very reliable and helpful in the management of their medications. Eighty-four percent of participants expressed a desire to use the machine in the future. The technology-enhanced medication management device in this study is an acceptable tool for older adults to manage medication in collaboration with home care nurses. Improved usability and cost models for medication dispensers are areas for future research.
....m., Eastern Standard Time (E.S.T.). The meeting will be held at the Hilton Alexandria Old Town, 1767 King Street, Alexandria, VA 22314 in Salon BC on the main floor. The Hilton Alexandria Old Town is...
Hatz, Maximilian H M; Sonnenschein, Tim; Blankart, Carl Rudolf
Studies have often stated that individual-level determinants are important drivers for the adoption of medical devices. Empirical evidence supporting this claim is, however, scarce. At the individual level, physicians' adoption motivation was often considered important in the context of adoption decisions, but a clear notion of its dimensions and corresponding measurement scales is not available. To develop and subsequently validate a scale to measure the motivation to adopt medical devices of hospital-based physicians. The development and validation of the physician-motivation-adoption (PMA) scale were based on a literature search, internal expert meetings, a pilot study with physicians, and a three-stage online survey. The data collected in the online survey were analyzed using exploratory factor analysis (EFA), and the PMA scale was revised according to the results. Confirmatory factor analysis (CFA) was conducted to test the results from the EFA in the third stage. Reliability and validity tests and subgroup analyses were also conducted. Overall, 457 questionnaires were completed by medical personnel of the National Health Service England. The EFA favored a six-factor solution to appropriately describe physicians' motivation. The CFA confirmed the results from the EFA. Our tests indicated good reliability and validity of the PMA scale. This is the first reliable and valid scale to measure physicians' adoption motivation. Future adoption studies assessing the individual level should include the PMA scale to obtain more information about the role of physicians' motivation in the broader adoption context. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.
Muniz Janaína Barbosa
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.
Mantus, David; Pisano, Douglas J
...: A Guide for Prescription Drugs, Medical Devices, and Biologics, Second Edition are covered in a straightforward format. It is a compilation and commentary of selected laws and regulations pertaining to the development and approval of drugs, biologics, and medical devices in the United States. It is not intended to take the place of an actual r...
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)
de Mol, Bastian A.
Patient health often depends on medical devices and implants. Thanks to these advancements, trust in and expectations of medical technology are high. But history shows critical device failures of heart valves, breast implants, hip prostheses and heart stimulators occurring under the regulatory
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.
...] Food and Drug Administration/Xavier University Global Medical Device Conference AGENCY: Food and Drug... ``FDA/Xavier University Global Medical Device Conference.'' This 3-day public conference includes.... Combination Products Panel. Update on Quality System Regulations. Warning Letter and Enforcement Action Trends...
..., radiological, or nuclear agent. For the exception to apply, it is necessary for the investigator and an.... FDA-2003-N-0212; (formerly Docket No. 2003N-0355)] Medical Devices; Exception From General... interim final rule (IFR) entitled ``Medical Devices; Exception From General Requirements for Informed...
...] Medical Device Epidemiology Network 2011: Second Annual Public Workshop AGENCY: Food and Drug... public workshop entitled ``Medical Device Epidemiology Network (MDEpiNet) 2011: Second Annual Public... and to facilitate discussion among FDA and all stakeholders with expertise in epidemiology and health...
Römer, GertWillem R.B.E.; Stuyt, Harry J.A.
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
... 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...
Schmettow, Martin; Schnittker, Raphaela; Schraagen, Jan Maarten
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
How do active implantable medical devices react in the presence of strong magnetic fields in the frequency range between extremely low frequency (ELF) to radiofrequency (RF) as they are emitted by electronic security systems (ESS)? There are three different sorts of ESSs: electronic article surveillance (EAS) devices, metal detector (MDS) devices, and radiofrequency identification (RFID) systems. Common to all is the production of magnetic fields. There is an abundance of literature concerning interference by ESS gates with respect to if there is an influence possible and if such an influence can bear a risk for the AIMD wearers. However, there has been no attempt to study the physical mechanism nor to develop a model of how and under which conditions magnetic fields can influence pacemakers and defibrillators and how they could be disarmed by technological means. It is too often assumed that interference of AIMD with ESS is inevitable. Exogenous signals of similar intensity and rhythm to heart signals can be misinterpreted and, thus, confuse the implant. Important for the interference coupling mechanism is the differentiation between a "unipolar" and a "bipolar" system. With respect to magnetic fields, the left side implanted pacemaker is the most unfavorable case as the lead forms approximately a semicircular area of maximum 225 cm2 into which a voltage can be induced. This assumption yields an interference coupling model that can be expressed by simple mathematics. The worst-case conditions for induced interference voltages are a coupling area of 225 cm2 that is representative for a large human, a homogeneous magnetic field perpendicular to the area formed by the lead, and a unipolar ventricular pacemaker system that is implanted on the left side of the thorax and has the highest interference sensitivity. In bipolar systems the fields must be 17 times larger when compared to a unipolar system to have the same effect. The magnetic field for interfering with ICDs
Phelps, Megan; Scott, Karen M.; Chauffeté-Manillier, Martine; Lenne, Frédéric; Le Jeunne, Claire
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…
... 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...
Simcoe, Donna; Juneja, Renu; Scott, Gayle Nicholas; Sridharan, Kanaka; Williams-Hughes, Celeste
During the 9th Annual Meeting of the International Society for Medical Publication Professionals (ISMPP, April 29-May 1, 2013 in Baltimore, MD), ∼650 participants attended two of 13 available roundtable sessions. Participants included medical publication professionals from industry, communication agencies, and journals. DISCUSSION TOPICS: Roundtable participants discussed how to best interpret and implement various guidances, such as Good Publication Practices 2 (GPP2), the International Committee of Medical Journal Editors (ICMJE) guidelines, and the Physician Payment Sunshine Act. The impact of and compliance with Corporate Integrity agreements (CIAs) on medical publication planning practices was debated. Roundtable participants also discussed ways of advancing both advocacy for the medical publication professional field and internal and external collaborations. The development of review manuscripts, publications from regions newly emerging in publication planning, medical devices publications, and real-world experience publications were discussed. Participants also considered the benefits and uncertainties of new technologies in medical publications such as multimedia and social media. This is the first ever article to be published following the well-attended ISMPP roundtable sessions. The objective of this manuscript is to summarize key learnings that will aid continued discussions about challenges and opportunities facing medical publication professionals.
The winds of change world-wide have swept medical education in the last fifteen years. Today, Australia's medical students are older and drawn from more diverse socio-economic, ethnic and geographic backgrounds than twenty years ago, and there is now an equal mix of men and women in medical school. Admission policies have been rewritten to broaden access with a range of entry options now available including direct entry from high school and graduate entry following a first degree. Curricula have been revised and modes of learning transformed. This paper describes these changes and discusses the implications for medical schools and for planning the future workforce.
Ross, Joseph S; Blount, Katrina L; Ritchie, Jessica D; Hodshon, Beth; Krumholz, Harlan M
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 po...
... device offering comparable advantage over existing approved alternatives have been granted expedited... clinical test center certification. 5. Candidates for interagency or public-private partnerships to foster...
These are the abstracts of the 2017 American College of Medical Toxicology (ACMT) Annual Scientific Meeting. Included here are 120 abstracts that will be presented in March 2017, including research studies from around the globe and the ToxIC collaboration, clinically significant case reports describing new toxicologic phenomena, and encore presentations from other scientific meetings.
... NUCLEAR REGULATORY COMMISSION Advisory Committee on the Medical Uses of Isotopes: Meeting Notice AGENCY: U.S. Nuclear Regulatory Commission. ACTION: Notice of Meeting. SUMMARY: The U.S. Nuclear... Uses of Isotopes (ACMUI) on January 5, 2011, to discuss: (1) The ACMUI reporting structure; (2...
... NUCLEAR REGULATORY COMMISSION Advisory Committee on the Medical Uses of Isotopes: Meeting Notice AGENCY: U.S. Nuclear Regulatory Commission. ACTION: Notice of meeting. SUMMARY: The U.S. Nuclear... Uses of Isotopes (ACMUI) on December 15, 2011, to discuss the ACMUI's recommendations on proposed...
... NUCLEAR REGULATORY COMMISSION Advisory Committee on the Medical Uses of Isotopes: Meeting Notice AGENCY: U.S. Nuclear Regulatory Commission. ACTION: Notice of meeting. SUMMARY: The U.S. Nuclear... Uses of Isotopes (ACMUI) on March 5, 2013, to discuss the draft report of the ACMUI Rulemaking...
... NUCLEAR REGULATORY COMMISSION Advisory Committee on the Medical Uses of Isotopes: Meeting Notice AGENCY: U.S. Nuclear Regulatory Commission. ACTION: Notice of meeting. SUMMARY: The U.S. Nuclear... Uses of Isotopes (ACMUI) on February 7, 2012, to discuss the ACMUI Permanent Implant Brachytherapy...
... NUCLEAR REGULATORY COMMISSION Advisory Committee on the Medical Uses of Isotopes; Meeting Notice AGENCY: U.S. Nuclear Regulatory Commission. ACTION: Notice of meeting. SUMMARY: The U.S. Nuclear... Uses of Isotopes (ACMUI) on October 18, 2011, to discuss the ACMUI Permanent Implant Brachytherapy...
Agrawal, A.; Aronson, J.K.; Britten, N.; Ferner, R.E.; Smet, P.A.G.M. de; Fialova, D.; Fitzgerald, R.J.; Likic, R.; Maxwell, S.R.; Meyboom, R.H.; Minuz, P.; Onder, G.; Schachter, M.; Velo, G.
Here we discuss 15 recommendations for reducing the risks of medication errors: 1. Provision of sufficient undergraduate learning opportunities to make medical students safe prescribers. 2. Provision of opportunities for students to practise skills that help to reduce errors. 3. Education of
... comment (or of the person signing the comment, if submitted on behalf of an association, business, labor... . FOR FURTHER INFORMATION CONTACT: Angela Ward, Nurse Consultant, Medical Programs Division, (202) 366..., motor carriers, drivers, and representatives of medical and scientific associations. Oral comments on...
... diagnosis of cystic fibrosis or for other uses if the drug intended for use with the device bears adequate... 50520) for classification of iontophoresis devices for specialized uses (for the diagnosis of cystic... cystic fibrosis or other uses if the labeling of the drug intended for use with the device bears adequate...
..., and D, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel's telephone number is 301-977-8900. Contact... of the trial was to demonstrate that the time until the first event of all-cause mortality, heart... special needs. If you require special accommodations due to a disability, please contact AnnMarie Williams...
... guidewire and to track the bioprosthesis over the aortic arch and for crossing and positioning in the native...-dilate the native annulus) and a crimper. FDA intends to make background material available to the public... Advisory Committee Act (5 U.S.C. app. 2). Dated: April 19, 2012. Jill Hartzler Warner, Acting Associate...
... track the bioprosthesis over the aortic arch and for crossing and positioning in the native valve. The... native annulus) and a crimper. On July 21, 2011, the committee will discuss, make recommendations, and... Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: June 15, 2011. Jill Hartzler Warner, Acting...
... the Federal Register about last minute modifications that impact a previously announced advisory... eye for visual correction of aphakia and postoperative refractive astigmatism secondary to removal of... the contact person on or before April 1, 2013. Oral presentations from the public will be scheduled...
... Stroke in Intracranial Stenosis'' (SAMMPRIS), published in the New England Journal of Medicine (2011;365... Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1535, Silver Spring, MD 20993-0002, 301...
...: (1) Centrifugal type pumps utilize a rotor to impart energy to the blood in an extracorporeal circuit... cardiopulmonary blood pumps for use in cardiopulmonary bypass circuits for periods of up to six hours. Micro... blood pumps for use in cardiopulmonary bypass circuits for periods of up to six hours, but FDA did not...
..., sponsored by Hologic, Inc. The Selenia Dimensions 3D System is currently approved for breast cancer... synthetic 2D images from the DBT data. Hologic requests to expand the indications for use to allow the...
... lesion lengths per patient of 280 mm. \\1\\ ``Fr'' stands for French. It is a term that defines the... registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open... hearing session. The contact person will notify interested persons regarding their request to speak by...
.../Gaithersburg, Grand Ballroom, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel's telephone number is 301-977... Washington, DC area). A notice in the Federal Register about last minute modifications that impact a... safety and effectiveness data from the ``Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke...
... Washington DC North/Gaithersburg, Salons A, B, C, and D, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel's... notice in the Federal Register about last minute modifications that impact a previously announced... Technology. The WATCHMAN LAA Closure Technology is a percutaneously delivered permanent cardiac implant...
Risiken und Nebenwirkungen der Integration medizinischer Software in klinische IT-Strukturen – Erlanger Memorandum [Software as a medical device – side effects when applying the new European regulation on medical devices for IT products
Kaiser, J.; Gassner, U.M.; Reng, M.; Prokosch, H.U.; Bürkle, T.
[english] European medical device regulations have been altered to cover pure software applications as well. They now may be classified as a medical device if used for medical diagnostics and/or medical treatment. Slowly, these regulations are being implemented into national law of the EEC member states, for example into the German MPG (Medical Product Law).For some software applications such as Picture Archiving and Communication systems (PACS) a classification as medical device is – at leas...
Zhang, Meng; Raghunathan, Anand; Jha, Niraj K
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.
Brown, James E; Qiang, Rui; Stadnik, Paul J; Stotts, Larry J; Von Arx, Jeffrey A
Magnetic resonance imaging (MRI) is the preferred modality for soft tissue imaging because of its nonionizing radiation and lack of contrast agent. Due to interactions between the MR system and active implantable medical devices (AIMDs), patients with implants such as pacemakers are generally denied access to MRI, which presents a detriment to that population. It has been estimated that 50-75% of patients with a cardiac device were denied access to MRI scanning and, moreover, that 17% of pacemaker patients need an MRI within 12 months of implantation . In recent years, AIMD manufacturers, such as Biotronik, have assessed the conditional safety of devices in MRI.
Zippel, Claus; Bohnet-Joschko, Sabine
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.
Clou, E; Dompnier, M; Kably, B; Leplay, C; Poupon, E; Archer, V; Paul, M
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.
... between the vertebral bodies into the disc space from L3-S1 to help provide stabilization and to help.... This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Orthopaedic and Rehabilitation...
... General Medical Sciences; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory... clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of General Medical Sciences Special Emphasis Panel; 2011 NIH Director's Pioneer Awards. Date: May 2-4, 2011. Time: 7:45 a.m...
...The Food and Drug Administration (FDA) is classifying the non- powered suction apparatus device intended for negative pressure wound therapy (NPWT) into class II (special controls). The special control that will apply to the device is the guidance document entitled ``Class II Special Controls Guidance Document: Non-Powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy.'' 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. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability for the guidance document entitled ``Class II Special Controls Guidance Document: Non-Powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy.''
The Food and Drug Administration (FDA) is classifying the diurnal pattern recorder system 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 diurnal pattern recorder system's 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.
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.
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.
The Food and Drug Administration (FDA) is classifying the Magnetic Surgical Instrument System 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 magnetic surgical instrument system's 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.
Gad, Shayne C
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
The Food and Drug Administration (FDA or we) is classifying the surgical smoke precipitator 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 surgical smoke precipitator'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.
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.
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.
Kim, Do-Hyun; Kim, Moon S.; Hwang, Jeeseong
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.
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
Inaba, Michiko; Bell, Christina; Tamura, Bruce; Kasuya, Richard; Masaki, Kamal
Good clinician-family communication is essential for the provision of high-quality patient care. Families rate the communication skills of clinicians as critical clinical skills. However, there has been no structured training of fellow communication skills while leading family meetings in the University of Hawai'i Geriatric Medicine Fellowship Program. Effective training to develop communication skills with families will better prepare Geriatric Medicine fellows for this important task, and ultimately improve the quality of care they provide to these patients and patients' families.
... DEPARTMENT OF HOMELAND SECURITY Coast Guard [Docket No. USCG-2011-0138] Merchant Mariner Medical..., Maryland 20674-0075. For further information about the Paul Hall Center hotel facilities or services for... participation, we are inviting public comment on the issues to be considered by the working groups as listed in...
Gatwood, Justin D; Johnson, Jordan; Jerkins, Brian
To compare use of topical medications between a wireless monitoring device and validated self-reported measures of glaucoma medication adherence. This study involved adults from a group ophthalmology practice diagnosed with and being medicinally treated for glaucoma who were not scheduled for a surgery during the study period. Subjects were required to use a new wireless device to dispense their glaucoma medication for 2 months, and were surveyed at baseline and immediately following the study to assess mobile phone use, glaucoma-related self-efficacy, and medication adherence. Complete data (survey and accurate device recordings) were available for 23 subjects at both baseline and endpoint. Median adherence, as measured by the device, was 82% and dropped slightly between 30-day periods, from 83% to 77%. Similarly, the percent adherent (dosing at least 75% of the time) dropped significantly between months according to both the device (78.3% and 52.2%) and a self-reported measure (63% and 56%). Kappa statistics indicated low agreement between the device and self-report when classifying adherent status. A majority of subjects interviewed found the device easy to use, indicated that it did not interfere with medication-taking or normal activities, and were not bothered by their physician knowing when medication was dispensed. In this pilot, nearly all Kali Drop devices performed as expected, providing real-time data on medication use over a 60-day period. Data suggested that self-reported and electronic estimates of glaucoma medication use differ, but additional testing of this new device is needed to corroborate the data observed.
... delivery process. External mechanical support of the perianal region is intended to help prevent the occurrence of external hemorrhoids associated with vaginal childbirth. FDA has identified the following risks... type of device must submit to FDA a premarket notification, prior to marketing the device, which...
... Patient Transport AGENCY: Food and Drug Administration, HHS. ACTION: Final order. SUMMARY: The Food and... premarket notification requirements for powered patient transport devices commonly known as stairway chair... effect for stairway chair lifts. All other devices classified under FDA's powered patient transport...
... make recommendations regarding the proposed classification of implanted blood access devices for hemodialysis from class III to class II. The class III implanted blood access devices for hemodialysis include... tubing terminating in rigid Luer lock connectors for attachment to a dialysis machine. Subcutaneous...
... 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...
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).
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.
Kasparick, Martin; Schmitz, Malte; Andersen, Björn; Rockstroh, Max; Franke, Stefan; Schlichting, Stefan; Golatowski, Frank; Timmermann, Dirk
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.
Whipple, Elizabeth C; Allgood, Kacy L; Larue, Elizabeth M
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.
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
Wagner, J L
Today, computers are used in several important and fast-growing medical imaging modalities, such as digital subtraction angiography, positron emission tomography, magnetic resonance imaging, nuclear medicine, and diagnostic ultrasound. The ultimate test for the computer in medical imaging will be its ability to replace traditional film-based radiography as the mechanism for displaying, communicating, and storing imaging information. This transition will require radiologists and other imagers to accept information in digital form. The speed of that acceptance depends on the economic incentives of the health care system. These are changing as a result of cost containment, which is moving away from fee-for-service toward bundled payment. The increase in capitated health plans will encourage the development of digital radiography systems that realistically trade-off the perceived quality needs of radiologists with the costs of producing and operating such systems.
Song, Jin-Zi; Wan, Min; Xu, Hui; Yao, Xiu-Jun; Zhang, Bo; Wang, Jin-Hong
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.
Grainger, David W.; van der Mei, Henny C.; Jutte, Paul C.; van den Dungen, Jan J. A. M.; Schultz, Marcus J.; van der Laan, Bernard F. A. M.; Zaat, Sebastian A. J.; Busscher, Henk J.
Biomaterials-associated infection incidence represents an increasing clinical challenge as more people gain access to medical device technologies worldwide and microbial resistance to current approaches mounts. Few reported antimicrobial approaches to implanted biomaterials ever get commercialized
Burnik, Urban; Dobravec, Štefan; Meža, Marko
Software-based medical devices need to be maintained throughout their entire life cycle. The efficiency of after-sales maintenance can be improved by managing medical systems remotely. This paper presents how to design the remote access function extensions in order to prevent risks imposed by uncontrolled remote access. A thorough analysis of standards and legislation requirements regarding safe operation and risk management of medical devices is presented. Based on the formal requirements, a multi-layer machine design solution is proposed that eliminates remote connectivity risks by strict separation of regular device functionalities from remote management service, deploys encrypted communication links and uses digital signatures to prevent mishandling of software images. The proposed system may also be used as an efficient version update of the existing medical device designs.
Jensen, Troels Victor; Parslov, Jakob Filippson; Mortensen, Niels Henrik
and V&V test view. This will allow for V&V-related documentation to follow the product platform, and thereby enable carry-over of test documentation packages from one product family to another. Hence, this approach can provide significant competitive advantages to companies as it increases R......Medical device companies are continuously challenged with the ability to prove compliance with increasingly complex regulatory frameworks. Operating under heavy regulatory requirements may therefore cause significant delays to the lead time of new medical devices and thus contribute significantly...... to time-to-market for even simple medical device development projects. In this paper we illustrate how medical device companies can reduce their research and development (R&D) efforts needed to prove compliance when developing new product families by means of platforming and modularization. The results...
"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...
will enable the creation of complete electronic health records and will introduce error resistance into networked medical device systems. We are...technological advances, interoperability poses safety and medico -legal challenges as well. The development of standards and production of
Triani, Gerry; Doe, Simon
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
Schvartzman, Javier A; Krupitzki, Hugo; Merialdi, Mario; Betrán, Ana Pilar; Requejo, Jennifer; Nguyen, My Huong; Vayena, Effy; Fiorillo, Angel E; Gadow, Enrique C; Vizcaino, Francisco M; von Petery, Felicitas; Marroquin, Victoria; Cafferata, María Luisa; Mazzoni, Agustina; Vannevel, Valerie; Pattinson, Robert C; Gülmezoglu, A Metin; Althabe, Fernando; Bonet, Mercedes
A prolonged and complicated second stage of labour is associated with serious perinatal complications. The Odon device is an innovation intended to perform instrumental vaginal delivery presently under development. We present an evaluation of the feasibility and safety of delivery with early prototypes of this device from an early terminated clinical study. Hospital-based, multi-phased, open-label, pilot clinical study with no control group in tertiary hospitals in Argentina and South Africa. Multiparous and nulliparous women, with uncomplicated singleton pregnancies, were enrolled during the third trimester of pregnancy. Delivery with Odon device was attempted under non-emergency conditions during the second stage of labour. The feasibility outcome was delivery with the Odon device defined as successful expulsion of the fetal head after one-time application of the device. Of the 49 women enrolled, the Odon device was inserted successfully in 46 (93%), and successful Odon device delivery as defined above was achieved in 35 (71%) women. Vaginal, first and second degree perineal tears occurred in 29 (59%) women. Four women had cervical tears. No third or fourth degree perineal tears were observed. All neonates were born alive and vigorous. No adverse maternal or infant outcomes were observed at 6-weeks follow-up for all dyads, and at 1 year for the first 30 dyads. Delivery using the Odon device is feasible. Observed genital tears could be due to the device or the process of delivery and assessment bias. Evaluating the effectiveness and safety of the further developed prototype of the BD Odon Device™ will require a randomized-controlled trial. ANZCTR ACTRN12613000141741 Registered 06 February 2013. Retrospectively registered.
... components of surgically implanted medical devices. 300.113 Section 300.113 Education Regulations of the... surgically implanted medical devices. (a) Hearing aids. Each public agency must ensure that hearing aids worn...) External components of surgically implanted medical devices. (1) Subject to paragraph (b)(2) of this...
Calcagnini, G; Mattei, E; Censi, F; Triventi, M; Lo Sterzo, R; Marchetta, E; Bartolini, P
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.
The reprocessing of medical devices, in particular surgical instruments, is an extremely technical and highly regulated industry. There are many guidance documents, and European and international standards that cover different aspects of decontamination. This article provides an outline of the main documents covering the critical elements of reprocessing which aim to ensure that reusable medical devices are provided which are fit for purpose and safe for patient use.
evaluating a variety of security technologies ranging from RFID access control to security testing products. Recently, there has been a dramatic...Award Number: W81XWH-09-1-0705 TITLE: “Medical Device Plug-and-Play Interoperability Standards and Technology Leadership” PRINCIPAL INVESTIGATOR...20 Sept 2015 4. TITLE AND SUBTITLE “Medical Device Plug-and-Play Interoperability 5a. CONTRACT NUMBER Standards and Technology Leadership” 5b
Full Text Available Background and objectives : Meetings are inseparable part of organizational world which cost high. The aim of this study was to analyze the effectiveness of the meetings held in Tabriz University of Medical Sciences from personnel’s perspective in management setting. Material and Methods : This is a cross-sectional, descriptive study. The study community consisted of 207 managers in different directorship positions in which 82 of them were selected as the sample by using Kookran formula. Data were collected using researcher-made which its validity and reliability were achieved according to Likert spectrum. Data were analyzed by SPSS software version 16. The applied tests included independent T test and Anova. Results : Personnel dedicated 75% of total score for pre meeting processes and meeting management and 32% for the effectiveness of the meetings in the process of achieving the goals, satisfaction from holding the meetings and effective participation in the meetings. In other words, they were compliant with the quality of the meetings but disagreed on the effectiveness of the meetings. Also, these findings showed meaningful relationship between effectiveness and quality of the meetings with age and educational courses. However, there was no meaningful difference between effectiveness and quality of the meetings with gender, level of education and field of study (p>0.05. Conclusion : In order to improve the quality and effectiveness of the meetings, it is necessary to hold meetings’ invitation, beginning and finishing on-time. In addition, participants should be focused and informed about the subjects of the meeting. Furthermore, empowering managers and personnel in different management positions by holding educational packages and workshops is suggested.
...., Gaithersburg, MD. Contact Person: Tracy Phillips, Food and Drug Administration, Center for Devices and... special needs. If you require special accommodations due to a disability, please contact AnnMarie Williams...
... and Mechanical Safety Performance Testing. Inflammation/Foreign Body Response..... Section 10... and it is identified as a device using focused ultrasound to produce localized, mechanical motion... for mechanical cellular membrane disruption intended for noninvasive aesthetic use. FDA has identified...
.... There are no other changes. FOR FURTHER INFORMATION CONTACT: Avena Russell, Center for Devices and..., MD 20993-0002, 301-796-3805, Avena[email protected] , or please use the FDA Advisory Committee...
... 20877. The hotel's telephone number is (301) 977-8900. Contact Person: Avena Russell, Center for Devices..., Silver Spring, MD 20993-0002, Avena[email protected] , (301) 796-3805, or FDA Advisory Committee...
... 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...
... 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...
... 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...
... unsafe medical devices. FDA also recognizes that continuous improvement activities, as part of an... . Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration... device failure or function. The recall process establishes a mechanism for firms that produce and market...
... safety and quality. DATES: Submit either electronic or written comments by May 10, 2013. ADDRESSES: Submit electronic comments to http://www.regulations.gov . Submit written comments to the Division of... situations in the future. Scenario A. Marketed Devices Already in Use for Patient Care Medical devices in use...
Bruzzi, M S; Linehan, J H
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.
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0616... with the increasing use of wireless, Internet- and network-connected devices and the frequent... cybersecurity in medical devices. It does not create or confer any rights for or on any person and does not...
Haghi, Mostafa; Thurow, Kerstin; Stoll, Regina
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...
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
Kessler, Larry; Ramsey, Scott D; Tunis, Sean; Sullivan, Sean D
The pace of medical technological development shows no sign of abating. Analyzing the effect of major federal health agencies on the availability of such technology is critical. This paper describes functions of three government health agencies: the Centers for Medicare and Medicaid Services (CMS), the Food and Drug Administration (FDA), and the National Institutes of Health (NIH). Certain medical technologies fall into gaps between these agencies, which pose challenges in today's era of demand for evidence-based medicine. We suggest new policy and pragmatic strategies that can close the gaps and move decision making relevant to technology forward more rapidly than is now the case.
Zhao, Jinhai; Hou, Wensheng; Chen, Haiyan; Tang, Wei; Wang, Yihui
A Web-based technology system was put forward aiming at the actual problems of the long maintenance cycle and the difficulties of the maintenance and repairing of medical equipments. Based on analysis of platform system structure and function, using the key technologies such as search engine, BBS, knowledge base and etc, a platform for medical equipment service technician to use by online or offline was designed. The platform provides users with knowledge services and interactive services, enabling users to get a more ideal solution.
de Faria, Jose Weber Vieira; Teixeira, Manoel Jacobsen; de Moura Sousa Júnior, Leonardo; Otoch, Jose Pinhata; Figueiredo, Eberval Gadelha
OBJECTIVE The authors sought to construct, implement, and evaluate an interactive and stereoscopic resource for teaching neuroanatomy, accessible from personal computers. METHODS Forty fresh brains (80 hemispheres) were dissected. Images of areas of interest were captured using a manual turntable and processed and stored in a 5337-image database. Pedagogic evaluation was performed in 84 graduate medical students, divided into 3 groups: 1 (conventional method), 2 (interactive nonstereoscopic), and 3 (interactive and stereoscopic). The method was evaluated through a written theory test and a lab practicum. RESULTS Groups 2 and 3 showed the highest mean scores in pedagogic evaluations and differed significantly from Group 1 (p 0.05). Size effects, measured as differences in scores before and after lectures, indicate the effectiveness of the method. ANOVA results showed significant difference (p higher learning when compared with traditional teaching resources.
Simulation-based medical education can provide medical training in a nonjudgmental, patient-safe, and effective environment. Although simulation has been a relatively new addition to medical education, the aeronautical, judicial, and military fields have used simulation training for hundreds of years, with positive outcomes. Simulation-based medical education can be used in a variety of settings, such as hospitals, outpatient clinics, medical schools, and simulation training centers. As the author describes in the present article, residencies currently accredited by the American Osteopathic Association can use a simulation-based medical education curriculum to meet training requirements of the 6 competencies identified by the Accreditation Council for Graduate Medical Education. The author also provides specific guidance on providing training and assessment in the professionalism competency.
... an increased risk of medical device error. Also, there is no single available source of medical...- clinical environments. FDA is aware of and concerned with the risk of medical errors that result from lost... HUMAN SERVICES Food and Drug Administration Accessible Medical Device Labeling in a Standard Content and...
... use of absorbable materials (including synthetic polymers as well as erodible metals) in medical... Absorbable Medical Devices: Lessons Learned From Correlations of Bench Testing and Clinical Performance... Bench Testing and Clinical Performance.'' FDA is co-sponsoring the workshop together with ASTM...
reflect our vision of progressing medical device interoperability standards, whether specifically ICE-related or more generally applicable, and...White Coat Notes,” the Boston Globe online, June 2007. http://www.boston.com/yourlife/health/ blog /2007/06/getting_medical_1.html 6. Carr S, “Plug and
.... Diagnostics. assay and quality control material. P040024 (S51), FDA-2011-M-0735.... Medicis Aesthetics...-2011-M-0917] Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval.... H090002, FDA-2011-M-0848 BSD Medical Corp..... BSD-2000 November 18, 2011. hyperthermia system. P110010...
...- January 20, 2012. Diagnostics Inc. HBs2 Assay and Quality Control Material. P100005, FDA-2012-M-0082...-0208, FDA- 2012-M-0209, FDA-2012-M-0210, FDA-2012-M-0221, and FDA-2012-M-0250] Medical Devices... BSD Medical BSD-2000 November 18, 2011. Corporation. Hyperthermia System. H100004, FDA-2011-M-0919...
Markiewicz, Katarzyna; van Til, Janine Astrid; Steuten, Lotte Maria Gertruda; IJzerman, Maarten Joost
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
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.
Vincent, Christopher James; Li, Yunqiu; Blandford, Ann
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.
Gittard, Shaun D; Narayan, Roger J
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
Hanus, Josef; Nosek, Tomas; Zahora, Jiri; Bezrouk, Ales; Masin, Vladimir
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.
Restivo, Léa; Apostolidis, Thémis; Bouhnik, Anne-Déborah; Garciaz, Sylvain; Aurran, Thérèse; Julian-Reynier, Claire
The contribution of patients' non-medical characteristics to individual physicians' decision-making has attracted considerable attention, but little information is available on this topic in the context of collective decision-making. Medical decision-making at cancer centres is currently carried out using a collective approach, at MultiDisciplinary Team (MDT) meetings. The aim of this study was to determine how patients' non-medical characteristics are presented at MDT meetings and how this information may affect the team's final medical decisions. Observations were conducted at a French Cancer Centre during MDT meetings at which non-standard cases involving some uncertainty were discussed from March to May 2014. Physicians' verbal statements and predefined contextual parameters were collected with a non-participant observational approach. Non numerical data collected in the form of open notes were then coded for quantitative analysis. Univariate and multivariate statistical analyses were performed. In the final sample of patients' records included and discussed (N = 290), non-medical characteristics were mentioned in 32.8% (n = 95) of the cases. These characteristics corresponded to demographics in 22.8% (n = 66) of the cases, psychological data in 11.7% (n = 34), and relational data in 6.2% (n = 18). The patient's age and his/her "likeability" were the most frequently mentioned characteristics. In 17.9% of the cases discussed, the final decision was deferred: this outcome was positively associated with the patients' non-medical characteristics and with uncertainty about the outcome of the therapeutic options available. The design of the study made it difficult to draw definite cause-and-effect conclusions. The Social Representations approach suggests that patients' non-medical characteristics constitute a kind of tacit professional knowledge that may be frequently mobilised in physicians' everyday professional practice. The links observed between patients
Ellaway, Rachel H; Fink, Patricia; Graves, Lisa; Campbell, Alanna
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.
Over 80% of all Nuclear Medicine procedures make use of the radionuclide Tc-99 for SPECT imaging of heart disease, cancer and other disorders. Historically TC-99 has been produced from a generator through the decay of Mo-99 where the Mo-99 is a fission product of U-235. Five reactors around the world supply the market. However, these reactors are aging (many over 50 years old) and governments are reluctant to replace them. Therefore researchers have turned to accelerators as a potential source of this important radionuclide. In Canada the government has funded research project for two accelerator approaches: Mo-100(gamma,n)Mo-99 and Mo-100(p,2n)Tc-99m where the photons are generated from the conversion of high powered electrons into Bremsstrahlung radiation and the protons generated in low energy cyclotrons (15-25 MeV). The goal of these project is to provide the Government with sufficient information so that an informed decision can be made with respect to future supplies of medical isotopes for Canada. International interest has been expressed by the IAEA as a way to allow Member States with existing cyclotron programs to take advantage of the direct production route. This talk will describe the challenges with the approaches and the progress to date.
Liu, Jessica J; Bell, Chaim M; Matelski, John J; Detsky, Allan S; Cram, Peter
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
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.
Full Text Available , subcellular and molecular level • The CSIR is well positioned to assist industry to design, develop and manufacture photonic-based point-of-care devices. • Advantages – Cost reduction per analysis – Portable device, possibly also equipment free – Low... devices and diagnostics lifecycle management platform – Examples of technology platforms ‹#› 3 Overview of SA medical device industry • ~30 multinationals companies • ~ 26 local manufacturers • Employ less than 50 people • Employs over 20 000 • 94...
Kramer, Daniel B; Tan, Yongtian T; Sato, Chiaki; Kesselheim, Aron S
Regulatory bodies weighing market approval for novel medical devices must balance the benefits and potential hazards carefully. We performed a legal and policy review of appraoches in the US, EU, Japan, and China to device regulation with a focus on postmarket surveillance. These markets share broad features such as a heavy reliance on passive adverse event collection, reflected by growing enthusiasm for more active and dynamic mechanisms such as unique device identification. More immediately, US and EU systems might benefit from scheduled, compulsory, and consequential re-examination of select devices, as is done in Japan and China, in order to strengthen post-market protection of patients and bolster public health.
... A, B, C and D, 620 Perry Pkwy., Gaithersburg, MD. Contact Person: Tracy Phillips, Center for Devices... 20993, 301-796-6150, Tracy[email protected] , or FDA Advisory Committee Information Line, 1-800-741... special needs. If you require special accommodations due to a disability, please contact AnnMarie Williams...
... 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... communication to an external recorder which records the date and time of ingestion as well as the unique serial...
... application for the Kineflex/C Cervical Artificial Disc sponsored by SpinalMotion. The Kineflex/C is a metal-on-metal (cobalt chrome molybdenum alloy) cervical total disc replacement device. The Kineflex/C is... discectomy for intractable radiculopathy or myelopathy due to a single-level abnormality localized to the...
... for Breast- Cancer Screening,'' New England Journal of Medicine, 353: 1773-1783, 2005. 3. Yaffe, M., A..., 10903 New Hampshire Ave., Bldg. 66, rm. G304, Silver Spring, MD 20993-0002, 301-796-6887; or Kyle J. Myers, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave...
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 878 [Docket No... Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is classifying the... (special controls). The special control that will apply to the device is the guidance document entitled...
...; Classification of the Near Infrared Brain Hematoma Detector AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is classifying the Near Infrared (NIR) Brain... device, which contains information about the NIR Brain Hematoma Detector they intend to market. II...
Full Text Available A multiplicity of laws, standards, and recommendations regulate the marketing of medical devices. Therefore, legal regulations do not release the specialists in the fields of medicine and dentistry from the responsibility to gather as much information as possible about the products used or to request this information from the manufacturer. Safety data sheets for medical devices can be downloaded from the Internet. They are an important source of information about the biocompatibility of dental materials as they were investigated by the manufacturers. Appropriate safety labels on the wrappings should be considered. The manufacturer/importer is responsible for its products and is potentially liable for damages. The medical doctors and dentists should use only those medical devices for which appropriate information is available.
Sleath, Betsy; Carpenter, Delesha M; Ayala, Guadalupe X; Williams, Dennis; Davis, Stephanie; Tudor, Gail; Yeatts, Karin; Gillette, Chris
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.
Nine experts on dust formation and their physical and behavioural characteristics attended the first Research Coordination Meeting (RCM) on Characterization of Size, Composition and Origins of Dust in Fusion Devices held at IAEA Headquarters on 10-12 December 2008. Participants summarized recent relevant developments related to dust in fusion devices. The specific objectives of the CRP and a detailed work plan were formulated. Discussions, conclusions and recommendations of the RCM are briefly described in this report. (author)
Unique device identifiers for coronary stent postmarket surveillance and research: a report from the Food and Drug Administration Medical Device Epidemiology Network Unique Device Identifier demonstration.
Tcheng, James E; Crowley, Jay; Tomes, Madris; Reed, Terrie L; Dudas, Joseph M; Thompson, Kweli P; Garratt, Kirk N; Drozda, Joseph P
Although electronic product identification in the consumer sector is ubiquitous, unique identification of medical devices is just being implemented in 2014. To evaluate unique device identifiers (UDIs) in health care, the US Food and Drug Administration (FDA) funded the Medical Device Epidemiology Network initiative, including a demonstration of the implementation of coronary stent UDI data in the information systems of a multihospital system (Mercy Health). This report describes the first phase of the demonstration. An expert panel of interventional cardiologists nominated by the American College of Cardiology and the Society for Cardiovascular Angiography and Interventions was convened with representatives of industry, health system members of the Healthcare Transformation Group, the American College of Cardiology National Cardiovascular Data Registry, and FDA to articulate concepts needed to best use UDI-associated data. The expert panel identified 3: (1) use cases for UDI-associated data (eg, research), (2) a supplemental data set of clinically relevant attributes (eg, stent dimensions), and (3) governance and administrative principles for the authoritative management of these data. Eighteen use cases were identified, encompassing clinical care, supply chain management, consumer information, research, regulatory, and surveillance domains. In addition to the attributes of the FDA Global Unique Device Identification Database, 9 additional coronary stent-specific attributes were required to address use case requirements. Recommendations regarding governance were elucidated as foundational principles for UDI-associated data management. This process for identifying requisite extensions to support the effective use of UDI-associated data should be generalizable. Implementation of a UDI system for medical devices must anticipate both global and device-specific information. Copyright © 2014 Mosby, Inc. All rights reserved.
Trkov, A.; Forrest, R.; Mengoni, A.
The first Research Co-ordination Meeting of the Nuclear Data Libraries for Advance Systems - Fusion Devices (FENDL - 3) was held at the IAEA Headquarters in Vienna from 2 to 5 December 2008. A summary of the meeting is given in this report along with discussions which took place. An important outcome of the meeting was the agreement to create a new FENDL-3.0 Starter Library. Finally, a list of task assignments was prepared together with the plan for future CRP activities. (author)
Sawan, Mohamed E.
The second Research Co-ordination Meeting of the Nuclear Data Libraries for Advanced Systems - Fusion Devices (FENDL - 3) was held at the IAEA Headquarters in Vienna from 23 to 26 March 2010. A summary of the meeting is given in this report along with the discussions which took place. An important outcome of the meeting was the decision to provide ENDF data libraries (FENDL-3/T) by April 2011. Finally, a list of task assignments was prepared together with the plan for future CRP activities. (author)
... graduate medical education, evaluation of teaching programs especially in terms of meeting community needs..., will begin with an update and an opportunity to comment on HRSA's Bureau of Health Professions... Dentistry, Bureau of Health Professions, Health Resources and Services Administration, Room 9A- 27, Parklawn...
... Administration's Bureau of Health Professions (BHPr). Speakers during the morning session will address critical... funding for graduate medical education (GME), the reconfiguring of health professions training programs at... demand. The meeting on November 10, 2011 will start with a presentation on teaching health centers. This...
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Council on... advise and make recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS... Committee on Energy and Commerce. The topic of discussion for this meeting is graduate medical education...
Bashir, R.; Afroze, B.; Zulfiqar, H. F.; Saleem, R.; Saleem, F.; Aslam, F.; Naz, S.
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)
Kasparick, Martin; Schlichting, Stefan; Golatowski, Frank; Timmermann, Dirk
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.
Yin, Jinghua; Luan, Shifang
Biomaterials and medical devices are broadly used in the diagnosis, treatment, repair, replacement or enhancing functions of human tissues or organs. Although the living conditions of human beings have been steadily improved in most parts of the world, the incidence of major human's diseases is still rapidly growing mainly because of the growth and aging of population. The compound annual growth rate of biomaterials and medical devices is projected to maintain around 10% in the next 10 years; and the global market sale of biomaterials and medical devices is estimated to reach $400 billion in 2020. In particular, the annual consumption of polymeric biomaterials is tremendous, more than 8000 kilotons. The compound annual growth rate of polymeric biomaterials and medical devices will be up to 15-30%. As a result, it is critical to address some widespread concerns that are associated with the biosafety of the polymer-based biomaterials and medical devices. Our group has been actively worked in this direction for the past two decades. In this review, some key research results will be highlighted.
de Ana, F J; Umstead, K A; Phillips, G J; Conner, C P
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.
Hung, K; Zhang, Y T; Tai, B
The world's ageing population and prevalence of chronic diseases have lead to high demand for tele-home healthcare, in which vital-signs monitoring is essential. An overview of state-of-art wearable technologies for remote patient-monitoring is presented, followed by case studies on a cuffless blood pressure meter, ring-type heart rate monitor, and Bluetoothtrade mark-based ECG monitor. Aim of our project is to develop a tele-home healthcare system which utilizes wearable devices, wireless communication technologies, and multisensor data fusion methods. As an important part of this system, a cuffless BP meter has been developed and tested on 30 subjects in a total of 71 trials over a period of five months. Preliminary results show a mean error (ME) of 1.82 mmHg and standard deviation of error (SDE) of 7.62 mmHg in systolic pressure; while ME and SDE in diastolic pressure are 0.45 mmHg and 5.27 mmHg, respectively.
Anand, K; Saini, Ks; Chopra, Y; Binod, Sk
'Medical Devices' include everything from highly sophisticated, computerized, medical equipment, right down to simple wooden tongue depressors. Regulations embody the public expectations for how buildings and facilities are expected to perform and as such represent public policy. Regulators, who develop and enforce regulations, are empowered to act in the public's interest to set this policy and are ultimately responsible to the public in this regard. Standardization contributes to the basic infrastructure that underpins society including health and environment, while promoting sustainability and good regulatory practice. The international organizations that produce International Standards are the International Electrotechnical Commission (IEC), the International Organization for Standardization (ISO), and the International Telecommunication Union (ITU). With the increasing globalization of markets, International Standards (as opposed to regional or national standards) have become critical to the trading process, ensuring a level playing field for exports, and ensuring that imports meet the internationally recognized levels of performance and safety. The development of standards is done in response to sectors and stakeholders that express a clearly established need for them. An industry sector or other stakeholder group typically communicates its requirement for standards to one of the national members. To be accepted for development, a proposed work item must receive a majority support of the participating members, who verify the global relevance of the proposed item. The regulatory authority (RA) should provide a method for the recognition of international voluntary standards and for public notification of such recognition. The process of recognition may vary from country to country. Recognition may occur by periodic publication of lists of standards that a regulatory authority has found will meet the Essential Principles. In conclusion, International standards
...] Draft Guidance for Industry and FDA Staff: Processing/ Reprocessing Medical Devices in Health Care... Devices in Health Care Settings: Validation Methods and Labeling.'' The recommendations in this guidance... Staff: Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling...
Nielsen, Lene; Christensen, Lars Rune; Sabers, Anne
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 the use of digital devices in treatments the protocols from the field of medicine is adopted. The question is whether or not this evidence based approach is useful when dealing with digital devices and whether the understanding of the efficiency of a treatment can be obtained without also looking...... at usability and lifestyle issues. Based on a case study of epilepsy, a literature study of protocols for investigating treatments using digital medical devices, the set-up of studies, the design of a current protocol for clinical trials, and finally preliminary results, we discuss if clinical trials have...
Rey-Ares, Lucila; Hernández-Vásquez, Akram; Garay, Osvaldo Ulises; Pichon Riviere, Andrés; Garcia Marti, Sebastián; Gilardino, Ramiro; Cabra, Hermilio Arturo; Augustovski, Federico
To describe and compare the requirements for medical devices licensing and reimbursement in four Latin-American countries. We conducted a literature search in major databases, and generic Internet engines, and interviewed key informants. We included all publications describing regulation and/or coverage and enriched them with key informant's interviews. We found that licensing processes are similar. The decision-making process for coverage is not formally different than the one used for drugs. Although countries differ, Brazil, Colombia and Mexico have an explicit process informed by Health Technology Assessment. In general, coverage policies are defined for procedures and don´t specify device brand or model, and for that reason they may reimburse without explicit one by one device evaluation. The process for licensing and reimbursement is broadly similar but less stringent than that for drugs. It allows the adoption of medical devices without individual comprehensive assessment.
Steffensen, Søren Langer; Merete H., Vestergaard,; Møller, Eva Horn
Materials for the next generation of medical devices will require not only the mechanical stability of current devices, but must also possess other properties such as sustained release of drugs in a controlled manner over a prolonged period of time. This work focuses on creating such a sophistica......Materials for the next generation of medical devices will require not only the mechanical stability of current devices, but must also possess other properties such as sustained release of drugs in a controlled manner over a prolonged period of time. This work focuses on creating...... such a sophisticated material by forming an interpenetrating polymer network (IPN) material through modification of silicone elastomers with a poly(2-hydroxyethyl methacrylate) (PHEMA)-based hydrogel. IPN materials with a PHEMA content in the range of 13%–38% (w/w) were synthesized by using carbon dioxide...
Moultrie, James; Sutcliffe, Laura Francesca Rose; Maier, Anja
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...... that supports decisions to be made within the realm of design engineers and beyond. The tool highlights areas which are influenced by design decisions taken, some of which are perceived to be outside of the direct control of designers....
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)
Wireless techniques can play an important role in next-generation, image-guided surgical techniques with integration strategies being the key. We present our investigations on three wireless applications. First, we validate a position and orientation independent method to noninvasively monitor wireless power delivery using current perturbation measurements of switched load modulation of the RF carrier. This is important for safe and efficient powering without using bulky batteries or invasive cables. Use of MRI transmit RF pulses for simultaneous powering is investigated in the second part. We develop system models for the MRI transmit chain, wireless powering circuits and a typical load. Detailed analysis and validation of nonlinear and cascaded modeling strategies are performed, useful for decoupled optimization of the harvester coil and RF-DC converter. MRI pulse sequences are investigated for suitability for simultaneous powering. Simulations indicate that a 1.8V, 2 mA load can be powered with a 100% duty cycle using a 30° fGRE sequence, despite the RF duty cycle being 44 mW for a 30° flip angle, consistent with model predictions. Investigations on imaging artifacts indicates that distortion is mostly restricted to within the physical span of the harvester coil in the imaging volume, with the homogeneous B1+ transmit field providing positioning flexibility to minimize this for simultaneous powering. The models are potentially valuable in designing wireless powering solutions for implantable devices with simultaneous real-time imaging in MRI-guided surgical suites. Finally in the last section, we model endovascular MRI coil coupling during RF transmit. FEM models for a series-resonant multimode coil and quadrature birdcage coil fields are developed and computationally efficient, circuit and full-wave simulations are used to model inductive coupling. The Bloch Siegert B1 mapping sequence is used for validating at 24, 28 and 34 microT background excitation
Martelli, Nicolas; van den Brink, Hélène; Borget, Isabelle
We describe here recent modifications to the French Coverage with Evidence Development (CED) scheme for innovative medical devices. CED can be defined as temporary coverage for a novel health product during collection of the additional evidence required to determine whether definitive coverage is possible. The principle refinements to the scheme include a more precise definition of what may be considered an innovative product, the possibility for device manufacturers to request CED either independently or in partnership with hospitals, and the establishment of processing deadlines for health authorities. In the long term, these modifications may increase the number of applications to the CED scheme, which could lead to unsustainable funding for future projects. It will also be necessary to ensure that the study conditions required by national health authorities are suitable for medical devices and that processing deadlines are met for the scheme to be fully operational. Overall, the modifications recently applied to the French CED scheme for innovative medical devices should increase the transparency of the process, and therefore be more appealing to medical device manufacturers. Copyright © 2016 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.
Ross, Joseph S; Blount, Katrina L; Ritchie, Jessica D; Hodshon, Beth; Krumholz, Harlan M
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.
Ross, Joseph S; Blount, Katrina L; Ritchie, Jessica D; Hodshon, Beth; Krumholz, Harlan M
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. PMID:26060416
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.
Moultrie, James; Sutcliffe, L.; Maier, Anja
This exploratory study seeks to explore the current state of design for the environment (DfE) in the development of medical devices; an historically risk averse industry that lags behind others in terms of addressing environmental considerations. A cross-sectional survey of 34 medical device...... designers, primarily in the UK and USA, was conducted in order to fulfil this objective. Findings indicate that there is significant motivation to enhance DfE practice, but that there are multiple barriers to this. Major barriers identified are a perception of the high cost of DfE, the industry’s current...
Full Text Available In a prospective descriptive laboratory study, 25 Helping Hand™ (HH (10 without and 15 with reminder system and 50 Medication Event Monitoring Systems (MEMS (25 with 18-month and 25 with 2-year battery life were manipulated twice daily following a predefined protocol during 3 consecutive weeks. Accuracy was determined using the fixed manipulation scheme as the reference. Perfect functioning (i.e., total absence of missing registrations and/or overregistrations was observed in 70% of the HH without, 87% of the HH with reminder, 20% MEMS with 18 months, and 100% with 2-year battery life respectively.
Howard, Jason J
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. PMID:25429243
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.
Martelli, N; van den Brink, H; Denies, F; Dervaux, B; Germe, A F; Prognon, P; Pineau, J
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.
Choi, Jong Soo; Lee, Jean Hyoung; Park, Jong Hwan; Nam, Han Seung; Kwon, Hyuknam; Kim, Dongsoo; Park, Seung Woo
Implementing an efficient Electronic Medical Record (EMR) system is regarded as one of the key strategies for improving the quality of healthcare services. However, the system's interoperability between medical devices and the EMR is a big barrier to deploying the EMR system in an outpatient clinical setting. The purpose of this study is to design a framework for a seamless and comprehensively integrated medical device interface system, and to develop and implement a system for accelerating the deployment of the EMR system. We designed and developed a framework that could transform data from medical devices into the relevant standards and then store them in the EMR. The framework is composed of 5 interfacing methods according to the types of medical devices utilized at an outpatient clinical setting, registered in Samsung Medical Center (SMC) database. The medical devices used for this study were devices that have microchips embedded or that came packaged with personal computers. The devices are completely integrated with the EMR based on SMC's long term IT strategies. First deployment of integrating 352 medical devices into the EMR took place in April, 2006, and it took about 48 months. By March, 2010, every medical device was interfaced with the EMR. About 66,000 medical examinations per month were performed taking up an average of 50GB of storage space. We surveyed users, mainly the technicians. Out of 73 that responded, 76% of the respondents replied that they were strongly satisfied or satisfied, 20% replied as being neutral and only 4% complained about the speed of the system, which was attributed to the slow speed of the old-fashioned medical devices and computers. The current implementation of the medical device interface system based on the SMC framework significantly streamlines the clinical workflow in a satisfactory manner. 2010 Elsevier Ireland Ltd. All rights reserved.
Penchaszadeh Víctor B
Full Text Available During the Ninth International Congress of Human Genetics which was held in Rio de Janeiro, Brazil, from 16 to 18 August 1996, a group of experts under the coordination of the authors discussed at length the state of medical genetics in Latin America. The facts and ideas presented at the meeting, which was sponsored by the Human Genetics Program of the World Health Organization (WHO and the Maternal and Child Health Program of the Pan American Health Organization, are examined in this document under three broad headings. The first verses on the history and current status of medical genetics in selected Latin American countries. This is followed by a discussion of the general features of medical genetics in the Region and by a final section of recommendations for promoting medical genetics in Latin America.
According to definition, chronic wounds do not show any tendency for healing over months. From the socio-economic perspective they are of great importance due to their frequency, patient burden and costs for the health system. In wound care, medical devices play a crucial, even more important role than drugs as nearly every wound needs at least a dressing. A wound passes through several phases of wound healing, which often demand different therapies and differentiated wound dressings in the sense of a "phase-adapted" wound therapy. "Modern wound care" reflects a cross-sectoral, interdisciplinary and interprofessional approach founded on evidence-based and quality-assured procedures according to the most recent medical knowledge. Clinical research on chronic wounds is characterised by a great variety of wound types and conditions, the strong impact of pathogenetic factors and complications, a multifaceted, frequently still manual therapy and long periods of healing. In many instances, several treatments are applied intermediately in the same patient, which serve different purposes and thus require different study endpoints. An analysis of the European Wound Management Association (EWMA) revealed that, on an international level, only few of the published clinical trials on chronic wounds meet the basic quality requirements. Accordingly, it is the objective to establish national and international consensus on standards of the methodology and interpretation of wound outcomes, such as the most recent EWMA activities and the German national consensus conference started in 2012. EXAMPLE OF A HIGH-QUALITY CLINICAL WOUND STUDY: As an example of a high quality randomised study on chronic wounds, hyperbaric oxygen treatment (HBOT) was evaluated as adjuvant treatment for diabetic foot ulcers compared to placebo (Löndahl et al., 2010). This trial is characterised by a diligent study design, a substantiated study rationale and an independent steering committee. Precise and
Lisa A. Hark
Full Text Available Deficiencies in medical school nutrition education have been noted since the 1960s. Nutrition-related non-communicable diseases, including heart disease, stroke, cancer, diabetes, and obesity, are now the most common, costly, and preventable health problems in the US. Training medical students to assess diet and nutritional status and advise patients about a healthy diet, exercise, body weight, smoking, and alcohol consumption are critical to reducing chronic disease risk. Barriers to improving medical school nutrition content include lack of faculty preparation, limited curricular time, and the absence of funding. Several new LCME standards provide important impetus for incorporating nutrition into existing medical school curriculum as self-directed material. Fortunately, with advances in technology, electronic learning platforms, and web-based modules, nutrition can be integrated and assessed across all four years of medical school at minimal costs to medical schools. Medical educators have access to a self-study nutrition textbook, Medical Nutrition and Disease, Nutrition in Medicine© online modules, and the NHLBI Nutrition Curriculum Guide for Training Physicians. This paper outlines how learner-directed nutrition content can be used to meet several US and Canadian LCME accreditation standards. The health of the nation depends upon future physicians’ ability to help their patients make diet and lifestyle changes.
Andersen, Björn; Kasparick, Martin; Ulrich, Hannes; Franke, Stefan; Schlamelcher, Jan; Rockstroh, Max; Ingenerf, Josef
The new medical device communication protocol known as IEEE 11073 SDC is well-suited for the integration of (surgical) point-of-care devices, so are the established Health Level Seven (HL7) V2 and Digital Imaging and Communications in Medicine (DICOM) standards for the communication of systems in the clinical IT infrastructure (CITI). An integrated operating room (OR) and other integrated clinical environments, however, need interoperability between both domains to fully unfold their potential for improving the quality of care as well as clinical workflows. This work thus presents concepts for the propagation of clinical and administrative data to medical devices, physiologic measurements and device parameters to clinical IT systems, as well as image and multimedia content in both directions. Prototypical implementations of the derived components have proven to integrate well with systems of networked medical devices and with the CITI, effectively connecting these heterogeneous domains. Our qualitative evaluation indicates that the interoperability concepts are suitable to be integrated into clinical workflows and are expected to benefit patients and clinicians alike. The upcoming HL7 Fast Healthcare Interoperability Resources (FHIR) communication standard will likely change the domain of clinical IT significantly. A straightforward mapping to its resource model thus ensures the tenability of these concepts despite a foreseeable change in demand and requirements.
George, Benjamin P; Venkataraman, Vinayak; Dorsey, E Ray; Johnston, S Claiborne
Medical devices are often introduced prior to randomized-trial evidence of efficacy and this slows completion of trials. Alternative regulatory approaches include restricting device use outside of trials prior to trial evidence of efficacy (like the drug approval process) or restricting out-of-trial use but permitting coverage within trials such as Medicare's Coverage with Study Participation (CSP). We compared the financial impact to manufacturers and insurers of three regulatory alternatives: (1) limited regulation (current approach), (2) CSP, and (3) restrictive regulation (like the current drug approval process). Using data for patent foramen ovale closure devices, we modeled key parameters including recruitment time, probability of device efficacy, market adoption, and device cost/price to calculate profits to manufacturers, costs to insurers, and overall societal impact on health. For manufacturers, profits were greatest under CSP-driven by faster market adoption of effective devices-followed by restrictive regulation. Societal health benefit in total quality-adjusted life years was greatest under CSP. Insurers' expenditures for ineffective devices were greatest with limited regulation. Findings were robust over a reasonable range of probabilities of trial success. Regulation restricting out-of-trial device use and extending limited insurance coverage to clinical trial participants may balance manufacturer and societal interests. © 2014 Wiley Periodicals, Inc.
He, Longjun; Ming, Xing; Xu, Lang; Liu, Qian
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.
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices; prominence of required label statements. 801.15 Section 801.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...) No exemption depending on insufficiency of label space, as prescribed in regulations promulgated...
Katzis, Konstantinos; Jones, Richard W; Despotou, George
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.
... 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...
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0916] Medical Device Classification Product Codes; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0916] Draft Guidance for Industry and Food and Drug Administration Staff; Medical Device Classification Product Codes; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. [[Page 126...
Polívková, A.; Hubáček, Tomáš; Staszek, M.; Švorčík, V.; Siegel, J.
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
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...
... submit a statement signed by the head of the applicant's firm or by its chief financial officer that the... also submit a statement signed by the head of the applicant's firm or by its chief financial officer...] Medical Device User Fee Rates for Fiscal Year 2012 AGENCY: Food and Drug Administration, HHS. ACTION...
Vallejo-Torres, Laura; Steuten, Lotte Maria Gertruda; Buxton, Martin J.; Girling, Alan J.; Lilford, Richard J.; Young, Terry
Objectives: Medical device companies are under growing pressure to provide health-economic evaluations of their products. Cost-effectiveness analyses are commonly undertaken as a one-off exercise at the late stage of development of new technologies; however, the benefits of an iterative use of
... 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...
... therapy). Combined treatment modalities (co-interventions) will also be evaluated (such as comparing two... medical devices, such as (but not limited to): Ultrasonic wound care systems, negative pressure therapy... pressure ulcers including but not limited to therapies that address the underlying contributing factors (e...
... total ankle May 27, 2009. Innovations, Inc. replacement system. P060004(S1) FDA-2011-M-0256... Carl.......... Chestnut Medical Pipeline embolization device.... April 6, 2011. Technologies, Inc. P100034 FDA-2011-M-0295...-0300....... Roche Molecular cobas HPV test April 19, 2011. Systems, Inc. P100029 FDA-2011-M-0296...
Li, Bin; He, Meng-qiao; Cao, Jian-wen
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".
Mulder, Femke; Piersma, Dorine; Veersema, Sebastiaan; van der Post, Joris; Roovers, Jan-Paul
The aim of this study was to present the validation and optimization process for a new innovative medical device to create a standardized episiotomy. We performed a preclinical validation study. This study was performed at the University hospital. Animal, cadaver. Together with technical engineers,
Kane, Michael J; Breen, Paul P; Quondamatteo, Fabio; ÓLaighin, Gearóid
The BION (Bionic Neuron) is a single channel implantable neurostimulator of unique design that can be delivered by injection. The development of the BION injectable neurostimulators exemplifies a challenging, but well posed medical design problem addressed with a successful strategy for prioritizing and resolving the biomedical and technological challenges. Though some performance requirements required post-evaluation revision, all fundamental goals were realized. A small number of significant design corrections occurred because the device requirements did not include the full scope of environmental demands. The design has spawned a number of variants optimized for diverse biomedical applications, and its clinical applications continue to evolve. The BION development history demonstrates design successes worth emulating and design pitfalls that may be avoidable for future medical device development teams. This paper serves as an introduction to the BION microstimulator technology and as an analysis of the design process used to develop the early clinical devices. Copyright © 2010 IPEM. Published by Elsevier Ltd. All rights reserved.
Jones, E.D.; Banks, W.W.; Altenbach, T.J.; Fischer, L.E.
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
Sutanto, E.; Chandra, F.; Dinata, R.
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.
Sutanto, E; Chandra, F; Dinata, R
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)
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
Wong, Kathie A; Hodgson, Luke; Garas, George; Malietzis, George; Markar, Sheraz; Rao, Christopher; von Segesser, Ludwig K; Athanasiou, Thanos
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.
Smith, Sheryl Winston; Sfekas, Andrew
As recent public and private initiatives have sought to increase the transparency of physician-industry financial relationships (including calls for restricting collaboration), it is important to understand the extent of physicians' contributions to new medical devices. We quantify the contribution of information from physician-founded startup companies to 170 premarket approval (PMA) applications filed by 4 large incumbent medical device manufacturers over the period 1978-2007. We ask: Are incumbents more likely to incorporate information from physician-founded firms than nonphysician-founded firms? We matched the text in 4 incumbent medical device firms' PMAs (Medtronic, Johnson & Johnson, Boston Scientific, and Guidant) to the text in patent applications of 118 startup companies that received investment from these incumbents between 1978 and 2007. We use a text-matching algorithm to quantify the information contribution from physician and nonphysician-founded startups to incumbent firms' PMAs. We analyze correlates of backward citations and degree of overlap between incumbents' PMAs and startups' patents using negative binomial and tobit regressions. On average, physician-founded companies account for 11% of the information in PMAs, compared with 4% from nonphysician-founded companies. Regression results show that incumbents are significantly more likely to cite physician-founded companies' patents and to incorporate them into new devices. Physicians are an important source of medical device innovation. The results suggest that restrictions on financial relationships between providers and industry, while potentially improving patients' trust, may result in reduced medical innovation if physicians found fewer startups or if incumbent firms reduce investments in physician-founded startups.
Sun, Qin; Yan, Liang
The expansion of applications of medical devices has attracted the increased attention of government regulatory bodies around the world to the safety and effectiveness of these products. Most developed countries, such as the United States and European Union, have developed well-established regulatory systems for medical devices, which have also consistently been amended to accommodate the changing requirements of safety and the trend of globalization.The current "Regulations for the Supervision and Administration of Medical Device (China)", established in 2000, has brought about great improvements for the safety and effectiveness of products, safeguarding public health. But there are still, at present, a lot of counterfeit and poor quality devices and device-related adverse events for lack of powerful post -market and in-use regulatory controls for products. It is therefore very urgent for the Chinese government to reform its medical device administration and management. This research paper analyses and compares the different requirements and executions of medical devices regulations in the EU, the US and China, to draw some experiences of the EU and US regimes that are very useful to China's regulatory reform. It is suggested that when developing a new scheme of medical devices regulatory reform in China, two prominent aspects have to be considered by policy makers and regulators. Firstly, the global trend of medical devices regulations has to be taken into account. Secondly, the experiences learned from the EU and US systems should be applied to the Chinese regulatory reform in combination with the concrete practice of China.
At the invitation of the Physical Research. Laboratory, the 58th Annual Meeting of the. Academy was held at Ahmedabad from 6 to 9. November 1992. The meetings were held at the. Physical Research Laboratory (PRL) and the. Space Applications Centre (SAC) and were organized by PRl, in cooperation with ~AC, the.
...] Joint Meeting of the Medical Imaging Drugs Advisory Committee and the Oncologic Drugs Advisory Committee... be open to the public. Name of Committees: Medical Imaging Drugs Advisory Committee and the Oncologic... Special Medical Programs. [FR Doc. 2013-04141 Filed 2-22-13; 8:45 am] BILLING CODE 4160-01-P ...
Yasunaga, Hideo; Ide, Hiroo; Imamura, Tomoaki
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.
Nandy, Poulomi; Young, Megan; Haugen, Shanil P; Katzenmeyer-Pleuss, Kristy; Gordon, Edward A; Retta, Stephen M; Wood, Steven C; Lucas, Anne D
One-way valves used in day use devices (used on multiple patients throughout a day without reprocessing between patients) are intended to reduce the potential for cross-contamination between patients resulting from the backflow of patient fluids. One-way valves are typically designed to withstand high levels of back pressure before failure; however, they may not be explicitly designed as a means of infection control as used in medical device applications. Five different medical grade one-way valves were placed in low pressure configurations. After flushing in the intended direction of flow, bacteriophage, bacteria, or dye was placed patient side for 24 hours. The upstream device side of the valve was then evaluated for microbial growth or presence of visible dye. Leakage (ie, backflow) of the microorganisms occurred with a variety of one-way valve designs across a range of fluid properties tested. This study describes testing of the one-way valves (component-level testing) for the potential of cross-contamination. Although day use medical device systems may use numerous other factors to prevent patient cross-contamination, this work demonstrates that one-way valves themselves may not prevent leakage of contaminated fluid if the fluid is able to reach the upstream side of the one-way valve. Published by Elsevier Inc.
Naar-King, Sylvie; Lam, Phebe; Ellis, Deborah; Bruzzese, Jean-Marie; Secord, Elizabeth
To describe the asthma medication device skills of high-risk African American adolescents and associations between skills and other components of illness management, 170 African American adolescents, with at least one hospitalization or two emergency department visits in the last year, demonstrated how they use their asthma quick-relief and controller medication devices. Observations were scored using an in vivo observation asthma skills checklist. To assess other areas of asthma management, adolescents and their primary caregiver were interviewed using the Family Asthma Management System Scales, Only 5% of adolescents correctly demonstrated all controller skills, and none of the adolescents correctly showed all quick-relief inhaler skills (5% showed between 90 and 95% of skills). Several components of asthma management predicting controller medication skills were attendance at an asthma specialty clinic, collaboration with provider, medication adherence, and quick-relief medication skills. These variables accounted for a total of 24% of the variance in controller medication skills, Results indicate the need for interventions directly targeting observed asthma management skills and the importance of relationship with providers.
Hatz, Maximilian H M; Schreyögg, Jonas; Torbica, Aleksandra; Boriani, Giuseppe; Blankart, Carl R B
Decisions to adopt medical devices at the hospital level have consequences for health technology assessment (HTA) on system level and are therefore important to decision makers. Our aim was to investigate the characteristics of organizations and individuals that are more inclined to adopt and utilize cardiovascular devices based on a comprehensive analysis of environmental, organizational, individual, and technological factors and to identify corresponding implications for HTA. Seven random intercept hurdle models were estimated using the data obtained from 1249 surveys completed by members of the European Society of Cardiology. The major findings were that better manufacturer support increased the adoption probability of 'new' devices (i.e. in terms of CE mark approval dates), and that budget pressure increased the adoption probability of 'old' devices. Based on our findings, we suggest investigating the role of manufacturer support in more detail to identify diffusion patterns relevant to HTA on system level, to verify whether it functions as a substitute for medical evidence of new devices, and to receive new insights about its relationship with clinical effectiveness and cost-effectiveness. © 2017 The Authors. Health Economics published by John Wiley & Sons, Ltd. © 2017 The Authors. Health Economics published by John Wiley & Sons, Ltd.
Robinson, James C; Brown, Timothy T
To quantify the potential reduction in hospital costs from adoption of best local practices in supply chain management and discharge planning. We performed multivariate statistical analyses of the association between total variable cost per procedure and medical device price and length of stay, controlling for patient and hospital characteristics. Ten hospitals in 1 major metropolitan area supplied patient-level administrative data on 9778 patients undergoing joint replacement, spine fusion, or cardiac rhythm management (CRM) procedures in 2008 and 2010. The impact on each hospital of matching lowest local market device prices and lowest patient length of stay (LOS) was calculated using multivariate regression analysis controlling for patient demographics, diagnoses, comorbidities, and implications. Average variable costs ranged from $11,315 for joint replacement to $16,087 for CRM and $18,413 for spine fusion. Implantable medical devices accounted for a large share of each procedure's variable costs: 44% for joint replacement, 39% for spine fusion, and 59% for CRM. Device prices and patient length-of-stay exhibited wide variation across hospitals. Total potential hospital cost savings from achieving best local practices in device prices and patient length of stay are 14.5% for joint replacement, 18.8% for spine fusion;,and 29.1% for CRM. Hospitals have opportunities for cost reduction from adoption of best local practices in supply chain management and discharge planning.
Popp, Walter; Rasslan, Ossama; Unahalekhaka, Akeau; Brenner, Pola; Fischnaller, Edith; Fathy, Maha; Goldman, Carol; Gillespie, Elizabeth
Reuse of single-use devices is common in most countries worldwide. We provide an overview of the issue from an international perspective. In many developing and transitional countries reuse of cheap single-use devices (needles, syringes, surgical gloves) is common leading to large numbers of unsafe interventions, specifically injections and, as a consequence, infection with hepatitis B, C or HIV. There are various reasons for reuse: limited resources, insufficient knowledge of healthcare workers and the belief of patients that injection is more beneficial than oral medication. Reuse of cheap single-use devices should cease and both medical staff and the public should be informed about potential safety risks associated with injection. In developed countries, reuse of single-use items is less common but may include expensive technical products. Reuse is regulated in many countries (e.g. US, Canada, some European countries) demanding ethical and legal considerations, high standards of reprocessing and training of staff, risk assessment, management and validation of reprocessing. Well regulated reprocessing can decrease the number of single-use devices reprocessed. In developing as well as developed countries, a decision to reprocess single-use devices should only be made after a critical reflection of advantages and disadvantages. Copyright 2010 Elsevier GmbH. All rights reserved.
Full Text Available Abstract Background Recombinant human growth hormone (r-hGH is used to treat: growth hormone deficiency in children and adults; children born small for gestational age; Turner's syndrome; and chronic renal failure. r-hGH is administered by daily subcutaneous injection and may be given using a number of different administration devices. The aim of this survey was, firstly, to identify which attributes of an r-hGH administration device are considered most important to physicians, teenage patients, parents of young children requiring GH and nurses who have experience of r-hGH administration, and, secondly, to determine how they rate existing devices in each of these key attributes. Methods The opinions of 67 individuals with experience in r-hGH administration were captured in discussion sessions. Parents, physicians and nurses were asked to rate 19 device attributes by completing a questionnaire, and to rank four different r-hGH administration devices (including a conceptual electronic device in order of preference. Results Reliability, ease of use, lack of pain during injection, safety in use, storage, and number of steps in preparation before use, during use and after were considered to be the five most desirable attributes of an r-hGH administration device. An electronic device was preferred to an automatic, multi-dose injection device, a needle-free injection device or a manual, ready-to-use, disposable injection device. Conclusion In the opinion of physicians, nurses and parents using r-hGH injection devices, an ideal device must combine reliability with simplicity, while delivering treatment with minimal pain. An electronic device, which combines many of the most useful features of existing devices with novel functions, was the preferred option for r-hGH administration.
Kim, Hyeong Gyun; Yoon, Jae Ho; Choi, Seong Dae
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
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)
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.
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
Paul, Nathanael R [ORNL; Kohno, Tadayoshi [University of Washington, Seattle
Portable implantable medical device systems are playing a larger role in modern health care. Increasing attention is now being given to the wireless control interface of these systems. Our position is that wireless security in portable implantable medical device systems is just a part of the overall system security, and increased attention is needed to address low-tech security issues.
...] Use of International Standard ISO-10993, ``Biological Evaluation of Medical Devices Part 1: Evaluation... use of the Office of Device Evaluation (ODE) General Program Memorandum G95-1 entitled ``Use of... guidance document entitled ``Use of International Standard ISO-10993, `Biological Evaluation of Medical...
... guidance entitled ``Radio Frequency Wireless Technology in Medical Devices; Guidance for Industry and Food... Wireless Technology in Medical Devices; Guidance for Industry and Food and Drug Administration Staff,'' you... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2006-D-0300...
Liu, Chenghu; Luo, Hongyu; Wan, Min; Hou, Li; Wang, Xin; Shi, Yanping
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.
Full Text Available Microbial biofilms are a major impediment to the use of indwelling medical devices, generating device-related infections with high morbidity and mortality. Major efforts directed towards preventing and eradicating the biofilm problem face difficulties because biofilms protect themselves very effectively by producing a polysaccharide coating, reducing biofilm sensitivity to antimicrobial agents. Techniques applied to combating biofilms have been primarily chemical. These have met with partial and limited success rates, leading to current trends of eradicating biofilms through physico-mechanical strategies. Here we review the different approaches that have been developed to control biofilm formation and removal, focusing on the utilization of acoustic energy to achieve these objectives.
Dror, Naama; Mandel, Mathilda; Hazan, Zadik; Lavie, Gad
Microbial biofilms are a major impediment to the use of indwelling medical devices, generating device-related infections with high morbidity and mortality. Major efforts directed towards preventing and eradicating the biofilm problem face difficulties because biofilms protect themselves very effectively by producing a polysaccharide coating, reducing biofilm sensitivity to antimicrobial agents. Techniques applied to combating biofilms have been primarily chemical. These have met with partial and limited success rates, leading to current trends of eradicating biofilms through physico-mechanical strategies. Here we review the different approaches that have been developed to control biofilm formation and removal, focusing on the utilization of acoustic energy to achieve these objectives. PMID:22574031
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
Hulstaert, F.; Neyt, M.; Vinck, I.
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...... 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...
Ilbawi, André M; Velazquez-Berumen, Adriana
Universal coverage of basic laboratory services is fundamental to achieving sustainable development goals and attaining health for all. Yet, comprehensive laboratory services are unavailable to large percentages of the global population. To help policymakers identify a basic package of services for cancer, the World Health Organization (WHO) published Priority Medical Devices for Cancer Management. The package of services includes key interventions, associated devices and technologies, and the requirements for health workforce and infrastructure. These services must be linked to national strategic policies and plans and regulatory and quality assurance processes. Copyright © 2017 Elsevier Inc. All rights reserved.
Lingg, Myriam; Wyss, Kaspar; Durán-Arenas, Luis
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
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
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
Ryu, Gyeong Suk; Lee, Yu Jeung
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
Slootweg, Irene A; Scherpbier, Albert; van der Leeuw, Renée; Heineman, Maas Jan; van der Vleuten, Cees; Lombarts, Kiki M J M H
The importance of team communication, or more specifically speaking up, for safeguarding quality of patient care is increasingly being endorsed in research findings. However, little is known about speaking up of clinical teachers in postgraduate medical training. In order to determine how clinical teachers demonstrate speaking up in formal teaching team meetings and what factors influence this, the authors carried out an exploratory study based on ethnographic principles. The authors selected 12 teaching teams and observed, audio recorded and analysed the data. Subsequently, during an interview, the program directors reflected on speaking up of those clinical teachers present during the meeting. Finally, the authors analysed iteratively all data, using a template analysis, based on Edmondson's behaviours of speaking up. The study was conducted from October 2013 to July 2014 and ten teams participated. During the teaching team meetings, the clinical teachers exhibited most of the behaviours of speaking up. "Sharing information" strongly resembles providing information and "talking about mistakes" occurs in a general sense and without commitment of improvement activities. "Asking questions" was often displayed by closed questions and at times several questions simultaneously. The authors identified factors that influence speaking up by clinical teachers: relational, cultural, and professional. The clinical teachers exhibit speaking up, but there is only limited awareness to discuss problems or mistakes and the discussion centred mainly on the question of blame. It is important to take into account the factors that influence speaking up, in order to stimulate open communication during the teaching team meetings.
Rogers, Joseph G; Boyle, Andrew J; O'Connell, John B; Horstmanshof, Douglas A; Haas, Donald C; Slaughter, Mark S; Park, Soon J; Farrar, David J; Starling, Randall C
Mechanical circulatory support is now a proven therapy for the treatment of patients with advanced heart failure and cardiogenic shock. The role for this therapy in patients with less severe heart failure is unknown. The objective of this study is to examine the impact of mechanically assisted circulation using the HeartMate II left ventricular assist device in patients who meet current US Food and Drug Administration-defined criteria for treatment but are not yet receiving intravenous inotropic therapy. This is a prospective, nonrandomized clinical trial of 200 patients treated with either optimal medical management or a mechanical circulatory support device. This trial will be the first prospective clinical evaluation comparing outcomes of patients with advanced ambulatory heart failure treated with either ongoing medical therapy or a left ventricular assist device. It is anticipated to provide novel insights regarding relative outcomes with each treatment and an understanding of patient and provider acceptance of the ventricular assist device therapy. This trial will also provide information regarding the risk of events in "stable" patients with advanced heart failure and guidance for the optimal timing of left ventricular assist device therapy. Copyright © 2014 Elsevier Inc. All rights reserved.
Full Text Available This review article describes fundamental aspects of cell membrane-inspired phospholipid polymers and their usefulness in the development of medical devices. Since the early 1990s, polymers composed of 2-methacryloyloxyethyl phosphorylcholine (MPC units have been considered in the preparation of biomaterials. MPC polymers can provide an artificial cell membrane structure at the surface and serve as excellent biointerfaces between artificial and biological systems. They have also been applied in the surface modification of some medical devices including long-term implantable artificial organs. An MPC polymer biointerface can suppress unfavorable biological reactions such as protein adsorption and cell adhesion – in other words, specific biomolecules immobilized on an MPC polymer surface retain their original functions. MPC polymers are also being increasingly used for creating biointerfaces with artificial cell membrane structures.
Hernando, M Elena; Pascual, Mario; Salvador, Carlos H; García-Sáez, Gema; Rodríguez-Herrero, Agustín; Martínez-Sarriegui, Iñaki; Gómez, Enrique J
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.
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.
Camara, Carmen; Peris-Lopez, Pedro; Tapiador, Juan E
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.
The Food and Drug Administration (FDA) is issuing a final regulation to confirm, with one change, the interim final rule (IFR) entitled "Medical Devices; Exception From General Requirements for Informed Consent." This final rule confirms the IFR's establishment of a new exception from the general requirements for informed consent to permit the use of investigational in vitro diagnostic devices to identify chemical, biological, radiological, or nuclear agents without informed consent in certain circumstances. FDA has created this exception to help ensure that individuals who may have been exposed to a chemical, biological, radiological, or nuclear agent are able to benefit from the timely use of the most appropriate diagnostic devices, including those that are investigational. This final rule adds a requirement that the investigator submit the required documentation to FDA, in addition to submitting it to the reviewing Institutional Review Board (IRB).
Beery, T; Baas, L
The environment is filled with wonderful examples of medical technology that provide emergency life support, improve well-being, and offer the possibility of a longer and more productive life. But these devices are no longer only a part of the external environment. As technology advances, more devices are becoming a part of the internal environment (i.e., our bodies) as well. For some people an implanted mechanical device, such as a cardiac pacemaker or a cardioverter defibrillator, is readily accepted; for others it may be seen as an encroachment. It may be a symbol of loss and debilitation or of independence and resilience. What makes the difference? How can nurses facilitate a healthy adjustment and healing in an era permeated with technology? A discussion of the symbolism, related theory, and nursing implications is provided.
Parker, Brent C.; Duhon, John; Yang, Claus C.; Wu, H. Terry; Hogstrom, Kenneth R.
In 2009, Mary Bird Perkins Cancer Center (MBPCC) established a Radiation Oncology Physics Residency Program to provide opportunities for medical physics residency training to MS and PhD graduates of the CAMPEP‐accredited Louisiana State University (LSU)‐MBPCC Medical Physics Graduate Program. The LSU‐MBPCC Program graduates approximately six students yearly, which equates to a need for up to twelve residency positions in a two‐year program. To address this need for residency positions, MBPCC has expanded its Program by developing a Consortium consisting of partnerships with medical physics groups located at other nearby clinical institutions. The consortium model offers the residents exposure to a broader range of procedures, technology, and faculty than available at the individual institutions. The Consortium institutions have shown a great deal of support from their medical physics groups and administrations in developing these partnerships. Details of these partnerships are specified within affiliation agreements between MBPCC and each participating institution. All partner sites began resident training in 2011. The Consortium is a network of for‐profit, nonprofit, academic, community, and private entities. We feel that these types of collaborative endeavors will be required nationally to reach the number of residency positions needed to meet the 2014 ABR certification requirements and to maintain graduate medical physics training programs. PACS numbers: 01.40.Fk, 01.40.gb PMID:24710434
Parker, Brent C; Duhon, John; Yang, Claus C; Wu, H Terry; Hogstrom, Kenneth R; Gibbons, John P
In 2009, Mary Bird Perkins Cancer Center (MBPCC) established a Radiation Oncology Physics Residency Program to provide opportunities for medical physics residency training to MS and PhD graduates of the CAMPEP-accredited Louisiana State University (LSU)-MBPCC Medical Physics Graduate Program. The LSU-MBPCC Program graduates approximately six students yearly, which equates to a need for up to twelve residency positions in a two-year program. To address this need for residency positions, MBPCC has expanded its Program by developing a Consortium consisting of partnerships with medical physics groups located at other nearby clinical institutions. The consortium model offers the residents exposure to a broader range of procedures, technology, and faculty than available at the individual institutions. The Consortium institutions have shown a great deal of support from their medical physics groups and administrations in developing these partnerships. Details of these partnerships are specified within affiliation agreements between MBPCC and each participating institution. All partner sites began resident training in 2011. The Consortium is a network of for-profit, nonprofit, academic, community, and private entities. We feel that these types of collaborative endeavors will be required nationally to reach the number of residency positions needed to meet the 2014 ABR certification requirements and to maintain graduate medical physics training programs.
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...
Dongo, Victor; Médico, Director General de la Dirección General de Medicamentos, Insumos y Drogas, Ministerio de Salud. Lima, Perú.
The Law of Pharmaceutical Products, Medical devices and Sanitary products N°. 29459, published in November, 2009, guides the regulations of these products, substituting Chapter III of the General Law of Health N°. 26842. Through this law, the most questioned aspects of the Law N°. 26842 have been modified, establishing requisites to apply for the sanitary registry of pharmaceutical products that are necessary to guarantee their efficacy, security and quality, also including the required t...
Nusser, Michael; Lindner, Ralf
From an innovation systems perspective the performance of the German medical devices industry, future challenges and barriers to innovation are assessed. Current performance indicators (e.g., R&D intensity, export growth rates) paint a favourable picture. Nonetheless, a number of innovation barriers are identified: in particular, insufficient network integration of small and medium-sized enterprises (SMEs) and ineffective policy coordination. Finally, recommendations addressing identified future challenges and innovation barriers are developed.
Shaffer, H.L.; Garcia, R.D.
A review is presented on the practical application of current dosimetry systems used in the monitoring of industrial radiation facilities. The dosimeter characteristics important for realistic routine monitoring, the problems associated with raw material receipt, calibration, packaging, and radiation, the reading of the routine dosimeter, and the process controls necessary for the use of a monitoring dosimeter within a medical device manufacturing facility are discussed. The setting of process parameters to reduce inefficiencies in irradiation of products are also introduced. (author)
A. B. Sulin
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.
Tolomiczenko, George; Sanger, Terry
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.
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.
Reed, Terrie L; Drozda, Joseph P; Baskin, Kevin M; Tcheng, James; Conway, Karen; Wilson, Natalia; Marinac-Dabic, Danica; Heise, Theodore; Krucoff, Mitchell W
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.
Vreugdenburg, T D; Willis, C D; Mundy, L; Hiller, J E
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.
Núñez-Beltrán, Arianna; López-Romero, Everardo; Cuéllar-Cruz, Mayra
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.
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.
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)
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.
Bernard, Lise; Eljezi, Teuta; Clauson, Hélène; Lambert, Céline; Bouattour, Yassine; Chennell, Philip; Pereira, Bruno; Sautou, Valérie
Infusion medical devices (MDs) used in hospitals are often made of plasticized polyvinylchloride (PVC). These plasticizers may leach out into infused solutions during clinical practice, especially during risk-situations, e.g multiple infusions in Intensive Care Units and thus may enter into contact with the patients. The migrability of the plasticizers is dependent of several clinical parameters such as temperature, contact time, nature of the simulant, etc… However, no data is available about the influence of the flow rate at which drug solutions are administrated. In this study, we evaluated the impact of different flow rates on the release of the different plasticizers during an infusion procedure in order to assess if they could expose the patients to more toxic amounts of plasticizers. Migration assays with different PVC infusion sets and extension lines were performed with different flow rates that are used in clinical practice during 1h, 2h, 4h, 8h and 24h, using a lipophilic drug simulant. From a clinical point of view, the results showed that, regardless of the plasticizer, the faster the flow rate, the higher the infused volume and the higher the quantities of plasticizers released, both from infusion sets and extension lines, leading to higher patient exposure. However, physically, there was no significant difference of the migration kinetics linked to the flow rate for a same medical device, reflecting complex interactions between the PVC matrix and the simulant. The migration was especially dependent on the nature and the composition of the medical device.
Yue, Lilly Q; Campbell, Gregory; Lu, Nelson; Xu, Yunling; Zuckerman, Bram
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.
Miguel-Cruz, Antonio; Rios-Rincón, Adriana; Haugan, Gregory L
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.
Schmettow, Martin; Schnittker, Raphaela; Schraagen, Jan Maarten
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.
Jarosławski, Szymon; Saberwal, Gayatri
Over 75% of the medical devices used in India are imported. Often, they are costly and maladapted to low-resource settings. We have prepared case studies of six firms in Bangalore that could contribute to solving this problem. They have developed (or are developing) innovative health care products and therefore are pioneers in the Indian health care sector, better known for its reverse engineering skills. We have sought to understand what enablers and barriers they encountered. Information for the case studies was collected through semi-structured interviews. Initially, over 40 stakeholders of the diagnostics sector in India were interviewed to understand the sector. However the focus here is on the six featured companies. Further information was obtained from company material and other published resources. In all cases, product innovation has been enabled by close interaction with local medical practitioners, links to global science and technology and global regulatory requirements. The major challenges were the lack of guidance on product specifications from the national regulatory agency, paucity of institutionalized health care payers and lack of transparency and formalized Health Technology Assessment in coverage decision-making. The absence of national evidence-based guidelines and of compulsory continuous education for medical practitioners were key obstacles in accessing the poorly regulated and fragmented private market. Innovative Indian companies would benefit from a strengthened capacity and interdisciplinary work culture of the national device regulatory body, institutionalized health care payers and medical councils and associations. Continuous medical education and national medical guidelines for medical practitioners would facilitate market access for innovative products.
Full Text Available Jason J Howard1,2 1Division of Orthopedic Surgery, Department of Surgery, Sidra Medical and Research Center, 2Department of Orthopedic Surgery, Weill Cornell Medical College, Doha, Qatar Abstract: Due to problems with wear particle generation and subsequent loosening using conventional metal-on-polyethylene total hip replacements, there has been a shift toward alternative bearing systems, including metal-on-metal (MoM, for younger, more active patients with degenerative joint disease. Based on positive results from early short-term clinical studies, MoM hip replacements were readily adopted by orthopedic surgeons with thousands being implanted worldwide over the past decade. Unacceptably high revision rates reported by two national joint registries called into question the rigorousness of the regulatory approval process for these implants, particularly with respect to premarket data requirements to prove safety, effectiveness, and the appropriateness of the regulatory pathway chosen. The purpose of this review was to investigate the balance between facilitating the introduction of new medical technologies and the need to ensure safety and effectiveness through comprehensive regulatory assessment. The case of MoM hip replacement devices was used to frame the investigation and subsequent discussions. The regulatory approval processes and post-market surveillance requirements associated with three common MoM hip replacements (two resurfacings: the Birmingham and articular surface replacement and the articular surface replacement XL total hip replacement were investigated. With respect to modern MoM hip replacement devices, the balance between facilitating the introduction of these new medical technologies and the need to ensure safety and effectiveness through comprehensive regulatory assessment was not achieved. The lessons learned from these experiences have application beyond joint replacements to the introduction of new medical technologies in
The organization and arrangements for the scientific meetings, cultural event and the visits to Lothal and SAC were superb. The Academy is grateful to the Physical Research Laboratory particularly R K Varma, Director, PRL, to the. Institute for Plasma Research and its Director. P K Kaw, to the Space Applications Centre and.
the Defence Minister, Government of India on some of his experiences in technology development in India. A summary of his lecture appears in this issue. In the afternoon the .... of steel armour for our Light Tank which has found wide application to meet the ... basic issues: how information is encoded in the structure of DNA ...
Nov 7, 1985 ... Business Meeting of Fellows. Evening Lecture. Architecture of the universe- R Cowsik ... and technical capabilities to plan, design and build satellites for earth observations, such as. Bhaskara I and II have ... Water Resources Systems Planning-. Some case studies for India. Edited by. Mahesh C Chaturvedi ...
Hatzold, Karin; Reed, Jason; Edgil, Dianna; Jaramillo, Juan; Castor, Delivette; Forsythe, Steven; Xaba, Sinokuthemba; Mugurungi, Owen
Background Fourteen African countries are scaling up voluntary medical male circumcision (VMMC) for HIV prevention. Several devices that might offer alternatives to the three WHO-approved surgical VMMC procedures have been evaluated for use in adults. One such device is PrePex, which was prequalified by the WHO in May 2013. We utilized data from one of the PrePex field studies undertaken in Zimbabwe to identify cost considerations for introducing PrePex into the existing surgical circumcision program. Methods and Findings We evaluated the cost drivers and overall unit cost of VMMC at a site providing surgical VMMC as a routine service (“routine surgery site”) and at a site that had added PrePex VMMC procedures to routine surgical VMMC as part of a research study (“mixed study site”). We examined the main cost drivers and modeled hypothetical scenarios with varying ratios of surgical to PrePex circumcisions, different levels of site utilization, and a range of device prices. The unit costs per VMMC for the routine surgery and mixed study sites were $56 and $61, respectively. The two greatest contributors to unit price at both sites were consumables and staff. In the hypothetical scenarios, the unit cost increased as site utilization decreased, as the ratio of PrePex to surgical VMMC increased, and as device price increased. Conclusions VMMC unit costs for routine surgery and mixed study sites were similar. Low service utilization was projected to result in the greatest increases in unit price. Countries that wish to incorporate PrePex into their circumcision programs should plan to maximize staff utilization and ensure that sites function at maximum capacity to achieve the lowest unit cost. Further costing studies will be necessary once routine implementation of PrePex-based circumcision is established. PMID:24801515