WorldWideScience

Sample records for medical device industry

  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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.

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

    Directory of Open Access Journals (Sweden)

    Burgess LJ

    2011-09-01

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

  7. 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... guidance entitled ``Medical Device Classification Product Codes.'' This document describes how device...

  8. [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").

  9. "Medical Alley": the rise of the medical device industry in Minnesota.

    Science.gov (United States)

    Rhees, David J

    2009-01-01

    This paper analyzes the factors that led to the establishment in Minnesota of a thriving network of advanced medical device firms sometimes referred to as "Medical Alley." Factors examined include a favorable "business-technology infrastructure" that included the University of Minnesota, the migration of high-tech professionals from other industries, the emergence of specialized services and suppliers, the availability of capital, government encouragement, and support from trade associations. The seminal role of Medtronic, Inc., founded in 1949, is examined, particularly the invention of the first wearable cardiac pacemaker by the company's co-founder Earl Bakken in 1957 and Medtronic's licensing of the first fully implantable pacemaker developed by Wilson Greatbatch and William Chardack in 1960. Some of the major spin-off's from Medtronic will be examined, particularly CPI (now part of Boston Scientific) and St. Jude Medical. The paper will broadly characterize the evolution of "Medical Alley to the present.

  10. 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

  11. 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.

  12. 77 FR 125 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Device Classification...

    Science.gov (United States)

    2012-01-03

    ... educate regulated industry and FDA Staff on how, when, and why to use classification product codes for... 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...

  13. 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

  14. Medical devices and conflict of interest: unique issues and an industry code to address them.

    Science.gov (United States)

    LaViolette, Paul A

    2007-03-01

    Development of medical devices requires interaction between physicians and industry that is considerably more intimate than that in pharmaceutical development. Progress in procedure-based medicine would be stalled if this collaboration were eliminated. This degree of interaction, however, creates conflicts of interest that must be managed to avoid compromising trust, credibility, and patient care. AdvaMed, a trade association for the medical device industry, has developed a code of ethics to manage many of these conflicts and to guide its members' interactions with health care professionals. This article reviews the rationale for the AdvaMed code and provides a brief in terms of c overview of the code itself.onflict-of-interest cons iderations, the world of medical devices is significantly dif-

  15. 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...

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

    DEFF Research Database (Denmark)

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

    2016-01-01

    . This intervention tool provides designers and product marketers with insights on how to improve the design of their medical devices and specifically allows consideration of the complex trade-offs between decisions that influence different life-cycle stages. Through the tool, actionable insight is created......The medical device industry is growing increasingly concerned about environmental impact of products. Whilst there are many tools aiming to support environmentally conscious design, they are typically complex to use, demand substantial data collection and are not tailored to the specific needs...

  17. 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.

  18. [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.

  19. 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

    . Issues noted include raw material choice and packaging decisions. The nature of single use business models is also critical, pointing towards the needs for a systemic rather than product focus. For this to be achieved, financial rewards must be evident to firms and the changing regulatory landscape might......This exploratory study seeks to explore the current state of design for the environment (DfE) in the development of medical devices; an historically risk averse industry that lags behind others in terms of addressing environmental considerations. A cross-sectional survey of 34 medical device...... reliance on a single-use business model for many current products and a lack of education about DfE topics on all sides. Designers felt that the most significant opportunities to implement DfE are in situations where they are able to exert direct control, mainly in the early stages of the design process...

  20. 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...

  1. 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...

  2. 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.

  3. 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...

  4. 77 FR 41413 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices: The Pre...

    Science.gov (United States)

    2012-07-13

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... establishment in 1995, the pre-IDE program has been a successful resource for both medical device applicants and... clinical studies conducted outside of the United States to support future U.S. marketing applications (Ref...

  5. 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.

  6. 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.

  7. 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 ...

  8. Association of medical students' reports of interactions with the pharmaceutical and medical device industries and medical school policies and characteristics: a cross-sectional study.

    Directory of Open Access Journals (Sweden)

    James S Yeh

    2014-10-01

    Full Text Available 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.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 education, size of school, and publicly

  9. Association of medical students' reports of interactions with the pharmaceutical and medical device industries and medical school policies and characteristics: a cross-sectional study.

    Science.gov (United States)

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

    2014-10-01

    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. 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 education, size of school, and publicly versus

  10. 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

  11. 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 ...

  12. A user-centred approach to requirements elicitation in medical device development: a case study from an industry perspective.

    Science.gov (United States)

    Martin, Jennifer L; Clark, Daniel J; Morgan, Stephen P; Crowe, John A; Murphy, Elizabeth

    2012-01-01

    The healthcare industry is dependent upon the provision of well designed medical devices. To achieve this it is recommended that user-centred design should begin early, and continue throughout device development. This is a challenge, particularly for smaller companies who may lack the necessary expertise and knowledge. The aim of this study was to conduct a rigorous yet focused investigation into the user requirements for a new medical imaging device. Open-ended semi-structured interviews were conducted with potential clinical users of the device to investigate the clinical need for the device and the potential benefits for patients and clinical users. The study identified a number of new and significant clinical needs that suggested that the concept of the device should be fundamentally changed. The clinical and organisational priorities of the clinical users were identified, as well as a number of factors that would act as barriers to the safe and effective adoption of the device. The developers reported that this focused approach to early requirements elicitation would result in an improved product, reduce the time to market, and save the time and cost of producing and evaluating an inappropriate prototype. Copyright © 2011 Elsevier Ltd and The Ergonomics Society. All rights reserved.

  13. 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.

  14. Biodegradable polymers: emerging excipients for the pharmaceutical and medical device industries.

    Directory of Open Access Journals (Sweden)

    Bhavesh Patel

    2013-12-01

    Full Text Available Worldwide many researchers are exploring the potential use of biodegradable polymerics as carriers for a wide range of therapeutic applications. In the past two decades, considerable progress has been made in the development of biodegradable polymeric materials, mainly in the biomedical and pharmaceutical industries due to their versatility, biocompatibility and biodegradability properties. The present review focuses on the use of biodegradable polymers in various therapeutic areas like orthopedic and contraceptive device, surgical sutures, implants, depot parenteral injections, etc. Biodegradable polymers have also contributed significantly to the development of drug-eluting stents (DES used for the treatment of obstructive coronary artery disease, such as angioplasty. Biodegradable synthetic polymers have potential applications in orthopedic device fixation due to properties that impact bone healing, formation, regeneration or substitution in the human body. The present review also emphasizes areas such as the chemistry of polymer synthesis, factors affecting the biodegradation, methods for the production of biodegradable polymer based formulations, the application of biodegradable polymers in dental implants, nasal drug deliveries, contraceptive devices, immunology, gene, transdermal, ophthalmic and veterinary applications, as well as, the sterilization of biodegradable based formulations and regulatory considerations for product filing.

  15. 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

  16. An academic, clinical and industrial update on electrospun, additive manufactured and imprinted medical devices.

    Science.gov (United States)

    Ryan, Christina N M; Fuller, Kieran P; Larrañaga, Aitor; Biggs, Manus; Bayon, Yves; Sarasua, Jose R; Pandit, Abhay; Zeugolis, Dimitrios I

    2015-01-01

    Electrospinning, additive manufacturing and imprint lithography scaffold fabrication technologies have attracted great attention in biomedicine, as they allow production of two- and three- dimensional constructs with tuneable topographical and geometrical features. In vitro data demonstrate that electrospun and imprinted substrates offer control over permanently differentiated and stem cell function. Advancements in functionalisation strategies have further enhanced the bioactivity and reparative capacity of electrospun and additive manufactured devices, as has been evidenced in several preclinical models. Despite this overwhelming success in academic setting, only a few technologies have reached the clinic and only a fraction of them have become commercially available products.

  17. 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...

  18. 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...

  19. 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...

  20. 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...

  1. 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

  2. Medical device alarms.

    Science.gov (United States)

    Borowski, Matthias; Görges, Matthias; Fried, Roland; Such, Olaf; Wrede, Christian; Imhoff, Michael

    2011-04-01

    The high number of false positive alarms has long been known to be a serious problem in critical care medicine - yet it remains unresolved. At the same time, threats to patient safety due to missing or suppressed alarms are being reported. The purpose of this paper is to present results from a workshop titled "Too many alarms? Too few alarms?" organized by the Section Patient Monitoring and the Workgroup Alarms of the German Association of Biomedical Engineering of the Association for Electrical, Electronic and Information Technologies. The current situation regarding alarms and their problems in intensive care, such as lack of clinical relevance, alarm fatigue, workload increases due to clinically irrelevant alarms, usability problems in alarm systems, problems with manuals and training, and missing alarms due to operator error are outlined, followed by a discussion of solutions and strategies to improve the current situation. Finally, the need for more research and development, focusing on signal quality considerations, networking of medical devices at the bedside, diagnostic alarms and predictive warnings, usability of alarm systems, education of healthcare providers, creation of annotated clinical databases for testing, standardization efforts, and patient monitoring in the regular ward, are called for.

  3. Class 1 devices case studies in medical devices design

    CERN Document Server

    Ogrodnik, Peter J

    2014-01-01

    The Case Studies in Medical Devices Design series consists of practical, applied case studies relating to medical device design in industry. These titles complement Ogrodnik's Medical Device Design and will assist engineers with applying the theory in practice. The case studies presented directly relate to Class I, Class IIa, Class IIb and Class III medical devices. Designers and companies who wish to extend their knowledge in a specific discipline related to their respective class of operation will find any or all of these titles a great addition to their library. Class 1 Devices is a companion text to Medical Devices Design: Innovation from Concept to Market. The intention of this book, and its sister books in the series, is to support the concepts presented in Medical Devices Design through case studies. In the context of this book the case studies consider Class I (EU) and 510(k) exempt (FDA) . This book covers classifications, the conceptual and embodiment phase, plus design from idea to PDS. These title...

  4. Engaging with economic evaluation methods: insights from small and medium enterprises in the UK medical devices industry after training workshops.

    Science.gov (United States)

    Craven, Michael P; Allsop, Matthew J; Morgan, Stephen P; Martin, Jennifer L

    2012-09-03

    With increased governmental interest in value assessment of technologies and where medical device manufacturers are finding it increasingly necessary to become more familiar with economic evaluation methods, the study sought to explore the levels of health economics knowledge within small and medium-sized enterprises (SMEs) and to scope strategies they employ to demonstrate the value of their products to purchasers. A short questionnaire was completed by participants attending one of five workshops on product development in the medical device sector that took place in England between 2007 and 2011. From all responses obtained, a large proportion of participants were based in SMEs (N = 43), and these responses were used for the analysis. Statistical analysis using non-parametric tests was performed on questions with approximately interval scales. Qualitative data from participant responses were analysed to reveal emerging themes. The questionnaire results revealed that 60% of SME participants (mostly company directors or managers, including product or project managers) rated themselves as having low or no knowledge of health economics prior to the workshops but the rest professed at least medium knowledge. Clinical trials and cost analyses or cost-effectiveness studies were the most highly cited means by which SMEs aim to demonstrate value of products to purchasers. Purchasers were perceived to place most importance on factors of safety, expert opinion, cost-effectiveness and price. However many companies did not utilise formal decision-making tools to prioritise these factors. There was no significant dependence of the use of decision-making tools in general with respect to professed knowledge of health economics methods. SMEs did not state a preference for any particular aspect of potential value when deciding whether to develop a product. A majority of SMEs stated they would use a health economics tool. Research and development teams or marketing and sales

  5. Engaging with economic evaluation methods: insights from small and medium enterprises in the UK medical devices industry after training workshops

    Directory of Open Access Journals (Sweden)

    Craven Michael P

    2012-09-01

    Full Text Available Abstract Background With increased governmental interest in value assessment of technologies and where medical device manufacturers are finding it increasingly necessary to become more familiar with economic evaluation methods, the study sought to explore the levels of health economics knowledge within small and medium-sized enterprises (SMEs and to scope strategies they employ to demonstrate the value of their products to purchasers. Methods A short questionnaire was completed by participants attending one of five workshops on product development in the medical device sector that took place in England between 2007 and 2011. From all responses obtained, a large proportion of participants were based in SMEs (N = 43, and these responses were used for the analysis. Statistical analysis using non-parametric tests was performed on questions with approximately interval scales. Qualitative data from participant responses were analysed to reveal emerging themes. Results The questionnaire results revealed that 60% of SME participants (mostly company directors or managers, including product or project managers rated themselves as having low or no knowledge of health economics prior to the workshops but the rest professed at least medium knowledge. Clinical trials and cost analyses or cost-effectiveness studies were the most highly cited means by which SMEs aim to demonstrate value of products to purchasers. Purchasers were perceived to place most importance on factors of safety, expert opinion, cost-effectiveness and price. However many companies did not utilise formal decision-making tools to prioritise these factors. There was no significant dependence of the use of decision-making tools in general with respect to professed knowledge of health economics methods. SMEs did not state a preference for any particular aspect of potential value when deciding whether to develop a product. A majority of SMEs stated they would use a health economics tool

  6. Basic concepts and issues: a primer on distribution and sales representative agreements in the medical device and durable medical equipment industries.

    Science.gov (United States)

    Burow, Heiko E; Kolls, Raymond C

    2006-01-01

    Counsel for a manufacturer of medical devices or durable medical equipment must have working knowledge of various legal disciplines to draft contracts with intermediaries (sales representatives and distributors) for the marketing and sale of the manufacturer's products. If the manufacturer wishes to sell its products abroad, counsel must become familiar with the laws and business practices of the target country, and methods of gaining access to the foreign market. This Article gives readers an overview of the applicable legal principles, under U.S. and foreign laws, in the areas of agency, contracts, healthcare regulation, consumer protection, intellectual property protection, and dealer protection. To aid counsel in drafting intermediary agreements, specific contractual terms and issues are explored in depth, including: appointment clauses, performance provisions, provisions concerning pricing and payment, protective clauses (shielding the manufacturer from liability), term and termination provisions, independent contractor clauses, export control clauses, recordkeeping and audit provisions, choice of law clauses, and dispute resolution clauses.

  7. 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 ...

  8. 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 ...

  9. 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.

  10. 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...

  11. 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...

  12. Sustaining the success of medical device innovation.

    Science.gov (United States)

    Fearis, Paul J; Craft, Brandon

    2016-11-01

    Paul Fearis is CEO of Clinvue, Brandon Craft is COO of Clinvue. Clinvue is medical device innovation consultancy specializing in Insight Informed Innovation in the medical industry. Paul and Brandon are also lecturers in innovation for the 'Center for Bioengineering, Innovation & Design' Masters course in Bioengineering Innovation & Design at the Johns Hopkins University, and guest lecturers at Rice University and Virginia Tech. Copyright © 2016 Elsevier Inc. All rights reserved.

  13. 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,...

  14. 78 FR 49529 - Radio Frequency Wireless Technology in Medical Devices; Guidance for Industry and Food and Drug...

    Science.gov (United States)

    2013-08-14

    ... of RF energy, and the RF wireless emissions from one product or device could potentially affect the... HUMAN SERVICES Food and Drug Administration (formerly Docket No. 2006D-0504) Radio Frequency Wireless...) is announcing the availability of the guidance entitled ``Radio Frequency Wireless Technology in...

  15. 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.

  16. 77 FR 7584 - Draft Guidance for Industry on Heparin for Drug and Medical Device Use; Monitoring Crude Heparin...

    Science.gov (United States)

    2012-02-13

    ... Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. See the... crude heparin contaminants and to recommend strategies to ensure that the heparin supply chain is not... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Heparin for Drug and...

  17. 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.

  18. 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

  19. Assurance Cases for Medical Devices

    Science.gov (United States)

    2011-04-28

    Test  your  audio   Submit  text  ques2ons       Q&A  addressed  at  the  end  of  today’s  session...SEI’s  Research,  Technology,  and  System   Solu2ons  program.  With  his  colleague  John   Goodenough ,  Weinstock...contact The SEI and Medical Devices *Charles B. Weinstock and John B. Goodenough , Towards an Assurance Case Practice for Medical Devices,

  20. 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

  1. 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.

  2. Wearable device implications in the healthcare industry.

    Science.gov (United States)

    Erdmier, Casey; Hatcher, Jason; Lee, Michael

    2016-01-01

    This manuscript analyses the impact of wearable device technology in the healthcare industry. The authors provide an exploration of the different types of wearable technology that are becoming popular or are emerging into the consumer market and the personal health information and other user data these devices collect. The applications of wearable technology to healthcare and wellness are discussed, along with the impact of these devices on the industry. Finally, an analysis is provided, describing the current regulations in the US and UK that govern wearable devices and the impact of these device regulations on users and healthcare professionals.

  3. [International progress of unique device identification for medical devices].

    Science.gov (United States)

    Yang, Wanjuan; Li, Jun; Li, Jingli

    2014-09-01

    Unique Device Identification (UDI) is a hot spot research area in the medical device administration. It comes a breakthrough from International Medical Device Regulators Forum (IMDRF) and government implementation recently. The article reviewed the advancement of IMDRF UDI program, discussed the framework for UDI system, analyzed the implementation of UDI in other countries, put forward some suggestions on the development of medical device coding system in our country.

  4. Medical devices regulations, standards and practices

    CERN Document Server

    Ramakrishna, Seeram; Wang, Charlene

    2015-01-01

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

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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:...

  10. 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.

  11. 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.

  12. 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).

  13. 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...

  14. [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.

  15. 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...

  16. 21 CFR 892.2040 - Medical image hardcopy device.

    Science.gov (United States)

    2010-04-01

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

  17. 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.

  18. 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...

  19. 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

  20. [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.

  1. 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 ...

  2. [Information safety test of digital medical device].

    Science.gov (United States)

    Liu, Jiong

    2014-07-01

    According to the background of the age of big data, the medical devices are informatized, we analyze the safety and efficiency for the information and data of digital medical devices or medical systems, also discussed some test methods. Lack of a suitable standard system of digital medical devices is a big problem both for domain standard and international standard. GB25000.51 is too ambiguous and free for testing, also not very operational. So this paper suggested some test advices and some prospective method. These test methods are helpful for finding the problem and performing the standards. What's more, these methods are famous in the world and used widely in the 3C region but just start in the medical region, which can promote the development of the medical devices.

  3. 基于波特“五力模型”分析我国医疗器械行业的现状及发展%Analysis of China’s Medical Device Industry Based on Porter’s “Five Forces Model”

    Institute of Scientific and Technical Information of China (English)

    王朋; 邱家学

    2012-01-01

      Based on the analysis of the global medical device industry development status, looking for the status and characteristics of China's medical device industry, using Porter's “five forces model "theory to explore the competitive forces of the medical device industry, and for our government and medical device manufacturing enterprises provide appropriate recommendations%  在分析全球医疗器械行业发展现状的基础上,寻找我国医疗器械行业的现状及特点,运用波特的“五力模型”理论探寻医疗器械行业目前的竞争力量,然后为我国政府和医疗器械生产企业提供合适的建议。

  4. 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

  5. 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.

  6. Mobile medical device connectivity: real world solutions.

    Science.gov (United States)

    Pettus, Dan

    2004-01-01

    Mobile medical devices, such as infusion pumps, provide an important therapeutic function. They are also valuable sources of information about treatment patterns at the point of care. However, these mobile devices have been independent islands of valuable information, unable to share the data they gather with other hospital information resources on a real time basis. Although data from these devices can provide significant improvements for medical safety and vital information needed for clinical best practice development, gathering that data poses significant challenges when interfacing with hospital information systems. Mobile medical devices move from place to place as independent actors, raising a series of security and identification issues when they need to be disconnected and reconnected using traditional tethered cable connections. The continuing lack of accepted communications protocol standards, in spite of the concentrated efforts of organizations like the IEEE and the Medical Information Bus (IEEE 1073) to establish them, has made integration into the hospital information system a complex and non-standard task. The rapid spread in availability and adoption of high-speed 802.11 wireless systems in hospitals offers a realistic connectivity solution for mobile medical devices. Inspite of this, the 802.11 standard is still evolving, and current security methods designed for user-based products like PDAs and laptop computers are not ideal for unmanned mobile medical devices because they assume the availability of a human operator to authenticate a wireless session. In the absence of accepted standards, manufacturers have created practical and innovative solutions to support the collection of clinical data from mobile medical devices and the integration of that data with hospital information systems. This paper will explore the potential benefits of integrating mobile medical devices into the hospital information system, and describe the challenges in

  7. 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.

  8. 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...

  9. 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...

  10. 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...

  11. 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

  12. 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.

  13. [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.

  14. Leveraging EHR investments through medical device connectivity.

    Science.gov (United States)

    Witonsky, Peter

    2012-08-01

    There are two primary factors for analyzing the cost of medical device integration: the total cost of ownership and gains in clinician efficiency. When calculating the long-term total cost of ownership, hospitals should consider the original acquisition cost, ongoing support costs, and also look at the incremental cost of adding a new device. In determining clinical efficiency, recent analyses show that medical device integration alleviates the initial negative impact of implementing an electronic health record and improves clinician efficiency by reducing clinicians' overall documentation activities.

  15. 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.

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

    Science.gov (United States)

    Yang, Xiaofang; Mu, Ruihong; Fan, Yubo; Wang, Chunren; Li, Deyu

    2017-04-01

    This article analyses the current situation and development of Chinese medical device testing institutes from the perspectives of the two most important functions - testing functions and medical device standardization functions. Areas Covered: The objective of the Chinese government regulations for medical device industry is to ensure the safety and effectiveness of medical devices for Chinese patients. To support the regulation system, the Chinese government has established medical device testing institutes at different levels for example, the national, provincial, and municipal levels. These testing institutes also play an important role in technical support during medical device premarket registration and post market surveillance, they are also the vital practitioners of Chinese medical device standardization. Expert Commentary: Chinese medical device testing institutes are technical departments established by government, and serve the regulatory functions of government agency. In recent years, with the rapid development of medical device industry as well as constantly increasing international and domestic medical device market, the importance of medical device testing institute is more prominent, However, there are still some problems unsolved, such as their overall capacity remains to be improved, construction of standardization is to be strengthened, etc.

  17. 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

  18. Medical devices for the anesthetist: current perspectives

    Directory of Open Access Journals (Sweden)

    Ingrande J

    2014-03-01

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

  19. 77 FR 6028 - Taxable Medical Devices

    Science.gov (United States)

    2012-02-07

    ... adhesives and snake bite kits.'' The Technical Explanation also emphasizes that ``items would only be exempt... subject to an IDE is not a ``taxable medical device'' under the proposed regulations. VI. Dental... for dental instruments and equipment. The proposed regulations do not adopt this suggestion. There is...

  20. [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.

  1. 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...

  2. 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.

  3. [Overview on the market, supervision and standardization of nanomaterial-contained medical devices].

    Science.gov (United States)

    Shao, Anliang; Xu, Liming

    2015-01-01

    In this paper, industry development and market tendency, supervision and standardization of nanomaterial-contained medical devices are overviewed comprehensively based on a large number of reference data including national and international information. Furthermore, the consideration about standardization of biological evaluation for nanomaterial-contained medical devices is discussed by combined some works performed in our laboratory.

  4. 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.

  5. 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.

  6. Marketing in Medical Imaging Industry

    Directory of Open Access Journals (Sweden)

    Shahrokh Aflaki

    2010-05-01

    Full Text Available A few decades ago when Henry Ford told his customers "He would give them a car of any color as long as it is black" he did not think that competitive space in market reaches to a point in which business leaders monitor their customers all the time to be able to provide products and services proportionate to continuously changing costumer expectations. In today's competitive markets, customer satisfaction is a key secret which guarantees the business survival and progress. Marketing is a new field which shows us how to satisfy customers and hence increase the number of them."nMany people think of marketing only as selling and advertising. Although important, they are only two of the many marketing functions and are often not the most important ones."nIn this lecture, first, customer oriented culture is described. Marketing mix in radiology industry, a building block of the marketing plan, and marketing research, a vital tool to construct the marketing information system, are next discussed. Ultimately, service levels and triangle marketing in a radiology service provider institute are presented. "nThe aim of this lecture is to give the radiology service provider managers a new idea about how to maintain and develop their market.

  7. 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.

  8. 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.

  9. Open-source hardware for medical devices.

    Science.gov (United States)

    Niezen, Gerrit; Eslambolchilar, Parisa; Thimbleby, Harold

    2016-04-01

    Open-source hardware is hardware whose design is made publicly available so anyone can study, modify, distribute, make and sell the design or the hardware based on that design. Some open-source hardware projects can potentially be used as active medical devices. The open-source approach offers a unique combination of advantages, including reducing costs and faster innovation. This article compares 10 of open-source healthcare projects in terms of how easy it is to obtain the required components and build the device.

  10. 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...

  11. 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

  12. 21 CFR 892.2010 - Medical image storage device.

    Science.gov (United States)

    2010-04-01

    ....2010 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2010 Medical image storage device. (a..., and digital memory. (b) Classification. Class I (general controls). The device is exempt from the...

  13. Ethylene Oxide Gas Sterilization of Medical Devices.

    Science.gov (United States)

    Shintani, Hideharu

    2017-01-01

     Ethylene oxide gas is an agent in the sterilization of medical devices due to its effectiveness and compatibility with most materials. The advantages and disadvantages, as well as its recommended uses, are explored in this review article. The variables and their relevance on process optimization are described, the types of processing cycles are detailed and emphasis is given to the design and validation of the sterilization process.

  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. The new medical-industrial complex.

    Science.gov (United States)

    Relman, A S

    1980-10-23

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

  16. 75 FR 35493 - Guidance for Industry on Systemic Lupus Erythematosus-Developing Medical Products for Treatment...

    Science.gov (United States)

    2010-06-22

    ... Systemic Lupus Erythematosus--Developing Medical Products for Treatment; Availability AGENCY: Food and Drug... availability of a guidance for industry entitled ``Systemic Lupus Erythematosus--Developing Medical Products..., therapeutic biological products, and medical devices for the treatment of systemic lupus erythematosus (SLE...

  17. 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 ...

  18. 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

  19. Industrial wireless networking with resource constraint devices

    NARCIS (Netherlands)

    Das, Kallol

    2015-01-01

    During the last decade, wireless technologies have revolutionized the industrial automation sector by enabling wireless sensing and actuation for industrial applications. Most of these recently developed industrial standards are built on top of IEEE802.15.4 interface, which uses 2.4GHz frequency ban

  20. Industrial wireless networking with resource constraint devices

    NARCIS (Netherlands)

    Das, Kallol

    2015-01-01

    During the last decade, wireless technologies have revolutionized the industrial automation sector by enabling wireless sensing and actuation for industrial applications. Most of these recently developed industrial standards are built on top of IEEE802.15.4 interface, which uses 2.4GHz frequency

  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. Employee Trust Based Industrial Device Deployment and Initial Key Establishment

    OpenAIRE

    Apala Ray; Johan Akerberg; Mats Bjorkman; Mikael Gidlund

    2016-01-01

    An efficient key management system is required to support cryptography. Most key management systems use either pre-installed shared keys or install initial security parameters using out-of-band channels. These methods create an additional burden for engineers who manage the devices in industrial plants. Hence, device deployment in industrial plants becomes a challenging task in order to achieve security. In this work, we present a device deployment framework that can support key management us...

  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. 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 the...

  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 Committee...

  8. 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.

  9. 76 FR 71577 - Guidance for Industry on Medication Guide Distribution Requirements and Inclusion of Medication...

    Science.gov (United States)

    2011-11-18

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Medication Guide Distribution Requirements and Inclusion of Medication Guides in Risk Evaluation and Mitigation Strategies; Availability...) is announcing the availability of a guidance for industry entitled ``Medication Guides--...

  10. 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...

  11. 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.

  12. A Biosystems Approach to Industrial Patient Monitoring and Diagnostic Devices

    CERN Document Server

    Baura, Gail

    2008-01-01

    A medical device is an apparatus that uses engineering and scientific principles to interface to physiology and diagnose or treat a disease. In this Lecture, we specifically consider thosemedical devices that are computer based, and are therefore referred to as medical instruments. Further, the medical instruments we discuss are those that incorporate system theory into their designs. We divide these types of instruments into those that provide continuous observation and those that provide a single snapshot of health information. These instruments are termed patient monitoring devices and diag

  13. 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.

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

    Science.gov (United States)

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

    2013-10-01

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

  15. 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

  16. 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

  17. 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 Medical...

  18. 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 ...

  19. Oversight of marketing relationships between physicians and the drug and device industry: a comparative study.

    Science.gov (United States)

    Jost, Timothy Stoltzfus

    2010-01-01

    Throughout the world, complex mutually-dependent relationships exist between physicians and pharmaceutical and medical device companies. This article focuses on one particular aspect of these relationships-payments made by drug and device companies to physicians and their organizations and institutions to market drugs and devices. It is widely believed that drug and device company marketing to physicians creates conflicts of interest that corrupt physician judgment and increase the cost of medical care. This article examines first the economic basis of physician/industry relationships that causes conflicts to arise. It next considers the measures that a number of developed countries have taken to respond to these relationships. Finally, it proposes an approach that would comprehensively address the problems caused by drug and device company marketing to physicians.

  20. CERN tests reveal security flaws with industrial network devices

    CERN Document Server

    Lüders, Stefan

    2006-01-01

    The CERN high energy particle physics facility at Geneva, Switzerland will incorporate a wide range of COTS industrial control systems within its next generation particle collider, the LHC. In particular, the Internet will be used to facilitate the remote access for accelerator and particle physicists and system experts based at several hundred locations around the globe. The integration of Industrial Ethernet and COTS PLCs within the LHC program focuses extreme attention on the industrial network cyber-security requirement. CERN's response has been to conduct operational research on the security resilience of networked industrial devices. As test team lead Stefan Lüders reports here, industrial networked devices put through the organisation's test procedures have generally shown up unexpected vulnerabilities.

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

    Science.gov (United States)

    2010-07-01

    ..., medical devices, and medical services. 597.511 Section 597.511 Money and Finance: Treasury Regulations... Licensing Policy § 597.511 In-kind donations of medicine, medical devices, and medical services. (a) Effective July 6, 2006, U.S. financial institutions are authorized to conduct all transactions...

  2. 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.

  3. Uneasy subjects: medical students' conflicts over the pharmaceutical industry.

    Science.gov (United States)

    Holloway, Kelly

    2014-08-01

    In this article I report on an investigation of the pharmaceutical industry's influence in medical education. Findings are based on fifty semi-structured interviews with medical students in the United States and Canada conducted between 2010 and 2013. Participant responses support the survey-based literature demonstrating that there is clear and pervasive influence of the pharmaceutical industry in medical education. They also challenge the theory that medical students feel entitled to industry gifts and uncritically accept industry presence. I investigate how medical students who are critical of the pharmaceutical industry negotiate its presence in the course of their medical education. Findings suggest that these participants do not simply absorb industry presence, but interpret it and respond in complex ways. Participants were uncomfortable with industry influence throughout their medical training and found multifaceted ways to resist. They struggled with power relations in medical training and the prevailing notion that industry presence is a normal part of medical education. I argue that this pervasive norm of industry presence is located in neoliberal structural transformations within and outside both education and medicine. The idea that industry presence is normal and inevitable represents a challenge for students who are critical of industry. Crown Copyright © 2014. Published by Elsevier Ltd. All rights reserved.

  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. Industry withdrawal from psychiatric medication development

    Directory of Open Access Journals (Sweden)

    Donald F. Klein

    2014-09-01

    Full Text Available Between 1950 and 1969, on a serendipitous basis, psychiatric drug development flourished. However, there has been a steep decline in the development of new medication classes. Instead of new molecular entities, slight molecular modifications producing “me-too” drugs attempted to garner market share. With failing profitability, industry is now withdrawing from psychiatric medication development. Managed care drastically shortened contact between patients and clinicians, so the possible observation of unexpected benefits has been nullified. The randomized, parallel-groups design met FDA requirements for specific pharmacological efficacy. However, it does not determine whether a patient who improved while drug-treated required the drug or would have gotten better on his own. Further, pathophysiology benefit remains obscure. The major psychotropic drugs have no benefits for normal subjects. Their remarkable benefits must stem from a necessary interaction with a pathophysiological state. Therefore, understanding therapeutic benefit by treating normal subjects becomes unlikely. The claim that therapeutic knowledge in psychiatry proceeds from bench to bedside has proven vacuous, primarily because of our limited understanding of brain pathophysiology. The utility of the alternative intensive design for understanding diagnosis, therapeutic benefit, and pathophysiology is emphasized.

  6. 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 compri...

  7. Cybersecurity and the Medical Device Product Development Lifecycle.

    Science.gov (United States)

    Jones, Richard W; Katzis, Konstantinos

    2017-01-01

    Protecting connected medical devices from evolving cyber related threats, requires a continuous lifecycle approach whereby cybersecurity is integrated within the product development lifecycle and both complements and re-enforces the safety risk management processes therein. This contribution reviews the guidance relating to medical device cybersecurity within the product development lifecycle.

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

    DEFF Research Database (Denmark)

    Hansen, Klaus Marius; Manikas, Konstantinos

    2016-01-01

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

  9. 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...

  10. 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...

  11. 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

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

    Directory of Open Access Journals (Sweden)

    Howard JJ

    2014-11-01

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

  13. 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.

  14. 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

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

    Science.gov (United States)

    Ransford, Benjamin; Kramer, Daniel B; Foo Kune, Denis; Auto de Medeiros, Julio; Yan, Chen; Xu, Wenyuan; Crawford, Thomas; Fu, Kevin

    2017-08-01

    Medical devices increasingly depend on software. While this expands the ability of devices to perform key therapeutic and diagnostic functions, reliance on software inevitably causes exposure to hazards of security vulnerabilities. This article uses a recent high-profile case example to outline a proactive approach to security awareness that incorporates a scientific, risk-based analysis of security concerns that supports ongoing discussions with patients about their medical devices. © 2017 The Authors. Pacing and Clinical Electrophysiology published by Wiley Periodicals, Inc.

  16. Radiofrequency identification and medical devices: the regulatory framework on electromagnetic compatibility. Part II: active implantable medical devices.

    Science.gov (United States)

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

    2012-05-01

    The number and the types of electromagnetic emitters to which patients with active implantable medical devices (AIMD) are exposed to in their daily activities have proliferated over the last decade. Radiofrequency identification (RFID) is an example of wireless technology applied in many fields. The interaction between RFID emitters and AIMD is an important issue for patients, industry and regulators, because of the risks associated with such interactions. The different AIMDs refer to different standards that address the electromagnetic immunity issue in different ways. Indeed, different test setups, immunity levels and rationales are used to guarantee that AIMDs are immune to electromagnetic nonionizing radiation. In this article, the regulatory framework concerning electromagnetic compatibility between RFID systems and AIMDs is analyzed to understand whether and how the application of the current AIMD standards allows for the effective control of the possible risks associated with RFID technology.

  17. Electronic business in the home medical equipment industry.

    Science.gov (United States)

    Wei, June; Graham, Michael J; Liu, Lai C

    2011-01-01

    This paper aims at developing electronic business solutions to increase value for the home medical equipment industry. First, an electronic strategic value chain model was developed for the home medical equipment industry. Second, electronic business solutions were mapped from this model. Third, the top 20 dominant companies in the home medical equipment industry were investigated to see the current adoption patterns of these electronic business solutions. The solutions will be beneficial to decision-makers in the information technology adoptions in the home medical equipment industry to increase the business values.

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

    Science.gov (United States)

    Pashkov, Vitalii; Harkusha, Andrii; Bytiak, Oleksii

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

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

    Science.gov (United States)

    Schofferman, Jerome

    2011-12-01

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

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

    Science.gov (United States)

    Brown, John

    2007-01-01

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

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

    Science.gov (United States)

    Niimi, Shingo

    2017-01-01

     Prototypes of medical devices are made in accordance with the needs of clinical practice, and for systems required during the initial process of medical device development for new surgical practices. Verification of whether these prototypes produce the intended performance specifications is conducted using basic tests such as mechanical and animal tests. The prototypes are then improved and modified until satisfactory results are obtained. After a prototype passes through a clinical trial process similar to that for new drugs, application for approval is made. In the approval application process, medical devices are divided into new, improved, and generic types. Reviewers judge the validity of intended use, indications, operation procedures, and precautions, and in addition evaluate the balance between risk and benefit in terms of efficacy and safety. Other characteristics of medical devices are the need for the user to attain proficiency in usage techniques to ensure efficacy and safety, and the existence of a variety of medical devices for which assessment strategies differ, including differences in impact on the body in cases in which a physical burden to the body or failure of a medical device develops. Regulatory science of medical devices involves prediction, judgment, and evaluation of efficacy, safety, and quality, from which data result which can become indices in the development stages from design to application for approval. A reduction in the number of animals used for testing, improvement in efficiency, reduction of the necessity for clinical trials, etc. are expected through rational setting of evaluation items.

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

    Science.gov (United States)

    2011-04-14

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 878 Medical Devices; General and Plastic Surgery...? 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...

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

    Science.gov (United States)

    2011-07-19

    ... 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 be...

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

    Science.gov (United States)

    2010-10-05

    ... 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... Surgery Devices Panel of the Medical Devices Advisory Committee would be held on November 18, 2010. On...

  5. 75 FR 68200 - Medical Devices; Radiology Devices; Reclassification of Full-Field Digital Mammography System

    Science.gov (United States)

    2010-11-05

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 892 Medical Devices; Radiology Devices... the Commissioner of Food and Drugs, 21 CFR part 892 is amended as follows: PART 892--RADIOLOGY DEVICES...

  6. 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...

  7. 医疗器械企业如何有效实施纠正和预防措施%How to Effectively Implement CAPA in Medical Device Industry

    Institute of Scientific and Technical Information of China (English)

    吕宏光; 张虎

    2013-01-01

      医疗器械质量体系法规和标准对纠正和预防措施均提出了要求,本文介绍了有效实施纠正和预防措施的步骤和程序,着重强调了纠正预防措施实施应关注有效性和充分性,避免流于形式。%Both of medical device regulation and quality system standard have the requirement to corrective and preventive action, this article introduce the step and procedure for effectively conduct corrective and preventive action, the corrective and preventive action should focus on effective and adequate and avoid externalism.

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

    Science.gov (United States)

    Tu, Pei-Weng; Wu, Shiow-Ing

    2015-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Tzu-Wei Li

    2015-01-01

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

  10. 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.

  11. 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.

  12. 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...

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

    Science.gov (United States)

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

    2013-09-01

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

  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. #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...

  16. [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.

  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. 76 FR 70150 - Draft Guidance for Industry and Food and Drug Administration Staff; Investigational Device...

    Science.gov (United States)

    2011-11-10

    ... Staff; Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies... guidance, FDA intends to facilitate early feasibility studies of medical devices, using appropriate risk mitigation strategies, under the IDE requirements. Early feasibility studies allow for limited early...

  20. 76 FR 80947 - Draft Guidance for Industry and Food and Drug Administration Staff; Investigational Device...

    Science.gov (United States)

    2011-12-27

    ... Staff; Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies... approaches FDA intends to facilitate early feasibility studies of medical devices, using appropriate risk..., early feasibility studies, as well as outlines the general principles for preparing and reviewing...

  1. Radiofrequency interference with medical devices. A technical information statement.

    Science.gov (United States)

    1998-01-01

    The past few years have seen increased reports that medical devices, such as pacemakers, apnea monitors, electrically powered wheelchairs, etc., have failed to operate correctly because of interference from various emitters of radiofrequency energy. This condition is called radiofrequency interference (RFI). The consequences of these failures range from inconvenience to serious injuries and death. Reasons for this problem are twofold: 1) increasing numbers of electronically controlled medical devices with inadequate electronic protection against RFI, and 2) a significant increase in the number of RF sources in the environment. Medical devices are widely used outside the hospital and may be attached to, or implanted in, patients. Portable wireless communications equipment, including cellular phones, handheld transceivers, and vehicle-mounted transceivers, comprise one of the largest sources of RFI. Some medical devices are especially sensitive to the type of digital modulation that some of the wireless communications devices utilize. The prevailing international standard for the RF immunity of medical devices is the 1993 revision of the International Electro-technical Commission (IEC) Standard IEC 60601-1-2. This standard sets a minimum immunity level of 3 volts per meter (V/m) in the 26-1000 MHz frequency range. For non-life supporting devices, testing is required only at the specific frequencies of 27.12, 40.68, and 915 MHz. Technology exists to protect, or "harden," most medical devices from RF fields that are much more intense than the 3 V/m level specified in present RFI standards. Most of these techniques, including shielding, grounding, and filtering, are not costly if they are incorporated into the initial design of the electronics system. COMAR recommends that the various parties involved in the manufacture and use of RFI-prone medical devices take steps to avoid serious RFI problems that may lead to safety hazards. Medical device manufacturers should

  2. 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?

  3. Formal verification of software-based medical devices considering medical guidelines.

    Science.gov (United States)

    Daw, Zamira; Cleaveland, Rance; Vetter, Marcus

    2014-01-01

    Software-based devices have increasingly become an important part of several clinical scenarios. Due to their critical impact on human life, medical devices have very strict safety requirements. It is therefore necessary to apply verification methods to ensure that the safety requirements are met. Verification of software-based devices is commonly limited to the verification of their internal elements without considering the interaction that these elements have with other devices as well as the application environment in which they are used. Medical guidelines define clinical procedures, which contain the necessary information to completely verify medical devices. The objective of this work was to incorporate medical guidelines into the verification process in order to increase the reliability of the software-based medical devices. Medical devices are developed using the model-driven method deterministic models for signal processing of embedded systems (DMOSES). This method uses unified modeling language (UML) models as a basis for the development of medical devices. The UML activity diagram is used to describe medical guidelines as workflows. The functionality of the medical devices is abstracted as a set of actions that is modeled within these workflows. In this paper, the UML models are verified using the UPPAAL model-checker. For this purpose, a formalization approach for the UML models using timed automaton (TA) is presented. A set of requirements is verified by the proposed approach for the navigation-guided biopsy. This shows the capability for identifying errors or optimization points both in the workflow and in the system design of the navigation device. In addition to the above, an open source eclipse plug-in was developed for the automated transformation of UML models into TA models that are automatically verified using UPPAAL. The proposed method enables developers to model medical devices and their clinical environment using clinical workflows as one

  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. 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.

  6. [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.

  7. Major Innovations and Trends in the Medical Device Sector

    OpenAIRE

    Bergsland, Jacob

    2012-01-01

    Activities related to medical innovation are accelerating and becoming increasingly important due to the demand for better and less invasive therapies, a rapidly aging population in the developed world and a globally larger population able to afford advanced medical care. Medical Innovation is occurring in the fields of pharmacy, diagnostics and therapeutic imaging, surgical products, interventional procedures and devices. Increasing understanding of basic disease processes further opens the ...

  8. Medical device risk management and its economic impact

    Directory of Open Access Journals (Sweden)

    Katerina Krsteva Jakimovska

    2013-10-01

    Full Text Available The importance of medical devices in everyday users/patients lives is imensse. This is the reason why emphasis must be put on safety during their use. Satisfactory safety level can be achived by implementation of quality and risk management standards. Medical device manufacturers must learn to deal with the potential risks by using theoretical and practical examples and measures in order to protect their users/patients and themselves from suffering huge losses arising from adverse events or recall of their products. The best moment for implementation of risk management methods and analysis begins from the device design and development through manufacturing, sales and distribution. These way medical device manufacturers will succseed in protecting their users/patients from serious adverse events and at the same time protect their brand and society status, while minimizing economic losses.

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

    Science.gov (United States)

    Howard, Jason J

    2014-01-01

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

  10. 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.

  11. 78 FR 58545 - Global Unique Device Identification Database; Draft Guidance for Industry; Availability

    Science.gov (United States)

    2013-09-24

    ... HUMAN SERVICES Food and Drug Administration Global Unique Device Identification Database; Draft Guidance... ``Global Unique Device Identification Database (GUDID).'' FDA is issuing this draft guidance to communicate... unique device identification system for medical devices along with implementation timeframes for certain...

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

    Science.gov (United States)

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

    2013-01-01

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

  13. Medical surveillance in the biotechnology industry.

    Science.gov (United States)

    Goldman, R H

    1991-01-01

    A medical program appropriate for employees in biomedical laboratories should be based upon specific understanding of the risks and hazards associated with the work activities. Components of a medical program might include: preplacement examinations, periodic monitoring evaluations, tracking of prolonged or unusual illness, specific illness or exposure-related evaluations, epidemiological studies, immunization programs, and exit (or termination) evaluations.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.    

  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. 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...

  1. 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...

  2. 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...

  3. 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...

  4. 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...

  5. 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...

  6. 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.

  7. 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%.

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

    Science.gov (United States)

    Wong, Kathie A; Hodgson, Luke; Garas, George; Malietzis, George; Markar, Sheraz; Rao, Christopher; von Segesser, Ludwig K; Athanasiou, Thanos

    2016-12-01

    Surgeons, as the consumers, must engage in commercial activity regarding medical devices since it directly has impacts on surgical practice and patient outcomes. Unique features defy traditional economic convention in this specific market partly because consumers do not usually pay directly. Greater involvement with commercial activity means better post-market surveillance of medical devices which leads to improved patient safety. The medical device industry has exhibited astonishing levels of growth and profitability reaching $398 billion on a global scale with new product development focusing on unmet clinical need. The industry has rapidly emerged within the context of an ageing population and a global surge in healthcare spending. But the market remains fragmented. The split of consumer, purchaser and payer leads to clinical need driving demand for new product development. This demand contributes to potentially large profit margins mainly contained by regulatory burden and liability issues. Demographic trends, prevalence of diseases and a huge capacity to absorb technology have sustained near unparalleled growth. To stay in the market, incremental development over the short term is essentially aided by responsiveness to demand. Disruptive product development is now more likely to come from multinational companies, in an increasingly expensive, regulated industry. Understanding healthcare organization can help explain the highly complex process of diffusion of innovations in healthcare that include medical devices. The time has come for surgeons to become actively involved with all aspects of the medical device life cycle including commercial activity and post-market surveillance. This is vital for improving patient care and ensuring patient safety. © The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

  9. Marketing norm perception among medical representatives in Indian pharmaceutical industry.

    Science.gov (United States)

    Nagashekhara, Molugulu; Agil, Syed Omar Syed; Ramasamy, Ravindran

    2012-03-01

    Study of marketing norm perception among medical representatives is an under-portrayed component that deserves further perusal in the pharmaceutical industry. The purpose of this study is to find out the perception of marketing norms among medical representatives. The research design is quantitative and cross sectional study with medical representatives as unit of analysis. Data is collected from medical representatives (n=300) using a simple random and cluster sampling using a structured questionnaire. Results indicate that there is no difference in the perception of marketing norms among male and female medical representatives. But there is a difference in opinion among domestic and multinational company's medical representatives. Educational back ground of medical representatives also shows the difference in opinion among medical representatives. Degree holders and multinational company medical representatives have high perception of marketing norms compare to their counterparts. The researchers strongly believe that mandatory training on marketing norms is beneficial in decision making process during the dilemmas in the sales field.

  10. Beware the Medical-Industrial Complex.

    Science.gov (United States)

    Stevens; Glatstein

    1996-01-01

    ". we must guard against the acquisition of unwarranted influence, whether sought or unsought, by the military industrial complex." Dwight D. Eisenhower, 34th President of the United States (1953-1961). Farewell Address, January 17, 1961. If Ike were with us today, he might well expand his views on power and influence to include modern American medicine. The corporatization of health care in the United States has moved rapidly in recent years. Physicians are now in a position that requires us to adapt to an increasingly Darwinian existence. Years of training to be "rugged individualists" pushing the frontiers of medical knowledge have not equipped us to fight corporate battles, nor to justify our treatment decisions to bean counters. When the most important consideration becomes the bottom line, then innovation, creativity, and research diminish in importance. They will, in fact, be selected against because they cost money. Up to now, these have been the hallmarks of American medicine, and we must strive to maintain our position of American leadership in biotechnology. New developments in cancer treatment include expensive technological "bells and whistles" which physicians must ultimately evaluate objectively, despite lush advertisements from companies with obvious vested interests, and authoritative testimonials from biased investigators who presumably believe in their own work to the point of straining credulity and denying common sense. The 3-D image that was created by a computer may look beautiful (and cost accordingly), but it is hard to believe that it can fundamentally change the outcome of patients when it does not add any new data that bear on basic issues. For example, where is the exact edge of the tumor? If one pays through the nose for increasing precision where there is no new accuracy, the purchase appears less attractive, perhaps, than the hype of the salesman or the enthusiasm of a neurosurgeon or a "stereotactic" radiation oncologist (showing

  11. Effects and Satisfaction of Medical Device Safety Information Reporting System Using Electronic Medical Record

    Science.gov (United States)

    Jang, Hye Jung; Choi, Young Deuk

    2017-01-01

    Objectives This paper describes an evaluation study on the effectiveness of developing an in-hospital medical device safety information reporting system for managing safety information, including adverse incident data related to medical devices, following the enactment of the Medical Device Act in Korea. Methods Medical device safety information reports were analyzed for 190 cases that took place prior to the application of a medical device safety information reporting system and during a period when the reporting system was used. Also, questionnaires were used to measure the effectiveness of the medical device safety information reporting system. The analysis was based on the questionnaire responses of 15 reporters who submitted reports in both the pre- and post-reporting system periods. Results Sixty-two reports were submitted in paper form, but after the system was set up, this number more than doubled to 128 reports in electronic form. In terms of itemized reporting, a total of 45 items were reported. Before the system was used, 23 items had been reported, but this increased to 32 items after the system was put to use. All survey variables of satisfaction received a mean of over 3 points, while positive attitude, potential benefits, and positive benefits all exceeded 4 points, each receiving 4.20, 4.20, and 4.13, respectively. Among the variables, time-consuming and decision-making had the lowest mean values, each receiving 3.53. Satisfaction was found to be high for system quality and user satisfaction, but relatively low for time-consuming and decision-making. Conclusions We were able to verify that effective reporting and monitoring of adverse incidents and the safety of medical devices can be implemented through the establishment of an in-hospital medical device safety information reporting system that can enhance patient safety and medical device risk management. PMID:28523207

  12. Effects and Satisfaction of Medical Device Safety Information Reporting System Using Electronic Medical Record.

    Science.gov (United States)

    Jang, Hye Jung; Choi, Young Deuk; Kim, Nam Hyun

    2017-04-01

    This paper describes an evaluation study on the effectiveness of developing an in-hospital medical device safety information reporting system for managing safety information, including adverse incident data related to medical devices, following the enactment of the Medical Device Act in Korea. Medical device safety information reports were analyzed for 190 cases that took place prior to the application of a medical device safety information reporting system and during a period when the reporting system was used. Also, questionnaires were used to measure the effectiveness of the medical device safety information reporting system. The analysis was based on the questionnaire responses of 15 reporters who submitted reports in both the pre- and post-reporting system periods. Sixty-two reports were submitted in paper form, but after the system was set up, this number more than doubled to 128 reports in electronic form. In terms of itemized reporting, a total of 45 items were reported. Before the system was used, 23 items had been reported, but this increased to 32 items after the system was put to use. All survey variables of satisfaction received a mean of over 3 points, while positive attitude, potential benefits, and positive benefits all exceeded 4 points, each receiving 4.20, 4.20, and 4.13, respectively. Among the variables, time-consuming and decision-making had the lowest mean values, each receiving 3.53. Satisfaction was found to be high for system quality and user satisfaction, but relatively low for time-consuming and decision-making. We were able to verify that effective reporting and monitoring of adverse incidents and the safety of medical devices can be implemented through the establishment of an in-hospital medical device safety information reporting system that can enhance patient safety and medical device risk management.

  13. 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.

  14. Study of the in vitro cytotoxicity testing of medical devices.

    Science.gov (United States)

    Li, Weijia; Zhou, Jing; Xu, Yuyin

    2015-09-01

    The cytotoxicity test is one of the biological evaluation and screening tests that use tissue cells in vitro to observe the cell growth, reproduction and morphological effects by medical devices. Cytotoxicity is preferred as a pilot project test and an important indicator for toxicity evaluation of medical devices as it is simple, fast, has a high sensitivity and can save animals from toxicity. Three types of cytotoxicity test are stated in the International Organization for Standardization 109993-5: Extract, direct contact and indirect contact tests. The xCELLigence real-time cell analysis system shows a significant potential in regards to cytotoxicity in recent years. The present review provides a brief insight into the in vitro cytotoxicity testing of medical devices.

  15. 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.

  16. [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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  1. [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.

  2. 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.

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

    Directory of Open Access Journals (Sweden)

    Jordan Deliversky

    2015-02-01

    Full Text Available Standards are produced for many different products and services, and may be created for company, national, regional or global application. In Europe there are three different categories of standard: International standard – a standard adopted by an international standardization organization; European standard – a standard adopted by a European standardization body; National standard – a standard adopted by a national standardization body and made available to the public. Harmonized standards play a special role in the EU. A harmonised standard is a European standard elaborated on the basis of a request from the European Commission to a recognised European Standards Organisation to develop a European standard that provides solutions for compliance with a legal provision. Most standards for dental materials have been harmonized through a so-called cumulative standard (EN 1641:2009 - Dentistry - Medical devices for dentistry - Materials. This European Standard specifies general requirements for materials used in the practice of dentistry for the restoration of the form and function of the dentition and which are medical devices. A multiplicity of laws, standards, and recommendations regulate the marketing of medical devices. The medical doctor and the dentist should be informed about the European and international standards concerning medical devices and use only those for which appropriate information is available. The manufacturer/importer is responsible for its products and is potentially liable for damages.

  4. 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.

  5. 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.

  6. 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.

  7. Polymer Coats Leads on Implantable Medical Device

    Science.gov (United States)

    2008-01-01

    s unique characteristics lend it to many commercial applications; uses that Bryant believed would ultimately benefit industry and the Nation. "LaRC-SI," he explains, "is a product created in a government laboratory, funded with money from the tax-paying public. What we discovered helps further the economic competitiveness of the United States, and it was our goal to initiate the technology transfer process to ensure that our work benefited the widest range of people." Several NASA centers, including Langley, have explored methods for using LaRC-SI in a number of applications from radiation shielding and as an adhesive to uses involving replacement of conventional rigid circuit boards. In the commercial realm, LaRC-SI can now be found in several commercial products, including the thin-layer composite unimorph ferroelectric driver and sensor (THUNDER) piezoelectric actuator, another "R&D 100" award winner (Spinoff 2005).

  8. Gestão do pré-desenvolvimento de produto: estudo de casos na indústria de equipamentos médico-hospitalares Management of fuzzy front end: case studies in medical device industry

    Directory of Open Access Journals (Sweden)

    Glauco Henrique de Sousa Mendes

    2012-08-01

    Full Text Available O pré-desenvolvimento engloba as primeiras etapas do processo de desenvolvimento de novos produtos, nas quais as decisões são mais estratégicas e tomadas, geralmente, com alto grau de incerteza. O objetivo é analisar e discutir as práticas de gestão do pré-desenvolvimento em um conjunto de empresas de pequeno e médio portes da indústria de equipamentos médico-hospitalares. A análise é baseada num modelo conceitual, desenvolvido a partir da revisão bibliográfica, composto por cinco dimensões de gestão: orientação estratégica; processo; organização; avaliação; e ferramentas. A pesquisa de campo indica que as empresas estudadas apresentam deficiências na adoção e estruturação de boas práticas de gestão do pré-desenvolvimento. O modelo conceitual proposto serve de base para análise, estruturação e melhoria das atividades e do desempenho do pré-desenvolvimento.The fuzzy front end encompasses the first stages of new product development process. In that phase and period, the decisions are more strategic and are usually made with a high degree of uncertainty. This article aims to analyze and discuss the fuzzy front end management practices in small and medium medical device companies. The analysis is based on a conceptual model that was developed from the literature review and it consists of five dimensions of management: strategic orientation, process, organization, evaluation and tools. The results provide evidence that the studied companies have deficiencies in the adoption of best practices for managing the fuzzy front end, and the conceptual model suggested could serve as a basis for analysis, structuring and improving the fuzzy front end activities and performance.

  9. 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.

  10. 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

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

    Energy Technology Data Exchange (ETDEWEB)

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

    1996-12-31

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

  12. 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.

  13. [Applications of polylactide and its copolymers in medical device fields].

    Science.gov (United States)

    Qi, Xuefei; Pang, Xiubing; Wu, Kan

    2014-07-01

    Polylactide and its copolymers are a kind of biomedical material andhave been approved by U.S. Food and Drug Administration. This paper briefly introduces its applications in surgical suture, orthopedics, plastic surgery, ophthalmology and other medical device fields, and also analyzes its development in our country.

  14. 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. Copyright © 2016. Published by Elsevier Inc.

  15. From in vivo to in vitro: The medical device testing paradigm shift.

    Science.gov (United States)

    Kerecman Myers, Dayna; Goldberg, Alan M; Poth, Albrecht; Wolf, Michael F; Carraway, Joseph; McKim, James; Coleman, Kelly P; Hutchinson, Richard; Brown, Ronald; Krug, Harald F; Bahinski, Anthony; Hartung, Thomas

    2017-05-25

    Amid growing efforts to advance the replacement, reduction, and refinement of the use of animals in research, there is a growing recognition that in vitro testing of medical devices can be more effective, both in terms of cost and time, and also more reliable than in vivo testing. Although the technological landscape has evolved rapidly in support of these concepts, regulatory acceptance of alternative testing methods has not kept pace. Despite the acceptance by regulators of some in vitro tests (cytotoxicity, gene toxicity, and some hemocompatibility assays), many toxicity tests still rely on animals (irritation, sensitization, acute toxicity, reproductive/developmental toxicity), even where other industrial sectors have already abandoned them. Bringing about change will require a paradigm shift in current approaches to testing - and a concerted effort to generate better data on risks to human health from exposure to leachable chemicals from medical devices, and to boost confidence in devices and alternative testing methods. To help advance these ideas, stir debate about best practices, and coalesce around a roadmap forward, the JHU-Center for Alternatives to Animal Testing (CAAT) hosted a symposium in Baltimore, Maryland, in December 2013 - believed to be the first gathering dedicated to the topic of in vitro testing of medical devices. Industry representatives, academics, and regulators in attendance presented evidence to support the unique strengths and challenges associated with the approaches currently in use as well as new methods under development, and drew next steps to push the field forward from their presentations and discussion.

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

    Science.gov (United States)

    Hojo, Taisuke

    2017-01-01

     Review, safety, and relief services of the Pharmaceuticals and Medical Devices Agency are primarily focused on scientifically evaluating pharmaceuticals, medical devices, and cellular and tissue-based products referring to their quality, efficacy, and safety, which requires a variety of scientific knowledge and methods. Pharmaceutical regulation should be established based on the most advanced scientific expertise at all times. In order to evaluate products that use cutting-edge technology such as induced pluripotent stem cells and information and communication technology adequately, since fiscal year 2012 the Science Committee has been established as a platform to exchange opinions among members from top-ranking domestic and international academia and to enhance personnel exchanges through the Initiative to Facilitate Development of Innovative Drugs. In addition, the Regulatory Science Center will be established in 2018 to increase the integrity of our services for product reviews and safety measures. In particular, requiring electronic data submissions for clinical trial applications followed by an advanced approach to analysis should not only enhance the quality of reviews of individual products but should also support the development of pharmaceuticals and medical devices by providing pharmaceutical affairs consultations on research and development strategies with various guidelines based on new insights resulting from product-bridging data analysis. Moreover, a database including electronic health records with comprehensive medical information collected mainly from 10 cooperating medical institutions will be developed with the aim of developing safety measures in a more timely manner using methods of pharmacoepidemiological analysis.

  18. 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...

  19. 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...

  20. 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

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

    Science.gov (United States)

    Haghi, Mostafa; Thurow, Kerstin; Stoll, Regina

    2017-01-01

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

  2. Of mugs, meals and more: the intricate relations between physicians and the medical industry.

    Science.gov (United States)

    Sahm, Stephan

    2013-05-01

    Empirical research has proven the influence exerted by the medical industry on physicians' decision-making. Physicians are the gatekeepers who determine how money is spent within the healthcare system. Hence, they are the target group of powerful lobbies in the field, i.e. the manufacturers of medical devices and the pharmaceutical industry. As clinical research lies in the hands of physicians, they play an exclusive and central role in launching new medical products. There are many ethical problems involved here: physicians may develop a mindset of entitlement; biased decisions may put patients at risk; academic interests and research activities will no longer be free if they are influenced considerably by financial incentives; fair resource allocation may be restricted. An aspect that has been neglected so far is the administrators' involvement as they not rarely expect physicians to acquire external financial resources from industry as benefits often lie with the institutions. To "protect" physicians from undue sway may be in the best interest of patients in order to guarantee a fair allocation of resources and to prevent the application of technologies (and medications) that would not have been used according to current standards of care. The latter may and obviously does put patients at risk. On the other hand, medico-industrial relations are of great importance. A considerable part of medical progress is driven by private industry. Yet, any co-operation between those who care for patients and industry ultimately has to serve the patient. Hence, strong policies to guide conduct are sorely needed. The following points are held to be pivotal in order to secure ethical conduct: (1) professional codes of ethics; (2) a stronger academic attitude amongst medical staff, (3) rules of transparency for medico-industrial relations including online disclosure and limiting scale of payments, (4) establishing rules (and laws) that ban unethical conduct and mandate vigorous

  3. 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'.

  4. 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.

  5. Micro Computer Tomography for medical device and pharmaceutical packaging analysis.

    Science.gov (United States)

    Hindelang, Florine; Zurbach, Raphael; Roggo, Yves

    2015-04-10

    Biomedical device and medicine product manufacturing are long processes facing global competition. As technology evolves with time, the level of quality, safety and reliability increases simultaneously. Micro Computer Tomography (Micro CT) is a tool allowing a deep investigation of products: it can contribute to quality improvement. This article presents the numerous applications of Micro CT for medical device and pharmaceutical packaging analysis. The samples investigated confirmed CT suitability for verification of integrity, measurements and defect detections in a non-destructive manner. Copyright © 2015 Elsevier B.V. All rights reserved.

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

    Directory of Open Access Journals (Sweden)

    Craven Michael P

    2011-02-01

    Full Text Available Abstract Background Academic literature and international standards bodies suggest that user involvement, via the incorporation of human factors engineering methods within the medical device design and development (MDDD process, offer many benefits that enable the development of safer and more usable medical devices that are better suited to users' needs. However, little research has been carried out to explore medical device manufacturers' beliefs and attitudes towards user involvement within this process, or indeed what value they believe can be added by doing so. Methods In-depth interviews with representatives from 11 medical device manufacturers are carried out. We ask them to specify who they believe the intended users of the device to be, who they consult to inform the MDDD process, what role they believe the user plays within this process, and what value (if any they believe users add. Thematic analysis is used to analyse the fully transcribed interview data, to gain insight into medical device manufacturers' beliefs and attitudes towards user involvement within the MDDD process. Results A number of high-level themes emerged, relating who the user is perceived to be, the methods used, the perceived value and barriers to user involvement, and the nature of user contributions. The findings reveal that despite standards agencies and academic literature offering strong support for the employment formal methods, manufacturers are still hesitant due to a range of factors including: perceived barriers to obtaining ethical approval; the speed at which such activity may be carried out; the belief that there is no need given the 'all-knowing' nature of senior health care staff and clinical champions; a belief that effective results are achievable by consulting a minimal number of champions. Furthermore, less senior health care practitioners and patients were rarely seen as being able to provide valuable input into the process. Conclusions Medical

  7. INDUSTRIAL DEVICE FOR THE ELECTROCHEMICAL ACTIVATION OF WATER

    Directory of Open Access Journals (Sweden)

    Krasavtsev B. E.

    2015-06-01

    Full Text Available We describe a stationary industrial plant for electrochemical activation (ECA of the water created on the creamery of "Yuzhni Polyus" in Kropotkin. It includes 4 diaphragm reactor - electrolyzer of a dielectric material volume of 200 liters each, control cabinet, power electrical equipment, water supply system, containers for activated water, pumping equipment for its transport and ventilation system. The anode and cathode chambers are separated by ion permeable diaphragm reactors of cotton filter cloth. The reactors operate pairwise in succession, one pair in the production mode, the other - in the mode of preparation. The anode is made of titanium sheet; the cathode is made of stainless steel 12HN9T. In the selection of the electrode material we used mass-spectrometric investigation of the chemical element composition of water before and after electrochemical activation. The device produces alkaline catholyte 15.84 m3 / day (pH 10,4 ÷ 11,71 and acid anolyte 3.36 m3 / day (pH 2,24 ÷ 3,1. Using the created device (power consumption –11,4 kW ∙ h / t meets the basic requirements of production – resource conservation, environmental safety, high performance and ease of use. These circuit diagram and photos of the installation allows reproducing it in other enterprises, contributing to the wider application of electrochemically activated water

  8. 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...

  9. 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...

  10. 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...

  11. 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...

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

    Science.gov (United States)

    2011-10-20

    ... 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...

  13. 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 meeting...

  14. Towards automated assistance for operating home medical devices.

    Science.gov (United States)

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

    2010-01-01

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

  15. 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.

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

    Science.gov (United States)

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

    2009-01-01

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

  17. 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.

  18. 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 ...

  19. 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...

  20. 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.

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 76 FR 77834 - Scientific Information Request on Intravascular Diagnostic and Imaging Medical Devices

    Science.gov (United States)

    2011-12-14

    ... Intravascular Diagnostic and Imaging Medical Devices AGENCY: Agency for Healthcare Research and Quality (AHRQ... intravascular diagnostic and imaging medical devices, including: Fractional Flow Reserve (FFR), Coronary Flow... Resonance Imaging (MRI), Elastrography, and Thermography. Scientific information is being solicited to...

  9. 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.

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

    DEFF Research Database (Denmark)

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

    2015-01-01

    Medical device companies are continuously challenged with the ability to prove compliance with increasingly complex regulatory frameworks. Operating under heavy regulatory requirements may therefore cause significant delays to the lead time of new medical devices and thus contribute significantly...

  11. How Does Medical Device Regulation Perform in the United States and the European Union? A Systematic Review

    Science.gov (United States)

    Kramer, Daniel B.; Xu, Shuai; Kesselheim, Aaron S.

    2012-01-01

    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 better assessment of

  12. 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

  13. 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.

  14. [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.

  15. 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...

  16. 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.

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

    Science.gov (United States)

    2011-04-01

    ... HUMAN SERVICES Food and Drug Administration Molecular and Clinical Genetics Panel of the Medical Devices... Molecular and Clinical Genetics Panel (the panel) of the Medical Devices Advisory Committee that published... meeting of the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee, and the...

  18. 78 FR 33849 - Battery-Powered Medical Devices Workshop: Challenges and Opportunities; Public Workshop; Request...

    Science.gov (United States)

    2013-06-05

    ... No. FDA-2013-N-0580] Battery-Powered Medical Devices Workshop: Challenges and Opportunities; Public... entitled ``Battery-Powered Medical Devices Workshop: Challenges and Opportunities''. The purpose of this workshop is to create awareness of the challenges related to battery-powered medical devices and...

  19. RF linear accelerators for medical and industrial applications

    CERN Document Server

    Hanna, Samy

    2012-01-01

    This unique resource offers you a clear overview of medical and industrial accelerators. Using minimal mathematics, this book focuses on offering thorough explanations of basic concepts surrounding the operation of accelerators. you find well illustrated discussions designed to help you use accelerator-based systems in a safer, more productive, and more reliable manner.This practical book details the manufacturing process for producing accelerators for medical and industrial applications. You become knowledgeable about the commonly encountered real-world manufacturing issues and potential sources of defects which help you avoid costly production problems. From principles of operation and the role of accelerators in cancer radiation therapy, to manufacturing techniques and future trends in accelerator design and applications, this easy-to-comprehend volume quickly brings you up-to-speed with the critical concepts you need to understand for your work in the field.

  20. 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.

  1. Learning curve estimation in medical devices and procedures: hierarchical modeling.

    Science.gov (United States)

    Govindarajulu, Usha S; Stillo, Marco; Goldfarb, David; Matheny, Michael E; Resnic, Frederic S

    2017-07-30

    In the use of medical device procedures, learning effects have been shown to be a critical component of medical device safety surveillance. To support their estimation of these effects, we evaluated multiple methods for modeling these rates within a complex simulated dataset representing patients treated by physicians clustered within institutions. We employed unique modeling for the learning curves to incorporate the learning hierarchy between institution and physicians and then modeled them within established methods that work with hierarchical data such as generalized estimating equations (GEE) and generalized linear mixed effect models. We found that both methods performed well, but that the GEE may have some advantages over the generalized linear mixed effect models for ease of modeling and a substantially lower rate of model convergence failures. We then focused more on using GEE and performed a separate simulation to vary the shape of the learning curve as well as employed various smoothing methods to the plots. We concluded that while both hierarchical methods can be used with our mathematical modeling of the learning curve, the GEE tended to perform better across multiple simulated scenarios in order to accurately model the learning effect as a function of physician and hospital hierarchical data in the use of a novel medical device. We found that the choice of shape used to produce the 'learning-free' dataset would be dataset specific, while the choice of smoothing method was negligibly different from one another. This was an important application to understand how best to fit this unique learning curve function for hierarchical physician and hospital data. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

  2. Providers' payment and delivery system reforms hold both threats and opportunities for the drug and device industries.

    Science.gov (United States)

    Robinson, James C

    2012-09-01

    For decades, medical device and specialty drug makers have produced a steady stream of breakthroughs and incremental improvements, from cancer therapies to orthopedic joint replacements, drug-eluting stents, and cardiac pacemakers. The advances were financed by a fragmented health care system that paid for whichever clinical technologies were favored by physicians without strong concern for cost. But now hospitals, health systems, insurers, and policy makers are embracing payment reforms that seek to control costs and foster uniformity in the adoption of new drugs and devices. This article explores payment reforms that will have an impact on the medical technology industry and describes opportunities for the industry to flourish in this new, more financially constrained landscape.

  3. 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.

  4. The Development of a Quality Management Framework for Evaluating Medical Device Reprocessing Practice in Healthcare Facilities.

    Science.gov (United States)

    Lorv, Bailey; Horodyski, Robin; Welton, Cynthia; Vail, John; Simonetto, Luca; Jokanovic, Danilo; Sharma, Richa; Mahoney, Angela Rea; Savoy-Bird, Shay; Bains, Shalu

    2017-01-01

    There is increasing awareness of the importance of medical device reprocessing (MDR) for the provision of safe patient care. Although industry service standards are available to guide MDR practices, there remains a lack of published key performance indicators (KPIs) and targets that are necessary to evaluate MDR quality for feedback and improvement. This article outlines the development of an initial framework that builds on established guidelines and includes service standards, KPIs and targets for evaluating MDR operations. This framework can support healthcare facilities in strengthening existing practices and enables a platform for collaboration towards better MDR performance management.

  5. 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,...

  6. A Project Course Sequence in Innovation and Commercialization of Medical Devices.

    Science.gov (United States)

    Eberhardt, Alan W; Tillman, Shea; Kirkland, Brandon; Sherrod, Brandon

    2017-07-01

    There exists a need for educational processes in which students gain experience with design and commercialization of medical devices. This manuscript describes the implementation of, and assessment results from, the first year offering of a project course sequence in Master of Engineering (MEng) in Design and Commercialization at our institution. The three-semester course sequence focused on developing and applying hands-on skills that contribute to product development to address medical device needs found within our university hospital and local community. The first semester integrated computer-aided drawing (CAD) as preparation for manufacturing of device-related components (hand machining, computer numeric control (CNC), three-dimensional (3D) printing, and plastics molding), followed by an introduction to microcontrollers (MCUs) and printed circuit boards (PCBs) for associated electronics and control systems. In the second semester, the students applied these skills on a unified project, working together to construct and test multiple weighing scales for wheelchair users. In the final semester, the students applied industrial design concepts to four distinct device designs, including user and context reassessment, human factors (functional and aesthetic) design refinement, and advanced visualization for commercialization. The assessment results are described, along with lessons learned and plans for enhancement of the course sequence.

  7. Device Data Ingestion for Industrial Big Data Platforms with a Case Study.

    Science.gov (United States)

    Ji, Cun; Shao, Qingshi; Sun, Jiao; Liu, Shijun; Pan, Li; Wu, Lei; Yang, Chenglei

    2016-02-26

    Despite having played a significant role in the Industry 4.0 era, the Internet of Things is currently faced with the challenge of how to ingest large-scale heterogeneous and multi-type device data. In response to this problem we present a heterogeneous device data ingestion model for an industrial big data platform. The model includes device templates and four strategies for data synchronization, data slicing, data splitting and data indexing, respectively. We can ingest device data from multiple sources with this heterogeneous device data ingestion model, which has been verified on our industrial big data platform. In addition, we present a case study on device data-based scenario analysis of industrial big data.

  8. Device Data Ingestion for Industrial Big Data Platforms with a Case Study †

    Science.gov (United States)

    Ji, Cun; Shao, Qingshi; Sun, Jiao; Liu, Shijun; Pan, Li; Wu, Lei; Yang, Chenglei

    2016-01-01

    Despite having played a significant role in the Industry 4.0 era, the Internet of Things is currently faced with the challenge of how to ingest large-scale heterogeneous and multi-type device data. In response to this problem we present a heterogeneous device data ingestion model for an industrial big data platform. The model includes device templates and four strategies for data synchronization, data slicing, data splitting and data indexing, respectively. We can ingest device data from multiple sources with this heterogeneous device data ingestion model, which has been verified on our industrial big data platform. In addition, we present a case study on device data-based scenario analysis of industrial big data. PMID:26927121

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

    Directory of Open Access Journals (Sweden)

    Kelly Farrah, MLIS, AHIP

    2016-09-01

    Full Text Available Objective: The study tested the performance of adverse effects search filters when searching for safety information on medical devices, procedures, and diagnostic tests in MEDLINE and Embase. Methods: The sensitivity of 3 filters was determined using a sample of 631 references from 131 rapid reviews related to the safety of health technologies. The references were divided into 2 sets by type of intervention: drugs and nondrug health technologies. Keyword and indexing analysis were performed on references from the nondrug testing set that 1 or more of the filters did not retrieve. Results: For all 3 filters, sensitivity was lower for nondrug health technologies (ranging from 53%– 87% than for drugs (88%–93% in both databases. When tested on the nondrug health technologies set, sensitivity was lower in Embase (ranging from 53%–81% than in MEDLINE (67%–87% for all filters. Of the nondrug records that 1 or more of the filters missed, 39% of the missed MEDLINE records and 18% of the missed Embase records did not contain any indexing terms related to adverse events. Analyzing the titles and abstracts of nondrug records that were missed by any 1 filter, the most commonly used keywords related to adverse effects were: risk, complications, mortality, contamination, hemorrhage, and failure. Conclusions: In this study, adverse effects filters were less effective at finding information about the safety of medical devices, procedures, and tests compared to information about the safety of drugs.

  10. Practical pathology perspectives for minimally invasive hyperthermic medical devices

    Science.gov (United States)

    Coad, James E.

    2011-03-01

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

  11. Thermally Stable and Sterilizable Polymer Transistors for Reusable Medical Devices.

    Science.gov (United States)

    Kyaw, Aung Ko Ko; Jamalullah, Feroz; Vaithieswari, Loga; Tan, Mein Jin; Zhang, Lian; Zhang, Jie

    2016-04-20

    We realize a thermally stable polymer thin film transistor (TFT) that is able to endure the standard autoclave sterilization for reusable medical devices. A thermally stable semiconducting polymer poly[4-(4,4-dihexadecyl-4Hcyclopenta[1,2-b:5,4-b]dithiophen-2-yl)-alt[1,2,5]thiadiazolo [3,4c] pyridine], which is stable up to 350 °C in N2 and 200 °C in air, is used as channel layer, whereas the biocompatible SU-8 polymer is used as a flexible dielectric layer, in addition to conventional SiO2 dielectric layer. Encapsulating with in-house designed composite film laminates as moisture barrier, both TFTs using either SiO2 or SU-8 dielectric layer exhibit good stability in sterilized conditions without significant change in mobility and threshold voltage. After sterilization for 30 min in autoclave, the mobility drops only 15%; from as-fabricated mobility of 1.4 and 1.3 cm(2) V(-1) s(-1) to 1.2 and 1.1 cm(2) V(-1) s(-1) for TFTs with SiO2 and SU-8 dielectric layer, respectively. Our TFT design along with experimental results reveal the opportunity on organic/polymer flexible TFTs in sterilizable/reusable medical device application.

  12. 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

  13. Nurses' attitudes towards medical devices in healthcare delivery: a systematic review.

    Science.gov (United States)

    Zhang, Wei; Barriball, K Louise; While, Alison E

    2014-10-01

    To describe nurses' attitudes towards medical devices and the factors influencing these attitudes. Nurses work in an increasingly technological environment with many medical devices supporting healthcare delivery. Understanding nurses' attitudes towards medical devices is important for their successful use. There has been no published systematic review which has examined nurses' attitudes towards the use of medical devices within nursing practice. A systematic review including all study designs. A search of six databases was undertaken for publications written in English dating from 1985-June 2013. The search yielded 30 studies. Nurses reported a multidimensional perception of medical devices. While some nurses recognised the potential contribution of medical devices to better outcomes for patients and themselves, the use of medical devices was also associated with increased personal stress, decreased autonomy and increased administrative time. The design of devices, knowledge and training relating to device management and use were identified as key factors influencing nurses' attitudes. To ensure adequate knowledge and skill, the provision of training on device management and use, together with good device designs, is essential to foster positive attitudes. Further studies focusing on developing improved understanding of nurses' attitudes are needed. Healthcare delivery increasingly incorporates the use of medical devices so that understanding nurses' attitudes towards medical devices is essential for their safe implementation. © 2014 John Wiley & Sons Ltd.

  14. 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...

  15. 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

  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. Barriers to innovation in the medical nutrition industry : A quantitative key opinion leader analysis

    NARCIS (Netherlands)

    Weenen, T.C.; Pronker, E.S.; Commandeur, H.R.; Claassen, E.

    2013-01-01

    Innovation is a necessity for survival in dynamic and complex industries such as the medical nutrition industry. To remain competitive, medical nutrition companies must embrace innovation activities that improve productivity. Nevertheless, innovation is a difficult undertaking and companies must fir

  18. Radiological protection, safety and security issues in the industrial and medical applications of radiation sources

    Science.gov (United States)

    Vaz, Pedro

    2015-11-01

    The use of radiation sources, namely radioactive sealed or unsealed sources and particle accelerators and beams is ubiquitous in the industrial and medical applications of ionizing radiation. Besides radiological protection of the workers, members of the public and patients in routine situations, the use of radiation sources involves several aspects associated to the mitigation of radiological or nuclear accidents and associated emergency situations. On the other hand, during the last decade security issues became burning issues due to the potential malevolent uses of radioactive sources for the perpetration of terrorist acts using RDD (Radiological Dispersal Devices), RED (Radiation Exposure Devices) or IND (Improvised Nuclear Devices). A stringent set of international legally and non-legally binding instruments, regulations, conventions and treaties regulate nowadays the use of radioactive sources. In this paper, a review of the radiological protection issues associated to the use of radiation sources in the industrial and medical applications of ionizing radiation is performed. The associated radiation safety issues and the prevention and mitigation of incidents and accidents are discussed. A comprehensive discussion of the security issues associated to the global use of radiation sources for the aforementioned applications and the inherent radiation detection requirements will be presented. Scientific, technical, legal, ethical, socio-economic issues are put forward and discussed.

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

    Science.gov (United States)

    Janß, Armin; Thorn, Johannes; Schmitz, Malte; Mildner, Alexander; Dell'Anna-Pudlik, Jasmin; Leucker, Martin; Radermacher, Klaus

    2017-08-25

    Nowadays, only closed and proprietary integrated operating room systems (IORS) from big manufacturers are available on the market. Hence, the interconnection of components from third-party vendors is only possible with increased time and costs. In the context of the German Federal Ministry of Education and Research (BMBF)-funded project OR.NET (2012-2016), the open integration of medical devices from different manufacturers was addressed. An integrated operating theater based on the open communication standard IEEE 11073 shall give clinical operators the opportunity to choose medical devices independently of the manufacturer. This approach would be advantageous especially for hospital operators and small- and medium-sized enterprises (SME) of medical devices. Actual standards and concepts regarding technical feasibility and the approval process do not cope with the requirements for a modular integration of medical devices in the operating room (OR), based on an open communication standard. Therefore, innovative approval strategies and corresponding certification and test procedures, which cover actual legal and normative standards, have to be developed in order to support the future risk management and the usability engineering process of open integrated medical devices in the OR. The use of standardized device and service profiles and a three-step testing procedure, including conformity, interoperability and integration tests are described in this paper and shall support the manufacturers to integrate their medical devices without disclosing the medical devices' risk analysis and related confidential expertise or proprietary information.

  20. Innovation Best Practices in the Medical Device Industry.

    Science.gov (United States)

    Ray, Partha P; Amaral, Joseph F; Hinoul, Piet

    2017-06-01

    Advances in patient care often germinate from keen clinical insights and a needs-based approach to innovation. Although there is an important role for incremental improvements to existing solutions, transformational innovation is what truly drives real shifts in clinical outcomes and subsequently patient satisfaction, market access, and economic value. A good example of this is the evolution of the coronary stent market. The best innovation programs are focused on unmet needs rather than solutions, call for a careful articulation of the specific problems to be solved, involve a deep dive within a clinical area, and seek to prioritize research and development investments into areas where the greatest impact can be expected. To enhance its ability to pursue breakthrough innovation, Johnson and Johnson (J&J) has organized itself along priority disease areas, created the global J&J Innovation organization to pursue external technology and know-how, and continues to partner closely with clinical practitioners. The process undertaken at J&J to acquire a microwave ablation technology and enter the interventional oncology space is a recent case study of these innovation principles and organizational focus in action. Copyright © 2017 Elsevier Inc. All rights reserved.

  1. Patenting in the European medical nutrition industry : Trends, opportunities and strategies

    NARCIS (Netherlands)

    Weenen, T.C.; Pronker, E.S.; Commandeur, H.R.; Claassen, E.

    2013-01-01

    Medical nutrition products are specific nutritional compositions for intervention in disease progression and symptom alleviation. This industry finds itself on the interface between the food and pharmaceutical industry and is still a relatively unknown industry. At present, insights concerning

  2. Explorando práticas do desenvolvimento de produtos em pequenas e médias empresas do setor de equipamentos médico-hospitalares Exploring new product development practices in small and medium enterprises in the medical device industry

    Directory of Open Access Journals (Sweden)

    Glauco Henrique de Sousa Mendes

    2012-01-01

    Full Text Available Fatores de sucesso no processo de desenvolvimento de produtos (PDP em empresas de pequeno e médio porte (PMEs do setor de equipamentos médico-hospitalares, do Estado de São Paulo, são identificados e analisados. Um modelo conceitual para explicar o relacionamento entre práticas de gestão do PDP e o desempenho dos novos produtos foi elaborado e testado. O modelo considera oito fatores: vantagem (ou diferenciação do produto, habilidades de marketing, fontes de tecnologia, habilidades da empresa, habilidades do líder de projeto, integração funcional, organização da equipe de projeto e qualidade de execução do PDP. Uma pesquisa de levantamento (survey foi realizada em 30 empresas desse setor, obtendo-se dados de 49 projetos de novos produtos. Os resultados apontam que a gestão do PDP, nessas empresas, deve atentar para ações que promovam as habilidades de marketing e a integração funcional durante o PDP e a qualidade na execução das atividades de pré-desenvolvimento, pois esses fatores, em relação aos demais, têm um impacto positivo relativamente maior no sucesso do novo produto.Critical success factors in new product development (NPD in small and medium enterprises (SMEs in the medical device industry are identified and analyzed. A conceptual model to explain the relationship between management practices and NPD performance was developed and tested. The model considers eight factors: product advantage, marketing skills, sources of technology, company skills, project leader skills, cross-functional integration, project teams' organization, and NPD proficiency. A survey was carried out in 30 companies in this industry collecting data from 49 new product projects. The results highlight the importance for this industry to emphasize activities related to marketing skills, cross-functional integration, and NPD proficiency since these factors have a positive influence on the new product success. Theoretical and managerial

  3. 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.

  4. Development of Transportation Package for Medical and Industrial Radioisotope

    Energy Technology Data Exchange (ETDEWEB)

    Seo, K. S.; Lee, J. C.; Bang, K. S. (and others)

    2007-06-15

    The objective of this project is development of RI transport package and establishment of transportation system. This report describes the objective of project, necessaries, state of related technology, scope and results, proposal for application etc. The scope of the project consist of establishment of performance test system for type-A package for medical use, development of type-B package for industrial use and development of casting technology for DU shield and evaluation of shielding efficiency. The research results obtained from this project are expected to be utilized as a basic data for design, analysis, test and license of transport package.

  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. Energy efficiency improvement of medical electric tools and devices

    Directory of Open Access Journals (Sweden)

    Meshkov Aleksandr S.

    2014-01-01

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

  7. 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.

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

    Science.gov (United States)

    2010-04-01

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

  9. 77 FR 74196 - Draft Guidance for Industry on Safety Considerations for Product Design To Minimize Medication...

    Science.gov (United States)

    2012-12-13

    ... Product Design To Minimize Medication Errors; Availability AGENCY: Food and Drug Administration, HHS... guidance for industry entitled ``Safety Considerations for Product Design to Minimize Medication Errors... using a systems approach to minimize medication errors relating to product design. The draft...

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

    Science.gov (United States)

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

    2012-08-01

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

  11. 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.

  12. Sodium Hypochlorite Treatment and Nitinol Performance for Medical Devices

    Science.gov (United States)

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

    2017-09-01

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

  13. 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

  14. Converting from ETO to radiation sterilization: Educating the medical supply industry

    Science.gov (United States)

    Bedward, D. A.; Brinston, R. M.; Kotler, J.

    1995-02-01

    In this paper the authors examine some relevant factors influencing the conversion from ethylene oxide sterilization to gamma sterilization. Marketing tactics to promote and stimulate this activity are reviewed. TEAM GAMMA, an educational vehicle developed by Nordion International Inc. is described from the concept acceptance to the very positive results obtained. The structure of this multi disciplinary team of consultants is described. Topics presented by this team include sterilization basics, material compatibility, device design manufacturing and other aspects of the sterilization process. The authors conclude that assisting in the education of the medical device manufacturers regarding the conversion from EtO to gamma processing provides payback for Nordion and the gamma processing industry. This assessment is based on the results of the ten seminars presented to date.

  15. Converting from EtO to radiation sterilization: educating the medical supply industry

    Energy Technology Data Exchange (ETDEWEB)

    Bedward, D.A.; Brinston, R.M.; Kotler, J. [Nordion International Inc., Ontario (Canada)

    1995-10-01

    This paper examines some relevant factors influencing the conversion from ethylene oxide sterilization to gamma sterilization. Marketing tactics to promote and stimulate this activity are reviewed. TEAM GAMMA, an educational vehicle developed by Norion International Inc., is described from the concept acceptance to the very positive results obtained. The structure of this multi disciplinary team of consultants is described. Topics presented by this team include sterilization basics, material compatability, device design manufacturing and other aspects of the sterilization process. It is concluded that assisting in the education of the medical device manufacturers regarding the conversion from EtO to gamma processing provides payback for Nordion and the gamma processing industry. This assessment is based on the results of the ten seminars presented to date. (author).

  16. 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-...

  17. Liability for damage caused by shortage and failure to use necessary medical devices

    Directory of Open Access Journals (Sweden)

    Cvetković Mihajlo

    2014-01-01

    Full Text Available In order to provide for successful, safe and high quality medical services, health care institutions need to be equipped with adequate medical devices. For this reason, every medical institution is legally obliged to have relevant medical devices. In case a patient has been deprived of some medical service for the lack of necessary medical devices (which the institution has been obliged to provide, the medical institution is responsible for the damage and harm sustained by the patient. The responsibility implies non-contractual liability (in tort law or pre-contractual liability (in contract law. In both cases, the liability is based on the presumed culpability. In order to be excluded from liability, the medical institution has to prove that the patient has been deprived of medical service (or that the institution has refused to enter into a medical service provider agreement on justifiable grounds, i.e. due to the lack of necessary medical devices. On the other hand, in case the medial institutions fail to provide needed care or violate their obligation to use medical devices when necessary, it is regarded as medical negligence (professional error. In most cases, it implies the liability of medical institutions for damage, injury or harm caused to the patient by medical services provided without applying a relevant medical device, whose use has been medically indicated. The liability is even more substantial in cases where the medical device has been available but the medical institutions has not applied it in medial treatment (even though its use has been medically indicated; such conduct is qualified as gross negligence.

  18. [Study on situations of review and pre-evaluation for medical device product specification in China].

    Science.gov (United States)

    Li, Baolin

    2013-07-01

    This paper researched on course of registration and administrative licensing for medical device product specification, analyzed the existing demands of review and pre-evaluation, discussed about how to improve and manage pre-evaluation results for testing laboratory and manufacturer in China, based on "Provision of Medical Device Product Specification Standardization", "Provision on Medical Device Registration" and relative documents of States Food & Drug Administration. It suggested that set up and maintain a professional team of review and approval staff, further strengthen standardization of medical device specification, arming at current situations of non-compatibility between documents and inconformity of performance in different provinces. It paid attention to control the quality of medical device to ensure the core of safety and effectiveness for using medical device.

  19. 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...

  20. [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.

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

    Science.gov (United States)

    Fearis, Kristy; Petrie, Aidan

    2017-03-01

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

  2. 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

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

    Science.gov (United States)

    Lang, Alexandra R; Martin, Jennifer L; Sharples, Sarah; Crowe, John A

    2014-01-01

    Purpose This study investigates the psychosocial aspects of adolescent medical device use and the impact on adolescent adherence and goals for the transitional years between child and adulthood. Patients and methods Interviews were carried out with 20 adolescents with cystic fibrosis, investigating adolescent medical device use and experiences in relation to their personal and social lives and development through the adolescent years. The qualitative dataset was thematically examined using a content analysis method. Results The results show that adolescent users of medical technologies want their independence and capabilities to be respected. Adolescent adherence to medical device use was associated with short- and long-term motivations, where older adolescents were able to comprehend the longer-term benefits of use against short-term inconvenience more acutely than younger adolescents. It was suggested that medical devices could provide a tool for communication with families and clinicians and could support adolescents as they take responsibility for managing their condition. Themes of “fitting into teenage life” and “use in the community” were associated with adolescents’ needs to form their own identity and have autonomy. Conclusion This study shows that adolescent needs regarding medical device use are complex. It provides evidence to suggest that devices designed inclusively for adolescents may lead to improved adherence and also facilitate transition through the adolescent years and achievement of adolescent goals. PMID:24669187

  4. 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...

  5. 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...

  6. Laser Isotope Enrichment for Medical and Industrial Applications

    Energy Technology Data Exchange (ETDEWEB)

    Leonard Bond

    2006-07-01

    Laser Isotope Enrichment for Medical and Industrial Applications by Jeff Eerkens (University of Missouri), Jay Kunze (Idaho State University), and Leonard Bond (Idaho National Laboratory) The principal isotope enrichment business in the world is the enrichment of uranium for commercial power reactor fuels. However, there are a number of other needs for separated isotopes. Some examples are: 1) Pure isotopic targets for irradiation to produce medical radioisotopes. 2) Pure isotopes for semiconductors. 3) Low neutron capture isotopes for various uses in nuclear reactors. 4) Isotopes for industrial tracer/identification applications. Examples of interest to medicine are targets to produce radio-isotopes such as S-33, Mo-98, Mo-100, W-186, Sn-112; while for MRI diagnostics, the non-radioactive Xe-129 isotope is wanted. For super-semiconductor applications some desired industrial isotopes are Si-28, Ga-69, Ge-74, Se-80, Te-128, etc. An example of a low cross section isotope for use in reactors is Zn-68 as a corrosion inhibitor material in nuclear reactor primary systems. Neutron activation of Ar isotopes is of interest in industrial tracer and diagnostic applications (e.g. oil-logging). . In the past few years there has been a sufficient supply of isotopes in common demand, because of huge Russian stockpiles produced with old electromagnetic and centrifuge separators previously used for uranium enrichment. Production of specialized isotopes in the USA has been largely accomplished using old ”calutrons” (electromagnetic separators) at Oak Ridge National Laboratory. These methods of separating isotopes are rather energy inefficient. Use of lasers for isotope separation has been considered for many decades. None of the proposed methods have attained sufficient proof of principal status to be economically attractive to pursue commercially. Some of the authors have succeeded in separating sulfur isotopes using a rather new and different method, known as condensation

  7. Industrial wireless monitoring with energy-harvesting devices

    NARCIS (Netherlands)

    Brian Blake, M.; Das, Kallol; Zand, P.; Havinga, Paul J.M.

    Vibration monitoring and analysis techniques are used increasingly for predictive maintenance. While traditional vibration monitoring relies on wired sensor networks, recent industrial technologies such as WirelessHART, ISA100.11a, and IEEE802.15.4e have brought a paradigm shift in the automation

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

    Science.gov (United States)

    Tolomiczenko, George; Sanger, Terry

    2015-01-01

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

  9. 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

  10. 78 FR 5185 - Guidance for Industry and Food and Drug Administration Staff; Humanitarian Use Device (HUD...

    Science.gov (United States)

    2013-01-24

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff; Humanitarian Use Device (HUD) Designations; Availability AGENCY: Food and Drug Administration, HHS. ACTION... public comment ``Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian...

  11. 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.

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

    Science.gov (United States)

    Bouchard, Maryse; Kohler, Jillian C; Orbinski, James; Howard, Andrew

    2012-05-03

    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. 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. 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. 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 wages and benefits for workers could be

  13. 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

  14. 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

  15. 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.

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

    Science.gov (United States)

    Blessing, Melissa M; Lin, Peter T

    2017-07-18

    Visual identification is the most common identification method used by medical examiners but is not always possible. Alternative methods include X-ray, fingerprint, or DNA comparison, but these methods require additional resources. Comparison of serial numbers on implanted medical devices is a rapid and definitive method of identification. To assess the practicality of using this method, we reviewed 608 consecutive forensic autopsies performed at a regional medical examiner office. Of these, 56 cases required an alternative method of identification due to decomposition (n = 35), gunshot wound (n = 9), blunt trauma (n = 6), or charring (n = 6). Of these 56 cases, eight (14.3%) were known to have an implanted medical device. Of these eight cases, five (63%) could be positively identified by comparing serial numbers. If an implanted medical device is known to be present, and medical records are available, identification by medical device serial number should be a first-line method. © 2017 American Academy of Forensic Sciences.

  17. 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,...

  18. 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.

    2016-01-01

    There is a global shift in the teaching methodology of science and engineering toward multidisciplinary, team-based processes. To meet the demands of an evolving technical industry and lead the way in engineering education, innovative curricula are essential. This paper describes the development of multidisciplinary, team-based learning environments in undergraduate and graduate engineering curricula focused on medical device design. In these programs, students actively collaborate with clinicians, professional engineers, business professionals, and their peers to develop innovative solutions to real-world problems. In the undergraduate senior capstone courses, teams of biomedical engineering (BME) and business students have produced and delivered numerous functional prototypes to satisfied clients. Pursuit of commercialization of devices has led to intellectual property (IP) disclosures and patents. Assessments have indicated high levels of success in attainment of student learning outcomes and student satisfaction with their undergraduate design experience. To advance these projects toward commercialization and further promote innovative team-based learning, a Master of Engineering (MEng) in Design and Commercialization was recently launched. The MEng facilitates teams of graduate students in engineering, life sciences, and business who engage in innovation-commercialization (IC) projects and coursework that take innovative ideas through research and development (R&D) to create marketable devices. The activities are structured with students working together as a “virtual company,” with targeted outcomes of commercialization (license agreements and new start-ups), competitive job placement, and/or career advancement. PMID:26902869

  19. 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.

  20. [Intelligent operating room suite : From passive medical devices to the self-thinking cognitive surgical assistant].

    Science.gov (United States)

    Kenngott, H G; Wagner, M; Preukschas, A A; Müller-Stich, B P

    2016-12-01

    Modern operating room (OR) suites are mostly digitally connected but until now the primary focus was on the presentation, transfer and distribution of images. Device information and processes within the operating theaters are barely considered. Cognitive assistance systems have triggered a fundamental rethinking in the automotive industry as well as in logistics. In principle, tasks in the OR, some of which are highly repetitive, also have great potential to be supported by automated cognitive assistance via a self-thinking system. This includes the coordination of the entire workflow in the perioperative process in both the operating theater and the whole hospital. With corresponding data from hospital information systems, medical devices and appropriate models of the surgical process, intelligent systems could optimize the workflow in the operating theater in the near future and support the surgeon. Preliminary results on the use of device information and automatically controlled OR suites are already available. Such systems include, for example the guidance of laparoscopic camera systems. Nevertheless, cognitive assistance systems that make use of knowledge about patients, processes and other pieces of information to improve surgical treatment are not yet available in the clinical routine but are urgently needed in order to automatically assist the surgeon in situation-related activities and thus substantially improve patient care.

  1. 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

  2. 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

  3. 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.

  4. Awareness and enforcement of guidelines for publishing industry-sponsored medical research among publication professionals: the Global Publication Survey.

    Science.gov (United States)

    Wager, Elizabeth; Woolley, Karen; Adshead, Viv; Cairns, Angela; Fullam, Josh; Gonzalez, John; Grant, Tom; Tortell, Stephanie

    2014-04-19

    To gather information about current practices and implementation of publication guidelines among publication professionals working in or for the pharmaceutical industry. Web-based survey publicised via email and social media to members of the International Society for Medical Publication Professionals (ISMPP) and other organisations from November 2012 to February 2013. 469 individuals involved in publishing industry-sponsored research in peer-reviewed journals, mainly working in pharmaceutical or device companies ('industry', n=144), communication agencies ('agency', n=238), contract research organisations (CRO, n=15) or as freelancers (n=34). Most respondents (78%) had worked on medical publications for ≥5 years and 62% had a PhD/MD. Over 90% of industry, agency and CRO respondents routinely refer to Good Publication Practice (GPP2) and the International Committee of Medical Journal Editors' Uniform Requirements. Most respondents (78% industry, 79% agency) received mandatory training on ethical publication practices. Over 90% of respondents' companies had publication guidelines or policies and required medical writing support to be acknowledged in publications (96% industry, 99% agency). Many industry respondents used publication management tools to monitor compliance with company guidelines and about half (46%) stated that their company had formal publication audits. Fewer agencies audited adherence to guidelines but 20% of agency respondents reported audits of employees and 6% audits of freelancers. Of concern, 37% of agency respondents reported requests from authors or sponsors that they believed were unethical, although 93% of these requests were withdrawn after respondents explained the need for compliance with guidelines. Most respondents' departments (63% industry, 58% agency, 60% CRO) had been involved in publishing studies with negative or inconclusive results. Within this sample, most publication professionals working in or for industry were aware of

  5. [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.

  6. 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

  7. 78 FR 27971 - Dental Products Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-05-13

    ... HUMAN SERVICES Food and Drug Administration Dental Products Panel of the Medical Devices Advisory...). The meeting will be open to the public. Name of Committee: Dental Products Panel of the Medical... and make recommendations on the proposed regulatory classification for dental devices known as...

  8. 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

  9. 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

  10. FDA regulatory affairs: a guide for prescription drugs, medical devices, and biologics

    National Research Council Canada - National Science Library

    Mantus, David; Pisano, Douglas J

    2008-01-01

    ...: A Guide for Prescription Drugs, Medical Devices, and Biologics, Second Edition are covered in a straightforward format. It is a compilation and commentary of selected laws and regulations pertaining to the development and approval of drugs, biologics, and medical devices in the United States. It is not intended to take the place of an actual r...

  11. A study on developpement of guideline on writing technical document for electrical medical devices: Dental x-ray equipment

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Seung Youl; Kim, Jae Ryang; Lee, Jun Ho; Park, Chang Won [Division of Medical Device Research, National Institute of Food and Drug Safety Evaluation, Mnistry of Food and Drug Safety (Korea, Republic of)

    2016-12-15

    Due to recent population aging, the number of check-up for senior citizens has increased steadily. According to this trend, the market size of dental X-ray equipment and the number of approval and review for these devices have simultaneously increased. The technical document of medical device is required for approval and review for medical device, and medical device companies needs to have work comprehension and expertise, as the document needs to include the overall contents such as performances, test criteria, etc.. Yet, since most of domestic manufacturers or importers of medical devices are small businesses, it is difficult for them to recruit professional manpower for approval of medical devices, and submission of inaccurate technical documents has increased. These problems lead to delay of the approval process and to difficulties in quick entering into the market. Especially, the Ministry of Food and Drug safety (MFDS) standards of a dental extra-oral X-ray equipment, a dental intra-oral X-ray equipment, an arm-type computed tomography, and a portable X-ray system have been recently enacted or not. this guideline of dental X-ray equipment adjusting revised standards was developed to help relative companies and reviewers. For this study, first, the methods to write technical document have been reviewed with revised international and domestic regulations and system. Second, the domestic and foreign market status of each item has been surveyed and analyzed. Third, the contents of technical documents already approved by MFDS have been analyzed to select the correct example, test items, criteria, and methods. Finally, the guideline has been developed based on international and domestic regulation, through close review of a consultative body composed of academic, industrial, research institute and government experts.

  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. 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...

  14. 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...

  15. 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...

  16. On the Origin and Development of the Medical Nutrition Industry

    NARCIS (Netherlands)

    T.C. Weenen (Tamar)

    2014-01-01

    markdownabstract__Abstract__ Product development in the health and life sciences is shifting from the development of target-specific pharmaceutical products to multi-target therapies, including medical nutrition. Medical nutrition consists of nutritional compositions, prescribed by medical professi

  17. The ABCs of the FDA: A Primer on the Role of the United States Food and Drug Administration in Medical Device Approvals and IR Research.

    Science.gov (United States)

    Adamovich, Ashley; Park, Susie; Siskin, Gary P; Englander, Meridith J; Mandato, Kenneth D; Herr, Allen; Keating, Lawrence J

    2015-09-01

    The role of the US Food and Drug Administration (FDA) in medical device regulation is important to device-driven specialties such as interventional radiology. Whether it is through industry-sponsored trials during the approval process for new devices or investigator-initiated research prospectively evaluating the role of existing devices for new or established procedures, interaction with the FDA is an integral part of performing significant research in interventional radiology. This article reviews the potential areas of interface between the FDA and interventional radiology, as understanding these areas is necessary to continue the innovation that is the hallmark of this specialty.

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

    Directory of Open Access Journals (Sweden)

    Lang AR

    2014-03-01

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

  19. A New Hemodynamic Ex Vivo Model for Medical Devices Assessment.

    Science.gov (United States)

    Maurel, Blandine; Sarraf, Christophe; Bakir, Farid; Chai, Feng; Maton, Mickael; Sobocinski, Jonathan; Hertault, Adrien; Blanchemain, Nicolas; Haulon, Stephan; Lermusiaux, Patrick

    2015-11-01

    In-stent restenosis (ISR) remains a major public health concern associated with an increased morbidity, mortality, and health-related costs. Drug-eluting stents (DES) have reduced ISR, but generate healing-related issues or hypersensitivity reactions, leading to an increased risk of late acute stent thrombosis. Assessments of new DES are based on animal models or in vitro release systems, which have several limitations. The role of flow and shear stress on endothelial cell and ISR has also been emphasized. The aim of this work was to design and first evaluate an original bioreactor, replicating ex vivo hemodynamic and biological conditions similar to human conditions, to further evaluate new DES. This bioreactor was designed to study up to 6 stented arteries connected in bypass, immersed in a culture box, in which circulated a physiological systolo-diastolic resistive flow. Two centrifugal pumps drove the flow. The main pump generated pulsating flows by modulation of rotation velocity, and the second pump worked at constant rotation velocity, ensuring the counter pressure levels and backflows. The flow rate, the velocity profile, the arterial pressure, and the resistance of the flow were adjustable. The bioreactor was placed in an incubator to reproduce a biological environment. A first feasibility experience was performed over a 24-day period. Three rat aortic thoracic arteries were placed into the bioreactor, immersed in cell culture medium changed every 3 days, and with a circulating systolic and diastolic flux during the entire experimentation. There was no infection and no leak. At the end of the experimentation, a morphometric analysis was performed confirming the viability of the arteries. We designed and patented an original hemodynamic ex vivo model to further study new DES, as well as a wide range of vascular diseases and medical devices. This bioreactor will allow characterization of the velocity field and drug transfers within a stented artery with new

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

    Science.gov (United States)

    Zippel, Claus; Bohnet-Joschko, Sabine

    2017-08-01

    Medical devices play a central role in the diagnosis and treatment of diseases but also bring the potential for adverse events, hazards or malfunction with serious consequences for patients and users. Medical device manufacturers are therefore required by law to monitor the performance of medical devices that have been approved by the competent authorities (post market surveillance). Conducting a nationwide online-survey in the German medical device sector in Q2/2014 in order to explore the current status of the use of post market instruments we obtained a total of 118 complete data sets, for a return rate of 36%. The survey included manufacturers of different sizes, producing medical devices of all risk classes. The post market instruments most frequently reported covered the fields of production monitoring and quality management as well as literature observation, regulatory vigilance systems, customer knowledge management and market observation while Post Market Clinical Follow-up and health services research were being used less for product monitoring. We found significant differences between the different risk classes of medical devices produced and the intensity of use of post market instruments. Differences between company size and the intensity of instruments used were hardly detected. Results may well contribute to the development of device monitoring which is a crucial element of the policy and regulatory system to identify device-related safety issues. Copyright © 2017 Elsevier B.V. All rights reserved.

  1. 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.

  2. Organization of medical aid for workers of industrial enterprises in contemporary conditions

    Directory of Open Access Journals (Sweden)

    I.G. Novokreshchenova

    2010-06-01

    Full Text Available The article deals with the problem of modern medical care for the working population. It presents the data concern¬ing organization of medical care for workers of oil producing and oil-refining industry, and tendencies of development of medical organizations various in property forms in the system of rendering medical aid for the employees. It has been determined that the processes of medical care for the industrial workers need to be optimized, and it is possible in the united economic-organizing system that allows to provide succession and complete correspondence to medical and social needs of the working population

  3. 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

    ... information about FDA drug and device regulation to the regulated industry. Date and Time: The public... Waterside Hotel, 777 Waterside Dr., Norfolk, VA 23510, 800-325- 3535, or 757-622-6664, FAX: 757-625-8271..., contact the Sheraton Norfolk Waterside Hotel before May 21, 2010, citing meeting code ``AFDO Conference...

  4. 75 FR 70112 - Medical Devices; General and Plastic Surgery Devices; Classification of Non-Powered Suction...

    Science.gov (United States)

    2010-11-17

    ... Devices; Classification of Non-Powered Suction Apparatus Device Intended for Negative Pressure Wound... Administration (FDA) is classifying the non- powered suction apparatus device intended for negative pressure... is the guidance document entitled ``Class II Special Controls Guidance Document: Non-Powered Suction...

  5. 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.

  6. Developing IEEE medical device standards: a case study, wearable cuffless blood pressure measuring devices.

    Science.gov (United States)

    Carey, Carole C; Zhang, Yuang-Ting

    2010-01-01

    The Institute of Electrical and Electronics Engineers Standards Association (IEEE-SA) is a leading standards developing organization of global industry standards in a wide-range of industries, including biomedical and healthcare.

  7. 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

  8. WOSMIP II- Workshop on Signatures of Medical and Industrial Isotope Production

    Energy Technology Data Exchange (ETDEWEB)

    Matthews, Murray; Achim, Pascal; Auer, M.; Bell, Randy; Bowyer, Ted W.; Braekers, Damien; Bradley, Ed; Briyatmoko, Budi; Berglund, Helena; Camps, Johan; Carranza, Eduardo C.; Carty, Fitz; DeCaire, Richard; Deconninck, Benoit; DeGeer, Lars E.; Druce, Michael; Friese, Judah I.; Hague, Robert; Hoffman, Ian; Khrustalev, Kirill; Lucas, John C.; Mattassi, G.; Mattila, Aleski; Nava, Elisabetta; Nikkinin, Mika; Papastefanou, Constantin; Piefer, Gregory R.; Quintana, Eduardo; Ross, Ole; Rotty, Michel; Sabzian, Mohammad; Saey, Paul R.; Sameh, A. A.; Safari, M.; Schoppner, Michael; Siebert, Petra; Unger, Klaus K.; Vargas, Albert

    2011-11-01

    Medical and industrial fadioisotopes are fundamental tools used in science, medicine and industry with an ever expanding usage in medical practice where their availability is vital. Very sensitive environmental radionuclide monitoring networks have been developed for nuclear-security-related monitoring [particularly Comprehensive Test-Ban-Treaty (CTBT) compliance verification] and are now operational.

  9. 76 FR 10908 - Draft Guidance for Industry on Medication Guides-Distribution Requirements and Inclusion of...

    Science.gov (United States)

    2011-02-28

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Medication Guides... Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Medication Guides... healthcare professional for administration to a patient instead of being dispensed directly to the...

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

    Science.gov (United States)

    Mitchell, Ulrike H

    2015-01-01

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

  11. [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.

  12. 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.

  13. 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.

  14. 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

  15. Interoperability of medical device information and the clinical applications: an HL7 RMIM based on the ISO/IEEE 11073 DIM.

    Science.gov (United States)

    Yuksel, Mustafa; Dogac, Asuman

    2011-07-01

    Medical devices are essential to the practice of modern healthcare services. Their benefits will increase if clinical software applications can seamlessly acquire the medical device data. The need to represent medical device observations in a format that can be consumable by clinical applications has already been recognized by the industry. Yet, the solutions proposed involve bilateral mappings from the ISO/IEEE 11073 Domain Information Model (DIM) to specific message or document standards. Considering that there are many different types of clinical applications such as the electronic health record and the personal health record systems, the clinical workflows, and the clinical decision support systems each conforming to different standard interfaces, detailing a mapping mechanism for every one of them introduces significant work and, thus, limits the potential health benefits of medical devices. In this paper, to facilitate the interoperability of clinical applications and the medical device data, we use the ISO/IEEE 11073 DIM to derive an HL7 v3 Refined Message Information Model (RMIM) of the medical device domain from the HL7 v3 Reference Information Mode (RIM). This makes it possible to trace the medical device data back to a standard common denominator, that is, HL7 v3 RIM from which all the other medical domains under HL7 v3 are derived. Hence, once the medical device data are obtained in the RMIM format, it can easily be transformed into HL7-based standard interfaces through XML transformations because these interfaces all have their building blocks from the same RIM. To demonstrate this, we provide the mappings from the developed RMIM to some of the widely used HL7 v3-based standard interfaces.

  16. 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...

  17. An investigation into the feasibility of locating portable medical devices using radio frequency identification devices and technology.

    Science.gov (United States)

    Britton, J

    2007-01-01

    Portable medical devices represent an important resource for assisting healthcare delivery. The movement of portable devices often results in them being unavailable when needed. Tracking equipment using radiofrequency identification technology/devices (RFID) may provide a promising solution to the problems encountered in locating portable equipment. An RFID technology trial was undertaken at Royal Alexandra Hospital, Paisley. This involved the temporary installation of three active readers and attaching actively transmitting radio frequency tags to different portable medical devices. The active readers and computer system were linked using a bespoke data network. Tags and readers from two separate manufacturers were tested. Reliability difficulties were encountered when testing the technology from the first manufacturer, probably due to the casing of the medical device interfering with the signal from the tag. Improved results were obtained when using equipment from the second manufacturer with an overall error rate of 12.3%. Tags from this manufacturer were specifically designed to overcome problems observed with the first system tested. Findings from this proof of concept trial suggest that RFID technology could be used to track the location of equipment in a hospital.

  18. 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...

  19. 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...

  20. 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...

  1. 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...

  2. 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...

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

    Science.gov (United States)

    2012-04-05

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

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

    Science.gov (United States)

    2010-08-16

    ... 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...

  5. 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 Gynecology...

  6. 77 FR 38177 - TRICARE; Off-Label Uses of Devices; Partial List of Examples of Unproven Drugs, Devices, Medical...

    Science.gov (United States)

    2012-06-27

    ... Cosmetic Act, and are also regulated under that law, biological products are approved for marketing under... marketing of these products. Partial List of Examples of Unproven Drugs, Devices, and Medical Treatments or... result in an annual effect of $100 million or more on the national economy or which would have other...

  7. 77 FR 26769 - Educational Forum on Medical Device Reporting, Complaint Files, and Recalls, Corrections, and...

    Science.gov (United States)

    2012-05-07

    ... Device Industry Coalition (FMDIC), is announcing a public workshop entitled ``Educational Forum on... the regulated industry, particularly small businesses. DATES: Date and Time: The public workshop will... Renaissance Dallas Hotel, 2222 Stemmons Freeway, Dallas, TX 75207. Directions and lodging information are...

  8. Medical devices; radiology devices; reclassification of full-field digital mammography system. Final rule.

    Science.gov (United States)

    2010-11-05

    The Food and Drug Administration (FDA) is announcing the reclassification of the full-field digital mammography (FFDM) system from class III (premarket approval) to class II (special controls). The device type is intended to produce planar digital x-ray images of the entire breast; this generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories. The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Full-Field Digital Mammography System." FDA is reclassifying the device into class II (special controls) because general controls along with special controls will provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device.

  9. Stakeholders’ analysis of the medical tourism industry: development strategies in Isfahan

    OpenAIRE

    Jabbari, Alireza; Ferdosi, Masoud; Keyvanara, Mahmoud; Agharahimi, Zahra

    2013-01-01

    Introduction: Policy makers and decision makers must identify the stakeholders in medical tourism, who will be affected by and/or affect this industry, and determine their status for partnership. The aim of this study was to identify the main stakeholders in Isfahan's medical tourism, analyze them, and provide strategies for developing this industry. Materials and Methods: A qualitative study was conducted in 2011. At first, the key stakeholders in medical tourism were identified in accordanc...

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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...

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

    Science.gov (United States)

    2013-01-07

    ... 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...

  17. 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.

  18. 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.

  19. 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 ...

  20. Analysis of metallic medical devices after cremation: The importance in identification.

    Science.gov (United States)

    De Angelis, Danilo; Collini, Federica; Muccino, Enrico; Cappella, Annalisa; Sguazza, Emanuela; Mazzucchi, Alessandra; Cattaneo, Cristina

    2017-03-01

    The recovery of a charred cadaver raises many issues concerning personal identification; the presence of prosthetic materials may provide very important and decisive information. Who is involved in the recovery of a charred body or of burnt human fragments, should therefore be able to recognize medical devices even if modified by fire effects. Metallic residues (585kg) that came from 2785 cremations were studied. Medical devices were then divided by type and material in order to esteem the representativeness of each typology. The study illustrates the great presence of metal medical devices that could be of great help in identifying bodies and underlines that metallic medical devices types and morphology should be known by forensic practitioner involved in identification cases and that this kind of material can still be identified by physician and dentists, even if exposed to very high temperatures. Copyright © 2016 The Chartered Society of Forensic Sciences. Published by Elsevier B.V. All rights reserved.

  1. 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

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

    National Research Council Canada - National Science Library

    Shunmugaperumal, Tamilvanan

    2010-01-01

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

  3. MEDICAL TOURISM INDUSTRY CHALLENGES IN THE CONTEXT OF GLOBALIZATION

    Directory of Open Access Journals (Sweden)

    Carmen, IORDACHE

    2014-07-01

    Full Text Available Medical tourism is not a new concept, even though there is still no international consensus on the name of this phenomenon that is manifesting itself for thousands of years. It is defined by moving patients in various countries to obtain medical care and combined with certain tourist facilities. Increased flow of patients seeking treatment abroad is a global phenomenon linked to economic growth which generates income revenue and a high level of education. Internationally, medical tourism increases by 20% per year, global market for medical tourism at present is estimated to be about 100 billion dollars. This study tries to highlight a conceptual analysis of medical tourism, the targeting of medical tourism flows and major destinations and the proposed tourism development strategies based on the experience of several countries medical.

  4. 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...

  5. 78 FR 14015 - Medical Devices; Exemption From Premarket Notification; Class II Devices; Powered Patient Transport

    Science.gov (United States)

    2013-03-04

    ... chairs (which are different from wheelchairs) continue to require submission of 510(k)s. FDA is... known as stairway chair lifts. These devices are used to assist in the transfer of a person with a... stairway chair lifts, class II devices, from premarket notification and establishes conditions for...

  6. 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.

  7. 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.

  8. 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).

  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. 76 FR 15986 - Food and Drug Administration/Xavier University Global Medical Device Conference

    Science.gov (United States)

    2011-03-22

    ... accommodations. The conference headquarter hotel is the Downtown Cincinnati Hilton Netherlands Plaza, 35 West 5th... Activities. Inspection Readiness. Training. International Regulatory Update. FDCA, Anti Kickback and False.... Using Electronic Medical Records. Cooperative Research Activities Between Academia and Industry. FDA...

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

    Science.gov (United States)

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

    2011-05-01

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

  12. 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.

  13. 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”. ...

  14. 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.

  15. Relations between professional medical associations and the health-care industry, concerning scientific communication and continuing medical education: a policy statement from the European Society of Cardiology.

    Science.gov (United States)

    2012-06-01

    Physicians have an ethical duty to keep up-to-date with current knowledge. Professional medical associations such as the European Society of Cardiology (ESC) support these obligations. In Europe, the costs of continuing medical education (CME) are insufficiently supported from governments and employers; however, medical associations have been criticized for accepting alternative financial support from industry. Medical education and training in research include learning how to assess the quality and reliability of any information. There is some risk of bias in any form of scientific communication including intellectual, professional, and financial and it is essential that in particular, the latter must be acknowledged by full disclosure. It is essential that there is strong collaboration between basic and clinical researchers from academic institutions on the one hand, with engineers and scientists from the research divisions of device and pharmaceutical companies on the other. This is vital so that new diagnostic methods and treatments are developed. Promotion of advances by industry may accelerate their implementation into clinical practice. Universities now frequently exhort their academic staff to protect their intellectual property or commercialize their research. Thus, it is not commercial activity or links per se that have become the target for criticism but the perceived influence of commercial enterprises on clinical decision-making or on messages conveyed by professional medical organizations. This document offers the perspective of the ESC on the current debate, and it recommends how to minimize bias in scientific communications and CME and how to ensure proper ethical standards and transparency in relations between the medical profession and industry.

  16. Relations between professional medical associations and healthcare industry, concerning scientific communication and continuing medical education: a policy statement from the European Society of Cardiology.

    Science.gov (United States)

    2012-01-01

    Physicians have an ethical duty to keep up-to-date with current knowledge. Professional medical associations such as the European Society of Cardiology (ESC) support these obligations. In Europe, the costs of continuing medical education (CME) are insufficiently supported from governments and employers; however, medical associations have been criticized for accepting alternative financial support from industry. Medical education and training in research include learning how to assess the quality and reliability of any information. There is some risk of bias in any form of scientific communication including intellectual, professional, and financial and it is essential that in particular, the latter must be acknowledged by full disclosure. It is essential that there is strong collaboration between basic and clinical researchers from academic institutions on the one hand, with engineers and scientists from the research divisions of device and pharmaceutical companies on the other. This is vital so that new diagnostic methods and treatments are developed. Promotion of advances by industry may accelerate their implementation into clinical practice. Universities now frequently exhort their academic staff to protect their intellectual property or commercialize their research. Thus, it is not commercial activity or links per se that have become the target for criticism but the perceived influence of commercial enterprises on clinical decision-making or on messages conveyed by professional medical organizations. This document offers the perspective of the ESC on the current debate, and it recommends how to minimize bias in scientific communications and CME and how to ensure proper ethical standards and transparency in relations between the medical profession and industry. Copyright © 2012. Published by Elsevier España.

  17. [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.

  18. 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.

  19. 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.

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

    Science.gov (United States)

    Faunce, Thomas Alured

    2006-03-28

    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.

  1. 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.

  2. An industrial radiography exposure device based on measurement of transmitted gamma-ray intensity

    Science.gov (United States)

    Polee, C.; Chankow, N.; Srisatit, S.; Thong-Aram, D.

    2015-05-01

    In film radiography, underexposure and overexposure may happen particularly when lacking information of specimen material and hollowness. This paper describes a method and a device for determining exposure in industrial gamma-ray radiography based on quick measurement of transmitted gamma-ray intensity with a small detector. Application software was developed for Android mobile phone to remotely control the device and to display counting data via Bluetooth communication. Prior to film exposure, the device is placed behind a specimen to measure transmitted intensity which is inversely proportional to the exposure. Unlike in using the conventional exposure curve, correction factors for source decay, source-to- film distance, specimen thickness and kind of material are not needed. The developed technique and device make radiographic process economic, convenient and more reliable.

  3. 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.

  4. 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.

  5. Enabling Medical Device Interoperability for the Integrated Clinical Environment

    Science.gov (United States)

    2016-12-01

    built a Clinical Scenario Repository, defined governance , and fine-tuned it with feedback from clinicians. We created an open -source, freely available...and point-of-care access to accurate, comprehensive, contextually rich clinical data for all acuity levels of healthcare. Open platforms of plug-and...prototype Data Logger on the MD PnP open platform • Improve playback to support adverse event analysis • Continue research with Unique Device

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

    NARCIS (Netherlands)

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

    2016-01-01

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

  7. 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...

  8. 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

  9. 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'',...

  10. 75 FR 55803 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-09-14

    ..., from 8 a.m. to 6 p.m. Location: Hilton Washington DC North/Gaithersburg, Ballroom, 620 Perry Pkwy., Gaithersburg, MD. Contact Person: James Engles, Center for Devices and Radiological Health, Food and Drug...

  11. 76 FR 36548 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-06-22

    ... 21, 2011, from 8 a.m. to 6 p.m. Location: Hilton Washington DC North/Gaithersburg, 620 Perry Pkwy., Gaithersburg, MD 20877. Contact Person: James Swink, Center for Devices and Radiological Health, Food and Drug...

  12. Medical simulation technology: educational overview, industry leaders, and what's missing.

    Science.gov (United States)

    Spooner, Nicholas; Hurst, Stephen; Khadra, Mohamed

    2012-01-01

    Modern medical simulation technology (MST) debuted in 1960 with the development of Resusci Annie (Laerdal 2007), which assisted students in the acquisition of proper ventilation and compression techniques used during basic life support. Following a steady stream of subsequent technological advances and innovations, MST manufacturers are now able to offer training aids capable of facilitating innovative learning in such diverse areas as human patient simulators, simulated clinical environments, virtual procedure stations, virtual medical environments, electronic tutors, and performance recording. The authors list a number of the most popular MSTs presently available while citing evaluative efforts undertaken to date regarding the efficacy of MST to the medical profession. They conclude by proposing a variety of simulation innovations of prospective interest to both medical and technology personnel while offering healthcare administrators a series of recommended considerations when planning to integrate MST into existing medical systems.

  13. 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.

  14. 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.

  15. Development of advanced electron holographic techniques and application to industrial materials and devices.

    Science.gov (United States)

    Yamamoto, Kazuo; Hirayama, Tsukasa; Tanji, Takayoshi

    2013-06-01

    The development of a transmission electron microscope equipped with a field emission gun paved the way for electron holography to be put to practical use in various fields. In this paper, we review three advanced electron holography techniques: on-line real-time electron holography, three-dimensional (3D) tomographic holography and phase-shifting electron holography, which are becoming important techniques for materials science and device engineering. We also describe some applications of electron holography to the analysis of industrial materials and devices: GaAs compound semiconductors, solid oxide fuel cells and all-solid-state lithium ion batteries.

  16. 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

  17. EXPERIENCES IN THE AIR SPINNING TO MANUFACTURE MEDICAL DEVICES

    Directory of Open Access Journals (Sweden)

    MARSAL Feliu

    2015-05-01

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

  18. 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.

  19. 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.

  20. Preclinical medical students′ usage of electronic devices in lectures: A cross-sectional study

    Directory of Open Access Journals (Sweden)

    Rex W. H. Hui

    2016-01-01

    Full Text Available Background and Objectives: Electronic devices such as laptops, tablets, and smartphones are commonly used in clinical clerkships, problem-based learning, and practicals. However, there is limited literature on electronic device usage in medical lectures. This study aimed to (1 assess preclinical medical students′ pattern and reason for electronic device usage in lectures and (2 assess the effect of lecture content and student factors on device usage. Materials and Methods: This was a cross-sectional study from the year 1 to 3 medical students of the Li Ka Shing Faculty of Medicine, The University of Hong Kong. The data was collected through self-administrated questionnaires. The questionnaire was distributed twice to the same cohort of students, once after their basic medical science lectures, another after humanities lectures. Categorical variables were compared by Chi-squared test or Fisher′s exact test; continuous variables were compared by Mann-Whitney U-test or Kruskal-Wallis H-test. Results: Five hundred and seventy-nine valid questionnaires were collected. Students spent more time on electronic devices for learning in science lectures when compared with humanities lectures (P < 0.001. In contrast, students spent more time for nonlearning purposes in humanities lectures (P < 0.001. In science lectures, the mode of admission to medical school (P < 0.05 and year of study (P < 0.001 were factors affecting the device usage. Conclusions: Lecture content, mode of admission, and year of study have a significant impact on the electronic device usage in preclinical medical lectures. Appropriate interventions are necessary to help the students make better use of their devices and decrease the time spent on nonlearning purposes, particularly in humanities lectures.

  1. 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.

  2. 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.

  3. Medical informatics: A boon to the healthcare industry

    Directory of Open Access Journals (Sweden)

    Dinesh Bhatia

    2010-01-01

    Full Text Available Newer healthcare technologies and treatment procedures are being developed rapidly, and clinicians are incorporating them into their daily practice. They are integrating the past and the present knowledge for better patient healthcare. Previously, it had been difficult to organize, store and retrieve medical and patient information. But, today, with the advent of computers and, moreover, information technology has led to the development of medical informatics that is helping physicians to overcome these challenges. Medical informatics deals with all aspects of understanding and promoting the effective organization analysis, management and use of information in healthcare, which are being highlighted in this review paper.

  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. 76 FR 25696 - Guidance for Industry on Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products...

    Science.gov (United States)

    2011-05-05

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Dosage Delivery Devices for Orally... entitled ``Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products.'' This document is... over-the-counter (OTC) liquid drug products packaged with dosage delivery devices (e.g.,...

  6. What is the relationship of medical humanitarian organisations with mining and other extractive industries?

    Directory of Open Access Journals (Sweden)

    Philippe Calain

    Full Text Available Philippe Calain discusses the health and environmental hazards of extractive industries like mining and explores the tensions that arise when medical humanitarian organizations are called to intervene in emergencies involving the extractive sector.

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

    OpenAIRE

    Lang, Alexandra R; Martin, Jennifer L.; Sharples, Sarah; Crowe, John A.

    2014-01-01

    Alexandra R Lang,1 Jennifer L Martin,2 Sarah Sharples,1 John A Crowe3 1Human Factors Research Group, Faculty of Engineering, University of Nottingham, Nottingham, UK; 2Mindtech Healthcare Technology Cooperative (Htc), Faculty of Medicine and Health Sciences, Institute of Mental Health, Nottingham, UK; 3Biomedical Engineering, Faculty of Engineering, University of Nottingham, UK Purpose: This study investigates the psychosocial aspects of adolescent medical device use and the impact on adoles...

  8. Safety cases for medical devices and health information technology: involving health-care organisations in the assurance of safety.

    Science.gov (United States)

    Sujan, Mark A; Koornneef, Floor; Chozos, Nick; Pozzi, Simone; Kelly, Tim

    2013-09-01

    In the United Kingdom, there are more than 9000 reports of adverse events involving medical devices annually. The regulatory processes in Europe and in the United States have been challenged as to their ability to protect patients effectively from unreasonable risk and harm. Two of the major shortcomings of current practice include the lack of transparency in the safety certification process and the lack of involvement of service providers. We reviewed recent international standardisation activities in this area, and we reviewed regulatory practices in other safety-critical industries. The review showed that the use of safety cases is an accepted practice in UK safety-critical industries, but at present, there is little awareness of this concept in health care. Safety cases have the potential to provide greater transparency and confidence in safety certification and to act as a communication tool between manufacturers, service providers, regulators and patients.

  9. Center for Semiconductor Materials and Device Modeling: expanding collaborative research opportunities between government, academia, and industry

    Science.gov (United States)

    Perconti, Philip; Bedair, Sarah S.; Bajaj, Jagmohan; Schuster, Jonathan; Reed, Meredith

    2016-09-01

    To increase Soldier readiness and enhance situational understanding in ever-changing and complex environments, there is a need for rapid development and deployment of Army technologies utilizing sensors, photonics, and electronics. Fundamental aspects of these technologies include the research and development of semiconductor materials and devices which are ubiquitous in numerous applications. Since many Army technologies are considered niche, there is a lack of significant industry investment in the fundamental research and understanding of semiconductor technologies relevant to the Army. To address this issue, the US Army Research Laboratory is establishing a Center for Semiconductor Materials and Device Modeling and seeks to leverage expertise and resources across academia, government and industry. Several key research areas—highlighted and addressed in this paper—have been identified by ARL and external partners and will be pursued in a collaborative fashion by this Center. This paper will also address the mechanisms by which the Center is being established and will operate.

  10. 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

  11. 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.

  12. 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.

  13. Embrittlement phenomenon of Ag core MP35N cable as lead conductor in medical device.

    Science.gov (United States)

    Wang, Ling; Li, Bernie; Zhang, Haitao

    2013-02-01

    Ag core MP35N (Ag/MP35N) wire has been used in lead electric conductor wires in the medical device industry for many years. Recently it was noticed that the combination of silver and MP35N restricts its wire drawing process. The annealing temperature in Ag/MP35N has to be lower than the melting temperature of pure Ag (960 °C), which cannot fully anneal MP35N. The lower annealing temperature results in a highly cold worked MP35N, which significantly reduces Ag/MP35N ductility. The embrittlement phenomenon of Ag/MP35N cable was observed in tension and bending deformation. The effect of the embrittlement on the wire flex fatigue life was evaluated using a newly developed flex fatigue testing method. The Ag/MP35N cable fatigue results was analyzed with a Coffin-Manson approach and compared to the MP35N cable fatigue results. The root causes of the Ag/Mp35N embrittlement phenomenon are discussed. Copyright © 2012 Elsevier Ltd. All rights reserved.

  14. 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

  15. 78 FR 77689 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2013-12-24

    ... the dental application of fluoride and local anesthesia of the intact tympanic membrane uses from the... anesthesia of the intact tympanic membrane) into class II and for all other uses into class III. FDA... Medicine; Ear, Nose and Throat; and Dental Device Classification Panels (see the preamble to the proposed...

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

    Science.gov (United States)

    2011-02-07

    ... the brain. The device is intended to be used as a monotherapy, after surgical and radiation options... session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session... the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda...

  17. 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...

  18. 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...

  19. 75 FR 35495 - Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-06-22

    ... Devices Advisory Committee. General Function of the Committee: To provide advice and recommendations to... should have normal gonioscopic anatomy and a visually significant cataract eligible for... formal oral presentations should notify the contact person and submit a brief statement of the general...

  20. 76 FR 58019 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-09-19

    ... and 27, 2011, from 8 a.m. to 6 p.m. Location: Hilton Washington, DC, North/Gaithersburg, salons A, B, C, and D, 620 Perry Pkwy., Gaithersburg, MD. Contact Person: James Swink, Center for Devices and...: james.swink@fda.hhs.gov , or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in...

  1. 76 FR 63928 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-10-14

    ... and 8, 2011, from 8 a.m. to 6 p.m. Location: Hilton Washington DC North/Gaithersburg, Salons A, B, C... Person: James Swink, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, james.swink@fda.hhs.gov or FDA Advisory Committee Information...

  2. 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,...

  3. 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.

  4. 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.

  5. Four challenges in medical image analysis from an industrial perspective.

    Science.gov (United States)

    Weese, Jürgen; Lorenz, Cristian

    2016-10-01

    Today's medical imaging systems produce a huge amount of images containing a wealth of information. However, the information is hidden in the data and image analysis algorithms are needed to extract it, to make it readily available for medical decisions and to enable an efficient work flow. Advances in medical image analysis over the past 20 years mean there are now many algorithms and ideas available that allow to address medical image analysis tasks in commercial solutions with sufficient performance in terms of accuracy, reliability and speed. At the same time new challenges have arisen. Firstly, there is a need for more generic image analysis technologies that can be efficiently adapted for a specific clinical task. Secondly, efficient approaches for ground truth generation are needed to match the increasing demands regarding validation and machine learning. Thirdly, algorithms for analyzing heterogeneous image data are needed. Finally, anatomical and organ models play a crucial role in many applications, and algorithms to construct patient-specific models from medical images with a minimum of user interaction are needed. These challenges are complementary to the on-going need for more accurate, more reliable and faster algorithms, and dedicated algorithmic solutions for specific applications.

  6. Assessment And Testing of Industrial Devices Robustness Against Cyber Security Attacks

    CERN Document Server

    Tilaro, F

    2011-01-01

    CERN (European Organization for Nuclear Research),like any organization, needs to achieve the conflicting objectives of connecting its operational network to Internet while at the same time keeping its industrial control systems secure from external and internal cyber attacks. With this in mind, the ISA-99[0F1] international cyber security standard has been adopted at CERN as a reference model to define a set of guidelines and security robustness criteria applicable to any network device. Devices robustness represents a key link in the defense-in-depth concept as some attacks will inevitably penetrate security boundaries and thus require further protection measures. When assessing the cyber security robustness of devices we have singled out control system-relevant attack patterns derived from the well-known CAPEC[1F2] classification. Once a vulnerability is identified, it needs to be documented, prioritized and reproduced at will in a dedicated test environment for debugging purposes. CERN - in collaboration ...

  7. Viewing industrial systems and devices at Fuji Electric; Fuji Denki no sangyoyo system kiki. Tenbo

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1999-01-10

    This paper views the industrial systems and devices at Fuji Electric. The year 1998 had business stagnation still continued, with capital investments for production increase having decreased sharply in the consumer field. On the other hand, investments increased in the areas of renewal, simplification, and man-power saving. Large rectifiers for aluminum refining and soda electrolysis gained a large amount of supply to overseas countries partly because of the effects from the foreign exchange market. In the technical aspect, demands have increased on opening and down-sizing of information and control devices in electrical installations for heavy industry fields, which led to increase in personal computer introduction. The heavy electric machine field has amalgamated more closely with the information and control fields. Fuji Electric has provided systems and devices that contribute to higher information density, reliability and functions of different plants. This paper introduces the record of the company in the fields of power electronics, electric power conversion, information devices and systems, speed variable driving systems, power generating and transforming systems, rotating machines, and electric heating. (NEDO)

  8. 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.

  9. Josephson junction devices: Model quantum mechanical systems and medical applications

    Science.gov (United States)

    Chen, Josephine

    In this dissertation, three experiments using Josephson junction devices are described. In Part I, the effect of dissipation on tunneling between charge states in a superconducting single-electron transistor (sSET) was studied. The sSET was fabricated on top of a semi-conductor heterostructure with a two-dimensional electron gas (2DEG) imbedded beneath the surface. The 2DEG acted as a dissipative ground plane. The sheet resistance of the 2DEG could be varied in situ by applying a large voltage to a gate on the back of the substrate. The zero-bias conductance of the sSET was observed to increase with increasing temperature and 2DEG resistance. Some qualitative but not quantitative agreement was found with theoretical calculations of the functional dependence of the conductance on temperature and 2DEG resistance. Part II describes a series of experiments performed on magnesium diboride point-contact junctions. The pressure between the MgB2 tip and base pieces could be adjusted to form junctions with different characteristics. With light pressure applied between the two pieces, quasiparticle tunneling in superconductor-insulator-superconductor junctions was measured. From these data, a superconducting gap of approximately 2 meV and a critical temperature of 29 K were estimated. Increasing the pressure between the MgB2 pieces formed junctions with superconductor-normal metal-superconductor characteristics. We used these junctions to form MgB2 superconducting quantum interference devices (SQUIDS). Noise levels as low as 35 fT/Hz1/2 and 4 muphi 0/Hz1/2 at 1 kHz were measured. In Part III, we used a SQUID-based instrument to acquire magnetocardiograms (MCG), the magnetic field signal measured from the human heart. We measured 51 healthy volunteers and 11 cardiac patients both at rest and after treadmill exercise. We found age and sex related differences in the MCG of the healthy volunteers that suggest that these factors should be considered when evaluating the MCG for

  10. 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.

  11. Attitudes of Medical School Faculty toward Gifts from the Pharmaceutical Industry.

    Science.gov (United States)

    Banks, James W., III; Mainous, Arch G., III

    1992-01-01

    A survey of 248 University of Kentucky medical school faculty investigated attitudes toward American Medical Association policy concerning gifts from the pharmaceutical industry. Faculty generally agreed with the guidelines but felt gifts did not influence prescribing behaviors. PhD faculty favored more prescriptive policy than did MD faculty.…

  12. Attitudes of Medical School Faculty toward Gifts from the Pharmaceutical Industry.

    Science.gov (United States)

    Banks, James W., III; Mainous, Arch G., III

    1992-01-01

    A survey of 248 University of Kentucky medical school faculty investigated attitudes toward American Medical Association policy concerning gifts from the pharmaceutical industry. Faculty generally agreed with the guidelines but felt gifts did not influence prescribing behaviors. PhD faculty favored more prescriptive policy than did MD faculty.…

  13. 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.

  14. [Biodegradable synthetic polymers for the design of implantable medical devices: the ligamentoplasty case].

    Science.gov (United States)

    Garric, Xavier; Nottelet, Benjamin; Pinese, Coline; Leroy, Adrien; Coudane, Jean

    2017-01-01

    The sector of implantable medical devices is a growing sector of health products especially dynamic in the field of research. To improve the management of patients and to meet clinical requirements, researchers are developing new types of medical devices. They use different families of biomaterials presenting various chemical and physical characteristics in order for providing clinicians with health products optimized for biomedical applications. In this article, we aim to show how, starting from a family of biomaterials (degradable polymers), it is possible to design an implantable medical device for the therapeutic management of the failure of anterior cruciate ligament. The main steps leading to the design of a total ligament reinforcement are detailed. They range from the synthesis and characterization of degradable polymer to the shaping of the knitted implant, through the assessment of the study of the impact of sterilization on mechanical properties and checking cytocompatibility. © 2017 médecine/sciences – Inserm.

  15. 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 

  16. 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.

  17. Advanced biosensing methodologies developed for evaluating performance quality and safety of emerging biophotonics technologies and medical devices (Conference Presentation)

    Science.gov (United States)

    Ilev, Ilko K.; Walker, Bennett; Calhoun, William; Hassan, Moinuddin

    2016-03-01

    Biophotonics is an emerging field in modern biomedical technology that has opened up new horizons for transfer of state-of-the-art techniques from the areas of lasers, fiber optics and biomedical optics to the life sciences and medicine. This field continues to vastly expand with advanced developments across the entire spectrum of biomedical applications ranging from fundamental "bench" laboratory studies to clinical patient "bedside" diagnostics and therapeutics. However, in order to translate these technologies to clinical device applications, the scientific and industrial community, and FDA are facing the requirement for a thorough evaluation and review of laser radiation safety and efficacy concerns. In many cases, however, the review process is complicated due the lack of effective means and standard test methods to precisely analyze safety and effectiveness of some of the newly developed biophotonics techniques and devices. There is, therefore, an immediate public health need for new test protocols, guidance documents and standard test methods to precisely evaluate fundamental characteristics, performance quality and safety of these technologies and devices. Here, we will overview our recent developments of novel test methodologies for safety and efficacy evaluation of some emerging biophotonics technologies and medical devices. These methodologies are based on integrating the advanced features of state-of-the-art optical sensor technologies and approaches such as high-resolution fiber-optic sensing, confocal and optical coherence tomography imaging, and infrared spectroscopy. The presentation will also illustrate some methodologies developed and implemented for testing intraocular lens implants, biochemical contaminations of medical devices, ultrahigh-resolution nanoscopy, and femtosecond laser therapeutics.

  18. The inherent weaknesses in industrial control systems devices; hacking and defending SCADA systems

    Science.gov (United States)

    Bianco, Louis J.

    The North American Electric Reliability Corporation (NERC) is about to enforce their NERC Critical Infrastructure Protection (CIP) Version Five and Six requirements on July 1st 2016. The NERC CIP requirements are a set of cyber security standards designed to protect cyber assets essential the reliable operation of the electric grid. The new Version Five and Six requirements are a major revision to the Version Three (currently enforced) requirements. The new requirements also bring substations into scope alongside Energy Control Centers. When the Version Five requirements were originally drafted they were vague, causing in depth discussions throughout the industry. The ramifications of these requirements has made owners look at their systems in depth, questioning how much money it will take to meet these requirements. Some owners saw backing down from routable networks to non-routable as a means to save money as they would be held to less requirements within the standards. Some owners saw removing routable connections as a proper security move. The purpose of this research was to uncover the inherent weaknesses in Industrial Control Systems (ICS) devices; to show how ICS devices can be hacked and figure out potential protections for these Critical Infrastructure devices. In addition, this research also aimed to validate the decision to move from External Routable connectivity to Non-Routable connectivity, as a security measure and not as a means of savings. The results reveal in order to ultimately protect Industrial Control Systems they must be removed from the Internet and all bi-directional external routable connections must be removed. Furthermore; non-routable serial connections should be utilized, and these non-routable serial connections should be encrypted on different layers of the OSI model. The research concluded that most weaknesses in SCADA systems are due to the inherent weaknesses in ICS devices and because of these weaknesses, human intervention is

  19. Stakeholders’ analysis of the medical tourism industry: development strategies in Isfahan

    Science.gov (United States)

    Jabbari, Alireza; Ferdosi, Masoud; Keyvanara, Mahmoud; Agharahimi, Zahra

    2013-01-01

    Introduction: Policy makers and decision makers must identify the stakeholders in medical tourism, who will be affected by and/or affect this industry, and determine their status for partnership. The aim of this study was to identify the main stakeholders in Isfahan's medical tourism, analyze them, and provide strategies for developing this industry. Materials and Methods: A qualitative study was conducted in 2011. At first, the key stakeholders in medical tourism were identified in accordance with the experts’ idea and literature review. Then we interviewed the key stakeholders. Data analysis was conducted using the stakeholders’ analyses, which helped in developing strategies. Results: The result showed that the key stakeholders were made up of nine groups. They included the provincial governance of Isfahan, the Cultural Heritage and Tourism Organization of Isfahan, the Chamber of Commerce, the Medical Council, the Isfahan University of Medical Sciences, health service providers, tourism services providers, investors, and the Tosea Saderat Bank. The rate of knowledge of the Cultural Heritage and Tourism Organization of Isfahan, clinic and international relationship of Isfahan University of Medical Sciences from government policy about medical tourism were very much. Private Hospitals, the Medical Council, investors, and the University of Medical Sciences had great power. Private hospitals, clinics, the Cultural Heritage and Tourism Organization of Isfahan, and the University of Medical Sciences were in the supporter position. The effected strategies were the included strategies, focused on increasing power; increasing support, and on maintaining the position. Conclusion: There are different stakeholders in the medical tourism industry. Thus, policy makers can plan, make a policy and decision, and use effective strategies to develop medical tourism by designing a medical tourism stakeholders’ network, a medical tourism provincial council, and clarify the

  20. Stakeholders' analysis of the medical tourism industry: development strategies in Isfahan.

    Science.gov (United States)

    Jabbari, Alireza; Ferdosi, Masoud; Keyvanara, Mahmoud; Agharahimi, Zahra

    2013-01-01

    Policy makers and decision makers must identify the stakeholders in medical tourism, who will be affected by and/or affect this industry, and determine their status for partnership. The aim of this study was to identify the main stakeholders in Isfahan's medical tourism, analyze them, and provide strategies for developing this industry. A qualitative study was conducted in 2011. At first, the key stakeholders in medical tourism were identified in accordance with the experts' idea and literature review. Then we interviewed the key stakeholders. Data analysis was conducted using the stakeholders' analyses, which helped in developing strategies. The result showed that the key stakeholders were made up of nine groups. They included the provincial governance of Isfahan, the Cultural Heritage and Tourism Organization of Isfahan, the Chamber of Commerce, the Medical Council, the Isfahan University of Medical Sciences, health service providers, tourism services providers, investors, and the Tosea Saderat Bank. The rate of knowledge of the Cultural Heritage and Tourism Organization of Isfahan, clinic and international relationship of Isfahan University of Medical Sciences from government policy about medical tourism were very much. Private Hospitals, the Medical Council, investors, and the University of Medical Sciences had great power. Private hospitals, clinics, the Cultural Heritage and Tourism Organization of Isfahan, and the University of Medical Sciences were in the supporter position. The effected strategies were the included strategies, focused on increasing power; increasing support, and on maintaining the position. There are different stakeholders in the medical tourism industry. Thus, policy makers can plan, make a policy and decision, and use effective strategies to develop medical tourism by designing a medical tourism stakeholders' network, a medical tourism provincial council, and clarify the roles and responsibilities of stakeholders.

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

    DEFF Research Database (Denmark)

    Sandler, Niklas; Salmela, Ida; Fallarero, Adyary

    2014-01-01

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

  2. 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.

  3. 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

  4. 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.

  5. Rule-based medical device adaptation for the digital operating room.

    Science.gov (United States)

    Franke, Stefan; Neumuth, Thomas

    2015-08-01

    A workflow-driven cooperative operating room needs to be established in order to successfully unburden the surgeon and the operating room staff very time-consuming information-seeking and configuration tasks. We propose an approach towards the integration of intraoperative surgical workflow management and integration technologies. The concept of rule-based behavior is adapted to situation-aware medical devices. A prototype was implemented and experiments with sixty recorded brain tumor removal procedures were conducted to test the proposed approach. An analysis of the recordings indicated numerous applications, such as automatic display configuration, room light adaptation and pre-configuration of medical devices and systems.

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

    Science.gov (United States)

    Ross, Joseph S; Blount, Katrina L; Ritchie, Jessica D; Hodshon, Beth; Krumholz, Harlan M

    2015-01-01

    In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA) to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA's pre-market approval (PMA) pathway. We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%), nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives.

  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. 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.

  10. Medical students' exposure to and attitudes about the pharmaceutical industry: a systematic review.

    Directory of Open Access Journals (Sweden)

    Kirsten E Austad

    2011-05-01

    Full Text Available The relationship between health professionals and the pharmaceutical industry has become a source of controversy. Physicians' attitudes towards the industry can form early in their careers, but little is known about this key stage of development.We performed a systematic review reported according to PRISMA guidelines to determine the frequency and nature of medical students' exposure to the drug industry, as well as students' attitudes concerning pharmaceutical policy issues. We searched MEDLINE, EMBASE, Web of Science, and ERIC from the earliest available dates through May 2010, as well as bibliographies of selected studies. We sought original studies that reported quantitative or qualitative data about medical students' exposure to pharmaceutical marketing, their attitudes about marketing practices, relationships with industry, and related pharmaceutical policy issues. Studies were separated, where possible, into those that addressed preclinical versus clinical training, and were quality rated using a standard methodology. Thirty-two studies met inclusion criteria. We found that 40%-100% of medical students reported interacting with the pharmaceutical industry. A substantial proportion of students (13%-69% were reported as believing that gifts from industry influence prescribing. Eight studies reported a correlation between frequency of contact and favorable attitudes toward industry interactions. Students were more approving of gifts to physicians or medical students than to government officials. Certain attitudes appeared to change during medical school, though a time trend was not performed; for example, clinical students (53%-71% were more likely than preclinical students (29%-62% to report that promotional information helps educate about new drugs.Undergraduate medical education provides substantial contact with pharmaceutical marketing, and the extent of such contact is associated with positive attitudes about marketing and skepticism

  11. An industry perspective on Canadian patients' involvement in medical tourism: implications for public health.

    Science.gov (United States)

    Johnston, Rory; Crooks, Valorie A; Adams, Krystyna; Snyder, Jeremy; Kingsbury, Paul

    2011-05-31

    The medical tourism industry, which assists patients with accessing non-emergency medical care abroad, has grown rapidly in recent years. A lack of reliable data about medical tourism makes it difficult to create policy, health system, and public health responses to address the associated risks and shortcomings, such as spread of infectious diseases, associated with this industry. This article addresses this knowledge gap by analyzing interviews conducted with Canadian medical tourism facilitators in order to understand Canadian patients' involvement in medical tourism and the implications of this involvement for public health. Semi-structured phone interviews were conducted with 12 medical facilitators from 10 companies in 2010. An exhaustive recruitment strategy was used to identify interviewees. Questions focused on business dimensions, information exchange, medical tourists' decision-making, and facilitators' roles in medical tourism. Thematic analysis was undertaken following data collection. Facilitators helped their Canadian clients travel to 11 different countries. Estimates of the number of clients sent abroad annually varied due to demand factors. Facilitators commonly worked with medical tourists aged between 40 and 60 from a variety of socio-economic backgrounds who faced a number of potential barriers including affordability, fear of the unfamiliar, and lack of confidence. Medical tourists who chose not to use facilitators' services were thought to be interested in saving money or have cultural/familial connections to the destination country. Canadian doctors were commonly identified as barriers to securing clients. No effective Canadian public health response to medical tourism can treat medical tourists as a unified group with similar motivations for engaging in medical tourism and choosing similar mechanisms for doing so. This situation may be echoed in other countries with patients seeking care abroad. Therefore, a call for a comprehensive public

  12. An industry perspective on Canadian patients' involvement in Medical Tourism: implications for public health

    Directory of Open Access Journals (Sweden)

    Snyder Jeremy

    2011-05-01

    Full Text Available Abstract Background The medical tourism industry, which assists patients with accessing non-emergency medical care abroad, has grown rapidly in recent years. A lack of reliable data about medical tourism makes it difficult to create policy, health system, and public health responses to address the associated risks and shortcomings, such as spread of infectious diseases, associated with this industry. This article addresses this knowledge gap by analyzing interviews conducted with Canadian medical tourism facilitators in order to understand Canadian patients' involvement in medical tourism and the implications of this involvement for public health. Methods Semi-structured phone interviews were conducted with 12 medical facilitators from 10 companies in 2010. An exhaustive recruitment strategy was used to identify interviewees. Questions focused on business dimensions, information exchange, medical tourists' decision-making, and facilitators' roles in medical tourism. Thematic analysis was undertaken following data collection. Results Facilitators helped their Canadian clients travel to 11 different countries. Estimates of the number of clients sent abroad annually varied due to demand factors. Facilitators commonly worked with medical tourists aged between 40 and 60 from a variety of socio-economic backgrounds who faced a number of potential barriers including affordability, fear of the unfamiliar, and lack of confidence. Medical tourists who chose not to use facilitators' services were thought to be interested in saving money or have cultural/familial connections to the destination country. Canadian doctors were commonly identified as barriers to securing clients. Conclusions No effective Canadian public health response to medical tourism can treat medical tourists as a unified group with similar motivations for engaging in medical tourism and choosing similar mechanisms for doing so. This situation may be echoed in other countries with patients

  13. To recognize the use of international standards for making harmonized regulation of medical devices in Asia-pacific.

    Science.gov (United States)

    Anand, K; Saini, Ks; Chopra, Y; Binod, Sk

    2010-07-01

    'Medical Devices' include everything from highly sophisticated, computerized, medical equipment, right down to simple wooden tongue depressors. Regulations embody the public expectations for how buildings and facilities are expected to perform and as such represent public policy. Regulators, who develop and enforce regulations, are empowered to act in the public's interest to set this policy and are ultimately responsible to the public in this regard. Standardization contributes to the basic infrastructure that underpins society including health and environment, while promoting sustainability and good regulatory practice. The international organizations that produce International Standards are the International Electrotechnical Commission (IEC), the International Organization for Standardization (ISO), and the International Telecommunication Union (ITU). With the increasing globalization of markets, International Standards (as opposed to regional or national standards) have become critical to the trading process, ensuring a level playing field for exports, and ensuring that imports meet the internationally recognized levels of performance and safety. The development of standards is done in response to sectors and stakeholders that express a clearly established need for them. An industry sector or other stakeholder group typically communicates its requirement for standards to one of the national members. To be accepted for development, a proposed work item must receive a majority support of the participating members, who verify the global relevance of the proposed item. The regulatory authority (RA) should provide a method for the recognition of international voluntary standards and for public notification of such recognition. The process of recognition may vary from country to country. Recognition may occur by periodic publication of lists of standards that a regulatory authority has found will meet the Essential Principles. In conclusion, International standards

  14. 78 FR 38994 - Implanted Blood Access Devices for Hemodialysis; Draft Guidance for Industry and Food and Drug...

    Science.gov (United States)

    2013-06-28

    ... HUMAN SERVICES Food and Drug Administration Implanted Blood Access Devices for Hemodialysis; 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...

  15. Industrial systems and devices of Fuji Electric. Prospects; Guji Denki no Sangyoyo system kiki. Tenbo

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2000-01-10

    This paper describes industrial systems and devices being discussed or having been developed already by Fuji Electric. Harmonics suppressing and energy saving multi-level inverters with outputs of 3.3 kV and 6.6 kV to directly drive high voltage induction motors; 132-kV direct dropping aluminum electrolyzing rectifier; three-output thyristor rectifier for soda electrolysis of ion exchange membrane method; arbitrary waveform type power supply adopting IGBT inverter as aluminum sash coloring power supply; open integral surveillance control system; high-efficiency and energy saving permanent magnet synchronous motor, applicable to rotating machines up to medium capacity and speed variable driving systems; cubicle type gas insulated switching device; power receiving and transforming facility renewing devices; large-scale wind power generation facilities; protection control unit integrating different functions; structural improvement in high-frequency induction furnace and temperature control systems; zinc removing induction dissolution system introduced with induction heating method, and levitation and dissolution system; new type uninterruptible power supply system; photovoltaic inverter; gas turbine cogeneration facilities; clean room with high cleanliness; and clean devices. (NEDO)

  16. 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.

  17. 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.

  18. Adapting the IDEAL Framework and Recommendations for medical device evaluation: A modified Delphi survey.

    Science.gov (United States)

    Pennell, Christopher P; Hirst, Allison; Sedrakyan, Art; McCulloch, Peter G

    2016-04-01

    Current regulatory systems for medical device marketing approval lack adequate requirements for evidence of safety and efficacy. The Total Product Life Cycle (TPLC) concept, with clinical use and marketing expanding as evidence develops, has won support, but lacks a template to define evidence requirements at different stages. The IDEAL Framework & Recommendations, originally developed for new surgical procedures, might provide such a template, but may require modification. We conducted a Delphi expert consensus exercise to determine how IDEAL might be modified to accommodate the needs of device regulation. 34 experts were invited to participate in 3 rounds of questioning, with feedback of the results of each round to participants before the next. 27 of 34 experts responded in at least one survey round. Experts agreed that, after appropriate modifications, IDEAL could form an evidence template for a TPLC-based regulatory system. Necessary modifications include a new Stage 0 should guide reporting of pre-clinical studies, expansion of registries to all stages, and omission of IDEAL stages 2 and 3 for "successor" devices under certain conditions. A standard approach to TPLC evaluation of medical devices does not currently exist. The IDEAL Framework, if modified appropriately, could fill such a void and improve the safety of new medical devices. Copyright © 2016 IJS Publishing Group Limited. Published by Elsevier Ltd. All rights reserved.

  19. 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...

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

    NARCIS (Netherlands)

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

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