WorldWideScience

Sample records for charter medical devices

  1. Medical Device Safety

    Science.gov (United States)

    A medical device is any product used to diagnose, cure, or treat a condition, or to prevent disease. They range ... may need one in a hospital. To use medical devices safely Know how your device works. Keep instructions ...

  2. Implantable electronic medical devices

    CERN Document Server

    Fitzpatrick, Dennis

    2014-01-01

    Implantable Electronic Medical Devices provides a thorough review of the application of implantable devices, illustrating the techniques currently being used together with overviews of the latest commercially available medical devices. This book provides an overview of the design of medical devices and is a reference on existing medical devices. The book groups devices with similar functionality into distinct chapters, looking at the latest design ideas and techniques in each area, including retinal implants, glucose biosensors, cochlear implants, pacemakers, electrical stimulation t

  3. Development of Medical Devices

    OpenAIRE

    Limaye, Dnyanesh

    2016-01-01

    The medical devices sector helps save lives by providing innovative health care solutions regarding diagnosis, prevention, monitoring, treatment, and alleviation. Medical devices are classified into 1 of 3 categories in the order of increasing risk: Class I, Class II, and Class III.1 Medical devices are distinguished from drugs for regulatory purposes based on mechanism of action. Unlike drugs, medical devices operate via physical or mechanical means and are not dependent on metabolism to acc...

  4. The physician charter on medical professionalism from the Chinese perspective: a comparative analysis.

    Science.gov (United States)

    Jin, Pingyue

    2015-07-01

    The charter of medical professionalism in the new millennium (Charter) has been endorsed worldwide, including by the Chinese Medical Doctor Association from 2005. Six years later, the association drafted a Chinese version of medical professionalism based on the Charter, the Chinese Medical Doctor Declaration (Declaration). This Declaration encompasses six tenets, which have large areas of overlap with the Charter. Meanwhile, certain differences also exist between the universal professionalism that the Charter aims to disseminate and the ideal Chinese professionalism that the Declaration endeavours to bolster. In this paper, we explore the unique aspects of the Declaration in contrast with the Charter to gain a deeper understanding of professionalism in the particular context of China. The Declaration may omit some valuable commitments found in the Charter, but it includes longstanding Confucian and cultural traditions of China, as well as consideration of current social circumstances. The Declaration thus re-establishes the ideal of universal professionalism in light of the Chinese context. PMID:25341734

  5. 76 FR 8637 - Medical Devices; Medical Device Data Systems

    Science.gov (United States)

    2011-02-15

    ... Devices; Medical Device Data Systems AGENCY: Food and Drug Administration, HHS. ACTION: Final rule... device are not medical devices. (Response) FDA agrees that the term ``medical device data'' could be... medical devices. (Response) An MDDS is intended to be a communication conduit for medical device data.......

  6. New Medical Device Evaluation.

    Science.gov (United States)

    Ikeda, Koji

    2016-01-01

    In this presentation, as a member of the Harmonization by Doing (HBD) project, I discuss the significance of regulatory science in global medical device development and our experience in the international collaboration process for medical devices. In Japan, most innovative medical therapeutic devices were previously developed and exported by foreign-based companies. Due to this device lag, Japanese had minimal opportunities for receiving treatment with innovative medical devices. To address this issue, the Japanese government has actively accepted foreign clinical trial results and promoted global clinical trials in projects such as HBD. HBD is a project with stakeholders from academia, regulatory authorities, and industry in the US and Japan to promote global clinical trials and reduce device lags. When the project started, medical device clinical trials were not actively conducted in Japan at not just hospitals but also at medical device companies. We started to identify issues under the concept of HBD. After 10 years, we have now become key members in global clinical trials and able to obtain approvals without delay. Recently, HBD has started promoting international convergence. Physicians and regulatory authorities play central roles in compiling guidelines for the clinical evaluation of medical device development, which will be a more active field in the near future. The guidelines compiled will be confirmed with members of academia and regulatory authorities in the United Sates. PMID:27040333

  7. Medical Device Safety

    Science.gov (United States)

    ... Communication Date Mycobacterium chimaera Infections Associated with Sorin Group Deutschland GmbH Stӧckert 3T Heater-Cooler System: FDA Safety Communication 06/01/16 More Medical Device Safety Communications ...

  8. MDR (Medical Device Reporting)

    Data.gov (United States)

    U.S. Department of Health & Human Services — This database allows you to search the CDRH's database information on medical devices which may have malfunctioned or caused a death or serious injury during the...

  9. A Medical Delivery Device

    DEFF Research Database (Denmark)

    2010-01-01

    The present invention relates to a medical delivery device comprising at least two membrane electrode assembly units each of which comprises three layers: an upper and a lower electrode and a selective ionic conductive membrane provided there-between. At least one of the three layers are shared by...

  10. Preventing medical device recalls

    CERN Document Server

    Raheja, Dev

    2014-01-01

    Introduction to Medical Device RequirementsIntroductionThe ChallengesSources of ErrorsUnderstanding the Science of Safety     Overview of FDA Quality System Regulation     Overview of Risk Management Standard ISO 14971     Overview of FDA Device Approval Process     Overview of Regulatory Requirements for Clinical TrialsSummaryReferencesPreventing Recalls during Specification WritingIntroductionConduct Requirements Analysis to Identify Missing RequirementsSpecifications for Safety, Durability, and

  11. Designing sustainable medical devices

    OpenAIRE

    Marshall, J-L; Hinton, M; Wrobel, L; Troisi, G

    2009-01-01

    Stakeholders in the medical device manufacturing industry are becoming more concerned about the environmental impact of their products and processes. The consumers are also becoming more aware of the negative impact that manufacturers can have on the environment. Government initiatives continue to increase environmental awareness through the development of new policy and legislation, encouraging industry to become more accountable for the environmental impact of their products and operations....

  12. 77 FR 17529 - Notice of Charter Renewal: Advisory Committee on the Medical Uses of Isotopes

    Science.gov (United States)

    2012-03-26

    ... COMMISSION Notice of Charter Renewal: Advisory Committee on the Medical Uses of Isotopes AGENCY: U.S. Nuclear... Medical Uses of Isotopes (ACMUI) for a period of two years. SUPPLEMENTARY INFORMATION: The U.S. Nuclear... Medical Uses of Isotopes for the two year period commencing on March 14, 2012 is in the public...

  13. Human Factors and Medical Devices

    International Nuclear Information System (INIS)

    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

  14. Barriers to medical device innovation

    Directory of Open Access Journals (Sweden)

    Bergsl

    2014-06-01

    Full Text Available Jacob Bergsland, Ole Jakob Elle, Erik Fosse The Intervention Centre, Oslo University Hospital, Institute of Clinical Medicine, University of Oslo, Oslo, Norway Abstract: The US Food and Drug Administration (FDA has defined a medical device as a health care product that does not achieve it's purpose by chemical action or by being metabolized. This means that a vast number of products are considered medical devices. Such devices play an essential role in the practice of medicine. The FDA classifies medical devices in three classes, depending on the risk of the device. Since Class I and II devices have relatively simple requirements for getting to the market, this review will focus on “implantable devices”, which, in general, belong to Class III. The European Union and Canada use a slightly different classification system. While early generations of medical devices were introduced without much testing, either technical or clinical, the process of introducing a Class III medical device from concept to clinical practice has become strongly regulated and requires extensive technological and clinical testing. The modern era of implantable medical devices may be considered to have started in the 1920s with development of artificial hips. The implantable pacemaker was another milestone and pacemakers and cardioverters/defibrillators have since saved millions of lives and created commercial giants in the medical device industry. This review will include some examples of cardiovascular devices. Similar considerations apply to the total implantable device market, although clinical and technological applications obviously vary considerably. Keyword: implantable, FDA, regulation, CE-mark, innovation

  15. Surgical tools and medical devices

    CERN Document Server

    Jackson, Mark

    2016-01-01

    This new edition presents information and knowledge on the field of biomedical devices and surgical tools. The authors look at the interactions between nanotechnology, nanomaterials, design, modeling, and tools for surgical and dental applications, as well as how nanostructured surfaces can be created for the purposes of improving cell adhesion between medical devices and the human body. Each original chapter is revised in this second edition and describes developments in coatings for heart valves, stents, hip and knee joints, cardiovascular devices, orthodontic applications, and regenerative materials such as bone substitutes. There are also 8 new chapters that address: Microvascular anastomoses Inhaler devices used for pulmonary delivery of medical aerosols Surface modification of interference screws Biomechanics of the mandible (a detailed case study) Safety and medical devices The synthesis of nanostructured material Delivery of anticancer molecules using carbon nanotubes Nano and micro coatings for medic...

  16. 77 FR 6028 - Taxable Medical Devices

    Science.gov (United States)

    2012-02-07

    ..., the definition of ``taxable medical device'' under section 4191 limits taxable medical devices to... medical devices, such as medical device data systems, under long-term, multi-year contracts. Under these... Internal Revenue Service 26 CFR Part 48 RIN 1545-BJ44 Taxable Medical Devices AGENCY: Internal...

  17. Implantable Medical Devices

    Science.gov (United States)

    ... therapy’ in end-stage heart failure patients when heart transplantation is not an option. How does an LVAD work? A common type of LVAD has a tube that pulls blood from the left ... Procedures and Surgeries At-A-Glance Cardiac Medications ...

  18. Medical Equipment Maintenance Programme Overview WHO Medical device technical series

    CERN Document Server

    Organization, World Health

    2011-01-01

    WHO and partners have been working towards devising an agenda an action plan tools and guidelines to increase access to appropriate medical devices. This document is part of a series of reference documents being developed for use at the country level. The series will include the following subject areas: . policy framework for health technology . medical device regulations . health technology assessment . health technology management . needs assessment of medical devices . medical device procurement . medical equipment donations . medical equipment inventory management . medical equipment maint

  19. Price transparency for medical devices.

    Science.gov (United States)

    Pauly, Mark V; Burns, Lawton R

    2008-01-01

    Hospital buyers of medical devices contract with manufacturers with market power that sell differentiated products. The medical staff strongly influences hospitals' choice of devices. Sellers have sought to limit disclosure of transaction prices. Policy-makers have proposed legislation mandating disclosure, in the interest of greater transparency. We discuss why a manufacturer might charge different prices to different hospitals, the role that secrecy plays, and the consequences of secrecy versus disclosure. We argue that hospital-physician relationships are key to understanding what manufacturers gain from price discrimination. Price disclosure can catalyze a restructuring of those relationships, which, in turn, can improve hospital bargaining. PMID:18997210

  20. Medical devices and human engineering

    CERN Document Server

    Bronzino, Joseph D

    2014-01-01

    Known as the bible of biomedical engineering, The Biomedical Engineering Handbook, Fourth Edition, sets the standard against which all other references of this nature are measured. As such, it has served as a major resource for both skilled professionals and novices to biomedical engineering.Medical Devices and Human Engineering, the second volume of the handbook, presents material from respected scientists with diverse backgrounds in biomedical sensors, medical instrumentation and devices, human performance engineering, rehabilitation engineering, and clinical engineering.More than three doze

  1. Validation of medical modeling & simulation training devices and systems.

    Science.gov (United States)

    Magee, J Harvey

    2003-01-01

    For almost a decade, research has been conducted in many areas of science to develop medical simulation training devices and even comprehensive training systems. To propel the field, the Telemedicine and Advanced Technology Research Center (TATRC), an agency of the United States Army Medical Research Materiel Command (USAMRMC), has been managing a portfolio of research projects in the area of Medical Modeling and Simulation (MM&S) since 1999. Significant progress has made to identify and harness enabling technologies. Generally, these developments can be categorized in four areas: (1) PC-based interactive multimedia, (2) Digitally Enhanced Mannequins, (3) Virtual Workbench, or "part-task", simulators, and (4) Total Immersion Virtual Reality (TIVR). Many medical simulation-training systems have shown great potential to improve medical training, but the potential shown has been based largely on anecdotal feedback from informal user studies. Formal assessment is needed to determine the degree to which simulator(s) train medical skills and the degree to which skills learned on a simulator transfer to the practice of care. A robust methodology is required as a basis for these assessments. Several scientific workshops sponsored in 2001 focused on algorithm and metrics development in support of surgical simulation. Also in 2001, TATRC chartered a Simulation Working Group (SWG) to develop a robust methodology upon which to base an assessment of the effectiveness of simulation training devices and systems. After the terrorist attacks of September 11, 2001, attention was redirected for a period, and progress was delayed. In the summer of 2002, TATRC chartered a follow-on group called the Validation, Metrics and Simulation (VMAS) Committee. The poster will highlight and summarize the development of the methodology and identify validation studies to be conducted (supported by various funding sources and research programs). The interaction between TATRC and the National Capital

  2. [Consideration of Mobile Medical Device Regulation].

    Science.gov (United States)

    Peng, Liang; Yang, Pengfei; He, Weigang

    2015-07-01

    The regulation of mobile medical devices is one of the hot topics in the industry now. The definition, regulation scope and requirements, potential risks of mobile medical devices were analyzed and discussed based on mobile computing techniques and the FDA guidance of mobile medical applications. The regulation work of mobile medical devices in China needs to adopt the risk-based method. PMID:26665948

  3. 77 FR 72924 - Taxable Medical Devices

    Science.gov (United States)

    2012-12-07

    ...'' are not taxable medical devices. The definition of a device in section 201(h) of the FFDCA includes... Internal Revenue Service 26 CFR Part 48 RIN 1545-BJ44 Taxable Medical Devices AGENCY: Internal Revenue... provide guidance on the excise tax imposed on the sale of certain medical devices, enacted by the...

  4. 78 FR 18233 - Medical Devices; Technical Amendment

    Science.gov (United States)

    2013-03-26

    .../ MedicalDevices/ pma/. DeviceRegulationa ndGuidance/ HowtoMarketYourDe vice/ PremarketSubmissi ons..., 876, 878, 880, 882, 884, 886, 888, 890, and 892 Medical Devices; Technical Amendment AGENCY: Food and... outdated Web site addresses affecting certain regulations regarding medical devices. Publication of...

  5. Advancing Competency-Based Medical Education: A Charter for Clinician-Educators.

    Science.gov (United States)

    Carraccio, Carol; Englander, Robert; Van Melle, Elaine; Ten Cate, Olle; Lockyer, Jocelyn; Chan, Ming-Ka; Frank, Jason R; Snell, Linda S

    2016-05-01

    The International Competency-Based Medical Education (ICBME) Collaborators have been working since 2009 to promote understanding of competency-based medical education (CBME) and accelerate its uptake worldwide. This article presents a charter, supported by a literature-based rationale, which is meant to provide a shared mental model of CBME that will serve as a path forward in its widespread implementation.At a 2013 summit, the ICBME Collaborators laid the groundwork for this charter. Here, the fundamental principles of CBME and professional responsibilities of medical educators in its implementation process are described. The authors outline three fundamental principles: (1) Medical education must be based on the health needs of the populations served; (2) the primary focus of education and training should be the desired outcomes for learners rather than the structure and process of the educational system; and (3) the formation of a physician should be seamless across the continuum of education, training, and practice.Building on these principles, medical educators must demonstrate commitment to teaching, assessing, and role modeling the range of identified competencies. In the clinical setting, they must provide supervision that balances patient safety with the professional development of learners, being transparent with stakeholders about level of supervision needed. They must use effective and efficient assessment strategies and tools for basing transition decisions on competence rather than time in training, empowering learners to be active participants in their learning and assessment. Finally, advancing CBME requires program evaluation and research, faculty development, and a collaborative approach to realize its full potential. PMID:26675189

  6. Making Medical Devices Safer at Home

    Science.gov (United States)

    ... For Consumers Home For Consumers Consumer Updates Making Medical Devices Safer at Home Share Tweet Linkedin Pin it ... Tips for Consumers Patients and consumers are using medical devices more often at home—not just in health ...

  7. Medical devices regulations, standards and practices

    CERN Document Server

    Ramakrishna, Seeram; Wang, Charlene

    2015-01-01

    Medical Devices and Regulations: Standards and Practices will shed light on the importance of regulations and standards among all stakeholders, bioengineering designers, biomaterial scientists and researchers to enable development of future medical devices. Based on the authors' practical experience, this book provides a concise, practical guide on key issues and processes in developing new medical devices to meet international regulatory requirements and standards. Provides readers with a global perspective on medical device regulationsConcise and comprehensive information on how to desig

  8. 75 FR 16351 - Medical Devices; Technical Amendment

    Science.gov (United States)

    2010-04-01

    ..., and 1050 Medical Devices; Technical Amendment AGENCY: Food and Drug Administration, HHS. ACTION: Final.... 360hh- 360ss). The Safe Medical Devices Act of 1990 (SMDA) (Public Law 101- 629), transferred the... protection. 21 CFR Part 1020 Electronic products, Medical devices, Radiation protection, Reporting...

  9. Metrological Reliability of Medical Devices

    Science.gov (United States)

    Costa Monteiro, E.; Leon, L. F.

    2015-02-01

    The prominent development of health technologies of the 20th century triggered demands for metrological reliability of physiological measurements comprising physical, chemical and biological quantities, essential to ensure accurate and comparable results of clinical measurements. In the present work, aspects concerning metrological reliability in premarket and postmarket assessments of medical devices are discussed, pointing out challenges to be overcome. In addition, considering the social relevance of the biomeasurements results, Biometrological Principles to be pursued by research and innovation aimed at biomedical applications are proposed, along with the analysis of their contributions to guarantee the innovative health technologies compliance with the main ethical pillars of Bioethics.

  10. Magnetically driven medical devices: a review.

    Science.gov (United States)

    Sliker, Levin; Ciuti, Gastone; Rentschler, Mark; Menciassi, Arianna

    2015-01-01

    A widely accepted definition of a medical device is an instrument or apparatus that is used to diagnose, prevent or treat disease. Medical devices take a broad range of forms and utilize various methods to operate, such as physical, mechanical or thermal. Of particular interest in this paper are the medical devices that utilize magnetic field sources to operate. The exploitation of magnetic fields to operate or drive medical devices has become increasingly popular due to interesting characteristics of magnetic fields that are not offered by other phenomena, such as mechanical contact, hydrodynamics and thermodynamics. Today, there is a wide range of magnetically driven medical devices purposed for different anatomical regions of the body. A review of these devices is presented and organized into two groups: permanent magnetically driven devices and electromagnetically driven devices. Within each category, the discussion will be further segregated into anatomical regions (e.g., gastrointestinal, ocular, abdominal, thoracic, etc.). PMID:26295303

  11. Advanced Capabilities Medical Suction Device Project

    Data.gov (United States)

    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...

  12. Medical device labeling and advertising: an overview.

    Science.gov (United States)

    Basile, E M; Armentrout, E; Reeves, K N

    1999-01-01

    The Food and Drug Administration (FDA) has the authority under the Federal Food, Drug, and Cosmetic Act (FDCA) to regulate the labeling of all medical devices. This statement, however, is not as simple as it appears. The regulation of medical device labels and labeling, closely linked to the advertisement of medical devices, is a dynamic area, and FDA is struggling to address the new issues that arise daily in this area. This article seeks to: 1) provide the background necessary to understand the current law and FDA's regulation of medical devices; 2) summarize the law and regulations governing medical devices; 3) define "intended use" and explain its importance; and 4) discuss several areas that are of particular interest to FDA, including promotion of uncleared or unapproved devices and uses, Internet promotion, press releases, and comparative claims. PMID:11824451

  13. Learning from adverse incidents involving medical devices.

    Science.gov (United States)

    Amoore, John; Ingram, Paula

    While an adverse event involving a medical device is often ascribed to either user error or device failure, the causes are typically multifactorial. A number of incidents involving medical devices are explored using this approach to investigate the various causes of the incident and the protective barriers that minimised or prevented adverse consequences. User factors, including mistakes, omissions and lack of training, conspired with background factors--device controls and device design, storage conditions, hidden device damage and physical layout of equipment when in use--to cause the adverse events. Protective barriers that prevented or minimised the consequences included staff vigilance, operating procedures and alarms. PMID:12715578

  14. 78 FR 15878 - Taxable Medical Devices; Correction

    Science.gov (United States)

    2013-03-13

    ... Internal Revenue Service 26 CFR Part 48 RIN 1545-BJ44 Taxable Medical Devices; Correction AGENCY: Internal..., 2012 (77 FR 72924). The final regulations provide guidance on the excise tax imposed on the sale of certain medical devices, enacted by the Health Care and Education Reconciliation Act of 2010...

  15. 78 FR 15877 - Taxable Medical Devices; Correction

    Science.gov (United States)

    2013-03-13

    ... Internal Revenue Service 26 CFR Part 48 RIN 1545-BJ44 Taxable Medical Devices; Correction AGENCY: Internal..., 2012 (77 FR 72924). The final regulations provide guidance on the excise tax imposed on the sale of certain medical devices, enacted by the Health Care and Education Reconciliation Act of 2010...

  16. Medical devices for the anesthetist: current perspectives

    OpenAIRE

    Lemmens, Hendrikus

    2014-01-01

    Jerry Ingrande, Hendrikus JM LemmensDepartment of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, CA, USAAbstract: Anesthesiologists are unique among most physicians in that they routinely use technology and medical devices to carry out their daily activities. Recently, there have been significant advances in medical technology. These advances have increased the number and utility of medical devices available to the anesthesiologist. There is...

  17. Medical Device Development: the challenge for ergonomics

    OpenAIRE

    Jennifer L Martin; Norris, Beverley J.; Murphy, Elizabeth; Crowe, John A.

    2008-01-01

    High quality, well designed medical devices are necessary to provide safe and effective clinical care for patients as well as to ensure the health and safety of professional and lay device users. Capturing the user requirements of users and incorporating these into design is an essential component of this. The field of ergonomics has an opportunity to assist, not only with this area, but also to encourage a more general consideration of the user during medical device development. A review ...

  18. 76 FR 24495 - Reprocessing of Reusable Medical Devices; Public Workshop

    Science.gov (United States)

    2011-05-02

    ... affecting reprocessing quality, device design as it relates to reprocessing reusable medical devices... HUMAN SERVICES Food and Drug Administration Reprocessing of Reusable Medical Devices; Public Workshop... Medical Devices Workshop.'' The purpose of the workshop is to discuss factors affecting the...

  19. Contextual inquiry for medical device design

    CERN Document Server

    Privitera, Mary Beth

    2015-01-01

    Contextual Inquiry for Medical Device Design helps users understand the everyday use of medical devices and the way their usage supports the development of better products and increased market acceptance. The text explains the concept of contextual inquiry using real-life examples to illustrate its application. Case studies provide a frame of reference on how contextual inquiry is successfully used during product design, ultimately producing safer, improved medical devices. Presents the ways contextual inquiry can be used to inform the evaluation and business case of technologyHelps users

  20. 21 CFR 892.2010 - Medical image storage device.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical image storage device. 892.2010 Section 892.2010 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2010 Medical image storage device. (a) Identification. A medical image storage device...

  1. Home Medical Device Retailers by ZIP Code

    Data.gov (United States)

    U.S. Department of Health & Human Services — MAP:http://cdphdata.maps.arcgis.com/apps/PanelsLegend/index.html?appid=fafb2... This table represents a current listing of Home Medical Device Retailers (HMDR)...

  2. Using Zigbee to integrate medical devices.

    Science.gov (United States)

    Frehill, Paul; Chambers, Desmond; Rotariu, Cosmin

    2007-01-01

    Wirelessly enabling Medical Devices such as Vital Signs Monitors, Ventilators and Infusion Pumps allows central data collection. This paper discusses how data from these types of devices can be integrated into hospital systems using wireless sensor networking technology. By integrating devices you are protecting investment and opening up the possibility of networking with similar devices. In this context we present how Zigbee meets our requirements for bandwidth, power, security and mobility. We have examined the data throughputs for various medical devices, the requirement of data frequency, security of patient data and the logistics of moving patients while connected to devices. The paper describes a new tested architecture that allows this data to be seamlessly integrated into a User Interface or Healthcare Information System (HIS). The design supports the dynamic addition of new medical devices to the system that were previously unsupported by the system. To achieve this, the hardware design is kept generic and the software interface for different types of medical devices is well defined. These devices can also share the wireless resources with other types of sensors being developed in conjunction on this project such as wireless ECG (Electrocardiogram) and Pulse-Oximetry sensors. PMID:18003568

  3. 78 FR 9349 - Medical Devices; Ophthalmic Devices; Classification of the Eyelid Weight

    Science.gov (United States)

    2013-02-08

    ... seq.), as amended by the Medical Device Amendments of 1976 (Pub. L. 94-295), the Safe Medical Devices.../downloads/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA... HUMAN SERVICES Food and Drug Administration 21 CFR Part 886 Medical Devices; Ophthalmic...

  4. Medical device-related pressure ulcers

    Directory of Open Access Journals (Sweden)

    Black JM

    2016-08-01

    Full Text Available Joyce M Black,1 Peggy Kalowes2 1Adult Health and Illness Department, College of Nursing, University of Nebraska Medical Center, Omaha, NE, 2Nursing Research and Innovation, Long Beach Memorial Miller Children’s & Women’s Hospital, Long Beach, CA, USA Abstract: Pressure ulcers from medical devices are common and can cause significant morbidity in patients of all ages. These pressure ulcers appear in the shape of the device and are most often found from the use of oxygen delivery devices. A hospital program designed to reduce the number of pressure ulcers from medical devices was successful. The program involved the development of a team that focused on skin, the results were then published for the staff to track their performance, and it was found that using foam dressings helped reduce the pressure from the device. The incidence of ulcers from medical devices has remained at zero at this hospital since this program was implemented. Keywords: pressure ulcer, medical device related

  5. Handheld Diagnostic Device Delivers Quick Medical Readings

    Science.gov (United States)

    2014-01-01

    To monitor astronauts' health remotely, Glenn Research Center awarded SBIR funding to Cambridge, Massachusetts-based DNA Medical Institute, which developed a device capable of analyzing blood cell counts and a variety of medical biomarkers. The technology will prove especially useful in rural areas without easy access to labs.

  6. Medical ice slurry production device

    Science.gov (United States)

    Kasza, Kenneth E.; Oras, John; Son, HyunJin

    2008-06-24

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

  7. 76 FR 45268 - Reprocessing of Reusable Medical Devices

    Science.gov (United States)

    2011-07-28

    ... reprocessing quality, device design as it relates to the reprocessing of reusable medical devices, reprocessing..., including reprocessing quality, device design as it relates to the reprocessing of reusable medical devices...'' at......

  8. 21 CFR 892.2020 - Medical image communications device.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical image communications device. 892.2020 Section 892.2020 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image communications device. (a) Identification. A medical...

  9. 21 CFR 892.2040 - Medical image hardcopy device.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical image hardcopy device. 892.2040 Section 892.2040 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device. (a) Identification. A medical image hardcopy...

  10. International Standards for Radiation Sterilization of Medical Devices

    International Nuclear Information System (INIS)

    For a terminally sterilized medical device to be designated '' STERILE '', probability of finding the viable micro-organisms in the device shall be equal to or less than 1 x 10-6 (EN 556-1:2001: Sterilization of medical devices - Requirements for medical devices to be designated '' STERILE '' - Part 1: Requirements for terminally sterilized medical devices). Author presents the main legal aspects of the international standards for radiation sterilization of medical devices

  11. 77 FR 25183 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-04-27

    ... HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices... the Medical Devices Advisory Committee. General Function of the Committee: To provide advice and... Commissioner for Special Medical Programs. BILLING CODE 4160-01-P...

  12. Regulatory affairs for biomaterials and medical devices

    CERN Document Server

    Amato, Stephen F; Amato, B

    2014-01-01

    All biomaterials and medical devices are subject to a long list of regulatory practises and policies which must be adhered to in order to receive clearance. This book provides readers with information on the systems in place in the USA and the rest of the world. Chapters focus on a series of procedures and policies including topics such as commercialization, clinical development, general good practise manufacturing and post market surveillance.Addresses global regulations and regulatory issues surrounding biomaterials and medical devicesEspecially useful for smaller co

  13. 77 FR 19293 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Meeting

    Science.gov (United States)

    2012-03-30

    ... the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee. Submit... INFORMATION: Name of Committee: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory... with or considering hip replacement (...

  14. Modelling degradation of bioresorbable polymeric medical devices

    CERN Document Server

    Pan, J

    2015-01-01

    The use of bioresorbable polymers in stents, fixation devices and tissue engineering is revolutionising medicine. Both industry and academic researchers are interested in using computer modelling to replace some experiments which are costly and time consuming. This book provides readers with a comprehensive review of modelling polymers and polymeric medical devices as an alternative to practical experiments. Chapters in part one provide readers with an overview of the fundamentals of biodegradation. Part two looks at a wide range of degradation theories for bioresorbable polymers and devices.

  15. The medical device industry developments in software risk management

    CERN Document Server

    Burton, John; McCaffery, Fergal; hAodha, Micheal O

    2009-01-01

    The Medical Device industry is one of the fastest growing industries in the world. Device manufacturers are producing increasingly sophisticated and complex medical device software to differentiate themselves in the battle for dominance in this sector.

  16. Medical devices for the anesthetist: current perspectives

    Directory of Open Access Journals (Sweden)

    Ingrande J

    2014-03-01

    Full Text Available Jerry Ingrande, Hendrikus JM LemmensDepartment of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, CA, USAAbstract: Anesthesiologists are unique among most physicians in that they routinely use technology and medical devices to carry out their daily activities. Recently, there have been significant advances in medical technology. These advances have increased the number and utility of medical devices available to the anesthesiologist. There is little doubt that these new tools have improved the practice of anesthesia. Monitoring has become more comprehensive and less invasive, airway management has become easier, and placement of central venous catheters and regional nerve blockade has become faster and safer. This review focuses on key medical devices such as cardiovascular monitors, airway equipment, neuromonitoring tools, ultrasound, and target controlled drug delivery software and hardware. This review demonstrates how advances in these areas have improved the safety and efficacy of anesthesia and facilitate its administration. When applicable, indications and contraindications to the use of these novel devices will be explored as well as the controversies surrounding their use.Keywords: catheters, echocardiography, ultrasound, fiberoptic bronchoscope, laryngeal mask airway, closed-loop anesthesia

  17. Electron beam sterilisation of heterogeneous medical devices

    Science.gov (United States)

    Sadat, T.; Morisseau, MrD.; Ross, MissA.

    1993-07-01

    Electron beam radiation is used in the sterilisation of medical disposable devices. High energy, 10 MeV, electron beam linear accelerators are in use worldwide for this purpose. The dose distribution achieved in the products treated influences the efficiency of treatment. This paper looks at the dose distribution achieved with such machines and the methods used to define it in heterogeneous products.

  18. Electron beam sterilisation of heterogeneous medical devices

    International Nuclear Information System (INIS)

    Electron beam radiation is used in the sterilization of medical disposable devices. High energy, 10 MeV, electron beam linear accelerators are in use worldwide for this purpose. The dose distribution achieved in the products treated influences the efficiency of treatment. This paper looks at the dose distribution achieved with such machines and the methods used to define it in heterogeneous products. (author)

  19. The grays of medical device color additives.

    Science.gov (United States)

    Seidman, Brenda

    2014-01-01

    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

  20. Bluetooth Communication for Battery Powered Medical Devices

    Science.gov (United States)

    Babušiak, Branko; Borik, Štefan

    2016-01-01

    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.

  1. 31 CFR 597.511 - In-kind donations of medicine, medical devices, and medical services.

    Science.gov (United States)

    2010-07-01

    ..., medical devices, and medical services. 597.511 Section 597.511 Money and Finance: Treasury Regulations... Licensing Policy § 597.511 In-kind donations of medicine, medical devices, and medical services. (a... medicine, medical devices, and medical services to the Palestinian Authority Ministry of Health,...

  2. 31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.

    Science.gov (United States)

    2010-07-01

    ..., medical devices, and medical services. 595.513 Section 595.513 Money and Finance: Treasury Regulations...-kind donations of medicine, medical devices, and medical services. (a) Effective July 6, 2006..., medical devices, and medical services to the Palestinian Authority Ministry of Health, provided that...

  3. 31 CFR 594.515 - In-kind donations of medicine, medical devices, and medical services.

    Science.gov (United States)

    2010-07-01

    ..., medical devices, and medical services. 594.515 Section 594.515 Money and Finance: Treasury Regulations....515 In-kind donations of medicine, medical devices, and medical services. (a) Effective July 6, 2006..., medical devices, and medical services to the Palestinian Authority Ministry of Health, provided that...

  4. Power Approaches for Implantable Medical Devices

    Directory of Open Access Journals (Sweden)

    Achraf Ben Amar

    2015-11-01

    Full Text Available Implantable medical devices have been implemented to provide treatment and to assess in vivo physiological information in humans as well as animal models for medical diagnosis and prognosis, therapeutic applications and biological science studies. The advances of micro/nanotechnology dovetailed with novel biomaterials have further enhanced biocompatibility, sensitivity, longevity and reliability in newly-emerged low-cost and compact devices. Close-loop systems with both sensing and treatment functions have also been developed to provide point-of-care and personalized medicine. Nevertheless, one of the remaining challenges is whether power can be supplied sufficiently and continuously for the operation of the entire system. This issue is becoming more and more critical to the increasing need of power for wireless communication in implanted devices towards the future healthcare infrastructure, namely mobile health (m-Health. In this review paper, methodologies to transfer and harvest energy in implantable medical devices are introduced and discussed to highlight the uses and significances of various potential power sources.

  5. Power Approaches for Implantable Medical Devices.

    Science.gov (United States)

    Ben Amar, Achraf; Kouki, Ammar B; Cao, Hung

    2015-01-01

    Implantable medical devices have been implemented to provide treatment and to assess in vivo physiological information in humans as well as animal models for medical diagnosis and prognosis, therapeutic applications and biological science studies. The advances of micro/nanotechnology dovetailed with novel biomaterials have further enhanced biocompatibility, sensitivity, longevity and reliability in newly-emerged low-cost and compact devices. Close-loop systems with both sensing and treatment functions have also been developed to provide point-of-care and personalized medicine. Nevertheless, one of the remaining challenges is whether power can be supplied sufficiently and continuously for the operation of the entire system. This issue is becoming more and more critical to the increasing need of power for wireless communication in implanted devices towards the future healthcare infrastructure, namely mobile health (m-Health). In this review paper, methodologies to transfer and harvest energy in implantable medical devices are introduced and discussed to highlight the uses and significances of various potential power sources. PMID:26580626

  6. Medical device data systems and FDA regulation. Should medical device data systems require FDA clearance?

    Science.gov (United States)

    Kelley, Peter

    2010-01-01

    It is widely understood why medical devices need to be regulated by the FDA and other governing bodies. However medical software does not typically require the same level of regulation. Currently the FDA is investigating whether one type of medical software, Medical Device Data Systems (MDDS), should require FDA clearance because of the potential risk they impose when interconnected with medical devices. Hospitals are looking to implement MDDS because the technology allows nursing staff to spend more time on direct patient care and reduces charting errors. This article will explore the FDA's proposal and will review the possible risks and provide a rationale for why MDDS should be regulated by the FDA and why MDDS vendors should have the right level of quality and risk management procedures in place to ensure that they are developing and bringing to market the safest products possible. PMID:20677470

  7. Security for wireless implantable medical devices

    CERN Document Server

    Hei, Xiali

    2013-01-01

    In the treatment of chronic diseases, wireless Implantable Medical Devices (IMDs) are commonly used to communicate with an outside programmer (reader). Such communication raises serious security concerns, such as the ability for hackers to gain access to a patient's medical records. This brief provides an overview of such attacks and the new security challenges, defenses, design issues, modeling and performance evaluation in wireless IMDs.  While studying the vulnerabilities of IMDs and corresponding security defenses, the reader will also learn the methodologies and tools for designing securi

  8. 76 FR 12973 - Neurological Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice

    Science.gov (United States)

    2011-03-09

    ... HUMAN SERVICES Food and Drug Administration Neurological Devices Panel of the Medical Devices Advisory... Medical Devices Advisory Committee. This meeting was announced in the Federal Register of February 7, 2011... meeting of the Neurological Devices Panel of the Medical Devices Advisory Committee would be held on...

  9. 78 FR 14013 - Medical Devices; Exemption From Premarket Notification; Class II Devices; Wheelchair Elevator

    Science.gov (United States)

    2013-03-04

    .../MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080198.htm or by sending an email request... HUMAN SERVICES Food and Drug Administration 21 CFR Part 890 Medical Devices; Exemption From Premarket... Part 890 Medical devices, Physical medicine devices. Therefore, under the Federal Food, Drug,...

  10. 78 FR 68714 - Medical Devices; Ophthalmic Devices; Classification of the Scleral Plug

    Science.gov (United States)

    2013-11-15

    ... Device Amendments of 1976 (the 1976 amendments) (Pub. L. 94-295), the Safe Medical Devices Act of 1990... HUMAN SERVICES Food and Drug Administration 21 CFR Part 886 Medical Devices; Ophthalmic Devices... regulation of medical devices intended for human use. Section 513 of the FD&C Act (21 U.S.C....

  11. Prospects of radiation sterilization of medical devices

    International Nuclear Information System (INIS)

    Since radiation sterilization was first introduced in the United States in 1956 in the field of disposable medical devices, it has become an indispensable technique for sterilization because of the following reasons: (1) introduction into dialyzers, (2) introduction in medical device makers, (3) development of disposable medical devices associated with developing both high molecular chemistry and cool sterilization, (4) rationality of sterilization process, and (5) problems of sterilization with ethylene oxide gas. To promote the further development of radiation sterilization, the following items are considered necessary: (1) an increase in the number of facilities for radiation sterilization, (2) recommendation of the international standardization of sterilization method, (3) decrease in radiation doses associated with sterilization, (4) development of electron accelerators and bremsstrahlung equipments for radiation sources, and (5) simplification of sterilization process management. Factors precluding the development of radiation sterilization are: (1) development of other methods than radiation sterilization, (2) development of technique for sterile products, (3) high facility cost, (4) high irradiation cost, (5) benefits and limits of sterilization markets, and (6) influences of materials. (N.K.)

  12. Stretchable bioelectronics for medical devices and systems

    CERN Document Server

    Ghaffari, Roozbeh; Kim, Dae-Hyeong

    2016-01-01

    This book highlights recent advances in soft and stretchable biointegrated electronics. A renowned group of authors address key ideas in the materials, processes, mechanics, and devices of soft and stretchable electronics; the wearable electronics systems; and bioinspired and implantable biomedical electronics. Among the topics discussed are liquid metals, stretchable and flexible energy sources, skin-like devices, in vitro neural recording, and more. Special focus is given to recent advances in extremely soft and stretchable bio-inspired electronics with real-world clinical studies that validate the technology. Foundational theoretical and experimental aspects are also covered in relation to the design and application of these biointegrated electronics systems. This is an ideal book for researchers, engineers, and industry professionals involved in developing healthcare devices, medical tools and related instruments relevant to various clinical practices.

  13. Initiatives in the Australian Medical Devices Industry

    International Nuclear Information System (INIS)

    The medical device industry is as diverse as it is specialised and calls on the innovative use of design and components and utilises all facets of precision manufacturing from printed circuit boards, injection-moulded plastics to engineering, using a wide range of materials. It generally requires exacting standards, starting with design, particularly for devices that are invasive or have direct contact with the human body. Of course this brings the further consideration of sterilisation and whether it is for single or multiple use. There is an ever-present need to produce more accurate less invasive and cheaper devices. The driving motivation appears to be meeting clinical needs at a reduced cost. The push to treat people outside the hospital is growing, creating new demands and directions. The advent of the Internet and wireless technology has opened a whole new direction of research and development opportunities

  14. How can software SMEs become medical device software SMEs

    OpenAIRE

    Mc Caffery, Fergal; Casey, Valentine; Mc Hugh, Martin

    2011-01-01

    peer-reviewed Today the amount of software content within medical devices has grown considerably and will continue to do so as the level of complexity of medical devices continues to increase. This is driven by the fact that software is introduced to produce sophisticated medical devices that would not be possible using only hardware. This therefore presents opportunities for software development SMEs to become medical device software development organisations. However, some obstacles need...

  15. Differences Between Clinical Trials of Medical Devices and Drugs

    Institute of Scientific and Technical Information of China (English)

    ZHANG Zhi-jun; LIU Wei

    2014-01-01

    How to design clinical trials for medical devices is a problem plaguing the industry today. As there are many differences in clinical trials of medical devices and drugs. This paper describes the differences of the two points from the perspectivs of defi-nition of medical devices and drugs, scope, phasing, subjects and design of clinical trials in details, aiming to help the related personnel make scientific decisions while conduct-ing clinical trial design for medical devices.

  16. Medical device vigilance systems: India, US, UK, and Australia

    Directory of Open Access Journals (Sweden)

    Pooja Gupta

    2010-11-01

    Full Text Available Pooja Gupta, Manthan D Janodia, Puralea C Jagadish, Nayanabhirama UdupaManipal Collge of Pharmaceutical Sciences, Manipal University, Manipal, Karnataka, IndiaAbstract: The term medical device includes a wide category of products ranging from therapeutic medical devices exerting their effects locally such as tissue cutting, wound covering or propping open clogged arteries, to highly sophisticated computerized medical equipment and diagnostic medical devices. To achieve uniformity among the national medical device regulatory systems and increase the access to safe, effective, and clinically beneficial medical technologies, the Global Harmonization Task Force (GHTF was conceived in 1992 by five members: European Union, United States, Australia, Japan, and Canada. All regulated countries have clearly defined medical devices, as has the GHTF. Although GHTF has tried to achieve harmonization with respect to medical devices, some differences still exist in the national laws of the countries of GHTF. Further, regulated countries have classified medical devices on the basis of their associated risk. In the Indian regulatory system, medical devices are still considered as drugs. In 2006, the Medical Device Regulation Bill was recommended to consolidate laws for medical devices and to establish the Medical Device Regulatory Authority of India. In addition, medical devices are not classified by any Indian regulatory authority. Although India has moved towards harmonizing its medical device regulations with those of regulated countries, this study aims to identify whether India should have a vigilance system in harmony with those of GHTF or develop its own system for medical devices.Keywords: medical device, vigilance, regulatory systems, GHTF, India

  17. Assessment of technical documentation of Annex II medical devices

    NARCIS (Netherlands)

    Roszek B; Drongelen AW van; Geertsma RE; Tienhoven EAE van; BMT

    2005-01-01

    An investigation was carried out on the availability and quality of the technical documentation (file) of medical devices. Manufacturers of medical devices are obliged to prepare and maintain documentation complying with the provisions in the Medical Device Directive (MDD). Manufacturers are legall

  18. 21 CFR 801.6 - Medical devices; misleading statements.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices; misleading statements. 801.6 Section 801.6 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.6 Medical devices; misleading statements. Among representations in the labeling of...

  19. 21 CFR 801.127 - Medical devices; expiration of exemptions.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices; expiration of exemptions. 801.127 Section 801.127 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions From Adequate Directions for Use § 801.127 Medical devices; expiration of exemptions. (a) If...

  20. 78 FR 5327 - Medical Devices; Ophthalmic Devices; Classification of the Scleral Plug

    Science.gov (United States)

    2013-01-25

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 886 Medical Devices; Ophthalmic Devices...), the Safe Medical Devices Act of 1990 (Pub. L. 101-629), the Food and Drug Administration Modernization... the regulation of medical devices intended for human use. Section 513 of the FD&C Act (21 U.S.C....

  1. Design controls for the medical device industry

    CERN Document Server

    Teixeira, Marie B

    2013-01-01

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

  2. Practical design control implementation for medical devices

    CERN Document Server

    Justiniano, Jose

    2003-01-01

    Bringing together the concepts of design control and reliability engineering, this book is a must for medical device manufacturers. It helps them meet the challenge of designing and developing products that meet or exceed customer expectations and also meet regulatory requirements. Part One covers motivation for design control and validation, design control requirements, process validation and design transfer, quality system for design control, and measuring design control program effectiveness. Part Two discusses risk analysis and FMEA, designing-in reliability, reliability and design verific

  3. Software Process Improvement to Assist Medical Device Software Development Organisations to Comply with the Amendments to the Medical Device Directive

    OpenAIRE

    Mc Hugh, Martin; McCaffery, Fergal; Casey, Valentine

    2012-01-01

    peer-reviewed A recent revision to the European Medical Device Directive (MDD) 2007/47/EC made fourteen amendments to the original directive (93/42/EEC). A number of these changes directly affect the development of software for use in healthcare. The most significant change in relation to medical device software development is that standalone software is now seen as an active medical device and should be developed following state of the art medical device software development p...

  4. Reassessing Pre-market Regulation of Class III Medical Devices

    OpenAIRE

    Zollinger, Geri

    2003-01-01

    Regulation of medical devices has evolved over the past twenty-five years. Initially, Congress created a regime where the safety and efficacy of all medical devices would be reviewed to varying degrees, depending on the risk posed by the device. Class III devices, the most dangerous class of devices, were to each have a safety and efficacy review. To permit new market entrants on similar grounds as those marketing devices prior to the 1976 Amendments, Congress also created a premarket notific...

  5. Integrated Microbatteries for Implantable Medical Devices

    Science.gov (United States)

    Whitacre, Jay; West, William

    2008-01-01

    Integrated microbatteries have been proposed to satisfy an anticipated need for long-life, low-rate primary batteries, having volumes less than 1 mm3, to power electronic circuitry in implantable medical devices. In one contemplated application, such a battery would be incorporated into a tubular hearing-aid device to be installed against an eardrum. This device is based on existing tube structures that have already been approved by the FDA for use in human ears. As shown in the figure, the battery would comprise a single cell at one end of the implantable tube. A small volume of Li-based primary battery cathode material would be compacted and inserted in the tube near one end, followed by a thin porous separator, followed by a pressed powder of a Li-containing alloy. Current-collecting wires would be inserted, with suitably positioned insulators to prevent a short circuit. The battery would contain a liquid electrolyte consisting of a Li-based salt in an appropriate solvent. Hermetic seals would be created by plugging both ends with a waterproof polymer followed by deposition of parylene.

  6. Regulatory science based approach in development of novel medical devices.

    Science.gov (United States)

    Sakuma, Ichiro

    2015-08-01

    For development rational evaluation method for medical devices' safety and efficacy, regulatory science studies are important. Studies on regulatory affairs related to a medical device under development should be conducted as well as its technological development. Clinical performance of a medical device is influenced by performance of the device, medical doctors' skill, pathological condition of a patient, and so on. Thus it is sometimes difficult to demonstrate superiority of the device in terms of clinical outcome although its efficacy as a medical device is accepted. Setting of appropriate end points is required to evaluate a medical device appropriately. Risk assessment and risk management are the basis of medical device safety assurance. In case of medical device software, there are difficulties in identifying the risk due to its complexity of user environment and different design and manufacturing procedure compared with conventional hardware based medical devices. Recent technological advancement such as information and communication technologies (ICT) for medical devices and wireless network has raised new issue on risk management: cybersecurity. We have to watch closely the progress of safety standard development. PMID:26736611

  7. On the impact of medical device regulations on software architecture

    DEFF Research Database (Denmark)

    Hansen, Klaus Marius; Manikas, Konstantinos

    the device. Moreover, we review software modularity in the implementation of software medical device and propose a set of preliminary principles for architectural design of software medical device based on a set of constrains identified from the reviewed regulations.......Compliance to regulations and regulatory approval are requirements for many medical device software systems. In this paper, we investigate the implications of medical device software regulations to the design of software systems. We do so by focusing on the American and European regulatory...... authorities and review the legal requirements for regulatory approval of medical devices. We define a simplified process for regulatory approval, consisting of five steps, and enhance this process by descriptions of how to decide whether a software system is a medical device and how to identify the class of...

  8. 76 FR 63928 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-10-14

    ... HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices... the Medical Devices Advisory Committee. General Function of the Committee: To provide advice and... stable, optimal medical therapy, and who have left bundle branch block (LBBB) with a QRS duration...

  9. 75 FR 7282 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-02-18

    ... HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices... the Medical Devices Advisory Committee. General Function of the Committee: To provide advice and... Warner, Acting Associate Commissioner for Special Medical Programs. BILLING CODE 4160-01-S...

  10. 75 FR 16365 - Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on...

    Science.gov (United States)

    2010-04-01

    ... 515 and 515A of the act by providing procedures for the premarket approval of medical devices intended... HUMAN SERVICES Food and Drug Administration 21 CFR Part 814 RIN 0910-AG29 Medical Devices; Pediatric... the regulations on premarket approval of medical devices to include requirements relating to...

  11. Security and privacy for implantable medical devices

    CERN Document Server

    Carrara, Sandro

    2014-01-01

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

  12. 76 FR 58019 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-09-19

    ... HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices... the Medical Devices Advisory Committee. General Function of the Committee: To provide advice and... Medtronic Ablation Frontiers Cardiac Ablation System is a catheter-based device developed for the...

  13. 75 FR 36660 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2010-06-28

    ... Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide... HUMAN SERVICES Food and Drug Administration Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION:...

  14. 78 FR 11208 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-02-15

    ... HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices... the Medical Devices Advisory Committee. General Function of the Committee: To provide advice and... three major components: The delivery catheter, the steerable sleeve, and the MitraClip device. The...

  15. 78 FR 77688 - Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-12-24

    ... HUMAN SERVICES Food and Drug Administration Ophthalmic Devices Panel of the Medical Devices Advisory...). The meeting will be open to the public. Name of Committee: Ophthalmic Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  16. 76 FR 6625 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-02-07

    ... HUMAN SERVICES Food and Drug Administration Neurological Devices Panel of the Medical Devices Advisory... Devices Advisory Committee. General Function of the Committee: To provide advice and recommendations to... Embolization Device (PED), sponsored by Chestnut Medical. The PED is indicated for the endovascular...

  17. 76 FR 71983 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2011-11-21

    ... Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide... HUMAN SERVICES Food and Drug Administration Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION:...

  18. 78 FR 13350 - Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-02-27

    ... HUMAN SERVICES Food and Drug Administration Ophthalmic Devices Panel of the Medical Devices Advisory...). The meeting will be open to the public. Name of Committee: Ophthalmic Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  19. 75 FR 44273 - Radiological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-07-28

    ... HUMAN SERVICES Food and Drug Administration Radiological Devices Panel of the Medical Devices Advisory...). The meeting will be open to the public. Name of Committee: Radiological Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  20. 76 FR 48871 - Immunology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-08-09

    ... 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 Devices Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  1. 75 FR 72832 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-11-26

    ... HUMAN SERVICES Food and Drug Administration Neurological Devices Panel of the Medical Devices Advisory...). The meeting will be open to the public. Name of Committee: Neurological Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  2. 77 FR 73034 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-12-07

    ... HUMAN SERVICES Food and Drug Administration Neurological Devices Panel of the Medical Devices Advisory...). The meeting will be open to the public. Name of Committee: Neurological Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  3. 78 FR 67365 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-11-12

    ... HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices... the Medical Devices Advisory Committee. General Function of the Committee: To provide advice and... percutaneously delivered permanent cardiac implant placed in the left atrial appendage. This device is...

  4. 77 FR 7589 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-02-13

    ... HUMAN SERVICES Food and Drug Administration Neurological Devices Panel of the Medical Devices Advisory...). The meeting will be open to the public. Name of Committee: Neurological Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide advice and ] recommendations...

  5. 76 FR 36548 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-06-22

    ... HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices... the Medical Devices Advisory Committee. General Function of the Committee: To provide advice and... vote on information related to the humanitarian device exemption for the Berlin Heart EXCOR...

  6. 75 FR 35495 - Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-06-22

    ... HUMAN SERVICES Food and Drug Administration Ophthalmic Devices Panel of the Medical Devices Advisory...). The meeting will be open to the public. Name of Committee: Ophthalmic Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  7. 77 FR 42503 - Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-07-19

    ... HUMAN SERVICES Food and Drug Administration Ophthalmic Devices Panel of the Medical Devices Advisory...). The meeting will be open to the public. Name of Committee: Ophthalmic Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  8. 77 FR 61768 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-10-11

    ... HUMAN SERVICES Food and Drug Administration Neurological Devices Panel of the Medical Devices Advisory...). The meeting will be open to the public. Name of Committee: Neurological Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  9. 77 FR 50701 - Radiological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-08-22

    ... HUMAN SERVICES Food and Drug Administration Radiological Devices Panel of the Medical Devices Advisory...). The meeting will be open to the public. Name of Committee: Radiological Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide advice and recommendations...

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

    Science.gov (United States)

    2011-03-16

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: Microbiology Devices Panel of the Medical Devices Advisory...

  11. 77 FR 16925 - Medical Devices; Neurological Devices; Classification of the Near Infrared Brain Hematoma Detector

    Science.gov (United States)

    2012-03-23

    ... Electrical safety and electromagnetic compatibility (EMC). Interference with other devices........ Electrical... HUMAN SERVICES Food and Drug Administration 21 CFR Part 882 Medical Devices; Neurological Devices... individually or cumulatively have a significant effect on the human environment. Therefore, neither...

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

    Science.gov (United States)

    ... Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Medical Devices Home Medical Devices Products and Medical Procedures Home Health and Consumer Devices Brochure - Home Healthcare Medical Devices: Infusion Therapy - Getting the Most Out of Your ...

  13. An update on mobile phones interference with medical devices

    International Nuclear Information System (INIS)

    Mobile phones' electromagnetic interference with medical devices is an important issue for the medical safety of patients who are using life-supporting medical devices. This review mainly focuses on mobile phones' interference with implanted medical devices and with medical equipment located in critical areas of hospitals. A close look at the findings reveals that mobile phones may adversely affect the functioning of medical devices, and the specific effect and the degree of interference depend on the applied technology and the separation distance. According to the studies' findings and the authors' recommendations, besides mitigating interference, using mobile phones at a reasonable distance from medical devices and developing technology standards can lead to their effective use in hospital communication systems. (authors)

  14. 75 FR 69447 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices...

    Science.gov (United States)

    2010-11-12

    ... Collection; Comment Request; Medical Devices; Device Tracking AGENCY: Food and Drug Administration, HHS... device information is collected to facilitate identifying the current location of medical devices and... solicits comments on information collection requirements for the tracking of medical devices. DATES:...

  15. 76 FR 67463 - Pediatric Medical Devices; Public Workshop; Request for Comments

    Science.gov (United States)

    2011-11-01

    ... medical devices and pediatric device approvals or clearance; the scientific and regulatory limitations and... to support pediatric effectiveness claims for medical devices and pediatric device approvals or... HUMAN SERVICES Food and Drug Administration Pediatric Medical Devices; Public Workshop; Request...

  16. Characteristics of a medical device software development framework

    OpenAIRE

    Clarke, Paul; Lepmets, Marion; Mc Caffery, Fergal; Finnegan, Anita; Dorling, Alec; Eagles, Sherman

    2014-01-01

    peer-reviewed This paper aims to describe the software development settings of medical device domain focusing on the demands of the safety critical software processes. Medical device software developers have to adhere to a number of regulations and standards. This paper addresses the most important characteristics of a software development framework that could support medical device software developers in their efforts to comply with these regulations as well as to improve their software d...

  17. Metrology and Standards Needs for Some Categories of Medical Devices

    OpenAIRE

    Chiao, J. C.; Goldman, Julian M.; Heck, David A.; Kazanzides, Peter; Peine, William J.; Stiehl, James B.; Yen, Dwight; Dagalakis, Nicholas G.

    2008-01-01

    With rapid advances in meso-, micro- and nano-scale technology devices and electronics, a new generation of advanced medical devices is emerging, which promises medical treatment that is less invasive and more accurate, automated, and effective. We examined the technological and economic status of five categories of medical devices. A set of metrology needs is identified for each of these categories and suggestions are made to address them.

  18. The role of the user within the medical device design and development process: medical device manufacturers' perspectives

    OpenAIRE

    Craven Michael P; Kuljis Jasna; Barnett Julie; Money Arthur G; Martin Jennifer L; Young Terry

    2011-01-01

    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 with...

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

    Science.gov (United States)

    ... to Prepare for and Handle Power Outages for Medical Devices that Require Electricity Center for De CDRH vices ... to Prepare for and Handle Power Outages for Medical Devices that Require Electricity As a home medical device ...

  20. 77 FR 66847 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-11-07

    ... HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices... the Medical Devices Advisory Committee. General Function of the Committee: To provide advice and... releasing external pressure during systole to reduce left ventricular workload. On March 9, 1979 (44...

  1. 21 CFR 801.63 - Medical devices; warning statements for devices containing or manufactured with...

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices; warning statements for devices containing or manufactured with chlorofluorocarbons and other class I ozone-depleting substances. 801.63 Section 801.63 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING...

  2. 75 FR 81282 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-12-27

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices... the Medical Devices Advisory Committee. General Function of the Committee: To provide advice...

  3. 76 FR 55398 - Immunology Devices Panel of the Medical Devices Advisory Committee: Notice of Postponement of...

    Science.gov (United States)

    2011-09-07

    ... HUMAN SERVICES Food and Drug Administration Immunology Devices Panel of the Medical Devices Advisory... of the Medical Devices Advisory Committee scheduled for October 14, 2011. The meeting was announced in the Federal Register of August 9, 2011 (76 FR 48871). The meeting is postponed so that FDA...

  4. 76 FR 56200 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-09-12

    ... HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices... the Medical Devices Advisory Committee. General Function of the Committee: To provide advice and... and are pre-loaded onto 6 or 7 Fr \\1\\ (diameter of 2 or 2.3 mm) delivery systems. Upon deployment,...

  5. 76 FR 12743 - Medical Device Reporting; Malfunction Reporting Frequency

    Science.gov (United States)

    2011-03-08

    ... HUMAN SERVICES Food and Drug Administration Medical Device Reporting; Malfunction Reporting Frequency... continue to submit malfunction reports in full compliance with FDA's Medical Device Reporting regulation... supporting, or life sustaining, must continue to report in full compliance with part 803, pending further...

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

    Science.gov (United States)

    Hanson, Jacob J; Hitchcock, Robert W

    2009-01-01

    Despite their sophistication and value, single-use medical devices have become commodity items in the developed world. Cheap raw materials along with large scale manufacturing and distribution processes have combined to make many medical devices more expensive to resterilize, package and restock than to simply discard. This practice is not sustainable or scalable on a global basis. As the petrochemicals that provide raw materials become more expensive and the global reach of these devices continues into rapidly developing economies, there is a need for device designs that take into account the total life-cycle of these products, minimize the amount of non-renewable materials consumed and consider alternative hybrid reusable / disposable approaches. In this paper, we describe a methodology to perform life cycle and functional analyses to create additional design requirements for medical devices. These types of sustainable approaches can move the medical device industry even closer to the "triple bottom line"--people, planet, profit. PMID:19964137

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

    Science.gov (United States)

    Hao, Aiyu; Wang, Ling

    2015-01-01

    At present, hospitals in our country have basically established the HIS system, which manages registration, treatment, and charge, among many others, of patients. During treatment, patients need to use medical devices repeatedly to acquire all sorts of inspection data. Currently, the output data of the medical devices are often manually input into information system, which is easy to get wrong or easy to cause mismatches between inspection reports and patients. For some small hospitals of which information construction is still relatively weak, the information generated by the devices is still presented in the form of paper reports. When doctors or patients want to have access to the data at a given time again, they can only look at the paper files. Data integration between medical devices has long been a difficult problem for the medical information system, because the data from medical devices are lack of mandatory unified global standards and have outstanding heterogeneity of devices. In order to protect their own interests, manufacturers use special protocols, etc., thus causing medical decices to still be the "lonely island" of hospital information system. Besides, unfocused application of the data will lead to failure to achieve a reasonable distribution of medical resources. With the deepening of IT construction in hospitals, medical information systems will be bound to develop towards mobile applications, intelligent analysis, and interconnection and interworking, on the premise that there is an effective medical device integration (MDI) technology. To this end, this paper presents a MDI model based on the Internet of Things (IoT). Through abstract classification, this model is able to extract the common characteristics of the devices, resolve the heterogeneous differences between them, and employ a unified protocol to integrate data between devices. And by the IoT technology, it realizes interconnection network of devices and conducts associate matching

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

    Science.gov (United States)

    Ray, Arnab; Jetley, Raoul; Jones, Paul L; Zhang, Yi

    2010-01-01

    This paper demonstrates the benefits of adopting model-based design techniques for engineering medical device software. By using a patient-controlled analgesic (PCA) infusion pump as a candidate medical device, the authors show how using models to capture design information allows for i) fast and efficient construction of executable device prototypes ii) creation of a standard, reusable baseline software architecture for a particular device family, iii) formal verification of the design against safety requirements, and iv) creation of a safety framework that reduces verification costs for future versions of the device software. 1. PMID:21142522

  9. 78 FR 77689 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2013-12-24

    ... Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide... Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice... published a proposed rule (44 FR 50520) for classification of iontophoresis devices for specialized...

  10. 78 FR 66942 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2013-11-07

    ... Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide... Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice... device is intended to climb stairs. On June 12, 2013 (78 FR 35173), FDA issued a proposed order which,...

  11. 76 FR 36993 - Medical Devices; Neurological Devices; Clarification of Classification for Human Dura Mater...

    Science.gov (United States)

    2011-06-24

    ... CFR Part 882 Medical devices, Neurological devices. Therefore, under the Federal Food, Drug, and... Devices; Neurological Devices; Clarification of Classification for Human Dura Mater; Technical Amendment...). In the Federal Register of November 24, 2004 (69 FR 68612), FDA published a final rule...

  12. 75 FR 4407 - The Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-01-27

    ... HUMAN SERVICES Food and Drug Administration The Neurological Devices Panel of the Medical Devices... System for Epilepsy sponsored by Medtronic, Inc. This device is indicated as adjunctive therapy for reducing the frequency of seizures in individuals diagnosed with epilepsy. For this device, a...

  13. 77 FR 15779 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2012-03-16

    ...: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/default.htm ; and http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/Device...-2011-M-0917] Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket...

  14. Patient's rights charter in Iran.

    Directory of Open Access Journals (Sweden)

    Alireza Parsapoor

    2014-01-01

    Full Text Available Given the importance of patient's rights in healthcare, special attention has been given to the concept of patient's rights by the Ministry of Health and Medical Education in Iran. Iranian patient's rights charter has been compiled with a novel and comprehensive approach. This charter aims to elucidate rights of recipients of health services as well as observing ethical standards in medicine. This paper presents the Iranian patient's rights charter. Based on a study done from 2007 to 2009, the charter has been finalized through an extensive consultation involving all stakeholders, patients, physicians, nurses, lawyers, patient associations and health policy makers. The developed charter was adopted by the Ministry of Health in December 2009. Iranian patient's rights charter has been formulated in the framework of 5 chapters and 37 articles including vision and an explanatory note. The five chapters concern right to receiving appropriate services, right to access desired and enough information, right to choose and decide freely about receiving healthcare, right to privacy and confidentiality, and finally right to access an efficient system of dealing with complaints which have been explained in 14, 9, 7, 4 and 3 articles, respectively.  The paper concludes that, adopting the patient's rights charter is a valuable measure to meet patient's rights; however, a serious challenge is how to implement and acculturate observing patient's rights in practice in our healthcare system in Iran.

  15. ASSEMBLY AND METHOD FOR DISINFECTING LUMENS OF MEDICAL DEVICES

    DEFF Research Database (Denmark)

    2010-01-01

    The invention relates to an assembly for sterilizing surfaces and lumens of a medical device with a light source. The light source can emit light that reduces the number of or removes micro organisms from the lumen and/or surfaces of the medical device. The invention relates to an assembly...... 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 the...... light source allowing the light to the inlet of the lumen of the medical device and protecting the light source from liquid gaining access to the light source,-a separate non-transparent unit being provided with a first coupling part and a second coupling part, where the first coupling part of the...

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

    Data.gov (United States)

    U.S. Department of Health & Human Services — SUMMARY DDOD use case request for consolidated, consistent reporting of medical device recalls. WHAT IS A USE CASE? A “Use Case” is a request that was made by the...

  17. Massive transfusion: Analysis of practices according to available medical devices.

    OpenAIRE

    Bourne, Cindy; Cabelguenne, Delphine; David, Jean-Stéphane; Rioufol, Catherine; Piriou, Vincent

    2012-01-01

    INTRODUCTION: An assessment of practices and available medical devices during the treatment of a massive haemorrhage has been realised in the shock unit of our hospital. MATERIAL AND METHODS: Parameters influencing transfusion flow rate have been identified. Medical devices and equipment to accelerate the flow rate were analyzed on the basis of manufacturers' data and users opinion in relation with their practices. RESULTS: The system, from blood bags to venous access, influences flow rate: r...

  18. Piezoelectric materials and devices applications in engineering and medical sciences

    CERN Document Server

    Vijaya, M S

    2012-01-01

    Piezoelectric Materials and Devices: Applications in Engineering and Medical Sciences provides a complete overview of piezoelectric materials, covering all aspects of the materials starting from fundamental concepts. The treatment includes physics of piezoelectric materials, their characteristics and applications. The author uses simple language to explain the theory of piezoelectricity and introduce readers to the properties and design of different types of piezoelectric materials, such as those used in engineering and medical device applications.This book: Introduces various types of dielect

  19. Ethylene oxide sterilization of medical devices: a review

    OpenAIRE

    Mendes, Gisela C. C.; Brandão, Teresa R. S.; Cristina L.M. Silva

    2007-01-01

    Ethylene oxide (EO) is a well-known sterilizing agent. However, only recently has its use significantly emerged, based on its range of applications in the field of new medical device development and sterilization. This paper describes the progress in terms of EO sterilization and concludes that it remains a promising field to explore and develop. The EO action mechanism and toxicity are analyzed, and a critical analysis is made on how it is possible to use EO sterilization for medical devices...

  20. Requirements for Evaluation on Drug-medical Device

    Institute of Scientific and Technical Information of China (English)

    2009-01-01

    The administration of combination products in U.S.Food and Drug Administration(FDA)are analyzed and summarized in this paper.Furthermore,the technical evaluation on drug-medical device in the State Food and Drug Administration of China(SFDA)is also illustrated.Meanwhile,this paper discusses how to promote the development of drug-medical device in the administration and technical evaluation.

  1. Strengths of Taiwan’s Medical Device Industry

    Directory of Open Access Journals (Sweden)

    Tsz-Yin Chang

    2012-03-01

    Full Text Available 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 the past few years and have become potential export-oriented medical devices for Taiwan. Taiwan’s manufacturers can quite professionally deal with issues such as flexible manufacturing and process cost management, and they are rather competitive in emerging markets that demand high quality and fair prices. These qualities help maintain the continuous increase in export momentum. In addition, international manufacturers, one after the other, are establishing their research and development centers in China and purchasing related parts and components locally to form their supply chains in Asia. This helps Taiwan’s manufacturers in other industrial sectors who are proactively making investments in the medical device industry and driving high value for the industry get the upper hand when they seek to connect with the global medical device industry, as well as be able to cut into the international medical device supply chain in the future.

  2. 78 FR 49272 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-08-13

    ... HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices... long-term pulmonary support systems, one of the remaining preamendments class III devices regulated... depth of compressions for the duration of CPR. On January 8, 2013 (78 FR 1162), FDA issued a...

  3. 77 FR 12064 - Radiological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-02-28

    ... HUMAN SERVICES Food and Drug Administration Radiological Devices Panel of the Medical Devices Advisory... Devices Advisory Committee. General Function of the Committee: To provide advice and recommendations to... April 9, 2009 (74 FR 16214), for breast transilluminators, one of the remaining preamendments class...

  4. 78 FR 20328 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee: Notice of...

    Science.gov (United States)

    2013-04-04

    ... Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee scheduled for April 5, 2013. The meeting was announced in the Federal Register of November 29, 2012 (77 FR 71195). The meeting... Devices Advisory Committee: Notice of Postponement of Meeting AGENCY: Food and Drug Administration,...

  5. 77 FR 71195 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2012-11-29

    ... Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide... Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice... July 6, 2012 (77 FR 39953), FDA issued a proposed rule which, if made final, would make...

  6. 78 FR 26786 - Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-05-08

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Microbiology Devices Panel of the Medical Devices Advisory...). The meeting will be open to the public. Name of Committee: Microbiology Devices Panel of the...

  7. 76 FR 50485 - Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Amendment of...

    Science.gov (United States)

    2011-08-15

    ... Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee. This meeting was announced in the Federal Register of July 14, 2011 (76 FR 41507). The amendment is being made to reflect a... HUMAN SERVICES Food and Drug Administration Obstetrics and Gynecology Devices Panel of the...

  8. 77 FR 18829 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-03-28

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices... (FDA). The meeting will be open to the public. Name of Committee: Circulatory System Devices Panel...

  9. 78 FR 46977 - Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-08-02

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Ophthalmic Devices Panel of the Medical Devices Advisory...). The meeting will be open to the public. Name of Committee: Ophthalmic Devices Panel of the...

  10. Medical devices in dermatology using DLP technology from Texas Instruments

    Science.gov (United States)

    Kock, M.; Lüllau, F.

    2012-03-01

    The market of medical devices is growing continuously worldwide. With the DLP™ technology from Texas Instruments Lüllau Engineering GmbH in Germany has realized different applications in the medical discipline of dermatology. Especially a new digital phototherapy device named skintrek™ PT5 is revolutionizing the treatment of skin diseases like psoriasis , Vitiligo and other Eczema. The functions of the new phototherapy device can only be realized through DLP™ technology which is not only be used for the selective irradiation process. In combination with other optical systems DLP™ technology undertakes also other functionalities like 3D-topology calculation und patient movement compensation.

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

    Science.gov (United States)

    Baim, Donald S; Donovan, Aine; Smith, John J; Briefs, Nancy; Geoffrion, Richard; Feigal, David; Kaplan, Aaron V

    2007-04-01

    New technologies introduced over the past three decades have transformed medical diagnosis and treatment, and significantly improved patient outcomes. These changes have been mediated by the introduction of new medical devices, particularly for the treatment of cardiovascular, orthopedic, and ophthalmic disorders. These devices, in turn, have created large markets and spawned a burgeoning medical device industry, including six Fortune 500 companies whose combined market capitalization now exceeds 400 billion dollars. This success story, which has unquestionably benefited patients and society alike, has been dependent upon an intense collaboration among industry, clinicians, and regulatory authorities. However, when physicians actively involved in patient care participate in such collaborations, they are increasingly vulnerable to creating potential conflicts between these two (clinical and device development) roles. Such conflicts, which may ultimately erode public trust, have important consequences not only for the individual physicians, but also for their parent institutions, their patients, sponsoring companies, and the entire clinical research enterprise that makes the development and introduction of new devices possible. The third Dartmouth Device Development Symposium held in October 2005 brought together thought leaders within the medical device community, including academicians, clinical investigators, regulators from the Food and Drug Administration and Centers for Medicare and Medicaid Services (CMS), large and small device manufacturers and the financial (venture capital and investment banks) community. The Symposium examined the conflicts of interest encountered during the early development and commercialization of a medical device. The goal of these discussions was to (1) identify and characterize the conflicts that arise and (2) provide strategies to address these conflicts. This manuscript was prepared by a writing committee to provide a summary

  12. The medical physics of ventricular assist devices

    Energy Technology Data Exchange (ETDEWEB)

    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)

    2005-03-01

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

  13. Implantable photonic devices for improved medical treatments

    Science.gov (United States)

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

    2014-10-01

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

  14. The medical physics of ventricular assist devices

    International Nuclear Information System (INIS)

    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

  15. On the Charter Question: Black Marxism and Black Nationalism

    Science.gov (United States)

    Stern, Mark; Hussain, Khuram

    2015-01-01

    This article brings two black intellectual traditions to bear on the question of charter schools: black Marxism and black nationalism. The authors examine the theoretical and rhetorical devices used to talk about charters schools by focusing on how notions of "black liberation" are deployed by the charter movement, and to what end. The…

  16. 76 FR 44489 - Medical Devices; Neurological Devices; Classification of Repetitive Transcranial Magnetic...

    Science.gov (United States)

    2011-07-26

    ...; Hazards caused by electromagnetic interference and electrostatic discharge hazards; and Hearing loss. FDA... electromagnetic Electromagnetic compatibility. interference and electrostatic discharge hazards. Labeling. Hearing... HUMAN SERVICES Food and Drug Administration 21 CFR Part 882 Medical Devices; Neurological...

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

    Science.gov (United States)

    Khan, Yasser; Ostfeld, Aminy E; Lochner, Claire M; Pierre, Adrien; Arias, Ana C

    2016-06-01

    Advances in wireless technologies, low-power electronics, the internet of things, and in the domain of connected health are driving innovations in wearable medical devices at a tremendous pace. Wearable sensor systems composed of flexible and stretchable materials have the potential to better interface to the human skin, whereas silicon-based electronics are extremely efficient in sensor data processing and transmission. Therefore, flexible and stretchable sensors combined with low-power silicon-based electronics are a viable and efficient approach for medical monitoring. Flexible medical devices designed for monitoring human vital signs, such as body temperature, heart rate, respiration rate, blood pressure, pulse oxygenation, and blood glucose have applications in both fitness monitoring and medical diagnostics. As a review of the latest development in flexible and wearable human vitals sensors, the essential components required for vitals sensors are outlined and discussed here, including the reported sensor systems, sensing mechanisms, sensor fabrication, power, and data processing requirements. PMID:26867696

  18. 76 FR 6551 - Medical Devices; General and Plastic Surgery Devices; Classification of Contact Cooling System...

    Science.gov (United States)

    2011-02-07

    .... Software Validation Section 8. Animal Testing Section 9. Clinical Testing Section 11. Electromagnetic... Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 301 et seq.) as amended by the Medical... of Subjects in 21 CFR Part 878 Medical devices. Therefore, under the Federal Food, Drug, and...

  19. Medical Device Data and Modeling for Clinical Decision Making

    CERN Document Server

    Zaleski, John R

    2010-01-01

    This cutting-edge volume is the first book that provides you with practical guidance on the use of medical device data for bioinformatics modeling purposes. You learn how to develop original methods for communicating with medical devices within healthcare enterprises and assisting with bedside clinical decision making. The book guides in the implementation and use of clinical decision support methods within the context of electronic health records in the hospital environment.This highly valuable reference also teaches budding biomedical engineers and bioinformaticists the practical benefits of

  20. 77 FR 14272 - Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus Serological...

    Science.gov (United States)

    2012-03-09

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 Medical Devices; Immunology and Microbiology... AND MICROBIOLOGY DEVICES 0 1. The authority citation for 21 CFR part 866 continues to read as...

  1. 78 FR 13347 - Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory...

    Science.gov (United States)

    2013-02-27

    ... From the Federal Register Online via the Government Publishing Office ] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces...

  2. 76 FR 20840 - Medical Devices; General and Plastic Surgery Devices; Classification of the Low Level Laser...

    Science.gov (United States)

    2011-04-14

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 878 Medical Devices; General and Plastic Surgery Devices; Classification of the Low Level Laser System for Aesthetic Use AGENCY: Food and Drug... level laser system for aesthetic use into class II (special controls). The special control(s) that...

  3. EUROPEAN AND INTERNATIONAL STANDARDS ON MEDICAL DEVICES FOR DENTISTRY.

    Directory of Open Access Journals (Sweden)

    Jordan Deliversky

    2015-02-01

    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.

  4. A Review of Simulators with Haptic Devices for Medical Training.

    Science.gov (United States)

    Escobar-Castillejos, David; Noguez, Julieta; Neri, Luis; Magana, Alejandra; Benes, Bedrich

    2016-04-01

    Medical procedures often involve the use of the tactile sense to manipulate organs or tissues by using special tools. Doctors require extensive preparation in order to perform them successfully; for example, research shows that a minimum of 750 operations are needed to acquire sufficient experience to perform medical procedures correctly. Haptic devices have become an important training alternative and they have been considered to improve medical training because they let users interact with virtual environments by adding the sense of touch to the simulation. Previous articles in the field state that haptic devices enhance the learning of surgeons compared to current training environments used in medical schools (corpses, animals, or synthetic skin and organs). Consequently, virtual environments use haptic devices to improve realism. The goal of this paper is to provide a state of the art review of recent medical simulators that use haptic devices. In particular we focus on stitching, palpation, dental procedures, endoscopy, laparoscopy, and orthopaedics. These simulators are reviewed and compared from the viewpoint of used technology, the number of degrees of freedom, degrees of force feedback, perceived realism, immersion, and feedback provided to the user. In the conclusion, several observations per area and suggestions for future work are provided. PMID:26888655

  5. Medical Devices Assess, Treat Balance Disorders

    Science.gov (United States)

    2009-01-01

    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.

  6. 77 FR 35690 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2012-06-14

    ... Internet may obtain the documents at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/default.htm and http://www.fda.gov/MedicalDevices/ProductsandMedical...-0208, FDA- 2012-M-0209, FDA-2012-M-0210, FDA-2012-M-0221, and FDA-2012-M-0250] Medical...

  7. 77 FR 3781 - Pediatric Medical Devices; Public Workshop; Reopening of Comment Period

    Science.gov (United States)

    2012-01-25

    ... data can be used to support pediatric effectiveness claims for medical devices and pediatric device... support pediatric effectiveness claims for medical devices and pediatric device approvals or clearance, 2... HUMAN SERVICES Food and Drug Administration Pediatric Medical Devices; Public Workshop; Reopening...

  8. 76 FR 55394 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices...

    Science.gov (United States)

    2011-09-07

    ... Collection; Comment Request; Medical Devices: Humanitarian Use Devices AGENCY: Food and Drug Administration... of information technology. Medical Devices: Humanitarian Use Devices--21 CFR Part 814 (OMB Control... to grant HUD designation of a medical device; (2) exempt an HUD from the effectiveness...

  9. Development of wearable medical device for Bio-MEMS

    Science.gov (United States)

    Nakanishi, Naoyuki; Yamamoto, Hidetake; Tsuchiya, Kazuyoshi; Uetsuji, Yasutomo; Nakamachi, Eiji

    2006-01-01

    Biomedical Micro Electro Mechanical Systems (Bio-MEMS) have been applied to the development of a variety of health care related products including health Monitoring Systems (HMS) and Drug Delivery Systems (DDS). We focus on research to develop the new type compact medical device used for blood sugar control. The new type compact medical device comprises (1) a micropump system to extract blood using a pressure change occurred by electrolysis, (2) a platinum (Pt) electrode as a blood sugar sensor immobilized Glucose Oxidase (GOx) and attached to the gate electrode of Metal-Oxide-Semiconductor Field Effect Transistor (MOSFET) to detect the amount of glucose in extracted blood, and (3) a micropump system to inject insulin using a pressure change occurred by electrolysis. The device can extract blood in a few microliter through a painless microneedle with the micropump, which used the pressure change occurred by electrolysis. The liquid extraction ability of the micropump system through a microneedle, which is 3.8 mm in length and 100 μm in internal diameter, was measured. The wearable medical device with using the micropump controlled by electrolysis could extract human blood at the speed of 0.15 μl/sec. If the wearable medical device extracts human blood for 6 seconds, it is enough human blood volume to measure a glucose level, compared to the amount of commercial based glucose level monitor. The compact medical device with the air bubble that occurred by electrolysis could inject insulin at the speed of 6.15μl/sec.

  10. Risk evaluation of medical and industrial radiation devices

    International Nuclear Information System (INIS)

    In 1991, the NRC, Division of Industrial and Medical Nuclear Safety, began a program to evaluate the use of probabilistic risk assessment (PRA) in regulating medical devices. This program represents an initial step in an overall plant to evaluate the use of PRA in regulating the use of nuclear by-product materials. The NRC envisioned that the use of risk analysis techniques could assist staff in ensuring that the regulatory approach was standardized, understandable, and effective. Traditional methods of assessing risk in nuclear power plants may be inappropriate to use in assessing the use of by-product devices. The approaches used in assessing nuclear reactor risks are equipment-oriented. Secondary attention is paid to the human component, for the most part after critical system failure events have been identified. This paper describes the risk methodology developed by Lawrence Livermore National Laboratory (LLNL), initially intended to assess risks associated with the use of the Gamma Knife, a gamma stereotactic radiosurgical device. For relatively new medical devices such as the Gamma Knife, the challenge is to perform a risk analysis with very little quantitative data but with an important human factor component. The method described below provides a basic approach for identifying the most likely risk contributors and evaluating their relative importance. The risk analysis approach developed for the Gamma Knife and described in this paper should be applicable to a broader class of devices in which the human interaction with the device is a prominent factor. In this sense, the method could be a prototypical model of nuclear medical or industrial device risk analysis

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

    Science.gov (United States)

    Kusche, Kristopher P

    2009-01-01

    The academic medical center is faced with the unique challenge of meeting the multi-faceted needs of both a modern healthcare organization and an academic institution, The need for security to protect patient information must be balanced by the academic freedoms expected in the college setting. The Albany Medical Center, consisting of the Albany Medical College and the Albany Medical Center Hospital, was challenged with implementing a solution that would preserve the availability, integrity and confidentiality of business, patient and research data stored on mobile devices. To solve this problem, Albany Medical Center implemented a mobile encryption suite across the enterprise. Such an implementation comes with complexities, from performance across multiple generations of computers and operating systems, to diversity of application use mode and end user adoption, all of which requires thoughtful policy and standards creation, understanding of regulations, and a willingness and ability to work through such diverse needs. PMID:19382736

  12. 76 FR 48169 - Advancing Regulatory Science for Highly Multiplexed Microbiology/Medical Countermeasure Devices...

    Science.gov (United States)

    2011-08-08

    ... Microbiology/ Medical Countermeasure Devices; Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION... following public meeting: ``Advancing Regulatory Science for Highly Multiplexed Microbiology/Medical... multiplexed microbiology/medical countermeasure (MCM) devices, their clinical application and public...

  13. 78 FR 63225 - Ear, Nose and Throat Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-10-23

    ... HUMAN SERVICES Food and Drug Administration Ear, Nose and Throat Devices Panel of the Medical Devices... the Medical Devices Advisory Committee. General Function of the Committee: To provide advice and... Commissioner for Special Medical Programs. BILLING CODE 4160-01-P...

  14. Assessment of technical documentation of medical devices for clinical investigation

    NARCIS (Netherlands)

    Roszek B; Bruijn ACP de; Drongelen AW van; Geertsma RE; BMT

    2007-01-01

    The technical documentation on non-market approved medical devices intended for clinical investigation contains major shortcomings. This could imply increased risks which could affect patient safety. The investigation described here focused on the availability and quality of the technical documentat

  15. In vitro biocompatibility testing of biomaterials and medical devices.

    Science.gov (United States)

    Müller, U

    2008-01-01

    Biomaterials used for medical devices must be thoroughly tested according to ISO 10993 before their introduction so that any negative effects on the body are known about and prevented. By using in vitro laboratory tests, dangers for patients and unnecessary animal experiments can be avoided. Here, in vitro tests for cell compatibility (cytotoxicity) and blood compatibility (haemocompatibility) are described. PMID:18605289

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

    CERN Document Server

    Hermawan, Hendra

    2016-01-01

    This book presents an introduction to biomaterials with the focus on the current development and future direction of biomaterials and medical devices research and development in Indonesia. It is the first biomaterials book written by selected academic and clinical experts experts on biomaterials and medical devices from various institutions and industries in Indonesia. It serves as a reference source for researchers starting new projects, for companies developing and marketing products and for governments setting new policies. Chapter one covers the fundamentals of biomaterials, types of biomaterials, their structures and properties and the relationship between them. Chapter two discusses unconventional processing of biomaterials including nano-hybrid organic-inorganic biomaterials. Chapter three addresses biocompatibility issues including in vitro cytotoxicity, genotoxicity, in vitro cell models, biocompatibility data and its related failure. Chapter four describes degradable biomaterial for medical implants...

  17. French Sizing of Medical Devices is not Fit for Purpose

    Energy Technology Data Exchange (ETDEWEB)

    Kibriya, Nabil, E-mail: nabskib@yahoo.co.uk; 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)

    2013-08-01

    PurposeThe purpose of the study is to quantify the variation in the metric equivalent of French size in a range of medical devices, from various manufacturers, used in interventional radiology.MethodsThe labelling of a range of catheters, introducers, drains, balloons, stents, and endografts was examined. Products were chosen to achieve a broad range of French sizes from several manufacturers. To assess manufacturing accuracy, eight devices were selected for measurement using a laser micrometer. The external diameters of three specimens of each device were measured at centimeter intervals along the length of the device to ensure uniformity.ResultsA total of 200 labels of interventional radiology equipment were scrutinized. The results demonstrate a wide variation in the metric equivalent of French sizing. Labelled products can vary in diameter across the product range by up to 0.79 mm.The devices selected for measurement with the non-contact laser micrometer demonstrate acceptable manufacturing consistency. The external diameter differed by 0.05 mm on average.ConclusionsOur results demonstrate wide variation in the interpretation of the French scale by different manufacturers of medical devices. This has the potential to lead to problems using coaxial systems especially when the products are from different manufacturers. It is recommended that standard labelling should be employed by all manufacturers conveying specific details of the equipment. Given the wide variation in the interpretation of the French scale, our opinion is that this scale either needs to be abandoned or be strictly defined and followed.

  18. French Sizing of Medical Devices is not Fit for Purpose

    International Nuclear Information System (INIS)

    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

  19. Research on dose setting for radiation sterilization of medical device

    International Nuclear Information System (INIS)

    Objective: To establish the radiation sterilization dose for medical devices using data of bioburden on the medical device. Methods: Firstly determination of recovery ratio and correction coefficient of the microbiological test method was used according to ISO11737 standard, then determination of bioburden on the products, finally the dose setting was completed based on the Method 1 in ISO11137 standard. Results: Fifteen kinds of medical devices were tested. Bioburden range was from 8.6-97271.2 CFU/device, recovery ration range 54.6%-100%, correction co-efficiency range 1.00-1.83, D10 distribution from 1.40 to 2.82 kGy, verification dose (dose at SAL = 10-2) range 5.1-17.6 kGy and sterilization dose (dose at SAL 10-6) range 17.5-32.5 kGy. Conclusion: One hundred samples of each kind of product were exposed to the pre-determined verification dose and then the sterility test was performed. Each sterility test showed positive number was not greater than two. This indicated that the sterilization dose established for each kind of product was statistically acceptable

  20. Establishing a National Medical Device Registry in Saudi Arabia: Lessons Learned and Future Work.

    Science.gov (United States)

    Al-Surimi, Khaled; Househ, Mowafa; Almohandis, Essam; Alshagathrh, Fahd

    2015-01-01

    Medical device evaluation presents several unique challenges due to the great diversity and complexity of medical devices and their rapid technological evolution. There has been a variety of work conducted on the development of disease based registries and health surveillance systems in Saudi Arabia. However, the progress of medical device registry systems and post-market medical device surveillance systems remains in its infancy in Saudi Arabia and within the region. In 2007, a royal decree assigned the responsibility for regulating medical devices to the Saudi Food and Drug Authority (SFDA). Soon afterwards, the SFDA established the Medical Devices National Registry (MDNR) to house medical device information relating to manufacturers, agents, suppliers and end-users. The aim of this paper is to provide an overview on the Medical Device National Registry (MDNR) in Saudi Arabia and describe the current experience and future work of establishing a comprehensive medical device registry and post-market surveillance system in Saudi Arabia. PMID:26152943

  1. The radiation resistance of the bioburden from medical devices

    International Nuclear Information System (INIS)

    An extensive study of the radiation resistance of microbial species constituting the bioburden of a number of different medical devices obtained from Japanese medical device manufacturers has been carried out. A standard protocol for determining radiation resistance was used and validated at the fourteen centres involved in the study. Individual microbial isolates from the bioburden obtained from seven different devices manufactured in these centres were studied. A total of 3742 unselected isolates were obtained, of which 197 failed to survive long enough for subsequent radiation resistance studies. The remainder were subjected to an initial screen test to identify those organisms that were sensitive to the lethal effects of radiation with a D10 of < 1.5kGy. The 465 isolates that survived the screen doses were then tested for survival in an incremental series of radiation doses using methods similar to those of Whitby (1979) and Yan and Tallentire (1995). The isolates from 'dry' devices were more resistant than those obtained from the one water filled ('wet') device studied. The overall distribution of radiation resistance among the isolates was considered to be similar to that forming the 'Standard Distribution of Resistance' (SDR) included in the ISO International Standard 11137 'Sterilization of Health Care Products - Requirements for validation and routine control - Radiation sterilization'

  2. The radiation resistance of the bioburden from medical devices

    Energy Technology Data Exchange (ETDEWEB)

    Takehisa, M.; Shintani, H.; Sekiguchi, M.; Koshikawa, T.; Oonishi, T.; Tsuge, M.; Sou, K.; Yamase, Y.; Kinoshita, S.; Tsukamoto, H.; Endo, T.; Yashima, K.; Nagai, M.; Ishigaki, K.; Sato, Y.; Whitby, J. L

    1998-06-01

    An extensive study of the radiation resistance of microbial species constituting the bioburden of a number of different medical devices obtained from Japanese medical device manufacturers has been carried out. A standard protocol for determining radiation resistance was used and validated at the fourteen centres involved in the study. Individual microbial isolates from the bioburden obtained from seven different devices manufactured in these centres were studied. A total of 3742 unselected isolates were obtained, of which 197 failed to survive long enough for subsequent radiation resistance studies. The remainder were subjected to an initial screen test to identify those organisms that were sensitive to the lethal effects of radiation with a D{sub 10} of < 1.5kGy. The 465 isolates that survived the screen doses were then tested for survival in an incremental series of radiation doses using methods similar to those of Whitby (1979) and Yan and Tallentire (1995). The isolates from 'dry' devices were more resistant than those obtained from the one water filled ('wet') device studied. The overall distribution of radiation resistance among the isolates was considered to be similar to that forming the 'Standard Distribution of Resistance' (SDR) included in the ISO International Standard 11137 'Sterilization of Health Care Products - Requirements for validation and routine control - Radiation sterilization'.

  3. The radiation resistance of the bioburden from medical devices

    Science.gov (United States)

    Takehisa, M.; Shintani, H.; Sekiguchi, M.; Koshikawa, T.; Oonishi, T.; Tsuge, M.; Sou, K.; Yamase, Y.; Kinoshita, S.; Tsukamoto, H.; Endo, T.; Yashima, K.; Nagai, M.; Ishigaki, K.; Sato, Y.; Whitby, J. L.

    1998-06-01

    An extensive study of the radiation resistance of microbial species constituting the bioburden of a number of different medical devices obtained from Japanese medical device manufacturers has been carried out. A standard protocol for determining radiation resistance was used and validated at the fourteen centres involved in the study. Individual microbial isolates from the bioburden obtained from seven different devices manufactured in these centres were studied. A total of 3742 unselected isolates were obtained, of which 197 failed to survive long enough for subsequent radiation resistance studies. The remainder were subjected to an initial screen test to identify those organisms that were sensitive to the lethal effects of radiation with a D 10 of < 1.5kGy. The 465 isolates that survived the screen doses were then tested for survival in an incremental series of radiation doses using methods similar to those of Whitby (1979) and Yan and Tallentire(1995). The isolates from "dry" devices were more resistant than those obtained from the one water filled ("wet") device studied. The overall distribution of radiation resistance among the isolates was considered to be similar to that forming the "Standard Distribution of Resistance" (SDR) included in the ISO International Standard 11137 "Sterilization of Health Care Products — Requirements for validation and routine control — Radiation sterilization".

  4. 78 FR 50422 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2013-08-19

    ... the documents at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsand...-0724, FDA-2013-M-0738, and FDA-2013-M-0758] Medical Devices; Availability of Safety and Effectiveness...., Docket No. Applicant Trade name Approval date P120016, FDA-2013-M-0592..... Cardiva Medical, Inc....

  5. 75 FR 49502 - Medical Device User Fee Act; Public Meeting; Request for Comments

    Science.gov (United States)

    2010-08-13

    ... provided to help potential meeting participants better understand the history and evolution of the medical... HUMAN SERVICES Food and Drug Administration Medical Device User Fee Act; Public Meeting; Request for... the medical device user fee program. The current legislative authority for the medical device user...

  6. 42 CFR 419.66 - Transitional pass-through payments: Medical devices.

    Science.gov (United States)

    2010-10-01

    ... devices. (a) General rule. CMS makes a pass-through payment for a medical device that meets the... 42 Public Health 3 2010-10-01 2010-10-01 false Transitional pass-through payments: Medical devices.... (3) Except for medical devices identified in paragraph (e) of this section, CMS determines the...

  7. The role of the user within the medical device design and development process: medical device manufacturers' perspectives

    Directory of Open Access Journals (Sweden)

    Craven Michael P

    2011-02-01

    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

  8. Ethics considerations for medical device R&D.

    Science.gov (United States)

    Citron, Paul

    2012-01-01

    Medical devices have emerged as an important clinical option to treat certain serious diseases for which there are no equivalently effective surgical or pharmaceutical alternatives. Although all clinical activities impose high ethical standards of comportment to protect patients, medical device R&D and product application have a number of relatively unique aspects that distinguish them from other technologies such as pharmaceuticals. These include the following: R&D project selection; regulatory requirements, and their intended and unintended effects; when is a new product design sufficiently safe and effective for routine use in patients; and, physician-industry relationships in the innovation process in the context of real or perceived conflict of interest (COI). Each of these factors has implications for the delivery of care, health care leadership, and patient well-being. PMID:23217435

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

    Science.gov (United States)

    Zhang, Fei; Hackworth, Steven A; Liu, Xiaoyu; Chen, Haiyan; Sclabassi, Robert J; Sun, Mingui

    2009-01-01

    Witricity is a newly developed technique for wireless energy transfer. This paper presents a frequency adjustable witricity system to power medical sensors and implantable devices. New witricity resonators are designed for both energy transmission and reception. A prototype platform is described, including an RF power source, two resonators with new structures, and inductively coupled input and output stages. In vitro experiments, both in open air and using a human head phantom consisting of simulated tissues, are employed to verify the feasibility of this platform. An animal model is utilized to evaluate in vivo energy transfer within the body of a laboratory pig. Our experiments indicate that witricity is an effective new tool for providing a variety of medical sensors and devices with power. PMID:19964948

  10. A security assurance framework for networked medical devices

    OpenAIRE

    Finngegan, Anita; Mc Caffery, Fergal; Coleman, Gerry

    2013-01-01

    peer-reviewed This paper presents work for the development of a framework to assure the security of networked medical devices being incorporated. The paper focuses on one component of the framework, which addresses system development processes, and the assurance of these through the use of a Process Assessment Model with a major focus on the security risk management process. With the inclusion of a set of specific security controls and assurance processes, the purpose is to increase awaren...

  11. Balancing Agility and Discipline in a Medical Device Software Organisation

    OpenAIRE

    Mc Hugh, Martin; McCaffery, Fergal; Fitzgerald, Brian; Stol, Klass-Jan; COADY, Garret; Casey, Valentine

    2013-01-01

    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...

  12. Development of nanotoxicology: implications for drug delivery and medical devices

    OpenAIRE

    Bhattacharjee, S.; Brayden, David James

    2015-01-01

    Current nanotoxicology research suffers from suboptimal in vitro models, lack of in vitro–in vivo correlations, variability within in vitro protocols, deficits in both material purity and physicochemical characterization. Reliable nanomaterial toxicity and mechanistic insights are required for health and toxicity risk assessments. Much in vitro toxicological data is inconclusive in designating whether nanomaterials for drug delivery and medical device implants are truly safe. A critique is pr...

  13. PROMOTING BREAKTHROUGH MEDICAL INNOVATION: INSIGHTS FROM AN ANALYSIS OF RECENT TRANSFORMATIVE DRUGS, BIOLOGICS AND MEDICAL DEVICES

    OpenAIRE

    Xu, Shuai

    2014-01-01

    Given the recent concern from multiple healthcare stakeholders that the pipeline of medical innovation is slowing, this thesis provides insights on how to spur breakthrough medical innovation in present day. The findings and recommendations are derived from one of the largest collections of interview transcripts from biomedical innovators (n=143) responsible for developing critical devices, drugs and diagnostics used in medicine today. An exemplary case (coronary artery stent) was selected ...

  14. Antimicrobial selenium nanoparticle coatings on polymeric medical devices

    Science.gov (United States)

    Tran, Phong A.; Webster, Thomas J.

    2013-04-01

    Bacteria colonization on medical devices remains one of the most serious complications following implantation. Traditional antibiotic treatment has proven ineffective, creating an increasingly high number of drug-resistant bacteria. Polymeric medical devices represent a significant portion of the total medical devices used today due to their excellent mechanical properties (such as durability, flexibility, etc). However, many polymers (such as polyvinyl chloride (PVC), polyurethane (PU) and silicone) become readily colonized and infected by bacteria immediately after use. Therefore, in this study, a novel antimicrobial coating was developed to inhibit bacterial growth on PVC, PU and silicone. Specifically, here, the aforementioned polymeric substrates were coated with selenium (Se) nanoparticles in situ. The Se-coated substrates were characterized using scanning electron microscopy, energy dispersive x-ray spectroscopy and bacteria assays. Most importantly, bacterial growth was significantly inhibited on the Se-coated substrates compared to their uncoated counterparts. The reduction of bacteria growth directly correlated with the density of Se nanoparticles on the coated substrate surfaces. In summary, these results demonstrate that Se should be further studied as a novel anti-bacterial polymeric coating material which can decrease bacteria functions without the use of antibiotics.

  15. Antimicrobial selenium nanoparticle coatings on polymeric medical devices

    International Nuclear Information System (INIS)

    Bacteria colonization on medical devices remains one of the most serious complications following implantation. Traditional antibiotic treatment has proven ineffective, creating an increasingly high number of drug-resistant bacteria. Polymeric medical devices represent a significant portion of the total medical devices used today due to their excellent mechanical properties (such as durability, flexibility, etc). However, many polymers (such as polyvinyl chloride (PVC), polyurethane (PU) and silicone) become readily colonized and infected by bacteria immediately after use. Therefore, in this study, a novel antimicrobial coating was developed to inhibit bacterial growth on PVC, PU and silicone. Specifically, here, the aforementioned polymeric substrates were coated with selenium (Se) nanoparticles in situ. The Se-coated substrates were characterized using scanning electron microscopy, energy dispersive x-ray spectroscopy and bacteria assays. Most importantly, bacterial growth was significantly inhibited on the Se-coated substrates compared to their uncoated counterparts. The reduction of bacteria growth directly correlated with the density of Se nanoparticles on the coated substrate surfaces. In summary, these results demonstrate that Se should be further studied as a novel anti-bacterial polymeric coating material which can decrease bacteria functions without the use of antibiotics. (paper)

  16. Campaign to gather medical devices containing radium: results

    International Nuclear Information System (INIS)

    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 1011 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)

  17. Regulation E 69-14. Monitoring requirements for medical devices

    International Nuclear Information System (INIS)

    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.

  18. 77 FR 19534 - Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus Serological...

    Science.gov (United States)

    2012-04-02

    ..., HHS. ACTION: Final rule; correction. SUMMARY: In the Federal Register of March 9, 2012 (76 FR 14272..., 301- 796-6694. SUPPLEMENTARY INFORMATION: In FR Doc. 2012-5675 appearing on page 14272 in the Federal... HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 Medical Devices; Immunology and...

  19. 75 FR 57968 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2010-09-23

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Gastroenterology and Urology Devices Panel of the Medical... Administration (FDA). The meeting will be open to the public. Name of Committee: Gastroenterology and...

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

    Science.gov (United States)

    2012-03-28

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Gastroenterology and Urology Devices Panel of the Medical... Administration (FDA). The meeting will be open to the public. Name of Committee: Gastroenterology and...

  1. 77 FR 38177 - TRICARE; Off-Label Uses of Devices; Partial List of Examples of Unproven Drugs, Devices, Medical...

    Science.gov (United States)

    2012-06-27

    ... Examples of Unproven Drugs, Devices, Medical Treatments, or Procedures AGENCY: Office of the Secretary..., and medical treatments or procedures proscribed in TRICARE regulations. We are removing the partial...) clarifying the TRICARE exclusion of unproven drugs, devices, and medical treatments or procedures and...

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

    Science.gov (United States)

    Bachmor, T; Schöchlin, J; Bolz, A

    2002-01-01

    Equipping medical devices with long range telemetry opens completely new possibilities for emergency response, home care and remote diagnosis. Mobile communications nowadays seem to be a generally accepted part of our modern world, but bridging the gap between new (consumer-) technologies and medical devices still is a challenge today. Providing a telemetry link (GSM) is just the trivial part--ensuring security, reliability and service management are the more critical tasks that need to be addressed. Therefore, a complete system concept consists of an automatic fleet management (e.g. periodic device-initiated service calls) as well as customer relationship management (CRM), including technical service and a trouble-ticket system. PMID:12451860

  3. 75 FR 51829 - Public Workshop on Medical Devices and Nanotechnology: Manufacturing, Characterization, and...

    Science.gov (United States)

    2010-08-23

    ... HUMAN SERVICES Food and Drug Administration Public Workshop on Medical Devices and Nanotechnology...) is announcing a public workshop entitled ``Medical Devices & Nanotechnology: Manufacturing....htm (select the appropriate meeting from the list). Registrants must provide the following...

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

    Science.gov (United States)

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

    2009-12-01

    The improvised explosive device (IED), in all its forms, has become the most significant threat to troops operating in Afghanistan and Iraq. These devices range from rudimentary home made explosives to sophisticated weapon systems containing high-grade explosives. Within this broad definition they may be classified as roadside explosives and blast mines, explosive formed pojectile (EFP) devices and suicide bombings. Each of these groups causeinjury through a number of different mechanisms and can result in vastly different injury profiles. The "Global War on Terror" has meant that incidents which were previously exclusively seen in conflict areas, can occur anywhere, and clinicians who are involved in emergency trauma care may be required to manage casualties from similar terrorist attacks. An understanding of the types of devices and their pathophysiological effects is necessary to allow proper planning of mass casualty events and to allow appropriate management of the complex poly-trauma casualties they invariably cause. The aim of this review article is to firstly describe the physics and injury profile from these different devices and secondly to present the current clinical evidence that underpins their medical management. PMID:20397601

  5. The effects of cosmic radiation on implantable medical devices

    International Nuclear Information System (INIS)

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

  6. The effects of cosmic radiation on implantable medical devices

    Energy Technology Data Exchange (ETDEWEB)

    Bradley, P. [Wollongong Univ., NSW (Australia)

    1996-12-31

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

  7. A software process development,assessment and improvement framework,for the medical device industry

    OpenAIRE

    Mc Caffery, Fergal; Donnelly, Peter; Dorling, Alec; Wilkie, F.G.

    2004-01-01

    peer-reviewed This paper describes a software process development, assessment and improvement framework, structured to ensure regulatory compliance for the software developed in medical devices. Software is becoming an increasingly important aspect of medical devices and medical device regulation. Medical devices can only be marketed if compliance and approval from the appropriate regulatory bodies of the Food and Drug Administration (US requirement), and the European Commission under its ...

  8. OR.NET - Approaches for Risk Analysis and Measures of Dynamically Interconnected Medical Devices

    OpenAIRE

    Kühn, Franziska; Leucker, Martin; Mildner, Alexander

    2014-01-01

    Nowadays, it lacks an open, standardized and dynamic interconnection of medical devices. All existing combinations of medical devices consist of isolated solutions with proprietary interfaces, as no common standards for networking and the exchange of data of medical devices exist. This situation leads to confusing operating rooms and inefficient operations. Thus, new strategies need to be developed for the authorization of dynamically interconnected medical devices. Primarily, those concern ...

  9. [The management of implantable medical device and the application of the internet of things in hospitals].

    Science.gov (United States)

    Zhou, Li; Xu, Liang

    2011-11-01

    Implantable medical device is a special product which belongs to medical devices. It not only possesses product characteristics in common, but also has specificity for safety and effectiveness. Implantable medical device must be managed by the relevant laws and regulations of the State Food and Drug Administration. In this paper, we have used cardiac pacemakers as an example to describe the significance of the management of implantable medical device products and the application of the internet of things in hospitals. PMID:22379772

  10. Semantic interoperability of ambient intelligent medical devices and e-health systems

    OpenAIRE

    Ali, Safdar

    2010-01-01

    State-of-the-art mobile medical devices provide important therapeutic functions with valuable information of treatment patterns at the point-of-care. However, such devices mostly remain independent islands of information being unable to share the medical data they gather with other medical devices, hospital information system or laboratory information system on a real-time basis. Standards organizations such as IEEE have made various attempts to resolve the medical devices' interoperability p...

  11. On the evaluation of the safety aspects of nanomaterials in medical devices – a regulatory perspective

    OpenAIRE

    Wu, Eva; Chan, Christopher; Li, Albert

    2013-01-01

    Nanotechnology is widely used in many aspects of the design and manufacture of medical devices. To date, many of these new medical devices, referred to as nano medical devices, have been submitted to health authorities for premarket regulatory review. There are ongoing discussions between medical device manufacturers and regulatory authorities regarding the standards and methods required for the evaluation process. Taking into consideration aspects including nano-toxicology and biocompatibili...

  12. Power sources and electrical recharging strategies for implantable medical devices

    Institute of Scientific and Technical Information of China (English)

    Xiaojuan WEI; Jing LIU

    2008-01-01

    Implantable medical devices (IMDs) are crit-ically requested for the survival of patients subject to certain serious diseases such as bradycardia, fibrillation, diabetes, and disability, etc. Appropriate working of an active implantable medical device (IMD) heavily relies on the continuous supply of electricity. In this sense, long-term powering and recharging of an IMD via a highly safe, efficient and convenient way is, therefore, extremely important in clinics. Several conventional batteries, such as lithium cell, nuclear cell and bio-fuel cell, etc., have been developed to power IMDs. Meanwhile, the recharge of IMD from outside of the human body is also under investigation. In this paper, some of the most typical IMD batteries are reviewed. Their advantages and disadvantages are compared. In addition, several emer-ging innovations to recharge or directly drive the implanted batteries, including electromagnetic energy transmission, piezoelectric power generation, thermoelec-tric devices, ultrasonic power motors, radio frequency recharging and optical recharging methods, etc., are also discussed. Some fundamental and practical issues thus involved are summarized, and future prospects in this area are made.

  13. Fracture prediction of cardiac lead medical devices using Bayesian networks

    International Nuclear Information System (INIS)

    A novel Bayesian network methodology has been developed to enable the prediction of fatigue fracture of cardiac lead medical devices. The methodology integrates in-vivo device loading measurements, patient demographics, patient activity level, in-vitro fatigue strength measurements, and cumulative damage modeling techniques. Many plausible combinations of these variables can be simulated within a Bayesian network framework to generate a family of fatigue fracture survival curves, enabling sensitivity analyses and the construction of confidence bounds on reliability predictions. The method was applied to the prediction of conductor fatigue fracture near the shoulder for two market-released cardiac defibrillation leads which had different product performance histories. The case study used recently published data describing the in-vivo curvature conditions and the in-vitro fatigue strength. The prediction results from the methodology aligned well with the observed qualitative ranking of field performance, as well as the quantitative field survival from fracture. This initial success suggests that study of further extension of this method to other medical device applications is warranted. - Highlights: • A new method to simulate the fatigue experience of an implanted cardiac lead. • Fatigue strength and use conditions are incorporated within a Bayesian network. • Confidence bounds reflect the uncertainty in all input parameters. • A case study is presented using market released cardiac leads

  14. Mechanism of controlled release kinetics from medical devices

    Directory of Open Access Journals (Sweden)

    A. Raval

    2010-06-01

    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.

  15. 21 CFR 801.150 - Medical devices; processing, labeling, or repacking.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices; processing, labeling, or repacking. 801.150 Section 801.150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Other Exemptions § 801.150 Medical devices; processing, labeling, or repacking. (a) Except...

  16. 21 CFR 801.15 - Medical devices; prominence of required label statements.

    Science.gov (United States)

    2010-04-01

    ... 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 SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.15 Medical devices; prominence of required label statements....

  17. 21 CFR 801.116 - Medical devices having commonly known directions.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices having commonly known directions. 801.116 Section 801.116 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions From Adequate Directions for Use § 801.116 Medical devices having commonly known...

  18. 31 CFR 560.533 - Brokering sales of agricultural commodities, medicine, and medical devices.

    Science.gov (United States)

    2010-07-01

    ... 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...

  19. 31 CFR 538.526 - Brokering sales of agricultural commodities, medicine, and medical devices.

    Science.gov (United States)

    2010-07-01

    ... 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...

  20. 21 CFR 801.5 - Medical devices; adequate directions for use.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices; adequate directions for use. 801.5 Section 801.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.5 Medical devices; adequate directions for use. Adequate directions for...

  1. 76 FR 22805 - Medical Devices; Reclassification of the Topical Oxygen Chamber for Extremities

    Science.gov (United States)

    2011-04-25

    ... Amendments of 1976 (the 1976 Amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the Food and... specific medical devices under 21 U.S.C. 360k, even though product sponsors have some flexibility in how... guidance. List of Subjects in 21 CFR Part 878 Medical devices. Therefore, under the Federal Food, Drug,...

  2. 76 FR 74789 - Scientific Information Request on Pressure Ulcer Treatment Medical Devices

    Science.gov (United States)

    2011-12-01

    ... Ulcer Treatment Medical Devices AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS. ACTION... medical devices, such as (but not limited to): Ultrasonic wound care systems, negative pressure therapy... systematically requesting information (e.g., details of studies conducted) from medical device...

  3. 76 FR 77834 - Scientific Information Request on Intravascular Diagnostic and Imaging Medical Devices

    Science.gov (United States)

    2011-12-14

    ... Intravascular Diagnostic and Imaging Medical Devices AGENCY: Agency for Healthcare Research and Quality (AHRQ... intravascular diagnostic and imaging medical devices, including: Fractional Flow Reserve (FFR), Coronary Flow... medical devices, including those that describe adverse events, as specified in the key questions...

  4. 76 FR 36989 - Medical Devices; Exception From General Requirements for Informed Consent

    Science.gov (United States)

    2011-06-24

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 50 Medical Devices; Exception From General... interim final rule (IFR) entitled ``Medical Devices; Exception From General Requirements for Informed... medical devices under 21 U.S.C. 360k. Papike v. Tambrands, Inc., 107 F.3d 737, 740-42 (9th Cir. 1997)....

  5. 75 FR 58414 - Dental Products Panel of the Medical Devices Advisory Committee; Amendment of Notice

    Science.gov (United States)

    2010-09-24

    ... HUMAN SERVICES Food and Drug Administration Dental Products Panel of the Medical Devices Advisory... Medical Devices Advisory Committee. This meeting was announced in the Federal Register of June 11, 2010... announced that a meeting of the Dental Products Panel of the Medical Devices Advisory Committee would...

  6. 78 FR 12067 - Extreme Weather Effects on Medical Device Safety and Quality

    Science.gov (United States)

    2013-02-21

    ... HUMAN SERVICES Food and Drug Administration Extreme Weather Effects on Medical Device Safety and Quality... medical device safety and quality. FDA is announcing at this time its request for comments on the topic of extreme weather effects on medical device safety and quality. DATES: Submit either electronic or...

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

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices; Spanish-language version of certain required statements. 801.16 Section 801.16 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.16 Medical devices; Spanish-language version...

  8. 78 FR 41065 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices...

    Science.gov (United States)

    2013-07-09

    ... appropriate, and other forms of information technology. Medical Devices; Third-Party Review Under FDAMA--21 U... Collection; Comment Request; Medical Devices; Third-Party Review Under the Food and Drug Administration... with medical devices third-party review under the Food and Drug Administration Modernization Act...

  9. Development of bacterially resistant polyurethane for coating medical devices

    International Nuclear Information System (INIS)

    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.

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

    Science.gov (United States)

    Donovan, Aine; Kaplan, Aaron V

    2012-01-01

    The past fifty years has witnessed dramatic progress in the understanding and treatment of patients suffering from cardiovascular disease leading to symptomatic relief and impressive increases in longevity. These advances have been due in large part to the development, study and implementation of new technology. Within interventional cardiology in particular, these advances have been driven by the availability of new technology in the form of medical devices. Successful device development efforts require close collaboration among basic scientist, clinician-inventors/entrepreneurs, clinician-investigators and corporations. Though the role of the clinician is central to this process, these activities present important conflicts-of-interest (COIs). The purpose of this paper is to 1) characterize these conflicts, 2) provide a context from which to approach their management and 3) recommend management strategies. PMID:23217436

  11. Development of medical electronic devices in the APL space department

    Science.gov (United States)

    Newman, A. L.

    1985-01-01

    Several electronic devices for automatically correcting specific defects in a body's physiologic regulation and allowing approximately normal functioning are described. A self-injurious behavior inhibiting system (SIBIS) is fastened to the arm of a person with chronic self-injurious behavior patterns. An electric shock is delivered into the arm whenever the device senses above-threshold acceleration of the head such as occur with head-bangers. Sounding a buzzer tone with the shock eventually allows transference of the aversive stimulus to the buzzer so shocks are no longer necessary. A programmable implantable medication system features a solenoid pump placed beneath the skin and refueled by hypodermic needle. The pump functions are programmable and can deliver insulin, chemotherapy mixes and/or pain killers according to a preset schedule or on patient demand. Finally, an automatic implantible defibrillator has four electrodes attached directly to the heart for sensing electrical impulses or emitting them in response to cardiac fibrillation.

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

    International Nuclear Information System (INIS)

    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/ cm3 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)

  13. El Centro de Cardioestimuladores del Uruguay. CCC Medical Devices

    OpenAIRE

    Pablo Darscht

    2011-01-01

    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 e...

  14. 78 FR 21612 - Medical Device Classification Product Codes; Guidance for Industry and Food and Drug...

    Science.gov (United States)

    2013-04-11

    ...The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Medical Device Classification Product Codes.'' This document describes how device product codes are used in a variety of FDA program areas to regulate and track medical devices regulated by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research......

  15. FEM used in improvement of quality of medical devices

    Directory of Open Access Journals (Sweden)

    B. Ziębowicz

    2010-07-01

    Full Text Available Purpose: The fundamental aim of this research was to determine the biomechanical characteristics of the medical bed made of carbon steel and an assessment of its stability. To define the biomechanical characteristics of the bed design, the finite element method (FEM was applied. Additionally, the risk analysis was conducted according to the directives of ISO 14971 standard.Design/methodology/approach: The research was carried out on the typical rehabilitation bed. To define the biomechanical characteristics of this equipment, the finite element method was applied. Geometric model of medical bed, was discretized by means of SOLID 95 element. Appropriate boundary conditions imitating phenomena in the real system with appropriate accuracy were established. The aim of biomechanical analysis was calculation of displacements and stresses in the bed’s construction elements in a function of the applied loading. In order to carry out calculations, 3 models of diverse variants of loading were selected – safe working load - model 1, transverse stability - model 2 and longitudinal stability - model 3.Findings: The analyses showed the difference in displacements, strains and stresses in the characteristic points depending on the selected loading. That also helped to determine maximal loading causing the exceeding of the yield stress of the bed’s components.Research limitations/implications: The limitations were connected with simplification of numerical model of femur as well as with the selected boundary conditions.Practical implications: The obtained results can be useful in the designing process (modification of requirements regarding design and construction, as well as materials used in the production of the device, and reduction of risk as far as possible to the patient. They prove that 3D geometrical analysis works quite well for assistive medical devices design.Originality/value: Stress-strain-displacement characteristics of the medical bed

  16. Safety and cleaning of medical materials and devices.

    Science.gov (United States)

    Merritt, K; Hitchins, V M; Brown, S A

    2000-01-01

    A study was undertaken to evaluate different procedures to safely remove microorganisms, protein, and mammalian cells from materials and provide a suitable method for cleaning and assessing effectiveness of cleaning medical devices for reuse or for analysis of failure. Safety considerations for the personnel performing the cleaning or handling the device after cleaning are important issues. Polystyrene plates (96 well) were used to simulate device surfaces not amenable to manual scrubbing. Staphylococcus epidermidis, Candida albicans, Escherichia coli, Pseudomonas aeruginosa, and oral flora were grown in the plates. The plates were stained with crystal violet and the optical densities recorded. The results indicated that E. coli did not adhere well and Pseudomonas formed clumps that were easily detached from the surface of the plates. However, S. epi, C. albicans, and the oral organisms formed adherent biofilms that were difficult to remove from the plates. Detergents with enzymes and sodium hypochlorite (NaOCl) bleach were both effective in removing the biofilm. Other detergents and surfactants were not effective. The aldehyde agents did not remove the organisms and made further cleaning difficult. Allowing the biofilm to dry first made cleaning very difficult. Only the NaOCl bleach could subsequently remove the dried or aldehyde fixed organisms from the wells. The same 96-well polystyrene plate format was used to measure the amount of protein and cell adherence as well as the effectiveness of subsequent cleaning. Bradford reagent was used to detect protein as a measure of the cleaning efficacy. As with the bacteria, NaOCl bleach was effective at removing the protein and cells that had been dried or fixed by formalin or alcohol, whereas detergent with enzymes was not very effective. This study confirmed that used medical devices, contaminated with microorganisms, protein, and/or mammalian cells, should not be allowed to dry before cleaning and that a thorough

  17. Practical pathology perspectives for minimally invasive hyperthermic medical devices

    Science.gov (United States)

    Coad, James E.

    2011-03-01

    Currently, hyperthermic-based minimally invasive medical devices are available for the treatment of dysfunctional and neoplastic tissues in a variety of organ systems. These therapies employ a spectrum of modalities for delivering heat energy to the targeted tissue, including radiofrequency/microwave, high intensity focused ultrasound, conductive/convective sources and others. While differences in energy transfer and organ systems exist, hyperthermic treatment sites show a spectrum of changes that intimately correlate with the thermal history generated in the tissue (temperature-time dependence). As a result, these hyperthermic medical technologies can be viewed using a "gradient" approach. First, the thermal applications themselves can be globally categorized along a high-dose ablation to low-dose ablation to lowdose non-ablative rejuvenating slope. Second, the resultant tissue changes can be viewed along a decreasing thermal dose gradient from thermally/heat-fixed tissue necrosis to coagulative tissue necrosis to partial tissue necrosis (transition zone) to subtle non-necrotizing tissue changes. Finally, a gradient of cellular and structural protein denaturation is present, especially within the transition zone and adjacent viable tissue region. A hyperthermic treatment's location along these gradients depends more on the overall thermal history it generates than the amount of energy it deposits into the tissue. The features of these gradients are highlighted to provide a better understanding of hyperthermic device associated tissue changes and their associated healing responses.

  18. Effectiveness of adverse effects search filters: drugs versus medical devices

    Science.gov (United States)

    Farrah, Kelly; Mierzwinski-Urban, Monika; Cimon, Karen

    2016-01-01

    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. PMID:27366123

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

    Directory of Open Access Journals (Sweden)

    Burgess LJ

    2011-09-01

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

  20. Medical devices in India: a perspective of guidelines and the way forward

    Directory of Open Access Journals (Sweden)

    Sandeep Sewlikar

    2014-10-01

    Full Text Available In recent times, emerging countries including India have become favored destination for medical device companies to leverage the growth opportunities. However, the Indian regulatory system is not ready to meet the challenges that may come up with growing medical device business. It needs major amendments to current Drugs and Cosmetic Act 1940, to include medical device as a separate entity. Like in developed world, the challenges could be addressed by defining medical devices, risk based classification of devices, guidelines for device safety surveillance, and clinical trials for medical devices. Drugs and Cosmetic (Amendment Bill 2013, which is yet to be released has addressed the concerns to some extent. However, it needs a major revamp to establish effective regulatory framework for medical devices. [Int J Basic Clin Pharmacol 2014; 3(5.000: 764-767

  1. 75 FR 47606 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2010-08-06

    ... HUMAN SERVICES Food and Drug Administration General and Plastic Surgery Devices Panel of the Medical.... ACTION: Notice. SUMMARY: The meeting of the General and Plastic Surgery Devices Panel of the Medical... Federal Register of June 24, 2010 (75 FR 36102). The meeting is postponed so that FDA can review...

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

    Science.gov (United States)

    Matsuoka, Atsuko

    2012-01-01

    In the market of medical devices, non-Japanese products hold a large part even in Japan. To overcome this situation, the Japanese government has been announcing policies to encourage the medical devices industry, such as the 5-year strategy for medical innovation (June 6, 2012). The Division of Medical Devices has been contributing to rapid marketing of medical devices by working out the standards for approval review and accreditation of medical devices, guidances on evaluation of medical devices with emerging technology, and test methods for biological safety evaluation of medical devices, as a part of practice in the field of regulatory science. The recent outcomes are 822 standards of accreditation for Class II medical devices, 14 guidances on safety evaluation of medical devices with emerging technology, and the revised test methods for biological safety evaluation (MHLW Notification by Director, OMDE, Yakushokuki-hatsu 0301 No. 20 "Basic Principles of Biological Safety Evaluation Required for Application for Approval to Market Medical Devices"). PMID:23243983

  3. 76 FR 42713 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...

    Science.gov (United States)

    2011-07-19

    ... General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee. This meeting was announced in the Federal Register of July 7, 2011 (76 FR 39882). The amendment is being made to reflect a... HUMAN SERVICES Food and Drug Administration General and Plastic Surgery Devices Panel of the...

  4. 75 FR 61507 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...

    Science.gov (United States)

    2010-10-05

    ... General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee. This meeting was announced in the Federal Register of August 16, 2010 (75 FR 49940). The amendment is being made to reflect a... HUMAN SERVICES Food and Drug Administration General and Plastic Surgery Devices Panel of the...

  5. Which barriers prevent the efficient use of resources in medical device sectors?

    Science.gov (United States)

    Simoens, Steven

    2009-01-01

    This article aims to examine barriers to the efficient use of resources relating to medical devices, by focusing specifically on an economic analysis of the market structure of medical devices and on the assessment procedures for medical devices. A desktop analysis was conducted of the health economic literature relating to both of these aspects. This information was structured and analysed with a view to identifying and discussing the major issues that may threaten the efficient use of medical devices. Medical device sectors do not tend to operate as perfectly competitive markets because of the presence of heterogeneous products, information asymmetry and a restricted number of manufacturers. There is a need for government intervention to keep prices down, restrict public reimbursement and promote an efficient use of medical devices. Assessment procedures governing pricing and reimbursement of medical devices are lacking, are in development, or have only recently been established in the majority of developed countries. There is limited transparency and less formal attention of decision makers to assessment of the efficient use of resources in medical device sectors as compared with medicines. In conclusion, there is a need for more studies exploring the safety, effectiveness, cost effectiveness and budget impact of medical devices, so that decision makers can make informed pricing and reimbursement decisions based on objective analyses. Additionally, there is a need for more formal assessment systems for medical devices. PMID:19905034

  6. 76 FR 16350 - Medical Devices; Ovarian Adnexal Mass Assessment Score Test System; Labeling; Black Box Restrictions

    Science.gov (United States)

    2011-03-23

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 Medical Devices; Ovarian Adnexal Mass..., Medical devices. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated... warning in labeling and advertising by restricting the device under section 520(e) of the Federal...

  7. 78 FR 41069 - Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Food and Drug...

    Science.gov (United States)

    2013-07-09

    ...The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Medical Device Reporting for Manufacturers.'' This draft guidance describes and explains the current FDA regulation that addresses reporting and recordkeeping requirements applicable to manufacturers of medical devices for certain device-related adverse events. This draft guidance is intended......

  8. Association of Medical Students' Reports of Interactions with the Pharmaceutical and Medical Device Industries and Medical School Policies and Characteristics: A Cross-Sectional Study

    OpenAIRE

    Yeh, James S.; Austad, Kirsten E.; Franklin, Jessica M; Susan Chimonas; Eric G Campbell; Jerry Avorn; Kesselheim, Aaron S.

    2014-01-01

    Editors' Summary Background Making and selling prescription drugs and medical devices is big business. To promote their products, pharmaceutical and medical device companies build relationships with physicians by providing information on new drugs, by organizing educational meetings and sponsored events, and by giving gifts. Financial relationships begin early in physicians' careers, with companies providing textbooks and other gifts to first-year medical students. In medical school settings,...

  9. Counterfeit drugs and medical devices in developing countries

    Directory of Open Access Journals (Sweden)

    Glass BD

    2014-03-01

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

  10. 21 CFR 803.15 - How will I know if you require more information about my medical device report?

    Science.gov (United States)

    2010-04-01

    ... about my medical device report? 803.15 Section 803.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE REPORTING General Provisions § 803.15 How will I know if you require more information about my medical device report? (a)...

  11. A United States Market Entry Analysis for a New Medical Device

    OpenAIRE

    Doerfling, Paul; Inouye, Sarah; Poznanski, Leon

    2008-01-01

    This report provides an analysis of the market opportunities for a medical device developed by io, a New Zealand based company. The device simulates a high altitude, low oxygen environment to encourage the body to develop more red blood cells. Potential medical benefits derived from anecdotal sources have encouraged the company to begin clinical trials to determine efficacy as a medical device. Before committing to a beachhead market, io is interested in understanding the business opportuniti...

  12. 78 FR 35940 - Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; Draft...

    Science.gov (United States)

    2013-06-14

    ... premarket submissions to provide effective cybersecurity management and to reduce the risk that device... Submissions for Management of Cybersecurity in Medical Devices.'' This guidance identifies cybersecurity... draft guidance document entitled ``Content of Premarket Submissions for Management of Cybersecurity...

  13. A process assessment model for security assurance of networked medical devices

    OpenAIRE

    Finnegan, Anita; Mc Caffery, Fergal; Coleman, Gerry

    2013-01-01

    peer-reviewed The recent introduction of networked medical devices has posed many benefits for both the healthcare industry and improved patient care. However, because of the complexity of these devices, in particular the advanced communication ability of these devices, security is becoming an increasing concern. This paper presents work to develop a framework to assure the security of medical devices being incorporated into an IT network. It begins by looking at the development processes ...

  14. Devices for medical diagnosis with GaN lasers

    Science.gov (United States)

    Kwasny, Miroslaw; Mierczyk, Zygmunt

    2003-10-01

    This paper presents laser-induced fluroescence method (LIF) employing endogenous ("autofluroescence") and exogenous fluorophores. LIF is applied for clinical diagnosis in dermatology, gynaecology, urology, lung tumors as well as for early dentin caries. We describe the analysers with He-Ne, He-Cd, and SHG Nd:YAG lasers and new generation systems based on blue semiconductor GaN lasers that have been implemented into clinical practice till now. The LIF method, fundamental one for many medical applications, with excitation radiation of wavelength 400 nm could be appl,ied only using tunable dye lasers or titanium lasers adequte for laboratory investigations. Development of GaN laser shows possibility to design portable, compact diagnostic devices as multi-channel analysers of fluorescence spectra and surface imaging devoted to clinical application. The designed systems used for spectra measurement and registration of fluorescence images include lasers of power 5-30 mW and generate wavelengths of 405-407 nm. They are widely used in PDT method for investigation of superficial distribution of accumulation kinetics of all known photosensitizers, their elimination, and degradation as well as for treatment of superficial lesions of mucosa and skin. Excitation of exogenous porphrins in Soret band makes possible to estimate their concentration and a period of healthy skin photosensitivity that occurs after photosensitiser injections. Due to high sensitivity of spectrum analysers, properties of photosensitisers can be investigated in vitro (e.g. their aggregation, purity, chromatographic distributions) when their concentrations are 2-3 times lower in comparison to concentrations investigated with typical spectrofluorescence methods. Dentistry diagnosis is a new field in which GaN laser devices can be applied. After induction with blue light, decreased autofluorescence intensity can be observed when dentin caries occur and strong characteristic bands of endogenous porphyrines

  15. National Transuranic Program Charter

    International Nuclear Information System (INIS)

    The National Transuranic Program Plan and Charter describes the functional elements of the National TRU Program, organizational relationships, programmatic responsibilities, division of work scope among the various DOE organizations that comprise the program, and program baselines against which overall progress will be measured. The charter defines the authorities and responsibilities of various organizations involved in the management of TRU waste throughout the DOE complex

  16. The Style Evolution of Glasses: Acknowledging Well-being for Wearable Medical Device

    Directory of Open Access Journals (Sweden)

    Lydia Royeen

    2015-10-01

    Full Text Available The focus of Peta Bush’s work is to create wearable medical devices that address all qualities of the individual, including physical, mental, emotional, and psychosocial aspects. Peta is completing a practice-based research PhD titled “Therapeutic jewelry: The craft of people-centric devices for wellbeing.” Her passion for creating wearable medical devices that are multi-dimensional stems from her personal experiences, as she has Ehlers-Danlos syndrome. In addition, she uses her knowledge of well-being and the biopsychosocial model when creating her wearable medical devices. Peta currently uses technology, such as 3D printing, as one method to fabricate her collection. Her aspirations are for this concept of wearable medical devices to become mainstream, similar to glasses, and to remove the stigma associated with wearable medical devices.

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

    NARCIS (Netherlands)

    Rademakers, C.

    2009-01-01

    In the past decennia medical technology has rapidly developed. Nowadays it plays an important role in all medical fields. It introduced technologic solutions for many medical problems and it definitely increased the possibilities in the medical field to increase the quality of life. However with thi

  18. Automatic radioisotope production devices adapted to a medical cyclotron

    International Nuclear Information System (INIS)

    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 4He and 3He, 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.)

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

    Science.gov (United States)

    Minnifield, Nona K.

    2012-01-01

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

  20. Online Medical Device Use Prediction: Assessment of Accuracy.

    Science.gov (United States)

    Maktabi, Marianne; Neumuth, Thomas

    2016-01-01

    Cost-intensive units in the hospital such as the operating room require effective resource management to improve surgical workflow and patient care. To maximize efficiency, online management systems should accurately forecast the use of technical resources (medical instruments and devices). We compare several surgical activities like using the coagulator based on spectral analysis and application of a linear time variant system to obtain future technical resource usage. In our study we examine the influence of the duration of usage and total usage rate of the technical equipment to the prediction performance in several time intervals. A cross validation was conducted with sixty-two neck dissections to evaluate the prediction performance. The performance of a use-state-forecast does not change whether duration is considered or not, but decreases with lower total usage rates of the observed instruments. A minimum number of surgical workflow recordings (here: 62) and >5 minute time intervals for use-state forecast are required for applying our described method to surgical practice. The work presented here might support the reduction of resource conflicts when resources are shared among different operating rooms. PMID:27577445

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

    Science.gov (United States)

    Smith, Colleen

    2015-01-01

    Internet crowdfunding, a new and increasingly popular method of raising capital to develop products and businesses, has recently come into conflict with the Food and Drug Administration's (FDA's) regulation of medical devices. This Article examines the issues that arise when companies pre-sell medical devices via crowdfunding campaigns before gaining FDA approval of the devices. Because Internet crowdfunding has only been in use for a few years, little has been written about it academically, particularly about its interaction with FDA regulations. The rising interest in crowdfunding, coupled with the downturn in investment in the American medical device industry, make this a salient issue that is ripe for FDA review. This Article uses the crowdfunding campaign Scanadu, a medical device company, conducted in 2013 to raise money to develop its in-home diagnostic device, the "Scout," as a starting point for this analysis. Because it is extremely costly to develop a device and obtain FDA approval, medical device companies should be able to utilize crowdfunding to raise the necessary capital. However, because of the possible dangers medical devices pose, FDA needs to review the risks created by allowing companies to crowdfund medical devices and should issue guidance to help companies comply with FDA regulations while still allowing them to take advantage of the benefits of crowdfunding. This guidance should ensure the continued commitment to consumer safety that is at the core of FDA regulation. PMID:26292478

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

    Directory of Open Access Journals (Sweden)

    Muniz Janaína Barbosa

    2003-01-01

    Full Text Available Asthma results from a combination of three essential features: airflow obstruction, hyperresponsiveness of airways to endogenous or exogenous stimuli and inflammation. Inadequacy of the techniques to use different inhalation devices is one of the causes of therapeutic failure. The main purpose of this study was to evaluate how 20 medical students, 36 resident physicians of Internal Medicine/Pediatrics, and 40 asthma patients used three devices for inhalation therapy containing placebo. All patients were followed at the Pulmonary Outpatient Service of Botucatu Medical School and had been using inhaled medication for at least six months. The following devices were evaluated: metered dose inhalers (MDI, dry powder inhalers (DPI, and MDI attached to a spacer device. A single observer applied a protocol containing the main steps necessary to obtain a good inhaler technique to follow and grade the use of different devices. Health care professionals tested all three devices and patients tested only the device being used on their management. MDI was the device best known by doctors and patients. MDI use was associated with errors related to the coordination between inspiration and device activation. Failure to exhale completely before inhalation of the powder was the most frequent error observed with DPI use. In summary, patients did not receive precise instruction on how to use inhaled medication and health care professionals were not well prepared to adequately teach their patients.

  3. 76 FR 65200 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee: Notice of...

    Science.gov (United States)

    2011-10-20

    ...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......

  4. 75 FR 18219 - Drug and Medical Device Forum on Food and Drug Administration Drug and Device Requirements and...

    Science.gov (United States)

    2010-04-09

    ... HUMAN SERVICES Food and Drug Administration Drug and Medical Device Forum on Food and Drug Administration Drug and Device Requirements and Supplier Controls; Public Educational Forum AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public educational forum. SUMMARY: The Food and Drug Administration...

  5. 75 FR 391 - Medical Device Quality System Regulation Educational Forum on Risk Management Through the Product...

    Science.gov (United States)

    2010-01-05

    ...The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Southwest Region (SWR), Dallas District Office (DALDO), in collaboration with the FDA Medical Device Industry Coalition (FMDIC), is announcing a public workshop entitled ``Medical Device Quality System Regulation Educational Forum on Risk Management through the Product Life Cycle.'' This public workshop is intended to......

  6. Challenges in Evaluating and Standardizing Medical Devices in Health Care Facilities

    OpenAIRE

    Ventola, C. Lee

    2008-01-01

    Advances in medical technologies have led to improved diagnoses and treatments, but medical devices do not always undergo the rigorous review process that is applied to drugs. To control costs, some health care facilities are becoming more selective in how they evaluate new devices.

  7. 76 FR 82129 - Medical Devices; Ovarian Adnexal Mass Assessment Score Test System; Labeling; Black Box Restrictions

    Science.gov (United States)

    2011-12-30

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 Medical Devices; Ovarian Adnexal Mass... 21 CFR Part 866 Biologics, Laboratories, Medical devices. Therefore, under the Federal Food, Drug... surgery. In the Federal Register of March 23, 2011 (76 FR 16292 at 12694), FDA published a final rule...

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

    Science.gov (United States)

    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 life-threatening infections. Other types of medical devices such as bronchoscopes and duod...

  9. 78 FR 27971 - Dental Products Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-05-13

    ... HUMAN SERVICES Food and Drug Administration Dental Products Panel of the Medical Devices Advisory...). The meeting will be open to the public. Name of Committee: Dental Products Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  10. 77 FR 32644 - Medical Devices; Exemption From Premarket Notification: Wheelchair Elevator

    Science.gov (United States)

    2012-06-01

    ... HUMAN SERVICES Food and Drug Administration Medical Devices; Exemption From Premarket Notification... (1976 amendments) (Pub. L. 94-295)), as amended by the Safe Medical Devices Act of 1990 (SMDA) (Pub. L....'' That guidance is available through the Internet at http://www.fda. ]...

  11. 75 FR 29560 - Identifying Unmet Public Health Needs and Facilitating Innovation in Medical Device Development...

    Science.gov (United States)

    2010-05-26

    ... Innovation in Medical Device Development; Notice of Public Workshop; Request for Comments AGENCY: Food and... Facilitating Innovation in Medical Device Development.'' The purpose of the workshop is to obtain public input... that describes your experience and/or expertise relevant to your proposed presentation. In order...

  12. 77 FR 26769 - Educational Forum on Medical Device Reporting, Complaint Files, and Recalls, Corrections, and...

    Science.gov (United States)

    2012-05-07

    ... public workshop is to provide information about FDA's Medical Device Quality Systems Regulation (QSR) to... Renaissance Dallas Hotel, 2222 Stemmons Freeway, Dallas, TX 75207. Directions and lodging information are... HUMAN SERVICES Food and Drug Administration Educational Forum on Medical Device Reporting,...

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

    Science.gov (United States)

    2011-11-21

    ... Regulatory Science for Highly Multiplexed Microbiology/ Medical Countermeasure Devices'' that published in the Federal Register of August 8, 2011 (76 FR 48169). In the notice, FDA requested public comments... Microbiology/ Medical Countermeasure Devices; Public Meeting; Reopening of Comment Period AGENCY: Food and...

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

    Science.gov (United States)

    2013-06-05

    ... HUMAN SERVICES Food and Drug Administration Battery-Powered Medical Devices Workshop: Challenges and... following public workshop entitled ``Battery-Powered Medical Devices Workshop: Challenges and Opportunities''. The purpose of this workshop is to create awareness of the challenges related to...

  15. A Review of the Design Process for Implantable Orthopedic Medical Devices

    OpenAIRE

    Aitchison, G.A; Hukins, D. W. L.; Parry, J.J; Shepherd, D.E.T; Trotman, S.G

    2009-01-01

    The design process for medical devices is highly regulated to ensure the safety of patients. This paper will present a review of the design process for implantable orthopedic medical devices. It will cover the main stages of feasibility, design reviews, design, design verification, manufacture, design validation, design transfer and design changes.

  16. 75 FR 45641 - Medical Device User Fee Rates for Fiscal Year 2011

    Science.gov (United States)

    2010-08-03

    ... HUMAN SERVICES Food and Drug Administration Medical Device User Fee Rates for Fiscal Year 2011 AGENCY... announcing the ] fee rates and payment procedures for medical device user fees for fiscal year (FY) 2011. The... Commissioner for Policy. BILLING CODE 4160-01-S...

  17. Medical Devices that Treat Obesity: What to Know

    Science.gov (United States)

    ... an electrical stimulation system, gastric balloons, and a gastric emptying system. Patients with these devices should be monitored ... sealed. Balloons should be removed after six months. Gastric Emptying System This recently approved device includes a tube ...

  18. Swarm Intelligent Selection and Optimization of Machining System Parameters for Microchannel Fabrication in Medical Devices

    OpenAIRE

    Vázquez Lepe, Elisa; Ciurana, Quim de; Rodríguez González, Ciro Ángel; Thepsonthi, Thanongsak; Özel, Tuǧrul

    2011-01-01

    Current technology trends in medical device industry calls for fabrication of massive arrays of microfeatures such as microchannels on to nonsilicon material substrates with high accuracy, superior precision, and high throughput. Microchannels are typical features used in medical devices for medication dosing into the human body, analyzing DNA arrays or cell cultures. In this study, the capabilities of machining systems for micro-end milling have been evaluated by conducting experiments, regr...

  19. 75 FR 17143 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Science.gov (United States)

    2010-04-05

    ... Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Documents; Availability...) is announcing the availability of draft special controls guidance documents for 11 neurological and physical medicine devices. FDA has developed a draft special controls guidance document for each of the...

  20. Integrated Forest Management Charter

    Energy Technology Data Exchange (ETDEWEB)

    Hansen, Leslie A. [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

    2015-08-24

    The purpose of this charter is to establish, maintain, and implement programs for the protection, preservation, and enhancement of the land and water resources of Los Alamos National Laboratory in a changing climate.

  1. Medical device design for adolescent adherence and developmental goals: a case study of a cystic fibrosis physiotherapy device

    Directory of Open Access Journals (Sweden)

    Lang AR

    2014-03-01

    Full Text Available Alexandra R Lang,1 Jennifer L Martin,2 Sarah Sharples,1 John A Crowe3 1Human Factors Research Group, Faculty of Engineering, University of Nottingham, Nottingham, UK; 2Mindtech Healthcare Technology Cooperative (Htc, Faculty of Medicine and Health Sciences, Institute of Mental Health, Nottingham, UK; 3Biomedical Engineering, Faculty of Engineering, University of Nottingham, UK Purpose: This study investigates the psychosocial aspects of adolescent medical device use and the impact on adolescent adherence and goals for the transitional years between child and adulthood. Patients and methods: Interviews were carried out with 20 adolescents with cystic fibrosis, investigating adolescent medical device use and experiences in relation to their personal and social lives and development through the adolescent years. The qualitative dataset was thematically examined using a content analysis method. Results: The results show that adolescent users of medical technologies want their independence and capabilities to be respected. Adolescent adherence to medical device use was associated with short- and long-term motivations, where older adolescents were able to comprehend the longer-term benefits of use against short-term inconvenience more acutely than younger adolescents. It was suggested that medical devices could provide a tool for communication with families and clinicians and could support adolescents as they take responsibility for managing their condition. Themes of “fitting into teenage life” and “use in the community” were associated with adolescents' needs to form their own identity and have autonomy. Conclusion: This study shows that adolescent needs regarding medical device use are complex. It provides evidence to suggest that devices designed inclusively for adolescents may lead to improved adherence and also facilitate transition through the adolescent years and achievement of adolescent goals. Keywords: young people, teenagers

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

    CERN Document Server

    Abuhav, Itay

    2011-01-01

    Although complex and lengthy, the process of certification for the ISO 13485 can be easily mastered using the simple method outlined in ISO 13485: A Complete Guide to Quality Management in the Medical Device Industry. Written by an experienced industry professional, this practical book provides a complete guide to the ISO 13485 Standard certification for medical device manufacturing. Filled with examples drawn from the author's experience and spanning different sectors and fields of the medical device industry, the book translates the extra ordinary requirements and objectives of the standard

  3. Medical devices for restless legs syndrome – clinical utility of the Relaxis pad

    Science.gov (United States)

    Mitchell, Ulrike H

    2015-01-01

    Restless Legs Syndrome or Willis–Ekbom Disease, a neurosensory disorder, can be treated with pharmaceuticals or conservatively. This review focuses on conservative treatments, more specifically on treatments with medical devices. Two modes of action, enhancement of circulation and counter stimulation, are introduced. Medical devices that use enhancement of circulation as their mechanism of action are whole body vibration, pneumatic compression, and near-infrared light. Medical devices that use counter stimulation include transcutaneous electrical nerve stimulation and the vibration Relaxis pad. The clinical utility of the Relaxis pad and its place in therapy is proposed. PMID:26664128

  4. US FDA Releases Final Rule on Medical Device Data Systems:What Does This Mean for Device Manufacturers

    OpenAIRE

    Mc Hugh, Martin; McCaffery, Fergal; Casey, Valentine

    2011-01-01

    On 16 April 2011, the US Food and Drug Administration’s (FDA’s) final rule on medical device data systems (MDDSs) came into force. This rule attempts to remove the uncertainty surrounding the safety classification of certain information technology systems used in healthcare. Devices that now meet the criteria of being an MDDS are classified as Class I (general controls). However, this final ruling explicitly precludes specific software applications that meet the definition of an MDDS, such as...

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

    CERN Document Server

    Gad, Shayne C

    2008-01-01

    Capturing the growth of the global medical device market in recent years, this practical new guide is essential for all who are responsible for ensuring safety in the use and manufacture of medical devices. It has been extensively updated to reflect significant advances, incorporating combination products and helpful case examples of current real-life problems in the field.The Third Edition explores these key current trends:global device marketscontinually advancing technologythe increasing harmonization of device safety regulation worldwideEach aspect of safety evaluation is considered in ter

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

    Directory of Open Access Journals (Sweden)

    Maresova P

    2015-10-01

    Full Text Available Petra Maresova,1 Marek Penhaker,1,2 Ali Selamat,1,3 Kamil Kuca1,41Faculty of Informatics and Management, University of Hradec Králové, Hradec Králové, Czech Republic; 2Department of Cybernetics and Biomedical Engineering, Faculty of Electrical Engineering and Computer Science, Technical University of Ostrava, Poruba, Czech Republic; 3Faculty of Computing, Universiti Teknologi Malaysia, Johor Bahru, Johor, Malaysia; 4Center for Biomedical Research, University Hospital Hradec Králové, Hradec Králové, Czech RepublicAbstract: The high quality of public health improves not only healthy life expectancy, but also the productivity of labor. The most important part of the health care sector is the medical technology industry. The aim of this study is to analyze the current situation in the medical device industry in Europe, its potential strengths and weaknesses in the context of topical economic and demographic development. The contribution specifies an analysis of the economic state of the medical device industry in the context of demographic development of European Union’s macroeconomic indicators and views of experts in the field of medical device development, concerning the opportunities for entities involved in the medical device market. There is fierce competition on the European market. The innovative activity is stable and well regulated by responsible authorities. Worldwide, the medical device market is expected to grow.Keywords: technology context, medical device, Europe, expenditure, review

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

    Science.gov (United States)

    Hanus, Josef; Nosek, Tomas; Zahora, Jiri; Bezrouk, Ales; Masin, Vladimir

    2013-01-01

    We designed and evaluated an innovative computer-aided-learning environment based on the on-line integration of computer controlled medical diagnostic devices and a medical information system for use in the preclinical medical physics education of medical students. Our learning system simulates the actual clinical environment in a hospital or primary care unit. It uses a commercial medical information system for on-line storage and processing of clinical type data acquired during physics laboratory classes. Every student adopts two roles, the role of 'patient' and the role of 'physician'. As a 'physician' the student operates the medical devices to clinically assess 'patient' colleagues and records all results in an electronic 'patient' record. We also introduced an innovative approach to the use of supportive education materials, based on the methods of adaptive e-learning. A survey of student feedback is included and statistically evaluated. The results from the student feedback confirm the positive response of the latter to this novel implementation of medical physics and informatics in preclinical education. This approach not only significantly improves learning of medical physics and informatics skills but has the added advantage that it facilitates students' transition from preclinical to clinical subjects. PMID:22200603

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

    Science.gov (United States)

    2015-11-20

    The Food and Drug Administration (FDA or the Agency) is classifying the ultraviolet (UV) radiation chamber disinfection device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the UV radiation chamber disinfection device classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. PMID:26595943

  9. 21 CFR 801.1 - Medical devices; name and place of business of manufacturer, packer or distributor.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices; name and place of business of manufacturer, packer or distributor. 801.1 Section 801.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.1 Medical devices; name and place...

  10. 75 FR 70112 - Medical Devices; General and Plastic Surgery Devices; Classification of Non-Powered Suction...

    Science.gov (United States)

    2010-11-17

    ... wound therapy (NPWT) into class II (special controls). The special control that will apply to the device... Guidance Document: Non-powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy...

  11. ANSTO and CSIRO: supporting the medical devices and sensors industry in Australia

    International Nuclear Information System (INIS)

    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

  12. 77 FR 2071 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2012-01-13

    ...-0563, FDA- 2011-M-0564, FDA-2011-M-0600, FDA-2011-M-0601, FDA-2011-M-0630, and FDA-2011-M-0707] Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications...

  13. 75 FR 38532 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2010-07-02

    ...-0063, FDA- 2010-M-0135, FDA-2010-M-0158] Medical Devices; Availability of Safety and Effectiveness... In the Federal Register of January 30, 1998 (63 FR 4571), FDA published a final rule that revised...

  14. 76 FR 17136 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2011-03-28

    ...-0558, FDA- 2010-M-0557, and FDA-2010-M-0591] Medical Devices; Availability of Safety and Effectiveness.... SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of January 30, 1998 (63 FR 4571), FDA...

  15. The application of electron beam equipment for the sterilization of medical devices

    International Nuclear Information System (INIS)

    The use of electron beam equipment for the sterilization of medical devices is described. Sterilization costs are compared for the following processes: ETO, heat (steam), radiation (Co-60, Linac, Dynamitron). (U.K.)

  16. "Made in India": How′s that for an indigenous medical device?

    Directory of Open Access Journals (Sweden)

    Ganne S Umamaheswara Rao

    2013-01-01

    Full Text Available With increasing costs of imported equipment, there is a need for Indigenization of medical devices in India. The resources including skilled manpower to develop equipment of a good standard are available in the country. What plagues the developmental process is the lack of adequate interaction between the medical profession and the technologists and reluctance of the industry to venture into the medical device manufacturing. A much bigger and more serious road-block is the lack of formal certification and regulatory processes for these devices. Medical practitioners should be open to evaluating and accepting indigenous equipment that pass the requisite standards. Formal mechanisms should be developed to orient both physicians and engineers to the technical and commercial issues of device development.

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

    OpenAIRE

    Chang-Seop Park

    2014-01-01

    After two recent security attacks against implantable medical devices (IMDs) have been reported, the privacy and security risks of IMDs have been widely recognized in the medical device market and research community, since the malfunctioning of IMDs might endanger the patient’s life. During the last few years, a lot of researches have been carried out to address the security-related issues of IMDs, including privacy, safety, and accessibility issues. A physician accesses IMD through an extern...

  18. BIOCOMPATIBILITY OF MEDICAL DEVICES – LEGAL REGULATIONS IN THE EUROPEAN UNION.

    OpenAIRE

    Mariela Yaneva-Deliverska; Jordan Deliversky; Maya Lyapina

    2015-01-01

    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 denta...

  19. Medical devices for restless legs syndrome – clinical utility of the Relaxis pad

    OpenAIRE

    Uh, Mitchell

    2015-01-01

    Ulrike H Mitchell Department of Exercise Sciences, Brigham Young University, Provo, UT, USA Abstract: Restless Legs Syndrome or Willis–Ekbom Disease, a neurosensory disorder, can be treated with pharmaceuticals or conservatively. This review focuses on conservative treatments, more specifically on treatments with medical devices. Two modes of action, enhancement of circulation and counter stimulation, are introduced. Medical devices that use enhancement of circulation as their mec...

  20. 78 FR 16684 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2013-03-18

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration General and Plastic Surgery Devices Panel of the Medical... Administration (FDA). The meeting will be open to the public. Name of Committee: General and Plastic...

  1. 76 FR 41507 - Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-07-14

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Obstetrics and Gynecology Devices Panel of the Medical... Administration (FDA). The meeting will be open to the public. Name of Committee: Obstetrics and...

  2. 76 FR 39882 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2011-07-07

    ... HUMAN SERVICES Food and Drug Administration General and Plastic Surgery Devices Panel of the Medical... Administration (FDA). The meeting will be open to the public. Name of Committee: General and Plastic Surgery... contact person on or before August 24, 2011. Oral presentations from the public will be scheduled...

  3. 75 FR 49940 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2010-08-16

    ... HUMAN SERVICES Food and Drug Administration General and Plastic Surgery Devices Panel of the Medical... Administration (FDA). The meeting will be open to the public. Name of Committee: General and Plastic Surgery... November 9, 2010. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2...

  4. 76 FR 62419 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2011-10-07

    ... HUMAN SERVICES Food and Drug Administration General and Plastic Surgery Devices Panel of the Medical... Administration (FDA). The meeting will be open to the public. Name of Committee: General and Plastic Surgery.... Oral presentations from the public will be scheduled between approximately 1 p.m. and 2...

  5. 76 FR 14415 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2011-03-16

    ... HUMAN SERVICES Food and Drug Administration General and Plastic Surgery Devices Panel of the Medical... Administration (FDA). The meeting will be open to the public. Name of Committee: General and Plastic Surgery... contact person on or before April 19, 2011. Oral presentations from the public will be scheduled...

  6. 77 FR 20642 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2012-04-05

    ... HUMAN SERVICES Food and Drug Administration General and Plastic Surgery Devices Panel of the Medical... Administration (FDA). The meeting will be open to the public. Name of Committee: General and Plastic Surgery... be made to the contact person on or before June 11, 2012. Oral presentations from the public will...

  7. 75 FR 36102 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2010-06-24

    ... HUMAN SERVICES Food and Drug Administration General and Plastic Surgery Devices Panel of the Medical... Administration (FDA). The meeting will be open to the public. Name of Committee: General and Plastic Surgery.... Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m....

  8. 78 FR 30928 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2013-05-23

    ... HUMAN SERVICES Food and Drug Administration General and Plastic Surgery Devices Panel of the Medical... Administration (FDA). The meeting will be open to the public. Name of Committee: General and Plastic Surgery... the contact person on or before June 7, 2013. Oral presentations from the public will be...

  9. A Structured Approach for Investigating the Causes of Medical Device Adverse Events

    Directory of Open Access Journals (Sweden)

    John N. Amoore

    2014-01-01

    Full Text Available Aim. Medical device-related adverse events are often ascribed to “device” or “operator” failure although there are more complex causes. A structured approach, viewing the device in its clinical context, is developed to assist in-depth investigations of the causes. Method. Medical device applications involve devices, clinical teams, patients, and supporting infrastructure. The literature was explored for investigations and approaches to investigations, particularly structured approaches. From this a conceptual framework of causes was developed based primarily on device and clinical team caring for the patient within a supporting infrastructure, each aspect having detailed subdivisions. The approach was applied to incidents from the literature and an anonymous incident database. Results. The approach identified and classified the underlying causes of incidents described in the literature, exploring the details of “device,” “operator,” or “infrastructure” failures. Applied to incident databases it suggested that causes differ between device types and identified the causes of device unavailability. Discussion. The structured approach enables digging deeper to uncover the wider causes rather than ascribing to device or user fault. It can assess global patterns of causes. It can help develop consistent terminology for describing and sharing information on the causes of medical device adverse events.

  10. Charter School Contracts. Policy Guide

    Science.gov (United States)

    Cass, Rebecca

    2009-01-01

    The charter school concept was first introduced in 1991 when the Minnesota Legislature passed the nation's first charter school law. As of this writing in 2009, 40 states and the District of Columbia have charter school legislation. While the specific characteristics and nuances of these laws vary from state to state, almost every state law…

  11. Charter Schools and Market Segmentation

    Science.gov (United States)

    Batie, Michael

    2009-01-01

    This dissertation was undertaken to examine the effect(s) of charter school marketing on the Los Angeles Unified School District (LAUSD) education landscape with respect to the stratification of charter schools. Information from four sources: school websites, a survey of charter school parents, existing online statistics and data, and various…

  12. Sterilization by irradiation of plastic medical devices - an overview. Pt. 1

    International Nuclear Information System (INIS)

    Sterilization by ionizing radiation has become, next to ethylene oxide treatment, the most important ''cold'' sterilization process for medical devices made from plastics. The importance of the radiation process and the use of plastics in medical applications are briefly described in this part 1 of a review. (orig./MG)

  13. 75 FR 44267 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Science.gov (United States)

    2010-07-28

    ... April 5, 2010 (75 FR 17093), FDA published a notice announcing the availability of draft special... for the notice that appeared in the Federal Register of April 5, 2010 (75 FR 17143). In the notice... Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening...

  14. 75 FR 47604 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Science.gov (United States)

    2010-08-06

    ... July 28, 2010 (75 FR 44267). The document reopened the comment period for a notice of availability of..., Silver Spring, MD 20993, 301-796-9148. SUPPLEMENTARY INFORMATION: In FR Doc. 2010-18406, appearing on... Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening...

  15. 78 FR 69694 - Changing Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of Obesity...

    Science.gov (United States)

    2013-11-20

    ... Gastroenterological Association (AGA) Web site: http://www.gastro.org/education-meetings/live-meetings/aga-fda... 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...

  16. 77 FR 43846 - Food and Drug Administration Pediatric Medical Devices Workshop; Notice of Workshop

    Science.gov (United States)

    2012-07-26

    ... 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...

  17. 21 CFR 801.122 - Medical devices for processing, repacking, or manufacturing.

    Science.gov (United States)

    2010-04-01

    ... manufacturing. 801.122 Section 801.122 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND....122 Medical devices for processing, repacking, or manufacturing. A device intended for processing... act if its label bears the statement “Caution: For manufacturing, processing, or repacking”....

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

    Science.gov (United States)

    Bruzzi, M S; Linehan, J H

    2013-09-01

    In the midst of a rich environment for medical device development and manufacturing, universities can play a critical role by developing relevant training programs to produce entrepreneurs who can be efficient and successful in creating early stage companies by understanding deeply the issues involved in creating a useful device, how to raise money, designing early clinical studies and locating manufacturing partners. PMID:23494126

  19. Use of wound dressings to enhance prevention of pressure ulcers caused by medical devices.

    Science.gov (United States)

    Black, Joyce; Alves, Paulo; Brindle, Christopher Tod; Dealey, Carol; Santamaria, Nick; Call, Evan; Clark, Michael

    2015-06-01

    Medical device related pressure ulcers (MDR PUs) are defined as pressure injuries associated with the use of devices applied for diagnostic or therapeutic purposes wherein the PU that develops has the same configuration as the device. Many institutions have reduced the incidence of traditional PUs (sacral, buttock and heel) and therefore the significance of MDR PU has become more apparent. The highest risk of MDR PU has been reported to be patients with impaired sensory perception, such as neuropathy, and an impaired ability for the patient to communicate discomfort, for example, oral intubation, language barriers, unconsciousness or non-verbal state. Patients in critical care units typify the high-risk patient and they often require more devices for monitoring and therapeutic purposes. An expert panel met to review the evidence on the prevention of MDR PUs and arrived at these conclusions: (i) consider applying dressings that demonstrate pressure redistribution and absorb moisture from body areas in contact with medical devices, tubing and fixators, (ii) in addition to dressings applied beneath medical devices, continue to lift and/or move the medical device to examine the skin beneath it and reposition for pressure relief and (iii) when simple repositioning does not relieve pressure, it is important not to create more pressure by placing dressings beneath tight devices. PMID:23809279

  20. 77 FR 50113 - ASTM International-Food and Drug Administration Workshop on Absorbable Medical Devices: Lessons...

    Science.gov (United States)

    2012-08-20

    ... 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... establishing correlations between in vitro and in vivo degradation of absorbable implant devices, and...

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

    Science.gov (United States)

    Calcagnini, G; Mattei, E; Censi, F; Triventi, M; Lo Sterzo, R; Marchetta, E; Bartolini, P

    2011-05-01

    This paper investigates the electromagnetic compatibility of 45 critical care medical devices (infusion pumps, defibrillators, monitors, lung ventilators, anesthesia machines and external pacemakers) with various types of wireless local area network (WLAN, IEEE 802.11 b/g, 2.45 GHz, 100 mW) adapters. Interference is evaluated by performing ad-hoc tests according to the ANSI C63.18 recommended practice. The behavior of the devices during the tests was monitored using patient simulators/device testers specific for each device class. Electromagnetic interference cases were observed in three of 45 devices at a maximum distance of 5 cm. In two cases the interference caused malfunctions that may have clinical consequences for the patient. The authors' findings show that the use of these wireless local area network adapters can be considered reasonably safe, although interference may occur if they are operated at very close distance (<10 cm) to the medical devices. PMID:21451319

  2. Kinetic and thermal energy harvesters for implantable medical devices and biomedical autonomous sensors

    International Nuclear Information System (INIS)

    Implantable medical devices usually require a battery to operate and this can represent a severe restriction. In most cases, the implantable medical devices must be surgically replaced because of the dead batteries; therefore, the longevity of the whole implantable medical device is determined by the battery lifespan. For this reason, researchers have been studying energy harvesting techniques from the human body in order to obtain batteryless implantable medical devices. The human body is a rich source of energy and this energy can be harvested from body heat, breathing, arm motion, leg motion or the motion of other body parts produced during walking or any other activity. In particular, the main human-body energy sources are kinetic energy and thermal energy. This paper reviews the state-of-art in kinetic and thermoelectric energy harvesters for powering implantable medical devices. Kinetic energy harvesters are based on electromagnetic, electrostatic and piezoelectric conversion. The different energy harvesters are analyzed highlighting their sizes, energy or power they produce and their relative applications. As they must be implanted, energy harvesting devices must be limited in size, typically about 1 cm3. The available energy depends on human-body positions; therefore, some positions are more advantageous than others. For example, favorable positions for piezoelectric harvesters are hip, knee and ankle where forces are significant. The energy harvesters here reported produce a power between 6 nW and 7.2 mW; these values are comparable with the supply requirements of the most common implantable medical devices; this demonstrates that energy harvesting techniques is a valid solution to design batteryless implantable medical devices. (topical review)

  3. Medical Devices; Obstetrical and Gynecological Devices; Classification of the Intravaginal Culture System. Final order.

    Science.gov (United States)

    2016-01-01

    The Food and Drug Administration (FDA) is classifying the intravaginal culture 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 intravaginal culture 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. PMID:26742184

  4. Medical Devices; Gastroenterology-Urology Devices; Classification of the Prostate Lesion Documentation System. Final order.

    Science.gov (United States)

    2015-11-23

    The Food and Drug Administration (FDA) is classifying the prostate lesion documentation 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 prostate lesion documentation system 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. PMID:26595945

  5. Medical Devices; Ophthalmic Devices; Classification of the Diurnal Pattern Recorder System. Final order.

    Science.gov (United States)

    2016-05-31

    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. PMID:27236873

  6. Medical Devices; Neurological Devices; Classification of the Thermal System for Insomnia. Final order.

    Science.gov (United States)

    2016-07-11

    The Food and Drug Administration (FDA) is classifying the thermal system for insomnia 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 thermal system for insomnia'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. PMID:27400464

  7. Implantable Glucose BioFuel Cells for Medical Devices

    International Nuclear Information System (INIS)

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

  8. BIOCOMPATIBILITY OF MEDICAL DEVICES – LEGAL REGULATIONS IN THE EUROPEAN UNION.

    Directory of Open Access Journals (Sweden)

    Mariela Yaneva-Deliverska

    2015-02-01

    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.

  9. Using a Handheld Device for Patient Data Collection: A Pilot for Medical Countermeasures Surveillance.

    Science.gov (United States)

    Daley, Matthew F; Goddard, Kristin; McClung, Melissa; Davidson, Arthur; Weiss, Gretchen; Palen, Ted; Nyirenda, Carsie; Platt, Richard; Courtney, Brooke; Reichman, Marsha E

    2016-01-01

    Medical countermeasures (MCMs) are medical products used during public health emergencies. This study, conducted within the Mini-Sentinel Initiative, sought to develop the patient identification and matching processes necessary to assess safety outcomes for MCMs. A handheld device was used to collect identifying information (e.g., name, birthdate, and sex) from the driver's licenses of 421 individuals presenting for routine care at their primary care medical office. Overall, 374 individuals (88.8%) could be linked to their electronic health data using driver's license information. The device was also pilot-tested at a seasonal influenza immunization clinic: detailed vaccine information (e.g., lot number and manufacturer) was captured with a high degree of accuracy. This investigation demonstrated that a handheld device is a feasible means of collecting patient identity and medical product receipt data. This capacity should be useful for safety surveillance of MCMs, particularly when dispensed in settings outside the traditional health-care delivery system. PMID:26843667

  10. 21 CFR 803.21 - Where can I find the reporting codes for adverse events that I use with medical device reports?

    Science.gov (United States)

    2010-04-01

    ... events that I use with medical device reports? 803.21 Section 803.21 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE REPORTING... reporting codes for adverse events that I use with medical device reports? (a) The MEDWATCH Medical...

  11. Who is Responsible for Evaluating the Safety and Effectiveness of Medical Devices? The Role of Independent Technology Assessment

    OpenAIRE

    Feldman, Mitchell D.; Petersen, Amy J.; Karliner, Leah S.; Tice, Jeffrey A.

    2007-01-01

    Introduction The global medical technology industry brings thousands of devices to market every year. However, significant gaps persist in the scientific literature, in the medical device approval process, and in the realm of postmarketing surveillance. Although thousands of drugs obtain approval only after review in randomized controlled trials, relatively few new medical devices are subject to comparable scrutiny. Objective To improve health outcomes, we must enhance our scrutiny of medical...

  12. A double inductively coupled plasma for sterilization of medical devices

    International Nuclear Information System (INIS)

    A double inductively coupled low pressure plasma for sterilization of bio-medical materials is introduced. It is developed for homogeneous treatment of three-dimensional objects. The short treatment times and low temperatures allow the sterilization of heat sensitive materials like ultra-high-molecular-weight-polyethylene or polyvinyl chloride. Using a non-toxic atmosphere reduces the total process time in comparision with common methods. Langmuir probe measurements are presented to show the difference between ICP- and CCP-mode discharges, the spatial homogeneity and the influence on the sterilization efficiency. To know more about the sterilization mechanisms optical emission is measured and correlated with sterilization results

  13. Device for the sterilization of radioactive inserts for medical purposes

    International Nuclear Information System (INIS)

    The sterilization of radium needles (applicators) is possible with the device. The system has the simultaneous function of a shielding container (concrete or lead chamber), of a washing vessel and of a sterilization chamber. The shielding container surrounds the cleaning vessel into which the cleaning liquids can be sprayed and extracted again and into which a bactericide gas (ethylene oxide with CO or freon) can be introduced. Due to the poison gas sterilization of the applicators collected in the wash vessel or sterilization chamber, a temperature of 800C is not exceeded so that the soldered points on the applicators do not become loose. (DG)

  14. 75 FR 68200 - Medical Devices; Radiology Devices; Reclassification of Full-Field Digital Mammography System

    Science.gov (United States)

    2010-11-05

    ... FR 31040), FDA issued a proposed rule to reclassify the device, full-field digital mammography system... discussed in the preamble to the proposed rule (73 FR 31040) and comments on the proposed rule and...

  15. Opportunities and challenges for the development of polymer-based biomaterials and medical devices

    Science.gov (United States)

    Yin, Jinghua

    2016-01-01

    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. PMID:27047681

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

    Science.gov (United States)

    Kasparick, Martin; Schlichting, Stefan; Golatowski, Frank; Timmermann, Dirk

    2015-08-01

    Surgical procedures become more and more complex and the number of medical devices in an operating room (OR) increases continuously. Today's vendor-dependent solutions for integrated ORs are not able to handle this complexity. They can only form isolated solutions. Furthermore, high costs are a result of vendor-dependent approaches. Thus we present a service-oriented device communication for distributed medical systems that enables the integration and interconnection between medical devices among each other and to (medical) information systems, including plug-and-play functionality. This system will improve patient's safety by making technical complexity of a comprehensive integration manageable. It will be available as open standards that are part of the IEEE 11073 family of standards. The solution consists of a service-oriented communication technology, the so called Medical Devices Profile for Web Services (MDPWS), a Domain Information & Service Model, and a binding between the first two mechanisms. A proof of this concept has been done with demonstrators of real world OR devices. PMID:26736609

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

    International Nuclear Information System (INIS)

    Radiation treatment is getting important position for sterilizing medical devices and for packaging films of foods. Recently, survey of bioburden is an important technique for evaluation of sterility doses for medical devices. However, many studies have been done mainly on the irradiation effects of spore-forming bacteria in medical devices. In this study, radiation sensitivity of spore-forming bacteria and fungi were examined after the survey on distribution of microorganisms in several kinds of medical devices. The main contaminant in disposable syringes, needles and conical flasks were consisted of Bacillus, with lesser amount of Micrococcus, Pseudomonas, Peptococcaceae and fungi as positive of 5 - 60 % in the medical devices which cultivated in thioglycolate broth. Bacillus group were identified as B. pumilus, B. sphaericus, B. coagulans, B. megaterium and etc. Fungi were isolated a lesser amounts compared with spore-forming bacteria and identified as Blastomyces, Penicillium, Haplosporangium, Euricoa and Audeobasidium. Peptococaceae were not isolated after irradiation with a dose of 0.1 Mrad even the samples were contaminated with high percentage. The D10 values of dryed endospores of Bacillus-isolates which attached to the filter paper with pepton-glycerin were obtained to be 0.11 - 0.19 Mrad. The D10 values of many isolates of fungi in dry condition were obtained below 0.08 Mrad. However, the isolate of Aureobasidium is radiation-resistant, and it's D10 values was obtained as 0.28 Mrad under aerobic and anaerobic dry condition. (author)

  18. Integrating Six Sigma into a Quality Management System in the Medical Device Industry

    Directory of Open Access Journals (Sweden)

    Nadica Hrgarek

    2009-06-01

    Full Text Available Normal 0 21 false false false MicrosoftInternetExplorer4 Six Sigma is a valuable management strategy to improve business processes, reduce development and production costs, increase profit margin and improve customer satisfaction. The purpose of this paper is to describe how applicable Six Sigma concepts may complement and support formal quality management systems (QMS in the medical device industry.A significant number of issues, which increase the development costs and times, is often found during different phases of a medical device life cycle. Some defects with high patient safety risk may result in dangerous and very costly product recalls.The basic idea of this paper is to explore the possibilities of integrating Six Sigma techniques with an existing QMS throughout the entire life cycle of a medical device. This paper addresses how Six Sigma techniques, when appropriately integrated into the QMS at medical device companies, can eliminate defects earlier in the medical device life cycle, identify major opportunities for cost savings, focus on customer needs and expectations, and improve the overall business processes.

  19. Synthetic diamond devices for medical dosimetry applied to radiotherapy

    International Nuclear Information System (INIS)

    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)

  20. A Maturity Grid Assessment Tool for Environmentally Conscious Design in the Medical Device Industry

    DEFF Research Database (Denmark)

    Moultrie, James; Sutcliffe, Laura Francesca Rose; Maier, Anja

    2016-01-01

    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...... created 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 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...

  1. Determination and analysis of bioburden on medical devices treated by radiation sterilization

    International Nuclear Information System (INIS)

    In order to investigate the influence of initially contaminated microorganisms on medical devices for treatment by γ-radiation sterilization, 620 batches of products collected from more than 50 manufactures in jiangsu, zhejiang, shanghai and so on have been inspected by use of iso11737-1 2006 sterilization of medical devices-microbiological methods-part 1. the results show that the rate is 7.9%, 43.5%, 26.0%, 18.2% 4.4% when batch average bioburden (cfu/piece) with group ≤1.5, 1.510 000 respectively. the result provided reference for establishing the sterilization dose and the parameters for radiation sterilization, moist heat sterilization and ethylene oxide sterilization and provided guidance for produce and quality control of medical devices. (authors)

  2. Development of Thin-Film Battery Powered Transdermal Medical Devices

    Energy Technology Data Exchange (ETDEWEB)

    Bates, J.B.; Sein, T.

    1999-07-06

    Research carried out at ORNL has led to the development of solid state thin-film rechargeable lithium and lithium-ion batteries. These unique devices can be fabricated in a variety of shapes and to any required size, large or small, on virtually any type of substrate. Because they have high energies per unit of volume and mass and because they are rechargeable, thin-film lithium batteries have potentially many applications as small power supplies in consumer and special electronic products. Initially, the objective of this project was to develop thin-film battery powered products. Initially, the objective of this project was to develop thin-film battery powered transdermal electrodes for recording electrocardiograms and electroencephalograms. These ''active'' electrode would eliminate the effect of interference and improve the reliability in diagnosing heart or brain malfunctions. Work in the second phase of this project was directed at the development of thin-film battery powered implantable defibrillators.

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

    Science.gov (United States)

    Maak, Travis G; Wylie, James D

    2016-08-01

    Medical device regulation is a controversial topic in both the United States and the European Union. Many physicians and innovators in the United States cite a restrictive US FDA regulatory process as the reason for earlier and more rapid clinical advances in Europe. The FDA approval process mandates that a device be proved efficacious compared with a control or be substantially equivalent to a predicate device, whereas the European Union approval process mandates that the device perform its intended function. Stringent, peer-reviewed safety data have not been reported. However, after recent high-profile device failures, political pressure in both the United States and the European Union has favored more restrictive approval processes. Substantial reforms of the European Union process within the next 5 to 10 years will result in a more stringent approach to device regulation, similar to that of the FDA. Changes in the FDA regulatory process have been suggested but are not imminent. PMID:27195383

  4. Critical challenges to the design of drug-eluting medical devices.

    Science.gov (United States)

    Luk, Andrew; Junnarkar, Gunjan

    2013-04-01

    Drug-eluting devices cover a wide variety of possible product concepts. The design constraints for modified or sustained local delivery technologies that are compatible with medical devices are quite different from those constraints with any conventional dosage forms. To develop a successful development strategy from proof-of-concept to commercialization, it is of paramount importance to assess how drug delivery affects the desired mechanism of action of such combination products. Starting at the feasibility stage, the project team must have a clear understanding of the performance targets expected by patients and physicians/surgeons. In addition, R&D staff must anticipate and proactively address the differences in technical, quality and regulatory requirements from drug delivery and medical device perspectives. Through the eyes of drug delivery, this article will describe common challenges encountered in the development of drug-eluting devices and offer relevant mitigation strategies. PMID:23557288

  5. Exploratory Study of the State of Environmentally Conscious Design in the Medical Device Industry

    DEFF Research Database (Denmark)

    Moultrie, James; Sutcliffe, L.; Maier, Anja

    2015-01-01

    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...... reliance on a single-use business model for many current products and a lack of education about DfE topics on all sides. Designers felt that the most significant opportunities to implement DfE are in situations where they are able to exert direct control, mainly in the early stages of the design process...

  6. Innovating in the medical device industry - challenges & opportunities ESB 2015 translational research symposium.

    Science.gov (United States)

    Bayon, Y; Bohner, M; Eglin, D; Procter, P; Richards, R G; Weber, J; Zeugolis, D I

    2016-09-01

    The European Society for Biomaterials 2015 Translational Research Symposium focused on 'Innovating in the Medical Device Industry - Challenges & Opportunities' from different perspectives, i.e., from a non-profit research organisation to a syndicate of small and medium-sized companies and large companies. Lecturers from regulatory consultants, industry and research institutions described the innovation process and regulatory processes (e.g., 510K, PMA, combination product) towards market approval. The aim of the present article is to summarise and explain the main statements made during the symposium, in terms of challenges and opportunities for medical device industries, in a constantly changing customer and regulatory environment. PMID:27552808

  7. Radiation as a microbiological contamination control of drugs, cosmetics and medical devices

    International Nuclear Information System (INIS)

    This paper deals with current status of radiation sterilization or disinfection of drugs, cosmetics, their materials, and medical devices, and with quality control as a tool for securing microbiological safety, especially current status of sterilization tests. Ointment containing tetracyclin, steroid hormones, gelatin, and enzymes are presented as drug samples to be irradiated, and explanations for radiation sterilization of these drugs are provided. An outline of the application of radiation in cosmetics and medical devices is given. Issues are also provided from the viewpoint of safey and effectiveness of radiation sterilization. (Namekawa, K.)

  8. 78 FR 14015 - Medical Devices; Exemption From Premarket Notification; Class II Devices; Powered Patient Transport

    Science.gov (United States)

    2013-03-04

    ..., 1998 (63 FR 3142). Section 510(m)(2) of the FD&C Act provides that FDA may exempt a device from..., p. 3.) In the Federal Register of June 1, 2012 (77 FR 32642), FDA published a notice announcing that... against the criteria laid out in the Class II 510(k) Exemption Guidance and in 63 FR 3142, and agrees...

  9. 78 FR 24426 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2013-04-25

    ... information related to the premarket approval application for the Kineflex Lumbar Artificial Disc sponsored by SpinalMotion. The Kineflex Lumbar Artificial Disc is a metal-on-metal (cobalt chrome molybdenum alloy) lumbar total disc replacement device. The Kineflex Lumbar Artificial Disc is indicated for...

  10. 76 FR 16292 - Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass...

    Science.gov (United States)

    2011-03-23

    ... Devices; Classification of Ovarian Adnexal Mass Assessment Score Test System AGENCY: Food and Drug... ovarian adnexal mass assessment score test system into class II (special controls). The special control... Staff; Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test...

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

    Science.gov (United States)

    2011-04-21

    ... (FDA) is correcting a final rule that appeared in the Federal Register of March 23, 2011 (76 FR 16292..., Rm. 3208, Silver Spring, MD 20993-0002, 301-796-9148. SUPPLEMENTARY INFORMATION: In FR Doc. 2011-6620... Devices; Classification of Ovarian Adnexal Mass Assessment Score Test System; Correction AGENCY: Food...

  12. 76 FR 51876 - Medical Devices; Ophthalmic Devices; Classification of the Eyelid Thermal Pulsation System

    Science.gov (United States)

    2011-08-19

    ...; Classification of the Eyelid Thermal Pulsation System AGENCY: Food and Drug Administration, HHS. ACTION: Final...., submitted a petition requesting classification of the LipiFlow Thermal Pulsation System under section 513(f... system into class II (special controls). The Agency is classifying the device into class II...

  13. 78 FR 60291 - Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies...

    Science.gov (United States)

    2013-10-01

    ... program for early feasibility study IDE applications (November 10, 2011, 76 FR 70152) to solicit... feasibility study IDE application and explains the requirements applicable to modifications to the device design or clinical study protocol during the early feasibility study. DATES: Submit either electronic...

  14. 78 FR 28733 - Medical Devices; General Hospital and Personal Use Monitoring Devices; Classification of the...

    Science.gov (United States)

    2013-05-16

    ... Testing. Clinical Evaluation. Failure to excrete Animal Testing. Usability Human Factors Testing. Labeling... Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were not in commercial... Designation Under Section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act From Proteus Biomedical,...

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

    Science.gov (United States)

    Howard, Jason J

    2014-01-01

    With some of the richest economies in the world, the Gulf Cooperation Council (GCC) is undergoing rapid growth not only in its population but also in health care expenditure. Despite the GCC’s abundance of hydrocarbon-based wealth, the drivers of the medical device industry in the GCC are still in flux, with gains yet to be made in areas of infrastructure, regulation, and reimbursement. However, the regional disease burden, expanding health insurance penetration, increasing privatization, and a desire to attract skilled expatriate health care providers have led to favorable conditions for the medical device market in the GCC. The purpose of this article is to investigate the current state of the GCC medical device industry, with respect to market, regulation, and reimbursement, paying special attention to the three largest medical device markets: Saudi Arabia, the United Arab Emirates, and Qatar. The GCC would seem to represent fertile ground for the development of medical technologies, especially those in line with the regional health priorities of the respective member states. PMID:25429243

  16. Efifcient Methods for Approaching Functional Safety to Hardware Systems of Medical Devices

    Institute of Scientific and Technical Information of China (English)

    KIMGi-young; WANGDa-wei; PARKHo-joon; JANG Joong-soon

    2015-01-01

    A medical device is an instrument that includes components, parts, or accessories to diagnose or treat patients. Since the complexity of medical devices has increased in recent years, functional safety and basic safety are required to ensure the overall device safety. Functional safety is part of the overall safety that relates to the equipment under control (EUC) and to the EUC control system that depends on the correct functionality of the electrical/electronic/programmable electronic (E/E/PE) safety-related systems. This study proposes approach methods to functional safety of medical devices for which it is important to correctly identify the safety functions and the safety integrity level (SIL). The relationship between the functional safety and essential performance is identiifed focusing on the safety function. The essential performance of E/E/PE systems is deifned as the safety function of the functional safety. The target SIL of the essential performance is determined according to the potential risk levels, based on the classiifcation rules of medical devices. This approach is applied to the pulse oximeter as a case study. The target SIL for the functionality of the power-failure alarm condition is determined to be SIL1. The target SILs of other functions are determined as SIL2.

  17. New French Coverage with Evidence Development for Innovative Medical Devices: Improvements and Unresolved Issues.

    Science.gov (United States)

    Martelli, Nicolas; van den Brink, Hélène; Borget, Isabelle

    2016-01-01

    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. PMID:26797231

  18. Medical Device-Associated Candida Infections in a Rural Tertiary Care Teaching Hospital of India

    Directory of Open Access Journals (Sweden)

    Sachin C. Deorukhkar

    2016-01-01

    Full Text Available Health care associated infections (HCAIs add incrementally to the morbidity, mortality, and cost expected of the patient’s underlying diseases alone. Approximately, about half all cases of HCAIs are associated with medical devices. As Candida medical device-associated infection is highly drug resistant and can lead to serious life-threatening complications, there is a need of continuous surveillance of these infections to initiate preventive and corrective measures. The present study was conducted at a rural tertiary care hospital of India with an aim to evaluate the rate of medical device-associated Candida infections. Three commonly encountered medical device-associated infections (MDAI, catheter-associated urinary tract infection (CA-UTI, intravascular catheter-related blood stream infections (CR-BSI, and ventilator-associated pneumonia (VAP, were targeted. The overall rate of MDAI in our hospital was 2.1 per 1000 device days. The rate of Candida related CA-UTI and CR-BSI was noted as 1.0 and 0.3, respectively. Untiring efforts taken by team members of Hospital Acquired Infection Control Committee along with maintenance of meticulous hygiene of the hospital and wards may explain the low MDAI rates in our institute. The present surveillance helped us for systematic generation of institutional data regarding MDAI with special reference to role of Candida spp.

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

    OpenAIRE

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

    2012-01-01

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

  20. Perceptions and practices regarding use of personal listening devices among medical students in coastal South India

    OpenAIRE

    T. Rekha; Unnikrishnan, B; Prasanna P Mithra; Nithin Kumar; Mario Joseph Bukelo; Kirthinath Ballala

    2011-01-01

    Today′s generation enjoys having music at their fingertips. This has led to an increase in the usage of personal listening devices (PLDs) over the past decade. There are significant concerns regarding harmful effects of PLD use. To find out the perception and practice of medical students regarding use of PLDs. Cross-sectional study was carried out in Mangalore, Coastal south India. Data were collected using a 31 item semi structured questionnaire that was distributed among 570 medical student...

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

    Science.gov (United States)

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

    2016-01-01

    We review the recent development of mobile detection instruments used for medical diagnostics, and consider the relative advantages of approaches that utilize the internal sensing capabilities of commercially available mobile communication devices (such as smartphones and tablet computers) compared to those that utilize a custom external sensor module. In this review, we focus specifically upon mobile medical diagnostic platforms that are being developed to serve the need in global health, personalized medicine, and point-of-care diagnostics. PMID:26952640

  2. Growth strategy for a battery supplier to the implantable medical device market

    OpenAIRE

    Gramm, Prescott

    2005-01-01

    This project develops strategic recommendations for the growth of the Eaglepicher (EP) Medical Energy Products (MEP) group - a battery supplier to Implantable Medical Device (IMD) manufacturers. The analysis evaluates the key external competitive forces of the battery industry and finds the IMD market to be most attractive. The internal characteristics of the firm are examined using industry benchmarking and a value chain analysis. The current strategy is examined by integrating the external ...

  3. Towards fabrication of 3D printed medical devices to prevent biofilm formation

    DEFF Research Database (Denmark)

    Sandler, Niklas; Salmela, Ida; Fallarero, Adyary;

    2014-01-01

    The use of three-dimensional (3D) printing technologies is transforming the way that materials are turned into functional devices. We demonstrate in the current study the incorporation of anti-microbial nitrofurantoin in a polymer carrier material and subsequent 3D printing of a model structure......, which resulted in an inhibition of biofilm colonization. The approach taken is very promising and can open up new avenues to manufacture functional medical devices in the future....

  4. 75 FR 72829 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2010-11-26

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Medical Devices; Availability of Safety and Effectiveness... In the Federal Register of January 30, 1998 (63 FR 4571), FDA published a final rule that revised...

  5. 76 FR 29153 - Medical Devices; Reclassification of the Topical Oxygen Chamber for Extremities; Correction

    Science.gov (United States)

    2011-05-20

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 878 Medical Devices; Reclassification of the... appeared in the Federal Register of April 25, 2011 (76 FR 22805). The document announced that FDA is..., MD 20993-0002, 301- 796-6438. SUPPLEMENTARY INFORMATION: In FR Doc. 2011-9899 appearing on page...

  6. Highly sensitive pyrogen detection on medical devices by the monocyte activation test

    NARCIS (Netherlands)

    Stang, Katharina; Fennrich, Stefan; Krajewski, Stefanie; Stoppelkamp, Sandra; Burgener, Iwan Anton; Wendel, Hans-Peter; Post, Marcell

    2014-01-01

    Pyrogens are components of microorganisms, like bacteria, viruses or fungi, which can induce a complex inflammatory response in the human body. Pyrogen contamination on medical devices prior operation is still critical and associated with severe complications for the patients. The aim of our study w

  7. 21 CFR 610.42 - Restrictions on use for further manufacture of medical devices.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Restrictions on use for further manufacture of medical devices. 610.42 Section 610.42 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS GENERAL BIOLOGICAL PRODUCTS STANDARDS Testing Requirements for Communicable Disease Agents §...

  8. Introduction: Feature Issue on Phantoms for the Performance Evaluation and Validation of Optical Medical Imaging Devices

    OpenAIRE

    Hwang, Jeeseong; Ramella-Roman, Jessica C.; Nordstrom, Robert

    2012-01-01

    The editors introduce the Biomedical Optics Express feature issue on “Phantoms for the Performance Evaluation and Validation of Optical Medical Imaging Devices.” This topic was the focus of a technical workshop that was held on November 7–8, 2011, in Washington, D.C. The feature issue includes 13 contributions from workshop attendees.

  9. Test method for the microbial barrier properties of packaging for medical devices ; RIVM method

    NARCIS (Netherlands)

    Bruijn ACP de; Asten JAAM van; LGM

    1995-01-01

    One of the most important qualities of packaging for medical devices is the ability to keep the contents sterile. The quality of the packaging is determined by the quality of the material and the quality of the seals. The former is usually tested with test methods using micro-organisms. In hospitals

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

    Data.gov (United States)

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

  11. 77 FR 74630 - Medical Waivers for Merchant Mariner Credential Applicants With Anti-Tachycardia Devices or...

    Science.gov (United States)

    2012-12-17

    ... Federal Register (73 FR 3316). Background and Purpose On September 7, 2012, the Coast Guard published a... to mariners who have anti-tachycardia devices or ICDs (77 FR 55174). The notice contains a detailed... SECURITY Coast Guard 46 CFR Part 10 Medical Waivers for Merchant Mariner Credential Applicants With...

  12. Inductively heated shape memory polymer for the magnetic actuation of medical devices.

    Science.gov (United States)

    Buckley, Patrick R; McKinley, Gareth H; Wilson, Thomas S; Small, Ward; Benett, William J; Bearinger, Jane P; McElfresh, Michael W; Maitland, Duncan J

    2006-10-01

    Presently, there is interest in making medical devices such as expandable stents and intravascular microactuators from shape memory polymer (SMP). One of the key challenges in realizing SMP medical devices is the implementation of a safe and effective method of thermally actuating various device geometries in vivo. A novel scheme of actuation by Curie-thermoregulated inductive heating is presented. Prototype medical devices made from SMP loaded with nickel zinc ferrite ferromagnetic particles were actuated in air by applying an alternating magnetic field to induce heating. Dynamic mechanical thermal analysis was performed on both the particle-loaded and neat SMP materials to assess the impact of the ferrite particles on the mechanical properties of the samples. Calorimetry was used to quantify the rate of heat generation as a function of particle size and volumetric loading of ferrite particles in the SMP. These tests demonstrated the feasibility of SMP actuation by inductive heating. Rapid and uniform heating was achieved in complex device geometries and particle loading up to 10% volume content did not interfere with the shape recovery of the SMP. PMID:17019872

  13. Inductively Heated Shape Memory Polymer for the Magnetic Actuation of Medical Devices

    Energy Technology Data Exchange (ETDEWEB)

    Buckley, P; Mckinley, G; Wilson, T; Small, W; Benett, W; Bearinger, J; McElfresh, M; Maitland, D

    2005-09-06

    Presently there is interest in making medical devices such as expandable stents and intravascular microactuators from shape memory polymer (SMP). One of the key challenges in realizing SMP medical devices is the implementation of a safe and effective method of thermally actuating various device geometries in vivo. A novel scheme of actuation by Curie-thermoregulated inductive heating is presented. Prototype medical devices made from SMP loaded with Nickel Zinc ferrite ferromagnetic particles were actuated in air by applying an alternating magnetic field to induce heating. Dynamic mechanical thermal analysis was performed on both the particle-loaded and neat SMP materials to assess the impact of the ferrite particles on the mechanical properties of the samples. Calorimetry was used to quantify the rate of heat generation as a function of particle size and volumetric loading of ferrite particles in the SMP. These tests demonstrated the feasibility of SMP actuation by inductive heating. Rapid and uniform heating was achieved in complex device geometries and particle loading up to 10% volume content did not interfere with the shape recovery of the SMP.

  14. Standards for medical device communication: X73 PoC-MDC.

    Science.gov (United States)

    Galarraga, Miguel; Serrano, Luis; Martínez, Ignacio; de Toledo, Paula

    2006-01-01

    When using a number of medical devices from very different manufacturers with different proprietary formats the problem of a lack of interoperability emerges. Connectivity and communications are then limited and the systems and users can not exploit all the possibilities that Information and Communication Technologies offer today. The use and application of standards can be the solution to bring light to this confusion of languages in this Tower of Babel. There are several standards applicable to medical information systems interoperability and, analyzing these different options, the X73 PoC-MDC (ISO11073/IEEE1073) set of standards for Point of Care Medical Device Communication is the best positioned international standard to provide interoperability in these communications. PMID:17095823

  15. Comments on the Japanese study of the radiation resistance of the bioburden of medical devices

    International Nuclear Information System (INIS)

    The findings obtained in an extensive study of the radiation resistance electrons, even with a broad energy sa number of medical devices has been carried out by Takehisa et al. and reported in this number of this Journal. The following paper reviews the expected behaviour of the reported populations under the conditions specified in ISO Standard 11137 Method 1, which is widely used in the determination of the radiation sterilization dose required for sterilization of medical devices. The populations reported for 'dry' devices contain a higher proportion of more radiation resistant microbes than that found in the standard distribution of resistance (SDR) that is used for setting the sterilization dose in Method 1. A possible alternative dose setting method for more resistant microbial populations is introduced and discussed

  16. Comments on the Japanese study of the radiation resistance of the bioburden of medical devices

    Energy Technology Data Exchange (ETDEWEB)

    Whitby, James L

    1998-06-01

    The findings obtained in an extensive study of the radiation resistance electrons, even with a broad energy sa number of medical devices has been carried out by Takehisa et al. and reported in this number of this Journal. The following paper reviews the expected behaviour of the reported populations under the conditions specified in ISO Standard 11137 Method 1, which is widely used in the determination of the radiation sterilization dose required for sterilization of medical devices. The populations reported for 'dry' devices contain a higher proportion of more radiation resistant microbes than that found in the standard distribution of resistance (SDR) that is used for setting the sterilization dose in Method 1. A possible alternative dose setting method for more resistant microbial populations is introduced and discussed.

  17. Comments on the Japanese study of the radiation resistance of the bioburden of medical devices

    Science.gov (United States)

    Whitby, James L.

    1998-06-01

    The findings obtained in an extensive study of the radiation resistance of microbes forming the bioburden of a number of medical devices has been carried out by Takehisa et al. and reported in this number of this Journal. The following paper reviews the expected behaviour of the reported populations under the conditions specified in ISO Standard 11137 Method 1, which is widely used in the determination of the radiation sterilization dose required for sterilization of medical devices. The populations reported for "dry" devices contain a higher proportion of more radiation resistant microbes than that found in the standard distribution of resistance (SDR) that is used for setting the sterilization dose in Method 1. A possible alternative dose setting method for more resistant microbial populations is introduced and discussed.

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

    Energy Technology Data Exchange (ETDEWEB)

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

    1995-09-01

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

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

    International Nuclear Information System (INIS)

    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

  20. Globus MEDICUS - federation of DICOM medical imaging devices into healthcare Grids.

    Science.gov (United States)

    Erberich, Stephan G; Silverstein, Jonathan C; Chervenak, Ann; Schuler, Robert; Nelson, Marvin D; Kesselman, Carl

    2007-01-01

    The Digital Imaging and Communications in Medicine (DICOM) standard defines Radiology medical device interoperability and image data exchange between modalities, image databases - Picture Archiving and Communication Systems (PACS) - and image review end-points. However the scope of DICOM and PACS technology is currently limited to the trusted and static environment of the hospital. In order to meet the demand for ad-hoc tele-radiology and image guided medical procedures within the global healthcare enterprise, a new technology must provide mobility, security, flexible scale of operations, and rapid responsiveness for DICOM medical devices and subsequently medical image data. Grid technology, an informatics approach to securely federate independently operated computing, storage, and data management resources at the global scale over public networks, meets these core requirements. Here we present an approach to federate DICOM and PACS devices for large-scale medical image workflows within a global healthcare enterprise. The Globus MEDICUS (Medical Imaging and Computing for Unified Information Sharing) project uses the standards-based Globus Toolkit Grid infrastructure to vertically integrate a new service for DICOM devices - the DICOM Grid Interface Service (DGIS). This new service translates between DICOM and Grid operations and thus transparently extends DICOM to Globus based Grid infrastructure. This Grid image workflow paradigm has been designed to provide not only solutions for global image communication, but fault-tolerance and disaster recovery using Grid data replication technology. Actual use-case of 40 MEDICUS Grid connected international hospitals of the Childerns Oncology Group and the Neuroblastoma Cancer Foundation and further clinical applications are discussed. The open-source Globus MEDICU http://dev.globus.org/wiki/Incubator/MEDICUS. PMID:17476069

  1. Dynamic DICOM configuration in a service-oriented medical device architecture.

    Science.gov (United States)

    Schlamelcher, Jan; Onken, Michael; Eichelberg, Marco; Hein, Andreas

    2015-08-01

    A surgical intervention raises additional requirements to a medical device network, be it security concerns or the demand for just-in-time integration of an additional devices. The German national flagship project OR.NET aims to satisfy these requirements by defining, implementing and validating an integration solution for safe and dynamic networking. This work presents an approach to incorporate imaging related medical devices into a dynamic plug and play operating room (OR) network utilizing the existing Digital Imaging and Communications in Medicine (DICOM) protocol. The presented approach was created as part of the OR.NET project to realize the integration of DICOM devices into the developed infrastructure, both in regard to newly created DICOM devices with direct support of the OR.NET protocol and the integration of existing DICOM devices (e.g. image archives) employing a gateway. Preliminary evaluation results indicate that the approach is viable and that no critical transmission delays are introduced by the prototypical gateway implementation. PMID:26736608

  2. Integrating medical devices in the operating room using service-oriented architectures.

    Science.gov (United States)

    Ibach, Bastian; Benzko, Julia; Schlichting, Stefan; Zimolong, Andreas; Radermacher, Klaus

    2012-08-01

    Abstract With the increasing documentation requirements and communication capabilities of medical devices in the operating room, the integration and modular networking of these devices have become more and more important. Commercial integrated operating room systems are mainly proprietary developments using usually proprietary communication standards and interfaces, which reduce the possibility of integrating devices from different vendors. To overcome these limitations, there is a need for an open standardized architecture that is based on standard protocols and interfaces enabling the integration of devices from different vendors based on heterogeneous software and hardware components. Starting with an analysis of the requirements for device integration in the operating room and the techniques used for integrating devices in other industrial domains, a new concept for an integration architecture for the operating room based on the paradigm of a service-oriented architecture is developed. Standardized communication protocols and interface descriptions are used. As risk management is an important factor in the field of medical engineering, a risk analysis of the developed concept has been carried out and the first prototypes have been implemented. PMID:22718585

  3. Dangers Facing the Earth Charter

    Science.gov (United States)

    Ruiz, Javier Reyes

    2010-01-01

    The article explores social and educational processes that could undermine the Earth Charter's promise. It points out that the meaning of the Charter would be affected if it is used in a doctrinaire manner, if individuals or groups assume the role of its legitimate and expert emissaries, if it takes on a messianic tone in its central ideas, if it…

  4. Boot Camps for Charter Boards

    Science.gov (United States)

    Kronholz, June

    2015-01-01

    This article addresses the question of who owns the responsibility when a charter school gets into trouble--when its students aren't learning, or it misses its enrollment targets, or money runs short, or it closes. Upon presenting this question to a director of a charter school, a board member, and a Massachusetts-based education consultant and…

  5. Charter Schooling and Democratic Justice

    Science.gov (United States)

    Abowitz, Kathleen Knight; Karaba, Robert

    2010-01-01

    As the mixed achievements of charter schools come under more intense political inspection, the conceptual underpinnings of current charter school reform remain largely unexamined. This article focuses on one moral-political concept centrally related to school reform and policy, the concept of justice. Using examples from the state of Ohio, the…

  6. Charter School Replication. Policy Guide

    Science.gov (United States)

    Rhim, Lauren Morando

    2009-01-01

    "Replication" is the practice of a single charter school board or management organization opening several more schools that are each based on the same school model. The most rapid strategy to increase the number of new high-quality charter schools available to children is to encourage the replication of existing quality schools. This policy guide…

  7. 77 FR 16036 - Guidance for Industry, Third Parties and Food and Drug Administration Staff; Medical Device ISO...

    Science.gov (United States)

    2012-03-19

    ... Submission Program'' was published for comment in the Federal Register of May 20, 2010 (75 FR 28257... Administration Staff; Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program; Availability... (FDA) is announcing the availability of the guidance entitled ``Medical Device ISO 13485:2003...

  8. 21 CFR 801.128 - Exceptions or alternatives to labeling requirements for medical devices held by the Strategic...

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Exceptions or alternatives to labeling requirements for medical devices held by the Strategic National Stockpile. 801.128 Section 801.128 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions From Adequate Directions...

  9. Radiation sterilization of medical devices. Effects of ionizing radiation on ultra-high molecular-weight polyethylene

    International Nuclear Information System (INIS)

    Sterilization by ionizing radiation has become, next to ethylene oxide treatment, the most important ''cold'' sterilization process for medical devices made from plastics. The effects of ionizing radiation on the most important polymer for medical devices, ultra-high molecular-weight polyethylene, are briefly described in this review. (author)

  10. Distributed Real-Time Emulation of Formally-Defined Patterns for Safe Medical Device Control

    CERN Document Server

    Sun, Mu; 10.4204/EPTCS.36.9

    2010-01-01

    Safety of medical devices and of their interoperation is an unresolved issue causing severe and sometimes deadly accidents for patients with shocking frequency. Formal methods, particularly in support of highly reusable and provably safe patterns which can be instantiated to many device instances can help in this regard. However, this still leaves open the issue of how to pass from their formal specifications in logical time to executable emulations that can interoperate in physical time with other devices and with simulations of patient and/or doctor behaviors. This work presents a specification-based methodology in which virtual emulation environments can be easily developed from formal specifications in Real-Time Maude, and can support interactions with other real devices and with simulation models. This general methodology is explained in detail and is illustrated with two concrete scenarios which are both instances of a common safe formal pattern: one scenario involves the interaction of a provably safe ...

  11. A Real time Data Acquisition and Monitoring Device for Medical Applications based on Android Platform

    Directory of Open Access Journals (Sweden)

    Jithin Krishnan

    2013-09-01

    Full Text Available An android based real time data acquisition and monitoring device is presented here. The system finds its initial application in medical field .it serves as a remote monitor for measuring and analysing along with logging of data from patients. The system comprises of two parts. A data acquisition (DaQ part connected to patient side and an android based display device on the receiving end. The Data Acquisition part contains sensors for picking up the vital signs from the patients, signal conditioning circuits and a Bluetooth transceiver to transmit data wirelessly to the display device. The Display Device then displays the data received from the transmitter in a readable form and also logs the data into a excel form so that it can be taken out digitally and analysed.

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

    Science.gov (United States)

    Noon, Christian; Holub, Joseph; Winer, Eliot

    2013-03-01

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

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2015-12-15

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

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

    Directory of Open Access Journals (Sweden)

    Martin Jennifer L

    2012-07-01

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

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

    Directory of Open Access Journals (Sweden)

    Ross JS

    2015-05-01

    Full Text Available Joseph S Ross, Katrina L Blount, Jessica D Ritchie, Beth Hodshon, Harlan M Krumholz Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA Background: In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA's pre-market approval (PMA pathway. Methods and results: We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%, nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Conclusion: Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives. Keywords: FDA, PMA pathway, post-market surveillance

  16. More Middle-Class Families Choose Charters

    Science.gov (United States)

    Whitmire, Richard

    2015-01-01

    The rise in middle-class students attending charter schools is largely masked by the overall growth of charter schools: over the last five years, the number of charter schools has grown nationally from 4,690 to just over 6,000. There are now 43 communities where at least 20 percent of the students attend charters, reports the National Alliance for…

  17. Characterizing HIV medication adherence for virologic success among individuals living with HIV/AIDS: Experience with the CNS HIV Antiretroviral Therapy Effects Research (CHARTER) cohort

    OpenAIRE

    B. Biswas; Spitznagel, E.; Collier, A.C.; Gelman, B.B.; McArthur, J.C.; Morgello, S; McCutchan, J A; CLIFFORD, D.B.

    2014-01-01

    Antiretroviral therapy (ART) has changed HIV related illness from terminal to chronic by suppressing viral load which results in immunologic and clinical improvement. Success with ART is dependent on optimal adherence, commonly categorized as >95%. As medication type, class and frequency of use continue to evolve, we assessed adherence levels related to viral suppression. Using a cross-sectional analysis with secondary data (n = 381) from an ongoing multi-site study on impact of ART on the Ce...

  18. Regulation of medical devices in radiology: current standards and future opportunities.

    Science.gov (United States)

    Smith, J J

    2001-02-01

    Today's radiology community depends heavily on cutting-edge diagnostic and therapeutic medical devices to serve patients. These products are regulated by the U.S. Food and Drug Administration (FDA) under a system that grants marketing approval for only those indications for which the safety and effectiveness have been established. Although this complex system is the result of a societal decision to ensure device safety and effectiveness, it has the potential to delay product marketing and impede innovation. Medical device regulation recently has undergone major changes with the enactment of the Food and Drug Administration Modernization Act of 1997 (FDAMA), legislation that is intended to increase system efficiency while retaining the requirement of safety and effectiveness. However, many of the envisioned improvements cannot occur without cooperative interaction between stakeholders in the device development process, including the FDA and the clinical medicine community. The radiology field must continue to build on its strong history of productive dialogue with the FDA to transform the legislative vision of FDAMA into regulatory reality. Such action will ensure timely access to the new device technologies that are necessary for the growth of our specialty and the effective care of our patients. PMID:11161144

  19. The comparative study of the performance of display devices in medical imaging system

    International Nuclear Information System (INIS)

    Objective: To analyze the effects of three different display devices on the interpretation of imaging data in medical imaging system. Methods: The luminance-meter L100 and the test patterns provided by the American Association of Physicists in Medicine (AAPM) were used to assess the performance of three display devices (the spherical, flat panel and liquid crystal display devices3awko9). The corresponding luminance response was compared with the reference criteria provided by AAPM Task Group 18 (AAPM TG18). DR chest photography was taken on CDRAD2.0 contrast-detail phantom using the following experimental parameters: 100 mA, 80 kVp, and the exposure times for 6, 10, 12, and 16 ms. After each exposure, the surface dose of phantom was recorded and the image quality factor (IQF) was calculated. Statistical analysis of IQF was performed using ANOVA. Results: The maximum luminance values in the spherical, flat panel and liquid crystal display devices were 170, 59 and 231 cd/m2 and the luminance ratio was 257, 99 and 350 respectively. There was a significant difference in the IQF between the liquid crystal display device and other two display devices. Conclusion: The liquid crystal display device has the better image quality. (authors)

  20. Application of the active shape model in a commercial medical device for bone densitometry

    DEFF Research Database (Denmark)

    Thodberg, Hans Henrik; Rosholm, Anders

    2003-01-01

    sufficient list of initial guesses for the ASM. The performance of ASM and the experience with the integration of ASM in a commercial medical device is reported. The ASM achieves 99.5% reconstruction success and is able to validate its own reconstruction in 97% of the cases. The system (Pronosco X......Osteoporosis is a common disorder characterised mainly by low bone mineral density (BMD), and leading to an increased risk of fracture. We have developed a new device that estimates BMD from ordinary hand radiographs. A crucial element of this method is the reconstruction of the metacarpals. This...

  1. Designing a program to assess potential induced radioactivity in electron beam sterilization of medical devices

    International Nuclear Information System (INIS)

    ISO 11137-1:2006 requires that the potential for induced radioactivity be evaluated for medical devices irradiated with electrons with energy more than 10 MeV. For a manufacturing operation where new devices are being developed, a practical program for making such an evaluation needs to be engrained in the process. A program was developed such that the induced radioactivity evaluation is imbedded in the development of the irradiation process. - Highlights: • A program is described to evaluate induced radioactivity in electron beam. • The program entails evaluation of design prior to manufacturing. • Radiation measurement is done immediately following irradiation. • The instrument has adequate sensitivity for this purpose

  2. Statistical innovations in the medical device world sparked by the FDA.

    Science.gov (United States)

    Campbell, Gregory; Yue, Lilly Q

    2016-01-01

    The world of medical devices while highly diverse is extremely innovative, and this facilitates the adoption of innovative statistical techniques. Statisticians in the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA) have provided leadership in implementing statistical innovations. The innovations discussed include: the incorporation of Bayesian methods in clinical trials, adaptive designs, the use and development of propensity score methodology in the design and analysis of non-randomized observational studies, the use of tipping-point analysis for missing data, techniques for diagnostic test evaluation, bridging studies for companion diagnostic tests, quantitative benefit-risk decisions, and patient preference studies. PMID:26372890

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

    International Nuclear Information System (INIS)

    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

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

    International Nuclear Information System (INIS)

    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

  5. [Establishment and management of documentation within QMS of medical device enterprises].

    Science.gov (United States)

    Tian, Shaolei

    2013-09-01

    The objectives of QMS for quality assurance of products are achieved by formulation, implement, and management of document system. Document (includes record) system is important constituent part of QMS. In this paper, the important issues and relative requirements of GMP on the establishment and management of documentation within quality management system (QMS) of medical device enterprises are discussed with the aim of providing reference for relative enterprises to build and improve their QMS and to implement GMP. PMID:24409796

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

    OpenAIRE

    Williams PAH; Woodward AJ

    2015-01-01

    Patricia AH Williams, Andrew J Woodward eHealth Research Group and Security Research Institute, Edith Cowan University, Perth, WA, Australia Abstract: The increased connectivity to existing computer networks has exposed medical devices to cybersecurity vulnerabilities from which they were previously shielded. For the prevention of cybersecurity incidents, it is important to recognize the complexity of the operational environment as well as to catalog the technical vulnerabilities. Cybersecur...

  7. A Pharmacological and Toxicological Profile of Silver as an Antimicrobial Agent in Medical Devices

    OpenAIRE

    Alan B. G. Lansdown

    2010-01-01

    Silver is used widely in wound dressings and medical devices as a broad-spectrum antibiotic. Metallic silver and most inorganic silver compounds ionise in moisture, body fluids, and secretions to release biologically active A g + . The ion is absorbed into the systemic circulation from the diet and drinking water, by inhalation and through intraparenteral administration. Percutaneous absorption of A g + through intact or damaged skin is low. A g + binds strongly to metallothionein, albumins, ...

  8. Med-Trace: traceability assessment method for medical device software development

    OpenAIRE

    Casey, Valentine; Mc Caffery, Fergal

    2011-01-01

    peer-reviewed Traceability is central to medical device software development and is an essential requirement for regulatory approval. To achieve compliance an effective traceability process needs to be in place. This process must ensure the need for clear linkages and traceability from software requirements - including risks - through the different stages of the software development and maintenance lifecycles. This is difficult to achieve due to the lack of specific guidance which the medi...

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

    OpenAIRE

    Gittard, Shaun D; Narayan, Roger J

    2010-01-01

    Laser-based direct writing of materials has undergone significant development in recent years. The ability to modify a variety of materials at small length scales and using short production times provides laser direct writing with unique capabilities for fabrication of medical devices. In many laser-based rapid prototyping methods, microscale and submicroscale structuring of materials is controlled by computer-generated models. Various laser-based direct write methods, including selective las...

  10. Classroom to Clinic: Merging Education and Research to Efficiently Prototype Medical Devices

    OpenAIRE

    Hanumara, Nevan C.; Begg, Nikolai D.; Walsh, Conor; Custer, David; Gupta, Rajiv; Osborn, Lynn R.; Slocum, Alexander H.

    2013-01-01

    Innovation in patient care requires both clinical and technical skills, and this paper presents the methods and outcomes of a nine-year, clinical-academic collaboration to develop and evaluate new medical device technologies, while teaching mechanical engineering. Together, over the course of a single semester, seniors, graduate students, and clinicians conceive, design, build, and test proof-of-concept prototypes. Projects initiated in the course have generated intellectual property and peer...

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

    OpenAIRE

    World Bank, (WB)

    2011-01-01

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

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

    OpenAIRE

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

    2013-01-01

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

  13. Balancing innovation and medical device regulation: the case of modern metal-on-metal hip replacements

    Directory of Open Access Journals (Sweden)

    Howard JJ

    2016-08-01

    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

  14. Processing single-use medical devices for use in surgery – importance, status quo and potential

    Directory of Open Access Journals (Sweden)

    Krüger, Colin M.

    2008-09-01

    Full Text Available In summary, it is possible with the technology and scientific knowledge currently available to allow products intended for single use to be reprocessed using validated and certified processing procedures, while maintaining the full function and without any loss in quality. How many times a product can be re-processed must be determined separately for each individual medical technology device; it is not possible to make any kind of blanket statement as to the permissible number of cycles. This is due to the differing construction, the various combinations of materials and the diverse demands made of each device during clinical use. The exigency of the reprocessing issue is evident both to the user and the primary manufacturer. For the user, where there is a correspondingly high-quality primary product with suitably costed, technically-sound and certified reprocessing procedures, repeat usage can mean real savings while maintaining full functionality in each use. For the primary manufacturers of highly specialised instruments, only part of which can be represented by the medical facility in terms of a corresponding DRG (Diagnosis-Related Group, it is reprocessing that opens the door to widespread routine clinical use. The patient, in turn, benefits greatly from this, since his demand for medical treatment using the most up-to-date technology is taken into account. If processing complies in full with medical technology and hygiene directives, from the medical point of view (without being able to definitively evaluate each individual case using this criterion the specific advantages of the reprocessing procedure are obvious. In order to establish broad acceptance for the purposes of good marketing, corresponding controlling and quality instruments have to be developed to allow the decision-making process regarding the permissibility of the reprocessing of a certain device and the number of times it can be reprocessed using this procedure to be made

  15. Determination of bisphenol A in water and the medical devices used in hemodialysis treatment.

    Science.gov (United States)

    Bacle, Astrid; Thevenot, Sarah; Grignon, Claire; Belmouaz, Mohamed; Bauwens, Marc; Teychene, Benoit; Venisse, Nicolas; Migeot, Virginie; Dupuis, Antoine

    2016-05-30

    Bisphenol A (BPA) is an endocrine disruptor found in food containers and plastic beverages and also in medical devices such as dialyzers. The aim of this study is while taking into account the BPA originating in medical devices and the water used in dialysate production, to provide the first published investigation of overall potential exposure to BPA during hemodialysis treatment in patients suffering from end-stage renal disease. BPA concentration in water (at each step of purification treatment) and in dialysate and BPA leaching from dialyzers were determined using solid-phase extraction coupled to ultra-high-performance-liquid chromatography tandem mass spectrometry. We have corroborated the hypothesis that a significant amount of BPA may migrate from dialyzers and also demonstrated that BPA is provided by the water used in dialysate production (8.0±5.2ngL(-1) on average) and by dialysis machine and dialysate cartridges, leading to dialysate contamination of 22.7±15.6ngL(-1) on average. Taking into account all the sources of BPA contamination that may come into play during a hemodialysis session, the highest exposure could reach an estimated 140ng/kg b.w./day for hemodialyzed patients, directly available for systemic exposure. Finally, BPA contamination should be taken into account as concerns both the medical devices commonly used in hemodialysis and purified water production systems. PMID:27012980

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

    Directory of Open Access Journals (Sweden)

    Carlos García Sánchez

    2013-01-01

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

  17. Cost analysis of integrating the PrePex medical device into a voluntary medical male circumcision program in Zimbabwe.

    Directory of Open Access Journals (Sweden)

    Emmanuel Njeuhmeli

    Full Text Available 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.

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

    International Nuclear Information System (INIS)

    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)

  19. System-level design trade-offs for truly wearable wireless medical devices.

    Science.gov (United States)

    Chen, Guangwei; Rodriguez-Villegas, Esther

    2010-01-01

    Power and current management in emerging wearable medical devices, intended to continuously monitor physiological signals, are crucial design issues. The overall size of the electronic part of these systems is generally going to be dominated by the size of the batteries. Unfortunately, the options of smaller batteries do not only come at the expense of a lower capacity and hence shorter operation time. It also significantly constrains the amount of available current that can be used by different electronic blocks, as well as their operating power supply voltage. This paper discusses all the typical power and current management system level issues in the design of a typical miniature wearable wireless medical device. The discussion is illustrated with experimental results obtained with two devices built using two of the currently most popular low power commercial transceivers in the market, the Texas Instruments (TI) CC2500 and the Nordic Semiconductor nRF24L01+. The numbers presented can be used as a more realistic guidance of the energy per bit required in a real system implementation, as opposed to the ideal figures normally quoted by the manufacturers. Furthermore the analysis in this paper can also be extrapolated to the design of future wireless monitoring wearable devices with further optimized radio transceivers. PMID:21096352

  20. Mobility Charters and Manifestos

    DEFF Research Database (Denmark)

    Jensen, Ole B.

    2010-01-01

    This paper explore a number of different cases of articulating notions of ‘correct’ mobility behavior and practice by looking into charters, manifestos and codes of mobility regulation. Within such discourses of ‘correct mobility’ more or less subtle expressions of power as well as normative and...... ethical positions on mobility prevail. Such ‘imagined correct mobility behavior’ are drawing on larger issues of societal change that need to be brought out in a critical analysis and discussion reflecting the attempts to control, design and orchestrate mobility patterns. The paper therefore argues within...... 2007, the English ‘Highway Code Booklets’ from the 1930’s, 40’s and 50’s, the ‘City Slow Charter’, the ‘New Urbanism Charter’ as attempts to codify and order mobility and mobile practices....

  1. The role of the Pharmaceuticals and Medical Devices Agency and healthcare professionals in post-marketing safety.

    Science.gov (United States)

    Mori, Kazuhiko; Watanabe, Meguru; Horiuchi, Naoya; Tamura, Atsushi; Kutsumi, Hiromu

    2014-04-01

    The development of drugs and medical devices is necessary for medical progress; however, safety measures need to be put in place to protect the health of the population. In order to ensure the safety of drugs and medical devices, it is important to determine measures for appropriate management of risks at any time during the development phase, the regulatory review and the post-marketing phase. Adverse events detected in clinical trials are limited due to the restricted numbers of patients enrolled in the trials. Therefore, it is almost impossible to predict rare serious adverse events during the post-marketing phase. The revised Pharmaceutical Affairs Act was established in Japan in November 20, 2013. The new act focuses on increased safety of drugs and medical devices. The Pharmaceuticals and Medical Devices Agency (PMDA) is the regulatory authority in Japan that promotes safety measures from the development phase through to the post-marketing phase. In the post-marketing phase, the PMDA collects information from the medical product companies and healthcare professionals, as well as instructing and advising them with regard to post-marketing safety measures for each drug and medical device. Since Japan has a national health insurance system, a new drug or a medical device is available throughout the country when the drug price or medical fee is listed in the National Health Insurance price list. Healthcare professionals in medical institutions must learn about the drugs and medical devices they handle, and should make an effort to maintain patient safety. The PMDA medi-navi is a very useful electronic mail delivery service that provides critical information for protecting patients from health hazards caused by adverse events. The 'risk management plan' is also important as it contains important information about safety profile and post-marketing measures of a new drug. PMID:26183623

  2. Charter Halibut Limited Access Program

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — This limited access system limits the number of charter vessels that may participate in the guided sport fishery for halibut in area 2C and 3A. NMFS issues a...

  3. Earth Charter and nuclear energy

    International Nuclear Information System (INIS)

    The chapter presents Earth Charter, where are listed the principles in 4 sections: 1) respect and take care of the life community; 2) environmental integrity; social and economic welfare; 4) democracy, no-violence and peace

  4. Toward a Framework of the Process of Open Innovation — Case of Acclarent in the Medical Device Industry

    OpenAIRE

    Hua-Hsin Wan; Xiaohong Iris Quan

    2014-01-01

    Using a case study of Acclarent, a medical device company, this paper attempts to propose a framework to further illustrate the process of open innovation in the medical device industry. We examined five elements in the mechanism of the open innovation process. Our paper shows how the success of Acclarent — a medical device start-up — depends on effective management of the flow of knowledge to satisfy unmet needs, while integrating in-depth knowledge of FDA regulations and third-party payers'...

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

    Science.gov (United States)

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

    2013-01-01

    While research investigating direct-to-consumer advertising of therapeutic goods in Australia has historically focused on prescription medicines, recent action taken by regulators against companies promoting medical devices has placed the industry into the spotlight. Despite the need to effectively regulate direct-to-consumer advertising of medical devices due to its potential harms, inadequacies in the current regulatory system have been noted. Under the present system, devices with a questionable evidence base may enter the Australian marketplace without an evaluation of their effectiveness, and regulators are reliant on industry self-regulation and consumer complaints to draw attention to cases of advertising misconduct. Although some successes in the present system have been observed, we argue that the outlined inadequacies continue to enable the promotion of medical devices to consumers without thorough or sufficient examination of evidence. PMID:22032398

  6. Critical factors in the translation of improved antimicrobial strategies for medical implants and devices.

    Science.gov (United States)

    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

    2013-12-01

    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 for physician use and patient benefit. This is not for lack of ideas since many thousands of claims to new approaches to antimicrobial efficacy are reported. Lack of translation of reported ideas into medical products approved for use, results from conflicting goals and purposes between the various participants involved in conception, validation, development, commercialization, safety and regulatory oversight, insurance reimbursement, and legal aspects of medical device innovation. The scientific causes, problems and impressive costs of the limiting clinical options for combating biomaterials-associated infection are well recognized. Demands for improved antimicrobial technologies constantly appear. Yet, the actual human, ethical and social costs and consequences of their occurrence are less articulated. Here, we describe several clinical cases of biomaterials-associated infections to illustrate the often-missing human elements of these infections. We identify the current societal forces at play in translating antimicrobial research concepts into clinical implant use and their often-orthogonal constituencies, missions and policies. We assert that in the current complex environment between researchers, funding agencies, physicians, patients, providers, producers, payers, regulatory agencies and litigators, opportunities for translatable successes are minimized under the various risks assumed in the translation process. This argues for an alternative approach to more effectively introduce new biomaterials and device technologies that can address the clinical issues by providing patients and medical practitioners new options for desperate clinical conditions ineffectively

  7. Balancing innovation and medical device regulation: the case of modern metal-on-metal hip replacements

    Science.gov (United States)

    Howard, Jason J

    2016-01-01

    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 general, particularly for those who have a significant potential for harm. In this regard, a series of recommendations have been developed to contribute to the evolution of the medical device regulatory process.

  8. Growth and innovation in medical devices: a conversation with Stryker chairman John Brown. Interview by Lawton R. Burns.

    Science.gov (United States)

    Brown, John

    2007-01-01

    John Brown, current chairman and past chief executive officer (CEO) of the Stryker Corporation, reviews the development of his device firm and the medical device industry over the past thirty years. Brown describes the trajectory of innovation in medical devices and the managerial and organizational strategy he pioneered at Stryker to achieve consistently high growth rates over the long term. He also shares his perspective on some of the current policy issues facing the device industry today, including product safety, conflicts of interest, rising product prices, and direct-to-consumer advertising. PMID:17472967

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

    Science.gov (United States)

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

    2016-01-01

    The content related to the quality during life-cycle in operation of medical device includes daily use, repair volume, preventive maintenance, quality control and adverse event monitoring. In view of this, the article aims at discussion on the quality evaluation method of medical devices during their life cycle in operation based on the Analytic Hierarchy Process (AHP). The presented method is proved to be effective by evaluating patient monitors as example. The method presented in can promote and guide the device quality control work, and it can provide valuable inputs to decisions about purchase of new device. PMID:27197489

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

    Directory of Open Access Journals (Sweden)

    Maya Lyapina

    2015-02-01

    Full Text Available Defining a given product as a medical device and interpretation of the application of the classification rules fall within the competence of the competent authorities of the Member States where the product is on the market. Different interpretations of Community legislation occur, and, can put public health at risk and distort the internal market. Borderline cases are considered to be those cases where it is not clear from the outset whether a given product is a medical device, an in vitro diagnostic medical device, an active implantable medical device or not. Classification cases can be described as those cases where there exists a difficulty in the uniform application of the classification rules as laid down in the Medical Devices Directive (MDD, or where for a given device, depending on interpretation of the rules, different classifications can occur. The aim of the present work is to make a brief review on discussion on classification in the community regulatory framework for medical devices of some dentistry products.

  11. Open-source medical devices (OSMD) design of a small animal radiotherapy system

    International Nuclear Information System (INIS)

    Open-Source Medical Devices (OSMD) was initiated with the goal of facilitating medical research by developing medical technologies including both hardware and software on an open-source platform. Our first project was to develop an integrated imaging and radiotherapy device for small animals that includes computed tomography (CT), positron emission tomography (PET) and radiation therapy (RT) modalities for which technical specifications were defined in the first OSMD conference held in Madison, Wisconsin, USA in December 2011. This paper specifically focuses on the development of a small animal RT (micro-RT) system by designing a binary micro multileaf collimator (bmMLC) and a small animal treatment planning system (SATPS) to enable intensity modulated RT (IMRT). Both hardware and software projects are currently under development and their current progresses are described. After the development, both bmMLC and TPS will be validated and commissioned for a micro-RT system. Both hardware design and software development will be open-sourced after completion.

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

    Directory of Open Access Journals (Sweden)

    Chang-Seop Park

    2014-01-01

    Full Text Available After two recent security attacks against implantable medical devices (IMDs have been reported, the privacy and security risks of IMDs have been widely recognized in the medical device market and research community, since the malfunctioning of IMDs might endanger the patient’s life. During the last few years, a lot of researches have been carried out to address the security-related issues of IMDs, including privacy, safety, and accessibility issues. A physician accesses IMD through an external device called a programmer, for diagnosis and treatment. Hence, cryptographic key management between IMD and programmer is important to enforce a strict access control. In this paper, a new security architecture for the security of IMDs is proposed, based on a 3-Tier security model, where the programmer interacts with a Hospital Authentication Server, to get permissions to access IMDs. The proposed security architecture greatly simplifies the key management between IMDs and programmers. Also proposed is a security mechanism to guarantee the authenticity of the patient data collected from IMD and the nonrepudiation of the physician’s treatment based on it. The proposed architecture and mechanism are analyzed and compared with several previous works, in terms of security and performance.

  13. Assurance of medical device quality with quality management system: an analysis of good manufacturing practice implementation in Taiwan.

    Science.gov (United States)

    Li, Tzu-Wei; Tu, Pei-Weng; Liu, Li-Ling; Wu, Shiow-Ing

    2015-01-01

    The implementation of an effective quality management system has always been considered a principal method for a manufacturer to maintain and improve its product and service quality. Globally many regulatory authorities incorporate quality management system as one of the mandatory requirements for the regulatory control of high-risk medical devices. The present study aims to analyze the GMP enforcement experience in Taiwan between 1998 and 2013. It describes the regulatory implementation of medical device GMP requirement and initiatives taken to assist small and medium-sized enterprises in compliance with the regulatory requirement. Based on statistical data collected by the competent authority and industry research institutes, the present paper reports the growth of Taiwan local medical device industry after the enforcement of GMP regulation. Transition in the production, technologies, and number of employees of Taiwan medical device industry between 1998 and 2013 provides the competent authorities around the world with an empirical foundation for further policy development. PMID:26075255

  14. Assurance of Medical Device Quality with Quality Management System: An Analysis of Good Manufacturing Practice Implementation in Taiwan

    Directory of Open Access Journals (Sweden)

    Tzu-Wei Li

    2015-01-01

    Full Text Available The implementation of an effective quality management system has always been considered a principal method for a manufacturer to maintain and improve its product and service quality. Globally many regulatory authorities incorporate quality management system as one of the mandatory requirements for the regulatory control of high-risk medical devices. The present study aims to analyze the GMP enforcement experience in Taiwan between 1998 and 2013. It describes the regulatory implementation of medical device GMP requirement and initiatives taken to assist small and medium-sized enterprises in compliance with the regulatory requirement. Based on statistical data collected by the competent authority and industry research institutes, the present paper reports the growth of Taiwan local medical device industry after the enforcement of GMP regulation. Transition in the production, technologies, and number of employees of Taiwan medical device industry between 1998 and 2013 provides the competent authorities around the world with an empirical foundation for further policy development.

  15. Effect of Rating Modification on a Fuzzy-Based Modular Architecture for Medical Device Design and Development

    Directory of Open Access Journals (Sweden)

    Celestine C. Aguwa

    2012-01-01

    Full Text Available The goal of this research is to determine the effect of customer ratings on the optimal number of modules for medical device design. Medical devices have a 90% failure rate in their first prototype tests according to the international testing body, Intertek. To address this key issue of quality, we present an integrated, collaborative, modular architecture method for medical device design and development. A typical glucometer is used as proof of concept to demonstrate the methodology and analyze the impact of changing the customer ratings on the optimal number of modules and minimum deviation. The implication of this research is to generate scholarly work and to reduce the number of potential failure points in medical devices by determining the optimal number of modules.

  16. A web-application that extends functionality of medical device for tumor treatment by means of electrochemotherapy

    International Nuclear Information System (INIS)

    Electrochemotherapy (ECT) is a novel method for efficient tumor treatment in clinical environment. It combines local drug delivery and application of short high voltage pulses, which permeabilize the plasma membrane by electroporation. Drug can enter only the cells with permeabilzed membrane. Recently, medical device CliniporatorTM for controlled electroporation was developed. Here, we present a web-application that extends the functionality of this medical device. The aim of the application is to collect, store and to allow the analysis of every ECT application using this medical device. The application helps transferring data collected by device during the electroporation process to the central database, and enables filling of medical records through the web-forms. The application is based on technologies ASP, HTML, Flash, JavaScript, XML and others. The application main advantages are easy and rapid data access, scalability and independence of client computer operating system as well as easy application debugging and upgrading. (author)

  17. How does medical device regulation perform in the United States and the European union? A systematic review.

    Directory of Open Access Journals (Sweden)

    Daniel B Kramer

    Full Text Available BACKGROUND: Policymakers and regulators in the United States (US and the European Union (EU are weighing reforms to their medical device approval and post-market surveillance systems. Data may be available that identify strengths and weakness of the approaches to medical device regulation in these settings. METHODS AND FINDINGS: We performed a systematic review to find empirical studies evaluating medical device regulation in the US or EU. We searched Medline using two nested categories that included medical devices and glossary terms attributable to the US Food and Drug Administration and the EU, following PRISMA guidelines for systematic reviews. We supplemented this search with a review of the US Government Accountability Office online database for reports on US Food and Drug Administration device regulation, consultations with local experts in the field, manual reference mining of selected articles, and Google searches using the same key terms used in the Medline search. We found studies of premarket evaluation and timing (n = 9, studies of device recalls (n = 8, and surveys of device manufacturers (n = 3. These studies provide evidence of quality problems in pre-market submissions in the US, provide conflicting views of device safety based largely on recall data, and relay perceptions of some industry leaders from self-surveys. CONCLUSIONS: Few studies have quantitatively assessed medical device regulation in either the US or EU. Existing studies of US and EU device approval and post-market evaluation performance suggest that policy reforms are necessary for both systems, including improving classification of devices in the US and promoting transparency and post-market oversight in the EU. Assessment of regulatory performance in both settings is limited by lack of data on post-approval safety outcomes. Changes to these device approval and post-marketing systems must be accompanied by ongoing research to ensure that there is

  18. Nuclear Safety Charter

    International Nuclear Information System (INIS)

    The AREVA 'Values Charter' reaffirmed the priority that must be given to the requirement for a very high level of safety, which applies in particular to the nuclear field. The purpose of this Nuclear Safety Charter is to set forth the group's commitments in the field of nuclear safety and radiation protection so as to ensure that this requirement is met throughout the life cycle of the facilities. It should enable each of us, in carrying out our duties, to commit to this requirement personally, for the company, and for all stakeholders. These commitments are anchored in organizational and action principles and in complete transparency. They build on a safety culture shared by all personnel and maintained by periodic refresher training. They are implemented through Safety, Health, and Environmental management systems. The purpose of these commitments, beyond strict compliance with the laws and regulations in force in countries in which we operate as a group, is to foster a continuous improvement initiative aimed at continually enhancing our overall performance as a group. Content: 1 - Organization: responsibility of the group's executive management and subsidiaries, prime responsibility of the operator, a system of clearly defined responsibilities that draws on skilled support and on independent control of operating personnel, the general inspectorate: a shared expertise and an independent control of the operating organization, an organization that can be adapted for emergency management. 2 - Action principles: nuclear safety applies to every stage in the plant life cycle, lessons learned are analyzed and capitalized through the continuous improvement initiative, analyzing risks in advance is the basis of Areva's safety culture, employees are empowered to improve nuclear Safety, the group is committed to a voluntary radiation protection initiative And a sustained effort in reducing waste and effluent from facility Operations, employees and subcontractors are treated

  19. Development of software for safety critical medical devices - an interview-based survey of state of practice

    OpenAIRE

    Lindholm, Christin; Höst, Martin

    2008-01-01

    To be able to survive in the long run the medical device industry of today needs effective development processes and ways to secure quality. These development processes and quality assurance processes must follow the different laws and regulations over the world depending on what market the organisations are established on. Organisations have been developing medical devices and systems over many years but now this type of products contain more and more software. The development of softwar...

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

    Science.gov (United States)

    Sharma, Jitendra

    2012-01-01

    Technology is major stimulus for change and is imbibed in various forms; especially in the field of medical devices and bio-medical instruments used in life and death situations. Cardiotocograph (CTG), a foetal heart rate and uterine contraction monitoring and measurement machine, is a valuable tool in the process of childbirth. The Quality Function Deployment (QFD) is an engineering technique with the number one priority being to satisfy the customer. The aim of using QFD in this paper is to highlight the limitations and complexities of the present instrument. The paper attempts to first discuss out the operational details of the instrument along with a brief review of the relevant literature. Following this, its functional analysis is carried out through QFD - a TQM tool. The resultant outcome enlists CTG functions with their Raw Weight and Priority Score. A detailed theoretical analysis of results pinpoints basic functional limitation of exiting machine. PMID:23008844

  1. Managerial Guidelines for Market Penetration and Expansion: A Case Study of a Medical Devices Manufacturer

    Directory of Open Access Journals (Sweden)

    Vlastimil Juppa

    2013-06-01

    Full Text Available This article brings managerial guidelines for new markets expansion and current market penetration on an example of a Czech medical devices manufacturer. We describe the strategy in evaluation of the opportunities in the territories, of setting up the benchmarks, the steps how to deal with the partners in current territories and how to approach the acquisition of new territories. We show how significant is the sales growth for financials, we mention the limit defined in the Theory of Sustainable Growth. We show how important the level is, how the products are advanced and how important is to have unique products.

  2. Analysis of intellectual properties on animal-derived regenerative, implantable medical devices.

    Science.gov (United States)

    Wang, Hongman; Li, Chunying

    2016-03-01

    This article analyses and summarizes issues of intellectual property involved in animal-derived regenerative, implantable medical devices (ADRIMD) in order to better understand global trends in patent applications and disclosures, the legal status of patent families (i.e. sets of patents filed in various countries to protect a single invention), and International Patent Classification topics such as main assignee and core expertise. Analysis of research trends will enhance and inform the decision-making capacity of researchers, investors, government regulators and other stake-holders as they undertake to develop, deploy, invest in or regulate ADRIMD. PMID:26816653

  3. Classroom to Clinic: Merging Education and Research to Efficiently Prototype Medical Devices.

    Science.gov (United States)

    Hanumara, Nevan C; Begg, Nikolai D; Walsh, Conor; Custer, David; Gupta, Rajiv; Osborn, Lynn R; Slocum, Alexander H

    2013-01-01

    Innovation in patient care requires both clinical and technical skills, and this paper presents the methods and outcomes of a nine-year, clinical-academic collaboration to develop and evaluate new medical device technologies, while teaching mechanical engineering. Together, over the course of a single semester, seniors, graduate students, and clinicians conceive, design, build, and test proof-of-concept prototypes. Projects initiated in the course have generated intellectual property and peer-reviewed publications, stimulated further research, furthered student and clinician careers, and resulted in technology licenses and start-up ventures. PMID:27170859

  4. Classroom to Clinic: Merging Education and Research to Efficiently Prototype Medical Devices

    Science.gov (United States)

    Begg, Nikolai D.; Walsh, Conor; Custer, David; Gupta, Rajiv; Osborn, Lynn R.; Slocum, Alexander H.

    2013-01-01

    Innovation in patient care requires both clinical and technical skills, and this paper presents the methods and outcomes of a nine-year, clinical-academic collaboration to develop and evaluate new medical device technologies, while teaching mechanical engineering. Together, over the course of a single semester, seniors, graduate students, and clinicians conceive, design, build, and test proof-of-concept prototypes. Projects initiated in the course have generated intellectual property and peer-reviewed publications, stimulated further research, furthered student and clinician careers, and resulted in technology licenses and start-up ventures.

  5. Raman spectroscopy for rapid discrimination of Staphylococcus epidermidis clones related to medical device-associated infections

    International Nuclear Information System (INIS)

    We report on the potential application of Raman spectroscopy for the fast typing of Staphylococcus epidermidis (S. epidermidis) strains related to medical device-associated infections. In this study bacterial colonies were directly probed on culture plates and Raman spectra were recorded from volumes containing approximately 10 bacteria. The spectra contain information on the molecular composition of the whole bacteria, such as fatty acids, carbohydrates, proteins and nucleic acids, DNA as well as RNA. We demonstrate the potential to discriminate different S. epidermidis clones, even after only short Raman exposure/collection times

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

    DEFF Research Database (Denmark)

    Kelly, Janet; Matthews, Ben

    2010-01-01

    Participation in design has typically focused on involving those who use, will use, or who represent the users of the products in development. In this paper we discuss our experiences designing with ‘pre-users’—people who have a relationship to the technology other than as a user or potential user...... of the product. We present a case study that documents how we worked with pre-users of two different types of medical technologies: hearing aids and insulin injection devices. Pre-users are people who do not currently use these products, but who are in a life situation for which these technologies...

  7. The Design and Management of Medical Device Clinical Trials Strategies and Challenges

    CERN Document Server

    Abdel-aleem, Salah M

    2011-01-01

    Clinical trials tasks and activities are widely diverse and require certain skill sets to both plan and execute. This book provides professionals in the field of clinical research with valuable information on the challenging issues of the design, execution, and management of clinical trials, and how to resolve these issues effectively. It discusses key obstacles such as challenges to patient recruitment, investigator and study site selection, and dealing with compliance issues. Through practical examples, professionals working with medical device clinical trials will discover the appropriate s

  8. Role of the clinical professional in the radiotherapy medical devices industry

    International Nuclear Information System (INIS)

    The aim of this work is to review relevant International Atomic Energy Agency (IAEA) publications and to report the results of a questionnaire study which included various aspects of the role of the clinical specialist industry. Although relatively neglected in the current literature, this is an important topic, particularly because of the lessons which must be learned from radiotherapy accidents. A more extensive questionnaire survey is planned for the future with a population size of some 200 clinical professionals currently working in the radiotherapy medical devices industry. (author)

  9. Distributed Real-Time Emulation of Formally-Defined Patterns for Safe Medical Device Control

    Directory of Open Access Journals (Sweden)

    José Meseguer

    2010-09-01

    Full Text Available Safety of medical devices and of their interoperation is an unresolved issue causing severe and sometimes deadly accidents for patients with shocking frequency. Formal methods, particularly in support of highly reusable and provably safe patterns which can be instantiated to many device instances can help in this regard. However, this still leaves open the issue of how to pass from their formal specifications in logical time to executable emulations that can interoperate in physical time with other devices and with simulations of patient and/or doctor behaviors. This work presents a specification-based methodology in which virtual emulation environments can be easily developed from formal specifications in Real-Time Maude, and can support interactions with other real devices and with simulation models. This general methodology is explained in detail and is illustrated with two concrete scenarios which are both instances of a common safe formal pattern: one scenario involves the interaction of a provably safe pacemaker with a simulated heart; the other involves the interaction of a safe controller for patient-induced analgesia with a real syringe pump.

  10. A balancing act: a phenomenological exploration of medical students' experiences of using mobile devices in the clinical setting

    Science.gov (United States)

    Rashid-Doubell, F; Mohamed, S; Elmusharaf, K; O'Neill, C S

    2016-01-01

    Objective The aims of this study were to describe the experiences of senior students using mobile devices in a clinical setting while learning and interacting with clinical teachers, patients and each other, and to identify challenges that facilitated or impeded the use of such devices in the hospital. Design Interpretative phenomenology was chosen to guide our enquiry. Semi-structured interviews were conducted to examine the experiences of five senior medical students using mobile devices in the clinical setting. Setting and participants Senior medical students at an international medical school in the Middle East. Results Three main themes emerged from the data analysis: learning; professional identity and transitioning from student to doctor. The findings showed that using mobile devices in the clinical area as a learning tool was not a formalised process. Rather, it was opportunistic learning at the bedside and on occasion a source of distraction from clinical teaching. Students needed to negotiate relationships between themselves, the clinical teacher and patients in order to ensure that they maintained an acceptable professional image. Participants experienced and negotiated the change from student to doctor making them mindful of using their devices at the bedside. Conclusions Mobile devices are part of daily life for a medical student and there is a need to adapt medical education in the clinical setting, to allow the students to use their devices in a sensitive manner. PMID:27142860

  11. Leading Charters: How Charter School Administrators Define Their Roles and Their Ability to Lead

    Science.gov (United States)

    Carpenter, Dick Michael, II; Peak, Charity

    2013-01-01

    Charter schools have been studied from numerous perspectives. One topic that remains under-researched, however, is charter school leadership. Therefore, we examine how charter administrators define their leadership roles and their ability to lead. Results indicate that charter principals see three primary functions in their leadership--building…

  12. 77 FR 44475 - Final Definitions, Requirements, and Selection Criteria; Charter Schools Program (CSP)-Charter...

    Science.gov (United States)

    2012-07-30

    ... incentives for high-quality charter schools to collaborate with non-chartered public schools and non... typically provided for traditional public schools. The purpose of the Collaboration Awards competition (CFDA...-chartered public schools (as defined in this notice) and non-chartered LEAs (as defined in this notice)...

  13. Medical Devices: European Union Policymaking and the Implementation of Health and Patient Safety in France: book review

    NARCIS (Netherlands)

    Chowdhury, N.

    2012-01-01

    by Christa Altenstetter Piscataway, NJ: Transaction Publishers, 2007, 302 pp., $ 49.95, Hardcover This book is a welcome addition to the political science literature on medical product policymaking. Most researchers see medical devices as a poorer and perhaps less glamourized neighbour of the pharma

  14. The International Charter and Flood Mapping

    OpenAIRE

    Shan, Jie

    2009-01-01

    An overview of recent Purdue activities related to the International Charter for Space and Major Disasters, including general information about The Charter, 3 Indiana flood examples, and a summary of the lessons learned therefrom.

  15. Pelagic Charter Boat Patrons (1999-2001)

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — This study describes several aspects of the charter fishing experience, including patrons' motivations for coming to Hawaii and going charter fishing, their related...

  16. Touch-free, gesture-based control of medical devices and software based on the leap motion controller.

    Science.gov (United States)

    Mauser, Stanislas; Burgert, Oliver

    2014-01-01

    There are several intra-operative use cases which require the surgeon to interact with medical devices. We used the Leap Motion Controller as input device and implemented two use-cases: 2D-Interaction (e.g. advancing EPR data) and selection of a value (e.g. room illumination brightness). The gesture detection was successful and we mapped its output to several devices and systems. PMID:24732520

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

    Directory of Open Access Journals (Sweden)

    Williams PAH

    2015-07-01

    Full Text Available Patricia AH Williams, Andrew J Woodward eHealth Research Group and Security Research Institute, Edith Cowan University, Perth, WA, Australia Abstract: The increased connectivity to existing computer networks has exposed medical devices to cybersecurity vulnerabilities from which they were previously shielded. For the prevention of cybersecurity incidents, it is important to recognize the complexity of the operational environment as well as to catalog the technical vulnerabilities. Cybersecurity protection is not just a technical issue; it is a richer and more intricate problem to solve. A review of the factors that contribute to such a potentially insecure environment, together with the identification of the vulnerabilities, is important for understanding why these vulnerabilities persist and what the solution space should look like. This multifaceted problem must be viewed from a systemic perspective if adequate protection is to be put in place and patient safety concerns addressed. This requires technical controls, governance, resilience measures, consolidated reporting, context expertise, regulation, and standards. It is evident that a coordinated, proactive approach to address this complex challenge is essential. In the interim, patient safety is under threat. Keywords: cybersecurity, security, safety, wireless, risk, medical devices

  18. Active implantable medical device EMI assessment for wireless power transfer operating in LF and HF bands

    Science.gov (United States)

    Hikage, Takashi; Nojima, Toshio; Fujimoto, Hiroshi

    2016-06-01

    The electromagnetic interference (EMI) imposed on active implantable medical devices by wireless power transfer systems (WPTSs) is discussed based upon results of in vitro experiments. The purpose of this study is to present comprehensive EMI test results gathered from implantable-cardiac pacemakers and implantable cardioverter defibrillators exposed to the electromagnetic field generated by several WPTSs operating in low-frequency (70 kHz–460 kHz) and high-frequency (6.78 MHz) bands. The constructed in vitro experimental test system based upon an Irnich’s flat torso phantom was applied. EMI test experiments are conducted on 14 types of WPTSs including Qi-compliant system and EV-charging WPT system mounted on current production EVs. In addition, a numerical simulation model for active implantable medical device (AIMD) EMI estimation based on the experimental test system is newly proposed. The experimental results demonstrate the risk of WPTSs emitting intermittent signal to affect the correct behavior of AIMDs when operating at very short distances. The proposed numerical simulation model is applicable to obtain basically the EMI characteristics of various types of WPTSs.

  19. Active implantable medical device EMI assessment for wireless power transfer operating in LF and HF bands.

    Science.gov (United States)

    Hikage, Takashi; Nojima, Toshio; Fujimoto, Hiroshi

    2016-06-21

    The electromagnetic interference (EMI) imposed on active implantable medical devices by wireless power transfer systems (WPTSs) is discussed based upon results of in vitro experiments. The purpose of this study is to present comprehensive EMI test results gathered from implantable-cardiac pacemakers and implantable cardioverter defibrillators exposed to the electromagnetic field generated by several WPTSs operating in low-frequency (70 kHz-460 kHz) and high-frequency (6.78 MHz) bands. The constructed in vitro experimental test system based upon an Irnich's flat torso phantom was applied. EMI test experiments are conducted on 14 types of WPTSs including Qi-compliant system and EV-charging WPT system mounted on current production EVs. In addition, a numerical simulation model for active implantable medical device (AIMD) EMI estimation based on the experimental test system is newly proposed. The experimental results demonstrate the risk of WPTSs emitting intermittent signal to affect the correct behavior of AIMDs when operating at very short distances. The proposed numerical simulation model is applicable to obtain basically the EMI characteristics of various types of WPTSs. PMID:27224201

  20. The medical device sector in Greece: An economic evaluation of the Magnetic Resonance Imaging (MRI market

    Directory of Open Access Journals (Sweden)

    Antonia Kaskarelis

    2012-07-01

    Full Text Available The medical devices equipment and more specifically the Magnetic Resonance Imaging (MRI units, open new horizons in the realization of diagnostic examinations, offering additionally an exceptionally reliable information in the process of the clinical decision-making. Aim: Aim of the present study is the general review of the medical devices sector globally but also in Greece and the economic analysis of the MRI market in Greece. Material and Methods: This study was realized using data concerning the number, the characteristics and the use of the MRI units for the year 2009. For the analysis of those data, simple methods of descriptive statistical analysis were applied. Results: The present research points out that the proportion of the MRI units per million of population ranks Greece in the third place globally after USA and Japan. Moreover, it was unveiled that only 13% of total MRI's units are installed in public hospitals, while their unequal distribution and their absence in the countryside are obvious. Conclusions: The findings confirmed the conclusion that the imperative need of strategic planning of supply, fair distribution and rational use of MRI units in Greece.

  1. Visualization analysis of research hotspots based on CiteSpace II: taking medical devices as an example

    Directory of Open Access Journals (Sweden)

    Liu DD

    2014-10-01

    Full Text Available Dong-Dong Liu, Sheng-Lin Liu, Jia-Hua Zhang Biomedical Engineering Laboratory, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Hubei Province, People's Republic of China Abstract: Biomedical engineering has been one of the hottest fields in biology and engineering. As an important branch, the medical device has achieved significant progress in the past decades. As a useful method in evaluative bibliometrics, mapping knowledge has been used to explore the trend of one field. In the present study, we retrieve literatures about the medical device from the Web of Science™ (2004–2013, and acquire 26,793 related records, then analyze time range, region distribution, and main research directions of the literatures, and try to use keywords combined with mapping knowledge to explore the main trends of the medical device, and then aim to provide more information for medical device research. Through the study, we discover: 1 the publications regarding medical devices show an upward trend over the past decade in general; 2 the percentage of publications in the USA (38.49% is the highest all over the world; 3 engineering (20.64% is the hottest research direction, and takes up about one-fifth of the total publications; 4 the Journal of the American Medical Association and The New England Journal of Medicine are among the two journals that are the most highly cited, followed by Science and The Lancet; and 5 keywords of the medical device include in vitro, quality-of-life, outcomes, management, mortality, depression, and so on. With the help of mapping knowledge, we dig out some hot topics of medical devices and provide more information through trend analysis, and we discover that our findings are related to previous research and further research can enlarge the number of records and optimize the algorithm. We provide a systematic approach for researchers to keep abreast of the development and state of the research of

  2. The geko™ electro-stimulation device for venous thromboembolism prophylaxis: a NICE medical technology guidance.

    Science.gov (United States)

    Summers, Jennifer A; Clinch, James; Radhakrishnan, Muralikrishnan; Healy, Andy; McMillan, Viktoria; Morris, Elizabeth; Rua, Tiago; Ofuya, Mercy; Wang, Yanzhong; Dimmock, Paul W; Lewis, Cornelius; Peacock, Janet L; Keevil, Stephen F

    2015-04-01

    The geko™ device is a single-use, battery-powered, neuromuscular electrostimulation device that aims to reduce the risk of venous thromboembolism (VTE). The National Institute for Health and Care Excellence (NICE) selected the geko™ device for evaluation, and invited the manufacturer, Firstkind Ltd, to submit clinical and economic evidence. King's Technology Evaluation Centre, an External Assessment Centre (EAC) commissioned by the NICE, independently assessed the evidence submitted. The sponsor submitted evidence related to the geko™ device and, in addition, included studies of other related devices as further clinical evidence to support a link between increased blood flow and VTE prophylaxis. The EAC assessed this evidence, conducted its own systematic review and concluded that there is currently limited direct evidence that geko™ prevents VTE. The sponsor's cost model is based on the assumption that patients with an underlying VTE risk and subsequently treated with geko™ will experience a reduction in their baseline risk. The EAC assessed this cost model but questioned the validity of some model assumptions. Using the EACs revised cost model, the cost savings for geko™ prophylaxis against a 'no prophylaxis' strategy were estimated as £197 per patient. Following a second public consultation, taking into account a change in the original draft recommendations, the NICE medical technologies guidance MTG19 was issued in June 2014. This recommended the adoption of the geko™ for use in people with a high risk of VTE and when other mechanical/pharmacological methods of prophylaxis are impractical or contraindicated in selected patients within the National Health Service in England. PMID:25403719

  3. Association of medical students' reports of interactions with the pharmaceutical and medical device industries and medical school policies and characteristics: a cross-sectional study.

    Directory of Open Access Journals (Sweden)

    James S Yeh

    2014-10-01

    Full Text Available BACKGROUND: Professional societies use metrics to evaluate medical schools' policies regarding interactions of students and faculty with the pharmaceutical and medical device industries. We compared these metrics and determined which US medical schools' industry interaction policies were associated with student behaviors. METHODS AND FINDINGS: Using survey responses from a national sample of 1,610 US medical students, we compared their reported industry interactions with their schools' American Medical Student Association (AMSA PharmFree Scorecard and average Institute on Medicine as a Profession (IMAP Conflicts of Interest Policy Database score. We used hierarchical logistic regression models to determine the association between policies and students' gift acceptance, interactions with marketing representatives, and perceived adequacy of faculty-industry separation. We adjusted for year in training, medical school size, and level of US National Institutes of Health (NIH funding. We used LASSO regression models to identify specific policies associated with the outcomes. We found that IMAP and AMSA scores had similar median values (1.75 [interquartile range 1.50-2.00] versus 1.77 [1.50-2.18], adjusted to compare scores on the same scale. Scores on AMSA and IMAP shared policy dimensions were not closely correlated (gift policies, r = 0.28, 95% CI 0.11-0.44; marketing representative access policies, r = 0.51, 95% CI 0.36-0.63. Students from schools with the most stringent industry interaction policies were less likely to report receiving gifts (AMSA score, odds ratio [OR]: 0.37, 95% CI 0.19-0.72; IMAP score, OR 0.45, 95% CI 0.19-1.04 and less likely to interact with marketing representatives (AMSA score, OR 0.33, 95% CI 0.15-0.69; IMAP score, OR 0.37, 95% CI 0.14-0.95 than students from schools with the lowest ranked policy scores. The association became nonsignificant when fully adjusted for NIH funding level, whereas adjusting for year of

  4. Are Charter School Unions Worth the Bargain?

    Science.gov (United States)

    Price, Mitch

    2011-01-01

    About 12 percent of all charter schools have bargaining agreements. Why do charter schools unionize? What is in these charter school contracts? Can they be considered innovative or models for union reform? And how do they compare to traditional district/union teacher contracts? Center on Reinventing Public Education legal analyst Mitch Price…

  5. New Hampshire Charter Schools Parent Study 2011

    Science.gov (United States)

    Julius, Tom

    2011-01-01

    This study was conducted in Spring 2011 with the purpose of better understanding the nature and experiences of New Hampshire charter school parents. Nine out of ten operating NH charter schools participated. Parents were invited to participate in an on-line survey and on-site focus group interviews. Results provide a profile of NH charter school…

  6. 34 CFR 300.7 - Charter school.

    Science.gov (United States)

    2010-07-01

    ... 34 Education 2 2010-07-01 2010-07-01 false Charter school. 300.7 Section 300.7 Education Regulations of the Offices of the Department of Education (Continued) OFFICE OF SPECIAL EDUCATION AND... DISABILITIES General Definitions Used in This Part § 300.7 Charter school. Charter school has the meaning...

  7. Is Racial Segregation Changing in Charter Schools?

    Science.gov (United States)

    Lee, Jin; Lubienski, Christopher

    2011-01-01

    Charter schools embody the theoretical potential to promote integration since they can draw students from across district boundaries that often reflect segregated residential patterns. While a number of studies have examined overall racial composition of charter schools, virtually no attention has been paid to how charter school enrollment…

  8. New Mexico Charter Schools Annual Report

    Science.gov (United States)

    New Mexico Public Education Department, 2013

    2013-01-01

    In 2011, the New Mexico legislature passed changes to the Charter School Act that provided more accountability for both charters and authorizers in New Mexico. As part of that law, the Public Education Department (PED) is asked to submit an annual report on the status of charter schools in New Mexico. This is the first report submitted under that…

  9. Evaluation of polyaniline-silicon devices as dosimeters for medical applications

    International Nuclear Information System (INIS)

    This work presents the results of the evaluation of polyaniline-silicon heterojunction devices as a detector of ionizing radiation typically used in medical applications. The samples were produced by spin coating deposition of thin polyaniline films (about 20 nm -:- 30 nm) over silicon substrates, followed by chemical doping and thermal evaporation of aluminum electrical contacts. Each device was electrically characterized by a current density vs voltage curve and presented the typical p-n junction behavior. Subsequently, the samples were exposed to Bremsstrahlung photon (6 MeV) and electron (9 MeV) beams, produced by a linear accelerator and a 60Co gamma radiation source. The radiation exposition was followed by another electrical characterization in order to verify the current density vs voltage curve shift according to the dose absorbed. The devices presented sensitivity for both low (2 Gy and 50 Gy) as well as high doses (750 Gy and 1500 Gy). A dose-proportional increase of the heterojunction direct current was observed after the exposition to the radiation. (author)

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

    Science.gov (United States)

    Holländer, Jenny; Genina, Natalja; Jukarainen, Harri; Khajeheian, Mohammad; Rosling, Ari; Mäkilä, Ermei; Sandler, Niklas

    2016-09-01

    The goal of the present study was to fabricate drug-containing T-shaped prototypes of intrauterine system (IUS) with the drug incorporated within the entire backbone of the medical device using 3-dimensional (3D) printing technique, based on fused deposition modeling (FDM™). Indomethacin was used as a model drug to prepare drug-loaded poly(ε-caprolactone)-based filaments with 3 different drug contents, namely 5%, 15%, and 30%, by hot-melt extrusion. The filaments were further used to 3D print IUS. The results showed that the morphology and drug solid-state properties of the filaments and 3D prototypes were dependent on the amount of drug loading. The drug release profiles from the printed devices were faster than from the corresponding filaments due to a lower degree of the drug crystallinity in IUS in addition to the differences in the external/internal structure and geometry between the products. Diffusion of the drug from the polymer was the predominant mechanism of drug release, whereas poly(ε-caprolactone) biodegradation had a minor effect. This study shows that 3D printing is an applicable method in the production of drug-containing IUS and can open new ways in the fabrication of controlled release implantable devices. PMID:26906174

  11. Team-Based Development of Medical Devices: An Engineering-Business Collaborative.

    Science.gov (United States)

    Eberhardt, Alan W; Johnson, Ophelia L; Kirkland, William B; Dobbs, Joel H; Moradi, Lee G

    2016-07-01

    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

  12. First experiences with the implementation of the European standard EN 62304 on medical device software for the quality assurance of a radiotherapy unit

    OpenAIRE

    Höss, Angelika; Lampe, Christian; Panse, Ralf; Ackermann, Benjamin; Naumann, Jakob; Jäkel, Oliver

    2014-01-01

    Background According to the latest amendment of the Medical Device Directive standalone software qualifies as a medical device when intended by the manufacturer to be used for medical purposes. In this context, the EN 62304 standard is applicable which defines the life-cycle requirements for the development and maintenance of medical device software. A pilot project was launched to acquire skills in implementing this standard in a hospital-based environment (in-house manufacture). Methods The...

  13. Innovative medical devices and hospital decision making: a study comparing the views of hospital pharmacists and physicians.

    Science.gov (United States)

    Billaux, Mathilde; Borget, Isabelle; Prognon, Patrice; Pineau, Judith; Martelli, Nicolas

    2016-06-01

    Objectives Many university hospitals have developed local health technology assessment processes to guide informed decisions about new medical devices. However, little is known about stakeholders' perceptions and assessment of innovative devices. Herein, we investigated the perceptions regarding innovative medical devices of their chief users (physicians and surgeons), as well as those of hospital pharmacists, because they are responsible for the purchase and management of sterile medical devices. We noted the evaluation criteria used to assess and select new medical devices and suggestions for improving local health technology assessment processes indicated by the interviewees. Methods We randomly selected 18 physicians and surgeons (nine each) and 18 hospital pharmacists from 18 French university hospitals. Semistructured interviews were conducted between October 2012 and August 2013. Responses were coded separately by two researchers. Results Physicians and surgeons frequently described innovative medical devices as 'new', 'safe' and 'effective', whereas hospital pharmacists focused more on economic considerations and considered real innovative devices to be those for which no equivalent could be found on the market. No significant difference in evaluation criteria was found between these groups of professionals. Finally, hospital pharmacists considered the management of conflicts of interests in local health technology assessment processes to be an issue, whereas physicians and surgeons did not. Conclusions The present study highlights differences in perceptions related to professional affiliation. The findings suggest several ways in which current practices for local health technology assessment in French university hospitals could be improved and studied. What is known about the topic? Hospitals are faced with ever-growing demands for innovative and costly medical devices. To help hospital management deal with technology acquisition issues, hospital

  14. [Safe reprocessing of medical devices with a view of the entire process chain. Recommendations of the VDI 5700 guidelines].

    Science.gov (United States)

    Kraft, M; Wille, F; Attenberger, J; Müller, U

    2014-12-01

    The reprocessing of medical devices for low pathogen or sterile use is in itself potentially risky even though the aim of reprocessing is the avoidance of hygienic or technically functional risks. The methodological principles of risk management for medical devices are described in the standard DIN EN ISO 14971. The recommendations of the Commission for Hospital Hygiene and Infectious Disease Prevention (Kommission für Krankenhaushygiene und Infektionsprävention KRINKO) of the Robert Koch Institute (RKI) and the Federal Institute for Drugs and Medical Devices (Bundesinstituts für Arzneimittel und Medizinprodukte BfArM) "hygiene requirements for the reprocessing of medical devices" clarify numerous reprocessing-specific risks and are structured with reference to the different steps of reprocessing. The aim was a practical combination of the normative risk management methodology with the process-oriented KRINKO/BfArM recommendations, which has provided an interdisciplinary group of experts moderated by the Association of German Engineers (VDI). The main contents of the VDI 5700 guidelines on "hazards associated with the reprocessing--risk management in the reprocessing of medical devices--measures for risk control" and the process of the development of these guidelines is described. PMID:25348217

  15. Promoting interdisciplinary project-based learning to build the skill sets for research and development of medical devices in academia.

    Science.gov (United States)

    Krishnan, Shankar

    2013-01-01

    The worldwide need for rapid expansion and diversification of medical devices and the corresponding requirements in industry pose arduous challenges for educators to train undergraduate biomedical engineering (BME) students. Preparing BME students for working in the research and development (R&D) in medical device industry is not easily accomplished by adopting traditional pedagogical methods. Even with the inclusion of the design and development elements in capstone projects, medical device industry may be still experience a gap in fulfilling their needs in R&D. This paper proposes a new model based on interdisciplinary project-based learning (IDPBL) to address the requirements of building the necessary skill sets in academia for carrying out R&D in medical device industry. The proposed model incorporates IDPBL modules distributed in a stepwise fashion through the four years of a typical BME program. The proposed model involves buy-in and collaboration from faculty as well as students. The implementation of the proposed design in an undergraduate BME program is still in process. However, a variant of the proposed IDPBL method has been attempted at a limited scale at the postgraduate level and has shown some success. Extrapolating the previous results, the adoption of the IDPBL to BME training seems to suggest promising outcomes. Despite numerous implementation challenges, with continued efforts, the proposed IDPBL will be valuable n academia for skill sets building for medical device R&D. PMID:24110394

  16. A medical application integrating remote 3D visualization tools to access picture archiving and communication system on mobile devices.

    Science.gov (United States)

    He, Longjun; Ming, Xing; Liu, Qian

    2014-04-01

    With computing capability and display size growing, the mobile device has been used as a tool to help clinicians view patient information and medical images anywhere and anytime. However, for direct interactive 3D visualization, which plays an important role in radiological diagnosis, the mobile device cannot provide a satisfactory quality of experience for radiologists. This paper developed a medical system that can get medical images from the picture archiving and communication system on the mobile device over the wireless network. In the proposed application, the mobile device got patient information and medical images through a proxy server connecting to the PACS server. Meanwhile, the proxy server integrated a range of 3D visualization techniques, including maximum intensity projection, multi-planar reconstruction and direct volume rendering, to providing shape, brightness, depth and location information generated from the original sectional images for radiologists. Furthermore, an algorithm that changes remote render parameters automatically to adapt to the network status was employed to improve the quality of experience. Finally, performance issues regarding the remote 3D visualization of the medical images over the wireless network of the proposed application were also discussed. The results demonstrated that this proposed medical application could provide a smooth interactive experience in the WLAN and 3G networks. PMID:24705800

  17. [Marketing approval and market surveillance of medical devices in Germany: Where does policy integration take place?].

    Science.gov (United States)

    Lang, Achim

    2014-01-01

    Since 2011 new regulatory measures regarding medical devices have been set up with the aim to eliminate obstacles to innovations and to find more coordinated ways to marketing authorisation and market surveillance. This essay investigates whether these new and existing coordination mechanisms build up to a Joined-up Government approach. The analysis shows that the regulatory process should be adjusted along several dimensions. First, many organisations lack awareness regarding their stakeholders and focus solely on their immediate organisational activities. Second, the regulatory process (marketing authorisation and market surveillance) is too fragmented for an effective communication to take place. Finally, the underlying strategy process is an ad-hoc approach lacking continuity and continued involvement of, in particular, the responsible federal ministries. PMID:25066351

  18. Medical device innovation: prospective solutions for an ecosystem in crisis. Adding a professional society perspective.

    Science.gov (United States)

    Krucoff, Mitchell W; Brindis, Ralph G; Hodgson, Patricia K; Mack, Michael J; Holmes, David R

    2012-07-01

    Barriers to medical device innovation compromise timelines and costs from bench to bedside. Fragmented strategies by individual competitors are no longer sustainable. Pragmatically focused pre-competitive collaboration across stakeholders approaches innovation as an ecosystem. Desiloing experience and expertise encourages high-impact infrastructure efficiencies unique to pre-competitive constructs. Alignment of processes and objectives across the regulatory, reimbursement, clinical research, and clinical practice enterprises, with particular attention to the total product life cycle and continuous accrual of safety information, promotes more predictable equipoise for speed of access relative to residual safety concerns. Professional societies are well positioned to convene pre-competitive dialogue, facilitate alignment, and add perspective to equipoise within the innovation ecosystem. PMID:22814785

  19. A new electromagnetic positioning method for tracking invaded medical devices using MARG sensors

    Science.gov (United States)

    Wang, Sen; Chen, Xiao-dong; Du, Cheng-yang; Wang, Yi; Yu, Dao-yin

    2013-08-01

    In clinical medicine, electromagnetic tracking (EMT) system, with its safely penetrating property for human tissue, has been an effective tracking and guiding method for invaded medical devices which are invisible inside a human body. However, traditional EMT system only implements magnetic methods to solve the complex 6-DOF equations and demands an ideal magnetic-field distribution model exited by electromagnetic coils or permanent magnet, resulting in poor anti-interference performance. This paper proposed a new method, combining EMT with the attitude convergence algorithm using MARG sensors. This fusion method reduces the information reliability on the external field, simplifies the complexity of magnetic analysis, and improves the robustness. Except for the accuracy testify experiment, we impose artificial interference to the DC voltage which excites external electromagnetic coils, and the tracking system could still maintain a high positioning stability.

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

    Science.gov (United States)

    Williams, Patricia Ah; Woodward, Andrew J

    2015-01-01

    The increased connectivity to existing computer networks has exposed medical devices to cybersecurity vulnerabilities from which they were previously shielded. For the prevention of cybersecurity incidents, it is important to recognize the complexity of the operational environment as well as to catalog the technical vulnerabilities. Cybersecurity protection is not just a technical issue; it is a richer and more intricate problem to solve. A review of the factors that contribute to such a potentially insecure environment, together with the identification of the vulnerabilities, is important for understanding why these vulnerabilities persist and what the solution space should look like. This multifaceted problem must be viewed from a systemic perspective if adequate protection is to be put in place and patient safety concerns addressed. This requires technical controls, governance, resilience measures, consolidated reporting, context expertise, regulation, and standards. It is evident that a coordinated, proactive approach to address this complex challenge is essential. In the interim, patient safety is under threat. PMID:26229513

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

    Science.gov (United States)

    Williams, Patricia AH; Woodward, Andrew J

    2015-01-01

    The increased connectivity to existing computer networks has exposed medical devices to cybersecurity vulnerabilities from which they were previously shielded. For the prevention of cybersecurity incidents, it is important to recognize the complexity of the operational environment as well as to catalog the technical vulnerabilities. Cybersecurity protection is not just a technical issue; it is a richer and more intricate problem to solve. A review of the factors that contribute to such a potentially insecure environment, together with the identification of the vulnerabilities, is important for understanding why these vulnerabilities persist and what the solution space should look like. This multifaceted problem must be viewed from a systemic perspective if adequate protection is to be put in place and patient safety concerns addressed. This requires technical controls, governance, resilience measures, consolidated reporting, context expertise, regulation, and standards. It is evident that a coordinated, proactive approach to address this complex challenge is essential. In the interim, patient safety is under threat. PMID:26229513

  2. Development of control system for critical parameters of medical device sterilization at an electron accelerator

    International Nuclear Information System (INIS)

    The hard- and software interfaces that provide on-line control and archiving of the basic parameters of the medical device sterilization (electron energy, beam current, width and shape of the beam scan, the conveyor speed and the absorbed dose in the treated products) have been developed at a radiation-industrial installation LU-10 of NSC KIPT. The main primary sensor of the control system is a stack-type monitor-absorber of the beam located behind the line of movement of the processed objects. Continuous monitoring of the processing parameters is performed by measuring and analyzing the currents from the plates of the monitor in a mode of ''radiation shadow'' created by irradiated objects. The structure of the control system, how it works and the calibration procedures for measuring channels are described.

  3. Immobilization of antibacterial chlorhexidine on stainless steel using crosslinking polydopamine film: Towards infection resistant medical devices.

    Science.gov (United States)

    Mohd Daud, Nurizzati; Saeful Bahri, Ihda Fithriyana; Nik Malek, Nik Ahmad Nizam; Hermawan, Hendra; Saidin, Syafiqah

    2016-09-01

    Chlorhexidine (CHX) is known for its high antibacterial substantivity and is suitable for use to bio-inert medical devices due to its long-term antibacterial efficacy. However, CHX molecules require a crosslinking film to be stably immobilized on bio-inert metal surfaces. Therefore, polydopamine (PDA) was utilized in this study to immobilize CHX on the surface of 316L type stainless steel (SS316L). The SS316L disks were pre-treated, modified with PDA film and immobilized with different concentrations of CHX (10mM-50mM). The disks were then subjected to various surface characterization analyses (ATR-FTIR, XPS, ToF-SIMS, SEM and contact angle measurement) and tested for their cytocompatibility with human skin fibroblast (HSF) cells and antibacterial activity against Escherichia coli and Staphylococcus aureus. The results demonstrated the formation of a thin PDA film on the SS316L surface, which acted as a crosslinking medium between the metal and CHX. CHX was immobilized via a reduction process that covalently linked the CHX molecules with the functional group of PDA. The immobilization of CHX increased the hydrophobicity of the disk surfaces. Despite this property, a low concentration of CHX optimized the viability of HSF cells without disrupting the morphology of adherent cells. The immobilized disks also demonstrated high antibacterial efficacy against both bacteria, even at a low concentration of CHX. This study demonstrates a strong beneficial effect of the crosslinked PDA film in immobilizing CHX on bio-inert metal, and these materials are applicable in medical devices. Specifically, the coating will restrain bacterial proliferation without suffocating nearby tissues. PMID:27153117

  4. Review and state of the art on radiation sterilization of medical devices

    Science.gov (United States)

    Dorpema, J. W.

    Review and state of art of radiation sterilization Radiation as a sterilization method was designed in the years 1950-1960. The decade afterwards the application for sterilization of medical products and devices was developped. Extensive studies performed on both the physical, chemical and (micro) biological aspects revealed the requirements for safety and efficacy. These efforts were highly stimulated by the IAEA and resulted in a elegant sterilization method. In product manufacturing, where sterilization represents a final step in the production sequence, radiation has eversince reached its widest application in the field of medical devices. As a spin off it initiated new ideas and approaches towards sterilization in general. Consequently sterility was redefined in terms of a probabilistic concept (10-6) and the bioburden determination method was introduced as a tool for both quality control and potential instrument for dose setting. However these refinements also created controversies, whereby the dose requirements became divided for Europe and North America. Moreover studies recently performed in Europe suggest even a further extension of this opinion gap. Detailed studies, on the clinical effects of low dose treated products (12.5 - 17.5 kGy) are needed to counterbalance the dose suggestions extracted from statistically based dose determinations (> 28 kGy ) and the microbiological resistance determinations ( > 28 - 30 kGy). Dose setting based on risk classification could be considered for distinct product categories. In the mean time a general acceptance of the originally, in the early seventhies, established minimum dose of 25 kGy would seem a reasonable compromise. As the interest for radiation sterilization as the favourable, non polluting and simple method is increasing rapidly over the last five years, both gamma- and beta driven sterilization plants will be needed. Harmonization on sterilization dose therfore requires high priority.

  5. Human-centered risk management for medical devices - new methods and tools.

    Science.gov (United States)

    Janß, Armin; Plogmann, Simon; Radermacher, Klaus

    2016-04-01

    Studies regarding adverse events with technical devices in the medical context showed, that in most of the cases non-usable interfaces are the cause for use deficiencies and therefore a potential harm for the patient and third parties. This is partially due to the lack of suitable methods for interlinking usability engineering and human-centered risk management. Especially regarding the early identification of human-induced errors and the systematic control of these failures, medical device manufacturers and in particular the developers have to be supported in order to guarantee reliable design and error-tolerant human-machine interfaces (HMI). In this context, we developed the HiFEM methodology and a corresponding software tool (mAIXuse) for model-based human risk analysis. Based on a two-fold approach, HiFEM provides a task-type-sensitive modeling structure with integrated temporal relations in order to represent and analyze the use process in a detailed way. The approach can be used from early developmental stages up to the validation process. Results of a comparative study with the HiFEM method and a classical process-failure mode and effect analysis (FMEA) depict, that the new modeling and analysis technique clearly outperforms the FMEA. Besides, we implemented a new method for systematic human risk control (mAIXcontrol). Accessing information from the method's knowledge base enables the operator to detect the most suitable countermeasures for a respective risk. Forty-one approved generic countermeasure principles have been indexed as a resulting combination of root causes and failures in a matrix. The methodology has been tested in comparison to a conventional approach as well. Evaluation of the matrix and the reassessment of the risk priority numbers by a blind expert demonstrate a substantial benefit of the new mAIXcontrol method. PMID:26985681

  6. A Tangible Bridge-An interview with Mr.Sun Ciyi,Secretary General of Shanghai Pudong Medical Device Trade Association

    Institute of Scientific and Technical Information of China (English)

    2009-01-01

    @@ Q:As the Secretary General of Shanghai Pudong Medical Device Trade Association (referred as "the Association").you have worked in the medical industry for many years.Could you tell us your opinion about the current situation of medical device market in China?

  7. Medical Devices; Ear, Nose, and Throat Devices; Classification of the Tympanic Membrane Contact Hearing Aid. Final order.

    Science.gov (United States)

    2016-01-21

    The Food and Drug Administration (FDA) is classifying the tympanic membrane contact hearing aid 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 tympanic membrane contact hearing aid'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. PMID:26803881

  8. Medical Devices; Gastroenterology-Urology Devices; Classification of the Metallic Biliary Stent System for Benign Strictures. Final order.

    Science.gov (United States)

    2016-07-13

    The Food and Drug Administration (FDA) is classifying the metallic biliary stent system for benign strictures 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 metallic biliary stent system for benign strictures' 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. PMID:27411238

  9. Medical Devices; Obstetrical and Gynecological Devices; Classification of the Gynecologic Laparoscopic Power Morcellation Containment System. Final order.

    Science.gov (United States)

    2016-06-21

    The Food and Drug Administration (FDA) is classifying the gynecologic laparoscopic power morcellation containment 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 gynecologic laparoscopic power morcellation containment 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. PMID:27328463

  10. Suitability of a thermoelectric power generator for implantable medical electronic devices

    Energy Technology Data Exchange (ETDEWEB)

    Yang Yang [Technical Institute of Physics and Chemistry, Chinese Academy of Sciences, Beijing 100080 (China); Wei Xiaojuan [Technical Institute of Physics and Chemistry, Chinese Academy of Sciences, Beijing 100080 (China); Liu Jing [Technical Institute of Physics and Chemistry, Chinese Academy of Sciences, Beijing 100080 (China)

    2007-09-21

    Embedding a thermoelectric generator (TEG) in a biological body is a promising way to supply electronic power in the long term for an implantable medical device (IMD). The unique merit of this method lies in its direct utilization of the temperature difference intrinsically existing throughout the whole biological body. However, little is known about the practicability of such a power generation strategy up to now. This paper attempts to evaluate the energy generation capacity of an implanted TEG subject to various physiological or environmental thermal conditions. Through theoretical analysis, it was found that the highest temperature gradient occurs near the skin surface of the human body, which suggested a candidate site for implanting and positioning the TEG. In addition, numerical simulations were performed on three-dimensional bioheat transfer problems in human bodies embedded with TEGs at different implantation depths and configurations. To further enhance energy generation of an implanted TEG, several external technical approaches by intentionally cooling or heating the skin surface were proposed and evaluated. Conceptual experiments either in vitro or in vivo were implemented to preliminarily test the theoretical predictions. Given the fact that an IMD generally require very little working energy, the TEG could serve well as a potential long-term energy supplier for such medical practices.

  11. Sterilization by irradiation of plastic medical devices - an overview. Pt. 2

    International Nuclear Information System (INIS)

    Sterilization by ionizing radiation has become, next to ethylene oxide treatment, the most important 'cold' sterilization process for medical devices made from plastics. The importance of the radiation process and the use of plastics in medical applications are briefly described in Part 1 of this review. Radiation-induced changes in plastics and their dependence on polymer stabilization (additives) and irradiation conditions (absorbed dose, irradiation atmosphere, dose rate) are discussed in Part 2. Ionizing radiation causes simultaneous scission and crosslinking of the polymeric chain molecules, which by altering the molecular weight distribution and structure (crystallinity, morphology) of the polymer, ultimately lead to changes in mechanical and functional properties. At the same time gases, low molecular-weight radiolysis products and unsaturated double bonds are formed and in the presence of oxygen, additional oxidation reactions take place. Part 3 discusses some of the chemical, physical and biological tests methods that can be used to investigate irradiated plastics, and it is attempted to review the relative radiation stability of different polymers and to indicate the limitations of such general stability assessments. (orig.)

  12. Examining the link between cash flow, market value, and research and development investment spending in the medical device industry.

    Science.gov (United States)

    Schmutz, Bryan P; Santerre, Rexford E

    2013-02-01

    Unlike the pharmaceutical industry, no empirical research has focused on the factors influencing research and development (R&D) spending in the medical device industry. To fill that gap, this study examines how R&D spending is influenced by prior year cash flow and corporate market value using multiple regression analysis and a panel data set of medical device companies over the period 1962-2008. The empirical findings suggest that the elasticities of R&D spending with respect to cash flow and corporate market value equal 0.58 and 0.31, respectively. Moreover, based upon these estimates, simulations show that the recently enacted excise tax on medical devices, taken alone, will reduce R&D spending by approximately $4 billion and thereby lead to a minimum loss of $20 billion worth of human life years over the first 10 years of its enactment. PMID:23303706

  13. Radiosterilization of medical devices to use in contact with blood and determination of volatile compounds generated

    International Nuclear Information System (INIS)

    Ethylene oxide gas (EOG) sterilization has been widely used for various kinds of medical devices, however, the toxicity of remaining EOG has become a problem. While radiosterilization with γ-ray is very effective, but there is a possibility that the materials composing those devices may be denatured. By radiation. So, whether volatile substances are generated by radiation was investigated with 4 polymers; acetylcellulose, polymethylmetacrylate, polyvinylalcohol copolymer and polyurethane. And ten-odd kinds of volatile compounds including acetaldehyde, methanol, ethanol butanol methyl- and propyl-formates, methylacetate etc. were detected and their amount were found to increase with an increase of radiation dose. Then, cytotoxicity test was conducted for these volatile compounds using a macrophage-like cell line, P388D1 derived from mouse and a fibroblast cell line, V79 from chinese hamster. From qualitative evaluation of these results, neither of the compounds generated by the γ-ray sterilization had significant toxicity at that level, but there was a close correlation between the cytotoxicity and acute toxicity due to i.p. or i.v. injection of some compounds of them. (M.N.)

  14. Compensating for Tissue Changes in an Ultrasonic Power Link for Implanted Medical Devices.

    Science.gov (United States)

    Vihvelin, Hugo; Leadbetter, Jeff; Bance, Manohar; Brown, Jeremy A; Adamson, Robert B A

    2016-04-01

    Ultrasonic power transfer using piezoelectric devices is a promising wireless power transfer technology for biomedical implants. However, for sub-dermal implants where the separation between the transmitter and receiver is on the order of several acoustic wavelengths, the ultrasonic power transfer efficiency (PTE) is highly sensitive to the distance between the transmitter and receiver. This sensitivity can cause large swings in efficiency and presents a serious limitation on battery life and overall performance. A practical ultrasonic transcutaneous energy transfer (UTET) system design must accommodate different implant depths and unpredictable acoustic changes caused by tissue growth, hydration, ambient temperature, and movement. This paper describes a method used to compensate for acoustic separation distance by varying the transmit (Tx) frequency in a UTET system. In a benchtop UTET system we experimentally show that without compensation, power transfer efficiency can range from 9% to 25% as a 5 mm porcine tissue sample is manipulated to simulate in situ implant conditions. Using an active frequency compensation method, we show that the power transfer efficiency can be kept uniformly high, ranging from 20% to 27%. The frequency compensation strategy we propose is low-power, non-invasive, and uses only transmit-side measurements, making it suitable for active implanted medical device applications. PMID:26054073

  15. Perceptions and practices regarding use of personal listening devices among medical students in coastal South India

    Directory of Open Access Journals (Sweden)

    T Rekha

    2011-01-01

    Full Text Available Today′s generation enjoys having music at their fingertips. This has led to an increase in the usage of personal listening devices (PLDs over the past decade. There are significant concerns regarding harmful effects of PLD use. To find out the perception and practice of medical students regarding use of PLDs. Cross-sectional study was carried out in Mangalore, Coastal south India. Data were collected using a 31 item semi structured questionnaire that was distributed among 570 medical students, of which 485 completed questionnaire were received giving an overall response rate of 86.14%. The study was approved by the departmental review board. Statistical analysis used: data were analyzed using SPSS Version 11.5, Chi-square test for association was used and P<0.05 was considered statistically significant. Of the total study participants, 83.1% of them used PLDs regularly, of whom 77.7% used it for more than 1 h a day. Overall, 18.0% of the study population was aware that prolonged use of PLDs could be harmful to their health. Majority of the study subjects (72.4% felt that the safe duration of listening to PLDs is 3 to 5 h. Among the subjects using PLDs ≥ 1 h, 60.1% preferred ear phones and among those using PLDs <1 h, 44.1% preferred earphones. Overall, 12.4% experienced temporary hearing loss on usage of PLDs. The use of PLDs among the medical students is on the rise, and they should be made more aware of the harmful effects associated with its use.

  16. 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

    Directory of Open Access Journals (Sweden)

    Kaiser, J.

    2012-12-01

    Full Text Available [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 least for parts of it – routine today, ruling e.g. the quality of medical monitor screens for assessment of x-ray pictures. For software applications such as patient data management systems (PDMS, electronic health records (EHR, laboratory information systems and similar systems this was not the case so far. This paper deals with the consequences which may arise if a PDMS used on intensive care units or even an EHR is now classified as a medical device, e.g. because it is able to deliver intelligent composite views on laboratory data, medical data, and treatment information to support diagnostic assessment or treatment advice.Modern clinical information systems, PDMS and EHR support the user with medical information and clinical decision support (CDSS. So there is doubt that they are used for diagnostics and/or treatment. Medical device regulations distinguish between medical product classes I (low risk, II and III (high risk of medical devices according to potential risks for the patient. IF CDSS functions e.g. as modules of a PDMS use vital sign values in the decision algorithms, the PDMS may even be classified as class II medical product, similar to e.g. intravenous pumps. If decision rules of a decision support-system are defined by IT-administrators working for a hospital itself it could even become manufacturer of the medical device.The authors discuss implications and demonstrate difficulties which arise for manufacturers as well as for hospitals or the

  17. Corruption in the health care sector: A barrier to access of orthopaedic care and medical devices in Uganda

    Science.gov (United States)

    2012-01-01

    Background Globally, injuries cause approximately as many deaths per year as HIV/AIDS, tuberculosis and malaria combined, and 90% of injury deaths occur in low- and middle- income countries. Given not all injuries kill, the disability burden, particularly from orthopaedic injuries, is much higher but is poorly measured at present. The orthopaedic services and orthopaedic medical devices needed to manage the injury burden are frequently unavailable in these countries. Corruption is known to be a major barrier to access of health care, but its effects on access to orthopaedic services is still unknown. Methods A qualitative case study of 45 open-ended interviews was conducted to investigate the access to orthopaedic health services and orthopaedic medical devices in Uganda. Participants included orthopaedic surgeons, related healthcare professionals, industry and government representatives, and patients. Participants’ experiences in accessing orthopaedic medical devices were explored. Thematic analysis was used to analyze and code the transcripts. Results Analysis of the interview data identified poor leadership in government and corruption as major barriers to access of orthopaedic care and orthopaedic medical devices. Corruption was perceived to occur at the worker, hospital and government levels in the forms of misappropriation of funds, theft of equipment, resale of drugs and medical devices, fraud and absenteeism. Other barriers elicited included insufficient health infrastructure and human resources, and high costs of orthopaedic equipment and poverty. Conclusions This study identified perceived corruption as a significant barrier to access of orthopaedic care and orthopaedic medical devices in Uganda. As the burden of injury continues to grow, the need to combat corruption and ensure access to orthopaedic services is imperative. Anti-corruption strategies such as transparency and accountability measures, codes of conduct, whistleblower protection, and higher

  18. Corruption in the health care sector: A barrier to access of orthopaedic care and medical devices in Uganda

    Directory of Open Access Journals (Sweden)

    Bouchard Maryse

    2012-05-01

    Full Text Available Abstract Background Globally, injuries cause approximately as many deaths per year as HIV/AIDS, tuberculosis and malaria combined, and 90% of injury deaths occur in low- and middle- income countries. Given not all injuries kill, the disability burden, particularly from orthopaedic injuries, is much higher but is poorly measured at present. The orthopaedic services and orthopaedic medical devices needed to manage the injury burden are frequently unavailable in these countries. Corruption is known to be a major barrier to access of health care, but its effects on access to orthopaedic services is still unknown. Methods A qualitative case study of 45 open-ended interviews was conducted to investigate the access to orthopaedic health services and orthopaedic medical devices in Uganda. Participants included orthopaedic surgeons, related healthcare professionals, industry and government representatives, and patients. Participants’ experiences in accessing orthopaedic medical devices were explored. Thematic analysis was used to analyze and code the transcripts. Results Analysis of the interview data identified poor leadership in government and corruption as major barriers to access of orthopaedic care and orthopaedic medical devices. Corruption was perceived to occur at the worker, hospital and government levels in the forms of misappropriation of funds, theft of equipment, resale of drugs and medical devices, fraud and absenteeism. Other barriers elicited included insufficient health infrastructure and human resources, and high costs of orthopaedic equipment and poverty. Conclusions This study identified perceived corruption as a significant barrier to access of orthopaedic care and orthopaedic medical devices in Uganda. As the burden of injury continues to grow, the need to combat corruption and ensure access to orthopaedic services is imperative. Anti-corruption strategies such as transparency and accountability measures, codes of conduct

  19. Overview on Taiwan Medical Device Supervision%台湾医疗器械监管概述

    Institute of Scientific and Technical Information of China (English)

    罗维娜; 邓刚; 胡雪燕; 袁鹏; 任海萍

    2013-01-01

    In this Article, the Definition of Medical Device, laws, regulations and criterions for medical and public health, Regulatory Authority and Pre-market review in Taiwan are summarized. It can make development and improvement on the Medical Device Supervision and Regulatory System, which wil be helpful to Medical administration in China.%本文对台湾医疗器械定义、法规体系及标准、监管机构和上市前审查等方面进行了介绍,为进一步加强我国医疗器械监管能力、完善医疗器械监管制度提供借鉴。

  20. Medical device regulations as a source of industrial leadership : A comparative study of American and European regulatory approaches

    OpenAIRE

    Ershova, Nadezda

    2011-01-01

    Medical technology industry which produces the whole range of medical devices from eye droppers to computer tomography scanners is characterized by serious learning problems of industry stakeholders due to its high technological complexity and product diversity. Majority of firms populating the sector are small companies with no revenues, and therefore, depending strongly on venture capital to get their products on the market. At the same time due to technologies which are successfully launch...