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 ... may need one in a hospital. To use medical devices safely Know how your device works. Keep ...

  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. 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

  5. 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...

  6. 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...

  7. 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

  8. [Medical device use errors].

    Science.gov (United States)

    Friesdorf, Wolfgang; Marsolek, Ingo

    2008-01-01

    Medical devices define our everyday patient treatment processes. But despite the beneficial effect, every use can also lead to damages. Use errors are thus often explained by human failure. But human errors can never be completely extinct, especially in such complex work processes like those in medicine that often involve time pressure. Therefore we need error-tolerant work systems in which potential problems are identified and solved as early as possible. In this context human engineering uses the TOP principle: technological before organisational and then person-related solutions. But especially in everyday medical work we realise that error-prone usability concepts can often only be counterbalanced by organisational or person-related measures. Thus human failure is pre-programmed. In addition, many medical work places represent a somewhat chaotic accumulation of individual devices with totally different user interaction concepts. There is not only a lack of holistic work place concepts, but of holistic process and system concepts as well. However, this can only be achieved through the co-operation of producers, healthcare providers and clinical users, by systematically analyzing and iteratively optimizing the underlying treatment processes from both a technological and organizational perspective. What we need is a joint platform like medilab V of the TU Berlin, in which the entire medical treatment chain can be simulated in order to discuss, experiment and model--a key to a safe and efficient healthcare system of the future. PMID:19213452

  9. Medical device regulation for manufacturers.

    Science.gov (United States)

    McAllister, P; Jeswiet, J

    2003-01-01

    Manufacturers of medical devices are held to a higher standard than manufacturers of many other products due to the potential severity of the consequences of introducing inferior or unsafe products to the market-place. In Canada, the medical device industry is regulated by Health Canada under the Medical Device Regulations of the Food and Drug Act. The Medical Device Regulations define requirements of medical device design, development and manufacture to ensure that products reaching the public are safe and effective. Health Canada also requires that medical device manufacturers maintain distribution records to ensure that devices can be traced to the source and consumers can be contacted successfully in the event that a device is recalled. Medical devices exported from Canada must be compliant with the regulations of the country of import. The Canadian Medical Device Regulations were based on the Medical Device Directives of the European Union thus facilitating approval of Canadian devices for the European market. The United States Food and Drug Administration has separate and distinct requirements for safety and quality of medical devices. While effort has been made to facilitate approval and trade of Canadian medical devices in the United States and the European Union, obtaining approval from multiple regulatory bodies can result in increased device development time and cost. The Global Harmonization Task Force is an organization composed of members from Japanese, Australian, European, Canadian and American medical device regulatory bodies. This organization was formed with the objective of harmonizing medical device regulations in an effort to facilitate international trade and standardize the quality of medical devices available to all countries. This paper discusses the requirements that must be met by manufacturers when designing and manufacturing medical devices.

  10. 77 FR 17529 - Notice of Charter Renewal: Advisory Committee on the Medical Uses of Isotopes

    Science.gov (United States)

    2012-03-26

    ... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION Notice of Charter Renewal: Advisory Committee on the Medical Uses of Isotopes AGENCY: U.S. Nuclear Regulatory Commission. ACTION: This notice is to announce the renewal of the Advisory Committee on the Medical Uses of Isotopes (ACMUI) for a...

  11. 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

  12. 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

  13. 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...

  14. 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 ...

  15. 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

  16. 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

  17. 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

  18. Medical applications of magnet devices

    Energy Technology Data Exchange (ETDEWEB)

    Hale, J.R.

    1975-09-01

    The use of magnetic devices in medically-related applications has often been frustrated by insufficient magnetic force, or by an inappropriately designed device. Magnetic treatment systems are discussed generally, and two systems are described in detail. First, a superconducting magnet, with integral orientation system, intended for use in intravascular catheter guidance is described. The maximum field and gradient produced by this solenoid are 20,000 Oe, and 2250 Oe/cm, respectively. The system is both powerful and easy to use, by virtue of its completely portable design. The second is a magnetic traction device which has been successfully employed in the treatment of esophageal atresia.

  19. 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

  20. 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.

  1. 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

  2. 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 ...

  3. 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 rule; technical amendment. SUMMARY: The Food and Drug Administration (FDA) is amending certain medical device regulations to correct statutory and regulatory references to ensure accuracy, consistency,...

  4. 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

  5. 77 FR 6028 - Taxable Medical Devices

    Science.gov (United States)

    2012-02-07

    ... Internal Revenue Service 26 CFR Part 48 RIN 1545-BJ44 Taxable Medical Devices AGENCY: Internal Revenue... certain medical devices under section 4191 of the Internal Revenue Code, enacted by the Health Care and... proposed regulations affect manufacturers, importers, and producers of taxable medical devices....

  6. 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.

  7. 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...

  8. 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

  9. 78 FR 15878 - Taxable Medical Devices; Correction

    Science.gov (United States)

    2013-03-13

    ..., 2012 (77 FR 72924). The final regulations provide guidance on the excise tax imposed on the sale of...., Example 11., and Example 13. The revisions read as follows: Sec. 48.4191-2 Taxable medical device... individual consumers who are not medical professionals, and if the design of the device demonstrates that...

  10. Medical devices and patient safety.

    Science.gov (United States)

    Mattox, Elizabeth

    2012-08-01

    Errors related to health care devices are not well understood. Nurses in intensive care and progressive care environments can benefit from understanding manufacturer-related error and device-use error, the principles of human factors engineering, and the steps that can be taken to reduce risk of errors related to health care devices.

  11. 76 FR 8637 - Medical Devices; Medical Device Data Systems

    Science.gov (United States)

    2011-02-15

    ... this organizational change to provide clarification of MDDS functionality and because this ordering is... of an order classifying the device in class I or class II. To change the classification of the device... which is of substantial importance in preventing impairment of human health or it presents a...

  12. 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 ...

  13. 21 CFR 892.2040 - Medical image hardcopy device.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical image hardcopy device. 892.2040 Section... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device. (a) Identification. A medical image hardcopy device is a device that produces a visible printed record of a...

  14. 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...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2010 Medical image storage device. (a) Identification. A medical image storage device is a device that provides electronic storage and...

  15. Charter on continuing medical education/continuing professional development approved by the UEMS Specialist Section and European Board of Anaesthesiology.

    Science.gov (United States)

    Alahuhta, S; Mellin-Olsen, J; Blunnie, W P; Knape, J T A

    2007-06-01

    The mission of the Section and Board of Anaesthesiology of the European Union of Medical Specialists (EUMS/UEMS) is to harmonize training and medical practice in all European countries to continuously improve the quality of care. The need for continuous medical education in the field of anaesthesiology has long been recognized. However, specialty-based competencies are not the only requirements for successful medical practice. The need to acquire medical, managerial, ethical, social and personal communication skills on top of specialty-based competencies has developed into the principle of continuous professional development, which embraces both objectives. The Section and Board of Anaesthesiology of the EUMS/UEMS has approved a proposal of its Standing Committee on Continuous Medical Education/Continuous Professional Development to adopt the following charter on the subject.

  16. 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

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

    Science.gov (United States)

    2012-11-19

    ... Food, Drug, and Cosmetic Act (the FD&C Act). The Food and Drug Administration (FDA) is in the process... HUMAN SERVICES Food and Drug Administration Medical Devices; Custom Devices; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for comments. SUMMARY: The Food and...

  18. 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... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image communications device. (a) Identification. A medical image communications device provides electronic transfer of...

  19. Irish medical device industry update.

    Science.gov (United States)

    Higgins, Sharon

    2005-12-01

    The continued growth of the Irish medical technology industry has not been accidental. The sector is proactive in its drive for excellence in all aspects of the business, from concept to commercialisation. This reports on some recent initiatives.

  20. 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

  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. 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

  3. 78 FR 15877 - Taxable Medical Devices; Correction

    Science.gov (United States)

    2013-03-13

    ..., 2012 (77 FR 72924). The final regulations provide guidance on the excise tax imposed on the sale of... Accordingly, the final regulations (TD 9604), that are the subject of FR Doc. 2012-29628, are corrected as... device to the FDA's'' is corrected to read ``of a taxable medical device to the FDA's''. 8. On page...

  4. Handheld Diagnostic Device Delivers Quick Medical Readings

    Science.gov (United States)

    2014-01-01

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

  5. 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...) is clarifying that device manufacturers and importers of all devices, including class I and...

  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. Regulatory affairs for biomaterials and medical devices

    CERN Document Server

    Amato, Stephen F; Amato, B

    2015-01-01

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

  8. 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.

  9. 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.

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

    Science.gov (United States)

    Cao, Shaoping; Yin, Chunguang; Zhao, Zhenying

    2013-03-01

    Through the establishment of implantable medical device information management system, with the aid of the regional joint sharing of resources, we further enhance the implantable medical device traceability management level, strengthen quality management, control of medical risk. PMID:23777076

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

    Science.gov (United States)

    Cao, Shaoping; Yin, Chunguang; Zhao, Zhenying

    2013-03-01

    Through the establishment of implantable medical device information management system, with the aid of the regional joint sharing of resources, we further enhance the implantable medical device traceability management level, strengthen quality management, control of medical risk.

  12. 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

  13. 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.

  14. Onboard tagging for smart medical devices.

    Science.gov (United States)

    Li, Kejia; Warren, Steve

    2011-01-01

    Most medical devices are 'dumb:' their role is to acquire, display, and forward data. They make few if any operational decisions based on those data. Onboard tagging is a means whereby a device can embed information about itself, its data, and the sensibility of those data into its data stream. This diagnostic add-on offers a move toward 'smart' devices that will have the ability to affect changes in operational modes based on onboard contextual decision making, such as decisions to avoid needless wireless transmission of corrupt data. This paper presents a description of three types of onboard tags that relate to device hardware (type I tag), signal statistics (type II tag), and signal viability for the intended application (type III tag). A custom wireless pulse oximeter is presented as a use case to show how type II and III tags that convey photoplethysmogram (PPG) statistics and usability specifiers can be calculated and embedded into the data stream without degrading performance.

  15. 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,...

  16. 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...

  17. 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.

  18. BIOANALYTICAL STANDARDIZING FOR SEROLOGICAL DIAGNOSTIC MEDICAL DEVICES

    Directory of Open Access Journals (Sweden)

    A. Yu. Galkin

    2015-04-01

    Full Text Available In article we analyzed national and international regulations concerning the quality and safety of medical devices for in vitro diagnostics. We discussed the possibility of a partial application of the recommendations of the State Pharmacopoeia of Ukraine to this type of product. The main guiding regulatory documents establishing requirements for quality and safety tools for the serological diagnosis products are The technical regulation on medical devices for the diagnosis in vitro, DSTU ISO 13485 “Medical devices. Quality management system. Regulatory requirements”, and DSTU ISO/IEC 17025 “General requirements for the competence of testing and calibration laboratories”. Similar requirements of the State Pharmacopoeia of Ukraine which are used for drug standardization can not be directly applied to the medical devises for in vitro diagnostics due to a number of features, namely, the serological diagnosis products pre-designed to determine the unknown concentration of a particular analyte in a biological material, the diagnostic kits has to include the control samples (internal standard systems that need to be calibrated. It was determined following parameters of bioanalytical standardization and validation characterization for of qualitative (semi quantitative test-kits for serological diagnosis: precision (convergence, intralaboratory precision and reproducibility, diagnostic and analytical specificity, diagnostic sensitivity. It’s necessary to inspect additional parameters for quantitative test-kits such as accuracy (precision, linearity, analytical sensitivity and range.

  19. 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...

  20. 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

  1. 75 FR 16365 - Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on...

    Science.gov (United States)

    2010-04-01

    ... business information, Medical devices, Medical research, Reporting and recordkeeping requirements... significant adverse comment. In the Federal Register of November 21, 1997 (62 FR 62466), you can find... submit certain medical device applications to include readily available information providing...

  2. Radiation Oncology and Medical Devices (Part 2)

    Institute of Scientific and Technical Information of China (English)

    Ning J. Yue; Ting Chen; Wei Zou

    2014-01-01

    Radiation oncology is one of the three major treatment modalities to manage cancer patient cares, and is a discipline mainly driven by technology and medical devices. Modern radiation treatments have become fairly complex and involve in utilizing a variety of medical devices to achieve the goal of providing conformal radiation dose coverage to the tumor target(s) while maximizing the sparing of normal organ structures. Recently, different forms of linear accelerators/radioactive source based machines have been invented and developed with the aim of providing improved treatments and more treatment options. Besides linear accelerators (Linac) that have been undergoing constant improvement and advancement and can deliver fairly complicated dose distribution patterns, imaging systems, computer information and calculation systems have been more and more integrated into radiotherapy processes. To bring radiotherapy to a potentially higher level, many institutions have either acquired or started to consider particle therapy, especially proton therapy. The complexity of modern radiotherapy demands in-depth understanding of radiation physics and machine engineering as well as computer information systems. This paper is intended to provide an introductory description of radiation oncology and related procedures, and to provide an overview of the current status of medical devices in radiotherapy in the United States of America. This paper covers the radiation delivery systems, imaging systems, treatment planning systems, record and verify systems, and QA systems.

  3. 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.

  4. 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

  5. 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.

  6. 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...

  7. 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

  8. 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...

  9. 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...

  10. 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

  11. Medical Devices that Treat Obesity: What to Know

    Science.gov (United States)

    ... For Consumers Home For Consumers Consumer Updates Medical Devices that Treat Obesity: What to Know Share Tweet ... requirements vary by device. back to top Which devices has the FDA approved to treat obesity? The ...

  12. Hacking medical devices a review - biomed 2013.

    Science.gov (United States)

    Frenger, Paul

    2013-01-01

    Programmable, implantable and external biomedical devices (such as pacemakers, defibrillators, insulin pumps, pain management pumps, vagus nerve stimulators and others) may be vulnerable to unauthorized access, commonly referred to as “hacking”. This intrusion may lead to compromise of confidential patient data or loss of control of the device itself, which may be deadly. Risks to health from unauthorized access is in addition to hazards from faulty (“buggy”) software or circuitry. Historically, this aspect of medical device design has been underemphasized by both manufacturers and regulatory bodies until recently. However, an insulin pump was employed as a murder weapon in 2001 and successful hacking of an implantable defibrillator was demonstrated in 2008. To remedy these problems, professional groups have announced a variety of design standards and the governmental agencies of several countries have enacted device regulations. In turn, manufacturers have developed new software products and hardware circuits to assist biomedical engineering firms to improve their commercial offerings. In this paper the author discusses these issues, reviewing known problems and zero-day threats, with potential solutions. He outlines his approach to secure software and hardware challenges using the Forth language. A plausible scenario is described in which hacking of an implantable defibrillator by terrorists results in a severe national security threat to the United States.

  13. Hacking medical devices a review - biomed 2013.

    Science.gov (United States)

    Frenger, Paul

    2013-01-01

    Programmable, implantable and external biomedical devices (such as pacemakers, defibrillators, insulin pumps, pain management pumps, vagus nerve stimulators and others) may be vulnerable to unauthorized access, commonly referred to as “hacking”. This intrusion may lead to compromise of confidential patient data or loss of control of the device itself, which may be deadly. Risks to health from unauthorized access is in addition to hazards from faulty (“buggy”) software or circuitry. Historically, this aspect of medical device design has been underemphasized by both manufacturers and regulatory bodies until recently. However, an insulin pump was employed as a murder weapon in 2001 and successful hacking of an implantable defibrillator was demonstrated in 2008. To remedy these problems, professional groups have announced a variety of design standards and the governmental agencies of several countries have enacted device regulations. In turn, manufacturers have developed new software products and hardware circuits to assist biomedical engineering firms to improve their commercial offerings. In this paper the author discusses these issues, reviewing known problems and zero-day threats, with potential solutions. He outlines his approach to secure software and hardware challenges using the Forth language. A plausible scenario is described in which hacking of an implantable defibrillator by terrorists results in a severe national security threat to the United States. PMID:23686179

  14. 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

  15. 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

  16. 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...

  17. 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...

  18. Radiofrequency identification and medical devices: the regulatory framework on electromagnetic compatibility. Part I: medical devices.

    Science.gov (United States)

    Censi, Federica; Mattei, Eugenio; Triventi, Michele; Bartolini, Pietro; Calcagnini, Giovanni

    2012-05-01

    Radiofrequency identification (RFID) technology has acheived significant success and has penetrated into various areas of healthcare. Several RFID-based applications are used in various modalities with the ultimate aim of improving patient care. When a wireless technology is used in a healthcare environment, attention must be paid to the potential risks deriving from its use; one of the most important being electromagnetic interference with medical devices. In this paper, the regulatory framework concerning the electromagnetic compatibility between RFID and medical devices is analyzed to understand whether and how the application of the current standards allows for the effective control of the risks of electromagnetic interference.

  19. 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.

  20. 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

  1. 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...

  2. 75 FR 16347 - Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on...

    Science.gov (United States)

    2010-04-01

    ... devices, Medical research, Reporting and recordkeeping requirements. 0 Therefore, under the Federal Food... U.S.C. 360e-1). Section 515A(a) of the act requires persons who submit certain medical device... known as the Pediatric Medical Device Safety and Improvement Act of 2007. Section 515A(c) of the...

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. 76 FR 51876 - Medical Devices; Ophthalmic Devices; Classification of the Eyelid Thermal Pulsation System

    Science.gov (United States)

    2011-08-19

    ..., 1976 (the date of enactment of the Medical Device Amendments of 1976), generally referred to as... HUMAN SERVICES Food and Drug Administration 21 CFR Part 886 Medical Devices; Ophthalmic Devices... system into class II (special controls). The Agency is classifying the device into class II...

  12. 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...

  13. 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...

  14. 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...

  15. 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...

  16. 76 FR 7220 - Medical Device Innovation Initiative; Request for Comments

    Science.gov (United States)

    2011-02-09

    ... HUMAN SERVICES Food and Drug Administration Medical Device Innovation Initiative; Request for Comments... Innovation Initiative'' (the report). The report proposes potential actions for FDA's Center for Devices and... global leader in medical device innovation and CDRH is committed to assuring that American patients...

  17. [USA approval of high-risk medical device].

    Science.gov (United States)

    Chang, Yongheng

    2013-03-01

    During the practice of supervision and management of medical device in different countries, the strict regulatory and needs of the program by the regulations is to be determined by the risk level of the medical equipment. This paper briefly describes the regulatory requirements of the United States to enter the market for high-risk medical device. PMID:23777072

  18. 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 ...

  19. 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:...

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

    Science.gov (United States)

    Mahmoud Pashazadeh, Ali; Aghajani, Mahdi; Nabipour, Iraj; Assadi, Majid

    2013-10-01

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

  1. 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...

  2. 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 ...

  3. 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...

  4. 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...

  5. 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,...

  6. 78 FR 11612 - Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on...

    Science.gov (United States)

    2013-02-19

    ... Part 814 Administrative practice and procedure, Confidential business information, Medical devices... the Pediatric Medical Device Safety and Improvement Act of 2007. The number of approved devices for..., 2010, FDA had published a proposed rule, along with a companion direct final rule (75 FR 16347), with...

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

    DEFF Research Database (Denmark)

    Hansen, Klaus Marius; Manikas, Konstantinos

    Compliance to regulations and regulatory approval are requirements for many medical device software systems. In this paper, we investigate the implications of medical device software regulations to the design of software systems. We do so by focusing on the American and European regulatory author...

  8. European Medical Device Directive : impact on nuclear medicine

    NARCIS (Netherlands)

    Kuyvenhoven, JD; Lahorte, P; Persyn, K; De Geest, E; van Loon, PW; Jacobs, F; van Rijk, PP; Lemahieu, [No Value; Dierckx, RA

    2001-01-01

    The European Council Directive 93/42/EEC concerning medical devices (14 June 1993) assigns new responsibilities and imposes technical requirements both to the manufacturer and user of medical devices. In this paper the general outlines of the directive are discussed with a particular emphasis on the

  9. 76 FR 45268 - Reprocessing of Reusable Medical Devices

    Science.gov (United States)

    2011-07-28

    ... Silver Spring, MD. In the Federal Register of May 2, 2011 (76 FR 24495), FDA announced the workshop and... HUMAN SERVICES Food and Drug Administration Reprocessing of Reusable Medical Devices AGENCY: Food and... Administration (FDA) is considering factors affecting the reprocessing of reusable medical devices,...

  10. 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.

  11. 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

  12. 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

  13. 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...

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

    Science.gov (United States)

    Neto, José Augusto; Figueiredo Damásio, Jemerson; Monthaler, Paul; Morais, Misael

    2015-01-01

    Worldwide medical device embedded software certification practices are currently focused on manufacturing best practices. In Brazil, the national regulatory agency does not hold a local certification process for software-intensive medical devices and admits international certification (e.g. FDA and CE) from local and international industry to operate in the Brazilian health care market. We present here a product-based certification process as a candidate process to support the Brazilian regulatory agency ANVISA in medical device software regulation. Center of Strategic Technology for Healthcare (NUTES) medical device embedded software certification is based on a solid safety quality model and has been tested with reasonable success against the Class I risk device Generic Infusion Pump (GIP).

  16. NEED FOR HARMONIZATION OF LABELING OF MEDICAL DEVICES: A REVIEW

    Directory of Open Access Journals (Sweden)

    Rajendra Songara,

    2010-06-01

    Full Text Available Medical device labeling is any information associated with a device targeted to the patient or lay caregiver. It is intended to help assure that the device is used safely and effectively. Medical device labeling is supplied in many formats, for example, as patient brochures, patient leaflets, user manuals, and videotapes. The European commission has discussed a series of agreements with third countries, Australia, New Zealand, USA, Canada, Japan and Eastern European countries wishing to join the EU, concerning the mutual acceptance of inspection bodies, proof of conformity in connection with medical devices. Device labeling is exceedingly difficult for manufacturers for many reasons like regulations from government bodies to ensure compliance, increased competent authority surveillance, increased audits and language requirements.

  17. Need for harmonization of labeling of medical devices: A review

    Directory of Open Access Journals (Sweden)

    Raiendra K Songara

    2010-01-01

    Full Text Available Medical device labeling is any information associated with a device targeted to the patient or lay caregiver. It is intended to help assure that the device is used safely and effectively. Medical device labeling is supplied in many formats, for example, as patient brochures, patient leaflets, user manuals, and videotapes. The European commission has discussed a series of agreements with third countries, Australia, New Zealand, USA, Canada, Japan and Eastern European countries wishing to join the EU, concerning the mutual acceptance of inspection bodies, proof of conformity in connection with medical devices. Device labeling is exceedingly difficult for manufacturers for many reasons like regulations from government bodies to ensure compliance, increased competent authority surveillance, increased audits and language requirements.

  18. A concept ideation framework for medical device design.

    Science.gov (United States)

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

    2015-06-01

    Medical device design is a challenging process, often requiring collaboration between medical and engineering domain experts. This collaboration can be best institutionalized through systematic knowledge transfer between the two domains coupled with effective knowledge management throughout the design innovation process. Toward this goal, we present the development of a semantic framework for medical device design that unifies a large medical ontology with detailed engineering functional models along with the repository of design innovation information contained in the US Patent Database. As part of our development, existing medical, engineering, and patent document ontologies were modified and interlinked to create a comprehensive medical device innovation and design tool with appropriate properties and semantic relations to facilitate knowledge capture, enrich existing knowledge, and enable effective knowledge reuse for different scenarios. The result is a Concept Ideation Framework for Medical Device Design (CIFMeDD). Key features of the resulting framework include function-based searching and automated inter-domain reasoning to uniquely enable identification of functionally similar procedures, tools, and inventions from multiple domains based on simple semantic searches. The significance and usefulness of the resulting framework for aiding in conceptual design and innovation in the medical realm are explored via two case studies examining medical device design problems.

  19. 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...

  20. 76 FR 42713 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...

    Science.gov (United States)

    2011-07-19

    ... HUMAN SERVICES Food and Drug Administration General and Plastic Surgery Devices Panel of the Medical... General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee. This meeting was... of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee would...

  1. #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...

  2. 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...

  3. 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…

  4. 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.../MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080198.htm or by sending an email request..., p. 3.) In the Federal Register of June 1, 2012 (77 FR 32642), FDA published a notice announcing...

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

    Science.gov (United States)

    2011-09-07

    ... in the Federal Register of August 9, 2011 (76 FR 48871). The meeting is postponed so that FDA can... HUMAN SERVICES Food and Drug Administration Immunology Devices Panel of the Medical Devices Advisory.... SUMMARY: The Food and Drug Administration (FDA) is postponing the meeting of the Immunology Devices...

  6. 76 FR 48871 - Immunology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-08-09

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

  7. 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...

  8. 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...

  9. 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... Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee. General...

  10. 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...

  11. 75 FR 14170 - Medical Device Epidemiology Network: Developing Partnership Between the Center for Devices and...

    Science.gov (United States)

    2010-03-24

    ... Between the Center for Devices and Radiological Health and Academia; Public Workshop AGENCY: Food and Drug... public workshop entitled ``Medical Device Epidemiology Network (MDEpiNet): Developing Partnership Between the Center for Devices and Radiological Health and Academia.'' The purpose of the public workshop...

  12. 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...

  13. 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.

  14. 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

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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

  20. PATIENT SATISFACTION WITH ORTHOPEDIC AND PROSTHETIC MEDICAL DEVICES

    Directory of Open Access Journals (Sweden)

    Ivona Malovecká

    2015-09-01

    Full Text Available Collecting information about patient satisfaction with orthopedic and prosthetic medical devices in terms of utility, tolerance, and compliance is essential for verifying and improving the quality of these devices. In addition, such information is useful for improving the patients’ quality of life, and the quality management systems of health care providers. This study assessed patient satisfaction with these devices from a sample of patients with orthopedic, neurologic, and rheumatic diseases at the Specialized Hospital for Orthopedic Prosthetics and at the premises of the Dispenser of Orthopedic and Prosthetic Medical Devices, both in Bratislava in the Slovak Republic. The assessment involved a translated and validated questionnaire about patient satisfaction with orthopedic and prosthetic medical devices to evaluate key factors of weight, fit, appearance, comfort, pain free, free of abrasiveness, ease of application, and durability of each device. The study samples consisted of patients with lower limb problems (42.5%, spine problems (26.9%, and a combination of leg and spine issues (25.9%. Orthopedic disease occurred in 73.6% of these patients, a combination of orthopedic and neurologic disease in 13.5%, and neurologic disease in 7.3%. Orthopedic insoles (36.3%, hip belts (17.6%, and the corset on the spine (5.2% were the most used devices. Overall, the medical devices rated highly, with a high proportion of patients voting “strongly satisfied” in five of the eight key factors (range 51.8 to 63.2%, followed by a moderately lower proportion for durability (43.5%, comfort (37.3%, and appearance (31.1%. The comfort in wearing the device received the greatest patient dissatisfaction (22.8% of patients, followed by appearance (12.4%, and then fit (7.3%.

  1. 77 FR 25183 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-04-27

    ... 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 Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a...

  2. 77 FR 71195 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2012-11-29

    ... From the Federal Register Online via the Government Publishing Office ] DEPARTMENT OF HEALTH AND 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: Notice. This notice announces a...

  3. 78 FR 20328 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee: Notice of...

    Science.gov (United States)

    2013-04-04

    ... HUMAN SERVICES Food and Drug Administration Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee: Notice of Postponement of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is postponing the meeting of...

  4. 78 FR 66942 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2013-11-07

    ... 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: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and...

  5. 76 FR 17422 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2011-03-29

    ... 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: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and...

  6. 75 FR 36660 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2010-06-28

    ... 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: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and...

  7. 76 FR 16292 - Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass...

    Science.gov (United States)

    2011-03-23

    ... 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...

  8. 76 FR 20840 - Medical Devices; General and Plastic Surgery Devices; Classification of the Low Level Laser...

    Science.gov (United States)

    2011-04-14

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 878 Medical Devices; General and Plastic Surgery... PLASTIC SURGERY DEVICES 0 1. The authority citation for 21 CFR part 878 continues to read as...

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

    Science.gov (United States)

    2011-02-07

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 878 Medical Devices; General and Plastic Surgery... follows: PART 878--GENERAL AND PLASTIC SURGERY DEVICES 0 1. The authority citation for 21 CFR part...

  10. 75 FR 68972 - Medical Devices; General and Plastic Surgery Devices; Classification of Tissue Adhesive With...

    Science.gov (United States)

    2010-11-10

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 878 Medical Devices; General and Plastic Surgery..., 21 CFR part 878 is amended as follows: PART 878--GENERAL AND PLASTIC SURGERY DEVICES 0 1. The... wounds from surgical incisions, including punctures from minimally invasive surgery, and...

  11. 77 FR 50701 - Radiological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-08-22

    .... The Selenia Dimensions 3D System is currently approved for breast cancer screening and diagnosis. The... HUMAN SERVICES Food and Drug Administration Radiological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ] ACTION: Notice. This...

  12. 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

  13. 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

  14. Bulk Metallic Glasses for Implantable Medical Devices and Surgical Tools.

    Science.gov (United States)

    Meagher, Philip; O'Cearbhaill, Eoin D; Byrne, James H; Browne, David J

    2016-07-01

    With increasing knowledge of the materials science of bulk metallic glasses (BMGs) and improvements in their properties and processing, they have started to become candidate materials for biomedical devices. A dichotomy in the types of medical applications has also emerged, in which some families of BMGs are being developed for permanent devices whilst another family - of Mg-based alloys - is showing promise in bioabsorbable implants. The current status of these metallurgical and technological developments is summarized.

  15. 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.

  16. 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

  17. 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.

  18. 76 FR 55394 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices...

    Science.gov (United States)

    2011-09-07

    ... to grant HUD designation of a medical device; (2) exempt an HUD from the effectiveness requirements... 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...

  19. 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.

  20. 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...

  1. 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

  2. Radiation sterilization of medical devices; Radiacyjna sterylizacja sprzetu medycznego

    Energy Technology Data Exchange (ETDEWEB)

    Kaluska, I.; Stuglik, Z. [Institute of Nuclear Chemistry and Technology, Warsaw (Poland)

    1996-12-31

    Overview of sterilization methods of medical devices has been given, with the special stress put on radiation sterilization. A typical validation program for radiation sterilization has been shown and also a comparison of European and ISO standards concerning radiation sterilization has been discussed. (author). 13 refs, 1 fig., 2 tabs.

  3. 76 FR 24495 - Reprocessing of Reusable Medical Devices; Public Workshop

    Science.gov (United States)

    2011-05-02

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Reprocessing of Reusable Medical Devices; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop; request for comments. The Food and Drug Administration (FDA)...

  4. 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

  5. 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

  6. 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...

  7. 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.

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

    Science.gov (United States)

    Voss, Thaddaeus J; Subbian, Vignesh; Beyette, Fred R

    2014-01-01

    Wearable devices are arguably one of the most rapidly growing technologies in the computing and health care industry. These systems provide improved means of monitoring health status of humans in real-time. In order to cope with continuous sensing and transmission of biological and health status data, it is desirable to move towards energy autonomous systems that can charge batteries using passive, ambient energy. This not only ensures uninterrupted data capturing, but could also eliminate the need to frequently remove, replace, and recharge batteries. To this end, energy harvesting is a promising area that can lead to extremely power-efficient portable medical devices. This paper presents an experimental prototype to study the feasibility of harvesting two energy sources, solar and thermoelectric energy, in the context of wearable devices. Preliminary results show that such devices can be powered by transducing ambient energy that constantly surrounds us.

  9. 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...

  10. 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....

  11. 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...

  12. 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

  13. 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

  14. Towards automated assistance for operating home medical devices.

    Science.gov (United States)

    Gao, Zan; Detyniecki, Marcin; Chen, Ming-Yu; Wu, Wen; Hauptmann, Alexander G; Wactlar, Howard D

    2010-01-01

    To detect errors when subjects operate a home medical device, we observe them with multiple cameras. We then perform action recognition with a robust approach to recognize action information based on explicitly encoding motion information. This algorithm detects interest points and encodes not only their local appearance but also explicitly models local motion. Our goal is to recognize individual human actions in the operations of a home medical device to see if the patient has correctly performed the required actions in the prescribed sequence. Using a specific infusion pump as a test case, requiring 22 operation steps from 6 action classes, our best classifier selects high likelihood action estimates from 4 available cameras, to obtain an average class recognition rate of 69%.

  15. Medical device-induced thrombosis: what causes it and how can we prevent it?

    Science.gov (United States)

    Jaffer, I H; Fredenburgh, J C; Hirsh, J; Weitz, J I

    2015-06-01

    Blood-contacting medical devices, such as vascular grafts, stents, heart valves, and catheters, are often used to treat cardiovascular diseases. Thrombus formation is a common cause of failure of these devices. This study (i) examines the interface between devices and blood, (ii) reviews the pathogenesis of clotting on blood-contacting medical devices, (iii) describes contemporary methods to prevent thrombosis on blood-contacting medical devices, (iv) explains why some anticoagulants are better than others for prevention of thrombosis on medical devices, and (v) identifies future directions in biomaterial research for prevention of thrombosis on blood-contacting medical devices.

  16. 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...

  17. 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...

  18. 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...

  19. 76 FR 36993 - Medical Devices; Neurological Devices; Clarification of Classification for Human Dura Mater...

    Science.gov (United States)

    2011-06-24

    ...). In the Federal Register of November 24, 2004 (69 FR 68612), FDA published a final rule regarding... of the final rule, human dura mater was regulated as a medical device under Sec. 882.5975. As stated... HUMAN SERVICES Food and Drug Administration 21 CFR Part 882 (formerly Docket No. 1997N-0484P)...

  20. 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... HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 Medical Devices; Immunology and...

  1. 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...

  2. 76 FR 71983 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2011-11-21

    ... 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...

  3. 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...

  4. 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...

  5. 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.

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

    Science.gov (United States)

    2010-10-05

    ... HUMAN SERVICES Food and Drug Administration General and Plastic Surgery Devices Panel of the Medical... 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...

  7. 75 FR 1395 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...

    Science.gov (United States)

    2010-01-11

    ... HUMAN SERVICES Food and Drug Administration General and Plastic Surgery Devices Panel of the Medical... the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee. This meeting was announced in the Federal Register of November 17, 2009 (74 FR 59194). The amendment is being...

  8. 76 FR 65200 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee: Notice of...

    Science.gov (United States)

    2011-10-20

    ... HUMAN SERVICES Food and Drug Administration General and Plastic Surgery Devices Panel of the Medical... 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)....

  9. 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.

  10. Materials Advances for Next-Generation Ingestible Electronic Medical Devices.

    Science.gov (United States)

    Bettinger, Christopher J

    2015-10-01

    Electronic medical implants have collectively transformed the diagnosis and treatment of many diseases, but have many inherent limitations. Electronic implants require invasive surgeries, operate in challenging microenvironments, and are susceptible to bacterial infection and persistent inflammation. Novel materials and nonconventional device fabrication strategies may revolutionize the way electronic devices are integrated with the body. Ingestible electronic devices offer many advantages compared with implantable counterparts that may improve the diagnosis and treatment of pathologies ranging from gastrointestinal infections to diabetes. This review summarizes current technologies and highlights recent materials advances. Specific focus is dedicated to next-generation materials for packaging, circuit design, and on-board power supplies that are benign, nontoxic, and even biodegradable. Future challenges and opportunities are also highlighted.

  11. 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

  12. 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...

  13. 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.

  14. 76 FR 34845 - Medical Devices; Ear, Nose, and Throat Devices; Classification of the Wireless Air-Conduction...

    Science.gov (United States)

    2011-06-15

    ... Drug Administration 21 CFR Part 874 Medical Devices; Ear, Nose, and Throat Devices; Classification of... to the Commissioner of Food and Drugs, 21 CFR part 874 is amended as follows: PART 874--EAR,...

  15. 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.

  16. [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.

  17. 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 ...

  18. 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 ...

  19. 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...

  20. 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.

  1. 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.

  2. Organisational impact: Definition and assessment methods for medical devices.

    Science.gov (United States)

    Roussel, Christophe; Carbonneil, Cédric; Audry, Antoine

    2016-02-01

    Health technology assessment (HTA) is a rapidly developing area and the value of taking non-clinical fields into consideration is growing. Although the health-economic aspect is commonly recognised, evaluating organisational impact has not been studied nearly as much. The goal of this work was to provide a definition of organisational impact in the sector of medical devices by defining its contours and exploring the evaluation methods specific to this field. Following an analysis of the literature concerning the impact of technologies on organisations as well as the medical literature, and also after reviewing the regulatory texts in this respect, the group of experts identified 12 types of organisational impact. A number of medical devices were carefully screened using the criteria grid, which proved to be operational and to differentiate properly. From the analysis of the practice and of the methods described, the group was then able to derive a few guidelines to successfully evaluate organisational impact. This work shows that taking organisational impact into consideration may be critical alongside of the other criteria currently in favour (clinically and economically). What remains is to confer a role in the decision-making process on this factor and one that meets the economic efficiency principle.

  3. 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...

  4. 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....

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 76 FR 7222 - Medical Device Innovation Initiative; Public Meeting; Request for Comments

    Science.gov (United States)

    2011-02-09

    ... HUMAN SERVICES Food and Drug Administration Medical Device Innovation Initiative; Public Meeting... ``CDRH's Medical Device Innovation Initiative Public Workshop.'' The purpose of the public meeting is to...) document, ``Medical Device Innovation Initiative'' (report). FDA is seeking input on a number of...

  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. 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.

  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. What the Internet means for the medical device industry.

    Science.gov (United States)

    Frank, T

    2000-12-01

    The Internet is dramatically changing the structure of the industry. For the first time, direct communication between all suppliers and all hospitals is available. The Internet-based electronic market place not only provides the ability to choose products from a standardized catalogue, but also to send orders direct to suppliers' enterprise resource planning systems. One-to-one marketing is also becoming a reality. Medical device manufacturers are advised to test the different electronic sales and marketing initiatives that are now available. PMID:11200157

  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. Enabling Reuse of Documentation in New Medical Device Development: A Systematic Architecting Approach

    DEFF Research Database (Denmark)

    Jensen, Troels Victor; Parslov, Jakob Filippson; Mortensen, Niels Henrik

    2015-01-01

    Medical device companies are continuously challenged with the ability to prove compliance with increasingly complex regulatory frameworks. Operating under heavy regulatory requirements may therefore cause significant delays to the lead time of new medical devices and thus contribute significantly...... to time-to-market for even simple medical device development projects. In this paper we illustrate how medical device companies can reduce their research and development (R&D) efforts needed to prove compliance when developing new product families by means of platforming and modularization. The results......&D efficiency while reducing time-to-market for new medical device development....

  17. Monitoring biofilm attachment on medical devices surfaces using hyperspectral imaging

    Science.gov (United States)

    Le, Hanh N. D.; Hitchins, Victoria M.; Ilev, Ilko K.; Kim, Do-Hyun

    2014-02-01

    Microbial biofilm is a colony of single bacteria cells (planktonic) that attached to surfaces, attract other microorganisms to attach and grow, and together they build an extracellular matrix composed of polysaccharides, protein, and DNA. Eventually, some cells will detach and spread to other surface. Biofilm on medical devices can cause severe infection to all age ranges from infant to adult. Therefore, it is important to detect biofilm in a fast and efficient manner. Hyperspectral imaging was utilized for distinguishing wide area of biofilm coverage on various materials and on different textures of stainless steeltest coupons. Not only is the coverage of biofilm important, but also the shear stress of biofilm on the attached surfaces is significant. This study investigates the effects of shear stress on the adhesion of biofilms on common medical device surfaces such as glass, polycarbonate, polytetrafluoroethylene, and stainless steel with different textures. Biofilm was grown using Ps. aeruginosa and growth was monitored after 24 and 48 hours at 37° C. The coupons covered with biofilm were tilted at 45 degrees and 90 degrees for 30 seconds to induce shear stress and Hyperspectral images were taken. We hypothesize that stronger attachment on rough surface would be able to withstand greater shear stress compared to smooth surface.

  18. 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.

  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. 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... unproven drugs, devices, medical treatments, or procedures will continue to be published in the TRICARE...-3907. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of August 31, 2009 (74 FR...

  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. 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

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

    Science.gov (United States)

    Matsuoka, Atsuko

    2012-01-01

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

  4. 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

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

  5. 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

  6. Energy efficiency improvement of medical electric tools and devices

    Directory of Open Access Journals (Sweden)

    Meshkov Aleksandr S.

    2014-01-01

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

  7. EDI system definition for a European medical device vigilance system.

    Science.gov (United States)

    Doukidis, G; Pallikarakis, N; Pangalos, G; Vassilacopoulos, G; Pramataris, K

    1996-01-01

    EDI is expected to be the dominant form of business communication between organizations moving to the Electronic Commerce era of 2000. The healthcare sector is already using EDI in the hospital supply function as well as in the clinical area and the reimbursement process. In this paper, we examine the use of EDI in the healthcare administration sector and more specifically its application to the Medical Device Vigilance System. Firstly, the potential of this approach is examined, followed by the definition of the EDI System Reference Model and the specification of the required system architecture. Each of the architecture's components are then explained in more detail, followed by the most important implementation options relating to them. PMID:9062886

  8. 21 CFR 801.16 - Medical devices; Spanish-language version of certain required statements.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices; Spanish-language version of....16 Medical devices; Spanish-language version of certain required statements. If devices restricted to prescription use only are labeled solely in Spanish for distribution in the Commonwealth of Puerto Rico...

  9. 78 FR 69694 - Changing Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of Obesity...

    Science.gov (United States)

    2013-11-20

    ... Devices in the Treatment of Obesity and Metabolic Diseases: How To Estimate and Reward True Patient... ``Changing Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of Obesity and... medical devices for the treatment of morbid obesity and other metabolic diseases and evolving...

  10. Nanobionics: the impact of nanotechnology on implantable medical bionic devices.

    Science.gov (United States)

    Wallace, G G; Higgins, M J; Moulton, S E; Wang, C

    2012-08-01

    The nexus of any bionic device can be found at the electrode-cellular interface. Overall efficiency is determined by our ability to transfer electronic information across that interface. The nanostructure imparted to electrodes plays a critical role in controlling the cascade of events that determines the composition and structure of that interface. With commonly used conductors: metals, carbon and organic conducting polymers, a number of approaches that promote control over structure in the nanodomain have emerged in recent years with subsequent studies revealing a critical dependency between nanostructure and cellular behaviour. As we continue to develop our understanding of how to create and characterise electromaterials in the nanodomain, this is expected to have a profound effect on the development of next generation bionic devices. In this review, we focus on advances in fabricating nanostructured electrodes that present new opportunities in the field of medical bionics. We also briefly evaluate the interactions of living cells with the nanostructured electromaterials, in addition to highlighting emerging tools used for nanofabrication and nanocharacterisation of the electrode-cellular interface.

  11. 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

  12. 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,...

  13. 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)...

  14. 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...

  15. 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 ...

  16. 78 FR 951 - Accessible Medical Device Labeling in a Standard Content and Format Public Workshop; Request for...

    Science.gov (United States)

    2013-01-07

    ... (RTI) focusing on healthcare professionals and their experiences with medical device labeling, and what.... Accessible labeling has been a growing problem for healthcare professionals who operate medical devices, lay... devices industry, healthcare practitioners, caregivers, and patients regarding a standard content...

  17. 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.

  18. 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.

  19. 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

  20. 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...

  1. 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

  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. 76 FR 67463 - Pediatric Medical Devices; Public Workshop; Request for Comments

    Science.gov (United States)

    2011-11-01

    ... Research Data to Support Pediatric Medical Device Claims: A Public Dialogue.'' The purpose of the public workshop is to receive public comment on the use of scientific research data, including published scientific literature, to support and establish pediatric indications for medical devices. The topics to...

  7. 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.

  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 15957 - Food and Drug Administration/Xavier University Global Medical Device Conference

    Science.gov (United States)

    2013-03-13

    ... Medical Device Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference... University, is announcing a public conference entitled ``FDA/Xavier University Global Medical Device... to protect the public health. The conference will provide those engaged in FDA-regulated...

  10. 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.

  11. 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...

  12. 21 CFR 801.125 - Medical devices for use in teaching, law enforcement, research, and analysis.

    Science.gov (United States)

    2010-04-01

    ... Directions for Use § 801.125 Medical devices for use in teaching, law enforcement, research, and analysis. A... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices for use in teaching, law enforcement, research, and analysis. 801.125 Section 801.125 Food and Drugs FOOD AND DRUG...

  13. 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... devices having commonly known directions. A device shall be exempt from section 502(f)(1) of the...

  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 draft guidance documents for 11 neurological and physical medicine devices. The document was published... Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening...

  15. 77 FR 23484 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device...

    Science.gov (United States)

    2012-04-19

    ... Among U.S. Children and Adolescents, 1999-2010,'' Journal of the American Medical Association, vol. 307... and Meta-Analysis,'' Journal of the American Medical Association, vol. 292, no. 14, pp. 1724-1728... Collection; Comment Request; Medical Device Decision Analysis: A Risk-Tolerance Pilot Study AGENCY: Food...

  16. 75 FR 70112 - Medical Devices; General and Plastic Surgery Devices; Classification of Non-Powered Suction...

    Science.gov (United States)

    2010-11-17

    ...)(1) of the FD&C Act, FDA issued an order on October 28, 2008, classifying the SNaP Wound Care Device...., submitted a petition requesting classification of the SNaP Wound Care Device under section 513(f)(2) of the... safety and effectiveness of the device. The device is assigned the generic name SNaP Wound Care...

  17. 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

  18. 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…

  19. Charter Schools: Experiments in Reform.

    Science.gov (United States)

    Dunn, David

    By March 1994, eight states had adopted charter-school legislation. This report defines the charter-school concept and describes its advantages and disadvantages. Proponents argue that charter schools offer flexibility, decentralized decision making, a performance accountability, and school choice, and increased pressure for change. Opponents…

  20. 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…

  1. Concordance of adherence measurement using self-reported adherence questionnaires and medication monitoring devices.

    Science.gov (United States)

    Shi, Lizheng; Liu, Jinan; Koleva, Yordanka; Fonseca, Vivian; Kalsekar, Anupama; Pawaskar, Manjiri

    2010-01-01

    The primary objective of this review was to identify and examine the literature on the association between medication adherence self-reported questionnaires (SRQs) and medication monitoring devices. The primary literature search was performed for 1980-2009 using PubMed, PubMed In Process and Non-Indexed, Ovid MEDLINE, Ovid MEDLINE In-Process, PsycINFO (EBSCO), CINAHL (EBSCO), Ovid HealthStar, EMBASE (Elsevier) and Cochrane Databases and using the following search terms: 'patient compliance', 'medication adherence', 'treatment compliance', 'drug monitoring', 'drug therapy', 'electronic', 'digital', 'computer', 'monitor', 'monitoring', 'drug', 'drugs', 'pharmaceutical preparations', 'compliance' and 'medications'. We identified studies that included SRQs and electronic monitoring devices to measure adherence and focused on the SRQs that were found to be moderately to highly correlated with the monitoring devices. Of the 1679 citations found via the primary search, 41 full-text articles were reviewed for correlation between monitoring devices and SRQs. A majority (68%) of articles reported high (27%), moderate (29%) or significant (12%) correlation between monitoring devices (37 using Medication Event Monitoring System [MEMS®] and four using other devices) and SRQs (11 identified and numerous other unnamed SRQs). The most commonly used SRQs were the Adult/Pediatric AIDS Clinical Trial Group (AACTG/PACTG; 24.4%, 10/41) followed by the 4-item Morisky (9.8%, 4/41), Brief Medication Questionnaire (9.8%, 4/41) and visual analogue scale (VAS; 7.3%, 3/41). Although study designs differed across the articles, SRQs appeared to report a higher rate of medication adherence (+14.9%) than monitoring devices. In conclusion, several medication adherence SRQs were validated using electronic monitoring devices. A majority of them showed high or moderate correlation with medication adherence measured using monitoring devices, and could be considered for measuring patient

  2. Design of tactile device for medical application using magnetorheological fluid

    Science.gov (United States)

    Oh, J. S.; Kim, J. K.; Lee, S. R.; Choi, S. B.; Song, B. K.

    2013-02-01

    For the tactile recognition of human organ in minimally invasive surgery (MIS), this paper presents a novel tactile device that incorporates with magnetorheological (MR fluid). The MR fluid is contained by diaphragm and several pins. The operator for MIS can feel different force (or stiffness) from the proposed tactile device by applying different magnetic field or current. In order to generate required force from the device, the repulsive force from the human body is measured as reference data and an appropriate size of tactile device is designed and manufactured. It has been demonstrated via experiment that the repulsive force corresponding to the human body can be achieved by applying proper control input current. In addition, it has been shown that we can control the repulsive force by dividing the tactile device by several sections.

  3. [Wearable Medical Devices' MCU Selection Analysis Based on the ARM Cortex-MO+ Architecture].

    Science.gov (United States)

    Wu, Zaoquan; Liu, Mengxing; Qin, Liping; Ye, Shuming; Chen, Hang

    2015-03-01

    According to the characteristics of low cost, high performance, high integration and long battery life of wearable medical devices, the mainstream low-power microcontroller(MCU) series were compared, and came to the conclusion that the MCU series based on ARM Cortex-M0+ architecture were suitable for the development of wearable medical devices. In aspects of power consumption, operational performance, integrated peripherals and cost, the MCU series based on Cortex-M0+ architecture of primary semiconductor companies were compared, aimed at providing the guides of MCU selection for wearable medical devices.

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

    Science.gov (United States)

    2015-11-20

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

  5. 78 FR 23940 - Use of International Standard ISO-10993, “Biological Evaluation of Medical Devices Part 1...

    Science.gov (United States)

    2013-04-23

    ... HUMAN SERVICES Food and Drug Administration Use of International Standard ISO-10993, ``Biological... International Standard ISO-10993, `Biological Evaluation of Medical Devices Part 1: Evaluation and Testing... entitled ``Use of International Standard ISO-10993, `Biological Evaluation of Medical Devices Part...

  6. 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

  7. A review of the economic tools for assessing new medical devices.

    Science.gov (United States)

    Craig, Joyce A; Carr, Louise; Hutton, John; Glanville, Julie; Iglesias, Cynthia P; Sims, Andrew J

    2015-02-01

    Whereas the economic evaluation of pharmaceuticals is an established practice within international health technology assessment (HTA) and is often produced with the support of comprehensive methodological guidance, the equivalent procedure for medical devices is less developed. Medical devices, including diagnostic products, are a rapidly growing market in healthcare, with over 10,000 medical technology patent applications filed in Europe in 2012-nearly double the number filed for pharmaceuticals. This increase in the market place, in combination with the limited, or constricting, budgets that healthcare decision makers face, has led to a greater level of examination with respect to the economic evaluation of medical devices. However, methodological questions that arise due to the unique characteristics of medical devices have yet to be addressed fully. This review of journal publications and HTA guidance identified these characteristics and the challenges they may subsequently pose from an economic evaluation perspective. These unique features of devices can be grouped into four categories: (1) data quality issues; (2) learning curve; (3) measuring long-term outcomes from diagnostic devices; and (4) wider impact from organisational change. We review the current evaluation toolbox available to researchers and explore potential future approaches to improve the economic evaluation of medical devices. PMID:25139635

  8. 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

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

    Science.gov (United States)

    Lansdowne, Krystal; Scully, Christopher G; Galeotti, Loriano; Schwartz, Suzanne; Marcozzi, David; Strauss, David G

    2015-06-01

    In 2010, the US Food and Drug Administration (Silver Spring, Maryland USA) created the Medical Countermeasures Initiative with the mission of development and promoting medical countermeasures that would be needed to protect the nation from identified, high-priority chemical, biological, radiological, or nuclear (CBRN) threats and emerging infectious diseases. The aim of this review was to promote regulatory science research of medical devices and to analyze how the devices can be employed in different CBRN scenarios. Triage in CBRN scenarios presents unique challenges for first responders because the effects of CBRN agents and the clinical presentations of casualties at each triage stage can vary. The uniqueness of a CBRN event can render standard patient monitoring medical device and conventional triage algorithms ineffective. Despite the challenges, there have been recent advances in CBRN triage technology that include: novel technologies; mobile medical applications ("medical apps") for CBRN disasters; electronic triage tags, such as eTriage; diagnostic field devices, such as the Joint Biological Agent Identification System; and decision support systems, such as the Chemical Hazards Emergency Medical Management Intelligent Syndromes Tool (CHEMM-IST). Further research and medical device validation can help to advance prehospital triage technology for CBRN events.

  10. 77 FR 14272 - Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus Serological...

    Science.gov (United States)

    2012-03-09

    ... device that was introduced or delivered for introduction into interstate commerce for commercial.... Risks to Health FDA has identified the risks to health associated with this type of device as a false... these risks to health associated specifically with this type of device. Table 1--Risks to Health...

  11. 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...

  12. 78 FR 49529 - Radio Frequency Wireless Technology in Medical Devices; Guidance for Industry and Food and Drug...

    Science.gov (United States)

    2013-08-14

    ... Technology in Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability... Medical Devices; Guidance for Industry and Food and Drug Administration Staff.'' This guidance document is... ``Radio Frequency Wireless Technology in Medical Devices; Guidance for Industry and Food and...

  13. 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...

  14. 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...

  15. 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...

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

    NARCIS (Netherlands)

    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.

    2013-01-01

    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 f

  17. "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.

  18. 77 FR 125 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Device Classification...

    Science.gov (United States)

    2012-01-03

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Medical Device Classification Product Codes; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ] SUMMARY: The Food and Drug Administration (FDA) is announcing the...

  19. 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...

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

    Science.gov (United States)

    2011-07-07

    ... 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...

  2. 76 FR 14415 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2011-03-16

    ... 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...

  3. 77 FR 20642 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2012-04-05

    ... 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...

  4. 75 FR 49940 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2010-08-16

    ... (near infrared), to image the skin through a thin layer of liquid (alcohol or oil), making lesion... 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...

  5. Soft hydrogels interpenetrating silicone – a polymer network for drug releasing medical devices

    DEFF Research Database (Denmark)

    Steffensen, Søren Langer; Merete H., Vestergaard,; Møller, Eva H;

    2016-01-01

    Materials for the next generation of medical devices will require not only the mechanical stability of current devices, but must also possess other properties such as sustained release of drugs in a controlled manner over a prolonged period of time. This work focuses on creating such a sophistica......Materials for the next generation of medical devices will require not only the mechanical stability of current devices, but must also possess other properties such as sustained release of drugs in a controlled manner over a prolonged period of time. This work focuses on creating...... of water uptake in approximately 25% (w/w) PHEMA, indicating that entrapment of gel occurs at low gel concentrations. The optimized IPN material was loaded with the antibiotic ciprofloxacin, and the resulting drug release was shown to inhibit bacterial growth when placed on agar, thus demonstrating...... the potential of this IPN material for future applications in drug-releasing medical devices....

  6. 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.

  7. 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...

  8. 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...

  9. 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...

  10. Salespeople in the Surgical Suite: Relationships between Surgeons and Medical Device Representatives

    Science.gov (United States)

    O’Connor, Bonnie; Pollner, Fran; Fugh-Berman, Adriane

    2016-01-01

    Background Industry payments to surgeons have received public attention, but little is known about the relationships between surgeons and medical device representatives. Medical device representatives ("device reps") have become an integral part of operating room personnel. The effect of their presence on patient care deserves discussion. Study Design We conducted a qualitative, ethnographic study to explore relationships between surgeons and medical device representatives, and characterize industry involvement in the training of surgeons. We used group and individual open-ended interviews to gain insight into the beliefs, values, and perspectives of surgeons and device reps. We conducted two focus groups, one with ear, nose, and throat surgeons, and one with hospital-based attending orthopedic surgeons. We also conducted individual interviews with three former or current medical device representatives, a director of a surgical residency program at an academic medical center, and a medical assistant for a multi-physician orthopedic practice. Results While surgeons view themselves as indisputably in charge, device reps work hard to make themselves unobtrusively indispensable in order to establish and maintain influence, and to imbue the products they provide with personalized services that foster a surgeon's loyalty to the reps and their companies. Surgeons view industry-funded training opportunities as a necessary service. Device reps and some surgeons believe that reps benefit patient care, by increasing efficiency and mitigating deficiencies among operating room personnel (including the surgeons themselves). Conclusions Our study raises ethical questions about the reliance of surgeons on device reps and device companies for education and surgical assistance and practical concerns regarding existing levels of competence among OR personnel. PMID:27486992

  11. 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.

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

    Directory of Open Access Journals (Sweden)

    Howard JJ

    2014-11-01

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

  13. 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...

  14. 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”....

  15. Medical Devices; General and Plastic Surgery Devices; Classification of the Internal Tissue Marker. Final order.

    Science.gov (United States)

    2015-08-01

    The Food and Drug Administration (FDA) is classifying the internal tissue marker 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 internal tissue marker'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.

  16. Medical Devices; General and Plastic Surgery Devices; Classification of the Magnetic Surgical Instrument System. Final order.

    Science.gov (United States)

    2016-09-21

    The Food and Drug Administration (FDA) is classifying the Magnetic Surgical Instrument System into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the magnetic surgical instrument system's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

  17. 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

  18. 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

  19. 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

  20. 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

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

    NARCIS (Netherlands)

    Markiewicz, Katarzyna; Til, van Janine A.; Steuten, Lotte M.G.; IJzerman, Maarten J.

    2016-01-01

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

  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. Approval of high-risk medical devices in the US: implications for clinical cardiology.

    Science.gov (United States)

    Rome, Benjamin N; Kramer, Daniel B; Kesselheim, Aaron S

    2014-01-01

    Since 1976, the US Food and Drug Administration (FDA) has used the premarket approval (PMA) process to approve high-risk medical devices, including implantable cardioverter defibrillators (ICDs), coronary stents, and artificial heart valves. The PMA process is widely viewed as a rigorous evaluation of device safety and effectiveness, though recent recalls-most notably related to underperforming ICD leads-have raised concerns about whether physicians and patients should sometimes be more wary about devices approved via this pathway. The FDA must utilize a "least burdensome" approach to approve new medical devices, and many widely used device models have been approved as supplements to existing PMA-approved devices with limited clinical testing. A recent Supreme Court ruling has made it difficult for patients harmed by unsafe PMA-approved devices to seek damages in court. Cardiologists who utilize high-risk medical devices should be aware that FDA approval of new devices relies on variable levels of evidence and does not necessarily indicate improved effectiveness over existing models. Clinician and patient engagement in postmarket surveillance and comparative effectiveness research remains imperative.

  4. 76 FR 21237 - Medical Devices; Obstetrical and Gynecological Devices; Classification of the Hemorrhoid...

    Science.gov (United States)

    2011-04-15

    ...The Food and Drug Administration (FDA) is classifying the hemorrhoid prevention pressure wedge into class II (special controls). The special controls will apply to the device in order to provide a reasonable assurance of safety and effectiveness of the device. A hemorrhoid prevention pressure wedge provides support to the perianal region during the labor and delivery...

  5. 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 draft... effective December 6, 2010. FOR FURTHER INFORMATION CONTACT: Mary Pastel, Center for Devices...

  6. 77 FR 16925 - Medical Devices; Neurological Devices; Classification of the Near Infrared Brain Hematoma Detector

    Science.gov (United States)

    2012-03-23

    ... classification will be the initial classification of the device. Within 30 days after the issuance of an order... intend to market this type of device must submit to FDA a premarket notification, prior to marketing the... Orders 12866 and 13563 direct Agencies to assess all costs and benefits of available...

  7. 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

  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. 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...

  10. 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.

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

    Science.gov (United States)

    Yin, Jinghua; Luan, Shifang

    2016-06-01

    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.

  12. 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

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

    Science.gov (United States)

    de Ana, F J; Umstead, K A; Phillips, G J; Conner, C P

    2013-09-01

    The innovation process has often been represented as a linear process which funnels customer needs through various business and process filters. This method may be appropriate for some consumer products, but in the medical device industry there are some inherent limitations to the traditional innovation funnel approach. In the medical device industry, there are a number of stakeholders who need to have their voices heard throughout the innovation process. Each stakeholder has diverse and unique needs relating to the medical device, the needs of one may highly affect the needs of another, and the relationships between stakeholders may be tenuous. This paper describes the application of a spiral innovation process to the development of a medical device which considers three distinct stakeholder voices: the Voice of the Customer, the Voice of the Business and the Voice of the Technology. The process is presented as a case study focusing on the front-end redesign of a class III medical device for an orthopedics company. Starting from project initiation and scope alignment, the process describes four phases, Discover, Envision, Create, and Refine, and concludes with value assessment of the final design features. PMID:23483372

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

    Science.gov (United States)

    de Ana, F J; Umstead, K A; Phillips, G J; Conner, C P

    2013-09-01

    The innovation process has often been represented as a linear process which funnels customer needs through various business and process filters. This method may be appropriate for some consumer products, but in the medical device industry there are some inherent limitations to the traditional innovation funnel approach. In the medical device industry, there are a number of stakeholders who need to have their voices heard throughout the innovation process. Each stakeholder has diverse and unique needs relating to the medical device, the needs of one may highly affect the needs of another, and the relationships between stakeholders may be tenuous. This paper describes the application of a spiral innovation process to the development of a medical device which considers three distinct stakeholder voices: the Voice of the Customer, the Voice of the Business and the Voice of the Technology. The process is presented as a case study focusing on the front-end redesign of a class III medical device for an orthopedics company. Starting from project initiation and scope alignment, the process describes four phases, Discover, Envision, Create, and Refine, and concludes with value assessment of the final design features.

  15. 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.

  16. 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

  17. 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.

  18. 78 FR 68714 - Medical Devices; Ophthalmic Devices; Classification of the Scleral Plug

    Science.gov (United States)

    2013-11-15

    ... the Federal Register of January 25, 2013 (78 FR 5327), FDA proposed to classify scleral plug devices..., before proposing ``any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or...

  19. 78 FR 77689 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2013-12-24

    ... published a proposed rule (44 FR 50520) for classification of iontophoresis devices for specialized uses (for the diagnosis of cystic fibrosis, fluoride uptake acceleration in dentistry, and for local anesthesia of the intact tympanic membrane) into class II and for all other uses into class III....

  20. 77 FR 12064 - Radiological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-02-28

    ... April 9, 2009 (74 FR 16214), for breast transilluminators, one of the remaining preamendments class III devices. On July 18, 1995 (60 FR 36639), FDA published a Final Rule that misbranded breast transilluminators and effectively placed them in class III based on the recommendation of the Obstetrics...

  1. 78 FR 19717 - Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory...

    Science.gov (United States)

    2013-04-02

    ... notice that appeared in the Federal Register of Wednesday, February 27, 2013 (78 FR 13347). The meeting... for up-to-date information on this meeting. SUPPLEMENTARY INFORMATION: In FR doc. 2013-04543... HUMAN SERVICES Food and Drug Administration Clinical Chemistry and Clinical Toxicology Devices Panel...

  2. 78 FR 14013 - Medical Devices; Exemption From Premarket Notification; Class II Devices; Wheelchair Elevator

    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....) In the Federal Register of June 1, 2012 (77 FR 32644), FDA published a notice announcing that this... criteria laid out in the Class II 510(k) Exemption Guidance and in 63 FR 3142, and agrees they weigh...

  3. 77 FR 42503 - Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-07-19

    ...) application for the Argus II Retinal Prosthesis System sponsored by Second Sight Medical Products, Inc. The... public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak...

  4. A bioinspired omniphobic surface coating on medical devices prevents thrombosis and biofouling.

    Science.gov (United States)

    Leslie, Daniel C; Waterhouse, Anna; Berthet, Julia B; Valentin, Thomas M; Watters, Alexander L; Jain, Abhishek; Kim, Philseok; Hatton, Benjamin D; Nedder, Arthur; Donovan, Kathryn; Super, Elana H; Howell, Caitlin; Johnson, Christopher P; Vu, Thy L; Bolgen, Dana E; Rifai, Sami; Hansen, Anne R; Aizenberg, Michael; Super, Michael; Aizenberg, Joanna; Ingber, Donald E

    2014-11-01

    Thrombosis and biofouling of extracorporeal circuits and indwelling medical devices cause significant morbidity and mortality worldwide. We apply a bioinspired, omniphobic coating to tubing and catheters and show that it completely repels blood and suppresses biofilm formation. The coating is a covalently tethered, flexible molecular layer of perfluorocarbon, which holds a thin liquid film of medical-grade perfluorocarbon on the surface. This coating prevents fibrin attachment, reduces platelet adhesion and activation, suppresses biofilm formation and is stable under blood flow in vitro. Surface-coated medical-grade tubing and catheters, assembled into arteriovenous shunts and implanted in pigs, remain patent for at least 8 h without anticoagulation. This surface-coating technology could reduce the use of anticoagulants in patients and help to prevent thrombotic occlusion and biofouling of medical devices.

  5. 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

  6. 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.)

  7. 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.

  8. 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.

  9. 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....

  10. 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 ...

  11. 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

  12. 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…

  13. 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…

  14. 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…

  15. 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

    a 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...

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

    Science.gov (United States)

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

    2006-05-01

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

  17. 75 FR 391 - Medical Device Quality System Regulation Educational Forum on Risk Management Through the Product...

    Science.gov (United States)

    2010-01-05

    ... on Risk Management Through the Product Life Cycle; Public Workshop AGENCY: Food and Drug... ``Medical Device Quality System Regulation Educational Forum on Risk Management through the Product Life... workshop: (1) Standards and guidance, (2) risk management in design, (3) risk management in execution,...

  18. 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...

  19. 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...

  20. 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 §...

  1. 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

  2. 78 FR 12664 - Human Subject Protection; Acceptance of Data From Clinical Studies for Medical Devices

    Science.gov (United States)

    2013-02-25

    ... FR 25692, May 9, 1997). Many of the principles underlying GCP have already been incorporated in FDA's... guidance for industry in 1997 (62 FR 25692, May 9, 1997). Proposed Sec. 812.28(a)(2) states the second... medical device, including data obtained in any clinical studies conducted outside the United...

  3. 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.

  4. The medical device industry and the biomedical engineer: current status and future trends.

    Science.gov (United States)

    Farley, B E

    1989-01-01

    The role of new and existing technology in the development of medical devices is examined. The impact of competition and economic and regulatory pressures is assessed. The identification of clinical needs is discussed. These include the needs to reduce liability, find less invasive alternatives to surgery, improve the quality of life, and prevent disease. Career opportunities are considered in some detail.

  5. 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...

  6. 75 FR 33315 - Dental Products Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-06-11

    ... received by FDA concerning the final rule on the classification of dental amalgam, which published in the... adequacy of the risk assessment performed by FDA in classifying dental amalgam in light of a new report on... HUMAN SERVICES Food and Drug Administration Dental Products Panel of the Medical Devices...

  7. Analyze of histopathelogical for medical devices and biological material on biocompatibility evaluation

    Institute of Scientific and Technical Information of China (English)

    NIE Wei; JIANG Hua; WANG Li; GUAN Jing-fang; SHI Hong-dao

    2001-01-01

    @@ The toxicity and biocompatibility of medical devices and biological material areprominent facts in evaluation of the material. There are two major methods to evaluate the biocompatibility of biological materials . one kind is to do vivo. The materialor extracts are used to study the effect of the material on the growth, metabolismand proliferation of the histocyte.

  8. 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

  9. 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...

  10. 78 FR 41069 - Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Food and Drug...

    Science.gov (United States)

    2013-07-09

    ... HUMAN SERVICES Food and Drug Administration Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability...

  11. 78 FR 21612 - Medical Device Classification Product Codes; Guidance for Industry and Food and Drug...

    Science.gov (United States)

    2013-04-11

    ... HUMAN SERVICES Food and Drug Administration Medical Device Classification Product Codes; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of...

  12. 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.

  13. 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

  14. 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.

  15. Comparative Review of Endoscopic Devices Articulations Technologies Developed for Minimally Invasive Medical Procedures

    Directory of Open Access Journals (Sweden)

    Julien Catherine

    2011-01-01

    Full Text Available This study introduces a comparative performance analysis of the technological solutions that have been used to build distal active articulations for minimally invasive medical procedures. The aim is to provide a practical and concise database and classification tool for anyone that wants to learn more about the technologies involved in minimally invasive medical devices, or for any designer interested in further improving these devices. A review of the different articulations developed in this field is therefore performed and organized by both actuation technology and structural architecture. Details are presented concerning the mechanical structures as well as the actuation and the mechanical transmission technologies available. The solutions are evaluated keeping as a reference some chosen required performances and characteristics for minimally invasive surgical procedures. Finally, a quantified comparison chart of these devices is given regarding selected criteria of interest for minimally invasive surgical application.

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  1. Regulatory Considerations in the Design and Manufacturing of Implantable 3D-Printed Medical Devices.

    Science.gov (United States)

    Morrison, Robert J; Kashlan, Khaled N; Flanangan, Colleen L; Wright, Jeanne K; Green, Glenn E; Hollister, Scott J; Weatherwax, Kevin J

    2015-10-01

    Three-dimensional (3D) printing, or additive manufacturing, technology has rapidly penetrated the medical device industry over the past several years, and innovative groups have harnessed it to create devices with unique composition, structure, and customizability. These distinctive capabilities afforded by 3D printing have introduced new regulatory challenges. The customizability of 3D-printed devices introduces new complexities when drafting a design control model for FDA consideration of market approval. The customizability and unique build processes of 3D-printed medical devices pose unique challenges in meeting regulatory standards related to the manufacturing quality assurance. Consistent material powder properties and optimal printing parameters such as build orientation and laser power must be addressed and communicated to the FDA to ensure a quality build. Postprinting considerations unique to 3D-printed devices, such as cleaning, finishing and sterilization are also discussed. In this manuscript we illustrate how such regulatory hurdles can be navigated by discussing our experience with our group's 3D-printed bioresorbable implantable device. PMID:26243449

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

    Science.gov (United States)

    Hannig, Jürgen; Siekmeier, Rüdiger

    2015-01-01

    The current European system for medical devices is governed by three EC directives: the Medical Device Directive 93/42/EEC, the In-Vitro Diagnostic Directive 98/79/EC and the Active Implantable Medical Device Directive 90/385/EEC and regulates marketing and post-market surveillance of medical devices in the European Economic Area. In cases of incidents and field safety corrective actions (FSCA) manufacturers have to inform the responsible Competent Authority, which is the Federal Institute for Drugs and Medical Devices (BfArM) and the public by field safety notices (FSN). In this study we analyzed FSN of medical devices exclusively serving for diagnostics or treatment in pulmonology (e.g. nebulizers, oxygen concentrators, pulse oximeters, lung function analyzers, and non-active devices for treatment). FSCA and FSN publicized by BfArM in 2005-2013 were analyzed in respect to the MEDDEV 2.12-1 rev 8. In total 41 FSCA were publicized for the included products. German and English FSN were found in 36/35 cases, respectively. FSN were clearly characterized as FSN in 22/20 cases and declaration of the type of action was found in 27/26 cases, respectively. Product names were provided in all cases. Lot numbers or other information for product characterization were available in 7/8 and 26/24 cases, respectively. Detailed information regarding FSCA and product malfunction were found in 27/33 and 36/35 cases, respectively. Information on product related risks with previous use of the affected product was provided in 24/23 cases. In 34/34 cases manufacturers provided information to mitigate product related risks. Requests to pass FSN to persons needing awareness were found in 10/14 cases. Contact data were provided in 30/30 cases. Confirmation that the Competent Authority was informed was found in 12/14 cases and in 19/18 cases a customer confirmation was included. The obtained data suggest that there is an increasing annual number of FSCA and most FSN fulfill the criteria of

  3. 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.

  4. 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...

  5. 77 FR 7584 - Draft Guidance for Industry on Heparin for Drug and Medical Device Use; Monitoring Crude Heparin...

    Science.gov (United States)

    2012-02-13

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Heparin for Drug and Medical Device Use; Monitoring Crude Heparin for Quality; Availability AGENCY: Food and Drug Administration, HHS... guidance for industry entitled ``Heparin for Drug and Medical Device Use: Monitoring Crude Heparin...

  6. 78 FR 38058 - Guidance for Industry on Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for...

    Science.gov (United States)

    2013-06-25

    ... From the Federal Register Online via the Government Publishing Office ] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Guidance for Industry on Heparin for Drug and Medical Device... guidance for industry entitled ``Heparin for Drug and Medical Device Use: Monitoring Crude Heparin...

  7. 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...

  8. 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.

  9. Understanding safety-critical interactions with a home medical device through Distributed Cognition.

    Science.gov (United States)

    Rajkomar, Atish; Mayer, Astrid; Blandford, Ann

    2015-08-01

    As healthcare shifts from the hospital to the home, it is becoming increasingly important to understand how patients interact with home medical devices, to inform the safe and patient-friendly design of these devices. Distributed Cognition (DCog) has been a useful theoretical framework for understanding situated interactions in the healthcare domain. However, it has not previously been applied to study interactions with home medical devices. In this study, DCog was applied to understand renal patients' interactions with Home Hemodialysis Technology (HHT), as an example of a home medical device. Data was gathered through ethnographic observations and interviews with 19 renal patients and interviews with seven professionals. Data was analyzed through the principles summarized in the Distributed Cognition for Teamwork methodology. In this paper we focus on the analysis of system activities, information flows, social structures, physical layouts, and artefacts. By explicitly considering different ways in which cognitive processes are distributed, the DCog approach helped to understand patients' interaction strategies, and pointed to design opportunities that could improve patients' experiences of using HHT. The findings highlight the need to design HHT taking into consideration likely scenarios of use in the home and of the broader home context. A setting such as home hemodialysis has the characteristics of a complex and safety-critical socio-technical system, and a DCog approach effectively helps to understand how safety is achieved or compromised in such a system.

  10. Mitigation of tracheobronchomalacia with 3D-printed personalized medical devices in pediatric patients.

    Science.gov (United States)

    Morrison, Robert J; Hollister, Scott J; Niedner, Matthew F; Mahani, Maryam Ghadimi; Park, Albert H; Mehta, Deepak K; Ohye, Richard G; Green, Glenn E

    2015-04-29

    Three-dimensional (3D) printing offers the potential for rapid customization of medical devices. The advent of 3D-printable biomaterials has created the potential for device control in the fourth dimension: 3D-printed objects that exhibit a designed shape change under tissue growth and resorption conditions over time. Tracheobronchomalacia (TBM) is a condition of excessive collapse of the airways during respiration that can lead to life-threatening cardiopulmonary arrests. We demonstrate the successful application of 3D printing technology to produce a personalized medical device for treatment of TBM, designed to accommodate airway growth while preventing external compression over a predetermined time period before bioresorption. We implanted patient-specific 3D-printed external airway splints in three infants with severe TBM. At the time of publication, these infants no longer exhibited life-threatening airway disease and had demonstrated resolution of both pulmonary and extrapulmonary complications of their TBM. Long-term data show continued growth of the primary airways. This process has broad application for medical manufacturing of patient-specific 3D-printed devices that adjust to tissue growth through designed mechanical and degradation behaviors over time.

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

    Science.gov (United States)

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

    2013-10-01

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

  12. 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.

  13. 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

  14. 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...... the ‘mobility turn’ that mobility is much more than movement from A to B. Seeing the cultural dimension as well as the underpinning power plays of normative mobility discourses opens up the reflection about imagined futures and imagined mobile subjects. Theoretically the paper bridges discourse studies...

  15. 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)

  16. 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

  17. 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...

  18. 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

  19. Flourescence-assay on traces of protein on re-usable medical devices: cleaning efficiency.

    Science.gov (United States)

    Verjat, D; Prognon, P; Darbord, J C

    1999-03-15

    The cleaning of re-usable medical devices before disinfection or sterilization is recognized as being an essential phase. Detection of residual proteins can be used to validate the process, provided a sufficiently sensitive method is employed. A fluorescent method is presented, using orthophtalaldehyde (OPA) bound to N,N dimethyl-2-mercaptoethylammonium, to demonstrate the presence of amino acids on a medical device following cleaning. The sensitivity of this method (10-5 g/l) was assessed and the applicability of this detection technique is verified, using three types of carriers (steel blades, glass tubes or ceramic penicylinders), three types of contaminants (yeast extract, bovine albumin with native sheep's blood and formaldehyde fixed fibrin). In this context, studies involving formaldehyde-fixed fibrin are more sensitive and are to be recommended. PMID:10053219

  20. 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...

  1. 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...

  2. 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...

  3. 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, ...

  4. [Options for a future-oriented innovation policy in the medical devices industry].

    Science.gov (United States)

    Nusser, Michael; Lindner, Ralf

    2010-01-01

    From an innovation systems perspective the performance of the German medical devices industry, future challenges and barriers to innovation are assessed. Current performance indicators (e.g., R&D intensity, export growth rates) paint a favourable picture. Nonetheless, a number of innovation barriers are identified: in particular, insufficient network integration of small and medium-sized enterprises (SMEs) and ineffective policy coordination. Finally, recommendations addressing identified future challenges and innovation barriers are developed.

  5. 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...

  6. 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

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

    DEFF Research Database (Denmark)

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

    2012-01-01

    data are available? We studied the premarket clinical evaluation of innovative high-risk medical devices in Europe compared with the US, and with medicines, where appropriate. Methods: The literature and regulatory documents were checked. Representatives from industry, Competent Authorities, Notified...... Bodies, Ethics Committees, and HTA agencies were consulted. We also discuss patient safety and the transparency of information. Results: In contrast to the US, there is no requirement in Europe to demonstrate the clinical efficacy of high-risk devices in the premarket phase. Patients in Europe can thus...... have earlier access to a potentially lifesaving device, but at the risk of insufficiently documented efficacy and safety. Variations in the stringency of clinical reviews, both at the level of Notified Bodies and Competent Authorities, do not guarantee patient safety. We tried to document the design...

  8. 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)

  9. 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.

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

    DEFF Research Database (Denmark)

    Patou, François; Pfreundt, Andrea; Zulfiqar, Azeem;

    2014-01-01

    C medical diagnostics context necessitates considering broader requirements, notably in terms of usability, flexibility, and integration capabilities. These characteristics call for multi-disciplinary design methodologies inspired from the field of systems engineering and constitute the motivations...... helping to address this challenge. Specifically, Lab-on-Chip (LoC) devices have a key role to play in the advent of Point-of-Care (PoC) medical applications, driving a shift of the medical diagnostics paradigm and the transition from a centralized, technical, high-throughput biological sample analysis...... programmable electrical readout from LoCs potentially comprehending varied transducers addressing different targeted biological markers. A smart-phone/tablet docking-station embeds the hardware interface necessary for the implementation of a smart-phone digital lock-in amplifier. The platform is tested...

  11. 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.

  12. 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.

  13. 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…

  14. 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'...

  15. 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.

  16. 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...

  17. [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

  18. 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

  19. 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.

  20. Medical and welfare device session. Toward medical treatment and welfare of tomorrow; Iryo fukushi kiki session. Ashita no iryo fukushi ni mukete

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2000-09-01

    This paper is the material distributed in the medical and welfare device session held under the auspices of NEDO in September 2000. Diversification of needs in the medical and welfare areas and handling of age advancement are the growing issue. NEDO is putting efforts toward enhancement of quality of life (QOL) and realization of the nation with great life by providing high-quality and high-efficiency medical and welfare services. The NEDO's efforts cover the areas of treating adult diseases such as cancers and cardiac diseases whose seriousness is growing, early diagnoses of diseases, medical treatment with low invasion, elderly people helping, reduction of helpers' burden, reduction of handicaps to elderly people and mentally and physically handicapped persons, and assistance to participation in the society. To achieve these goals, NEDO is implementing the following four projects: research and development of medical and welfare device technologies, researches of medical science and engineering collaboration type, and promotion of developing welfare techno-systems and practical application of welfare appliances. Developments are being made toward practical application of medical and welfare devices with excellent safety and convenience, of low cost and high performance. The session gave the keynote addresses related to medical treatment and prevention of brain diseases; brain, the universe and MRI (the world of mind as seen in images), and high-tech medical treatments to protect brain (challenge to brain that starts now). (NEDO)

  1. 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.

  2. 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.

  3. 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…

  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 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…

  6. 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…

  7. 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

  8. 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)

  9. 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.

  10. 75 FR 28257 - Draft Guidance for Industry, Third Parties and Food and Drug Administration Staff; Medical Device...

    Science.gov (United States)

    2010-05-20

    ... Japanese Medical Device Ministry of Health, Labour and Welfare system. This notice of availability and... Program.'' It does not create or confer any rights for or on any person and does not operate to bind...

  11. 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.

  12. 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.

  13. 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...

  14. Inhaled medication and inhalation devices for lung disease in patients with cystic fibrosis: A European consensus

    DEFF Research Database (Denmark)

    Heijerman, Harry; Westerman, Elsbeth; Conway, Steven;

    2009-01-01

    In cystic fibrosis inhalation of drugs for the treatment of CF related lung disease has been proven to be highly effective. Consequently, an increasing number of drugs and devices have been developed for CF lung disease or are currently under development. In this European consensus document we...... review the current status of inhaled medication in CF, including the mechanisms of action of the various drugs, their modes of administration and indications, their effects on lung function, exacerbation rates, survival and quality of life, as well as side effects. Specifically we address antibiotics......, mucolytics/mucous mobilizers, anti-inflammatory drugs, bronchodilators and combinations of solutions. Additionally, we review the current knowledge on devices for inhalation therapy with regard to optimal particle sizes and characteristics of wet nebulisers, dry powder and metered dose inhalers. Finally, we...

  15. Residual Isocyanates in Medical Devices and Products: A Qualitative and Quantitative Assessment

    Science.gov (United States)

    Franklin, Gillian; Harari, Homero; Ahsan, Samavi; Bello, Dhimiter; Sterling, David A.; Nedrelow, Jonathan; Raynaud, Scott; Biswas, Swati; Liu, Youcheng

    2016-01-01

    We conducted a pilot qualitative and quantitative assessment of residual isocyanates and their potential initial exposures in neonates, as little is known about their contact effect. After a neonatal intensive care unit (NICU) stockroom inventory, polyurethane (PU) and PU foam (PUF) devices and products were qualitatively evaluated for residual isocyanates using Surface SWYPE™. Those containing isocyanates were quantitatively tested for methylene diphenyl diisocyanate (MDI) species, using UPLC-UV-MS/MS method. Ten of 37 products and devices tested, indicated both free and bound residual surface isocyanates; PU/PUF pieces contained aromatic isocyanates; one product contained aliphatic isocyanates. Overall, quantified mean MDI concentrations were low (4,4′-MDI = 0.52 to 140.1 pg/mg) and (2,4′-MDI = 0.01 to 4.48 pg/mg). The 4,4′-MDI species had the highest measured concentration (280 pg/mg). Commonly used medical devices/products contain low, but measurable concentrations of residual isocyanates. Quantifying other isocyanate species and neonatal skin exposure to isocyanates from these devices and products requires further investigation.

  16. 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.

  17. 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.

  18. 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

  19. 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

  20. 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.

  1. 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

  2. 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

  3. A study on radiation sterilization of medical devices in the South of China

    Science.gov (United States)

    Zhutang, Wen; Riyou, Lou; Meilan, Li; Xueqin, Liu; Najie, Lin; Mingsheng, Zeng

    1993-10-01

    In this paper, directing at the peculiarity of south China, the technique and quality control of Co-80 r radiation sterilization of medical devices have been studied. Radiation dose setting is determined by the AAMI method. Experiment shows that radiation treatment has no effect upon the attributes of the products. Under the same condition of packing and environment, storing time of radiation sterilization is 4 times than that of sterilization by heat. Clinical appliances of 1000 carton products show that radiation sterilization products are safe and reliable.

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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.

  9. 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

  10. 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

  11. 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.

  12. [Usability first. Model-based approach for the use-oriented risk analysis of medical devices].

    Science.gov (United States)

    Janß, A; Radermacher, K

    2014-12-01

    Due to increasing automation, the number and complexity of technical components have increased in the medical context (e.g., in the clinic or in the home care sector) in recent years. Besides new effective and efficient therapeutic and diagnostic options, these devices entail a wide range of functions and very complex (often computer-based) user interfaces that may lead to human-induced risk potential. A systematic and early human risk analysis and a usability evaluation allow medical device manufacturers to identify and control risks within the human-machine interaction very efficiently. At the Department of Medical Engineering in the Helmholtz Institute for Biomedical Engineering at the RWTH Aachen University, a formal-analytical methodology and a corresponding software tool for prospective human-risk analysis and model-based usability evaluation has been developed. Based on a twofold approach, user interactive process sequences and their potential impacts on the overall process are identified and the resulting use-related risks are assessed. For this, the tasks are categorized (in system and user tasks) and modeled and temporally related within the framework of a high-level task analysis. Within a subsequent cognitive low-level task analysis, potentially critical parallel process sequences are then tested in order to detect a potential resource overload of the user. The subsequent corresponding human-risk analysis is developed according to a knowledge base (checklist) of taxonomies related to human error. The HiFEM (human-function effect modeling) methodology is universally applicable and can be used for the evaluation of human-computer interfaces as well as for the analysis of purely mechanical control interfaces and simple hand-held instruments (such as a scalpel and implant). In a comparative study, the HiFEM method clearly outperforms the classic FMEA (failure modes and effects analysis) process with regard to effectiveness, efficiency, learnability, and

  13. In situ formation of antimicrobial silver nanoparticles and the impregnation of hydrophobic polycaprolactone matrix for antimicrobial medical device applications.

    Science.gov (United States)

    Tran, Phong A; Hocking, Dianna M; O'Connor, Andrea J

    2015-02-01

    Bacterial infection associated with medical devices remains a challenge to modern medicine as more patients are being implanted with medical devices that provide surfaces and environment for bacteria colonization. In particular, bacteria are commonly found to adhere more preferably to hydrophobic materials and many of which are used to make medical devices. Bacteria are also becoming increasingly resistant to common antibiotic treatments as a result of misuse and abuse of antibiotics. There is an urgent need to find alternatives to antibiotics in the prevention and treatment of device-associated infections world-wide. Silver nanoparticles have emerged as a promising non-drug antimicrobial agent which has shown effectiveness against a wide range of both Gram-negative and Gram-positive pathogen. However, for silver nanoparticles to be clinically useful, they must be properly incorporated into medical device materials whose wetting properties could be detrimental to not only the incorporation of the hydrophilic Ag nanoparticles but also the release of active Ag ions. This study aimed at impregnating the hydrophobic polycaprolactone (PCL) polymer, which is a FDA-approved polymeric medical device material, with hydrophilic silver nanoparticles. Furthermore, a novel approach was employed to uniformly, incorporate silver nanoparticles into the PCL matrix in situ and to improve the release of Ag ions from the matrix so as to enhance antimicrobial efficacy.

  14. 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.

  15. 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

  16. 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

  17. MR safety: fast T₁ thermometry of the RF-induced heating of medical devices.

    Science.gov (United States)

    Gensler, D; Fidler, F; Ehses, P; Warmuth, M; Reiter, T; Düring, M; Ritter, O; Ladd, M E; Quick, H H; Jakob, P M; Bauer, W R; Nordbeck, P

    2012-11-01

    Determining the MR compatibility of medical implants and devices is becoming increasingly relevant. In most cases, the heating of conductive implants due to radiefrequency (RF) excitation pulses is measured by fluoroptic temperature sensors in relevant tests for approval. Another common method to determine these heating effects is MR thermometry using the proton resonance frequency. This method gives good results in homogeneous phantoms. However in many cases, technical shortcomings such as susceptibility artifacts prohibit exact proton resonance frequency thermometry near medical implants. Therefore, this work aimed at developing a fast T₁-based method which allows controlled MR-related heating of a medical implant while simultaneously quantifying the spatial and temporal temperature distribution. To this end, an inversion recovery snapshot Fast Low-Angle Shot (FLASH) sequence was modified with additional off-resonant heating pulses. With an accelerated imaging method and a sliding-window technique, every 7.6 s a new temperature map could be generated with a spatial in-plane resolution of 2 mm. The temperature deviation from calculated temperature values to reference fluoroptic probe was found to be smaller than 1 K.

  18. 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

  19. 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

  20. Medical Devices; General and Plastic Surgery Devices; Classification of the Electrosurgical Device for Over-the-Counter Aesthetic Use. Final order.

    Science.gov (United States)

    2016-06-29

    The Food and Drug Administration (FDA) is classifying the electrosurgical device for over-the-counter aesthetic use 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 electrosurgical device for over-the-counter aesthetic use'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.

  1. 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

  2. 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

  3. 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

  4. [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

  5. 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.

  6. 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

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

    DEFF Research Database (Denmark)

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

    2015-01-01

    ciprofloxacin was loaded into the polymer matrix by a post-polymerization loading procedure. Sustained release of ciprofloxacin was demonstrated, and the release could be controlled by varying the hydrogel content in the range 13–38% (w/w) and by changing the concentration of ciprofloxacin during loading...... project was to introduce a novel antibacterial approach involving an advanced composite material applicable for medical devices. The polymeric composites investigated consisted of a hydrogel network of cross-linked poly(2-hydroxyethyl methacrylate) (PHEMA) embedded in a poly(dimethylsiloxane) (PDMS......) silicone elastomer produced using supercritical carbon dioxide (scCO2). In these materials, the hydrogel may contain an active pharmaceutical ingredient while the silicone elastomer provides the sufficient mechanical stability of the material. In these conceptual studies, the antimicrobial agent...

  8. 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

  9. 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

  10. Organ repair, hemostasis, and in vivo bonding of medical devices by aqueous solutions of nanoparticles.

    Science.gov (United States)

    Meddahi-Pellé, Anne; Legrand, Aurélie; Marcellan, Alba; Louedec, Liliane; Letourneur, Didier; Leibler, Ludwik

    2014-06-16

    Sutures are traumatic to soft connective tissues, such as liver or lungs. Polymer tissue adhesives require complex in vivo control of polymerization or cross-linking reactions and currently suffer from being toxic, weak, or inefficient within the wet conditions of the body. Herein, we demonstrate using Stöber silica or iron oxide nanoparticles that nanobridging, that is, adhesion by aqueous nanoparticle solutions, can be used in vivo in rats to achieve rapid and strong closure and healing of deep wounds in skin and liver. Nanoparticles were also used to fix polymer membranes to tissues even in the presence of blood flow, such as occurring after liver resection, yielding permanent hemostasis within a minute. Furthermore, medical devices and tissue engineering constructs were fixed to organs such as a beating heart. The simplicity, rapidity, and robustness of nanobridging bode well for clinical applications, surgery, and regenerative medicine.

  11. [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.

  12. Effects of a wireless local area network (LAN) system, a telemetry system, and electrosurgical devices on medical devices in a hospital environment.

    Science.gov (United States)

    Tan, K S; Hinberg, I

    2000-01-01

    Concerns have been raised about interference of wireless local area network (LAN) systems and telemetry systems with medical devices in hospitals. The authors have investigated the susceptibility of 65 electromedical devices to a wireless LAN system and a telemetry system in preselected areas of a hospital. Testing was based on the American National Standards Institute Standard C63.18. The wireless LAN system operated at 2.42 GHz with an output power of 100 mW. The telemetry system operated at 466 MHz with an output power of 4 mW. Of the 65 devices tested, only two hand-held Doppler units, a Mini Doppler Model D900 (Huntleigh Healthcare Ltd) and a Ultrasonic Doppler Model 811 (Parks Medical Electronics, Inc.), were affected by the LAN system. Placed within 10 cm of the LAN system in standby mode, both units emitted periodic high-pitched beating sounds, which could be misinterpreted as normal beating sounds from the patient. These changed to random static noise during data transmission by the LAN. Under normal conditions of use, a LAN system would never be placed this close to a medical device. The quality of data transmission from the LAN system changed from "good" to "acceptable" in the colonoscopy room. This deterioration in transmission quality could have been caused by the lead shielding in the room. Electrosurgical devices operating at 0.5 to 1 MHz did not affect the LAN system at distances up to 3 m. None of the devices was affected by the telemetry system. These findings suggest that wireless LAN systems and telemetry systems can be acceptable for use in hospitals. Nevertheless, other systems should be tested on potentially susceptible devices by the hospital before use.

  13. Ethnic Segregation in Arizona Charter Schools

    Directory of Open Access Journals (Sweden)

    Casey D. Cobb

    1999-01-01

    Full Text Available Among the criticisms of charter schools is their potential to further stratify schools along ethnic and class lines. This study addressed whether Arizona charter schools are more ethnically segregated than traditional public schools. In 1996-97, Arizona had nearly one in four of all charter schools in the United States. The analysis involved a series of comparisons between the ethnic compositions of adjacent charter and public schools in Arizona's most populated region and its rural towns. This methodology differed from the approach of many evaluations of charter schools and ethnic stratification in that it incorporated the use of geographic maps to compare schools' ethnic make-ups. The ethnic compositions of 55 urban and 57 rural charter schools were inspected relative to their traditional public school neighbors.

  14. 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.

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

    Science.gov (United States)

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

    2016-08-01

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

  16. 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

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

    Science.gov (United States)

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

    2016-08-01

    The process of engineering design requires the product development team to balance the needs and limitations of many stakeholders, including those of the user, regulatory organizations, and the designing institution. This is particularly true in medical device design, where additional consideration must be given for a much more complex user-base that can only be accessed on a limited basis. Given this inherent challenge, few projects exist that consider design domain concepts, such as aspects of a detailed design, a detailed view of various stakeholders and their capabilities, along with the user-needs simultaneously. In this paper, we present a novel information model approach that combines a detailed model of design elements with a model of the design itself, customer requirements, and of the capabilities of the customer themselves. The information model is used to facilitate knowledge capture and automated reasoning across domains with a minimal set of rules by adopting a terminology that treats customer and design specific factors identically, thus enabling straightforward assessments. A uniqueness of this approach is that it systematically provides an integrated perspective on the key usability information that drive design decisions towards more universal or effective outcomes with the very design information impacted by the usability information. This can lead to cost-efficient optimal designs based on a direct inclusion of the needs of customers alongside those of business, marketing, and engineering requirements. Two case studies are presented to show the method's potential as a more effective knowledge management tool with built-in automated inferences that provide design insight, as well as its overall effectiveness as a platform to develop and execute medical device design from a holistic perspective. PMID:27401857

  18. 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

  19. 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?

  20. [Experiences and recommendations of the German Federal Institute for Drugs and Medical Devices (BfArM) concerning clinical investigation of medical devices and the evaluation of serious adverse events (SAE)].

    Science.gov (United States)

    Renisch, B; Lauer, W

    2014-12-01

    An integral part of the conformity assessment process for medical devices is a clinical evaluation based on clinical data. Particularly in the case of implantable devices and products of risk class III clinical trials must be performed. Since March 2010 applications for the authorization of clinical trials as well as for the waiver of the authorization requirement must be submitted centrally in Germany to the appropriate federal authority, the Federal Institute for Drugs and Medical Devices (BfArM) or the Paul Ehrlich Institute (PEI). In addition to authorization, approval by the responsible ethics committee is also required under law in order to begin clinical testing of medical devices in Germany. In this paper, the legal framework for the clinical testing of medical devices as well as those involved and possible procedures including evaluation criteria for the initial application of a trial and subsequent amendments are presented in detail. In addition, the reporting requirements for serious adverse events (SAEs) are explained and possible consequences of the evaluation are presented. Finally, a summary of application and registration numbers for all areas of extensive experience of the BfArM as well as requests and guidance for applicants are presented.

  1. Demystifying Special Education in Virtual Charter Schools. Special Report. Primers on Special Education in Charter Schools

    Science.gov (United States)

    Rhim, Lauren Morando; Kowal, Julie

    2008-01-01

    This special report is a supplement to a series of special education primers created to inform state officials, authorizers and charter school operators about special education in the charter sector. The primer series also provides tools to help these stakeholders build charter school capacity to provide special education and related services. In…

  2. Understanding Charter School Governance: A Case Study of a Conversion Charter School Board of Directors

    Science.gov (United States)

    Silver, David Mark

    2010-01-01

    The charter school movement has been at the forefront of educational reform since the 1990s. The majority of charter school research has focused on academic achievement and issues of access, equity, and funding. Less attention has focused on charter school governance, yet evidence suggests that governance challenges represent a significant…

  3. 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.

  4. 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

  5. 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

  6. 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。

  7. The Effects of Closed-Loop Medical Devices on the Autonomy and Accountability of Persons and Systems.

    Science.gov (United States)

    Kellmeyer, Philipp; Cochrane, Thomas; Müller, Oliver; Mitchell, Christine; Ball, Tonio; Fins, Joseph J; Biller-Andorno, Nikola

    2016-10-01

    Closed-loop medical devices such as brain-computer interfaces are an emerging and rapidly advancing neurotechnology. The target patients for brain-computer interfaces (BCIs) are often severely paralyzed, and thus particularly vulnerable in terms of personal autonomy, decisionmaking capacity, and agency. Here we analyze the effects of closed-loop medical devices on the autonomy and accountability of both persons (as patients or research participants) and neurotechnological closed-loop medical systems. We show that although BCIs can strengthen patient autonomy by preserving or restoring communicative abilities and/or motor control, closed-loop devices may also create challenges for moral and legal accountability. We advocate the development of a comprehensive ethical and legal framework to address the challenges of emerging closed-loop neurotechnologies like BCIs and stress the centrality of informed consent and refusal as a means to foster accountability. We propose the creation of an international neuroethics task force with members from medical neuroscience, neuroengineering, computer science, medical law, and medical ethics, as well as representatives of patient advocacy groups and the public.

  8. The Effects of Closed-Loop Medical Devices on the Autonomy and Accountability of Persons and Systems.

    Science.gov (United States)

    Kellmeyer, Philipp; Cochrane, Thomas; Müller, Oliver; Mitchell, Christine; Ball, Tonio; Fins, Joseph J; Biller-Andorno, Nikola

    2016-10-01

    Closed-loop medical devices such as brain-computer interfaces are an emerging and rapidly advancing neurotechnology. The target patients for brain-computer interfaces (BCIs) are often severely paralyzed, and thus particularly vulnerable in terms of personal autonomy, decisionmaking capacity, and agency. Here we analyze the effects of closed-loop medical devices on the autonomy and accountability of both persons (as patients or research participants) and neurotechnological closed-loop medical systems. We show that although BCIs can strengthen patient autonomy by preserving or restoring communicative abilities and/or motor control, closed-loop devices may also create challenges for moral and legal accountability. We advocate the development of a comprehensive ethical and legal framework to address the challenges of emerging closed-loop neurotechnologies like BCIs and stress the centrality of informed consent and refusal as a means to foster accountability. We propose the creation of an international neuroethics task force with members from medical neuroscience, neuroengineering, computer science, medical law, and medical ethics, as well as representatives of patient advocacy groups and the public. PMID:27634714

  9. Medical Devices; General and Plastic Surgery Devices; Classification of the Electrosurgical Device for Over-the-Counter Aesthetic Use. Final order.

    Science.gov (United States)

    2016-06-29

    The Food and Drug Administration (FDA) is classifying the electrosurgical device for over-the-counter aesthetic use 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 electrosurgical device for over-the-counter aesthetic use'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:27373015

  10. Methicillin- and vancomycin-resistant Staphylococcus aureus in health care workers and medical devices

    Directory of Open Access Journals (Sweden)

    Angela Breves

    2015-06-01

    Full Text Available ABSTRACT Introduction: Cross-contamination by Staphylococcus aureus among patients, professionals and medical supplies in health facilities is a constant concern, leading many researchers to study the prevalence of this pathogen in asymptomatic carriers. Objective: We investigated the colonization and the antimicrobial susceptibility profile of Staphylococcus spp. on surfaces of medical articles and in professionals from two basic health units in the city of Rio de Janeiro. Materials and methods: Seventy-nine samples resulted in 49 isolates which underwent phenotypic and molecular characterization by polymerase chain reaction (PCR of coa, mecA and femA genes. Results: According to the phenotypes, the isolates were identified as S. aureus (n = 35, 71.42% and coagulase-negative Staphylococcus (CoNS (n = 14, 28.57%. Among these 14 isolates, 42.85% were methicillin-resistant coagulase negative Staphylococcus (MRCoNS. Among the 35 S. aureus, 31.42% were methicillin resistant (MRSA, and 2.8% were vancomycin resistant, characterized as VRSA. Sixty-eight percent were susceptible to methicillin (MSSA. Genes coa, femA and mecA were amplified from 75.51%, 71.42% and 30.61% of the isolates, respectively. After amplification of the mecA gene, 20.41% were characterized as MRSA, and 10.20% as MRCoNS. The vancomycin-resistant strain was characterized as VRSA after detection of the vanB gene. Conclusion: Our results show a higher frequency of MSSA and MRCoNS among S. aureus and CoNS respectively, colonizing devices and health professionals. However, the already described transfer of the staphylococcal cassette chromosome mec (SSCmec from MRCoNS to MSSA may alter these results, increasing the frequency of MRSA strains.

  11. 76 FR 6623 - Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-02-07

    ... HUMAN SERVICES Food and Drug Administration Molecular and Clinical Genetics Panel of the Medical Devices... meeting. A notice in the Federal Register about last minute modifications that impact a previously... line/phone line to learn about possible modifications before coming to the meeting. Agenda: On March...

  12. 77 FR 16036 - Guidance for Industry, Third Parties and Food and Drug Administration Staff; Medical Device ISO...

    Science.gov (United States)

    2012-03-19

    ... Australia Inspectorate; and the Japanese Ministry of Health, Labour and Welfare System for Medical Devices... Submission Program'' was published for comment in the Federal Register of May 20, 2010 (75 FR 28257... Submission Pilot Program.'' It does not create or confer any rights for or on any person and does not...

  13. 34 CFR 300.113 - Routine checking of hearing aids and external components of surgically implanted medical devices.

    Science.gov (United States)

    2010-07-01

    ... 34 Education 2 2010-07-01 2010-07-01 false Routine checking of hearing aids and external components of surgically implanted medical devices. 300.113 Section 300.113 Education Regulations of the Offices of the Department of Education (Continued) OFFICE OF SPECIAL EDUCATION AND REHABILITATIVE SERVICES, DEPARTMENT OF EDUCATION ASSISTANCE TO...

  14. 78 FR 68459 - Medical Device Development Tools; Draft Guidance for Industry, Tool Developers, and Food and Drug...

    Science.gov (United States)

    2013-11-14

    ... guidance to FDA staff, industry, healthcare providers, researchers, and patient and consumer groups on a... HUMAN SERVICES Food and Drug Administration Medical Device Development Tools; Draft Guidance for Industry, Tool Developers, and Food and Drug Administration Staff; Availability AGENCY: Food and...

  15. 78 FR 6825 - Accessible Medical Device Labeling in a Standard Content and Format Public Workshop; Request for...

    Science.gov (United States)

    2013-01-31

    ... Administration (FDA) is correcting a document that appeared in the Federal Register of January 7, 2013 (78 FR 951... Federal Register of January 7, 2013, in FR Doc. 951-953, on page 952, the following correction is made... HUMAN SERVICES Food and Drug Administration Accessible Medical Device Labeling in a Standard Content...

  16. The Potential Role of Polymethyl Methacrylate as a New Packaging Material for the Implantable Medical Device in the Bladder

    Directory of Open Access Journals (Sweden)

    Su Jin Kim

    2015-01-01

    Full Text Available Polydimethylsiloxane (PDMS is used in implantable medical devices; however, PDMS is not a completely biocompatible material for electronic medical devices in the bladder. To identify novel biocompatible materials for intravesical implanted medical devices, we evaluated the biocompatibility of polymethyl methacrylate (PMMA by analyzing changes in the levels of macrophages, macrophage migratory inhibitory factor (MIF, and inflammatory cytokines in the bladder. A ball-shaped metal coated with PMMA or PDMS was implanted into the bladders of rats, and after intravesical implantation, the inflammatory changes induced by the foreign body reaction were evaluated. In the early period after implantation, increased macrophage activity and MIF in the urothelium of the bladder were observed. However, significantly decreased macrophage activity and MIF in the bladder were observed after implantation with PMMA- or PDMS-coated metal in the later period. In addition, significantly decreased inflammatory cytokines such as IL-1β, IL-6, and TNF-α were observed with time. Based on these results, we suggest that MIF plays a role in the foreign body reaction and in the biocompatible packaging with PMMA for the implanted medical devices in the bladder.

  17. 78 FR 102 - Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical Device...

    Science.gov (United States)

    2013-01-02

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical Device Submissions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of...

  18. Charters, K-12 Aid Roiling Wash. State

    Science.gov (United States)

    Ujifusa, Andrew

    2012-01-01

    A tight race for governor, the heavy burden of rebuilding a school funding system recently declared unconstitutional, and a fourth ballot measure in two decades on charter schools has placed Washington state on an intense--and unpredictable--road for education this year. Washington is one of nine states that do not allow charter schools, and the…

  19. Help for Charters in Race for Space

    Science.gov (United States)

    Robelen, Erik W.

    2008-01-01

    The world of charter school facilities is sometimes strange. Many charter operators have had to show considerable creativity and resourcefulness in finding a place to educate their students, whether it's a former K-Mart or car dealership, a church facility, or space in an office complex. Obtaining and paying for adequate facilities are often big…

  20. Earth Charter, ESD and Chinese Philosophies

    Science.gov (United States)

    Liu, Yunhua; Constable, Alicia

    2010-01-01

    This article examines the relationship between the Earth Charter and education for sustainable development (ESD), as part of the UN Decade of Education for Sustainable Development. The areas of shared interest between the two are assessed and the invaluable nature of the Earth Charter as a resource outlining global values and principles for a…

  1. A Cost Estimation Tool for Charter Schools

    Science.gov (United States)

    Hayes, Cheryl D.; Keller, Eric

    2009-01-01

    To align their financing strategies and fundraising efforts with their fiscal needs, charter school leaders need to know how much funding they need and what that funding will support. This cost estimation tool offers a simple set of worksheets to help start-up charter school operators identify and estimate the range of costs and timing of…

  2. Books or Guards? Charter School Security Costs

    Science.gov (United States)

    DeAngelis, Karen J.; Brent, Brian O.

    2012-01-01

    Little is known about the costs charter schools incur to foster security--a vexing phenomenon when one considers policymakers' and parents' seemingly high and growing want for school safety. Using data from the National Center for Education Statistics and Texas, we reveal how much charter schools spend on security, how they put these resources to…

  3. State Policy Regimes and Charter School Performance

    Science.gov (United States)

    Pelz, Mikael L.

    2015-01-01

    The policy diffusion framework is critical to understanding the spread of policy innovations such as charter schools in the United States. This framework, however, is less instructive in explaining the state-by-state configuration of these policies. What explains the wide variation in charter school policy among states? This study addresses this…

  4. The Uneven Performance of Arizona's Charter Schools

    Science.gov (United States)

    Chingos, Matthew M.; West, Martin R.

    2015-01-01

    Arizona enrolls a larger share of its students in charter schools than any other state in the country, but no comprehensive examination exists of the impact of those schools on student achievement. Using student-level data covering all Arizona students from 2006 to 2012, we find that the performance of charter schools in Arizona in improving…

  5. Charter Schools and the Teacher Job Search

    Science.gov (United States)

    Cannata, Marisa

    2011-01-01

    This article examines the position of charter schools in prospective elementary teachers' job search decisions. Using a labor market segmentation framework, it explores teacher applicants' decisions to apply to charter schools. The data come from a mixed-methods longitudinal study of prospective teachers looking for their first job. This article…

  6. The effect of medical device dose-memory functions on patients’ adherence to treatment, confidence, and disease self-management

    Directory of Open Access Journals (Sweden)

    Hall RL

    2014-05-01

    Full Text Available Rebecca L Hall,1 Thomas Willgoss,1 Louise J Humphrey,1 Jens Harald Kongsø2 1Adelphi Values, Adelphi Mill, Bollington, Cheshire, UK; 2Novo Nordisk A/S, Novo Allé, Bagsværd, Denmark Background: Adherence to treatment is an important issue in chronic disease management and an indicator of patients’ ability to self-manage their condition and treatment. Some drug-dispensing and drug-delivery devices have been designed to support patients’ medication-taking behavior by including dose-memory and combined dose-memory and dose-reminder functions, which electronically store, and visually display dose-history information, enabling the patient to review, monitor, and/or be actively reminded about their medication doses.Purpose: This literature review explored the role and impact of these devices on patients’ treatment adherence, confidence with, and self-management of their condition and treatment.Materials and methods: A search of MEDLINE, Embase, and PsycINFO was performed to identify articles published in English from 2003–2013 that studied the effect of devices with dose-memory and combined dose-memory and dose-reminder functions on treatment adherence and users’ (patients, health care professionals [HCPs], and caregivers confidence, self-management behavior, and attitudes.Results: The database searches yielded 940 abstracts from which 13 articles met the inclusion criteria and were retained. Devices with dose-memory and combined dose-memory and dose-reminder functions were found to improve self-reported and electronically monitored treatment adherence in chronic conditions such as asthma, diabetes, and HIV. The ability of the devices to provide dose-history information and active medication reminders was considered valuable in disease management by patients, caregivers, and HCPs. The devices were found to enhance patients’ confidence in, and motivation to manage their medication and condition, and help reduce forgotten or incorrect

  7. Recovering fraudulent claims for Australian federal expenditure on pharmaceuticals and medical devices.

    Science.gov (United States)

    Faunce, Thomas; Urbas, Gregor; Skillen, Lesley; Smith, Marc

    2010-12-01

    The Australian Federal Government expends increasingly large amounts of money on pharmaceuticals and medical devices. It is likely, given government experience in other jurisdictions, that a significant proportion of this expenditure is paid as a result of fraudulent claims presented by corporations. In the United States, legislation such as the False Claims Act 1986 (US), the Fraud Enforcement and Recovery Act 2009 (US), the Stark (Physician Self-Referral) Statute 1995 (US), the Anti-Kickback Statute 1972 (US), the Food, Drug and Cosmetic Act 1938 (US), the Social Security Act 1965 (US), and the Patient Protection and Affordable Care Act 2010 (US) has created systematic processes allowing the United States Federal Government to recover billions of dollars in fraudulently made claims in the health and procurement areas. The crucial component involves the creation of financial incentives for information about fraud to be revealed from within the corporate sector to the appropriate state officials. This article explores the opportunities for creating a similar system in Australia in the health care setting.

  8. Innovative processes for electropolishing of medical devices made of stainless steels.

    Science.gov (United States)

    Eliaz, Noam; Nissan, Oded

    2007-11-01

    Currently, many medical devices are made of implantable metals such as 316LVM stainless steel. Electropolishing is a common process to obtain a smooth surface, free of contaminants and more passive, which allows for minimizing the foreign body response and cell adhesion. However, polishing of small implants with a highly complicated geometry and nonuniform metallurgy might result in unsatisfactory results. The objective of this work was to develop an electropolishing process effective for complex metallic implants such as artificial heart valve frames and miniature glaucoma implants. Polishing in an ultrasonic bath and pulsed voltage polishing processes were studied and compared to the standard ASTM process. Current-voltage curves were constructed for different solutions and bath temperatures. The polished parts were evaluated by stereomicroscopy, optical microscopy, atomic force microscopy, noncontact surface profilometry, and X-ray diffraction. Pulse polishing was found useful in eliminating the erosion effects of gas bubbles in solution. Electropolishing in an ultrasonic bath was found useful when a rough, patterned surface is needed, e.g. for osseointegration purposes. Preliminary animal studies followed by histopathology indicated that the polished surfaces stimulated only a moderate body reaction, as desired in such applications. The pronounced dependence of the measured roughness values on both the measurement technique and scanned area should inspire the preparation of a new test-method standard. PMID:17567863

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

    Directory of Open Access Journals (Sweden)

    Alan B. G. Lansdown

    2010-01-01

    Full Text Available 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 Ag+. The ion is absorbed into the systemic circulation from the diet and drinking water, by inhalation and through intraparenteral administration. Percutaneous absorption of Ag+ through intact or damaged skin is low. Ag+ binds strongly to metallothionein, albumins, and macroglobulins and is metabolised to all tissues other than the brain and the central nervous system. Silver sulphide or silver selenide precipitates, bound lysosomally in soft tissues, are inert and not associated with an irreversible toxic change. Argyria and argyrosis are the principle effects associated with heavy deposition of insoluble silver precipitates in the dermis and cornea/conjunctiva. Whilst these changes may be profoundly disfiguring and persistent, they are not associated with pathological damage in any tissue. The present paper discusses the mechanisms of absorption and metabolism of silver in the human body, presumed mechanisms of argyria and argyrosis, and the elimination of silver-protein complexes in the bile and urine. Minimum blood silver levels consistent with early signs of argyria or argyrosis are not known. Silver allergy does occur but the extent of the problem is not known. Reference values for silver exposure are discussed.

  10. Athrombogenic hydrogel coatings for medical devices--Examination of biological properties.

    Science.gov (United States)

    Butruk-Raszeja, Beata A; Łojszczyk, Ilona; Ciach, Tomasz; Kościelniak-Ziemniak, Magdalena; Janiczak, Karolina; Kustosz, Roman; Gonsior, Małgorzata

    2015-06-01

    In the article the authors present hydrogel coatings prepared from polyvinylpyrrolidone (PVP) macromolecules, which are chemically bonded to polyurethane (PU) substrate. The coating is designed to improve the surface hemocompatibility of blood-contacting medical devices. The coating was characterized in terms of physical properties (swelling ratio, hydrogel density, surface morphology, coating thickness, coating durability). In order to examine surface hemocompatibility, the materials were contacted with whole human blood under arterial flow simulated conditions followed by calculation of platelet consumption and the number of platelet aggregates. Samples were also contacted with platelet-poor plasma; the number of surface-adsorbed fibrinogen molecules was measured using ELISA assay. Finally, the inflammatory reaction after implantation was assessed, using New Zealand rabbits. The designed coating is characterized by high water content and excellent durability in aqueous environment - over a 35-day period, no significant changes in coating thickness were observed. Experiments with blood proved twice the reduction in adsorption of serum-derived fibrinogen together with a moderate reduction in the number of platelet aggregates formed during the contact of the material with blood. The analysis of an inflammatory reaction after the implantation confirmed high biocompatibility of the fabricated materials - studies have shown no toxic effects of the implanted material on the surrounding animal tissues. PMID:25912028

  11. Anti-biofilm activity of ultrashort cinnamic acid peptide derivatives against medical device-related pathogens.

    Science.gov (United States)

    Laverty, Garry; McCloskey, Alice P; Gorman, Sean P; Gilmore, Brendan F

    2015-10-01

    The threat of antimicrobial resistance has placed increasing emphasis on the development of innovative approaches to eradicate multidrug-resistant pathogens. Biofilm-forming microorganisms, for example, Staphylococcus epidermidis and Staphylococcus aureus, are responsible for increased incidence of biomaterial infection, extended hospital stays and patient morbidity and mortality. This paper highlights the potential of ultrashort tetra-peptide conjugated to hydrophobic cinnamic acid derivatives. These peptidomimetic molecules demonstrate selective and highly potent activity against resistant biofilm forms of Gram-positive medical device-related pathogens. 3-(4-Hydroxyphenyl)propionic)-Orn-Orn-Trp-Trp-NH2 displays particular promise with minimum biofilm eradication concentration (MBEC) values of 125 µg/ml against methicillin sensitive (ATCC 29213) and resistant (ATCC 43300) S. aureus and activity shown against biofilm forms of Escherichia coli (MBEC: 1000 µg/ml). Kill kinetics confirms complete eradication of established 24-h biofilms at MBEC with 6-h exposure. Reduced cell cytotoxicity, relative to Gram-positive pathogens, was proven via tissue culture (HaCaT) and haemolysis assays (equine erythrocytes). Existing in nature as part of the immune response, antimicrobial peptides display great promise for exploitation by the pharmaceutical industry in order to increase the library of available therapeutic molecules. Ultrashort variants are particularly promising for translation as clinical therapeutics as they are more cost-effective, easier to synthesise and can be tailored to specific functional requirements based on the primary sequence allowing factors such as spectrum of activity to be varied. PMID:26310860

  12. International scientific consensus on medical plantar pressure measurement devices: technical requirements and performance

    Directory of Open Access Journals (Sweden)

    Claudia Giacomozzi

    2012-01-01

    Full Text Available BACKGROUND: Since 2006, the Italian National Institute of Health (ISS has been conducting independent scientific activities to standardize the technical assessment of plantar pressure measurement devices (PMDs. MATERIAL AND METHODS: On the basis of the ISS results, in 2010 the Pedobarographic Group of the International Foot and Ankle Biomechanics community (i-FAB-PG promoted a consensus activity about the main technical requirements for the appropriate use of PMDs. The activity relied on a moodlebased on-line forum, documents exchange, discussions, reviews, meetings and a final survey. RESULTS: The participation of clinical and technical researchers, users, and manufacturers, contributed to the delivery of the hereby reported recommendations which specifically regard Medical PMDs in the form of platforms. CONCLUSIONS: The i-FAB-PG community reached overall agreement on the recommendations, with a few minor objections which are reported and commented in the document. RELEVANCE: The present document, the highest result achievable within a small scientific community, will hopefully represent the starting point of the wider process of establishing official international guidelines or standards, within scientific communities and standardization organizations.

  13. Practical aspects during sterilization validation for medical devices at IRASM Microbiological Laboratory

    International Nuclear Information System (INIS)

    Complete text of publication follows. The state of being free of living microorganisms is called sterility. The sterility state can be achieved by different means of sterilization. In practice the results of the process cannot be fully verified by tests, so the efficacy of the sterilization process must be validated. ISO 11137 established regulations for setting or substantiating the dose for achieving the desired sterility assurance level. The validation studies can be designed in particular for different types of product. Each product needs distinct protocol for bioburden determination and sterility testing. During time, the Microbiological Laboratories from Multipurpose Irradiation Center deals with different types of products, mainly for VDmax25 method. When it comes to microbiological evaluation the most challenging was cotton gauze. Special situation for establishing the sterilization validation method appears in cases of cotton, packed in large quantities. VDmax25 method can not be applied for items with average bioburden more than 1000 CFU / pack, no matter which is the weight of the package. This is a method limitation and implies increased costs for manufacturer, when choosing other method. For microbiological tests, culture condition should be selected in both cases the bioburden and sterility testing. These are time and money consuming. The costs can be reduced if taking into account some aspects. Reason for performing the bacteriostasis-fungistasis just for sterility testing will be given. The present study puts forward aspects during the validation studies for medical devices (cotton wool, cotton gauze, surgical sutures, dental screws), at IRASM Microbiological Laboratory.

  14. New regulations for medical devices: Rationale, advances and impact on research and patient care.

    Science.gov (United States)

    Labek, Gerold; Schöffl, Harald; Stoica, Christian Ioan

    2016-03-18

    A series of events relating to inferior medical devices has brought about changes in the legal requirements regarding quality control on the part of regulators. Apart from clinical studies, register and routine data will play an essential role in this context. To ensure adequate use of these data, adapted methodologies are required as register data in fact represent a new scientific entity. For the interpretation of register and routine data several limitations of published data should be taken into account. In many cases essential parameters of study cohorts - such as age, comorbidities, the patients' risk profiles or the hospital profile - are not presented. Required data and evaluation procedures differ significantly, for example, between hip and spine implants. A "one fits for all" methodology is quite unlikely to exist and vigorous efforts will be required to develop suitable standards in the next future. The new legislation will affect all high-risk products, besides joint implants also contact lenses, cardiac pacemakers or stents, for example, the new regulations can markedly enhance product quality monitoring. Register data and clinical studies should not be considered as competitors, they complement each other when used responsibly. In the future follow-up studies should increasingly focus on specific questions, while global follow-up investigations regarding product complication rates and surgical methods will increasingly be covered by registers.

  15. 75 FR 1396 - The General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee...

    Science.gov (United States)

    2010-01-11

    ... HUMAN SERVICES Food and Drug Administration The General Hospital and Personal Use Devices Panel of the...-market actions in response to insulin pump failures. Insulin pumps are intended for continuous delivery of insulin at set and variable rates and as an aid in the management of diabetes mellitus in...

  16. Details from the Dashboard: Charter Schools by Geographic Region

    Science.gov (United States)

    National Alliance for Public Charter Schools, 2012

    2012-01-01

    While a majority of charter schools nationwide operate in urban and suburban areas, charter schools exist in all corners of the nation, and are expanding into all types of communities. This "Details from the Dashboard" report presents statistics on the number of charter schools and students enrolled in charter schools by the four geographic…

  17. Assessment of risks of EMI for personal medical electronic devices (PMEDs) from emissions of millimeter-wave security screening systems

    Science.gov (United States)

    Witters, Donald; Bassen, Howard; Guag, Joshua; Addissie, Bisrat; LaSorte, Nickolas; Rafai, Hazem

    2013-06-01

    This paper describes research and testing of a representative group of high priority body worn and implantable personal medical electronic devices (PMEDs) for exposure to millimeter wave (MMW) advanced imaging technology (AIT) security systems used at airports. The sample PMEDs included in this study were implantable cardiac pacemakers, ICDs, neurostimulators and insulin pumps. These PMEDs are designed and tested for susceptibility to electromagnetic interference (EMI) under the present standards for medical device electromagnetic compatibility (EMC). However, the present standards for medical equipment do not address exposure to the much higher frequency fields that are emitted by MMW security systems. Initial AIT emissions measurements were performed to assess the PMED and passenger exposures. Testing protocols were developed and testing methods were tailored to the type of PMED. In addition, a novel exposure simulation system was developed to allow controlled EMC testing without the need of the MMW AIT system. Methodology, test results, and analysis are presented, along with an assessment of the human exposure and risks for PMED users. The results on this study reveal no effects on the medical devices from the exposure to the MMW security system. Furthermore, the human exposure measurements and analysis showed levels well below applicable standard, and the risks for PMED users and others we assessed to be very low. These findings apply to the types of PMEDs used in the study though these findings might suggest that the risks for other, similar PMEDs would likely be similar.

  18. Placing a price on medical device innovation: the example of total knee arthroplasty.

    Directory of Open Access Journals (Sweden)

    Lisa G Suter

    development, approval and implementation of novel technologies, particularly in orthopedics. Model-based evaluations such as this offer valuable, unique insights for evaluating technological innovation in medical devices.

  19. Discovery and Development of Synthetic and Natural Biomaterials for Protein Therapeutics and Medical Device Applications

    Science.gov (United States)

    Keefe, Andrew J.

    Controlling nonspecific protein interactions is important for applications from medical devices to protein therapeutics. The presented work is a compilation of efforts aimed at using zwitterionic (ionic yet charge neutral) polymers to modify and stabilize the surface of sensitive biomedical and biological materials. Traditionally, when modifying the surface of a material, the stability of the underlying substrate. The materials modified in this dissertation are unique due to their unconventional amorphous characteristics which provide additional challenges. These are poly(dimethyl siloxane) (PDMS) rubber, and proteins. These materials may seem dissimilar, but both have amorphous surfaces, that do not respond well to chemical modification. PDMS is a biomaterial extensively used in medical device manufacturing, but experiences unacceptably high levels of non-specific protein fouling when used with biological samples. To reduce protein fouling, surface modification is often needed. Unfortunately conventional surface modification methods, such as Poly(ethylene glycol) (PEG) coatings, do not work for PDMS due to its amorphous state. Herein, we demonstrate how a superhydrophilic zwitterionic material, poly(carboxybetaine methacrylate) (pCBMA), can provide a highly stable nonfouling coating with long term stability due to the sharp the contrast in hydrophobicity between pCBMA and PDMS. Biological materials, such as proteins, also require stabilization to improve shelf life, circulation time, and bioactivity. Conjugation of proteins with PEG is often used to increase protein stability, but has a detrimental effect on bioactivity. Here we have shown that pCBMA conjugation improves stability in a similar fashion to PEG, but also retains, or even improves, binding affinity due to enhanced protein-substrate hydrophobic interactions. Recognizing that pCBMA chemically resembles the combination of lysine (K) and glutamic acid (E) amino acids, we have shown how zwitterionic

  20. Antibacterial Peptide-Based Gel for Prevention of Medical Implanted-Device Infection.

    Directory of Open Access Journals (Sweden)

    Mihaela Mateescu

    Full Text Available Implanted medical devices are prone to infection. Designing new strategies to reduce infection and implant rejection are an important challenge for modern medicine. To this end, in the last few years many hydrogels have been designed as matrices for antimicrobial molecules destined to fight frequent infection found in moist environments like the oral cavity. In this study, two types of original hydrogels containing the antimicrobial peptide Cateslytin have been designed. The first hydrogel is based on alginate modified with catechol moieties (AC gel. The choice of these catechol functional groups which derive from mussel's catechol originates from their strong adhesion properties on various surfaces. The second type of gel we tested is a mixture of alginate catechol and thiol-terminated Pluronic (AC/PlubisSH, a polymer derived from Pluronic, a well-known biocompatible polymer. This PlubisSH polymer has been chosen for its capacity to enhance the cohesion of the composition. These two gels offer new clinical uses, as they can be injected and jellify in a few minutes. Moreover, we show these gels strongly adhere to implant surfaces and gingiva. Once gelled, they demonstrate a high level of rheological properties and stability. In particular, the dissipative energy of the (AC/PlubisSH gel detachment reaches a high value on gingiva (10 J.m-2 and on titanium alloys (4 J.m-2, conferring a strong mechanical barrier. Moreover, the Cateslytin peptide in hydrogels exhibited potent antimicrobial activities against P. gingivalis, where a strong inhibition of bacterial metabolic activity and viability was observed, indicating reduced virulence. Gel biocompatibility tests indicate no signs of toxicity. In conclusion, these new hydrogels could be ideal candidates in the prevention and/or management of periimplant diseases.