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 Medical Devices

    Science.gov (United States)

    ... Artery Disease Venous Thromboembolism Aortic Aneurysm More Implantable Medical Devices Updated:Sep 16,2016 For Rhythm Control ... a Heart Attack Introduction Medications Surgical Procedures Implantable Medical Devices • Life After a Heart Attack • Heart Attack ...

  3. 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

  4. Medical devices: US medical device regulation.

    Science.gov (United States)

    Jarow, Jonathan P; Baxley, John H

    2015-03-01

    Medical devices are regulated by the US Food and Drug Administration (FDA) within the Center for Devices and Radiological Health. Center for Devices and Radiological Health is responsible for protecting and promoting the public health by ensuring the safety, effectiveness, and quality of medical devices, ensuring the safety of radiation-emitting products, fostering innovation, and providing the public with accurate, science-based information about the products we oversee, throughout the total product life cycle. The FDA was granted the authority to regulate the manufacturing and marketing of medical devices in 1976. It does not regulate the practice of medicine. Devices are classified based on complexity and level of risk, and "pre-1976" devices were allowed to remain on the market after being classified without FDA review. Post-1976 devices of lower complexity and risk that are substantially equivalent to a marketed "predicate" device may be cleared through the 510(k) premarket notification process. Clinical data are typically not needed for 510(k) clearance. In contrast, higher-risk devices typically require premarket approval. Premarket approval applications must contain data demonstrating reasonable assurance of safety and efficacy, and this information typically includes clinical data. For novel devices that are not high risk, the de novo process allows FDA to simultaneously review and classify new devices. Devices that are not legally marketed are permitted to be used for clinical investigation purposes in the United States under the Investigational Device Exemptions regulation.

  5. 76 FR 22166 - Renewal of Charter for the National Emergency Medical Services Advisory Council (NEMSAC)

    Science.gov (United States)

    2011-04-20

    ... of the National Emergency Medical Services Advisory Council to provide advice and recommendations regarding emergency medical services (EMS) matters to the U.S. Department of Transportation, National... National Highway Traffic Safety Administration Renewal of Charter for the National Emergency...

  6. 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...

  7. 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...

  8. 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...

  9. 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

  10. 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.

  11. Barriers to medical device innovation

    OpenAIRE

    Bergsl; J.van*; Elle OJ; Fosse E

    2014-01-01

    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 ...

  12. Barriers to medical device innovation

    OpenAIRE

    Bergsland, Jacob; Elle,Ole Jacob; Fosse, Erik

    2014-01-01

    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 ...

  13. 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

  14. 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...

  15. 75 FR 16351 - Medical Devices; Technical Amendment

    Science.gov (United States)

    2010-04-01

    ... protection. 21 CFR Part 1020 Electronic products, Medical devices, Radiation protection, Reporting and... protection. 21 CFR Part 1040 Electronic products, Labeling, Lasers, Medical devices, Radiation protection, Reporting and recordkeeping requirements. 21 CFR Part 1050 Electronic products, Medical devices,...

  16. 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

  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. 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.

  19. 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.

  20. 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

  1. 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.

  2. 78 FR 15878 - Taxable Medical Devices; Correction

    Science.gov (United States)

    2013-03-13

    ... is not primarily intended for use in a medical institution or office or by a medical professional... lancets to medical institutions and offices, medical professionals, and retail businesses. The FDA... Internal Revenue Service 26 CFR Part 48 RIN 1545-BJ44 Taxable Medical Devices; Correction AGENCY:...

  3. 3D medical thermography device

    Science.gov (United States)

    Moghadam, Peyman

    2015-05-01

    In this paper, a novel handheld 3D medical thermography system is introduced. The proposed system consists of a thermal-infrared camera, a color camera and a depth camera rigidly attached in close proximity and mounted on an ergonomic handle. As a practitioner holding the device smoothly moves it around the human body parts, the proposed system generates and builds up a precise 3D thermogram model by incorporating information from each new measurement in real-time. The data is acquired in motion, thus it provides multiple points of view. When processed, these multiple points of view are adaptively combined by taking into account the reliability of each individual measurement which can vary due to a variety of factors such as angle of incidence, distance between the device and the subject and environmental sensor data or other factors influencing a confidence of the thermal-infrared data when captured. Finally, several case studies are presented to support the usability and performance of the proposed system.

  4. 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.

  5. [Software version and medical device software supervision].

    Science.gov (United States)

    Peng, Liang; Liu, Xiaoyan

    2015-01-01

    The importance of software version in the medical device software supervision does not cause enough attention at present. First of all, the effect of software version in the medical device software supervision is discussed, and then the necessity of software version in the medical device software supervision is analyzed based on the discussion of the misunderstanding of software version. Finally the concrete suggestions on software version naming rules, software version supervision for the software in medical devices, and software version supervision scheme are proposed.

  6. 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...

  7. 77 FR 69488 - Medical Devices; Custom Devices; Request for Comments

    Science.gov (United States)

    2012-11-19

    ... HUMAN SERVICES Food and Drug Administration Medical Devices; Custom Devices; Request for Comments AGENCY... of developing an implementation strategy and policy for the custom device exemption criteria in the FD&C Act amended by FDASIA. FDA is seeking information on appropriate uses of the custom...

  8. 77 FR 72924 - Taxable Medical Devices

    Science.gov (United States)

    2012-12-07

    ... lenses, hearing aids, and any other medical device determined by the Secretary to be of a type that is...) provides that the term taxable medical device does not include eyeglasses, contact lenses, hearing aids... taxes imposed on the sales of taxable articles by manufacturers, producers, and importers...

  9. The medical device R&D handbook

    CERN Document Server

    Kucklick, Theodore R

    2012-01-01

    Exploring the practical, entrepreneurial, and historical aspects of medical device development, this second edition of The Medical Device R&D Handbook provides a how-to guide for medical device product development. The book offers knowledge of practical skills such as prototyping, plastics selection, and catheter construction, allowing designers to apply these specialized techniques for greater innovation and time saving. The author discusses the historical background of various technologies, helping readers understand how and why certain devices were developed. The text also contains intervie

  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. Medical Device Development: the challenge for ergonomics

    OpenAIRE

    Martin, Jennifer L; 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 ...

  12. 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

  13. Anti-thrombotic technologies for medical devices.

    Science.gov (United States)

    Lavery, Karen S; Rhodes, Candace; Mcgraw, Adam; Eppihimer, Michael J

    2016-08-03

    Thrombosis associated with medical devices may lead to dramatic increases in morbidity, mortality and increased health care costs. Innovative strategies are being developed to reduce this complication and provide a safe biocompatible interface between device and blood. This article aims to describe the biological phenomena underlying device-associated thrombosis, and surveys the literature describing current and developing technologies designed to overcome this challenge. To reduce thrombosis, biomaterials with varying topographical properties and incorporating anti-thrombogenic substances on their surface have demonstrated potential. Overall, there is extensive literature describing technical solutions to reduce thrombosis associated with medical devices, but clinical results are required to demonstrate significant long-term benefits.

  14. 76 FR 8637 - Medical Devices; Medical Device Data Systems

    Science.gov (United States)

    2011-02-15

    ... whether APACHE Medical Systems or Apgar scores would be considered a clinical decision support system... does not address whether APACHE or Apgar Scoring would be considered clinical decision support systems. FDA expects that systems such as APACHE decision support systems and software-based Apgar...

  15. 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.

  16. 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.

  17. An approach to develop sustainable medical devices

    OpenAIRE

    Hede, Shantesh Digambar

    2013-01-01

    Tese de doutoramento Bioengenharia The development and commercialization of contemporary Medical Devices is inherently of a multidisciplinary nature. Consequently, they have to undergo a stringent regulatory compliance procedure in conformity with an ever increasingly fierce and competitive business environment. Throughout the product life cycle, medical devices would significantly consume renewable as well as non-renewable resources and as a result exert a substantial socia...

  18. Medical device-related pressure ulcers

    OpenAIRE

    Black JM; Kalowes P

    2016-01-01

    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 ox...

  19. 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

  20. Use of mobile devices for medical imaging.

    Science.gov (United States)

    Hirschorn, David S; Choudhri, Asim F; Shih, George; Kim, Woojin

    2014-12-01

    Mobile devices have fundamentally changed personal computing, with many people forgoing the desktop and even laptop computer altogether in favor of a smaller, lighter, and cheaper device with a touch screen. Doctors and patients are beginning to expect medical images to be available on these devices for consultative viewing, if not actual diagnosis. However, this raises serious concerns with regard to the ability of existing mobile devices and networks to quickly and securely move these images. Medical images often come in large sets, which can bog down a network if not conveyed in an intelligent manner, and downloaded data on a mobile device are highly vulnerable to a breach of patient confidentiality should that device become lost or stolen. Some degree of regulation is needed to ensure that the software used to view these images allows all relevant medical information to be visible and manipulated in a clinically acceptable manner. There also needs to be a quality control mechanism to ensure that a device's display accurately conveys the image content without loss of contrast detail. Furthermore, not all mobile displays are appropriate for all types of images. The smaller displays of smart phones, for example, are not well suited for viewing entire chest radiographs, no matter how small and numerous the pixels of the display may be. All of these factors should be taken into account when deciding where, when, and how to use mobile devices for the display of medical images.

  1. 77 FR 6028 - Taxable Medical Devices

    Science.gov (United States)

    2012-02-07

    ... related article, including any component, part, or accessory, that is recognized in the official National... ``taxable medical device'' does not include eyeglasses, contact lenses, hearing aids, and any other medical... upon the sales of taxable articles by manufacturers, producers, and importers (commonly referred to...

  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. [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.

  7. 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.

  8. 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.

  9. Smarter Charters

    Science.gov (United States)

    Kahlenberg, Richard D.; Potter, Halley

    2015-01-01

    Charter schools--what was their original promise? They would enroll diverse groups of students. They would give teachers the room and power to innovate. They would be educational laboratories that would find new ways to reach students, and they would share those lessons with other public schools. But charter schools haven't lived up to their…

  10. 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.

  11. Advances in Microelectronics for Implantable Medical Devices

    Directory of Open Access Journals (Sweden)

    Andreas Demosthenous

    2014-01-01

    Full Text Available Implantable medical devices provide therapy to treat numerous health conditions as well as monitoring and diagnosis. Over the years, the development of these devices has seen remarkable progress thanks to tremendous advances in microelectronics, electrode technology, packaging and signal processing techniques. Many of today’s implantable devices use wireless technology to supply power and provide communication. There are many challenges when creating an implantable device. Issues such as reliable and fast bidirectional data communication, efficient power delivery to the implantable circuits, low noise and low power for the recording part of the system, and delivery of safe stimulation to avoid tissue and electrode damage are some of the challenges faced by the microelectronics circuit designer. This paper provides a review of advances in microelectronics over the last decade or so for implantable medical devices and systems. The focus is on neural recording and stimulation circuits suitable for fabrication in modern silicon process technologies and biotelemetry methods for power and data transfer, with particular emphasis on methods employing radio frequency inductive coupling. The paper concludes by highlighting some of the issues that will drive future research in the field.

  12. 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

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

    Science.gov (United States)

    2013-10-01

    ... ``Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain... facilitate early feasibility studies of medical devices, using appropriate risk mitigation strategies, under the IDE regulations. Early feasibility studies allow for limited early clinical evaluations of...

  14. 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.

  15. 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.

  16. Implantable Medical Devices; Networking Security Survey

    Directory of Open Access Journals (Sweden)

    Siamak Aram

    2016-08-01

    Full Text Available The industry of implantable medical devices (IMDs is constantly evolving, which is dictated by the pressing need to comprehensively address new challenges in the healthcare field. Accordingly, IMDs are becoming more and more sophisticated. Not long ago, the range of IMDs’ technical capacities was expanded, making it possible to establish Internet connection in case of necessity and/or emergency situation for the patient. At the same time, while the web connectivity of today’s implantable devices is rather advanced, the issue of equipping the IMDs with sufficiently strong security system remains unresolved. In fact, IMDs have relatively weak security mechanisms which render them vulnerable to cyber-attacks that compromise the quality of IMDs’ functionalities. This study revolves around the security deficiencies inherent to three types of sensor-based medical devices; biosensors, insulin pump systems and implantable cardioverter defibrillators. Manufacturers of these devices should take into consideration that security and effectiveness of the functionality of implants is highly dependent on the design. In this paper, we present a comprehensive study of IMDs’ architecture and specifically investigate their vulnerabilities at networking interface.

  17. 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.

  18. Teaching medical device design using design control.

    Science.gov (United States)

    May-Newman, Karen; Cornwall, G Bryan

    2012-01-01

    The design of medical devices requires an understanding of a large number of factors, many of which are difficult to teach in the traditional educational format. This subject benefits from using a challenge-based learning approach, which provides focused design challenges requiring students to understand important factors in the context of a specific device. A course was designed at San Diego State University (CA, USA) that applied challenge-based learning through in-depth design challenges in cardiovascular and orthopedic medicine, and provided an immersive field, needs-finding experience to increase student engagement in the process of knowledge acquisition. The principles of US FDA 'design control' were used to structure the students' problem-solving approach, and provide a format for the design documentation, which was the basis of grading. Students utilized a combination of lecture materials, industry guest expertise, texts and readings, and internet-based searches to develop their understanding of the problem and design their solutions. The course was successful in providing a greatly increased knowledge base and competence of medical device design than students possessed upon entering the course.

  19. 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

  20. 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 ...

  1. 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.

  2. 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

  3. 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

  4. 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.

  5. 78 FR 68853 - International Medical Device Regulators Forum; Medical Device Single Audit Program International...

    Science.gov (United States)

    2013-11-15

    ... management systems and other specific regulatory requirements of the regulatory authorities participating in... Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD... Ministry of Health, Labour and Welfare and Pharmaceuticals and Medical Devices Agency, are...

  6. 75 FR 70112 - Medical Devices; General and Plastic Surgery Devices; Classification of Non-Powered Suction...

    Science.gov (United States)

    2010-11-17

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 878 Medical Devices; General and Plastic Surgery... Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 301 et seq.), as amended by the Medical Device... CFR Part 878 Medical devices. 0 Therefore, under the Federal Food, Drug, and Cosmetic Act and...

  7. 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...

  8. 76 FR 50485 - Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Amendment of...

    Science.gov (United States)

    2011-08-15

    ... HUMAN SERVICES Food and Drug Administration Obstetrics and Gynecology Devices Panel of the Medical... Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee. This meeting was announced... July 14, 2011, FDA announced that a meeting of the Obstetrics and Gynecology Devices Panel of...

  9. 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...

  10. 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.

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

    Science.gov (United States)

    Raths, David

    2009-02-01

    To get funding approved for medical device integration, ClOs suggest focusing on specific patient safety or staff efficiency pain points. Organizations that make clinical engineering part of their IT team report fewer chain-of-command issues. It also helps IT people understand the clinical goals because the engineering people have been working closely with clinicians for years. A new organization has formed to work on collaboration between clinical engineers and IT professionals. For more information, go to www.ceitcollaboration.org. ECRI Institute has written a guide to handling the convergence of medical technology and hospital networks. Its "Medical Technology for the IT Professional: An Essential Guide for Working in Today's Healthcare Setting" also details how IT professionals can assist hospital technology planning and acquisition, and provide ongoing support for IT-based medical technologies. For more information, visit www.ecri.org/ITresource.

  12. 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.

  13. Enabling Medical Device Interoperability for the Integrated Clinical Environment

    Science.gov (United States)

    2016-02-01

    Real-Time Blue Button for Patients and Families ,” that streams physiological data (including waveforms) from medical devices connected at our lab in...Interoperability Showcase at HIMSS14, we demonstrated a new ICE app, “Real-Time Blue Button for Patients and Families ,” that streams physiological data (including...waveforms) from medical devices connected at our lab in Cambridge, MA, as well as data from medical devices connected locally. At the SmartAmerica

  14. 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) Effective July 6, 2006, U.S. financial institutions are authorized to conduct all transactions...

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

    Science.gov (United States)

    ... Handle Power Outages for Medical Devices that Require Electricity Center for De CDRH vices and Rad lth ... Handle Power Outages for Medical Devices that Require Electricity As a home medical device user, it is ...

  16. Regulatory guidelines for medical devices in India: An overview

    Directory of Open Access Journals (Sweden)

    Nadimpalli Radhadevi

    2012-01-01

    Full Text Available The objective of the present study offers an overview of regulatory guidelines for medical devices in India. Medical devices are now a pervasive part of modern medical care. They are in many cases associated with quality of care. In some cases, the use of devices has certainly improved quality. In other cases, devices have been associated with many problems. The approach to quality of devices has depended largely on regulation .Recently introduced guidelines and the amendment in the law will provide adequate guidance for both the manufacturers and competent authorities to manage cases efficiently and appropriately. While these regulations and reforms promise to clarify, unify, and expedite the process of manufacturing and importing medical devices into India, they also pose their own challenges and complications. Understanding the regulatory reforms imminent in India will be crucial for foreign companies looking to enter or expand their business in India′s medical markets. It is hoped that the guidelines are implemented and regulated properly with effective outcome. This article highlights current regulations pertaining to applications for medical device registration certificates, medical device clinical trials, and medical device manufacturing/importation licenses.

  17. 76 FR 6551 - Medical Devices; General and Plastic Surgery Devices; Classification of Contact Cooling System...

    Science.gov (United States)

    2011-02-07

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 878 Medical Devices; General and Plastic Surgery... Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 301 et seq.) as amended by the Medical... of Subjects in 21 CFR Part 878 Medical devices. Therefore, under the Federal Food, Drug, and...

  18. 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…

  19. Market introduction of innovative high risk medical devices: towards a recast of the directive concerning medical devices.

    Science.gov (United States)

    Vinck, Imgard; Hulstaert, Frank; Van Brabandt, Hans; Neyt, Mattias; Stordeur, Sabine

    2011-12-01

    The European Conformity (CE) marking grants early market introduction to innovative high risk medical devices based on safety and device performance only, without any requirement to demonstrate clinical efficacy or effectiveness. Hence healthcare providers, patients and payers are informed neither about the added clinical value compared to an existing medical device nor about the risks incurred by using such innovations. In addition there is a lack of coherence and uniformity of approach in the assessment of high risk medical devices. These gaps may put the health and safety of patients in danger. The European Commission, in concert with Competent Authorities, industry, Notified Bodies, and other stakeholders, is working on a "recast" of the directives regulating medical devices. This article identifies and discusses the critical points of the pre-market clinical evaluation of innovative high-risk medical devices in the European legal framework and compares it with the USA.

  20. 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...

  1. 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...

  2. 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

  3. 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.

  4. 77 FR 19534 - Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus Serological...

    Science.gov (United States)

    2012-04-02

    ... 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 Devices; Classification of Norovirus Serological Reagents; Correction AGENCY: Food and Drug...

  5. 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

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

    Science.gov (United States)

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

    2010-01-01

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

  7. 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).

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

    Science.gov (United States)

    Shuai, Wanjun; Chao, Yong; Wang, Ning; Xu, Shining

    2011-07-01

    Clinical experiments are always used to evaluate the safety and validity of medical devices. The experiments have two types of clinical trying and testing. Ethic review must be done by the ethics committee of the medical department with the qualification of clinical research, and the approval must be made before the experiments. In order to ensure the safety and validity of clinical experiments of medical devices in medical institutions, the contents, process and approval criterions of the ethic review were analyzed and discussed.

  9. 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... Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 301 et seq.) as amended by the Medical Device... Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and...

  10. 76 FR 20840 - Medical Devices; General and Plastic Surgery Devices; Classification of the Low Level Laser...

    Science.gov (United States)

    2011-04-14

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 878 Medical Devices; General and Plastic Surgery...? In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U... Medical devices. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority...

  11. 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...

  12. Legal framework conditions for the reprocessing of medical devices.

    Science.gov (United States)

    Großkopf, Volker; Jäkel, Christian

    2008-09-03

    The processing of single-use products is permissible pursuant to medical device law. This is apparent both from the wording of the German Law on Medical Devices and from the purpose and the objectives underpinning the legislative materials. The prerequisite for processing is, however, compliance with the the Joint Recommendation of the Commission for Hospital Hygiene and the Prevention of Infection at the Robert Koch Institute (RKI) and the Federal Institute for Drugs and Medical Products (BfArM).For medical devices in the category "critical C", the RKI/BfArM-recommendation provides that the processor's quality management system must be certified by a body accredited by the Central Authority of the Federal States for Health Protection with regard to Medicinal Products and Medical Devices (Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten, ZLG). The certification must be carried out in accordance with EN ISO 13485:2003+AC:2007.On April 4, 2008 the Federal Health Ministry (Bundesministerium für Gesundheit, BMG) presented a progress report on the processing of medical devices. The BMG concludes that the legal framework for the processing of medical devices is sufficient, and that a prohibition on the processing of single-use products is inappropriate.

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

    Data.gov (United States)

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

  14. Quality management for the processing of medical devices.

    Science.gov (United States)

    Klosz, Kerstin

    2008-09-03

    Rules on the reprocessing of medical devices were put into place in Germany in 2001. The present article explains the background situation and the provisions that are currently in force.The implementation of these statutory requirements is described using the example of the quality management system of Germany's market leader, Vanguard AG. This quality management system was successfully certified pursuant to DIN EN ISO 13485:2003 for the scope "reprocessing of medical devices", including class "critical C", in accordance with the recommendation of the Commission for Hospital Hygiene and the Prevention of Infection at the Robert-Koch-Institute (RKI) and the German Federal Institute for Drugs and Medical Devices (BfArM) on the "Hygiene requirements for reprocessing of medical devices".

  15. 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...

  16. 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...

  17. 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.

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

    CERN Document Server

    Vijaya, M S

    2012-01-01

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

  19. 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.

  20. 78 FR 66941 - Design Considerations for Pivotal Clinical Investigations for Medical Devices; Guidance for...

    Science.gov (United States)

    2013-11-07

    ... for Medical Devices; Guidance for Industry, Clinical Investigators, Institutional Review Boards and... entitled ``Design Considerations for Pivotal Clinical Investigations for Medical Devices.'' This document... premarket submissions for medical devices and for FDA staff who review those submissions. This...

  1. [Key Technology and Quantity Control of Wearable Medical Devices].

    Science.gov (United States)

    Cui, Hongen; Yao, Shaowei

    2015-03-01

    In recent years, because the wearable medical devices can indicate the health monitoring index of blood sugar, blood pressure, heart rate, oxygen content, temperature, respiration of the human body anytime and anywhere, can also be used for the treatment of various diseases, accompanied by the development of large data, which will bring a subversive revolution for the medical device industry. This paper introduces the development of wearable devices, key technical index of main products, and to make a preliminary study on its quantity control.

  2. 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.

  3. Medical devices manufactured from latex: European regulatory initiatives.

    Science.gov (United States)

    De Jong, W H; Geertsma, R E; Tinkler, J J B

    2002-05-01

    In Europe the marketing of medical devices manufactured from latex is regulated by directives describing the essential (safety) requirements that products have to fulfill to obtain marketing approval. This paper describes the general requirements for marketing medical devices in Europe and, more specifically, the requirements for products manufactured from natural rubber latex. The requirements for marketing medical devices can be fulfilled by using the relevant harmonized European standards. These standards are regularly under revision to incorporate the latest scientific developments. For certain devices, for example, latex medical (examination and surgical) gloves, specific standards have been published. Medical devices manufactured from latex pose a serious problem because of the risk of induction of allergy both against the latex proteins inherently present (type I or immediate type allergy) and against chemicals added during processing (type IV or delayed type hypersensitivity) present as residues in the latex products. So, besides requirements for product quality in terms of barrier properties, strength, and sterility, the main focus consists of the allergy-inducing properties of the latex products. Recent developments have reopened the discussion on the value of total protein versus allergen determination in latex medical gloves. However, as long as minimal levels needed for both sensitization and elicitation have not been established, a safe maximum level for leachable proteins/allergens in latex products cannot be determined. A European Commission guidance document on the latex allergy problem is currently being drafted by experts from Competent Authorities.

  4. Medical device integration using mobile telecommunications infrastructure.

    Science.gov (United States)

    Moorman, Bridget A; Cockle, Richard A

    2013-01-01

    Financial pressures, an aging population, and a rising number of patients with chronic diseases, have encouraged the use of remote monitoring technologies. This usually entails at least one physiological parameter measurement for a clinician. Mobile telecommunication technologies lend themselves to this functionality, and in some cases, avoid some of the issues encountered with device integration. Moreover, the inherent characteristics of the mobile telecommunications infrastructure allow a coupling of business and clinical functions that were not possible before. Table I compares and contrasts some key aspect of device integration in and out of a healthcare facility. An HTM professional may be part of the team that acquires and/or manages a system using a mobile telecommunications technology. It is important for HTM professionals to ensure the data is in a standard format so that the interfaces across this system don't become brittle and break easily if one part changes. Moreover, the security and safety considerations of the system and the data should be a primary consideration in and y purchase, with attention given to the proper environmental and encryption mechanisms. Clinical engineers and other HTM professionals are unique in that they understand the patient/clinician/device interface and the need to ensure its safety and effectiveness regardless of geographical environment.

  5. Economic content in medical journal advertisements for medical devices and prescription drugs.

    Science.gov (United States)

    Ackerly, D Clay; Glickman, Seth W; Schulman, Kevin A

    2010-01-01

    Previous studies of economic content in medical journal advertisements have not examined all types of economic content and have not included advertisements for medical devices. To examine trends in the economic content of medical device and pharmaceutical advertisements in medical journals. Three reviewers examined pharmaceutical and medical device advertisements in six leading medical journals from 1997 through 2006. Product characteristics, economic claims and evidence to support those claims were evaluated. Economic content appeared in 23.5% (561/2389) of pharmaceutical and device advertisements; 11.9% made market share claims and 12.7% made other economic claims. From 1997 through 2006, the percentage of medical device advertisements containing economic content declined from 26.7% to 6.7% (p = 0.02), whereas the percentage of pharmaceutical advertisements containing economic content remained stable (21.6-22.0%; p = 0.99). For pharmaceuticals, price claims declined significantly (15.7-4.2%; p advertisements with economic claims provided supporting evidence. The prevalence and type of economic content in pharmaceutical and device advertisements changed between 1997 and 2006, which may reflect evolving market dynamics, such as changes in reimbursement systems. Furthermore, the lack of supporting evidence in medical device advertisements and pharmaceutical formulary claims are potential areas of concern that require additional scrutiny by regulators and journal editors.

  6. 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.

  7. 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

    2014-01-01

    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.

  8. 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.

  9. Measurement of Electromagnetic Fields Emitted from Some Medical Devices

    Directory of Open Access Journals (Sweden)

    Shaker Faisel

    2013-04-01

    Full Text Available     New medical devices such as surgery devices, physiotherapy devices, cosmetological devices and Magnetic Resonance Imaging (MRI systems generate a complex electromagnetic fields, so they consider as a potential   hazard for medical personnel during surgical procedures. The aim of this research is to detect the EMFs emitted from medical devices and determine the safety ranges from these devices which emit EMF radiations in order to protect Medical staff from its risks. The research has been performed in two parts, numerical calculation and practical measurement. Practical measurements are done in Dijlah hospital at Tikrit city. Obtaining results shows that the practical measurements are consistent with the mathematical calculation results. Comparison of these results with the safety standard guideline limits shows that they   are within the acceptable exposure limits recommended by the International Commission on Non-Ionizing Radiation Protection (ICNIRP and that means there is no health risk from exposure to these fields if the exposure is for a short and not continued periods and lay within the acceptable limits.    

  10. 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%.

  11. Intravascular foreign bodies: danger of unretrieved fragmented medical devices.

    Science.gov (United States)

    Tateishi, Minori; Tomizawa, Yasuko

    2009-01-01

    A warning on the danger of unretrieved device fragments and recommendations to mitigate the danger were issued by the Food and Drug Administration in January 2008. The causes of intravascular foreign bodies are classified into three main categories: improper manipulation and usage, device defects, and others, such as patient and anatomical factors. Device failure after long-term use is rarely predicted at the time of approval, since device abnormality is rarely experienced in animal studies and clinical trials conducted during development of the device. Stent fracture due to metal fatigue is one example. Complex complications could occur from simultaneous use of two or more devices with diverse characteristics. The success rate of percutaneous retrieval of intravascular foreign bodies has improved with the advances in commercially available devices. However, the procedure is not always successful and sometimes surgical removal becomes necessary. Appropriate device selection and acquisition of experience in using the device are important. When an intravascular foreign body cannot be retrieved, the risk of complication could be high. Magnetic resonance imaging examination sometimes causes adverse events, including burns due to the heat generated by metal movement. Such information should be correctly recorded. Furthermore, it is necessary to provide patients with adequate information about the characteristics of implanted devices and unretrieved fragments. We reviewed the literature on unretrieved medical device fragments and include articles that describe the Japanese experience.

  12. 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...

  13. 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...

  14. 78 FR 9349 - Medical Devices; Ophthalmic Devices; Classification of the Eyelid Weight

    Science.gov (United States)

    2013-02-08

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 886 Medical Devices; Ophthalmic Devices; Classification of the Eyelid Weight AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: The Food and Drug Administration (FDA) is proposing to classify the eyelid weight into class...

  15. 78 FR 19717 - Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory...

    Science.gov (United States)

    2013-04-02

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee: Notice of Change of Meeting Schedule AGENCY: Food and...

  16. 76 FR 22322 - Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass...

    Science.gov (United States)

    2011-04-21

    ... 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 Devices; Classification of Ovarian Adnexal Mass Assessment Score Test System; Correction AGENCY: Food...

  17. 77 FR 14272 - Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus Serological...

    Science.gov (United States)

    2012-03-09

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

  18. 77 FR 16925 - Medical Devices; Neurological Devices; Classification of the Near Infrared Brain Hematoma Detector

    Science.gov (United States)

    2012-03-23

    ... commercial distribution before May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976... delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, or a... device are restricted to prescription use in accordance with 21 CFR 801.109; (2) The labeling...

  19. 76 FR 16292 - Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass...

    Science.gov (United States)

    2011-03-23

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 Medical Devices; Immunology and Microbiology... for ovarian cancer. The ovarian adnexal mass assessment test system device is currently classified... delegated to the Commissioner of Food and Drugs, 21 CFR part 866 is amended as follows: PART...

  20. [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").

  1. Development of an Innovative Medical Cupping Device

    Directory of Open Access Journals (Sweden)

    Feng-Chyi Duh

    2016-10-01

    Full Text Available Temperature increases to influence the organs are often used in Chinese medicine therapy. A heat therapy cup was developed in this study with temperature control, timer, and heat therapy functions. The concept behind these therapeutic aids is traditional Chinese medicine combined with modern technology and the designs include timers and temperature control. The completed prototypes were used for cupping therapy. After testing, it was found that the standard deviation was greater at a lower temperature setting (To while at a higher To the standard deviation was lower. At To of 30, 40, 50, and 60°C, the relative changes in standard deviations were 5.27%, 2.50%, 2.66%, and 0.88%, respectively. The results indicated that the timer and temperature control functioned properly. Therefore, the designed medical aid, which is an important tool in Chinese medicine, can be provided to people of all ages to maintain health, help with rehabilitation, or to boost energy.

  2. 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.

  3. Risk management for medical devices in research projects

    Directory of Open Access Journals (Sweden)

    Sauter Christian

    2015-09-01

    Full Text Available In applied research for medical devices exists a conflict between effective research and regulations. While researchers need sufficient freedom the regulations require a complex technical documentation for a medical device. One relevant aspect of the regulations is risk management which takes time and therefore is ignored in many research projects. With adoptions to the standard the effort can be reduced: Identifying of risks can be focused on critical risks, measures can be categorised and only some categories need to be implemented. Research teams using this method can provide results which can be transferred into commercial products easier, cheaper and faster.

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

    Science.gov (United States)

    Casson, Alexander J; Rodriguez-Villegas, Esther

    2010-01-01

    Custom designed microchips, known as Application Specific Integrated Circuits (ASICs), offer the lowest possible power consumption electronics. However, this comes at the cost of a longer, more complex and more costly design process compared to one using generic, off-the-shelf components. Nevertheless, their use is essential in future truly wearable medical devices that must operate for long periods of time from physically small, energy limited batteries. This presentation will demonstrate the state-of-the-art in ASIC technology for providing online signal processing for use in these wearable medical devices.

  5. Smart alarms from medical devices in the OR and ICU.

    Science.gov (United States)

    Imhoff, Michael; Kuhls, Silvia; Gather, Ursula; Fried, Roland

    2009-03-01

    Alarms in medical devices are a matter of concern in critical and perioperative care. The high rate of false alarms is not only a nuisance for patients and caregivers, but can also compromise patient safety and effectiveness of care. The development of alarm systems has lagged behind the technological advances of medical devices over the last 20 years. From a clinical perspective, major improvements in alarm algorithms are urgently needed. This review gives an overview of the current clinical situation and the underlying problems, and discusses different methods from statistics and computational science and their potential for clinical application. Some examples of the application of new alarm algorithms to clinical data are presented.

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

    Science.gov (United States)

    Abrous-Anane, S; Benhassine, S; Lopez, S; Cristina, K; Mazeron, J-J

    2013-12-01

    Indication for radiotherapy is often questioned for patients equipped with implantable medical devices like infusion pumps as the radiation tolerance is poor or not known. We report here on the case of a patient who we treated with pelvic radiotherapy for cervical cancer and who had an infusion pump in iliac fossa. We conducted a series of tests on five identical pumps that insured that the treatment protocol is harmless to the implanted device.

  7. Medical devices and procedures in the hyperbaric chamber.

    Science.gov (United States)

    Kot, Jacek

    2014-12-01

    The aim of this paper is to present current controversies concerning the safety of medical devices and procedures under pressure in a hyperbaric chamber including: defibrillation in a multiplace chamber; implantable devices during hyperbaric oxygen treatment (HBOT) and the results of a recent European questionnaire on medical devices used inside hyperbaric chambers. Early electrical defibrillation is the only effective therapy for cardiac arrest caused by ventricular fibrillation or pulseless ventricular tachycardia. The procedure of defibrillation under hyperbaric conditions is inherently dangerous owing to the risk of fire, but it can be conducted safely if certain precautions are taken. Recently, new defibrillators have been introduced for hyperbaric medicine, which makes the procedure easier technically, but it must be noted that sparks and fire have been observed during defibrillation, even under normobaric conditions. Therefore, delivery of defibrillation shock in a hyperbaric environment must still be perceived as a hazardous procedure. Implantable devices are being seen with increasing frequency in patients referred for HBOT. These devices create a risk of malfunction when exposed to hyperbaric conditions. Some manufacturers support patients and medical practitioners with information on how their devices behave under increased pressure, but in some cases an individual risk-benefit analysis should be conducted on the patient and the specific implanted device, taking into consideration the patient's clinical condition, the indication for HBOT and the capability of the HBOT facility for monitoring and intervention in the chamber. The results of the recent survey on use of medical devices inside European hyperbaric chambers are also presented. A wide range of non-CE-certified equipment is used in European chambers.

  8. 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.

  9. 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.

  10. [Regulatory Science in the Review of Drugs and Medical Devices].

    Science.gov (United States)

    Koide, Akihiro

    2016-01-01

    The review of drugs and medical devices is an integral part of regulatory science. The Pharmaceuticals and Medical Devices Agency (PMDA) evaluates the efficacy, safety, and quality of drugs and medical devices after applications are submitted for regulatory approval. The products are approved when their benefits exceed their risks, i.e., an application is approved if the efficacy of the product in patients was demonstrated and the safety of the product is acceptable in view of its observed benefits. However, drugs and medical devices for which efficacy was not clearly demonstrated in clinical trials makes the decision to approve a difficult process. Under those circumstances, the approval process is based on the totality of information, such as the reason why clinical trials did not succeed and medical needs in Japan. The Wingspan stent system, which was approved for the treatment of intracranial arterial stenosis, is an example of a product with a use different from that intended by the US Food and Drug Administration and PMDA.

  11. Medical device related pressure ulcers in hospitalized patients.

    Science.gov (United States)

    Black, Joyce M; Cuddigan, Janet E; Walko, Maralyn A; Didier, L Alan; Lander, Maria J; Kelpe, Maureen R

    2010-10-01

    Most pressure ulcers occur over bony prominences such as heels and the sacrum. However, the National Pressure Ulcer Advisory Panel recognises that pressure ulcers can also occur on any tissue under pressure and thereby can develop beneath medical devices. This article reports on results from a secondary analysis of existing data collected by The Nebraska Medical Center on pressure ulcer quality improvement initiatives and outcomes. The purpose of this study was to quantify the extent of the problem and identify risk factors for medical device related (MDR) pressure ulcer development in hospitalised patients. A subset of data collected during eight quarterly pressure ulcer incidence and prevalence studies (N = 2178) was created and analysed. The overall rate of hospital-acquired pressure ulcers was 5·4% (113 of 2079). The proportion of patients with hospital-acquired ulcers related to medical devices was 34·5% (39 of 113). Findings indicate that if a patient had a medical device, they were 2·4 times more likely to develop a pressure ulcer of any kind. Numerous risk factors for pressure ulcer development were identified; however, none differentiated between those with MDR and traditional pressure ulcers.

  12. 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.

  13. 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.

  14. 31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.

    Science.gov (United States)

    2010-07-01

    ... Health must apply for a specific license from the Office of Foreign Assets Control. ... Relating to Money and Finance (Continued) OFFICE OF FOREIGN ASSETS CONTROL, DEPARTMENT OF THE TREASURY..., medical devices, and medical services to the Palestinian Authority Ministry of Health, provided that...

  15. 31 CFR 594.515 - In-kind donations of medicine, medical devices, and medical services.

    Science.gov (United States)

    2010-07-01

    ... Health must apply for a specific license from the Office of Foreign Assets Control. ... Relating to Money and Finance (Continued) OFFICE OF FOREIGN ASSETS CONTROL, DEPARTMENT OF THE TREASURY..., medical devices, and medical services to the Palestinian Authority Ministry of Health, provided that...

  16. 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.

  17. 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

  18. The dilemma over reprocessing single-use medical devices.

    Science.gov (United States)

    Parsons, M S

    1998-01-01

    Making informed decisions about the reuse of single-use medical devices requires considerable analysis, study and management buy-in. This article addresses such issues as the prevalence of the practice, the changing standards and guidelines, institutional responsibilities, risk and insurance concerns and the ethical issues posed by the concept of reuse.

  19. 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...

  20. 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.

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

    Science.gov (United States)

    Thurow, Kerstin; Stoll, Regina

    2017-01-01

    Objectives Wearable devices are currently at the heart of just about every discussion related to the Internet of Things. The requirement for self-health monitoring and preventive medicine is increasing due to the projected dramatic increase in the number of elderly people until 2020. Developed technologies are truly able to reduce the overall costs for prevention and monitoring. This is possible by constantly monitoring health indicators in various areas, and in particular, wearable devices are considered to carry this task out. These wearable devices and mobile apps now have been integrated with telemedicine and telehealth efficiently, to structure the medical Internet of Things. This paper reviews wearable health care devices both in scientific papers and commercial efforts. Methods MIoT is demonstrated through a defined architecture design, including hardware and software dealing with wearable devices, sensors, smart phones, medical application, and medical station analyzers for further diagnosis and data storage. Results Wearables, with the help of improved technology have been developed greatly and are considered reliable tools for long-term health monitoring systems. These are applied in the observation of a large variety of health monitoring indicators in the environment, vital signs, and fitness. Conclusions Wearable devices are now used for a wide range of healthcare observation. One of the most important elements essential in data collection is the sensor. During recent years with improvement in semiconductor technology, sensors have made investigation of a full range of parameters closer to realization. PMID:28261526

  2. The radiation resistance of the bioburden from medical devices

    Energy Technology Data Exchange (ETDEWEB)

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

    1998-06-01

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

  3. Tunable Ultrasonic Energy Harvesting for Implantable Biosensors and Medical Devices

    Science.gov (United States)

    Pellegrino, M.; Eovino, B. E.; Beker, L.; Bourouina, T.; Lin, L.

    2016-11-01

    This work reports a tunable ultrasonic energy harvesting (UEH) device capable of high power output and/or large bandwidth based on concentric piezoelectric ring-shaped structures. Two different designs are presented: (1) the single ring-shaped UEH (r-UEH), and (2) concentric r-UEHs. Concentric r-UEHs can save space and therefore can provide benefits in powering low-power implantable biosensors and medical devices. This paper presents results of simulation studies and initial experiments of a single r-UEH.

  4. Career development of biomedical engineers in medical device industry.

    Science.gov (United States)

    Ni, Quan; Pu, Yachuan

    2009-01-01

    With concerns of the current health care system, biomedical engineers have expertise, opportunity and responsibility in developing innovations that may improve cost, coverage and quality of health care delivery. This paper reviews the product development process in the medical device industry, and the associated training and experience required for biomedical engineers involved at each stage of the process. This paper also provides personal perspectives of some of the differences between established device companies and start-ups in the product development process and career paths for biomedical engineers.

  5. 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.

  6. Heparin coatings for improving blood compatibility of medical devices.

    Science.gov (United States)

    Biran, Roy; Pond, Daniel

    2016-12-29

    Blood contact with biomaterials triggers activation of multiple reactive mechanisms that can impair the performance of implantable medical devices and potentially cause serious adverse clinical events. This includes thrombosis and thromboembolic complications due to activation of platelets and the coagulation cascade, activation of the complement system, and inflammation. Numerous surface coatings have been developed to improve blood compatibility of biomaterials. For more than thirty years, the anticoagulant drug heparin has been employed as a covalently immobilized surface coating on a variety of medical devices. This review describes the fundamental principles of non-eluting heparin coatings, mechanisms of action, and clinical applications with focus on those technologies which have been commercialized. Because of its extensive publication history, there is emphasis on the CARMEDA(®) BioActive Surface (CBAS(®) Heparin Surface), a widely used commercialized technology for the covalent bonding of heparin.

  7. 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%.

  8. Auctions vs. Bargaining: An Empirical Analysis of Medical Device Procurement

    OpenAIRE

    Andrea Bonaccorsi; Thomas Lyon; Fabio Pammolli; Giuseppe Turchetti

    1999-01-01

    We test recent theory on the benefits of auctions and bargaining as alternative procurement mechanisms using data on the procurement of medical devices by Italian hospitals. Theory suggests that auctions perform well when cost control is the key concern, but are less effective at producing the optimal mix of quality and price for complex products where quality is difficult to verify. Consistent with the theory, we find that auctions are used more often when the influence of financial staff re...

  9. The role of user requirements research in medical device development

    OpenAIRE

    Shah, A; Alshawi, S

    2010-01-01

    Aims and Objectives: This research aims to suggest a concise framework to help in the better conceptualisation and integration of users in the medical device development (MDD) process. The current economic, political and social climate concerning the matter of healthcare delivery has resulted in the emergence of numerous users and user groups for whom the healthcare system has not previously catered for. These users have created ambiguity for the designers and manufacturers of ...

  10. 77 FR 19293 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Meeting

    Science.gov (United States)

    2012-03-30

    ... osteoarthritis, avascular necrosis, post-traumatic arthritis, ankylosis, protrusio acetabuli, and painful hip...: a. Non-inflammatory degenerative arthritis such as osteoarthritis, traumatic arthritis, avascular... Panel of the Medical Devices Advisory Committee beginning on March 30, 2012, and closing on May 9,...

  11. 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...

  12. 78 FR 25747 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2013-05-02

    ... 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...

  13. 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...

  14. 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...

  15. 76 FR 65200 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee: Notice of...

    Science.gov (United States)

    2011-10-20

    ... 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... and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee scheduled for December...

  16. 75 FR 1395 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...

    Science.gov (United States)

    2010-01-11

    ... 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... the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee. This...

  17. 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...: In the Federal Register of August 16, 2010, FDA announced that a meeting of the General and...

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

    Science.gov (United States)

    Luttge, Regina

    2010-03-01

    Using lithographic patterning techniques, normally we aim for the integration of structural elements into a more complex apparatus, which can be at various length scales, for example hand-held equipment. Nanoscale fabricated pillars, holes or wires have shown unique properties already and ordering these in specific arrangements results in novel phenomena normally not present in natural occuring materials. Such materials are called nanoarrays. Engineered nanoarrays belong therefore to the class of metamaterials. One example of a metamaterial is a material with a negative refractive index created by design of artificial structure. These exciting material properties bring about also new opportunities for applications. A functional device or system demanding some level of ordering in a material also requires a carefully designed manufacturing process. Here, we will present an overview of nanolithographic techniques for oxide nanoarrays. Bio-inspired templated nanoarrays will be described in perspective to other nanolithography techniques. These nanostructures can deliver new functionality, too. Moreover, (nano)structured materials can deliver specific functionality at the interface with biological material. Developing these materials, subsequently, we can look for medical applications where the properties of oxide nanoarrays are explored. Photonic crystals, for example, can be applied in medical diagnostic devices. In this paper, therefore oxide nanoarrays are introduced and the emerging technology for modification and tuning of medical device performance utilizing oxide nanoarrays is discussed.

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

    Directory of Open Access Journals (Sweden)

    Pablo Darscht

    2011-05-01

    Full Text Available Estudio de caso del Centro de Cardioestimuladores del Uruguay - CCC Medical Devices preparado a solicitud de Ingenio en el marco del proyecto financiado por la Iniciativa para Incubadoras de InfoDev - Grupo Banco Mundial. Este estudio detalla los pasos seguidos por una empresa nacional con un fuerte factor de innovación y los cambios producidos en el entorno de los negocios de la empresa. El comienzo de una pequeña empresa de marcapasos que tras pasar por diferentes etapas hoy gana mercados en el área de ingeniería para dispositivos médicos para diferentes empresas de investigación biomédica a nivel internacional.AbstractCase study of the Centro de Cardioestimuladores del Uruguay - CCC Medical Devices prepared on behalf of Ingenio within the project financed by de Incubator Initiative of InfoDev-World Bank Group. This study refers to the steps followed by a highly innovative local company and to the changes in its business environment. The start up of a small pacemakers company that after going through different stages is presently increasing its market share in the area of engineering of medical devices for biomedic research companies worldwide.

  20. 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.

  1. Antimicrobial selenium nanoparticle coatings on polymeric medical devices.

    Science.gov (United States)

    Tran, Phong A; Webster, Thomas J

    2013-04-19

    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.

  2. 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.

  3. US Food and Drug Administration Regulation of Medical Devices and Radiation Oncology: Can Reform Improve Safety?

    OpenAIRE

    Hattangadi, Jona A.; O'Reilly, James T.; Recht, Abram

    2011-01-01

    A review of the issues involved in medical device regulation in radiation oncology, including a general review of federal medical device regulation and explanations of the legal and regulatory framework.

  4. Nanostructured selenium for preventing biofilm formation on polycarbonate medical devices.

    Science.gov (United States)

    Wang, Qi; Webster, Thomas J

    2012-12-01

    Biofilms are a common cause of persistent infections on medical devices as they are easy to form and hard to treat. The objective of this study was for the first time to coat selenium (a natural element in the body) nanoparticles on the surface of polycarbonate medical devices (such as those used for medical catheters) and to examine their effectiveness at preventing biofilm formation. The size and distribution of selenium coatings were characterized using scanning electron microscopy and atomic force microscopy. The strength of the selenium coating on polycarbonate was assessed by tape-adhesion tests followed by atomic absorption spectroscopy. Results showed that selenium nanoparticles had a diameter of 50-100 nm and were well distributed on the polycarbonate surface. In addition, more than 50% of the selenium coating survived the tape-adhesion test as larger nanoparticles had less adhesion strength to the underlying polycarbonate substrate than smaller selenium nanoparticles. Most significantly, the results of this in vitro study showed that the selenium coatings on polycarbonate significantly inhibited Staphylococcus aureus growth to 8.9% and 27% when compared with an uncoated polycarbonate surface after 24 and 72 h, respectively. Importantly, this was accomplished without using antibiotics but rather with an element (selenium) that is natural to the human body. Thus, this study suggests that coating polymers (particularly, polycarbonate) with nanostructured selenium is a fast and effective way to reduce bacteria functions that lead to medical device infections. © 2012 Wiley Periodicals, Inc. J Biomed Mater Res Part A: 100A: 3205-3210, 2012.

  5. 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.

  6. An example of US Food and Drug Administration device regulation: medical devices indicated for use in acute ischemic stroke.

    Science.gov (United States)

    Peña, Carlos; Li, Khan; Felten, Richard; Ogden, Neil; Melkerson, Mark

    2007-06-01

    The Food and Drug Administration has established requirements for protecting the public health by assuring the safety and effectiveness of a variety of medical products including drugs, devices, and biological products, and for promoting public health by expediting the approval of treatments that are safe and effective. The Center for Devices and Radiological Health is the center within the agency that is responsible for pre- and postmarket regulation of medical devices. In this article, we review current regulation of medical devices, research and development programs, pre- and postmarket perspectives, and future considerations of medical devices, particularly as they relate to devices targeting acute ischemic stroke as an example of the process. We also review the Center for Devices and Radiological Health's historical perspective of acute ischemic stroke trials and clinical trial design considerations used in prior studies that have led to US market clearance as they are related to currently marketed devices indicated for acute ischemic stroke.

  7. [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.

  8. 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...

  9. 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.

  10. 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.

  11. 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.

  12. 75 FR 17143 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Science.gov (United States)

    2010-04-05

    ... Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Documents; Availability... physical medicine devices. FDA has developed a draft special controls guidance document for each of the 11... Guidance Document: Transcutaneous Electrical Stimulator for Aesthetic Purposes; Draft Guidance for...

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

    Science.gov (United States)

    Donovan, Aine; Kaplan, Aaron V

    2012-01-01

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

  14. 10 CFR 35.49 - Suppliers for sealed sources or devices for medical use.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Suppliers for sealed sources or devices for medical use. 35.49 Section 35.49 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL General Administrative Requirements § 35.49 Suppliers for sealed sources or devices for medical use. For medical use,...

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

    Science.gov (United States)

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

    2014-01-01

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

  16. 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

  17. Surgical hemostatic agents: assessment of drugs and medical devices.

    Science.gov (United States)

    Aubourg, R; Putzolu, J; Bouche, S; Galmiche, H; Denis, C; d'Andon, A; Maitrot, D; Partensky, C

    2011-12-01

    Surgical hemostatic agents are indicated to improve hemostasis when conventional techniques (compression, sutures or electrocoagulation) are inadequate. The National French Authority for Health (Haute Autorité de santé [HAS]) set out to assess these products (medical devices and agents) to determine their optimal utility. This evaluation included one class of products containing some form of human fibrinogen and thrombin and eight classes of medical devices and automated devices to prepare autologous fibrin. The assessment was based on a systematic review of the literature and expert opinion of health care professionals. The main measures of effectiveness of hemostatic agents were the success rate as expressed in terms of the time necessary to obtain adequate hemostasis, the volume of intra and/or postoperative blood loss, the need for blood transfusions, complication rate, duration of operations and hospital stay. A meta-analysis and 52 controlled randomized studies were selected involving cardiac or vascular surgery (19), ENT surgery (11), gastrointestinal surgery (5), urology (4), orthopedic surgery (4). Approximately half of the studies retained in this analysis evaluated blood derived agents (fibrin sealants) while the other half evaluated medical devices. The working group considered that there is not any evidence that these surgical hemostatic agents decrease the rates of transfusion, complications, reoperation, mortality, duration of operation and/or hospital stay. The working group considered that the use of surgical hemostatic agents to improve the safety of hemostasis in the absence of identified bleeding as an alternative to adequate conventional hemostasis was not justified. Surgical hemostatic agents can be used in ad hoc settings, as a complement to conventional methods to control persistent bleeding after conventional hemostatic techniques, or when abundant bleeding has led to biologic hemostatic disorders. The working group also distinguished

  18. Methodological choices for the clinical development of medical devices

    Directory of Open Access Journals (Sweden)

    Bernard A

    2014-09-01

    Full Text Available Alain Bernard,1 Michel Vaneau,2 Isabelle Fournel,3 Hubert Galmiche,2 Patrice Nony,4,5 Jean Michel Dubernard6 1Department of Thoracic Surgery CHU Bocage, Dijon, France; 2Department for Assessment of Medical Devices, HAS (French National Authority of Health, Saint-Denis La Plaine, France; 3Centre of Epidemiology of the Populations, Burgundy University, Dijon, France; 4Department of Clinical Pharmacology, Lyon University CNRS, Lyon, France; 5Laboratory of Biometry and Biology, CNRS, Lyon, France; 6HAS Board (French National Authority of Health, Saint-Denis La Plaine, France Abstract: Clinical evidence available for the assessment of medical devices (MDs is frequently insufficient. New MDs should be subjected to high quality clinical studies to demonstrate their benefit to patients. The randomized controlled trial (RCT is the study design reaching the highest level of evidence in order to demonstrate the efficacy of a new MD. However, the clinical context of some MDs makes it difficult to carry out a conventional RCT. The objectives of this review are to present problems related to conducting conventional RCTs and to identify other experimental designs, their limitations, and their applications. A systematic literature search was conducted for the period January 2000 to July 2012 by searching medical bibliographic databases. Problems related to conducting conventional RCTs of MDs were identified: timing the assessment, eligible population and recruitment, acceptability, blinding, choice of comparator group, and learning curve. Other types of experimental designs have been described. Zelen's design trials and randomized consent design trials facilitate the recruitment of patients, but can cause ethical problems to arise. Expertise-based RCTs involve randomization to a team that specializes in a given intervention. Sometimes, the feasibility of an expertise-based randomized trial may be greater than that of a conventional trial. Cross-over trials

  19. 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...

  20. Integrated Forest Management Charter

    Energy Technology Data Exchange (ETDEWEB)

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

    2015-08-24

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

  1. Pediatric medical devices: a look at significant US legislation to address unmet needs.

    Science.gov (United States)

    Samuels-Reid, Joy H; Blake, Erica D

    2014-03-01

    There are many barriers to the availability of medical devices intended for the pediatric population causing healthcare providers to use creative measures to address pediatric unmet device needs. The USA has taken significant legislative measures to spur medical device development and address the unmet needs in all pediatric subpopulations. For example, the Medical Device User Fee and Modernization Act of 2002 amended the Federal Food Drug and Cosmetic Act by adding new provisions intended to promote the development of safe and effective pediatric devices, and to protect the pediatric population during clinical trials. In 2004, the Medical Devices Technical Corrections Act was added to address potential difficulties in bringing pediatric devices to the market. Further, the Pediatric Medical Device Safety and Improvement Act of 2007 and the Food and Drug Administration Amendments Act of 2007 provided the FDA significant new responsibilities and authorities regarding pediatric use.

  2. 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...

  3. Missing data handling methods in medical device clinical trials.

    Science.gov (United States)

    Yan, Xu; Lee, Shiowjen; Li, Ning

    2009-11-01

    One of the major problems in the analysis of clinical trials is missing data caused by patients dropping out before study completion. The issue of missing data can result in biased treatment comparisons and can impact the interpretation of study results. Since the missing data mechanism is unknown and unverifiable in most situations, regulatory agencies often request various sensitivity analyses for handling missing data to evaluate the robustness of study results. This article discusses methods used to handle missing data in medical device clinical trials, focusing on tipping-point analysis as a general approach for the assessment of missing data impact. Tipping points are outcomes that result in a change of study conclusion. Such outcomes can be conveyed to clinical reviewers to determine if they are implausibly unfavorable. The analysis aids clinical reviewers in making judgment regarding treatment effect in the study. Three examples with a reasonably representative range of missing data rate are included to illustrate the methods referred.

  4. 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.

  5. Large Eddy Simulation of FDA's Idealized Medical Device.

    Science.gov (United States)

    Delorme, Yann T; Anupindi, Kameswararao; Frankel, Steven H

    2013-12-01

    A hybrid large eddy simulation (LES) and immersed boundary method (IBM) computational approach is used to make quantitative predictions of flow field statistics within the Food and Drug Administration's (FDA) idealized medical device. An in-house code is used, hereafter (W enoHemo(™) ), that combines high-order finite-difference schemes on structured staggered Cartesian grids with an IBM to facilitate flow over or through complex stationary or rotating geometries and employs a subgrid-scale (SGS) turbulence model that more naturally handles transitional flows [2]. Predictions of velocity and wall shear stress statistics are compared with previously published experimental measurements from Hariharan et al. [6] for the four Reynolds numbers considered.

  6. 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.

  7. Design of a computer program for the registration of implantable medical device, field safety corrective action and advers events, as a tool for medical device surveillance

    Directory of Open Access Journals (Sweden)

    Juan Francisco Márquez-Peiró

    2016-03-01

    Full Text Available Objective: To describe the features of computer program to support the activity of the responsible for surveillance of medical devices. To evaluate their use after one year of implementation in a hospital. Method: The stages of the process were: description of the activities of medical devices surveillance and implant registration, definition of functionality and data processing, creation of databases, implementation in a private hospital which manages PS, validation of the program and analysis of their usefulness. Results: SIVIPS was developed using Acces®. Main variables were described for all the activities of the responsible for medical device surveillance (implants, alert, medical device incidents, including for in vitro diagnostics and all the functionalities of the computer program. SIVIPS was introduced in a pharmacy service with one pharmacist for the management of medical devices. One year after its implementation we had registered 564 implants with a description by type of implant, 31 alerts and 6 incidents. SIVIPS allow monitoring of the actions taken in these cases. Conclusions: SIVIPS® is the first tool to support the activity of medical device surveillance. It is an easy tool that allows the registration of alerts and medical device related incidents, and registration of implants performed in the center, which will improve the traceability of the PS.

  8. 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

  9. [Perspectives on the development of quality management system for medical devices in China from the GMP aspects].

    Science.gov (United States)

    Jiang, Haihong

    2011-03-01

    The full implementation of GMP for medical devices, which is an important step to improve quality management system of medical devices production, will have a positive impact on the quality management system of medical device. It will improve and promote the development of quality management system for medical device, by updating the idea and rebuilding the frame and optimizing the contents.

  10. 76 FR 48169 - Advancing Regulatory Science for Highly Multiplexed Microbiology/Medical Countermeasure Devices...

    Science.gov (United States)

    2011-08-08

    ... following public meeting: ``Advancing Regulatory Science for Highly Multiplexed Microbiology/Medical... microbiology/MCM devices. The ultimate goal is to advance regulatory science for highly multiplexed devices... HUMAN SERVICES Food and Drug Administration Advancing Regulatory Science for Highly...

  11. 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 charter...

  12. 76 FR 67463 - Pediatric Medical Devices; Public Workshop; Request for Comments

    Science.gov (United States)

    2011-11-01

    ... diseases and conditions occurring from birth through the 21st year of life. Some devices are designed... for more general use. Designing pediatric medical devices can be challenging; children are often... children may be long-term device users--bringing new concerns about device longevity and long-...

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

    Science.gov (United States)

    2011-11-21

    ... paper entitled ''Advancing Regulatory Science for Highly Multiplexed Microbiology/Medical Countermeasure... the ``Advancing Regulatory Science for Highly Multiplexed Microbiology/Medical Countermeasure Devices... HUMAN SERVICES Food and Drug Administration Advancing Regulatory Science for Highly...

  14. 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…

  15. 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…

  16. Devices for medical diagnosis with GaN lasers

    Science.gov (United States)

    Kwasny, Miroslaw; Mierczyk, Zygmunt

    2003-10-01

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

  17. Methodological choices for the clinical development of medical devices.

    Science.gov (United States)

    Bernard, Alain; Vaneau, Michel; Fournel, Isabelle; Galmiche, Hubert; Nony, Patrice; Dubernard, Jean Michel

    2014-01-01

    Clinical evidence available for the assessment of medical devices (MDs) is frequently insufficient. New MDs should be subjected to high quality clinical studies to demonstrate their benefit to patients. The randomized controlled trial (RCT) is the study design reaching the highest level of evidence in order to demonstrate the efficacy of a new MD. However, the clinical context of some MDs makes it difficult to carry out a conventional RCT. The objectives of this review are to present problems related to conducting conventional RCTs and to identify other experimental designs, their limitations, and their applications. A systematic literature search was conducted for the period January 2000 to July 2012 by searching medical bibliographic databases. Problems related to conducting conventional RCTs of MDs were identified: timing the assessment, eligible population and recruitment, acceptability, blinding, choice of comparator group, and learning curve. Other types of experimental designs have been described. Zelen's design trials and randomized consent design trials facilitate the recruitment of patients, but can cause ethical problems to arise. Expertise-based RCTs involve randomization to a team that specializes in a given intervention. Sometimes, the feasibility of an expertise-based randomized trial may be greater than that of a conventional trial. Cross-over trials reduce the number of patients, but are not applicable when a learning curve is required. Sequential trials have the advantage of allowing a trial to be stopped early depending on the results of first inclusions, but they require an independent committee. Bayesian methods combine existing information with information from the ongoing trial. These methods are particularly useful in situations where the number of subjects is small. The disadvantage is the risk of including erroneous prior information. Other types of experimental designs exist when conventional trials cannot always be applied to the

  18. 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.

  19. 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...

  20. 75 FR 47606 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2010-08-06

    ... 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.... ACTION: Notice. SUMMARY: The meeting of the General and Plastic Surgery Devices Panel of the...

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

    Science.gov (United States)

    Smith, Colleen

    2015-01-01

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

  2. Introduction to patent strategies for medical device inventions.

    Science.gov (United States)

    Gutman, Siegmond Y; Capraro, Joe; Chen, Tom

    2016-11-01

    Siegmund Gutman is the Chair of the Life Sciences Patent practice and a partner at the global law firm of Proskauer Rose LLP. Siegmund's practice focuses on developing and executing business-oriented patent strategies for medical device, biotechnology, and biopharmaceutical clients, including early-stage and mature companies, as well as academic and other research organizations. His background combines a graduate degree in biophysical chemistry and molecular and cell biology with more than 25 years of experience in the life sciences industry, including serving as senior counsel at Amgen. Joe Capraro is a partner and the Boston Office Head at the law firm of Proskauer Rose LLP. Joe has more than 25 years of experience advising start-ups and established companies on intellectual property issues. Joe has amassed broad intellectual property and transactional experience over the years and provides clients with practical, business-oriented advice. Tom Chen is a senior associate in the Los Angeles office of Proskauer Rose LLP, where his practice focuses on patent litigation and counseling in the life sciences sector. Tom holds an A.B. in chemistry and pharmacology from Duke University, and an M.S. in biotechnology from Johns Hopkins University. Prior to joining Proskauer, Tom previously served as a judicial law clerk for the Honorable Alvin A. Schall of the U.S. Court of Appeals for the Federal Circuit, and the Honorable Leonard P. Stark of the U.S. District Court for the District of Delaware.

  3. 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.

  4. 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

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

    Science.gov (United States)

    2014-10-01

    Society of Anesthesiology Newsletter 70:5, May 2006. 3. Goldman JM, “Patient-Centric Networked Medical Device Interoperability,” part of Dagalakis NG...Interoperability Movement,” Anesthesiology News 34:12, December 2008. 19. Johnson C, “Medical devices lag in iPod age,” The Boston Globe, December 29 2008. 20

  7. Evaluating the Safety Profile of Non-Active Implantable Medical Devices Compared with Medicines

    NARCIS (Netherlands)

    Pane, J. (Josep); P.M. Coloma (Preciosa); K.M.C. Verhamme (Katia); M.C.J.M. Sturkenboom (Miriam); Rebollo, I. (Irene)

    2017-01-01

    textabstractRecent safety issues involving non-active implantable medical devices (NAIMDs) have highlighted the need for better pre-market and post-market evaluation. Some stakeholders have argued that certain features of medicine safety evaluation should also be applied to medical devices. Our obje

  8. 75 FR 391 - Medical Device Quality System Regulation Educational Forum on Risk Management Through the Product...

    Science.gov (United States)

    2010-01-05

    ... No. FDA-2009-N-0664] Medical Device Quality System Regulation Educational Forum on Risk Management... System Regulation Educational Forum on Risk Management through the Product Life Cycle.'' This public workshop is intended to provide information about FDA's Medical Device Quality Systems Regulation (QSR)...

  9. 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...

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

    NARCIS (Netherlands)

    Römer, GertWillem R.B.E.; Stuyt, Harry J.A.

    2007-01-01

    Medical devices produced by manufacturers are subject to regulatory review by authorities. Usually, medical devices are developed at universities and other research institutes. This implies that regulatory activities are to be carried out by the designer at these organizations also. And as early as

  11. [Licensing of Pharmaceuticals and Medical Devices in Germany: Weaknesses and Opportunities].

    Science.gov (United States)

    Reinhardt, D; Wildner, M

    2016-12-01

    The purpose of this study is to describe and compare the licensing of pharmaceuticals and medical devices in Germany. Weaknesses and opportunities of the respective processes are identified. Methods: To describe and compare the two approaches, a systematic literature review was conducted, followed by an archival analysis, guided by experts. Unstructured interviews were conducted with experts (users, financers, surveillants and producers) personally or by telephone to identify weaknesses and opportunities. The data were evaluated by content analysis according to Mayring and MAXQDA 11. The results were critically assessed by comparing them with the current academic literature. Results: A central market authorization for medical devices was mentioned often, but seems politically not viable. However, quality, methodology and depth of the analyses necessary for the licensing of medical devices, especially for high-risk devices, can and should strive for higher standards, comparable to those of pharmaceuticals. With regard to post-market surveillance, the systems for both pharmaceuticals and medical devices should be improved. Innovativeness and competitiveness of European medical device manufacturers should not be promoted by reduced evidence standards and patient safety. Subsidies or easier licensing procedures for small product lines with particular importance for public health, similar to orphan drug regulations, are more desirable. Conclusion: This study helps to identify areas of improvement for licensing of pharmaceuticals and medical devices. Concrete recommendations were developed. Higher evidence standards should be mandatory especially for high-risk devices, comparable to those of pharmaceuticals. Post-marketing surveillance should be improved for pharmaceuticals and medical devices.

  12. Improving the Methods for the Economic Evaluation of Medical Devices.

    Science.gov (United States)

    Tarricone, Rosanna; Callea, Giuditta; Ogorevc, Marko; Prevolnik Rupel, Valentina

    2017-02-01

    Medical devices (MDs) have distinctive features, such as incremental innovation, dynamic pricing, the learning curve and organisational impact, that need to be considered when they are evaluated. This paper investigates how MDs have been assessed in practice, in order to identify methodological gaps that need to be addressed to improve the decision-making process for their adoption. We used the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist supplemented by some additional categories to assess the quality of reporting and consideration of the distinctive features of MDs. Two case studies were considered: transcatheter aortic valve implantation (TAVI) representing an emerging technology and implantable cardioverter defibrillators (ICDs) representing a mature technology. Economic evaluation studies published as journal articles or within Health Technology Assessment reports were identified through a systematic literature review. A total of 19 studies on TAVI and 41 studies on ICDs were analysed. Learning curve was considered in only 16% of studies on TAVI. Incremental innovation was more frequently mentioned in the studies of ICDs, but its impact was considered in only 34% of the cases. Dynamic pricing was the most recognised feature but was empirically tested in less than half of studies of TAVI and only 32% of studies on ICDs. Finally, organisational impact was considered in only one study of ICDs and in almost all studies on TAVI, but none of them estimated its impact. By their very nature, most of the distinctive features of MDs cannot be fully assessed at market entry. However, their potential impact could be modelled, based on the experience with previous MDs, in order to make a preliminary recommendation. Then, well-designed post-market studies could help in reducing uncertainties and make policymakers more confident to achieve conclusive recommendations. © 2017 The Authors. Health Economics published by John Wiley & Sons, Ltd.

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

    OpenAIRE

    Ross JS; Blount KL; Ritchie JD; Hodshon B; Krumholz HM

    2015-01-01

    Joseph S Ross, Katrina L Blount, Jessica D Ritchie, Beth Hodshon, Harlan M Krumholz Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA Background: In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA) to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate po...

  14. 78 FR 14013 - Medical Devices; Exemption From Premarket Notification; Class II Devices; Wheelchair Elevator

    Science.gov (United States)

    2013-03-04

    ... Notification; Class II Devices; Wheelchair Elevator AGENCY: Food and Drug Administration, HHS. ACTION: Final... requesting exemption from premarket notification requirements for wheelchair elevator devices commonly known... another, usually in a wheelchair. This order exempts wheelchair elevators, class II devices,...

  15. 78 FR 58316 - Complex Issues in Developing Medical Devices for Pediatric Patients Affected by Rare Diseases...

    Science.gov (United States)

    2013-09-23

    ... workshop will help in developing a strategic plan to encourage and accelerate the development of new... medical devices for pediatric clinical practice; Humanitarian Device Exemption (HDE) marketing pathway... OOPD's functions is to designate devices as HUDs, which allows them to be eligible for...

  16. 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...

  17. Materials degradation in PVC medical devices, DEHP leaching and neonatal outcomes.

    Science.gov (United States)

    Latini, G; Ferri, M; Chiellini, F

    2010-01-01

    Polymeric materials play a key role in the production of medical and clinical devices thanks to their special features such as flexibility, easy processing and good price/performance ratio. Among the different polymeric matrixes, one of the most used is Poly(vinyl chloride) (PVC). At room temperature PVC is hard and brittle, thus great amounts (40-50%) of phthalate esters that act as plasticizers are added to the polymer to make it flexible and appropriate for medical use. Di-(2-ethylhexyl)-phthalate (DEHP) is the most widely used plasticizer in PVC medical devices. However, DEHP is not chemically bound to PVC and migrates from medical devices with time and use. The potential for DEHP to produce adverse effects in humans has been the subject of considerable discussion and debate in the scientific community. In particular, newborns in the new environment have to be considered at particularly increased risk, because of their small body size and the multiple medical device-related to the DEHP exposure. The major factors determining the degree to which DEHP migrates from medical devices are temperature, amount of DEHP in the device, storage time, shaking of the device while in contact with the medical solutions and degree of PVC degradation.

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

    Science.gov (United States)

    Carey, Jennifer L; Nader, Nathalie; Chai, Peter R; Carreiro, Stephanie; Griswold, Matthew K; Boyle, Katherine L

    2017-01-01

    A large number of medications and medical devices removed from the market by the US Food and Drug Administration over the past 4 decades specifically posed greater health risks to women. This article reviews the historical background of sex and gender in clinical research policy and describes several approved drugs and devices targeted for use in women that have caused major morbidity and mortality. The intended population for the medications and devices, population affected, approval process, and the basic and legal actions taken against the medication/drug company are also discussed. It is recognized that women are still at risk for harm from unsafe medications and devices, and continued improvements in legislation that promotes inclusion of sex and gender into the design and analysis of research will improve safety for both men and women.

  19. 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

  20. [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.

  1. Medical devices for restless legs syndrome - clinical utility of the Relaxis pad.

    Science.gov (United States)

    Mitchell, Ulrike H

    2015-01-01

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

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

    Science.gov (United States)

    Liu, Long; Shuai, Ma; Wang, Zhu; Li, Ping

    2012-01-01

    In order to effectively analyze and control use-related risk of medical devices, quantitative methodologies must be applied. Failure Mode and Effects Analysis (FMEA) is a proactive technique for error detection and risk reduction. In this article, an improved FMEA based on Fuzzy Mathematics and Grey Relational Theory is developed to better carry out user-related risk analysis for medical devices. As an example, the analysis process using this improved FMEA method for a certain medical device (C-arm X-ray machine) is described.

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

    CERN Document Server

    Abuhav, Itay

    2011-01-01

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

  4. 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...

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

    CERN Document Server

    Gad, Shayne C

    2008-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Maresova P

    2015-10-01

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

  7. 78 FR 14015 - Medical Devices; Exemption From Premarket Notification; Class II Devices; Powered Patient Transport

    Science.gov (United States)

    2013-03-04

    ... Notification; Class II Devices; Powered Patient Transport AGENCY: Food and Drug Administration, HHS. ACTION... requesting exemption from premarket notification requirements for powered patient transport devices commonly... FDA's powered patient transport regulations, including attendant-operated portable...

  8. 78 FR 77689 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2013-12-24

    ... FDA on April 9, 2009 , relating to the regulatory classification of iontophoresis devices, one of the remaining preamendments class III devices. Iontophoresis is a method of non- invasive transdermal delivery.... Iontophoresis devices generally consist of a controller, active and return electrode(s), and power supply...

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

    Science.gov (United States)

    2013-01-07

    ... caregivers, and patients themselves. As more medical devices migrate out of clinical care environments and... Labeling 1. Review the outline for a draft standard content and format of medical device labeling. 2... HUMAN SERVICES Food and Drug Administration Accessible Medical Device Labeling in a Standard Content...

  11. 34 CFR 300.113 - Routine checking of hearing aids and external components of surgically implanted medical devices.

    Science.gov (United States)

    2010-07-01

    ... components of surgically implanted medical devices. 300.113 Section 300.113 Education Regulations of the... surgically implanted medical devices. (a) Hearing aids. Each public agency must ensure that hearing aids worn...) External components of surgically implanted medical devices. (1) Subject to paragraph (b)(2) of...

  12. 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...

  13. Additive manufacturing of polymer melts for implantable medical devices and scaffolds.

    Science.gov (United States)

    Youssef, Almoatazbellah; Hollister, Scott J; Dalton, Paul D

    2017-02-28

    Melt processing is routinely used to fabricate medical polymeric devices/implants for clinical reconstruction and can be incorporated into quality systems procedures for medical device manufacture. As additive manufacturing (AM) becomes increasingly used for biomaterials and biofabrication, the translation of new, customizable, medical devices to the clinic becomes paramount. Melt processing is therefore a distinguishable group within AM that provides an avenue to manufacture scaffolds/implants with a clinical end-point. Three key melt processing AM technologies are highlighted in this review: melt micro-extrusion, selective laser sintering and melt electrospinning writing. The in vivo (including clinical) outcomes of medical devices and scaffolds made with these processes are reviewed. Together, they encompass the melt AM of scaffold architectures with feature sizes and resolutions ranging from 800 nm up to 700 μm.

  14. 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

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

    Science.gov (United States)

    ... Home Healthcare Medical Devices: Infusion Therapy - Getting the Most Out of Your Pump Share Tweet Linkedin Pin ... and accessories schedule routine maintenance What are the most common problems with an infusion pump and how ...

  16. 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...

  17. 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...

  18. 78 FR 30928 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2013-05-23

    ... 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...

  19. 76 FR 62419 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2011-10-07

    ... 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...

  20. 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...

  1. 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...

  2. 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...

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

    Science.gov (United States)

    2010-08-16

    ... 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. Interconnections of basic science research and product development in medical device design.

    Science.gov (United States)

    Privitera, Mary Beth; Design, M; Johnson, Jeffrey

    2009-01-01

    The relationship between basic science research and product design/development are intertwined. This paper explores the definition of basic science and design as it relates to medical device development. It is intended to serve as a reference for both researchers and device developers to assist in trans-disciplinary collaborative efforts in improving patient care as each are of equal importance. The definition of a medical device is broad and varied. This paper is aimed towards those devices which interact with tissue and are rooted in the tenets of science. Both the scientific method and the design process are compared with similarities and opposites identified. The paper concludes identifying fundamental principles of medical device development and highlights the importance of both entities.

  5. Using off-the-shelf medical devices for biomedical signal monitoring in a telemedicine system for emergency medical services.

    Science.gov (United States)

    Thelen, Sebastian; Czaplik, Michael; Meisen, Philipp; Schilberg, Daniel; Jeschke, Sabina

    2015-01-01

    In order to study new methods of telemedicine usage in the context of emergency medical services, researchers need to prototype integrated telemedicine systems. To conduct a one-year trial phase-intended to study a new application of telemedicine in German emergency medical services-we used off-the-shelf medical devices and software to realize real-time patient monitoring within an integrated telemedicine system prototype. We demonstrate its feasibility by presenting the integrated real-time patient monitoring solution, by studying signal delay and transmission robustness regarding changing communication channel characteristics, and by evaluating issues reported by the physicians during the trial phase. Where standards like HL7 and the IEEE 11073 family are intended to enable interoperability of product grade medical devices, we show that research prototypes benefit from the use of web technologies and simple device interfaces, as they simplify product development for a manufacturer and ease integration efforts for research teams. Embracing this approach for the development of new medical devices eases the constraint to use off-the-shelf products for research trials investigating innovative use of telemedicine.

  6. 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...

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

    Science.gov (United States)

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

    2013-01-01

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

  8. 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

  9. 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 

  10. 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”....

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

    Science.gov (United States)

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

    2015-06-01

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

  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. Charter Schools and Democratic Accountability

    Science.gov (United States)

    Henig, Jeffrey R.

    2017-01-01

    In this article, Jeffrey R. Henig states that there is no strong accountability at charter schools without the strong oversight of public officials. When charter schooling first erupted on the scene, policymakers and citizens had little choice but to base their reactions on theory, ideology, or hunch. However twenty-five years in, there is still…

  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; 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.

  17. Medical Devices; Cardiovascular Devices; Classification of the Steerable Cardiac Ablation Catheter Remote Control System. Final order.

    Science.gov (United States)

    2015-09-30

    The Food and Drug Administration (FDA) is classifying the steerable cardiac ablation catheter remote control 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 steerable cardiac ablation catheter remote control 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.

  18. 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.

  19. Medical devices; gastroenterology-urology devices; classification of the colon capsule imaging system. Final order.

    Science.gov (United States)

    2014-05-16

    The Food and Drug Administration (FDA) is classifying the colon capsule imaging 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 colon capsule imaging 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.

  20. Clinical use of medical devices in the 'Bermuda Triangle'.

    Science.gov (United States)

    Kessler, Larry; Ramsey, Scott D; Tunis, Sean; Sullivan, Sean D

    2004-01-01

    The pace of medical technological development shows no sign of abating. Analyzing the effect of major federal health agencies on the availability of such technology is critical. This paper describes functions of three government health agencies: the Centers for Medicare and Medicaid Services (CMS), the Food and Drug Administration (FDA), and the National Institutes of Health (NIH). Certain medical technologies fall into gaps between these agencies, which pose challenges in today's era of demand for evidence-based medicine. We suggest new policy and pragmatic strategies that can close the gaps and move decision making relevant to technology forward more rapidly than is now the case.

  1. [Web-based support system for medical device maintenance].

    Science.gov (United States)

    Zhao, Jinhai; Hou, Wensheng; Chen, Haiyan; Tang, Wei; Wang, Yihui

    2015-01-01

    A Web-based technology system was put forward aiming at the actual problems of the long maintenance cycle and the difficulties of the maintenance and repairing of medical equipments. Based on analysis of platform system structure and function, using the key technologies such as search engine, BBS, knowledge base and etc, a platform for medical equipment service technician to use by online or offline was designed. The platform provides users with knowledge services and interactive services, enabling users to get a more ideal solution.

  2. 77 FR 16239 - Medical Device User Fee Act; Public Meeting

    Science.gov (United States)

    2012-03-20

    ... and negotiated an agreement with regulated industry while periodically consulting with patient and... discussions with the device industry, and we have consulted with stakeholders as required by law. We began the... about this proposed statutory change). 3. Interactive Review FDA is proposing to continue to...

  3. 77 FR 15779 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2012-03-16

    ...-2011-M-0917] Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval... 28, 2011. P090024, FDA-2011-M-0737 Siemens Healthcare ADVIA CENTAUR HBEAG October 11, 2011.... H090002, FDA-2011-M-0848 BSD Medical Corp..... BSD-2000 November 18, 2011. hyperthermia system....

  4. 77 FR 35690 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Science.gov (United States)

    2012-06-14

    ...-0208, FDA- 2012-M-0209, FDA-2012-M-0210, FDA-2012-M-0221, and FDA-2012-M-0250] Medical Devices... BSD Medical BSD-2000 November 18, 2011. Corporation. Hyperthermia System. H100004, FDA-2011-M-0919..., 2012. Associates, Inc. Endoprosthesis. P100039, FDA-2012-M-0075 Siemens Healthcare ADVIA Centaur...

  5. 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

  6. 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.

  7. Using mobile devices to improve the safety of medication administration processes.

    Science.gov (United States)

    Navas, H; Graffi Moltrasio, L; Ares, F; Strumia, G; Dourado, E; Alvarez, M

    2015-01-01

    Within preventable medical errors, those related to medications are frequent in every stage of the prescribing cycle. Nursing is responsible for maintaining each patients safety and care quality. Moreover, nurses are the last people who can detect an error in medication before its administration. Medication administration is one of the riskiest tasks in nursing. The use of information and communication technologies is related to a decrease in these errors. Including mobile devices related to 2D code reading of patients and medication will decrease the possibility of error when preparing and administering medication by nurses. A cross-platform software (iOS and Android) was developed to ensure the five Rights of the medication administration process (patient, medication, dose, route and schedule). Deployment in November showed 39% use.

  8. 77 FR 8117 - Medical Devices; Cardiovascular Devices; Classification of the Endovascular Suturing System

    Science.gov (United States)

    2012-02-14

    ... in an magnetic resonance (MR) environment; (5) appropriate analysis and non-clinical testing should... market this type of device must submit to FDA a premarket notification, prior to marketing the device... individually or cumulatively have a significant effect on the human environment. Therefore, neither...

  9. 76 FR 21237 - Medical Devices; Obstetrical and Gynecological Devices; Classification of the Hemorrhoid...

    Science.gov (United States)

    2011-04-15

    ... Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before... was introduced or delivered for introduction into interstate commerce for commercial distribution..., distribution, and use of this device are restricted to ] prescription use in accordance with 21 CFR 801.109;...

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

    Science.gov (United States)

    2014-01-23

    The Food and Drug Administration (FDA) is classifying John Cunningham Virus (JCV) serological reagents into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

  11. Medical Devices; Immunology and Microbiology Devices; Classification of Trichomonas Vaginalis Nucleic Acid Assay. Final order.

    Science.gov (United States)

    2015-08-04

    The Food and Drug Administration (FDA) is classifying a Trichomonas vaginalis nucleic acid assay into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

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

    Science.gov (United States)

    2013-03-04

    The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from premarket notification requirements for wheelchair elevator devices commonly known as inclined platform lifts and vertical platform lifts. These devices are used to provide a means for a person with a mobility impairment caused by injury or other disease to move from one level to another, usually in a wheelchair. This order exempts wheelchair elevators, class II devices, from premarket notification and establishes conditions for exemption for this device that will provide a reasonable assurance of the safety and effectiveness of the device without submission of a premarket notification (510(k)). This exemption from 510(k), subject to these conditions, is immediately in effect for wheelchair elevators. All other devices classified under FDA's wheelchair elevator regulations, including attendant-operated stair climbing devices for wheelchairs and portable platform lifts, continue to require submission of 510(k)s. FDA is publishing this order in accordance with the section of the Food, Drug, and Cosmetic Act (the FD&C Act) permitting the exemption of a device from the requirement to submit a 510(k).

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

    Science.gov (United States)

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

    2010-01-01

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

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

    Science.gov (United States)

    Pereira, Dulce María Martínez; Rodríguez, Yadira Álvarez; Valdés, Yamila Cedeño; Ribas, Silvia Delgado

    2016-05-01

    Regulatory control of medical devices in Cuba is conducted through a system based on the Regulatory Program for Medical Devices as a way to ensure the safety, efficacy, and effectiveness of these technologies, which are in use by the National Health System. This program was launched in 1992, when the Regulations for State Evaluation and Registration of Medical Devices were approved. Its successive stages and the merging of regulatory activities for drugs and medical equipment have meant progress toward stronger, more transparent strategies and greater control of industry and the National Health System. Throughout its course the Cuban program has met with challenges and difficulties that it has addressed by drawing on its own experiences. During the new period, the greatest challenges revolve around ensuring that regulatory systems incorporate scientific evaluation, risk levels, maximum rigor through the use of technical standards, and the implementation of international recommendations, together with the application of the ISO 13485 certification scheme, enhanced market monitoring, and classification of medical devices in accordance with their relevance to the country's national health policies. From the regional standpoint, the greatest challenge lies in working toward regulatory convergence. The Collaborating Centre for the Regulation of Health Technologies will support the proposed regulatory strategy and established regional priorities, in particular in connection with the implementation of actions involving medical devices.

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

    Science.gov (United States)

    Vincent, Christopher James; Li, Yunqiu; Blandford, Ann

    2014-05-01

    Manufacturers of interactive medical devices, such as infusion pumps, need to ensure that devices minimise the risk of unintended harm during use. However, development teams face challenges in incorporating Human Factors. The aim of the research reported here was to better understand the constraints under which medical device design and development take place. We report the results of a qualitative study based on 19 semi-structured interviews with professionals involved in the design, development and deployment of interactive medical devices. A thematic analysis was conducted. Multiple barriers to designing for safety and usability were identified. In particular, we identified barriers to communication both between the development organisation and the intended users and between different teams within the development organisation. We propose the use of mediating representations. Artefacts such as personas and scenarios, known to provide integration across multiple perspectives, are an essential component of designing for safety and usability.

  16. 4D Printing of Shape Memory-Based Personalized Endoluminal Medical Devices.

    Science.gov (United States)

    Zarek, Matt; Mansour, Nicola; Shapira, Shir; Cohn, Daniel

    2017-01-01

    The convergence of additive manufacturing and shape-morphing materials is promising for the advancement of personalized medical devices. The capability to transform 3D objects from one shape to another, right off the print bed, is known as 4D printing. Shape memory thermosets can be tailored to have a range of thermomechanical properties favorable to medical devices, but processing them is a challenge because they are insoluble and do not flow at any temperature. This study presents here a strategy to capitalize on a series of medical imaging modalities to construct a printable shape memory endoluminal device, exemplified by a tracheal stent. A methacrylated polycaprolactone precursor with a molecular weight of 10 000 g mol(-1) is printed with a UV-LED stereolithography printer based on anatomical data. This approach converges with the zeitgeist of personalized medicine and it is anticipated that it will broadly expand the application of shape memory-exhibiting biomedical devices to myriad clinical indications.

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

    Science.gov (United States)

    Gittard, Shaun D; Narayan, Roger J

    2010-05-01

    Laser-based direct writing of materials has undergone significant development in recent years. The ability to modify a variety of materials at small length scales and using short production times provides laser direct writing with unique capabilities for fabrication of medical devices. In many laser-based rapid prototyping methods, microscale and submicroscale structuring of materials is controlled by computer-generated models. Various laser-based direct write methods, including selective laser sintering/melting, laser machining, matrix-assisted pulsed-laser evaporation direct write, stereolithography and two-photon polymerization, are described. Their use in fabrication of microstructured and nanostructured medical devices is discussed. Laser direct writing may be used for processing a wide variety of advanced medical devices, including patient-specific prostheses, drug delivery devices, biosensors, stents and tissue-engineering scaffolds.

  18. 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.

  19. Health Technology Assessment: managing the introduction and use of medical devices in clinical practice in Italy.

    Science.gov (United States)

    Migliore, Antonio; Ratti, Marco; Cerbo, Marina; Jefferson, Tom

    2009-05-01

    Technology assumes a key role in current clinical practice. A number of innovative or improved products are constantly being launched on the market and offered directly to the users (i.e., clinicians) or even to the patients. However, in most cases, the regulation for admission to commerce is slower than the innovation process and may be inadequate for assessing the real clinical effectiveness and safety of medical devices in the premarket phase. Health Technology Assessment (HTA) can be used as a tool for the evaluation of clinical effectiveness, cost-effectiveness and risk to patients of medical devices. HTA products (e.g., periodic reports) may aid healthcare payers to make informed choices regarding the appropriate use, coverage and reimbursement of medical devices. We present the strengths and limitations of the first three Italian HTA reports we coauthored and critically explore some of the aspects related to the introduction, adoption and use of medical technologies in clinical practice.

  20. Medical Device Plug-and-Play Interoperability Standards & Technology Leadership

    Science.gov (United States)

    2011-10-01

    DoD SBIR projects to develop a first-responder ICE Supervisor. TATRC BAA support has been instrumental in providing “program glue” to effectively...FDA has specifically asked AAMI (Association for the Advancement of Medical Instrumentation ) to pursue the development of interoperability...advances in mind. We also recognize that, as in all technological advances, interoperability poses safety and medico -legal challenges as well. The

  1. Towards a Better Corrosion Resistance and Biocompatibility Improvement of Nitinol Medical Devices

    Science.gov (United States)

    Rokicki, Ryszard; Hryniewicz, Tadeusz; Pulletikurthi, Chandan; Rokosz, Krzysztof; Munroe, Norman

    2015-04-01

    Haemocompatibility of Nitinol implantable devices and their corrosion resistance as well as resistance to fracture are very important features of advanced medical implants. The authors of the paper present some novel methods capable to improve Nitinol implantable devices to some marked degree beyond currently used electropolishing (EP) processes. Instead, a magnetoelectropolishing process should be advised. The polarization study shows that magnetoelectropolished Nitinol surface is more corrosion resistant than that obtained after a standard EP and has a unique ability to repassivate the surface. Currently used sterilization processes of Nitinol implantable devices can dramatically change physicochemical properties of medical device and by this influence its biocompatibility. The Authors' experimental results clearly show the way to improve biocompatibility of NiTi alloy surface. The final sodium hypochlorite treatment should replace currently used Nitinol implantable devices sterilization methods which rationale was also given in our previous study.

  2. 76 FR 43119 - Medical Devices; General and Plastic Surgery Devices; Classification of the Focused Ultrasound...

    Science.gov (United States)

    2011-07-20

    ... such as use of perfumes, facial creams, and sunlight. Use error represents those risks to the patient... market this type of device must submit to FDA a premarket notification, prior to marketing the...

  3. 78 FR 66942 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2013-11-07

    ... promote intervertebral body fusion. During the arthrodesis procedure, they are to be used with bone graft... under the heading of ``Intervertebral Fusion Device with Bone Graft, Solid-Sphere, Lumbar'',...

  4. 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 proposed Indication for Use for the Argus II (as stated in the HDE) is as follows: The Argus II System...

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

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

    Directory of Open Access Journals (Sweden)

    Mitchell UH

    2015-12-01

    Full Text Available 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 mechanism of action are whole body vibration, pneumatic compression, and near-infrared light. Medical devices that use counter stimulation include transcutaneous electrical nerve stimulation and the vibration Relaxis pad. The clinical utility of the Relaxis pad and its place in therapy is proposed. Keywords: whole body vibration, pneumatic compression, near-infrared light, conservative treatment, RLS/WED 

  11. Mobility Charters and Manifestos

    DEFF Research Database (Denmark)

    Jensen, Ole B.

    2010-01-01

    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......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...... 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...

  12. 75 FR 68200 - Medical Devices; Radiology Devices; Reclassification of Full-Field Digital Mammography System

    Science.gov (United States)

    2010-11-05

    ...; Reclassification of Full- Field Digital Mammography System AGENCY: Food and Drug Administration, HHS. ACTION: Final...-field digital mammography (FFDM) system from class III (premarket approval) to class II (special... generic type of device may include digital mammography acquisition software, full-field digital...

  13. 78 FR 11612 - Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on...

    Science.gov (United States)

    2013-02-19

    ... defines the term ``pediatric subpopulation'' to mean one of the following populations: Neonates; Infants... rule does not require additional clinical research or other costly efforts, and simply requires the... Pediatric Devices Working Group that includes the Agency for Healthcare Research and Quality, FDA,...

  14. 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...

  15. 75 FR 9422 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2010-03-02

    ... to FDA's reevaluation of the ReGen Collagen Scaffold (CS) device (marketed as the Menaflex ), which..., 2010. Oral presentations from the public will be scheduled at approximately 1 p.m., immediately following lunch. Those desiring to make formal oral presentations should notify the contact person...

  16. 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...

  17. Microneedle arrays as medical devices for enhanced transdermal drug delivery.

    Science.gov (United States)

    Garland, Martin J; Migalska, Katarzyna; Mahmood, Tuan Mazlelaa Tuan; Singh, Thakur Raghu Raj; Woolfson, A David; Donnelly, Ryan F

    2011-07-01

    In order to exploit the transdermal route for systemic delivery of a wide range of drug molecules, including peptide/protein molecules and genetic material, a means of disrupting the excellent barrier properties of the uppermost layer of the skin, the stratum corneum, must be sought. The use of microneedle (MN) arrays has been proposed as a method to temporarily disrupt the barrier function of the skin and thus enable enhanced transdermal drug delivery. MN arrays consist of a plurality of micron-sized needles, generally ranging from 25 to 2000 µm in height, of a variety of different shapes and composition (e.g., silicon, metal, sugars and biodegradable polymers). The application of such MN arrays to the skin results in the creation of aqueous channels that are orders of magnitude larger than molecular dimensions and, therefore, should readily permit the transport of macromolecules. This article will focus on recent and future developments for MN technology, focusing on the materials used for MN fabrication, the forces required for MN insertion and potential safety aspects that may be involved with the use of MN devices.

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

    Science.gov (United States)

    Ferguson, John E; Redish, A David

    2011-07-01

    Many medical devices that are implanted in the body use wires or wireless radiofrequency telemetry to communicate with circuitry outside the body. However, the wires are a common source of surgical complications, including breakage, infection and electrical noise. In addition, radiofrequency telemetry requires large amounts of power and results in low-efficiency transmission through biological tissue. As an alternative, the conductive properties of the body can be used to enable wireless communication with implanted devices. In this article, several methods of intrabody communication are described and compared. In addition to reducing the complications that occur with current implantable medical devices, intrabody communication can enable novel types of miniature devices for research and clinical applications.

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

    Science.gov (United States)

    Coyer, Fiona M; Stotts, Nancy A; Blackman, Virginia Schmied

    2014-12-01

    The aim of this study was to determine the prevalence, severity, location, aetiology, treatment and healing of medical device-related pressure ulcers (PUs) in intensive care patients for up to 7 days. A prospective repeated measures study design was used. Patients in six intensive care units of two major medical centres, one each in Australia and the USA, were screened 1 day per month for 6 months. Those with device-related ulcers were followed daily for up to 7 days. The outcome measures were device-related ulcer prevalence, pain, infection, treatment and healing. Fifteen of 483 patients had device-related ulcers and 9 of 15 with 11 ulcers were followed beyond screening. Their mean age was 60·5 years, and most were men, overweight and at increased risk of PU. Endotracheal (ET) and nasogastric (NG) tubes were the cause of most device-related ulcers. Repositioning was the most frequent treatment. Four of 11 ulcers healed within the 7-day observation period. In conclusion, device-related ulcer prevalence was 3·1%, similar to that reported in the limited literature available, indicating an ongoing problem. Systematic assessment and repositioning of devices are the mainstays of care. We recommend continued prevalence determination and that nurses remain vigilant to prevent device-related ulcers, especially in patients with NG and ET tubes.

  20. 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.

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

    Science.gov (United States)

    Zhang, Zhijun

    2012-07-01

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

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

    DEFF Research Database (Denmark)

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

    2015-01-01

    This exploratory study seeks to explore the current state of design for the environment (DfE) in the development of medical devices; an historically risk averse industry that lags behind others in terms of addressing environmental considerations. A cross-sectional survey of 34 medical device...... designers, primarily in the UK and USA, was conducted in order to fulfil this objective. Findings indicate that there is significant motivation to enhance DfE practice, but that there are multiple barriers to this. Major barriers identified are a perception of the high cost of DfE, the industry’s current...

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

    Directory of Open Access Journals (Sweden)

    Rockstroh Max

    2015-09-01

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

  4. 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.

  5. Evaluation of medical devices in thoracic radiograms in intensive care unit - time to pay attention!

    Science.gov (United States)

    Moreira, Ana Sofia Linhares; Afonso, Maria da Graça Alves; Dinis, Mónica Ribeiro dos Santos Alves; dos Santos, Maria Cristina Granja Teixeira

    2016-01-01

    Objective To identify and evaluate the correct positioning of the most commonly used medical devices as visualized in thoracic radiograms of patients in the intensive care unit of our center. Methods A literature search was conducted for the criteria used to evaluate the correct positioning of medical devices on thoracic radiograms. All the thoracic radiograms performed in the intensive care unit of our center over an 18-month period were analyzed. All admissions in which at least one thoracic radiogram was performed in the intensive care unit and in which at least one medical device was identifiable in the thoracic radiogram were included. One radiogram per admission was selected for analysis. The radiograms were evaluated by an independent observer. Results Out of the 2,312 thoracic radiograms analyzed, 568 were included in this study. Several medical devices were identified, including monitoring leads, endotracheal and tracheostomy tubes, central venous catheters, pacemakers and prosthetic cardiac valves. Of the central venous catheters that were identified, 33.6% of the subclavian and 23.8% of the jugular were malpositioned. Of the endotracheal tubes, 19.9% were malpositioned, while all the tracheostomy tubes were correctly positioned. Conclusion Malpositioning of central venous catheters and endotracheal tubes is frequently identified in radiograms of patients in an intensive care unit. This is relevant because malpositioned devices may be related to adverse events. In future studies, an association between malpositioning and adverse events should be investigated. PMID:27737432

  6. 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.

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

    Directory of Open Access Journals (Sweden)

    Sangita Revdiwala

    2012-01-01

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

  8. Nanomaterials and synergistic low-intensity direct current (LIDC) stimulation technology for orthopedic implantable medical devices.

    Science.gov (United States)

    Shirwaiker, Rohan A; Samberg, Meghan E; Cohen, Paul H; Wysk, Richard A; Monteiro-Riviere, Nancy A

    2013-01-01

    Nanomaterials play a significant role in biomedical research and applications because of their unique biological, mechanical, and electrical properties. In recent years, they have been utilized to improve the functionality and reliability of a wide range of implantable medical devices ranging from well-established orthopedic residual hardware devices (e.g., hip implants) that can repair defects in skeletal systems to emerging tissue engineering scaffolds that can repair or replace organ functions. This review summarizes the applications and efficacies of these nanomaterials that include synthetic or naturally occurring metals, polymers, ceramics, and composites in orthopedic implants, the largest market segment of implantable medical devices. The importance of synergistic engineering techniques that can augment or enhance the performance of nanomaterial applications in orthopedic implants is also discussed, the focus being on a low-intensity direct electric current (LIDC) stimulation technology to promote the long-term antibacterial efficacy of oligodynamic metal-based surfaces by ionization, while potentially accelerating tissue growth and osseointegration. While many nanomaterials have clearly demonstrated their ability to provide more effective implantable medical surfaces, further decisive investigations are necessary before they can translate into medically safe and commercially viable clinical applications. The article concludes with a discussion about some of the critical impending issues with the application of nanomaterials-based technologies in implantable medical devices, and potential directions to address these.

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

    DEFF Research Database (Denmark)

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

    2015-01-01

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

  10. 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... Food, Drug, and Cosmetic Act (21 U.S.C. 321(h)) and does not discuss classification products codes...

  11. 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.

  12. [Study on cytotoxicity tests of medical devices based on IC50].

    Science.gov (United States)

    Liu, Chenghu; Wu, Shifu; Hou, Li; Wang, Xin; Wang, Luanluan; Shi, Yanping

    2014-11-01

    To discuss IC50 application in cytotoxicity tests of medical devices, we firstly investigated the vibrating condition and endpoint of MTT method specified in ISO 10993-5: 2009. Furthermore, we demonstrated the application of IC50 in the result evaluation of MTT method. The experimental results show that usage of IC50 in quantitative evaluation of MTT method is feasible.

  13. 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...

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

    DEFF Research Database (Denmark)

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

    2016-01-01

    The medical device industry is growing increasingly concerned about environmental impact of products. Whilst there are many tools aiming to support environmentally conscious design, they are typically complex to use, demand substantial data collection and are not tailored to the specific needs of...

  15. Risk assessment of medical devices: Evaluation of microbiological and toxicological safety

    Science.gov (United States)

    Dorpema, J. W.

    1995-02-01

    Safety assessment of medical devices includes sterilization and biological evaluation or biocompatibility testing. Sterilization by ETO gas is critised for their carcinogenic potency or even banned. Mutual acceptance of biological evaluation test results is promoted by a laboratory accreditation and qualification program.

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

    Science.gov (United States)

    2011-08-01

    ... INFORMATION CONTACT: For information on the Medical Device User Fee and Modernization Act (MDUFMA): visit FDA... statement signed by the head of the applicant's firm or by its chief financial officer that the applicant... also submit a statement signed by the head of the applicant's firm or by its chief financial...

  17. [Administrative reform thinking on the regulations on the supervision and administration of medical devices].

    Science.gov (United States)

    Yue, Wei

    2014-09-01

    This paper learned and interpreted the regulations on the supervision and administration of medical devices, carded the thoughts of administrative reform, then put forward the "ten principles", including full supervision, classification supervision, risk classification, safety-effective-save, to encourage innovation, simplified license, scientific-standard, sincerity & self-discipline, clear responsibility, severe punishment, and discussed these priciples.

  18. Introduction: feature issue on phantoms for the performance evaluation and validation of optical medical imaging devices.

    Science.gov (United States)

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

    2012-06-01

    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.

  19. 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...

  20. 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...

  1. 77 FR 50113 - ASTM International-Food and Drug Administration Workshop on Absorbable Medical Devices: Lessons...

    Science.gov (United States)

    2012-08-20

    ... HUMAN SERVICES Food and Drug Administration ASTM International-Food and Drug Administration Workshop on... ``ASTM International-FDA Workshop on Absorbable Medical Devices: Lessons Learned From Correlations of Bench Testing and Clinical Performance.'' FDA is co-sponsoring the workshop together with...

  2. [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".

  3. 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.

  4. 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.

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

    Energy Technology Data Exchange (ETDEWEB)

    Whitby, James L

    1998-06-01

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

  6. About the numerical robustness of biomedical benchmark cases: Interlaboratory FDA's idealized medical device.

    Science.gov (United States)

    Zmijanovic, Vladeta; Mendez, Simon; Moureau, Vincent; Nicoud, Franck

    2017-01-01

    The need for reliable approaches in numerical simulations stands out as a critical issue for the development and optimization of cardiovascular biomedical devices. This led the US Food and Drug Administration to undertake a programme of validation of computational fluid dynamics methods for transitional and turbulent flows. In the current investigation, large-eddy simulation is used to simulate the flow in the first benchmark medical device, and results are confronted to the existing laboratory experiments. This idealized medical device has the particularity to feature transition to turbulence after a sudden expansion. The effects of numerical parameters and low-level inlet perturbations are investigated. Results indicate a considerable impact of numerical aspects on the prediction of the location of the transition to turbulence. The study also demonstrates that injecting small perturbations at the inflow greatly improves the streamwise velocity estimation in the transition region and substantially contributes to the robustness of the flow statistical data. Copyright © 2016 John Wiley & Sons, Ltd.

  7. Un-"Chartered" Waters: Balancing Montessori Curriculum and Accountability Measures in a Charter School

    Science.gov (United States)

    Scott, Catherine M.

    2017-01-01

    More than 6,000 charter schools exist in the United States, and of these 120 are Montessori charter schools. When studying charter school practices, researchers often examine issues such as performance accountability measures and effectiveness of charter school curricula. In doing so, the outcomes often overlook the challenges for teachers as they…

  8. 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…

  9. Utilizing Electronic Health Record Information to Optimize Medication Infusion Devices: A Manual Data Integration Approach.

    Science.gov (United States)

    Chuk, Amanda; Maloney, Robert; Gawron, Joyce; Skinner, Colin

    Health information technology is increasingly utilized within healthcare delivery systems today. Two examples of this type of technology include the capture of patient-specific information within an electronic health record and intravenous medication infusion devices equipped with dose error reduction software known as drug libraries. Automatic integration of these systems, termed intravenous (IV) interoperability, should serve as the goal toward which all healthcare systems work to maximize patient safety. For institutions lacking IV interoperability, we describe a manual approach of querying the electronic health record to incorporate medication administration information with data from infusion device software to optimize drug library settings. This approach serves to maximize utilization of available information to optimize medication safety provided by drug library software.

  10. 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...

  11. 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

  12. 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.

  13. Security Risks, Low-tech User Interfaces, and Implantable Medical Devices: A Case Study with Insulin Pump Infusion Systems

    Energy Technology Data Exchange (ETDEWEB)

    Paul, Nathanael R [ORNL; Kohno, Tadayoshi [University of Washington, Seattle

    2012-01-01

    Portable implantable medical device systems are playing a larger role in modern health care. Increasing attention is now being given to the wireless control interface of these systems. Our position is that wireless security in portable implantable medical device systems is just a part of the overall system security, and increased attention is needed to address low-tech security issues.

  14. 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…

  15. 78 FR 5239 - Public Charter Prospectuses

    Science.gov (United States)

    2013-01-24

    ... harm to consumers that took place when the charter operator Southern Sky Air & Tours, LLC d/b/a Direct... identify and contact tour participants regarding returning flights. Representatives of charter operators... affirmatively state that: (1) The contract between the charter operator and the direct air carrier is for...

  16. The Charter School Experience: Autonomy in Practice

    Science.gov (United States)

    McDonald, Tonya Senne

    2013-01-01

    While traditional public school and charter school systems continue to undergo dramatic reforms in response to the educational crisis, charter schools are praised as possessing the distinguishing characteristic of maintaining autonomy in exchange for increased accountability (Buckley & Schneider, 2009). The expectations for charter schools are…

  17. 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.

  18. 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.

  19. Eliciting preferences for medical devices in South Korea: A discrete choice experiment.

    Science.gov (United States)

    Lee, Hye-Jae; Bae, Eun-Young

    2017-03-01

    This study aims to identify the attributes that contribute to the value of medical devices and quantify the relative importance of them using a discrete choice experiment. Based on a literature review and expert consultation, seven attributes and their levels were identified-severity of disease (2), availability of substitutes (2), improvement in procedure (3), improvement in clinical outcomes (2), increase in survival (2), improvement in quality of life (3), and cost (4). Among 576 hypothetical profiles, optimal choice sets with 20 choices were developed and experts experienced in health technology assessment and reimbursement decision making in South Korea were surveyed. A total of 102 respondents participated in the survey. The results of the random-effect probit model showed that among the seven attributes, six, except for improvement in procedure, had a significant impact on respondents' choices on medical devices. Respondents were willing to pay the highest amount for devices that provided substantial improvements in quality of life, followed by increased survival, improved clinical outcome, treatment without substitutes, and technology for treating severe diseases. The findings of this experiment will inform decision-makers of the relative importance of the criteria and help them in reimbursement decision making of medical devices.

  20. 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.

  1. 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.

  2. 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.

  3. Safety-cost trade-offs in medical device reuse: a Markov decision process model.

    Science.gov (United States)

    Sloan, Thomas W

    2007-02-01

    Healthcare expenditures in the US are approaching 2 trillion dollars, and hospitals and other healthcare providers are under tremendous pressure to rein in costs. One cost-saving approach which is gaining popularity is the reuse of medical devices which were designed only for a single use. Device makers decry this practice as unsanitary and unsafe, but a growing number of third-party firms are willing to sterilize, refurbish, and/or remanufacture devices and resell them to hospitals at a fraction of the original price. Is this practice safe? Is reliance on single-use devices sustainable? A Markov decision process (MDP) model is formulated to study the trade-offs involved in these decisions. Several key parameters are examined: device costs, device failure probabilities, and failure penalty cost. For each of these parameters, expressions are developed which identify the indifference point between using new and reprocessed devices. The results can be used to inform the debate on the economic, ethical, legal, and environmental dimensions of this complex issue.

  4. 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

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

    Science.gov (United States)

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

    2013-12-01

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

  6. An introduction to future truly wearable medical devices--from application to ASIC.

    Science.gov (United States)

    Casson, Alexander J; Logesparan, Lojini; Rodriguez-Villegas, Esther

    2010-01-01

    This talk will provide an introduction to the "Towards future truly wearable medical devices: from application to ASIC" mini-symposium. For user comfort and acceptance long term physiological sensors must be discrete, comfortable and easy to use. These requirements place stringent limits on all aspects of the system design: from the overall application aim, to power generation issues, to low power electronic design techniques. For successful devices design issues in all of these areas must be solved simultaneously. The work here presents an overview and introduction to these topics.

  7. Medical device-related hospital-acquired pressure ulcers in children: an integrative review.

    Science.gov (United States)

    Murray, John S; Noonan, Catherine; Quigley, Sandy; Curley, Martha A Q

    2013-01-01

    The management, cost, physical and emotional suffering associated with pressure ulcers have a significant impact on the health status of patients-especially infants and children. The purpose of this integrative review was to identify factors associated with medical device-related (MDR) hospital acquired pressure ulcers (HAPUs) in the pediatric population. Pediatric MDR HAPUs are becoming more prevalent and require further exploration in terms of describing devices which cause injury and preventive interventions to improve patient outcomes. Opportunities to uncover new methods for addressing this important problem and to inform and advance the state of the science in this evolving area exist.

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

    DEFF Research Database (Denmark)

    Kelly, Janet; Matthews, Ben

    2010-01-01

    of the product. We present a case study that documents how we worked with pre-users of two different types of medical technologies: hearing aids and insulin injection devices. Pre-users are people who do not currently use these products, but who are in a life situation for which these technologies may...... be prescribed sometime in the future, judging by their current medical condition. This paper distinguishes pre-users from other types of users commonly involved in participatory design. We exemplify how they can contribute to design activities through the case. We discuss relevant methods for their involvement...

  9. Perivascular medical devices and drug delivery systems: Making the right choices.

    Science.gov (United States)

    Mylonaki, Ioanna; Allémann, Éric; Saucy, François; Haefliger, Jacques-Antoine; Delie, Florence; Jordan, Olivier

    2017-02-28

    Perivascular medical devices and perivascular drug delivery systems are conceived for local application around a blood vessel during open vascular surgery. These systems provide mechanical support and/or pharmacological activity for the prevention of intimal hyperplasia following vessel injury. Despite abundant reports in the literature and numerous clinical trials, no efficient perivascular treatment is available. In this review, the existing perivascular medical devices and perivascular drug delivery systems, such as polymeric gels, meshes, sheaths, wraps, matrices, and metal meshes, are jointly evaluated. The key criteria for the design of an ideal perivascular system are identified. Perivascular treatments should have mechanical specifications that ensure system localization, prolonged retention and adequate vascular constriction. From the data gathered, it appears that a drug is necessary to increase the efficacy of these systems. As such, the release kinetics of pharmacological agents should match the development of the pathology. A successful perivascular system must combine these optimized pharmacological and mechanical properties to be efficient.

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

    Directory of Open Access Journals (Sweden)

    Zhang R

    2015-04-01

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

  11. 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...

  12. [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.

  13. [Preliminary Study on Error Control of Medical Devices Test Reports Based on the Analytic Hierarchy Process].

    Science.gov (United States)

    Huang, Yanhong; Xu, Honglei; Tu, Rong; Zhang, Xu; Huang, Min

    2016-01-01

    In this paper, the common errors in medical devices test reports are classified and analyzed. And then the main 11 influence factors for these inspection report errors are summarized. The hierarchy model was also developed and verified by presentation data using MATLAB. The feasibility of comprehensive weights quantitative comparison has been analyzed by using the analytic hierarchy process. In the end, this paper porspects the further research direction.

  14. 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

  15. An extended protocol for usability validation of medical devices: research design and reference model.

    Science.gov (United States)

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

    2017-03-21

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

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

    Science.gov (United States)

    Heijerman, Harry; Westerman, Elsbeth; Conway, Steven; Touw, Daan; Döring, Gerd

    2009-09-01

    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 address the subject of testing new devices before market introduction.

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

    Science.gov (United States)

    Tarricone, Rosanna; Torbica, Aleksandra; Drummond, Michael

    2017-02-01

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

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

    Science.gov (United States)

    Chen, Guangwei; Rodriguez-Villegas, Esther

    2010-01-01

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

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

    Science.gov (United States)

    Reed, Terrie L; Drozda, Joseph P; Baskin, Kevin M; Tcheng, James; Conway, Karen; Wilson, Natalia; Marinac-Dabic, Danica; Heise, Theodore; Krucoff, Mitchell W

    2016-12-06

    The Medical Device Epidemiology Network (MDEpiNet) is a public private partnership (PPP) that provides a platform for collaboration on medical device evaluation and depth of expertise for supporting pilots to capture, exchange and use device information for improving device safety and protecting public health. The MDEpiNet SMART Think Tank, held in February, 2013, sought to engage expert stakeholders who were committed to improving the capture of device data, including Unique Device Identification (UDI), in key electronic health information. Prior to the Think Tank there was limited collaboration among stakeholders beyond a few single health care organizations engaged in electronic capture and exchange of device data. The Think Tank resulted in what has become two sustainable multi-stakeholder device data capture initiatives, BUILD and VANGUARD. These initiatives continue to mature within the MDEpiNet PPP structure and are well aligned with the goals outlined in recent FDA-initiated National Medical Device Planning Board and Medical Device Registry Task Force white papers as well as the vision for the National Evaluation System for health Technology.%.

  20. 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.

  1. 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.

  2. 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.

  3. 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

  4. Prevalence and nature of adverse medical device events in hospitalized children.

    Science.gov (United States)

    Brady, Patrick W; Varadarajan, Kartik; Peterson, Laura E; Lannon, Carole; Gross, Thomas

    2013-07-01

    Our objective was to describe the prevalence and nature of adverse medical device events (AMDEs) in tertiary care children's hospitals. In our retrospective cohort study of patients at 44 children's hospitals in the Pediatric Health Information System (PHIS), we included all inpatient stays with an AMDE-related diagnosis from January 1, 2004 to December 31, 2011. We identified AMDEs by diagnoses that specified a device in their definition. We included events present on admission as well as those complicating hospital stays. We described the characteristics of these admissions and patients, and stratified analysis by device category and presence of a complex chronic condition. Of 4,115,755 admissions in the PHIS database during the study period, 136,465 (3.3%) had at least 1 AMDE. Vascular access and nervous system devices together represented 44.4% of pediatric AMDE admissions. The majority (75.5%) of AMDE admissions were of children with complex chronic conditions. The most common age group was patients aged 2 years or less at the time of their first AMDE-related admission. AMDEs occur commonly in a population cared for in tertiary children's hospitals. Research to more specifically delineate AMDEs and their predictors are next steps to understand and improve device safety in children.

  5. 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.

  6. Medical-device risk management and public safety: using cost-benefit as a measurement of effectiveness

    Science.gov (United States)

    Hughes, Allen A.

    1994-12-01

    Public safety can be enhanced through the development of a comprehensive medical device risk management. This can be accomplished through case studies using a framework that incorporates cost-benefit analysis in the evaluation of risk management attributes. This paper presents a framework for evaluating the risk management system for regulatory Class III medical devices. The framework consists of the following sixteen attributes of a comprehensive medical device risk management system: fault/failure analysis, premarket testing/clinical trials, post-approval studies, manufacturer sponsored hospital studies, product labeling, establishment inspections, problem reporting program, mandatory hospital reporting, medical literature surveillance, device/patient registries, device performance monitoring, returned product analysis, autopsy program, emergency treatment funds/interim compensation, product liability, and alternative compensation mechanisms. Review of performance histories for several medical devices can reveal the value of information for many attributes, and also the inter-dependencies of the attributes in generating risk information flow. Such an information flow network is presented as a starting point for enhancing medical device risk management by focusing on attributes with high net benefit values and potential to spur information dissemination.

  7. Analysis of plasticizers in PVC medical devices: Performance comparison of eight analytical methods.

    Science.gov (United States)

    Bernard, L; Bourdeaux, D; Pereira, B; Azaroual, N; Barthélémy, C; Breysse, C; Chennell, P; Cueff, R; Dine, T; Eljezi, T; Feutry, F; Genay, S; Kambia, N; Lecoeur, M; Masse, M; Odou, P; Radaniel, T; Simon, N; Vaccher, C; Verlhac, C; Yessad, M; Décaudin, B; Sautou, V

    2017-01-01

    A wide variety of medical devices (MDs) used in hospitals are made of flexible plasticized polyvinylchloride (PVC). Different plasticizers are present in variable amounts in the PVC matrix of the devices and can leach out into the infused solutions and may enter into contact with the patients. The ARMED(1) project aims to assess the migration of these plasticizers from medical devices and therefore the level of exposure in patients. For the first task of the project, eight methods were developed to directly detect and quantify the plasticizers in the PVC matrix of the MDs. We compared the overall performances of the analytical methods using standardized and validated criteria in order to provide the scientific community with the guidance and the technical specifications of each method for the intended application. We have shown that routine rapid screening could be performed directly on the MDs using the FTIR technique, with cost-effective analyses. LC techniques may also be used, but with limits and only with individual quantification of the main plasticizers expected in the PVC matrix. GC techniques, especially GC-MS, are both more specific and more sensitive than other techniques. NMR is a robust and specific technique to precisely discriminate all plasticizers in a MD but is limited by its cost and its low ability to detect and quantify plasticizer contamination, e.g. by DEHP. All these results have been confirmed by a real test, called the " blind test " carried out on 10 MD samples.

  8. 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

  9. 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.

  10. 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.

  11. Overview of High-Risk Medical Device Innovation in Gastroenterology from 2000 to 2014: Enhancing the Pipeline.

    Science.gov (United States)

    Saleem, Nasir; Xu, Shuai

    2016-08-01

    Medical devices are a critical component in the diagnosis and treatment of diseases of the alimentary tract. The United States Food and Drug Administration database was mined for high-risk medical device development via the pre-market approval (PMA) pathway from 2000 to 2014. In total, there were only nine GI (gastrointestinal) devices approved during this period. Furthermore, only one GI device was granted expedited review. The clinical studies leading to approval were mostly limited to non-blinded, non-randomized studies. Only a minority of pivotal studies defined and met their primary endpoints (27 %). Eight out of nine devices were required to undergo post-marketing studies. Ultimately, cardiology led with 157 total approvals in the time period studied. GI ranked 12 out of 18 across various medical and surgical specialties and accounted for innovation in the field.

  12. 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.

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

    Directory of Open Access Journals (Sweden)

    Daniel B Kramer

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

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

    Science.gov (United States)

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

    2017-02-01

    Much criticism has been directed at the licencing requirements for medical devices (MDs) as they often result in a lack of robust evidence to inform health technology assessment (HTA) decisions. To better understand the current international decisional framework on MD technologies, we undertook three linked research studies: a review of the device regulatory procedures, a survey of current HTA practices and an empirical comparison of HTA reports of drugs versus MDs. Our review confirms that current device regulatory processes across the globe are substantially less stringent than drugs. As a result, international HTA agencies report that they face a number of challenges when assessing MDs, including reliance on suboptimal data to make clinical and cost-effectiveness decisions. Whilst many HTA agencies have adapted their processes and procedures to handle MD technology submissions, in our comparison of HTA reports we found little evidence of the application of methodologies that take account of device-specific issues, such as incremental development. Overall, our research reinforces the need for better linkage between licencing and HTA and the development and application of innovative HTA methodologies with the objective of securing faster patient access for those technologies that can be shown to represent good value for money. © 2017 The Authors. Health Economics Published by John Wiley & Sons, Ltd.

  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. 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…

  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. Importance of cleaning for reprocessing endoscopes and thermolabile sterile medical devices: French use and regulations.

    Science.gov (United States)

    Darbord, J C

    2004-04-01

    In France, endoscope maintenance regulations present some particularities in terms of the definitions and texts referring to the disinfection and sterilization of medical devices, with respect to the prion risk. The main measures specified are a double cleaning prior to disinfection, with some stipulations concerning the procedure itself, such as time limits, duration and rinsing. The use of aldehydes in cleaning products is prohibited and it is recommended that peracetic acid, or any chlorinated product, be used at the disinfection phase. For machines, the recycling of detergents or disinfectants is prohibited, and traceability procedures are mandatory. The French Agency for Safety of Health Products (AFSSAPS) is committed to providing standards that prevent any undesirable consequences for the patient, the operator or the equipment. All these measures will be described in a 'user's guide' intended for medical care units, to be released by the National Technical Committee on Nosocomial Infections (CTIN).

  19. 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

  20. 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

    , 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...... 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...

  1. 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.

  2. Evaluating the Safety Profile of Non-Active Implantable Medical Devices Compared with Medicines.

    Science.gov (United States)

    Pane, Josep; Coloma, Preciosa M; Verhamme, Katia M C; Sturkenboom, Miriam C J M; Rebollo, Irene

    2017-01-01

    Recent safety issues involving non-active implantable medical devices (NAIMDs) have highlighted the need for better pre-market and post-market evaluation. Some stakeholders have argued that certain features of medicine safety evaluation should also be applied to medical devices. Our objectives were to compare the current processes and methodologies for the assessment of NAIMD safety profiles with those for medicines, identify potential gaps, and make recommendations for the adoption of new methodologies for the ongoing benefit-risk monitoring of these devices throughout their entire life cycle. A literature review served to examine the current tools for the safety evaluation of NAIMDs and those for medicines. We searched MEDLINE using these two categories. We supplemented this search with Google searches using the same key terms used in the MEDLINE search. Using a comparative approach, we summarized the new product design, development cycle (preclinical and clinical phases), and post-market phases for NAIMDs and drugs. We also evaluated and compared the respective processes to integrate and assess safety data during the life cycle of the products, including signal detection, signal management, and subsequent potential regulatory actions. The search identified a gap in NAIMD safety signal generation: no global program exists that collects and analyzes adverse events and product quality issues. Data sources in real-world settings, such as electronic health records, need to be effectively identified and explored as additional sources of safety information, particularly in some areas such as the EU and USA where there are plans to implement the unique device identifier (UDI). The UDI and other initiatives will enable more robust follow-up and assessment of long-term patient outcomes. The safety evaluation system for NAIMDs differs in many ways from those for drugs, but both systems face analogous challenges with respect to monitoring real-world usage. Certain features

  3. 76 FR 61367 - Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal...

    Science.gov (United States)

    2011-10-04

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND..., Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Philip Desjardins, Center for Devices and Radiological.../Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/ucm109196.htm . II. Request for Comments...

  4. 75 FR 28257 - Draft Guidance for Industry, Third Parties and Food and Drug Administration Staff; Medical Device...

    Science.gov (United States)

    2010-05-20

    ... concerning this draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration... devices-- Quality management systems--Requirements for regulatory purposes,'' may voluntarily submit the... Japanese Medical Device Ministry of Health, Labour and Welfare system. This notice of availability...

  5. Migration of plasticizers from PVC medical devices: Development of an infusion model.

    Science.gov (United States)

    Bernard, L; Cueff, R; Chagnon, Mc; Abdoulouhab, F; Décaudin, B; Breysse, C; Kauffmann, S; Cosserant, B; Souweine, B; Sautou, V

    2015-10-15

    Alternatives to DEHP plasticizers are used in various PVC medical devices (MD) for infusion. As they are able to migrate from these MDs into infused solutions, they may come into contact with patient. Different and specific clinical parameters influence their migration in at-risk situations such as infusion. In contrast to the regulations for Food Contact Materials (MCDA), there is currently no acceptable migration limits for the use of these plasticizers in clinical situations. In order to assess their migration, and thus control the risks linked to these MDs, we developed a migration model for the plasticizers in MDs. To this end, we applied a cross-disciplinary methodological process similar to that used in the food-processing industry, taking into account the MDs' conditions of use in clinical practice. The simulation model is simple and includes the following conditions: MD should be tested with a dynamic method that respects our established clinical assumption (2 L of infused solutions via 13 dm(2) of plasticized PVC), at a temperature of 25 °C and during 24 h of contact, using a 50/50 (v/v) ethanol/water simulant. This model could be proposed as a tool for the safety evaluation of the patients' exposure risk to plasticizers from PVC medical devices for infusions.

  6. 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.

  7. 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.

  8. Micromachining NiTi tubes for use in medical devices by using a femtosecond laser

    Science.gov (United States)

    Hung, Chia-Hung; Chang, Fuh-Yu; Chang, Tien-Li; Chang, Yu-Ting; Huang, Kai-Wen; Liang, Po-Chin

    2015-03-01

    Recent growth in medical device technology has been substantially driven by developments in laser micromachining, which is a powerful fabrication technique in which nickel-titanium (Nitinol, NiTi) alloy materials that exhibit superelastic and shape memory properties are formed (e.g., self-expanding stents). In this study a NiTi tube curve surface process is proposed, involving a femtosecond laser process and a galvano-mirror scanner. The diameter of the NiTi tube was 5.116 mm, its thickness was 0.234 mm, and its length was 100 mm. The results indicated that during the machine process the ablation mechanism of the NiTi tubes was changed by altering the machining path. The path alteration enhanced the laser ablation rate from 12.3 to 26.7 μm/J. Thus the path alteration contributed to a wide kerf line, enabling the assisted air to efficiently remove the debris deposited at the bottom of the kerf during the laser ablation process. The results indicated that the NiTi tube curve process enhanced the laser ablation rate by two times and reduced the amount of energy accumulated within the materials by 50% or more. By altering the machining path using the scanning system, this process can decrease the production of heat affected zones (the accumulation of thermal energy) in medical device applications.

  9. Security risk of medical devices in IT networks: the case of an infusion and infusion syringe pump

    Science.gov (United States)

    Knackmuß, Jenny; Möller, Thomas; Pommerien, Wilfried; Creutzburg, Reiner

    2015-03-01

    Nowadays, wearable and implantable medical devices are being increasingly deployed to improve diagnosis, monitoring, and therapy for various medical conditions. Compared to other types of electronics and computing systems, security attacks on these medical devices have extreme consequences and must be carefully analyzed and prevented with strongest efforts. Often, the security vulnerabilities of such systems are not well understood or underestimated. The aim of this paper is to demonstrate security attacks that can easily be done in the laboratory on a popular infusion pump on the market, and also propose defenses against such attacks.

  10. An alternative for rapid administration of medication and fluids in the emergency setting using a novel device.

    Science.gov (United States)

    Lyons, Neal; Nejak, Daniel; Lomotan, Nadine; Mokszycki, Robert; Jamieson, Stephen; McDowell, Marc; Kulstad, Erik

    2015-08-01

    Routes of administration for medications and fluids in the acute care setting have primarily focused on oral, intravenous, or intraosseous routes, but, in many patients, none of these routes is optimal. A novel device (Macy Catheter; Hospi Corp) that offers an easy route for administration of medications or fluids via rectal mucosal absorption (proctoclysis) has recently become available in the palliative care market; we describe here the first known uses of this device in the emergency setting. Three patients presenting to the hospital with conditions limiting more typical routes of medication or fluid administration were treated with this new device; patients were administered water for hydration, lorazepam for treatment of alcohol withdrawal, ondansetron for nausea, acetaminophen for fever, aspirin for antiplatelet effect, and methimazole for hyperthyroidism. Placement of the device was straightforward, absorption of administered medications (judged by immediacy of effects, where observable) was rapid, and use of the device was well tolerated by patients, suggesting that this device may be an appealing alternative route to medication and fluid administration for a variety of indications in acute and critical care settings.

  11. 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.

  12. 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.

  13. 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.

  14. 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…

  15. Virtual Charter Schools: Realities and Unknowns

    Science.gov (United States)

    Torre, Daniela

    2013-01-01

    Virtual charter schools have emerged over the last decade as an increasingly popular alternative to traditional public schooling. Unlike their face-to-face counterparts, virtual charter schools educate students through blended or entirely online curricula. They present a host of new policy issues that should be scrutinized in order to ensure that…

  16. 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…

  17. The Story of a Charter School Closure.

    Science.gov (United States)

    Flynn, Susan L.; Arguelles, Lourdes

    2001-01-01

    The story of a charter school closure is told from the perspectives of students, parents, teachers, and community members, who felt that the sponsoring district revoked the charter for political reasons despite broad local support. The experience underscores the necessity of publicly subjecting the relationship of the public school system and the…

  18. 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…

  19. 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…

  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. Teacher Accountability at High Performing Charter Schools

    Science.gov (United States)

    Aguirre, Moises G.

    2016-01-01

    This study will examine the teacher accountability and evaluation policies and practices at three high performing charter schools located in San Diego County, California. Charter schools are exempted from many laws, rules, and regulations that apply to traditional school systems. By examining the teacher accountability systems at high performing…

  2. 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…

  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. 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

  5. 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

  6. Promoting interdisciplinary project-based learning to build the skill sets for research and development of medical devices in academia.

    Science.gov (United States)

    Krishnan, Shankar

    2013-01-01

    The worldwide need for rapid expansion and diversification of medical devices and the corresponding requirements in industry pose arduous challenges for educators to train undergraduate biomedical engineering (BME) students. Preparing BME students for working in the research and development (R&D) in medical device industry is not easily accomplished by adopting traditional pedagogical methods. Even with the inclusion of the design and development elements in capstone projects, medical device industry may be still experience a gap in fulfilling their needs in R&D. This paper proposes a new model based on interdisciplinary project-based learning (IDPBL) to address the requirements of building the necessary skill sets in academia for carrying out R&D in medical device industry. The proposed model incorporates IDPBL modules distributed in a stepwise fashion through the four years of a typical BME program. The proposed model involves buy-in and collaboration from faculty as well as students. The implementation of the proposed design in an undergraduate BME program is still in process. However, a variant of the proposed IDPBL method has been attempted at a limited scale at the postgraduate level and has shown some success. Extrapolating the previous results, the adoption of the IDPBL to BME training seems to suggest promising outcomes. Despite numerous implementation challenges, with continued efforts, the proposed IDPBL will be valuable n academia for skill sets building for medical device R&D.

  7. Mutual Recognition of the Food and Drug Administration and European Community Member State Conformity Assessment Procedures; pharmaceutical GMP inspection reports, medical device quality system evaluation reports, and certain medical device premarket evaluation reports--FDA. Proposed rule.

    Science.gov (United States)

    1998-04-10

    The Food and Drug Administration (FDA) is proposing to amend its regulations pursuant to an international agreement that is expected to be concluded between the United States and the European Community (EC) (Ref. 1). Under the terms of that agreement, FDA may normally endorse good manufacturing practice (GMP) inspection reports for pharmaceuticals provided by equivalent EC Member State regulatory authorities and medical device quality system evaluation reports and certain medical device premarket evaluation reports provided by equivalent conformity assessment bodies. FDA is taking this action to enhance its ability to ensure the safety and efficacy of pharmaceuticals and medical devices through more efficient and effective utilization of its regulatory resources. The agency is requesting comments on the proposed rule.

  8. 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.

  9. A medical application integrating remote 3D visualization tools to access picture archiving and communication system on mobile devices.

    Science.gov (United States)

    He, Longjun; Ming, Xing; Liu, Qian

    2014-04-01

    With computing capability and display size growing, the mobile device has been used as a tool to help clinicians view patient information and medical images anywhere and anytime. However, for direct interactive 3D visualization, which plays an important role in radiological diagnosis, the mobile device cannot provide a satisfactory quality of experience for radiologists. This paper developed a medical system that can get medical images from the picture archiving and communication system on the mobile device over the wireless network. In the proposed application, the mobile device got patient information and medical images through a proxy server connecting to the PACS server. Meanwhile, the proxy server integrated a range of 3D visualization techniques, including maximum intensity projection, multi-planar reconstruction and direct volume rendering, to providing shape, brightness, depth and location information generated from the original sectional images for radiologists. Furthermore, an algorithm that changes remote render parameters automatically to adapt to the network status was employed to improve the quality of experience. Finally, performance issues regarding the remote 3D visualization of the medical images over the wireless network of the proposed application were also discussed. The results demonstrated that this proposed medical application could provide a smooth interactive experience in the WLAN and 3G networks.

  10. Medical devices; obstetrical and gynecological devices; classification of the assisted reproduction embryo image assessment system. Final order.

    Science.gov (United States)

    2015-02-26

    The Food and Drug Administration (FDA) is classifying the Assisted Reproduction Embryo Image Assessment 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 Assisted Reproduction Embryo Image Assessment 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.

  11. 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.

  12. Explaining Charter School Effectiveness. NBER Working Paper No. 17332

    Science.gov (United States)

    Angrist, Joshua D.; Pathak, Parag A.; Walters, Christopher R.

    2011-01-01

    Estimates using admissions lotteries suggest that urban charter schools boost student achievement, while charter schools in other settings do not. We explore student-level and school-level explanations for these differences using a large sample of Massachusetts charter schools. Our results show that urban charter schools boost achievement well…

  13. For Grades or Money? Charter School Failure in North Carolina

    Science.gov (United States)

    Paino, Maria; Renzulli, Linda A.; Boylan, Rebecca L.; Bradley, Christen L.

    2014-01-01

    Purpose: Charter schools are unique public schools in part because this type of school can close if it fails to meet objectives set forth by the chartering body that approved it. Thus far, however, little research has been conducted into the causes of charter school closures. In this article, we examine charter school accountability. Research…

  14. Mobile phones as medical devices in mental disorder treatment: an overview

    DEFF Research Database (Denmark)

    Gravenhorst, Franz; Muaremi, Amir; Bardram, Jakob

    2015-01-01

    advantages and drawbacks of the most promising mobile phone technologies for detecting mood disorders like depression or bipolar disorder. Finally, we discuss practical implementation details, legal issues and business models for the introduction of mobile phones as medical devices.......Mental disorders can have a significant, negative impact on sufferers’ lives, as well as on their friends and family, healthcare systems and other parts of society. Approximately 25 % of all people in Europe and the USA experience a mental disorder at least once in their lifetime. Currently......, monitoring mental disorders relies on subjective clinical self-reporting rating scales, which were developed more than 50 years ago. In this paper, we discuss how mobile phones can support the treatment of mental disorders by (1) implementing human–computer interfaces to support therapy and (2) collecting...

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

    DEFF Research Database (Denmark)

    Hollander, Jenny; Genina, Natalja; Jukarainen, Harri

    2016-01-01

    The goal of the present study was to fabricate drug-containing T-shaped prototypes of intrauterine system (IUS) with the drug incorporated within the entire backbone of the medical device using 3-dimensional (3D) printing technique, based on fused deposition modeling (FDM™). Indomethacin was used...... 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...... 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...

  16. Antimicrobial Treatment of Polymeric Medical Devices by Silver Nanomaterials and Related Technology

    Science.gov (United States)

    Polívková, Markéta; Hubáček, Tomáš; Staszek, Marek; Švorčík, Václav; Siegel, Jakub

    2017-01-01

    Antimicrobial biocompatible polymers form a group of highly desirable materials in medicinal technology that exhibit interesting thermal and mechanical properties, and high chemical resistance. There are numerous types of polymers with antimicrobial activity or antimicrobial properties conferred through their proper modification. In this review, we focus on the second type of polymers, especially those whose antimicrobial activity is conferred by nanotechnology. Nanotechnology processing is a developing area that exploits the antibacterial effects of broad-scale compounds, both organic and inorganic, to form value-added medical devices. This work gives an overview of nanostructured antimicrobial agents, especially silver ones, used together with biocompatible polymers as effective antimicrobial composites in healthcare. The bactericidal properties of non-conventional antimicrobial agents are compared with those of conventional ones and the advantages and disadvantages are discussed. PMID:28212308

  17. 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.

  18. Generating appropriate clinical data for value assessment of medical devices: what role does regulation play?

    Science.gov (United States)

    Tarricone, Rosanna; Torbica, Aleksandra; Ferré, Francesca; Drummond, Mike

    2014-10-01

    Assessing the value of health technologies, through health technology assessment is critically dependent on the existence of relevant and robust clinical data on the efficacy, safety and ideally, effectiveness of the technologies concerned. However, in the case of medical devices, such clinical data may not always be available, because of the different nature of the regulatory requirements in different jurisdictions. Therefore, we conducted a systematic review of the regulatory requirements in seven major jurisdictions in order to identify current challenges and to suggest possible improvements. There are differences in the requirements across jurisdictions and in the balance between pre-market and post-market controls. Several improvements are required in order to generate adequate clinical data for health technology assessment.

  19. Research and development of metals for medical devices based on clinical needs

    Directory of Open Access Journals (Sweden)

    Takao Hanawa

    2012-01-01

    Full Text Available The current research and development of metallic materials used for medicine and dentistry is reviewed. First, the general properties required of metals used in medical devices are summarized, followed by the needs for the development of α + β type Ti alloys with large elongation and β type Ti alloys with a low Young's modulus. In addition, nickel-free Ni–Ti alloys and austenitic stainless steels are described. As new topics, we review metals that are bioabsorbable and compatible with magnetic resonance imaging. Surface treatment and modification techniques to improve biofunctions and biocompatibility are categorized, and the related problems are presented at the end of this review. The metal surface may be biofunctionalized by various techniques, such as dry and wet processes. These techniques make it possible to apply metals to scaffolds in tissue engineering.

  20. Research and development of metals for medical devices based on clinical needs

    Science.gov (United States)

    Hanawa, Takao

    2012-12-01

    The current research and development of metallic materials used for medicine and dentistry is reviewed. First, the general properties required of metals used in medical devices are summarized, followed by the needs for the development of α + β type Ti alloys with large elongation and β type Ti alloys with a low Young's modulus. In addition, nickel-free Ni-Ti alloys and austenitic stainless steels are described. As new topics, we review metals that are bioabsorbable and compatible with magnetic resonance imaging. Surface treatment and modification techniques to improve biofunctions and biocompatibility are categorized, and the related problems are presented at the end of this review. The metal surface may be biofunctionalized by various techniques, such as dry and wet processes. These techniques make it possible to apply metals to scaffolds in tissue engineering.

  1. [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.

  2. 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.

  3. 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?

  4. [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.

  5. Biofilm removal by medical device cleaners: comparison of two bioreactor detection assays.

    Science.gov (United States)

    Hadi, R; Vickery, K; Deva, A; Charlton, T

    2010-02-01

    Currently there are no standards for testing efficacy of medical device cleaners. With fears of prion transmission, residual protein on medical devices needs to be minimised. A bioreactor model was used to grow Pseudomonas aeruginosa biofilm on polytetrafluoroethylene coupons. The biofilm was subjected to various cleaners and residual biofilm was detected either by Crystal Violet assay (CrV) or a commercially available protein assay (PA) following hydrolysis of the biofilm. Percentage reduction of biofilm was compared with untreated controls in three independent tests. There was no significant difference in percentage biofilm reduction irrespective of whether the CrV or PA was used to detect residual biofilm. Processing of coupons attached to the bioreactor rod and position of coupon within the rod had no significant effect on cleaning efficiency or detection of residual biofilm. Both within-run and between-run variation was very low for good cleaners such as 10g/L NaOH, Zen, and 3M Rapid Multi-Enzyme Cleaner (RMEC) 70500 but was higher for poor cleaners such as Tween 20 which removed less than 20% of the biofilm. Confocal microscopy and electron microscopy provided visual confirmation of the assay results. We propose that this method is suitable as a test method for evaluating the efficacy of surgical instrument cleaners in removing biofilm, as both within-run and between-run variation was low, detection of residual biofilm can be done using either CrV or PA, and the apparatus is easy to use, cheap and readily available.

  6. Review and state of the art on radiation sterilization of medical devices

    Science.gov (United States)

    Dorpema, J. W.

    Review and state of art of radiation sterilization Radiation as a sterilization method was designed in the years 1950-1960. The decade afterwards the application for sterilization of medical products and devices was developped. Extensive studies performed on both the physical, chemical and (micro) biological aspects revealed the requirements for safety and efficacy. These efforts were highly stimulated by the IAEA and resulted in a elegant sterilization method. In product manufacturing, where sterilization represents a final step in the production sequence, radiation has eversince reached its widest application in the field of medical devices. As a spin off it initiated new ideas and approaches towards sterilization in general. Consequently sterility was redefined in terms of a probabilistic concept (10-6) and the bioburden determination method was introduced as a tool for both quality control and potential instrument for dose setting. However these refinements also created controversies, whereby the dose requirements became divided for Europe and North America. Moreover studies recently performed in Europe suggest even a further extension of this opinion gap. Detailed studies, on the clinical effects of low dose treated products (12.5 - 17.5 kGy) are needed to counterbalance the dose suggestions extracted from statistically based dose determinations (> 28 kGy ) and the microbiological resistance determinations ( > 28 - 30 kGy). Dose setting based on risk classification could be considered for distinct product categories. In the mean time a general acceptance of the originally, in the early seventhies, established minimum dose of 25 kGy would seem a reasonable compromise. As the interest for radiation sterilization as the favourable, non polluting and simple method is increasing rapidly over the last five years, both gamma- and beta driven sterilization plants will be needed. Harmonization on sterilization dose therfore requires high priority.

  7. 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.

  8. 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.

  9. Examining the link between cash flow, market value, and research and development investment spending in the medical device industry.

    Science.gov (United States)

    Schmutz, Bryan P; Santerre, Rexford E

    2013-02-01

    Unlike the pharmaceutical industry, no empirical research has focused on the factors influencing research and development (R&D) spending in the medical device industry. To fill that gap, this study examines how R&D spending is influenced by prior year cash flow and corporate market value using multiple regression analysis and a panel data set of medical device companies over the period 1962-2008. The empirical findings suggest that the elasticities of R&D spending with respect to cash flow and corporate market value equal 0.58 and 0.31, respectively. Moreover, based upon these estimates, simulations show that the recently enacted excise tax on medical devices, taken alone, will reduce R&D spending by approximately $4 billion and thereby lead to a minimum loss of $20 billion worth of human life years over the first 10 years of its enactment.

  10. Medical Devices; Immunology and Microbiology Devices; Classification of Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assay. Final order.

    Science.gov (United States)

    2015-11-02

    The Food and Drug Administration (FDA) is classifying a gastrointestinal microorganism multiplex nucleic acid-based assay into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

  11. Compensating for Tissue Changes in an Ultrasonic Power Link for Implanted Medical Devices.

    Science.gov (United States)

    Vihvelin, Hugo; Leadbetter, Jeff; Bance, Manohar; Brown, Jeremy A; Adamson, Robert B A

    2016-04-01

    Ultrasonic power transfer using piezoelectric devices is a promising wireless power transfer technology for biomedical implants. However, for sub-dermal implants where the separation between the transmitter and receiver is on the order of several acoustic wavelengths, the ultrasonic power transfer efficiency (PTE) is highly sensitive to the distance between the transmitter and receiver. This sensitivity can cause large swings in efficiency and presents a serious limitation on battery life and overall performance. A practical ultrasonic transcutaneous energy transfer (UTET) system design must accommodate different implant depths and unpredictable acoustic changes caused by tissue growth, hydration, ambient temperature, and movement. This paper describes a method used to compensate for acoustic separation distance by varying the transmit (Tx) frequency in a UTET system. In a benchtop UTET system we experimentally show that without compensation, power transfer efficiency can range from 9% to 25% as a 5 mm porcine tissue sample is manipulated to simulate in situ implant conditions. Using an active frequency compensation method, we show that the power transfer efficiency can be kept uniformly high, ranging from 20% to 27%. The frequency compensation strategy we propose is low-power, non-invasive, and uses only transmit-side measurements, making it suitable for active implanted medical device applications.

  12. Embedded Control in Wearable Medical Devices: Application to the Artificial Pancreas

    Directory of Open Access Journals (Sweden)

    Stamatina Zavitsanou

    2016-09-01

    Full Text Available Significant increases in processing power, coupled with the miniaturization of processing units operating at low power levels, has motivated the embedding of modern control systems into medical devices. The design of such embedded decision-making strategies for medical applications is driven by multiple crucial factors, such as: (i guaranteed safety in the presence of exogenous disturbances and unexpected system failures; (ii constraints on computing resources; (iii portability and longevity in terms of size and power consumption; and (iv constraints on manufacturing and maintenance costs. Embedded control systems are especially compelling in the context of modern artificial pancreas systems (AP used in glucose regulation for patients with type 1 diabetes mellitus (T1DM. Herein, a review of potential embedded control strategies that can be leveraged in a fully-automated and portable AP is presented. Amongst competing controllers, emphasis is provided on model predictive control (MPC, since it has been established as a very promising control strategy for glucose regulation using the AP. Challenges involved in the design, implementation and validation of safety-critical embedded model predictive controllers for the AP application are discussed in detail. Additionally, the computational expenditure inherent to MPC strategies is investigated, and a comparative study of runtime performances and storage requirements among modern quadratic programming solvers is reported for a desktop environment and a prototype hardware platform.

  13. The impact of HTA and procurement practices on the selection and prices of medical devices.

    Science.gov (United States)

    Callea, Giuditta; Armeni, Patrizio; Marsilio, Marta; Jommi, Claudio; Tarricone, Rosanna

    2017-02-01

    Technological innovation in healthcare yields better health outcomes but also drives healthcare expenditure, and governments are struggling to maintain an appropriate balance between patient access to modern care and the economic sustainability of healthcare systems. Health Technology Assessment (HTA) and centralized procurement are increasingly used to govern the introduction and diffusion of new technologies in an effort to make access to innovation financially sustainable. However, little empirical evidence is available to determine how they affect the selection of new technologies and unit prices. This paper focuses on medical devices (MDs) and investigates the combined effect of various HTA governance models and procurement practices on the two steps of the MD purchasing process (i.e., selecting the product and setting the unit price). Our analyses are based on primary data collected through a national survey of Italian public hospitals. The Italian National Health Service is an ideal case study because it is highly decentralized and because regions have adopted different HTA governance models (i.e., regional, hospital-based, double-level or no HTA), often in combination with centralized regional procurement programs. Hence, the Italian case allows us to test the impact of different combinations of HTA models and procurement programs in the various regions. The results show that regional HTA increases the probability of purchasing the costliest devices, whereas hospital-based HTA functions more like a cost-containment unit. Centralized regional procurement does not significantly affect MD selection and is associated with a reduction in the MD unit price: on average, hospitals located in regions with centralized procurement pay 10.1% less for the same product. Hospitals located in regions with active regional HTA programs pay higher prices for the same device (+23.2% for inexpensive products), whereas hospitals that have developed internal HTA programs pay 8

  14. 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

  15. Corruption in the health care sector: A barrier to access of orthopaedic care and medical devices in Uganda

    Science.gov (United States)

    2012-01-01

    Background Globally, injuries cause approximately as many deaths per year as HIV/AIDS, tuberculosis and malaria combined, and 90% of injury deaths occur in low- and middle- income countries. Given not all injuries kill, the disability burden, particularly from orthopaedic injuries, is much higher but is poorly measured at present. The orthopaedic services and orthopaedic medical devices needed to manage the injury burden are frequently unavailable in these countries. Corruption is known to be a major barrier to access of health care, but its effects on access to orthopaedic services is still unknown. Methods A qualitative case study of 45 open-ended interviews was conducted to investigate the access to orthopaedic health services and orthopaedic medical devices in Uganda. Participants included orthopaedic surgeons, related healthcare professionals, industry and government representatives, and patients. Participants’ experiences in accessing orthopaedic medical devices were explored. Thematic analysis was used to analyze and code the transcripts. Results Analysis of the interview data identified poor leadership in government and corruption as major barriers to access of orthopaedic care and orthopaedic medical devices. Corruption was perceived to occur at the worker, hospital and government levels in the forms of misappropriation of funds, theft of equipment, resale of drugs and medical devices, fraud and absenteeism. Other barriers elicited included insufficient health infrastructure and human resources, and high costs of orthopaedic equipment and poverty. Conclusions This study identified perceived corruption as a significant barrier to access of orthopaedic care and orthopaedic medical devices in Uganda. As the burden of injury continues to grow, the need to combat corruption and ensure access to orthopaedic services is imperative. Anti-corruption strategies such as transparency and accountability measures, codes of conduct, whistleblower protection, and higher

  16. 77 FR 59137 - Chartering and Field of Membership Manual for Federal Credit Unions

    Science.gov (United States)

    2012-09-26

    ... the public comments submitted. You may inspect paper copies of comments in NCUA's law library at 1775... living in the rural area may periodically travel to that small hub for shopping, entertainment, medical... charters, FCUs serving more populated rural districts must develop business and marketing plans...

  17. 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.

  18. Anodizing color coded anodized Ti6Al4V medical devices for increasing bone cell functions

    Directory of Open Access Journals (Sweden)

    Webster TJ

    2013-01-01

    Full Text Available Alexandra P Ross, Thomas J WebsterSchool of Engineering and Department of Orthopedics, Brown University, Providence, RI, USAAbstract: Current titanium-based implants are often anodized in sulfuric acid (H2SO4 for color coding purposes. However, a crucial parameter in selecting the material for an orthopedic implant is the degree to which it will integrate into the surrounding bone. Loosening at the bone–implant interface can cause catastrophic failure when motion occurs between the implant and the surrounding bone. Recently, a different anodization process using hydrofluoric acid has been shown to increase bone growth on commercially pure titanium and titanium alloys through the creation of nanotubes. The objective of this study was to compare, for the first time, the influence of anodizing a titanium alloy medical device in sulfuric acid for color coding purposes, as is done in the orthopedic implant industry, followed by anodizing the device in hydrofluoric acid to implement nanotubes. Specifically, Ti6Al4V model implant samples were anodized first with sulfuric acid to create color-coding features, and then with hydrofluoric acid to implement surface features to enhance osteoblast functions. The material surfaces were characterized by visual inspection, scanning electron microscopy, contact angle measurements, and energy dispersive spectroscopy. Human osteoblasts were seeded onto the samples for a series of time points and were measured for adhesion and proliferation. After 1 and 2 weeks, the levels of alkaline phosphatase activity and calcium deposition were measured to assess the long-term differentiation of osteoblasts into the calcium depositing cells. The results showed that anodizing in hydrofluoric acid after anodizing in sulfuric acid partially retains color coding and creates unique surface features to increase osteoblast adhesion, proliferation, alkaline phosphatase activity, and calcium deposition. In this manner, this study

  19. Anodizing color coded anodized Ti6Al4V medical devices for increasing bone cell functions.

    Science.gov (United States)

    Ross, Alexandra P; Webster, Thomas J

    2013-01-01

    Current titanium-based implants are often anodized in sulfuric acid (H(2)SO(4)) for color coding purposes. However, a crucial parameter in selecting the material for an orthopedic implant is the degree to which it will integrate into the surrounding bone. Loosening at the bone-implant interface can cause catastrophic failure when motion occurs between the implant and the surrounding bone. Recently, a different anodization process using hydrofluoric acid has been shown to increase bone growth on commercially pure titanium and titanium alloys through the creation of nanotubes. The objective of this study was to compare, for the first time, the influence of anodizing a titanium alloy medical device in sulfuric acid for color coding purposes, as is done in the orthopedic implant industry, followed by anodizing the device in hydrofluoric acid to implement nanotubes. Specifically, Ti6Al4V model implant samples were anodized first with sulfuric acid to create color-coding features, and then with hydrofluoric acid to implement surface features to enhance osteoblast functions. The material surfaces were characterized by visual inspection, scanning electron microscopy, contact angle measurements, and energy dispersive spectroscopy. Human osteoblasts were seeded onto the samples for a series of time points and were measured for adhesion and proliferation. After 1 and 2 weeks, the levels of alkaline phosphatase activity and calcium deposition were measured to assess the long-term differentiation of osteoblasts into the calcium depositing cells. The results showed that anodizing in hydrofluoric acid after anodizing in sulfuric acid partially retains color coding and creates unique surface features to increase osteoblast adhesion, proliferation, alkaline phosphatase activity, and calcium deposition. In this manner, this study provides a viable method to anodize an already color coded, anodized titanium alloy to potentially increase bone growth for numerous implant applications.

  20. Hawaii Charter Fishing Cost Earnings Survey 2012

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — These data represent a cost-earnings study of the main Hawaiian Island Charter fishing fleet in 2012. Data collected include fisher classification, vessel...

  1. 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.

  2. 77 FR 52741 - MDEpiNet 2012 Annual Meeting: The Medical Device Epidemiology Network as a Partnership for...

    Science.gov (United States)

    2012-08-30

    .../mdepinet ). By bridging evidentiary gaps, developing datasets, and innovating methodological approaches for conducting robust analytic studies, MDEpiNet aims to develop new ways to study medical devices that improve... and synthesis across the Total Product Life Cycle. This public workshop is open to all...

  3. 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...

  4. 77 FR 16036 - Guidance for Industry, Third Parties and Food and Drug Administration Staff; Medical Device ISO...

    Science.gov (United States)

    2012-03-19

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry, Third Parties and Food and Drug...--Requirements for regulatory purposes,'' (ISO 13485:2003) audit report provides FDA a degree of assurance of... GHTF founding members auditing systems include: The Canadian Medical Devices Conformity...

  5. 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...

  6. 76 FR 6623 - Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of Meeting

    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 Molecular and Clinical Genetics Panel of the Medical Devices... (FDA). The meeting will be open to the public. Name of Committee: Molecular and Clinical Genetics...

  7. Using Mobile Devices for Learning in Clinical Settings: A Mixed-Methods Study of Medical Student, Physician and Patient Perspectives

    Science.gov (United States)

    Scott, Karen M.; Nerminathan, Arany; Alexander, Shirley; Phelps, Megan; Harrison, Amanda

    2017-01-01

    This study was conducted with medical students, physicians, patients and carers in a paediatric and an adult hospital to determine use of mobile devices for learning, and beliefs and attitudes about others' use. Awareness of ethical, patient privacy and data security concerns was explored. The research was conducted using a mixed-methods…

  8. 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...

  9. Overcoming the Challenges of Conducting Early Feasibility Studies of Medical Devices in the United States.

    Science.gov (United States)

    Holmes, David R; Califf, Robert; Farb, Andrew; Abel, Dorothy; Mack, Michael; Syrek Jensen, Tamara; Zuckerman, Bram; Leon, Martin; Shuren, Jeff

    2016-10-25

    Initial clinical studies of new medical technologies involve a complex balance of research participant benefits versus risks and costs of uncertainty when novel concepts are tested. The Food and Drug Administration Center for Devices and Radiological Health has recently introduced the Early Feasibility Study (EFS) Program for facilitating the conduct of these studies under the Investigational Device Exemption regulations. However, a systematic approach is needed to successfully implement this program while affording appropriate preservation of the rights and interests of patients. For this to succeed, a holistic reform of the clinical studies ecosystem for performing early-stage clinical research in the United States is necessary. The authors review the current landscape of the U.S. EFS and make recommendations for developing an efficient EFS process to meet the goal of improving access to early-stage, potentially beneficial medical devices in the United States.

  10. 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

  11. 76 FR 34845 - Medical Devices; Ear, Nose, and Throat Devices; Classification of the Wireless Air-Conduction...

    Science.gov (United States)

    2011-06-15

    ... wireless air-conduction hearing aid, and it is identified as a wearable sound-amplifying device, intended to compensate for impaired hearing, that incorporates wireless technology in its programming or use... function due to Wireless technology design, wireless technology disruption such as description, and...

  12. Analysis of PVC plasticizers in medical devices and infused solutions by GC-MS.

    Science.gov (United States)

    Bourdeaux, Daniel; Yessaad, Mouloud; Chennell, Philip; Larbre, Virginie; Eljezi, Teuta; Bernard, Lise; Sautou, Valerie

    2016-01-25

    In 2008, di-(2-ethylhexyl) phthalate (DEHP), was categorized as CMR 1B under the CLP regulations and its use in PVC medical devices (MD) was called into question by the European authorities. This resulted in the commercialization of PVC MDs plasticized with the DEHP alternative plasticizers tri-octyl trimellitate (TOTM), di-(2-ethylhexyl) terephthalate (DEHT), di-isononyl cyclohexane-1,2-dicarboxylate (DINCH), di-isononyl phthalate (DINP), di-(2-ethylhexy) adipate (DEHA), and Acetyl tri-n-butyl citrate (ATBC). The data available on the migration of these plasticizers from the MDs are too limited to ensure their safe use. We therefore developed a versatile GC-MS method to identify and quantify both these newly used plasticizers and DEHP in MDs and to assess their migration abilities in simulant solution. The use of cubic calibration curves and the optimization of the analytical method by an experimental plan allowed us to lower the limit of plasticizer quantification. It also allowed wide calibration curves to be established that were adapted to this quantification in MDs during migration tests, irrespective of the amount present, and while maintaining good precision and accuracy. We then tested the developed method on 32 PVC MDs used in our hospital and evaluated the plasticizer release from a PVC MD into a simulant solution during a 24h migration test. The results showed a predominance of TOTM in PVC MDs accompanied by DEHP (plasticizers and a non-linear kinetic release.

  13. Analytical methods for the determination of DEHP plasticizer alternatives present in medical devices: a review.

    Science.gov (United States)

    Bernard, L; Décaudin, B; Lecoeur, M; Richard, D; Bourdeaux, D; Cueff, R; Sautou, V

    2014-11-01

    Until 2010, diethylhexylphthalate (DEHP) was the plasticizer most commonly used to soften PVC medical devices (MDs), because of a good efficiency/cost ratio. In flexible plasticized PVC, phthalates are not chemically bound to PVC and they are released into the environment and thus may come into contact with patients. The European Directive 2007/47/CE, classified DEHP as a product with a toxicity risk and restricted its use in MDs. MD manufacturers were therefore forced to quickly find alternatives to DEHP to maintain the elasticity of PVC nutrition tubings, infusion sets and hemodialysis lines. Several replacement plasticizers, so-called "alternative to DEHP plasticizers" were incorporated into the MDs. Nowadays, the risk of exposure to these compounds for hospitalized patients, particularly in situations classified "at risk", has not yet been evaluated, because migrations studies, providing sufficient exposure and human toxicity data have not been performed. To assess the risk to patients of DEHP plasticizer alternatives, reliable analytical methods must be first developed in order to generate data that supports clinical studies being conducted in this area. After a brief introduction of the characteristics and toxicity of the selected plasticizers used currently in MDs, this review outlines recently analytical methods available to determine and quantify these plasticizers in several matrices, allowing the evaluation of potential risk and so risk management.

  14. Migrability of PVC plasticizers from medical devices into a simulant of infused solutions.

    Science.gov (United States)

    Bernard, L; Cueff, R; Breysse, C; Décaudin, B; Sautou, V

    2015-05-15

    Medical devices (MD) for infusion and artificial nutrition are essentially made of plasticized PVC. The plasticizers in the PVC matrix can leach out into the infused solutions and may enter into contact with the patients. In order to assess the risk of patient exposure to these plasticizers we evaluated the migration performance of DEHP, DEHT, DINCH, and TOTM using a model adapted to the clinical use of the MDs. Each PVC tubing sample was immersed in a simulant consisting of a mixture of ethanol/water (50/50v/v) at 40°C and migration tests were carried out after 24h, 72h, and 10 days.DEHP had the highest migration ability, which increased over time. The amount of TOTM released was more than 20 times less than that of DEHP, which makes it an interesting alternative. DEHT is also promising, with a migration level three times smaller than DEHP. However, the migration ability of DINCH was similar to DEHP, with the released amounts equaling 1/8th of the initial amount in the tubing after 24h of contact. Taking into account the available toxicological data, TOTM and DEHT appear to be of particular interest. However, these data should be supplemented and correlated with clinical and toxicological studies on plasticizers and their metabolites.

  15. 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.

  16. 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.

  17. Regulating the economic evaluation of pharmaceuticals and medical devices: a European perspective.

    Science.gov (United States)

    Cookson, Richard; Hutton, John

    2003-02-01

    Throughout the developed world, economic evaluation of costly new pharmaceuticals and medical devices became increasingly widespread and systematic during the 1990s. However, serious concerns remain about the validity and relevance of this economic evidence, and about the transparency and accountability of its use in public sector reimbursement decisions. In this article, we summarise current concerns in Europe, based on interviews with European health economists from industry, universities, research institutes and consulting firms. We identify five challenges for European policy-makers, and conclude that there is considerable scope for improving decision-making without damaging incentives to innovate. The challenges are: (1). full publication of the economic evidence used in reimbursement decisions; (2). the redesign of licensing laws to improve the relevance of economic data available at product launch; (3). harmonisation of economic evaluation methodologies; (4). development of methodologies for evaluation of health inequality impacts; and (5). negotiation of price-performance deals to facilitate the use of economic evidence in post-launch pricing review decisions, as information is gathered from studies of product performance in routine use.

  18. 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.

  19. 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.

  20. Special funding schemes for innovative medical devices in French hospitals: the pros and cons of two different approaches.

    Science.gov (United States)

    Martelli, Nicolas; van den Brink, Hélène

    2014-07-01

    Financing innovative medical devices is an important challenge for national health policy makers, and a crucial issue for hospitals. However, when innovative medical devices are launched on the European market there is generally little clinical evidence regarding both efficacy and safety, both because of the flaws in the European system for regulating such devices, and because they are at an early stage of development. To manage the uncertainty surrounding the reimbursement of innovation, several European countries have set up temporary funding schemes to generate evidence about the effectiveness of devices. This article explores two different French approaches to funding innovative in-hospital devices and collecting supplementary data: the coverage with evidence development (CED) scheme introduced under Article L. 165-1-1 of the French Social Security Code; and national programs for hospital-based research. We discuss pros and cons of both approaches in the light of CED policies in Germany and the UK. The CED policies for devices share common limitations. Thus, transparency of CED processes should be enhanced and decisions need to be made in a timely way. Finally, we think that closer collaboration between manufacturers, health authorities and hospitals is essential to make CED policies more operational.

  1. Medical device-related hospital-acquired pressure ulcers: development of an evidence-based position statement.

    Science.gov (United States)

    Pittman, Joyce; Beeson, Terrie; Kitterman, Jessica; Lancaster, Shelley; Shelly, Anita

    2015-01-01

    Hospital-acquired pressure ulcers (HAPUs) are a problem in the acute care setting causing pain, loss of function, infection, extended hospital stay, and increased costs. In spite of best practice strategies, occurrences of pressure ulcers continue. Many of these HAPUs are related to a medical device. Correct assessment and reporting of device-related HAPUs were identified as an important issue in our organization. Following the Iowa Model for Evidence-Based Practice to Promote Quality Care, a task force was created, a thorough review of current evidence and clinical practice recommendations was performed, and a definition for medical device-related HAPU and an evidence-based position statement were developed. Content of the statement was reviewed by experts and appropriate revisions were made. This position statement provides guidance and structure to accurately identify and report device-related HAPU across our 18 healthcare facilities. Through the intentional focus on pressure ulcer prevention and evidence-based practice in our organization and the use of this position statement, identification and reporting of device-related HAPUs have improved with a decrease in overall HAPU rates of 33% from 2011 and 2012. This article describes the development and implementation of this device-related HAPU position statement within our organization.

  2. The Black Charter School Effect: Black Students in American Charter Schools

    Science.gov (United States)

    Almond, Monica R.

    2012-01-01

    This literature analysis examines the experiences of Black students in public charter schools in the United States by analyzing the current literature and enrollment data in this domain. Through the investigation of multiple empirical studies that examine the effects of charter schools on the academic achievement and enrollment trends of Black…

  3. 77 FR 44595 - Application for New Awards; Charter Schools Program (CSP)-Charter School Exemplary Collaboration...

    Science.gov (United States)

    2012-07-30

    ..., such as student scores on pre-tests and end-of-course tests; student performance on English language... disabilities, English learners, student transportation, professional development and training, and school... public charter schools and charter school LEAs, and sustained over the long-term. (e) Innovation (up...

  4. 77 FR 44475 - Final Definitions, Requirements, and Selection Criteria; Charter Schools Program (CSP)-Charter...

    Science.gov (United States)

    2012-07-30

    ... access to charter schools by students with disabilities'' and ``English learners.'' Definitions Comment... pre-tests and end-of-course tests; student performance on English language proficiency assessments... charter school LEAs, and sustained over the long-term. (5) Innovation. The extent to which the...

  5. 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.

  6. 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

  7. Precautionary practices of healthcare workers who disinfect medical and dental devices using high-level disinfectants.

    Science.gov (United States)

    Henn, Scott A; Boiano, James M; Steege, Andrea L

    2015-02-01

    BACKGROUND High-level disinfectants (HLDs) are used throughout the healthcare industry to chemically disinfect reusable, semicritical medical and dental devices to control and prevent healthcare-associated infections among patient populations. Workers who use HLDs are at risk of exposure to these chemicals, some of which are respiratory and skin irritants and sensitizers. OBJECTIVE To evaluate exposure controls used and to better understand impediments to healthcare workers using personal protective equipment while handling HLDs. DESIGN Web-based survey. PARTICIPANTS A targeted sample of members of professional practice organizations representing nurses, technologists/technicians, dental professionals, respiratory therapists, and others who reported handling HLDs in the previous 7 calendar days. Participating organizations invited either all or a random sample of members via email, which included a hyperlink to the survey. METHODS Descriptive analyses were conducted including simple frequencies and prevalences. RESULTS A total of 4,657 respondents completed the survey. The HLDs used most often were glutaraldehyde (59%), peracetic acid (16%), and ortho-phthalaldehyde (15%). Examples of work practices or events that could increase exposure risk included failure to wear water-resistant gowns (44%); absence of standard procedures for minimizing exposure (19%); lack of safe handling training (17%); failure to wear protective gloves (9%); and a spill/leak of HLD during handling (5%). Among all respondents, 12% reported skin contact with HLDs, and 33% of these respondents reported that they did not always wear gloves. CONCLUSION Findings indicated that precautionary practices were not always used, underscoring the importance of improved employer and worker training and education regarding HLD hazards.

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

    Science.gov (United States)

    Mateescu, Mihaela; Baixe, Sébastien; Garnier, Tony; Jierry, Loic; Ball, Vincent; Haikel, Youssef; Metz-Boutigue, Marie Hélène; Nardin, Michel; Schaaf, Pierre; Etienne, Olivier; Lavalle, Philippe

    2015-01-01

    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. PMID:26659616

  9. 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.

  10. Hospital-based health technology assessment in France: A focus on medical devices.

    Science.gov (United States)

    Martelli, Nicolas; Puc, Cyril; Szwarcensztein, Karine; Beuscart, Régis; Coulonjou, Hélène; Degrassat-Théas, Albane; Dutot, Camille; Epis de Fleurian, Anne-Aurélie; Favrel-Feuillade, Florence; Hounliasso, Iliona; Lechat, Philippe; Luigi, Emmanuel; Mairot, Laurent; Nguyen, Thao; Piazza, Laurent; Roussel, Christophe; Vienney, Cécile

    2017-02-01

    Hospital-based health technology assessment (HTA) guides decisions as to whether new healthcare products should be made available within hospital structures. Its extension to medical devices (MDs) makes it possible to analyse several relevant aspects of these healthcare products in addition to their clinical value, and such evaluations are of interest to national health authorities, other healthcare establishments and industry. The aim of this work was to formulate several recommendations for a blueprint for hospital-based HTA for MDs in France. Five themes based on the work of the European Adopting hospital-based HTA in the EU (AdHopHTA) project were defined. Each member of the roundtable was then allocated a documentation task based on their experience of the theme concerned, and a literature review was carried out. An inventory of hospital-based HTA was performed and six recommendations aiming to strengthen and improve this approach were put forward: (1) encouragement of the spread of the hospital-based HTA culture and participation in communications and the promotion of this approach to hospital decision-makers; (2) adaptation of hospital-based HTA to the needs of decision-makers, taking into account the financial timetable and strategic objectives of the healthcare establishment; (3) harmonisation of the dossiers requested from industry between healthcare establishments, based on a common core; (4) promotion of the sharing of hospital-based HTA data under certain conditions, with data dissociable from the HTA report and the use of a validated methodology for the literature review; (5) creation of a composite indicator reflecting data production effort and the sharing of HTA activities, to be taken into account in the distribution of funds allocated for teaching, research and innovation missions considered of general interest; (6) the transmission of information directly from local to national level by pioneering centres. This work highlights the major issues

  11. Poly-4-hydroxybutyrate (P4HB): a new generation of resorbable medical devices for tissue repair and regeneration.

    Science.gov (United States)

    Williams, Simon F; Rizk, Said; Martin, David P

    2013-10-01

    Poly-4-hydroxybutyrate (P4HB) is a thermoplastic, linear polyester, produced by recombinant fermentation, that can be converted into a wide range of resorbable medical devices. P4HB fibers are exceptionally strong, and can be designed to provide prolonged strength retention in vivo. In 2007, the FDA cleared a monofilament suture made from P4HB for general soft tissue approximation and/or ligation. Subsequently, surgical mesh devices for hernia repair, tendon and ligament repair, and plastic and reconstructive surgery have been introduced for clinical use. This review describes the unique properties of P4HB, its clinical applications, and potential uses that are under development.

  12. Charter Schools and Race: A Lost Opportunity for Integrated Education

    Directory of Open Access Journals (Sweden)

    Erica Frankenberg

    2003-09-01

    Full Text Available Segregation patterns in the nation's charter schools are studied. After reviewing state charter legislation that directly addresses issues of racial and ethnic balance of student enrollment, we briefly examine the racial composition and segregation of the charter school population nationally. School-level analyses, aggregated by state constitute the primary method of studying segregation in charter schools. First, we look at racial composition and segregation of charter schools by state. Then, we consider the differences in segregation between non-charter public schools (or simply "public schools" for convenience and charter schools, as well as segregation within the charter school sector. We conclude with a discussion of the article's findings and recommendations to promote further racial equity in this growing sector of public schools.

  13. Charter Schools, Civil Rights and School Discipline: A Comprehensive Review

    OpenAIRE

    Losen, Daniel J.; Keith, Michael A II; Hodson, Cheri L.; Martinez, Tia E

    2016-01-01

    This report, along with the companion spreadsheet, provides the first comprehensive description ever compiled of charter school discipline. In 2011-12, every one of the nation’s 95,000 public schools was required to report its school discipline data, including charter schools. This analysis, which includes more than 5,250 charter schools, focuses on out-of-school suspension rates at the elementary and secondary levels. The report describes the extent to which suspensions meted out by charter ...

  14. Evaluating oversight of human drugs and medical devices: a case study of the FDA and implications for nanobiotechnology.

    Science.gov (United States)

    Paradise, Jordan; Tisdale, Alison W; Hall, Ralph F; Kokkoli, Efrosini

    2009-01-01

    This article evaluates the oversight of drugs and medical devices by the U.S. Food and Drug Administration (FDA) using an integration of public policy, law, and bioethics approaches and employing multiple assessment criteria, including economic, social, safety, and technological. Criteria assessment and expert elicitation are combined with existing literature, case law, and regulations in an integrative historical case studies approach. We then use our findings as a tool to explore possibilities for effective oversight and regulatory mechanisms for nanobiotechnology. Section I describes oversight mechanisms for human drugs and medical devices and presents current nanotechnology products. Section II describes the results of expert elicitation research. Section III highlights key criteria and relates them to the literature and larger debate. We conclude with broad lessons for the oversight of nanobiotechnology informed by Sections I-III in order to provide useful analysis from multiple disciplines and perspectives to guide discussions regarding appropriate FDA oversight.

  15. [Rapid detection of residual cyclohexanone in disposable medical devices by ultraviolet photoionization ion mobility spectrometry (UV-IMS)].

    Science.gov (United States)

    Li, Hu; Han, Hai-yan; Niu, Wen-qi; Wang, Hong-mei; Huang, Chao-qun; Jiang, Hai-he; Chu, Yan-nan

    2012-01-01

    In the manufacture of disposable PVC medical devices, cyclohexanone is frequently used as an adhesive reagent, which can be released into the tube airspace or stored solution and thus may cause some adverse effects on patients in therapy. In this paper, an ultraviolet photoionization ion mobility spectrometry (UV-IMS) technique has been developed to detect cyclohexanone through monitoring the gas composition within a package of infusion sets. The concentrations of cyclohexanone were prepared by means of exponential dilution method, and the experiments show that the UV-IMS has a limit of detection at 15 ppb and its measurable linear dynamics range is over three orders of magnitude. The concentrations of cyclohexanone in three brands of infusion sets packages were determined to be 16.78, 17.59 and 46.69 ppm respectively. The UV-IMS is proposed as a tool for the quality control of medical devices to monitor illegal uses of chemical solvents like cyclohexanone.

  16. Developing a reproducible non-line-of-sight experimental setup for testing wireless medical device coexistence utilizing ZigBee.

    Science.gov (United States)

    LaSorte, Nickolas J; Rajab, Samer A; Refai, Hazem H

    2012-11-01

    The integration of heterogeneous wireless technologies is believed to aid revolutionary healthcare delivery in hospitals and residential care. Wireless medical device coexistence is a growing concern given the ubiquity of wireless technology. In spite of this, a consensus standard that addresses risks associated with wireless heterogeneous networks has not been adopted. This paper serves as a starting point by recommending a practice for assessing the coexistence of a wireless medical device in a non-line-of-sight environment utilizing 802.15.4 in a practical, versatile, and reproducible test setup. This paper provides an extensive survey of other coexistence studies concerning 802.15.4 and 802.11 and reports on the authors' coexistence testing inside and outside an anechoic chamber. Results are compared against a non-line-of-sight test setup. Findings relative to co-channel and adjacent channel interference were consistent with results reported in the literature.

  17. Usability and Safety of Software Medical Devices: Need for Multidisciplinary Expertise to Apply the IEC 62366: 2007.

    Science.gov (United States)

    Bras Da Costa, Sabrina; Beuscart-Zéphir, M C; Bastien, J-M Christian; Pelayo, Sylvia

    2015-01-01

    Software medical devices must now comply with the "ergonomics" essential requirement of the Medical Device Directive. However, the usability standard aiming to guide the manufacturers is very difficult to understand and apply. Relying on a triangulation of methods, this study aims to highlight the need to combine various expertises to be able to grasp the standard. To identify the areas of expertise on which the usability standard relies, an analytical review of this document was performed as well as an analysis of a discussion forum dedicated to it and an analysis of a case study of its application for CE marking. The results show that the IEC 62366 is a usability standard structured as a risk management one. It obviously requires Human Factors/Ergonomics expertise to be able to correctly identify and prevent risks of use errors, but it also requires risk management expertise to be able to grasp the issues of the risk analysis and master the related methods.

  18. Identification and quantification of 14 phthalates and 5 non-phthalate plasticizers in PVC medical devices by GC-MS.

    Science.gov (United States)

    Gimeno, Pascal; Thomas, Sébastien; Bousquet, Claudine; Maggio, Annie-Françoise; Civade, Corinne; Brenier, Charlotte; Bonnet, Pierre-Antoine

    2014-02-15

    A GC/MS method was developed for the identification and quantification of 14 phthalates: 8 phthalates classified H360 (DBP, DEHP, BBP, DMEP, DnPP, DiPP, DPP and DiBP), 3 phthalates proposed to be forbidden in medical devices (DnOP, DiNP and DiDP) and 3 other phthalates none regulated (DMP, DCHP and DEP) which may interfere with hormone function. In order to identify and quantify other plasticizers that are commonly used in PVC medical devices such as DEHP substitute, 5 non-phthalate plasticizers (ATBC, DEHA, DEHT, TOTM, and DINCH) were included in this study. Analyses are carried out on a GC/MS system with electron impact ionization mode (EI). The separation of plasticizers is obtained on a cross-linked 5%-phenyl/95%-dimethylpolysiloxane capillary column 30m×0.25mm (i.d.)×0.25μm film thickness using a gradient temperature. Compounds quantification is performed by external calibration using an internal standard. Validation elements on standard solutions were determined using the ISO 12787 standard approach. Plasticizers are extracted from PVC medical devices using THF for dissolving the PVC part of the sample followed by precipitation of the PVC by addition of ethanol. The supernatant is injected into a GC/MS system after dilution in ethanol. Different validation elements, including extraction recoveries for all compounds or for DEHP a cross-validation of the extraction process using the European pharmacopoeia monograph 3.1.14 as reference method, are discussed. Results obtained on 61 medical devices in PVC and 12 raw materials used as plasticizers are given.

  19. Evaluation of the Di(2-ethylhexyl)phthalate released from polyvinyl chloride medical devices that contact blood

    OpenAIRE

    Luo, Hongyu; Sun, Guangyu; Shi, Yanping; Shen, Yong; Xu, Kai

    2014-01-01

    Extraction methods that simulate those used in the clinic are recommended for obtaining extraction solutions. For polyvinyl chloride (PVC) medical devices that have contact with human blood, an alternative medium (ethanol/water mixture) is suggested as an extraction screening vehicle to evaluate the di(2-ethylhexyl)phthalate (DEHP) released. A test comparing the extraction ability between the alternative medium and whole blood from three healthy volunteers has been conducted. An experimental ...

  20. Bibliometric analysis of the literature from the mainland of China on animal-derived regenerative implantable medical devices

    Science.gov (United States)

    Wang, Hong-Man; Li, Fu-Yao

    2014-12-01

    Choosing animal-derived regenerative implantable medical devices based on tissue engineering technology as a research theme, this paper presents bibliometric analysis of relative literature from the mainland of China to understand such data as publication year and journal preference, authors' geographic location, research topics and core expertise to predict the research trends and provide an informed basis of decision making for researchers and clinicians.

  1. Encouraging Districts and Charters to Link Arms to Solve Problems

    Science.gov (United States)

    Lake, Robin J.

    2017-01-01

    Charter schools and school districts have been at odds since the first charter school law passed in 1991. Districts resent the competition and subsequent funding loss for traditional schools. Charters resent the lack of access to facilities and other resources and attempts to infringe on their autonomy. Yet a fast-growing number of school…

  2. 14 CFR 380.17 - Charters conducted by educational institutions.

    Science.gov (United States)

    2010-01-01

    ... conducted by educational institutions. (a) This section shall apply only to charters conducted by educational institutions for charter groups comprised of bona fide participants in a formal academic course of... conducted by educational institutions. (b) An educational institution conducting such a charter shall...

  3. 41 CFR 105-54.203-2 - Active charters file.

    Science.gov (United States)

    2010-07-01

    ... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false Active charters file. 105-54.203-2 Section 105-54.203-2 Public Contracts and Property Management Federal Property Management... charters file. The GSA Committee Management Officer retains each original signed charter in a file...

  4. 12 CFR 747.406 - Cancellation of charter.

    Science.gov (United States)

    2010-01-01

    ... the Federal credit union has been completed, the NCUA Board shall cancel the charter of the Federal... 12 Banks and Banking 6 2010-01-01 2010-01-01 false Cancellation of charter. 747.406 Section 747... and Procedures Applicable to Proceedings Relating to the Suspension or Revocation of Charters and...

  5. Performance-Based Accountability: Newarks Charter School Experience.

    Science.gov (United States)

    Callahan, Kathe; Sadovnik, Alan; Visconti, Louisa

    This study assessed how New Jersey's state accountability system encouraged or thwarted charter school success, how effectively performance standards were defined and enacted by authorizing agents, and how individual charter schools were developing accountability processes that made them more or less successful than their charter school…

  6. Charter Schools, Civil Rights and School Discipline: A Comprehensive Review

    Science.gov (United States)

    Losen, Daniel J.; Keith, Michael A., II; Hodson, Cheri L.; Martinez, Tia E.

    2016-01-01

    This report, along with the companion spreadsheet, provides the first comprehensive description ever compiled of charter school discipline. In 2011-12, every one of the nation's 95,000 public schools was required to report its school discipline data, including charter schools. This analysis, which includes more than 5,250 charter schools, focuses…

  7. Equity Overlooked: Charter Schools and Civil Rights Policy

    Science.gov (United States)

    Frankenberg, Erica; Siegel-Hawley, Genevieve

    2009-01-01

    The Civil Rights Project (CRP) is in the midst of an analysis of rapidly growing charter school enrollment, which the authors anticipate releasing next month. Similar to trends described in their 2003 report and in other research on racial isolation in charter schools, they find higher levels of segregation for black students in charter schools…

  8. Religious Charter Schools: Gaining Ground yet Still Undefined

    Science.gov (United States)

    Weinberg, Lawrence D.

    2009-01-01

    This article examines charter schools from the perspective of religious institutions and parents that may want to open such schools. Religion-based charter schools also pose unique policy and legal questions because charter schools are a singular reform method. It examines the relevant, recent and historical, legal cases, and relevant examples of…

  9. 77 FR 31682 - Renewal of Cultural Property Advisory Committee Charter

    Science.gov (United States)

    2012-05-29

    ... experts in archaeology, anthropology, or ethnology; experts in the international sale of cultural property... of Cultural Property Advisory Committee Charter SUMMARY: The Charter of the Department of State's Cultural Property Advisory Committee (CPAC) has been renewed for an additional two years. The Charter...

  10. 75 FR 28849 - Renewal of Cultural Property Advisory Committee Charter

    Science.gov (United States)

    2010-05-24

    ... in archaeology, anthropology, or ethnology; experts in the international sale of cultural property... of Cultural Property Advisory Committee Charter SUMMARY: The Charter of the Department of State's Cultural Property Advisory Committee (CPAC) has been renewed for an additional two years. The Charter...

  11. 22 CFR 8.8 - Chartering of committees.

    Science.gov (United States)

    2010-04-01

    ... information set forth in the charter of the parent committee. (3) Informal subgroups may not require a charter; however, the charter of the parent committee must cover this aspect of its organization. (4) The Advisory... other committees; the committee organization, composition of membership and officers'...

  12. School Food Environment of Charter Schools in St. Louis

    Science.gov (United States)

    Linsenmeyer, Whitney; Kelly, Patrick; Jenkins, Steve; Mattfeldt-Berman, Mildred

    2013-01-01

    Purpose/Objectives: The purpose of this study was to explore the school food environment of charter schools in Saint Louis, Missouri. The objectives were to: (1) describe the participation of charter schools in the National School Lunch Program and (2) describe the prevalence of competitive foods in charter schools. Methods: School administrators…

  13. Academic Achievement of Students in a Charter Homeschool

    Science.gov (United States)

    Leeds, Mary A.

    2009-01-01

    A recent development in education is the public charter school as a homeschool model. In several states across the nation, a child may enroll in an independent study program of a public charter school and base his or her studies in the home. This model in the realm of education is called charter homeschool. The state of California has over 120…

  14. The Relative Efficiency of Charter Schools: A Cost Frontier Approach

    Science.gov (United States)

    Gronberg, Timothy J.; Jansen, Dennis W.; Taylor, Lori L.

    2012-01-01

    Charters represent an expansion of public school choice, offering free, publicly funded educational alternatives to traditional public schools. One relatively unexplored research question concerning charter schools asks whether charter schools are more efficient suppliers of educational services than are traditional public schools. The potential…

  15. Extraterritorial reach of the FCPA: recommendations for U.S. medical device companies with activities in Europe.

    Science.gov (United States)

    Vollebregt, Erik

    2010-01-01

    Traditionally medical devices companies manage business compliance with anti-corruption and anti-fraud rules in a document-oriented way that does not always yield optimal results for the company. As a result, compliance issues are not optimally managed by the companies. Now that medical devices companies become ever more internationally active, they must also take into account the international dimensions of business compliance. This article intends to provide U.S. medical devices companies with activities in Europe with an insight in business compliance risks in the European Union (EU) and the risks related to U.S. statutes that may be applicable to a U.S. company's activities overseas. The article proposes a process-oriented and IT-supported way of structuring an international business compliance program, resulting in increased effectiveness of the program and increased competitiveness and risk management of the company as well as a high degree of acceptance of the procedures by the company's employees.

  16. Identification and quantification by (1)H nuclear magnetic resonance spectroscopy of seven plasticizers in PVC medical devices.

    Science.gov (United States)

    Genay, Stéphanie; Feutry, Frédéric; Masse, Morgane; Barthélémy, Christine; Sautou, Valérie; Odou, Pascal; Décaudin, Bertrand; Azaroual, Nathalie

    2017-02-01

    Medical devices are generally made of polyvinyl chloride plasticized by six authorized plasticizers as alternatives to di-(2-ethylhexyl)-phthalate (DEHP) classified as reprotoxic class 1b. These are acetyl tri-n-butyl citrate (ATBC), di-(2-ethylhexy) adipate (DEHA), di-(2-ethylhexyl) terephthalate (DEHT), di-isononyl cyclohexane-1,2-dicarboxylate (DINCH), di-isononyl phthalate (DINP), and tri-octyl trimellitate (TOTM). The main objective of this study was to propose a new method using (1)H NMR spectroscopy to determine and quantify these seven plasticizers in PVC sheets, standard infusion tubings, and commercially available medical devices. Two techniques were compared: dissolution in deuterated tetrahydrofuran and extraction by deuterated chloroform. Plasticizer (1)H NMR spectra were very similar in both deuterated solvents; dissolution and extraction provided similar results. The sensitivity of this method enabled us to detect and quantify the presence of minor plasticizers in PVC. In nine commercially available samples, the major plasticizer was identified and quantified by (1)H NMR. In six samples, one, two, or three minor plasticizers were identified and also quantified. DEHP was detected in only one tubing. NMR is therefore very convenient for studying plasticizers contained in medical devices. Only small quantities of solvents and sample are required. It is not necessary to dilute samples to enter a quantification range, and it is sufficiently sensitive to detect contaminants.

  17. Toward a treaty on safety and cost-effectiveness of pharmaceuticals and medical devices: enhancing an endangered global public good

    Directory of Open Access Journals (Sweden)

    Faunce Thomas

    2006-03-01

    Full Text Available Abstract • Expert evaluations of the safety, efficacy and cost-effectiveness of pharmaceutical and medical devices, prior to marketing approval or reimbursement listing, collectively represent a globally important public good. The scientific processes involved play a major role in protecting the public from product risks such as unintended or adverse events, sub-standard production and unnecessary burdens on individual and governmental healthcare budgets. • Most States now have an increasing policy interest in this area, though institutional arrangements, particularly in the area of cost-effectiveness analysis of medical devices, are not uniformly advanced and are fragile in the face of opposing multinational industry pressure to recoup investment and maintain profit margins. • This paper examines the possibility, in this context, of States commencing negotiations toward bilateral trade agreement provisions, and ultimately perhaps a multilateral Treaty, on safety, efficacy and cost-effectiveness analysis of pharmaceuticals and medical devices. Such obligations may robustly facilitate a conceptually interlinked, but endangered, global public good, without compromising the capacity of intellectual property laws to facilitate local product innovations.

  18. Effect of growth solution, membrane size and array connection on microbial fuel cell power supply for medical devices.

    Science.gov (United States)

    Roxby, Daniel N; Nham Tran; Pak-Lam Yu; Nguyen, Hung T

    2016-08-01

    Implanted biomedical devices typically last a number of years before their batteries are depleted and a surgery is required to replace them. A Microbial Fuel Cell (MFC) is a device which by using bacteria, directly breaks down sugars to generate electricity. Conceptually there is potential to continually power implanted medical devices for the lifetime of a patient. To investigate the practical potential of this technology, H-Cell Dual Chamber MFCs were evaluated with two different growth solutions and measurements recorded for maximum power output both of individual MFCs and connected MFCs. Using Luria-Bertani media and connecting MFCs in a hybrid series and parallel arrangement with larger membrane sizes showed the highest power output and the greatest potential for replacing implanted batteries.

  19. Texas charter school legislation and the evolution of open-enrollment charter schools.

    Directory of Open Access Journals (Sweden)

    Carrie Y. Barron Ausbrooks

    2005-03-01

    Full Text Available This article chronicles the evolution of legislation for Texas open-enrollment charter schools to their implementation by demonstrating how these schools have (or have not used their freedom from state-mandated requirements to develop innovative learning environments as well as to bring innovative curricula into the classroom. The investigative focus was on an analysis of Texas open-enrollment charter school legislation, from 1995 (74th legislative session to the 77th legislative session in 2001, and the characteristics of the state's 159 open-enrollment charter schools that were in operation during the 2001-2002 academic year. The authors found that charter school legislation has changed in response to concerns of all involved, and focuses on the need for balance between choice, innovation, and public accountability. Although charter schools are free from most state regulations, legislators were clearly interested in ensuring that this freedom does not impede charter schools' ability to provide a quality education to all students who attend them. The currently operating open-enrollment charter schools in Texas are more racially and economically segregated than other public schools in the state, and charter schools that targeted students most at risk for dropping out of school (and returning students who had previously dropped out differ from other schools in their stated teaching methods. Teacher turnover remains significantly greater than that for other public schools in the state. However, it does not appear to be specifically associated with schools that target disadvantaged students or minority students. The schools' mission statements suggest that innovative school environments are a factor in school design. Texas is poised to continue along the public education choice model. Charter school legislation provides a framework upon which charter schools may build to meet the educational needs of the students who choose to attend them

  20. 78 FR 46347 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices...

    Science.gov (United States)

    2013-07-31

    ... international standards ``ISO 9001: Quality Systems Model for Quality Assurance in Design/Development... device CGMP requirements with QS specifications in the international standard ``ISO 9001: Quality...