[Medical doctors driving technological innovation: questions about and innovation management approaches to incentive structures for lead users].

Science.gov (United States)

Bohnet-Joschko, Sabine; Kientzler, Fionn

2010-01-01

Management science defines user-generated innovations as open innovation and lead user innovation. The medical technology industry finds user-generated innovations profitable and even indispensable. Innovative medical doctors as lead users need medical technology innovations in order to improve patient care. Their motivation to innovate is mostly intrinsic. But innovations may also involve extrinsic motivators such as gain in reputation or monetary incentives. Medical doctors' innovative activities often take place in hospitals and are thus embedded into the hospital's organisational setting. Hospitals find it difficult to gain short-term profits from in-house generated innovations and sometimes hesitate to support them. Strategic investment in medical doctors' innovative activities may be profitable for hospitals in the long run if innovations provide first-mover competitive advantages. Industry co-operations with innovative medical doctors offer chances but also bear potential risks. Innovative ideas generated by expert users may result in even higher complexity of medical devices; this could cause mistakes when applied by less specialised users and thus affect patient safety. Innovations that yield benefits for patients, medical doctors, hospitals and the medical technology industry can be advanced by offering adequate support for knowledge transfer and co-operation models.

Medical innovation laws: an unnecessary innovation.

Science.gov (United States)

Richards, Bernadette

2016-06-01

Objective This paper aims to demonstrate that any suggestion that there is a need for specific innovation laws is flawed. Innovation is central to good medical practice and is adequately supported by current law. Methods The paper reviews the nature of medical innovation and outlines recent attempts in the UK to introduce specific laws aimed at 'encouraging' and 'supporting' innovation. The current legal framework is outlined and the role of the law in relation to medical innovation explored. Results The analysis demonstrates the cyclic relationship between medical advancement and the law and concludes that there is no requirement for specific innovation laws. Conclusions The law not only supports innovation and development in medical treatment but encourages it as central to a functioning medical system. There is no need to introduce specific laws aimed at medical innovation; to do so represents an unnecessary legal innovation and serves to complicate matters. What is known about the topic? Over recent months, there has been a great deal of discussion surrounding the law in the context of medical innovation. This was driven by the attempts in the UK to introduce specific laws in the Medical Innovation Bill. The general subject matter - negligence and the expected standard of care in the provision of treatment - is very well understood, but not in cases where the treatment can be described as innovative. The general rhetoric in both the UK and Australia around the Medical Innovation Bill demonstrates a lack of understanding of the position of the law with regards to innovative treatment. What does this paper add? This paper adds clarity to the debate. It presents the law and explains the manner in which the law can operate around innovative treatment. The paper asserts that medical innovation is both supported and encouraged by existing legal principles. What are the implications for practitioners? The paper presents an argument that can guide the policy position

Unmet needs: relevance to medical technology innovation?

Science.gov (United States)

McCarthy, Avril D; Sproson, Lise; Wells, Oliver; Tindale, Wendy

2014-01-01

This paper describes and discusses the role of unmet needs in the innovation of new medical technologies using the National Institute for Health Research Devices for Dignity (D4D) Healthcare Technology Co-operative as a case study. It defines an unmet need, providing a spectrum of classification and discusses the benefits and the challenges of identifying unmet need and its influence on the innovation process. The process by which D4D has captured and utilized unmet needs to drive technology innovation is discussed and examples given. It concludes by arguing that, despite the challenges, defining and reviewing unmet need is a fundamental factor in the success of medical technology innovation.

[Projects to accelerate the practical use of innovative medical devices to collaborate with TWIns, Center for Advanced Biomedical Sciences, Waseda University and School of Engineering, The University of Tokyo].

Science.gov (United States)

Niimi, Shingo; Umezu, Mitsuo; Iseki, Hiroshi; Harada, Hiroshi Kasanuki Noboru; Mitsuishi, Mamoru; Kitamori, Takehiko; Tei, Yuichi; Nakaoka, Ryusuke; Haishima, Yuji

2014-01-01

Division of Medical Devices has been conducting the projects to accelerate the practical use of innovative medical devices to collaborate with TWIns, Center for Advanced Biomedical Sciences, Waseda University and School of Engineering, The University of Tokyo. The TWIns has been studying to aim at establishment of preclinical evaluation methods by "Engineering Based Medicine", and established Regulatory Science Institute for Medical Devices. School of Engineering, The University of Tokyo has been studying to aim at establishment of assessment methodology for innovative minimally invasive therapeutic devices, materials, and nanobio diagnostic devices. This report reviews the exchanges of personnel, the implement systems and the research progress of these projects.

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

Science.gov (United States)

Bruzzi, M S; Linehan, J H

2013-09-01

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

[Innovation of characteristic medicinal cupping devices].

Science.gov (United States)

Li, Jianping; Zhang, Hui; Yang, Jianmei; Xu, Xinchun; Niu, Yanxia; Cai, Jun

2015-08-01

To compare the differences in the characteristic medicinal cupping therapy between the traditional cupping device and the innovated cupping device. Fifty patients of neck and low back pain were selected. The self-comparison was adopted. The cupping therapy was applied to the acupoints located on the left or right side with the traditional cupping device and the innovated cupping device. The cupping sites were centered at bilateral Quyuan (SI 13) and Dachangshu (BL 25). The cups were retained for 10 min. The traditional cupping device was the glass with smooth border, 100mL. The innovated cupping device was the vacuum-sucking cup. The operative time, medicinal leakage, comfort and cupping marks were observed for the two different cupping devices. The operative time with the innovated medicinal cupping device was shorter obviously compared with the traditional one at Quyuan (SI 13) and Dachangshu (BL 25, both Pcupping device was remarkably improved as compared with the traditional one at the two acupoints (both Pcupping operation (both P>0. 05). The cupping marks with the innovated medicinal cupping device were much deeper than those with the traditional one after cupping therapy. The innovated cupping device is more convenent and comfortable in operation during the characteristic medicinal cupping therapy.

Dynamics of device innovation: implications for assessing value.

Science.gov (United States)

Gelijns, Annetine C; Russo, Mark J; Hong, Kimberly N; Brown, Lawrence D; Ascheim, Deborah D; Moskowitz, Alan J

2013-10-01

In recent years, there has been growing interest in evaluating the health and economic impact of medical devices. Payers increasingly rely on cost-effectiveness analyses in making their coverage decisions, and are adopting value-based purchasing initiatives. These analytic approaches, however, have been shaped heavily by their use in the pharmaceutical realm, and are ill-adapted to the medical device context. This study focuses on the development and evaluation of left ventricular assist devices (LVADs) to highlight the unique challenges involved in the design and conduct of device trials compared with pharmaceuticals. Devices are moving targets characterized by a much higher degree of post-introduction innovation and "learning by using" than pharmaceuticals. The cost effectiveness ratio of left ventricular assist devices for destination therapy, for example, decreased from around $600,000 per life year saved based on results from the pivotal trial to around $100,000 within a relatively short time period. These dynamics pose fundamental challenges to the evaluation enterprise as well as the policy-making world, which this paper addresses.

[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").

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.

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.

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

Science.gov (United States)

Maresova, Petra; Penhaker, Marek; Selamat, Ali; Kuca, Kamil

2015-01-01

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.

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

Science.gov (United States)

2010-10-01

American Telemedicine Association), we demonstrated how continuous monitoring of the patient’s SpO2 and respiratory rate could detect the onset of...designed to monitor sepsis infection sounded its alarm continually, day and night. The device was built with an innovative algorithm to detect sepsis, but...transport Figure 3. This medical device has misread its sensors and inserted false data into patient’s permanent medical record. SPECIal FEaTuRE October

Purchasing medical innovation the right technology, for the right patient, at the right price

CERN Document Server

Robinson, James C

2015-01-01

Innovation in medical technology generates a remarkable supply of new drugs, devices, and diagnostics that improve health, reduce risks, and extend life. But these technologies are too often used on the wrong patient, in the wrong setting, or at an unaffordable price. The only way to moderate the growth in health care costs without undermining the dynamic of medical innovation is to improve the process of assessing, pricing, prescribing, and using new technologies. Purchasing Medical Innovation analyzes the contemporary revolution in the purchasing of health care technology, with a focus on th

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

Topological Insulators and Superconductors for Innovative Devices

Science.gov (United States)

2015-03-20

Final 3. DATES COVERED (From - To) 20120321 - 20150320 4. TITLE AND SUBTITLE Topological insulators and superconductors for innovative...locking, which hold promise for various innovative devices. Similarly, topological superconductors are associated with exotic surface states, which...298 (Rev. 8/98) Prescribed by ANSI Std. Z39.18 Final Report Title: Topological Insulators and Superconductors for Innovative Devices

Value-based purchasing of medical devices.

Science.gov (United States)

Obremskey, William T; Dail, Teresa; Jahangir, A Alex

2012-04-01

Health care in the United States is known for its continued innovation and production of new devices and techniques. While the intention of these devices is to improve the delivery and outcome of patient care, they do not always achieve this goal. As new technologies enter the market, hospitals and physicians must determine which of these new devices to incorporate into practice, and it is important these devices bring value to patient care. We provide a model of a physician-engaged process to decrease cost and increase review of physician preference items. We describe the challenges, implementation, and outcomes of cost reduction and product stabilization of a value-based process for purchasing medical devices at a major academic medical center. We implemented a physician-driven committee that standardized and utilized evidence-based, clinically sound, and financially responsible methods for introducing or consolidating new supplies, devices, and technology for patient care. This committee worked with institutional finance and administrative leaders to accomplish its goals. Utilizing this physician-driven committee, we provided access to new products, standardized some products, decreased costs of physician preference items 11% to 26% across service lines, and achieved savings of greater than $8 million per year. The implementation of a facility-based technology assessment committee that critically evaluates new technology can decrease hospital costs on implants and standardize some product lines.

MO-A-BRC-00: TG167: Clinical Recommendations for Innovative Brachytherapy Devices and Applicators

Energy Technology Data Exchange (ETDEWEB)

NONE

2016-06-15

Although a multicenter, Phase III, prospective, randomized trial is the gold standard for evidence-based medicine, it is rarely used to evaluate innovative radiotherapy devices because of many practical and ethical reasons. It is usually sufficient to compare the dose distributions and dose rates for determining equivalence of the innovative device to an existing one. Thus, quantitative evaluation of the dosimetric characteristics of an innovative brachytherapy device or application is a critical part in which physicists are actively involved. The physicist’s role, along with physician colleagues, in this process is highlighted for innovative products or applications and includes evaluation of 1) dosimetric considerations for clinical implementation (including calibrations, dose calculations, and radiobiological aspects) to comply with existing societal dosimetric prerequisites for sources in routine clinical use, 2) risks and benefits from regulatory and safety perspectives, and 3) resource assessment and preparedness. Further, calibration methods should be traceable to a primary standards dosimetry laboratory such as NIST in the U.S. or to other primary standards dosimetry laboratory located elsewhere. Clinical users should follow standards as approved by their country’s regulatory agencies that approved such a brachytherapy device. Integration of this system into the medical source calibration infrastructure of secondary standard dosimetry laboratories such as the ADCLs is encouraged before a source is introduced into widespread routine clinical use. The AAPM and GEC-ESTRO have developed guidelines for the safe and consistent application of brachytherapy using innovative brachytherapy devices and applications. The current report covers regulatory approvals, calibration, dose calculations, radiobiological issues, and overall safety concerns that should be addressed during the commissioning stage preceding clinical use. These guidelines are based on review of

MO-A-BRC-00: TG167: Clinical Recommendations for Innovative Brachytherapy Devices and Applicators

International Nuclear Information System (INIS)

2016-01-01

Although a multicenter, Phase III, prospective, randomized trial is the gold standard for evidence-based medicine, it is rarely used to evaluate innovative radiotherapy devices because of many practical and ethical reasons. It is usually sufficient to compare the dose distributions and dose rates for determining equivalence of the innovative device to an existing one. Thus, quantitative evaluation of the dosimetric characteristics of an innovative brachytherapy device or application is a critical part in which physicists are actively involved. The physicist’s role, along with physician colleagues, in this process is highlighted for innovative products or applications and includes evaluation of 1) dosimetric considerations for clinical implementation (including calibrations, dose calculations, and radiobiological aspects) to comply with existing societal dosimetric prerequisites for sources in routine clinical use, 2) risks and benefits from regulatory and safety perspectives, and 3) resource assessment and preparedness. Further, calibration methods should be traceable to a primary standards dosimetry laboratory such as NIST in the U.S. or to other primary standards dosimetry laboratory located elsewhere. Clinical users should follow standards as approved by their country’s regulatory agencies that approved such a brachytherapy device. Integration of this system into the medical source calibration infrastructure of secondary standard dosimetry laboratories such as the ADCLs is encouraged before a source is introduced into widespread routine clinical use. The AAPM and GEC-ESTRO have developed guidelines for the safe and consistent application of brachytherapy using innovative brachytherapy devices and applications. The current report covers regulatory approvals, calibration, dose calculations, radiobiological issues, and overall safety concerns that should be addressed during the commissioning stage preceding clinical use. These guidelines are based on review of

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 ...

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

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 ...

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.

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. Copyright © 2011 Associazione Italiana di Fisica Medica. Published by Elsevier Ltd. All rights reserved.

Avoiding pitfalls in the road from idea to certified product (and the harsh clinical environment thereafter) when innovating medical devices

NARCIS (Netherlands)

Wieringa, F.P.; Poley M.J.; Dumay, A.C.M.; Steen, A.F.W. van der

2007-01-01

Innovation in medical technology is a critical chain of events, ideally leading to an improved situation for patient and staff as well as a nice profit for the supplier of the innovation. Unfortunately many innovative ideas are not successful in practice. This is often due to lack of: • Medical

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

Innovation in Neurosurgery: Intellectual Property Strategy and Academia/Industrial Collaboration.

Science.gov (United States)

Murayama, Yuichi

2016-09-15

Neurosurgery has tremendous possibilities for development of innovative medical devices. However, most of the neurosurgical devices used in Japan are imported products. Promotion and development of domestic medical devices is highly encouraged and it is one of the pillars of Prime Minister Shinzo Abe's growth strategy of Japanese economy. Innovative "Made in Japan" medical devices can be developed by interdisciplinary collaboration between industries and academic institutions. Proper orientation of medical and engineering education, social and administrative awareness of the need of facilitating the medical devices creative process with corresponding regulatory changes, and appropriate medical and technological infrastructure establishment are needed for stimulating medical device innovation.

Biodesign process and culture to enable pediatric medical technology innovation.

Science.gov (United States)

Wall, James; Wynne, Elizabeth; Krummel, Thomas

2015-06-01

Innovation is the process through which new scientific discoveries are developed and promoted from bench to bedside. In an effort to encourage young entrepreneurs in this area, Stanford Biodesign developed a medical device innovation training program focused on need-based innovation. The program focuses on teaching systematic evaluation of healthcare needs, invention, and concept development. This process can be applied to any field of medicine, including Pediatric Surgery. Similar training programs have gained traction throughout the United States and beyond. Equally important to process in the success of these programs is an institutional culture that supports transformative thinking. Key components of this culture include risk tolerance, patience, encouragement of creativity, management of conflict, and networking effects. Copyright © 2015 Elsevier Inc. All rights reserved.

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

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.

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

2018-02-23

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.

Effects of Medical Device Regulations on the Development of Stand-Alone Medical Software: A Pilot Study.

Science.gov (United States)

Blagec, Kathrin; Jungwirth, David; Haluza, Daniela; Samwald, Matthias

2018-01-01

Medical device regulations which aim to ensure safety standards do not only apply to hardware devices but also to standalone medical software, e.g. mobile apps. To explore the effects of these regulations on the development and distribution of medical standalone software. We invited a convenience sample of 130 domain experts to participate in an online survey about the impact of current regulations on the development and distribution of medical standalone software. 21 respondents completed the questionnaire. Participants reported slight positive effects on usability, reliability, and data security of their products, whereas the ability to modify already deployed software and customization by end users were negatively impacted. The additional time and costs needed to go through the regulatory process were perceived as the greatest obstacles in developing and distributing medical software. Further research is needed to compare positive effects on software quality with negative impacts on market access and innovation. Strategies for avoiding over-regulation while still ensuring safety standards need to be devised.

Uptake and diffusion of medical technology innovation in Europe: what role for funding and procurement policies?

OpenAIRE

Torbica, Aleksandra; Cappellaro, Giulia

2010-01-01

The producers of medical technology constantly strive to innovate and to improve their products for the benefit of patients. With each new generation of devices enabling less invasive techniques, better clinical outcomes and reduced recovery times, patients are direct beneficiaries of this commitment to innovation. Innovation and patient access to technology are inseparably linked with each national health system's respective coverage, procurement and reimbursement policies. If a particular i...

Initiatives in the Australian Medical Devices Industry

International Nuclear Information System (INIS)

Whelan, Luke

2005-01-01

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

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. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

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.

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

Science.gov (United States)

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

2017-12-01

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

Virtual worlds are an innovative tool for medical device training in a simulated environment.

Science.gov (United States)

Patel, Vishal; Lee, Henry; Taylor, Dave; Aggarwal, Rajesh; Kinross, James; Darzi, Ara

2012-01-01

Medical infusion devices are an integral component within the delivery of healthcare management. The aim of this study was to develop a training simulation in the virtual world of Second Life for the management of adverse events associated with infusion devices. Forty nurses were subsequently recruited to participate within the simulation and assess its feasibility.

Case outsourcing medical device reprocessing.

Science.gov (United States)

Haley, Deborah

2004-04-01

IN THE INTEREST OF SAVING MONEY, many hospitals are considering extending the life of some single-use medical devices by using medical device reprocessing programs. FACILITIES OFTEN LACK the resources required to meet the US Food and Drug Administration's tough quality assurance standards. BY OUTSOURCING, hospitals can reap the benefits of medical device reprocessing without assuming additional staffing and compliance burdens. OUTSOURCING enables hospitals to implement a medical device reprocessing program quickly, with no capital investment and minimal effort.

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.

The Biological Responses to Magnesium-Based Biodegradable Medical Devices

Directory of Open Access Journals (Sweden)

Lumei Liu

2017-11-01

Full Text Available The biocompatibility of Magnesium-based materials (MBMs is critical to the safety of biodegradable medical devices. As a promising metallic biomaterial for medical devices, the issue of greatest concern is devices’ safety as degrading products are possibly interacting with local tissue during complete degradation. The aim of this review is to summarize the biological responses to MBMs at the cellular/molecular level, including cell adhesion, transportation signaling, immune response, and tissue growth during the complex degradation process. We review the influence of MBMs on gene/protein biosynthesis and expression at the site of implantation, as well as throughout the body. This paper provides a systematic review of the cellular/molecular behavior of local tissue on the response to Mg degradation, which may facilitate a better prediction of long-term degradation and the safe use of magnesium-based implants through metal innovation.

Human Factors and Medical Devices

International Nuclear Information System (INIS)

Dick Sawyer

1998-01-01

Medical device hardware- and software-driven user interfaces should be designed to minimize the likelihood of use-related errors and their consequences. The role of design-induced errors in medical device incidents is attracting widespread attention. The U.S. Food and Drug Administration (FDA) is fully cognizant that human factors engineering is critical to the design of safe medical devices, and user interface design is receiving substantial attention by the agency. Companies are paying more attention to the impact of device design, including user instructions, upon the performance of those health professionals and lay users who operate medical devices. Concurrently, the FDA is monitoring human factors issues in its site inspections, premarket device approvals, and postmarket incident evaluations. Overall, the outlook for improved designs and safer device operation is bright

OR.NET RT: how service-oriented medical device architecture meets real-time communication.

Science.gov (United States)

Pfeiffer, Jonas H; Kasparick, Martin; Strathen, Benjamin; Dietz, Christian; Dingler, Max E; Lueth, Tim C; Timmermann, Dirk; Radermacher, Klaus; Golatowski, Frank

2018-02-23

Today's landscape of medical devices is dominated by stand-alone systems and proprietary interfaces lacking cross-vendor interoperability. This complicates or even impedes the innovation of novel, intelligent assistance systems relying on the collaboration of medical devices. Emerging approaches use the service-oriented architecture (SOA) paradigm based on Internet protocol (IP) to enable communication between medical devices. While this works well for scenarios with no or only soft timing constraints, the underlying best-effort communication scheme is insufficient for time critical data. Real-time (RT) networks are able to reliably guarantee fixed latency boundaries, for example, by using time division multiple access (TDMA) communication patterns. However, deterministic RT networks come with their own limitations such as tedious, inflexible configuration and a more restricted bandwidth allocation. In this contribution we overcome the drawbacks of both approaches by describing and implementing mechanisms that allow the two networks to interact. We introduce the first implementation of a medical device network that offers hard RT guarantees for control and sensor data and integrates into SOA networks. Based on two application examples we show how the flexibility of SOA networks and the reliability of RT networks can be combined to achieve an open network infrastructure for medical devices in the operating room (OR).

[Medical Devices Law for pain therapists].

Science.gov (United States)

Regner, M; Sabatowski, R

2016-08-01

Medical Devices Law is a relatively new legal system, which has replaced the Medical Devices Regulations still well-known in Germany. German Medical Devices Law is based on European directives, which are, in turn, incorporated into national law by the Medical Devices Act. The Medical Devices Act is a framework law and covers a number of regulations that address specific topics within Medical Devices Law. In turn, in individual regulations, reference is made to guidelines, recommendations, etc. from other sources that provide detailed technical information on specific topics. Medical Devices Law is a very complex legal system, which needs to be permanently observed due to constant updating and adjustment. In the current article, the design and the structure of the system will be described, but special emphasis will be laid on important problem areas that need to be considered when applying and operating medical products, in this case by pain therapists in particular.

[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.

Assessment and diffusion of medical innovations in France: an overview.

Science.gov (United States)

Dubromel, Amélie; Geffroy, Loïc; Aulagner, Gilles; Dussart, Claude

2018-01-01

Background: In France, a significant part of health expenditure is publicly funding. This put a heavy burden on society. In an economic context requiring tight control of public spending, it seems relevant to control the diffusion of medical innovations. That is why health technology assessment is subject to an increasing interest at national level for management and approval decisions. This article provides an overview of the assessment and diffusion of medical innovation in France. Method: The data are extracted from French authorities or organisations websites and documents and from French legislative texts. In addition, regarding discussion, a search in MEDLINE database was carried out. Results: An overview of the assessment and diffusion of medical innovation in France is given by presenting the different types of medical innovations according to French health system definition (I); introducing French authorities participating to health technology assessment and describe assessment procedures of medical innovations (II); and giving details about market access process of innovative health product in France (III). Key opportunities and challenges of medical innovation assessment and diffusion in France are discussed at the end of this article. Conclusion: In France, medical innovation is considered as a crucial component for quality of care and performance of healthcare system. The aim of health technology assessment is to promote a secure and timely access to innovation for patients. Nevertheless, it appears necessary to improve regulatory mechanisms.

Managing perceived conflicts of interest while ensuring the continued innovation of medical technology.

Science.gov (United States)

Van Haute, Andrew

2011-09-01

If it were not for the ongoing collaboration between vascular surgeons and the medical technology industry, many of these advanced treatments used every day in vascular interventional surgery would not exist. The flip side of this coin is that these vital relationships create multiple roles for surgeons and must be appropriately managed. The dynamic process of innovation, along with factors such as product delivery technique refinement, education, testing and clinical trials, and product support, all make it necessary for ongoing and close collaboration between surgeons and the device industry. This unique relationship sometimes leads to the perception of conflicts of interest for physicians, in part because the competing pressures from the multiple, overlapping roles as clinician/caregiver/investigator/innovator/customer are significant. To address this issue, the Advanced Medical Technology Association (AdvaMed), the nation's largest medical technology association representing medical device and diagnostics companies, developed a Code of Ethics to guide medical technology companies in their interactions with health care professionals. First introduced in 1993, the AdvaMed Code strongly encourages both industry and physicians to commit to openness and high ethical standards in the conduct of their business interactions. The AdvaMed Code addresses many of the types of interactions that can occur between companies and health care professionals, including training, consulting agreements, the provision of demonstration and evaluation units, and charitable donations. By following the Code, companies send a strong message that treatment decisions must always be based on the best interest of the patient. Copyright © 2011. Published by Mosby, Inc.

Replication of clinical innovations in multiple medical practices.

Science.gov (United States)

Henley, N S; Pearce, J; Phillips, L A; Weir, S

1998-11-01

Many clinical innovations had been successfully developed and piloted in individual medical practice units of Kaiser Permanente in North Carolina during 1995 and 1996. Difficulty in replicating these clinical innovations consistently throughout all 21 medical practice units led to development of the interdisciplinary Clinical Innovation Implementation Team, which was formed by using existing resources from various departments across the region. REPLICATION MODEL: Based on a model of transfer of best practices, the implementation team developed a process and tools (master schedule and activity matrix) to quickly replicate successful pilot projects throughout all medical practice units. The process involved the following steps: identifying a practice and delineating its characteristics and measures (source identification); identifying a team to receive the (new) practice; piloting the practice; and standardizing, including the incorporation of learnings. The model includes the following components for each innovation: sending and receiving teams, an innovation coordinator role, an innovation expert role, a location expert role, a master schedule, and a project activity matrix. Communication depended on a partnership among the location experts (local knowledge and credibility), the innovation coordinator (process expertise), and the innovation experts (content expertise). Results after 12 months of working with the 21 medical practice units include integration of diabetes care team services into the practices, training of more than 120 providers in the use of personal computers and an icon-based clinical information system, and integration of a planwide self-care program into the medical practices--all with measurable improved outcomes. The model for sequential replication and the implementation team structure and function should be successful in other organizational settings.

Medical device software: defining key terms.

Science.gov (United States)

Pashkov, Vitalii; Gutorova, Nataliya; Harkusha, Andrii

one of the areas of significant growth in medical devices has been the role of software - as an integral component of a medical device, as a standalone device and more recently as applications on mobile devices. The risk related to a malfunction of the standalone software used within healthcare is in itself not a criterion for its qualification or not as a medical device. It is therefore, necessary to clarify some criteria for the qualification of stand-alone software as medical devices Materials and methods: Ukrainian, European Union, United States of America legislation, Guidelines developed by European Commission and Food and Drug Administration's, recommendations represented by international voluntary group and scientific works. This article is based on dialectical, comparative, analytic, synthetic and comprehensive research methods. the legal regulation of software which is used for medical purpose in Ukraine limited to one definition. In European Union and United States of America were developed and applying special guidelines that help developers, manufactures and end users to difference software on types standing on medical purpose criteria. Software becomes more and more incorporated into medical devices. Developers and manufacturers may not have initially appreciated potential risks to patients and users such situation could have dangerous results for patients or users. It is necessary to develop and adopt the legislation that will intend to define the criteria for the qualification of medical device software and the application of the classification criteria to such software, provide some illustrative examples and step by step recommendations to qualify software as medical device.

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.

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

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...

[Consideration of Mobile Medical Device Regulation].

Science.gov (United States)

Peng, Liang; Yang, Pengfei; He, Weigang

2015-07-01

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

Why change habits? Early modern medical innovation between medicalisation and medical culture.

Science.gov (United States)

Loetz, Francisca

2010-01-01

Based on a discussion of the concept of medicalisation and medical culture in Anglo-American, French-, and German-speaking historiography the paper argues that medical innovation in Europe from the sixteenth to the mid-nineteenth century should be approached in a different way. Instead of asking from the perspective of a too narrow concept of medicalisation why medical innovations were rejected by the population, (medical) historians should analyse medical culture and ask why people should have changed their health and illness behaviour. This conceptual argument is deduced from four empirical examples: the introduction of smallpox vaccination, "medical police," the problem of medical professionalization, and the questions arising around the relations between the healthy/sick and their practitioners.

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...

Medical device development.

Science.gov (United States)

Panescu, Dorin

2009-01-01

The development of a successful medical product requires not only engineering design efforts, but also clinical, regulatory, marketing and business expertise. This paper reviews items related to the process of designing medical devices. It discusses the steps required to take a medical product idea from concept, through development, verification and validation, regulatory approvals and market release.

A new model for graduate education and innovation in medical technology.

Science.gov (United States)

Yazdi, Youseph; Acharya, Soumyadipta

2013-09-01

We describe a new model of graduate education in bioengineering innovation and design- a year long Master's degree program that educates engineers in the process of healthcare technology innovation for both advanced and low-resource global markets. Students are trained in an iterative "Spiral Innovation" approach that ensures early, staged, and repeated examination of all key elements of a successful medical device. This includes clinical immersion based problem identification and assessment (at Johns Hopkins Medicine and abroad), team based concept and business model development, and project planning based on iterative technical and business plan de-risking. The experiential, project based learning process is closely supported by several core courses in business, design, and engineering. Students in the program work on two team based projects, one focused on addressing healthcare needs in advanced markets and a second focused on low-resource settings. The program recently completed its fourth year of existence, and has graduated 61 students, who have continued on to industry or startups (one half), additional graduate education, or medical school (one third), or our own Global Health Innovation Fellowships. Over the 4 years, the program has sponsored 10 global health teams and 14 domestic/advanced market medtech teams, and launched 5 startups, of which 4 are still active. Projects have attracted over US$2.5M in follow-on awards and grants, that are supporting the continued development of over a dozen projects.

The Role of Healthcare Technology Management in Facilitating Medical Device Cybersecurity.

Science.gov (United States)

Busdicker, Mike; Upendra, Priyanka

2017-09-02

This article discusses the role of healthcare technology management (HTM) in medical device cybersecurity and outlines concepts that are applicable to HTM professionals at a healthcare delivery organization or at an integrated delivery network, regardless of size. It provides direction for HTM professionals who are unfamiliar with the security aspects of managing healthcare technologies but are familiar with standards from The Joint Commission (TJC). It provides a useful set of recommendations, including relevant references for incorporating good security practices into HTM practice. Recommendations for policies, procedures, and processes referencing TJC standards are easily applicable to HTM departments with limited resources and to those with no resource concerns. The authors outline processes from their organization as well as best practices learned through information sharing at AAMI, National Health Information Sharing and Analysis Center (NH-ISAC), and Medical Device Innovation, Safety, and Security Consortium (MDISS) conferences and workshops.

International Standards for Radiation Sterilization of Medical Devices

International Nuclear Information System (INIS)

Miller, A.

2007-01-01

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

Innovating transformative medical devices and growing the local medical device manufacturing sector

CSIR Research Space (South Africa)

Bunn, Tony

2017-01-01

Full Text Available . The 4IR is marked by emerging technology breakthroughs in a number of fields, including robotics, genomics, biosensors and wearables, AI, the internet of things, quantum computing, big data predictive analytics, 3D printing/additive manufacturing... of personalized prosthetics and products • Personalized devices and technologies for precision medicine Secure Airway Clamp for safer Anaesthesia MANDIBULAR IMPLANTS PATIENT 2 PATIENT 1 PATIENT 3 PATIENT CT SCAN 3D PRINTED TITANIUM IMPLANT PROPOSED...

Medical tourism analysis under the innovation perspective

Directory of Open Access Journals (Sweden)

Keline Leão Ferreira

2016-05-01

Full Text Available Medical tourism, although being considered a recent phenomenon in Brazil, still represents an important opportunity for institutions that have health facilities, human resources and advanced technological level. This work aims to develop a reflection about this market based under the innovation theoretical perspectives. In order to support this analysis was conducted a multi case study in four health institutions located in the Brazilian south region. Results confirmed that these institutions developed innovations, classified as innovation in product, process, organizational and marketing. Moreover, the evidences indicated that the institution participation on medical tourism market, using innovation as a competitive advantage, helps to promote a new business design and organizational processes, adequate infrastructure, assigning a due importance to the marketing and management sectors, generating an external recognition, a larger network relationships, cooperation among peers, ensuring to these institutions an international standard of service delivery.

Body Implanted Medical Device Communications

Science.gov (United States)

Yazdandoost, Kamya Yekeh; Kohno, Ryuji

The medical care day by day and more and more is associated with and reliant upon concepts and advances of electronics and electromagnetics. Numerous medical devices are implanted in the body for medical use. Tissue implanted devices are of great interest for wireless medical applications due to the promising of different clinical usage to promote a patient independence. It can be used in hospitals, health care facilities and home to transmit patient measurement data, such as pulse and respiration rates to a nearby receiver, permitting greater patient mobility and increased comfort. As this service permits remote monitoring of several patients simultaneously it could also potentially decrease health care costs. Advancement in radio frequency communications and miniaturization of bioelectronics are supporting medical implant applications. A central component of wireless implanted device is an antenna and there are several issues to consider when designing an in-body antenna, including power consumption, size, frequency, biocompatibility and the unique RF transmission challenges posed by the human body. The radiation characteristics of such devices are important in terms of both safety and performance. The implanted antenna and human body as a medium for wireless communication are discussed over Medical Implant Communications Service (MICS) band in the frequency range of 402-405MHz.

Medical Devices

NARCIS (Netherlands)

Verkerke, Gijsbertus Jacob; Mahieu, H.F.; Geertsema, A.A.; Hermann, I.F.; van Horn, J.R.; Hummel, J. Marjan; van Loon, J.P.; Mihaylov, D.; van der Plaats, A.; Schraffordt Koops, H.; Schutte, H.K.; Veth, R.P.H.; de Vries, M.P.; Rakhorst, G.; Shi, Donglu

2004-01-01

The development of new medical devices is a very time-consuming and costly process. Besides the time between the initial idea and the time that manufacturing and testing of prototypes takes place, the time needed for the development of production facilities, production of test series, marketing,

Classification and evaluation of medical devices

Directory of Open Access Journals (Sweden)

Edina Vranić

2003-05-01

Full Text Available Medical devices and medical disposables contribute significantly to the quality and effectiveness of the health care system. It is necessary to commit scientifically sound regulatory environment that will provide consumers with the best medical care. This includes continued services to small manufacturers, readily available guidance on FDA requirements, predictable and reasonable response times on applications for marketing, and equitable enforcement. But in the public interest, this commitment to the industry must be coupled with a reciprocal commitment: that medical device firms will meet high standards in the design, manufacture, and evaluation of their products. The protections afforded our consumer, and the benefits provided the medical device industry, cannot be underestimated.

[New medical device hospital assessment: what kind of clinical data?].

Science.gov (United States)

Beaussier, H; Junot, H; Lancrenon, S; Faure, P

2012-01-01

Since 2003, the AP-HP medical devices committee (CODIMS) assess the therapeutic relevance of innovated medical device (MD) for the French AP-HP hospitals' group. To accomplish this task, the CODIMS asks manufacturers to bring out clinical arguments to justify the use of their MD in hospital. This work analyses retrospectively after 8years, all assessed MD until March 2011 and the scientific quality of the clinical data submitted by manufacturers to the CODIMS to purchase their MD. All MD were classed according to their certification's level (I, IIa, IIb, III, DMIA). The quality of available clinical studies (CS) provided by manufacturers for each case was assessed and classed according to five clinical relevance levels based on the evidence-based medecine standards (1-2: high methodology; 3-5: low methodology). One hundred and three MD files (80 % of class IIb and III MD) were analysed by the CODIMS (630CS). Our results highlight the lack of relevance of files that are provided to assess innovated MD: 29 files without any CS; concerning class IIb (32DMS, 221CS) and III (50, 342CS) MD, only 6 % of CS presented a correct clinical relevance level. And the situation did not get better during this assessment period. The CODIMS deplore the poor clinical relevance of files provided to assess MD (wrong comparator, inappropriate ends-points, insufficient follow-up to assess long-term security, small population studied). Future legislative developments for MD assessment are expected to improve this situation. Copyright © 2011 Elsevier Masson SAS. All rights reserved.

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

Radiological Medical Device Innovation: Approvals via the Premarket Approval Pathway From 2000 to 2015.

Science.gov (United States)

Ghobadi, Comeron W; Hayman, Emily L; Finkle, Joshua H; Walter, Jessica R; Xu, Shuai

2017-01-01

The aim of this study was to critically assess the clinical evidence leading to radiologic medical device approvals via the premarket approval pathway from 2000 to 2015. This study used the publically available FDA premarket database for radiologic device approvals over the past 15 years (September 1, 2000, to August 31, 2015). Approval characteristics were collected for each device, and statistical analysis was performed on the data for each pivotal trial. Additionally, methodological quality of the pivotal trial was determined using the Quality Assessment of Diagnostic Accuracy Studies tool. Twenty-three class III radiologic device approvals were identified, with breast imaging accounting for 16 (70%) and computer-aided detection software accounting for 9 (39%) approvals. The median premarket approval time was 475 days (range, 180-1,116). Twenty-one devices were approved on the basis of multireader, multicenter studies, one on the basis of a randomized controlled trial, and one on the basis of a preclinical technical equivalence trial. The median number of patients per pivotal trial was 201 (range, 25-3,946). Twenty-six of the 34 pivotal trials (76%) had at least one methodologic bias. Breast imaging devices had a greater number of patients per pivotal trial (P = .009) and more prospective studies. With regard to all modalities, increased time to device approval correlated with weaker trial quality (r = 0.600, P assessing diagnostic technologies. Given that radiologic devices play a key role in modern medicine, further efforts should be made to increase transparency of clinical data leading to approval. Copyright © 2016 American College of Radiology. Published by Elsevier Inc. All rights reserved.

Developing biomedical devices design, innovation and protection

CERN Document Server

Andreoni, Giuseppe; Colombo, Barbara

2013-01-01

During the past two decades incredible progress has been achieved in the instruments and devices used in the biomedical field. This progress stems from continuous scientific research that has taken advantage of many findings and advances in technology made available by universities and industry. Innovation is the key word, and in this context legal protection and intellectual property rights (IPR) are of crucial importance. This book provides students and practitioners with the fundamentals for designing biomedical devices and explains basic design principles. Furthermore, as an aid to the dev

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.

Addressing challenges of training a new generation of clinician-innovators through an interdisciplinary medical technology design program: Bench-to-Bedside.

Science.gov (United States)

Loftus, Patrick D; Elder, Craig T; D'Ambrosio, Troy; Langell, John T

2015-01-01

Graduate medical education has traditionally focused on training future physicians to be outstanding clinicians with basic and clinical science research skills. This focus has resulted in substantial knowledge gains, but a modest return on investment based on direct improvements in clinical care. In today's shifting healthcare landscape, a number of important challenges must be overcome to not only improve the delivery of healthcare, but to prepare future physicians to think outside the box, focus on and create healthcare innovations, and navigate the complex legal, business and regulatory hurdles of bringing innovation to the bedside. We created an interdisciplinary and experiential medical technology design competition to address these challenges and train medical students interested in moving new and innovative clinical solutions to the forefront of medicine. Medical students were partnered with business, law, design and engineering students to form interdisciplinary teams focused on developing solutions to unmet clinical needs. Over the course of six months teams were provided access to clinical and industry mentors, $500 prototyping funds, development facilities, and non-mandatory didactic lectures in ideation, design, intellectual property, FDA regulatory requirements, prototyping, market analysis, business plan development and capital acquisition. After four years of implementation, the program has supported 396 participants, seen the development of 91 novel medical devices, and launched the formation of 24 new companies. From our perspective, medical education programs that develop innovation training programs and shift incentives from purely traditional basic and clinical science research to also include high-risk innovation will see increased student engagement in improving healthcare delivery and an increase in the quality and quantity of innovative solutions to medical problems being brought to market.

Medical device market in China.

Science.gov (United States)

Boyer, Philip; Morshed, Bashir I; Mussivand, Tofy

2015-06-01

With China's growing old-age population and economic presence on the international stage, it has become important to evaluate its domestic and foreign market contribution to medical devices. Medical devices are instruments or apparatuses used in the prevention, rehabilitation, treatment, or knowledge generation with respect to disease or other abnormal conditions. This article provides information drawn from recent publications to describe the current state of the Chinese domestic market for medical devices and to define opportunities for foreign investment potential therein. Recent healthcare reforms implemented to meet rising demand due to an aging and migrating population are having a positive effect on market growth-a global market with a projected growth of 15% per year over the next decade. Copyright © 2015 International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.

Proposed changes to the reimbursement of pharmaceuticals and medical devices in Poland and their impact on market access and the pharmaceutical industry

Science.gov (United States)

Badora, Karolina; Caban, Aleksandra; Rémuzat, Cécile; Dussart, Claude; Toumi, Mondher

2017-01-01

ABSTRACT In Poland, two proposed amendments to the reimbursement act are currently in preparation; these are likely to substantially change the pricing and reimbursement landscape for both drugs and medical devices. Proposed changes include: alignment of medical device reimbursement with that of pharmaceuticals; relaxing the strict reimbursement criteria for ultra-orphan drugs; establishment of an additional funding category for vaccines; introduction of compassionate use, and a simplified reimbursement pathway for well-established off-label indications; appreciation of manufacturers’ innovation and research and development efforts by creating a dedicated innovation budget; introduction of a mechanism preventing excessive parallel import; prolonged duration of reimbursement decisions and reimbursement lists; and increased flexibility in defining drug programmes. Both amendments are still at a draft stage and many aspects of the new regulations remain unclear. Nonetheless, the overall direction of some of the changes is already evident and warrants discussion due to their high expected impact on pharmaceutical and device manufacturers. Here we evaluate the main changes proposed to the reimbursement of drugs, vaccines, and medical devices, and examine the impact they are likely to have on market access and pharmaceutical industry in Poland. PMID:29081924

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

Science.gov (United States)

Tarricone, Rosanna; Torbica, Aleksandra; Drummond, Michael

2017-02-01

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

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

Guidelines by the AAPM and GEC-ESTRO on the use of innovative brachytherapy devices and applications: Report of Task Group 167

International Nuclear Information System (INIS)

Nath, Ravinder; Rivard, Mark J.; DeWerd, Larry A.; Dezarn, William A.; Thompson Heaton, H.; Ibbott, Geoffrey S.; Meigooni, Ali S.; Ouhib, Zoubir; Rusch, Thomas W.; Siebert, Frank-André; Venselaar, Jack L. M.

2016-01-01

Although a multicenter, Phase III, prospective, randomized trial is the gold standard for evidence-based medicine, it is rarely used in the evaluation of innovative devices because of many practical and ethical reasons. It is usually sufficient to compare the dose distributions and dose rates for determining the equivalence of the innovative treatment modality to an existing one. Thus, quantitative evaluation of the dosimetric characteristics of innovative radiotherapy devices or applications is a critical part in which physicists should be actively involved. The physicist’s role, along with physician colleagues, in this process is highlighted for innovative brachytherapy devices and applications and includes evaluation of (1) dosimetric considerations for clinical implementation (including calibrations, dose calculations, and radiobiological aspects) to comply with existing societal dosimetric prerequisites for sources in routine clinical use, (2) risks and benefits from a regulatory and safety perspective, and (3) resource assessment and preparedness. Further, it is suggested that any developed calibration methods be traceable to a primary standards dosimetry laboratory (PSDL) such as the National Institute of Standards and Technology in the U.S. or to other PSDLs located elsewhere such as in Europe. Clinical users should follow standards as approved by their country’s regulatory agencies that approved such a brachytherapy device. Integration of this system into the medical source calibration infrastructure of secondary standard dosimetry laboratories such as the Accredited Dosimetry Calibration Laboratories in the U.S. is encouraged before a source is introduced into widespread routine clinical use. The American Association of Physicists in Medicine and the Groupe Européen de Curiethérapie-European Society for Radiotherapy and Oncology (GEC-ESTRO) have developed guidelines for the safe and consistent application of brachytherapy using innovative devices

Guidelines by the AAPM and GEC-ESTRO on the use of innovative brachytherapy devices and applications: Report of Task Group 167

Energy Technology Data Exchange (ETDEWEB)

Nath, Ravinder [Department of Therapeutic Radiology, School of Medicine, Yale University, New Haven, Connecticut 06510 (United States); Rivard, Mark J., E-mail: mark.j.rivard@gmail.com [Department of Radiation Oncology, School of Medicine, Tufts University, Boston, Massachusetts 02111 (United States); DeWerd, Larry A. [Accredited Dosimetry and Calibration Laboratory, University of Wisconsin, Madison, Wisconsin 53706 (United States); Dezarn, William A. [Department of Radiation Oncology, School of Medicine, Wake Forest University, Winston-Salem, North Carolina 27157 (United States); Thompson Heaton, H. [Hagerstown, Maryland 21740 (United States); Ibbott, Geoffrey S. [Department of Radiation Physics, University of Texas MD Anderson Cancer Center, Houston, Texas 77030 (United States); Meigooni, Ali S. [Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada 89169 (United States); Ouhib, Zoubir [Radiation Oncology, Lynn Regional Cancer Center, Delray Beach, Florida 33484 (United States); Rusch, Thomas W. [Xoft, Inc., A Subsidiary of iCAD, Inc., San Jose, California 95134 (United States); Siebert, Frank-André [Clinic of Radiotherapy, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel 24105 (Germany); Venselaar, Jack L. M. [Department of Medical Physics and Engineering, Instituut Verbeeten, Tilburg LA 5000 (Netherlands)

2016-06-15

Although a multicenter, Phase III, prospective, randomized trial is the gold standard for evidence-based medicine, it is rarely used in the evaluation of innovative devices because of many practical and ethical reasons. It is usually sufficient to compare the dose distributions and dose rates for determining the equivalence of the innovative treatment modality to an existing one. Thus, quantitative evaluation of the dosimetric characteristics of innovative radiotherapy devices or applications is a critical part in which physicists should be actively involved. The physicist’s role, along with physician colleagues, in this process is highlighted for innovative brachytherapy devices and applications and includes evaluation of (1) dosimetric considerations for clinical implementation (including calibrations, dose calculations, and radiobiological aspects) to comply with existing societal dosimetric prerequisites for sources in routine clinical use, (2) risks and benefits from a regulatory and safety perspective, and (3) resource assessment and preparedness. Further, it is suggested that any developed calibration methods be traceable to a primary standards dosimetry laboratory (PSDL) such as the National Institute of Standards and Technology in the U.S. or to other PSDLs located elsewhere such as in Europe. Clinical users should follow standards as approved by their country’s regulatory agencies that approved such a brachytherapy device. Integration of this system into the medical source calibration infrastructure of secondary standard dosimetry laboratories such as the Accredited Dosimetry Calibration Laboratories in the U.S. is encouraged before a source is introduced into widespread routine clinical use. The American Association of Physicists in Medicine and the Groupe Européen de Curiethérapie-European Society for Radiotherapy and Oncology (GEC-ESTRO) have developed guidelines for the safe and consistent application of brachytherapy using innovative devices

Legislative aspects of the development of medical devices.

Science.gov (United States)

Marešová, Petra; Klímová, Blanka; Krejcar, Ondřej; Kuča, Kamil

2015-09-01

European industry of medical device technologies represents 30% of all worlds sales. New health technologies bring effective treatment approaches, help shorten stays in hospital1),bring better treatment results and accelerate rehabilitation which leads to the earlier patients recovery.Legislative aspects are one of the key areas influencing the speed of development of medical devices and their launching. The aim of this article is to specify current state of legislation in the development of medical devices in the European Union in comparison with the market leaders such as China, Japan and USA.The best established market of medical devices is in the USA. Both Japan and China follow the USA model. However, a non-professional code of ethics in China in some respect contributes to the decrease of quality of medical devices, while Japan as well as the EU countries try really hard to conform to all the regulations imposed on the manufacturing of medical devices.

Optimize Use of Space Research and Technology for Medical Devices

Science.gov (United States)

Minnifield, Nona K.

2012-01-01

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

The Role of Devices in Staging Front End Innovation

DEFF Research Database (Denmark)

Clausen, Christian; Yoshinaka, Yutaka

2009-01-01

and parcel of the innovative process. The paper is grounded empirically in insight derived from industry practices and compares practices to current literature on the manage-ment of innovation, which portray Front End In-novation as a mere process of search and selection of product ideas. The paper examines...... into realisations. Inputs from different knowledge domains must be grappled with, both in terms of needing to be elucidated as well as synthesized, in the engineering design process. The paper argues that the existing research may be seen as a response to perceived difficulties in dealing with uncertain conditions...... or market and technological opportunities in the innovative process. In this respect, models are not neutral but offer certain framings, contribute translations and act as sensemaking devices....

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.

An update on mobile phones interference with medical devices

International Nuclear Information System (INIS)

Pashazadeh, A. M.; Aghajani, M.; Nabipour, I.; Assadi, M.

2013-01-01

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. (authors)

Curricular trends in Malaysian medical schools: innovations within.

Science.gov (United States)

Azila, Nor Mohd Adnan; Rogayah, Jaafar; Zabidi-Hussin, Zabidi Azhar Mohd Hussin

2006-09-01

Various curricular innovations were adopted by medical schools worldwide in an attempt to produce medical graduates that could meet future healthcare needs of society locally and globally. This paper presents findings on curricular approaches implemented in Malaysian medical schools, in trying to meet those needs. Information was obtained from published records, responses from various questionnaires, personal communication and involvement with curricular development. Curricular innovations tended to be implemented in new medical schools upon their establishment. Established medical schools seemed to implement these innovations much later. Curricular trends appear to move towards integration, student-centred and problem-based learning as well as community-oriented medical education, with the Student-centred learning, Problem-based learning, Integrated teaching, Community-based education, Electives and Systematic programme (SPICES) model used as a reference. The focus is based on the premise that although the short-term aim of undergraduate medical education in Malaysia is to prepare graduates for the pre-registration house officer year, they must be able to practise and make decisions independently and be sensitive to the needs of the country's multiracial, multi-religious, and often remote communities. In most cases, curricular planning starts with a prescriptive model where planners focus on several intended outcomes. However, as the plan is implemented and evaluated it becomes descriptive as the planners reassess the internal and external factors that affect outcomes. A common trend in community-oriented educational activities is evident, with the introduction of interesting variations, to ensure that the curriculum can be implemented, sustained and the intended outcomes achieved.

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

Medical device reliability and associated areas

National Research Council Canada - National Science Library

Dhillon, Balbir S

2000-01-01

.... Although the history of reliability engineering can be traced back to World War II, the application of reliability engineering concepts to medical devices is a fairly recent idea that goes back to the latter part of the 1960s when many publications on medical device reliability emerged. Today, a large number of books on general reliability have been...

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

Science.gov (United States)

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

2013-01-01

Innovation in patient care requires both clinical and technical skills, and this paper presents the methods and outcomes of a nine-year, clinical-academic collaboration to develop and evaluate new medical device technologies, while teaching mechanical engineering. Together, over the course of a single semester, seniors, graduate students, and clinicians conceive, design, build, and test proof-of-concept prototypes. Projects initiated in the course have generated intellectual property and peer-reviewed publications, stimulated further research, furthered student and clinician careers, and resulted in technology licenses and start-up ventures.

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.

[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.

Power Approaches for Implantable Medical Devices

Directory of Open Access Journals (Sweden)

Achraf Ben Amar

2015-11-01

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

How can we assess the value of complex medical innovations in practice?

Science.gov (United States)

Abrishami, Payam; Boer, Albert; Horstman, Klasien

2015-06-01

Rapid proliferation of medical innovations in the face of demographic changes and scarce resources is demanding a value-conscious entry of medical innovations into health care systems. An inquiry into value gains significance during the early diffusion phase of an innovation and becomes indispensable as the complexity of an innovation increases. In this editorial, we argue that a value assessment must pay attention to the social processes shaping the innovation's adoption and use, in particular, to the "promises" of the technology and actual "practices" with it. Promises and practices represent real-world value as they account for both outcomes and costs in practice. A systematic exploration of these loci of value, using insights from constructive technology assessment, enables us to make well-informed decisions on complex medical technologies.

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.

78 FR 21129 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of...

Science.gov (United States)

2013-04-09

... radiofrequency band ranging between 13 megahertz to 27.12 megahertz and is intended for the treatment of medical...] Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices...

Anti-malware software and medical devices.

Science.gov (United States)

2010-10-01

Just as much as healthcare information systems, medical devices need protection against cybersecurity threats. Anti-malware software can help safeguard the devices in your facility-but it has limitations and even risks. Find out what steps you can take to manage anti-malware applications in your devices.

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.

Bibliometric perspectives on medical innovation using the medical subject headings of PubMed

NARCIS (Netherlands)

Leydesdorff, L.; Rotolo, D.; Rafols, I.

2012-01-01

Multiple perspectives on the nonlinear processes of medical innovations can be distinguished and combined using the Medical Subject Headings (MeSH) of the MEDLINE database. Focusing on three main branches—"diseases," "drugs and chemicals," and "techniques and equipment"—we use base maps and overlay

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...

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

Science.gov (United States)

2013-11-15

... amendments), as ``preamendments devices.'' FDA classifies these devices after the Agency takes the following.... FDA-2012-N-1238] Medical Devices; Ophthalmic Devices; Classification of the Scleral Plug AGENCY: Food... scleral plugs in order to provide a reasonable assurance of safety and effectiveness of the device. The...

Time-variable medical education innovation in context

Directory of Open Access Journals (Sweden)

Stamy CD

2018-06-01

Full Text Available Christopher D Stamy,1 Christine C Schwartz,1 Danielle A Phillips,2 Aparna S Ajjarapu,3 Kristi J Ferguson,4,5 Debra A Schwinn6–8 1University of Iowa Carver College of Medicine, Iowa City, 2Des Moines University Osteopathic Medical Center, Des Moines, 3University of Iowa, 4Office of Consultation & Research in Medical Education, University of Iowa Carver College of Medicine, 5Department of Internal Medicine, 6Department of Anesthesia, 7Department of Biochemistry, 8Department of Pharmacology, University of Iowa Health Care, Iowa City, IA, USA Background: Medical education is undergoing robust curricular reform with several innovative models emerging. In this study, we examined current trends in 3-year Doctor of Medicine (MD education and place these programs in context. Methods: A survey was conducted among Deans of U.S. allopathic medical schools using structured phone interview regarding current availability of a 3-year MD pathway, and/or other variations in curricular innovation, within their institution. Those with 3-year programs answered additional questions. Results: Data from 107 institutions were obtained (75% survey response rate. The most common variation in length of medical education today is the accelerated 3-year pathway. Since 2010, 9 medical schools have introduced parallel 3-year MD programs and another 4 are actively developing such programs. However, the total number of students in 3-year MD tracks remains small (n=199 students, or 0.2% total medical students. Family medicine and general internal medicine are the most common residency programs selected. Benefits of 3-year MD programs generally include reduction in student debt, stability of guaranteed residency positions, and potential for increasing physician numbers in rural/underserved areas. Drawbacks include concern about fatigue/burnout, difficulty in providing guaranteed residency positions, and additional expense in teaching 2 parallel curricula. Four vignettes of

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. Copyright © 2014 American College of Radiology. Published by Elsevier Inc. All rights reserved.

77 FR 72924 - Taxable Medical Devices

Science.gov (United States)

2012-12-07

... in hospitals, doctors offices and other medical institutions, such as x-ray machines, magnetic... the medical device context include sales to hospitals and other medical service providers. Although... of a taxable article to charity constitutes a taxable use under section 4218. However, the IRS and...

Development of Implantable Medical Devices: From an Engineering Perspective

Directory of Open Access Journals (Sweden)

Yeun-Ho Joung

2013-09-01

Full Text Available From the first pacemaker implant in 1958, numerous engineering and medical activities for implantable medical device development have faced challenges in materials, battery power, functionality, electrical power consumption, size shrinkage, system delivery, and wireless communication. With explosive advances in scientific and engineering technology, many implantable medical devices such as the pacemaker, cochlear implant, and real-time blood pressure sensors have been developed and improved. This trend of progress in medical devices will continue because of the coming super-aged society, which will result in more consumers for the devices. The inner body is a special space filled with electrical, chemical, mechanical, and marine-salted reactions. Therefore, electrical connectivity and communication, corrosion, robustness, and hermeticity are key factors to be considered during the development stage. The main participants in the development stage are the user, the medical staff, and the engineer or technician. Thus, there are three different viewpoints in the development of implantable devices. In this review paper, considerations in the development of implantable medical devices will be presented from the viewpoint of an engineering mind.

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

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

Science.gov (United States)

2013-05-08

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Microbiology Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To...

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

Science.gov (United States)

2011-08-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Immunology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Immunology Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To...

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).

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...... of the device. Moreover, we review software modularity in the implementation of software medical device and propose a set of preliminary principles for architectural design of software medical device based on a set of constrains identified from the reviewed regulations....

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

Science.gov (United States)

2013-11-15

... its inaugural meeting in Singapore in 2012, identified a Work Group (WG) to develop specific documents... Assessment Method for the Recognition and Monitoring of Medical Device Auditing Organizations;'' and IMDRF...

Enhancing surgical innovation through a specialized medical school pathway of excellence in innovation and entrepreneurship: Lessons learned and opportunities for the future.

Science.gov (United States)

Cohen, Mark S

2017-11-01

The mission of an academic medical center and academic departments of surgery focuses on teaching, scholarship/research, and expertise of clinical care. The standard 4-year medical school curriculum and general surgery residency training are well balanced to expose trainees to these missions in varying degrees, yet the advancement of medicine as a field is predicated on the creation, development, and successful implementation of medical innovations. Surgeons, by virtue of their clinical training, are immersed in medical technology and are continually required to use this technology effectively in combination with their own technical skills and judgment to provide optimal patient care. As such, they routinely face the challenges of current technology and the need for innovation and improvement, leading many to become natural inventors. Having a good idea or innovation to improve patient care, however, is just the starting point of the complex process of implementing that idea in the clinic. Unfortunately, the vast majority of surgeons and medical students have no formal educational training on the innovation process regarding how good ideas can be developed successfully for clinical and commercial implementation. Added to this lack of formal education are the limited resources and time constraints that surgeons, residents, and medical students face in acquiring the educational skill set to adeptly navigate this innovation and entrepreneurial landscape. To address these challenges, the University of Michigan recently created the first pathway of excellence for medical students to focus their passions and interests in medical innovation and entrepreneurship. This program has been transformative for building a new culture of young, motivated medical innovators, many of whom have dedicated their talents already to addressing several key problems in surgical patient care. Copyright © 2017 Elsevier Inc. All rights reserved.

Challenges to Value-Enhancing Innovation in Health Care Delivery: Commonalities and Contrasts with Innovation in Drugs and Devices.

Science.gov (United States)

Garber, Steven; Gates, Susan M; Blume-Kohout, Margaret E; Burgdorf, James R; Wu, Helen

2012-01-01

Limiting the growth of health care costs while improving population health is perhaps the most important and difficult challenge facing U.S. health policymakers. The role of innovation in advancing these social goals is controversial, with many seeing innovation as a major cause of cost growth and many others viewing innovation as crucial for improving the quality of care and health outcomes. The authors argue that mitigating the tension between improving health and controlling costs requires more-nuanced perspectives on innovation. More specifically, they argue that policymakers should carefully distinguish between innovative activities that are worth their social costs and activities that are not worth their social costs and try to encourage the former and discourage the latter. The article considers innovation in drugs, devices, and methods of delivering health care, with particular attention to delivery.

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.

An Innovative Flow-Measuring Device: Thermocouple Boundary Layer Rake

Science.gov (United States)

Hwang, Danny P.; Fralick, Gustave C.; Martin, Lisa C.; Wrbanek, John D.; Blaha, Charles A.

2001-01-01

An innovative flow-measuring device, a thermocouple boundary layer rake, was developed. The sensor detects the flow by using a thin-film thermocouple (TC) array to measure the temperature difference across a heater strip. The heater and TC arrays are microfabricated on a constant-thickness quartz strut with low heat conductivity. The device can measure the velocity profile well into the boundary layer, about 65 gm from the surface, which is almost four times closer to the surface than has been possible with the previously used total pressure tube.

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

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

Science.gov (United States)

2012-03-28

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory...

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

Science.gov (United States)

2011-11-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory...

Open Innovation in practice: closed NPD networks leading to high innovation performance for SME's.

NARCIS (Netherlands)

Pullen, A.J.J.; de Weerd-Nederhof, Petronella C.; Groen, Arend J.; Fisscher, O.A.M.

2011-01-01

Cooperation with other organizations increases the innovation performance of organization, especially for small and medium-sized enterprises (SMEs) as they encounter liabilities of “smallness” (e.g., limited financial resources, and manpower). In the medical devices sector, collaboration with

42 CFR 410.36 - Medical supplies, appliances, and devices: Scope.

Science.gov (United States)

2010-10-01

... 42 Public Health 2 2010-10-01 2010-10-01 false Medical supplies, appliances, and devices: Scope... Services § 410.36 Medical supplies, appliances, and devices: Scope. (a) Medicare Part B pays for the following medical supplies, appliances and devices: (1) Surgical dressings, and splints, casts, and other...

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

Science.gov (United States)

2010-09-23

...] Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory... committee will discuss, make recommendations, and vote on information related to the PMA for the LAP-BAND...

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

Science.gov (United States)

2011-09-07

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Immunology Devices Panel of the Medical Devices Advisory Committee: Notice of Postponement of Meeting AGENCY... postponing the meeting of the Immunology Devices Panel of the Medical Devices Advisory Committee scheduled...

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...

Medical Devices; Obstetrical and Gynecological Devices; Classification of the Fetal Head Elevator. Final order.

Science.gov (United States)

2017-12-19

The Food and Drug Administration (FDA or we) is classifying the fetal head elevator into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the fetal head elevator's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Use of Physics Innovative Device for Improving Students‟ Motivation and Performance in Learning Selected Concepts in Physics

Directory of Open Access Journals (Sweden)

Virginia Songalia Sobremisana

2017-11-01

Full Text Available This research was focused on the development and evaluation of physics innovative device in enhancing students’ motivation and performance in learning selected concepts in physics. The Physics innovative device was developed based upon research on student difficulties in learning relevant concepts in physics and their attitudes toward the subject. Basic concepts in mechanics were also made as baselines in the development of the locally-produced Physics innovative learning device. Such learning devices are valuable resources when used either in lecture or demonstration classes. The developmental, descriptive and quasi-experimental research methods were utilized to determine the effectiveness, in terms of motivation and performance, of the innovative device in Physics. The instruments used for the data collection were the Instructional Materials Motivational Scale (IMMS developed by Keller and the students’ performance test. Pretest and posttest mean scores were measured to determine if there is a mean gain score difference between the experimental and control groups. The study revealed that the group taught with the Physics innovative device performed significantly better than those taught in the traditional method and also the use of Physics innovative device generally improved students’ understanding of concepts and led to higher academic achievements. Analysis of the students’ level of motivation showed that their interests were captured, the instructions they received were relevant to their personal goals and motives, their confidence to learn on their own were build-up, and learning for them was rewarding and important. In the four dimensions (ARCS of IMMS students were found to be attentive, confident, and in agreement in using the fun-learning tool having realize its applicability and relevance in learning their Physics lessons. Results of the study disclosed students and teachers consider the novel device acceptable because it is

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

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.

[Analysis of medical cost of atlantoaxial disorders in patients receiving innovated treatment technologies].

Science.gov (United States)

Wu, Yunxia; Liu, Zhongjun

2016-01-19

To explore the effects of innovated technologies and products on improving outcomes and decreasing medical costs by analyzing a total and subtotal medical costs of patients with atlantoaxial disorders. The medical costs of 1 489 patients with atlantoaxial disorders from Peking University Third Hospital from 2005 to 2014, who received innovated technologies and products treatment were retrospectively analyzed and compared.Descriptive analysis and ANOVA were used for statistical analysis, and SPSS 19.0 was used to analyze data. From 2005 to 2014, under the situation of a general increase in medical cost by 327%, the total medical costs were stable for patients who used innovated technologies and products for treatment, fluctuating from 20 851 in 2005 to 20 878 in 2014; however, the cases of operation increased year by year, from 88 in 2005 to 163 in 2014; the average length of stay decreased from 21 in 2005 to 10 in 2014; the total cases of transfusion were 22 from 2005 to 2014; the safety, stability and feasibility of the innovated technologies and products were illustrated through the decrease of average length of stay, the reduction of bleeding and the significance of outcomes. It is illustrated that the innovated technologies and products not only decrease patients' suffering and medical costs but also are safe, stable and feasible.

Handbook of materials for medical devices

National Research Council Canada - National Science Library

Davis, J. R

2003-01-01

... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii Introduction Chapter 1 Overview of Biomaterials and Their Use in Medical Devices . . . . . . . . . . . . . . . . 1 Uses for Biomaterials...

TU-E-BRD-01: President’s Symposium: The Necessity of Innovation in Medical Physics

Energy Technology Data Exchange (ETDEWEB)

Bayouth, J [University of Wisconsin, Madison, WI (United States); Siewerdsen, J [Johns Hopkins University, Baltimore, MD (United States); Wahl, E [Premiere Speakers Bureau, Franklin, TN (United States)

2014-06-15

This abstract will not blow you away, but speed-painting presenter Erik Wahl will certainly make a truly unique AAPM symposium that you will not want to miss. Along with clinical director John Bayouth and scientific leader Jeff Siewerdsen, this session will highlight innovation. To avoid being button pushers and irrelevant investigators of yesterday’s science, we must innovate. This is particularly challenging in the changing landscape of declining research funding and healthcare reimbursement. But all hope is not lost, Medical Physics is a field born out of innovation. As scientists we quickly translated the man-made and natural phenomena of radiation into a tool that could diagnose broken bones, locate foreign objects imbedded within the body, and treat a spectrum of diseases. As hyperbolae surrounding the curative powers of radiation overcame society, physicists continued their systematic pursuit of a fundamental understanding of radiation and applied their knowledge to enable the diagnostic and therapeutic power of this new tool. Health economics and the decline in research funding have put the Medical Physicist in a precarious position: how do we optimally participate in medical research and advanced patient care in the face of many competing needs? Today's diagnostic imaging and therapeutic approaches are tremendously sophisticated. Researchers and commercial vendors are producing technologies at a remarkable rate; to enable their safe and effective implementation Medical Physicists must work from a fundamental understanding of these technologies. This requires all of us, clinically practicing Medical Physicists, Researchers and Educators alike, to combine our training in scientific methods with innovation. Innovation is the key to our past, a necessity for our contemporary challenges, and critical for the future of Medical Physics. The keynote speakers for the 2014 AAPM Presidential Symposium session will address the way we approach these vitally

TU-E-BRD-01: President’s Symposium: The Necessity of Innovation in Medical Physics

International Nuclear Information System (INIS)

Bayouth, J; Siewerdsen, J; Wahl, E

2014-01-01

This abstract will not blow you away, but speed-painting presenter Erik Wahl will certainly make a truly unique AAPM symposium that you will not want to miss. Along with clinical director John Bayouth and scientific leader Jeff Siewerdsen, this session will highlight innovation. To avoid being button pushers and irrelevant investigators of yesterday’s science, we must innovate. This is particularly challenging in the changing landscape of declining research funding and healthcare reimbursement. But all hope is not lost, Medical Physics is a field born out of innovation. As scientists we quickly translated the man-made and natural phenomena of radiation into a tool that could diagnose broken bones, locate foreign objects imbedded within the body, and treat a spectrum of diseases. As hyperbolae surrounding the curative powers of radiation overcame society, physicists continued their systematic pursuit of a fundamental understanding of radiation and applied their knowledge to enable the diagnostic and therapeutic power of this new tool. Health economics and the decline in research funding have put the Medical Physicist in a precarious position: how do we optimally participate in medical research and advanced patient care in the face of many competing needs? Today's diagnostic imaging and therapeutic approaches are tremendously sophisticated. Researchers and commercial vendors are producing technologies at a remarkable rate; to enable their safe and effective implementation Medical Physicists must work from a fundamental understanding of these technologies. This requires all of us, clinically practicing Medical Physicists, Researchers and Educators alike, to combine our training in scientific methods with innovation. Innovation is the key to our past, a necessity for our contemporary challenges, and critical for the future of Medical Physics. The keynote speakers for the 2014 AAPM Presidential Symposium session will address the way we approach these vitally

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.

Results from an exploratory study to identify the factors that contribute to success for UK medical device small- and medium-sized enterprises.

Science.gov (United States)

Hourd, P C; Williams, D J

2008-07-01

This paper reports the results from an exploratory study that sets out to identify and compare the strategic approaches and patterns of business practice employed by 14 UK small- and medium-sized enterprises to achieve success in the medical device sector of the health-care industry. An interview-based survey was used to construct individual case studies of the medical device technology (MDT) companies. A cross-case analysis was performed to search for patterns and themes that cut across these individual cases. Exploratory results revealed the heterogeneity of MDT companies and the distinctive features of the MDT innovation process that emphasize the importance of a strategic approach for achieving milestones in the product development and exploitation process and for creating value for the company and its stakeholders. Recognizing the heterogeneity of MDT companies, these exploratory findings call for further investigation to understand better the influence of components of the MDT innovation process on the commercialization life cycle and value trajectory. This is required to assist start-up or spin-out MDT companies in the UK and worldwide to navigate the critical transitions that determine access to financial and consumer markets and enhance the potential to build a successful business. This will be important not only for bioscience-based companies but also for engineering-based companies aiming to convert their activities into medical devices and the health- and social-care market.

BIOANALYTICAL STANDARDIZING FOR SEROLOGICAL DIAGNOSTIC MEDICAL DEVICES

OpenAIRE

A. Yu. Galkin; A. G. Komar; A. A. Grigorenko

2015-01-01

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...

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

Science.gov (United States)

2010-10-05

...] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice... announcing an amendment to the notice of meeting of the General and Plastic Surgery Devices Panel of the..., FDA announced that a meeting of the General and Plastic Surgery Devices Panel of the Medical Devices...

The new innovative medical education system in Ethiopia ...

African Journals Online (AJOL)

User

Background: A New Innovative Medical Education Initiative (NIMEI) had been launched in Ethiopia in February ... development as well as for the overall health system of the country. .... A national survey was conducted in all regions of Ethiopia.

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.

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

Science.gov (United States)

2010-08-06

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of... General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee scheduled for August...

Fiber-optic Fourier transform infrared spectroscopy for remote label-free sensing of medical device surface contamination

Science.gov (United States)

Hassan, Moinuddin; Tan, Xin; Welle, Elissa; Ilev, Ilko

2013-05-01

As a potential major source of biochemical contamination, medical device surfaces are of critical safety concerns in the clinical practice and public health. The development of innovative sensing methods for accurate and real-time detection of medical device surface contamination is essential to protect patients from high risk infection. In this paper, we demonstrate an alternative fiber-optic Fourier Transform Infrared (FTIR) spectroscopy based sensing approach for remote, non-contact, and label-free detection of biochemical contaminants in the mid-infrared (mid-IR) region. The sensing probe is designed using mid-IR hollow fibers and FTIR measurements are carried out in reflection mode. Bovine Serum Albumin (BSA) and bacterial endotoxin of different concentrations under thoroughly dry condition are used to evaluate the detection sensitivity. The devised system can identify ≤0.0025% (≤4 × 1011 molecules) BSA and 0.5% (0.5 EU/ml) endotoxin concentration. The developed sensing approach may be applied to detect various pathogens that pose public health threats.

And the winners were... Innovation Awards

CERN Multimedia

2003-01-01

The winners of the 2003 Economist innovation awards included Tim Berners-Lee for the WWW and Dr. Damadian for his suggestion that NMR could be used as a medical detection device for cancer (1/2 page).

[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.

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

Science.gov (United States)

2013-03-18

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

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

Science.gov (United States)

2012-04-05

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

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

Science.gov (United States)

2011-03-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

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

Science.gov (United States)

2011-10-07

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

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

Science.gov (United States)

2010-08-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

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

Science.gov (United States)

2013-05-23

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

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

Science.gov (United States)

2011-07-07

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0478] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

Design considerations for medical devices in the home environment.

Science.gov (United States)

Kaufman-Rivi, Diana; Collins-Mitchell, Janette; Jetley, Raoul

2010-01-01

Patient demographics, economic forces, and technological advancements contribute to the rise in home care services. Advanced medical devices and equipment originally designed for use by trained personnel in hospitals and clinics are increasingly migrating into the home. Unlike the clinical setting, the home is an uncontrolled environment with additional hazards. The compatibility of the device with the recipient's knowledge, abilities, lifestyle, and home environment plays a significant role in their therapy and rehabilitation. The advent of new device technologies such as wireless devices and interoperability of systems lends a new and complex perspective for medical device use in the home that must also be addressed. Adequately assessing and matching the patient and their caregiver with the appropriate device technology while considering the suitability of the home environment for device operation and maintenance is a challenge that relies on good human factors principles. There is a need to address these challenges in the growing home care sector In this article, the authors take a look at some important considerations and design issues for medical devices used in the home care environment.

Innovative postmarket device evaluation using a quality registry to monitor thoracic endovascular aortic repair in the treatment of aortic dissection.

Science.gov (United States)

Beck, Adam W; Lombardi, Joseph V; Abel, Dorothy B; Morales, J Pablo; Marinac-Dabic, Danica; Wang, Grace; Azizzadeh, Ali; Kern, John; Fillinger, Mark; White, Rodney; Cronenwett, Jack L; Cambria, Richard P

2017-05-01

United States Food and Drug Administration (FDA)-mandated postapproval studies have long been a mainstay of the continued evaluation of high-risk medical devices after initial marketing approval; however, these studies often present challenges related to patient/physician recruitment and retention. Retrospective single-center studies also do not fully represent the spectrum of real-world performance nor are they likely to have a sufficiently large enough sample size to detect important signals. In recent years, The FDA Center for Devices and Radiological Health has been promoting the development and use of patient registries to advance infrastructure and methodologies for medical device investigation. The FDA 2012 document, "Strengthening the National System for Medical Device Post-market Surveillance," highlighted registries as a core foundational infrastructure when linked to other complementary data sources, including embedded unique device identification. The Vascular Quality Initiative (VQI) thoracic endovascular aortic repair for type B aortic dissection project is an innovative method of using quality improvement registries to meet the needs of device evaluation after market approval. Here we report the organization and background of this project and highlight the innovation facilitated by collaboration of physicians, the FDA, and device manufacturers. This effort used an existing national network of VQI participants to capture patients undergoing thoracic endovascular aortic repair for acute type B aortic dissection within a registry that aligns with standard practice and existing quality efforts. The VQI captures detailed patient, device, and procedural data for consecutive eligible cases under the auspices of a Patient Safety Organization (PSO). Patients were divided into a 5-year follow-up group (200 acute; 200 chronic dissections) and a 1-year follow-up group (100 acute; 100 chronic). The 5-year cohort required additional imaging details, and the 1-year

[Embracing medical innovation in the era of big data].

Science.gov (United States)

You, Suning

2015-01-01

Along with the advent of big data era worldwide, medical field has to place itself in it inevitably. The current article thoroughly introduces the basic knowledge of big data, and points out the coexistence of its advantages and disadvantages. Although the innovations in medical field are struggling, the current medical pattern will be changed fundamentally by big data. The article also shows quick change of relevant analysis in big data era, depicts a good intention of digital medical, and proposes some wise advices to surgeons.

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.

MedMon: securing medical devices through wireless monitoring and anomaly detection.

Science.gov (United States)

Zhang, Meng; Raghunathan, Anand; Jha, Niraj K

2013-12-01

Rapid advances in personal healthcare systems based on implantable and wearable medical devices promise to greatly improve the quality of diagnosis and treatment for a range of medical conditions. However, the increasing programmability and wireless connectivity of medical devices also open up opportunities for malicious attackers. Unfortunately, implantable/wearable medical devices come with extreme size and power constraints, and unique usage models, making it infeasible to simply borrow conventional security solutions such as cryptography. We propose a general framework for securing medical devices based on wireless channel monitoring and anomaly detection. Our proposal is based on a medical security monitor (MedMon) that snoops on all the radio-frequency wireless communications to/from medical devices and uses multi-layered anomaly detection to identify potentially malicious transactions. Upon detection of a malicious transaction, MedMon takes appropriate response actions, which could range from passive (notifying the user) to active (jamming the packets so that they do not reach the medical device). A key benefit of MedMon is that it is applicable to existing medical devices that are in use by patients, with no hardware or software modifications to them. Consequently, it also leads to zero power overheads on these devices. We demonstrate the feasibility of our proposal by developing a prototype implementation for an insulin delivery system using off-the-shelf components (USRP software-defined radio). We evaluate its effectiveness under several attack scenarios. Our results show that MedMon can detect virtually all naive attacks and a large fraction of more sophisticated attacks, suggesting that it is an effective approach to enhancing the security of medical devices.

Risk evaluation of medical and industrial radiation devices

International Nuclear Information System (INIS)

Jones, E.D.; Cunningham, R.E.; Rathbun, P.A.

1994-03-01

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

Fueling innovation in medical devices (and beyond): venture capital in health care.

Science.gov (United States)

Ackerly, D Clay; Valverde, Ana M; Diener, Lawrence W; Dossary, Kristin L; Schulman, Kevin A

2009-01-01

Innovation in health care requires new ideas and the capital to develop and commercialize those ideas into products or services. The necessary capital is often "venture capital," but the link between public policy and the venture capital industry has not been well examined. In this paper we explore the link between venture capital and innovation in health care, and we present new descriptive data from a survey of health care venture capital fund managers. Respondents generally viewed policy levers (for example, reimbursement and regulations) as important risks to venture capital investments, potentially affecting their ability to raise capital for early-stage investment funds.

Innovations in higher medical education

Directory of Open Access Journals (Sweden)

Popkov V.M.

2014-03-01

Full Text Available The article is devoted to the innovations in the higher medical education. Particular attention in this sphere is paid to the detailed analysis of the subject as a mechanism of cognition and psycho-emotional aspect. It should be noticed that the development of the university education demands the integration of functional systems to study the general medicine and the art of healing. In conclusion it has been found out that the new methodological approach is necessary to bring the teacher closer to the subject particularly to integrate the relation of the opposites.

Medical Devices; Neurological Devices; Classification of the External Vagal Nerve Stimulator for Headache. Final order.

Science.gov (United States)

2017-12-27

The Food and Drug Administration (FDA or we) is classifying the external vagal nerve stimulator for headache into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the external vagal nerve stimulator for headache's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Medical instruments and devices principles and practices

CERN Document Server

Schreiner, Steven; Peterson, Donald R

2015-01-01

Medical Instruments and Devices: Principles and Practices originates from the medical instruments and devices section of The Biomedical Engineering Handbook, Fourth Edition. Top experts in the field provide material that spans this wide field. The text examines how biopotential amplifiers help regulate the quality and content of measured signals. It includes instruments and devices that span a range of physiological systems and the physiological scale: molecular, cellular, organ, and system. The book chronicles the evolution of pacemakers and their system operation and discusses oscillometry, cardiac output measurement, and the direct and indirect methods of measuring cardiac output. The authors also expound on the mechanics and safety of defibrillators and cover implantable stimulators, respiration, and the structure and function of mechanical ventilators. In addition, this text covers in depth: Anesthesia Delivery Electrosurgical Units and Devices Biomedical Lasers Measuring Cellular Traction Forces Blood G...

Instructions included? Make safety training part of medical device procurement process.

Science.gov (United States)

Keller, James P

2010-04-01

Before hospitals embrace new technologies, it's important that medical personnel agree on how best to use them. Likewise, hospitals must provide the support to operate these sophisticated devices safely. With this in mind, it's wise for hospitals to include medical device training in the procurement process. Moreover, purchasing professionals can play a key role in helping to increase the amount of user training for medical devices and systems. What steps should you take to help ensure that new medical devices are implemented safely? Here are some tips.

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

Science.gov (United States)

2012-03-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2012-N-0165] Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus... AND MICROBIOLOGY DEVICES 0 1. The authority citation for 21 CFR part 866 continues to read as follows...

Guiding principles for successful innovation in regional medical education development.

Science.gov (United States)

Hays, Richard B

2006-01-01

This is an era of extraordinary expansion in medical education in both the developed and developing world. This article reflects on the author's experience in implementing new regional medical education programs, and distils ten principles to guide successful innovation once funding for such development has been achieved.

Preliminary results on an innovative plasmonic device for macromolecules analysis and sequencing

KAUST Repository

Francardi, Marco; Candeloro, Patrizio; Malara, Natalia Maria; Gentile, Francesco T.; Coluccio, Maria Laura; Perozziello, Gerardo; Gaggero, Aleesandro; De Angelis, Francesco De; Cherubini, Enrico; Di Fabrizio, Enzo M.

2013-01-01

In this work we present the fabrication and theoretical simulation for a new device constituted by a on Substrate Plasmonic Antenna (SPA) combined with a bio-functionalized Atomic Force Microscopy (AFM) cantilever. This device could represent a new strategy to sequence and analyze a single protein or DNA. The idea is to use an SPA composed of an innovative "wedding cake"shaped grating (WCG), in order to excite a Surface Plasmon Polariton (SPP) mode, and a 30-tilted Plasmonic Antenna (PA), able to compress adiabatically the SPP until the tip. The Plasmonic device is placed inside an electrical contact that could be used to unfold protein molecules or DNA. A bio-functionalized AFM tip can be used to fish a single biological element and for alignment with the SPA. Then the unfolded element could be scanned close to the PA and a Tip Enhanced Raman Signal (TERS) can be recorded from the biomolecule. The spatial resolution is limited by the size of the radius of curvature of the antenna, which in this work is about 15 nm, while the vertical scanning is controlled by the piezoelectric of the AFM set up. In this work we demonstrate the possibility to fabricate this innovative plasmonic device and we report FDTD simulations of the innovative WCG. The FDTD simulations show the generation of a plasmonic mode that, coupled with the antenna, give rise to an adiabatic compression which produce an increase of the electric field of about 40 times. © 2013 Elsevier B.V. All rights reserved.

Preliminary results on an innovative plasmonic device for macromolecules analysis and sequencing

KAUST Repository

Francardi, Marco

2013-11-01

In this work we present the fabrication and theoretical simulation for a new device constituted by a on Substrate Plasmonic Antenna (SPA) combined with a bio-functionalized Atomic Force Microscopy (AFM) cantilever. This device could represent a new strategy to sequence and analyze a single protein or DNA. The idea is to use an SPA composed of an innovative "wedding cake"shaped grating (WCG), in order to excite a Surface Plasmon Polariton (SPP) mode, and a 30-tilted Plasmonic Antenna (PA), able to compress adiabatically the SPP until the tip. The Plasmonic device is placed inside an electrical contact that could be used to unfold protein molecules or DNA. A bio-functionalized AFM tip can be used to fish a single biological element and for alignment with the SPA. Then the unfolded element could be scanned close to the PA and a Tip Enhanced Raman Signal (TERS) can be recorded from the biomolecule. The spatial resolution is limited by the size of the radius of curvature of the antenna, which in this work is about 15 nm, while the vertical scanning is controlled by the piezoelectric of the AFM set up. In this work we demonstrate the possibility to fabricate this innovative plasmonic device and we report FDTD simulations of the innovative WCG. The FDTD simulations show the generation of a plasmonic mode that, coupled with the antenna, give rise to an adiabatic compression which produce an increase of the electric field of about 40 times. © 2013 Elsevier B.V. All rights reserved.

Innovation of High Voltage Supply Adjustment Device on Diagnostic X-Ray Machine

International Nuclear Information System (INIS)

Sujatno; Wiranto Budi Santoso

2010-01-01

Innovation of high voltage supply adjustment device on diagnostic x-ray machine has been carried out. The innovation is conducted by utilizing an electronic circuit as a high voltage adjustment device. Usually a diagnostic x-ray machine utilizes a transformer or an auto-transformer as a high voltage supply adjustment device. A high power diagnostic x-ray machine needs a high power transformer which has big physical dimension. Therefore a box control where the transformer is located has to have big physical dimension. Besides, the price of the transformer is expensive and hardly found in local markets. In this innovation, the transformer is replaced by an electronic circuit. The main component of the electronic circuit is Triac BTA-40. As adjustment device, the triac is controlled by a variable resistor which is coupled by a stepper motor. A step movement of stepper motor varies a value of resistor. The resistor value determines the triac gate voltage. Furthermore the triac will open according to the value of electrical current flowing to the gate. When the gate is open, electrical voltage and current will flow from cathode to anode of the triac. The value of these electrical voltage and current depend on gate open condition. Then this triac output voltage is feed to diagnostic x-ray machine high voltage supply. Therefore the high voltage value of diagnostic x-ray machine is adjusted by the output voltage of the electronic circuit. By using this electronic circuit, the physical dimension of diagnostic x-ray machine box control and the price of the equipment can be reduced. (author)

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

INTERFACE ELECTRONIC MEDICAL CARD ON MOBILE DEVICE

Directory of Open Access Journals (Sweden)

Y. L. Nechyporenko

2013-05-01

Full Text Available The concept designed by electronic medical card for heterogeneous environment of medical information systems at various levels. Appropriate model and technical solution. Done evaluating operating systems for mobile devices. Designed and produced by the project mobile application on Android OS as an electronic medical record on a Tablet PC Acer.

Growing pains: medical device interoperability. Regulators and new standards are helping to bring about the convergence of medical devices and information management systems on IT networks.

Science.gov (United States)

Degaspari, John

2011-07-01

Both provider organizations and medical device vendors have made significant, if slow-going, progress over the last several years to network their digitally-enabled medical devices. Recent strides in both the regulatory and standards arenas have provided renewed impetus on the part of both stakeholder groups to bring more interoperability to disparate medical devices, resulting in better security and quality of patient data.

Lessons from innovation in drug-device combination products.

Science.gov (United States)

Couto, Daniela S; Perez-Breva, Luis; Saraiva, Pedro; Cooney, Charles L

2012-01-01

Drug-device combination products introduced a new dynamic on medical product development, regulatory approval, and corporate interaction that provide valuable lessons for the development of new generations of combination products. This paper examines the case studies of drug-eluting stents and transdermal patches to facilitate a detailed understanding of the challenges and opportunities introduced by combination products when compared to previous generations of traditional medical or drug delivery devices. Our analysis indicates that the largest barrier to introduce a new kind of combination products is the determination of the regulatory center that is to oversee its approval. The first product of a new class of combination products offers a learning opportunity for the regulator and the sponsor. Once that first product is approved, the leading regulatory center is determined, and the uncertainty about the entire class of combination products is drastically reduced. The sponsor pioneering a new class of combination products assumes a central role in reducing this uncertainty by advising the decision on the primary function of the combination product. Our analysis also suggests that this decision influences the nature (pharmaceutical, biotechnology, or medical devices) of the companies that will lead the introduction of these products into the market, and guide the structure of corporate interaction thereon. Copyright © 2011 Elsevier B.V. All rights reserved.

78 FR 18233 - Medical Devices; Technical Amendment

Science.gov (United States)

2013-03-26

... human environment. Therefore, neither an environmental assessment nor an environmental impact statement..., Confidential business information, Medical devices, Medical research, Reporting and recordkeeping requirements... revising the second sentence in paragraph (a) to read as follows: Sec. 870.3600 External pacemaker pulse...

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

Science.gov (United States)

2011-10-20

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee: Notice of... Administration (FDA) is postponing the meeting of the General and Plastic Surgery Devices Panel of the Medical...

Organizing NPD networks for high innovation performance: the case of Dutch medical devices SMEs

NARCIS (Netherlands)

Pullen, A.J.J.; Groen, Arend J.; de Weerd-Nederhof, Petronella C.; Fisscher, O.A.M.

2010-01-01

This research examines which combination of network characteristics (the network configuration) leads to high innovation performance for small and medium sized companies (SMEs). Even though research has paid significant attention to the relation between the external network and the innovation

Prospects of radiation sterilization of medical devices

International Nuclear Information System (INIS)

Hosobuchi, Kazunari

1992-01-01

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

Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Organophosphate Test System. Final order.

Science.gov (United States)

2017-10-18

The Food and Drug Administration (FDA or we) is classifying the organophosphate test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the organophosphate test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Medical Devices; Hematology and Pathology Devices; Classification of a Cervical Intraepithelial Neoplasia Test System. Final order.

Science.gov (United States)

2018-01-03

The Food and Drug Administration (FDA or we) is classifying the cervical intraepithelial neoplasia (CIN) test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the CIN test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Medical device innovation and the value analysis process.

Science.gov (United States)

Krantz, Heidi; Strain, Barbara; Torzewski, Jane

2017-09-01

Heidi A. Krantz, RN, BSN is the Director of Value Analysis at Johns Hopkins Bayview Medical Center in the Johns Hopkins Health System. Barbara Strain, MA, CVAHP is the Director of Value Management at the University of Virginia Health System. Jane Torzewski RN, MAN, MBA is a Senior Category Manager for the Mayo Clinic Physician Preference Contracting team. She previously was a Senior Clinical Value Analyst on the Mayo Clinic Value Analysis team. Copyright © 2018. Published by Elsevier Inc.

Assurance Cases for Medical Devices

Science.gov (United States)

2011-04-28

the patient, and the hospital setting. Some pumps allow the patient to control part of the injection process (e.g. to inject more painkiller ...overdose, incorrect therapy, etc.   Design and development decisions that bear on safety and effectiveness http://www.fda.gov/MedicalDevices

Electronic medical devices: a primer for pathologists.

Science.gov (United States)

Weitzman, James B

2003-07-01

Electronic medical devices (EMDs) with downloadable memories, such as implantable cardiac pacemakers, defibrillators, drug pumps, insulin pumps, and glucose monitors, are now an integral part of routine medical practice in the United States, and functional organ replacements, such as the artificial heart, pancreas, and retina, will most likely become commonplace in the near future. Often, EMDs end up in the hands of the pathologist as a surgical specimen or at autopsy. No established guidelines for systematic examination and reporting or comprehensive reviews of EMDs currently exist for the pathologist. To provide pathologists with a general overview of EMDs, including a brief history; epidemiology; essential technical aspects, indications, contraindications, and complications of selected devices; potential applications in pathology; relevant government regulations; and suggested examination and reporting guidelines. Articles indexed on PubMed of the National Library of Medicine, various medical and history of medicine textbooks, US Food and Drug Administration publications and product information, and specifications provided by device manufacturers. Studies were selected on the basis of relevance to the study objectives. Descriptive data were selected by the author. Suggested examination and reporting guidelines for EMDs received as surgical specimens and retrieved at autopsy. Electronic medical devices received as surgical specimens and retrieved at autopsy are increasing in number and level of sophistication. They should be systematically examined and reported, should have electronic memories downloaded when indicated, will help pathologists answer more questions with greater certainty, and should become an integral part of the formal knowledge base, research focus, training, and practice of pathology.

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.

Curriculum reform and evolution: Innovative content and processes at one US medical school.

Science.gov (United States)

Fischel, Janet E; Olvet, Doreen M; Iuli, Richard J; Lu, Wei-Hsin; Chandran, Latha

2018-03-11

Curriculum reform in medical schools continues to be an ever-present and challenging activity in medical education. This paper describes one school's experiences with specific curricular innovations that were developed or adapted and targeted to meet a clear set of curricular goals during the curriculum reform process. Those goals included: (a) promoting active learning and learner engagement; (b) establishing early professional identity; and (c) developing physician competencies in an integrated and contextual manner while allowing for individualized learning experiences for the millennial student. Six specific innovations championed by the school are described in detail. These included Themes in Medical Education, Translational Pillars, Stony Brook Teaching Families, Transition Courses, Educational Continuous Quality Improvement Processes, and our Career Advising Program. Development of the ideas and design of the innovations were done by faculty and student teams. We discuss successes and ongoing challenges with these innovations which are currently in the fourth year of implementation. Our curriculum reform has emphasized the iterative process of curriculum building. Based on our experience, we discuss general and practical guidelines for curriculum innovation in its three phases: setting the stage, implementation, and monitoring for the achievement of intended goals.

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.

78 FR 12329 - Distinguishing Medical Device Recalls From Product Enhancements; Reporting Requirements; Draft...

Science.gov (United States)

2013-02-22

... medical devices to take timely action to correct violative devices or remove them from the marketplace...] Distinguishing Medical Device Recalls From Product Enhancements; Reporting Requirements; Draft Guidance for... draft guidance entitled ``Distinguishing Medical Device Recalls From Product Enhancements; Reporting...

[Thoughts on the Witnessed Audit in Medical Device Single Audit Program].

Science.gov (United States)

Wen, Jing; Xiao, Jiangyi; Wang, Aijun

2018-02-08

Medical Device Single Audit Program is one of the key projects in International Medical Device Regulators Forum, which has much experience to be used for reference. This paper briefly describes the procedures and contents of the Witnessed Audit in Medical Device Single Audit Program. Some revelations about the work of Witnessed Audit have been discussed, for reference by the Regulatory Authorities and the Auditing Organizations.

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

Science.gov (United States)

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

2007-04-01

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

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

Science.gov (United States)

2010-11-05

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 892 [Docket No. FDA-2008-N-0273] Medical Devices; Radiology Devices; Reclassification of Full- Field Digital... and Drugs, 21 CFR part 892 is amended as follows: PART 892--RADIOLOGY DEVICES 0 1. The authority...

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

Science.gov (United States)

Blessing, Melissa M; Lin, Peter T

2018-05-01

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.

MEDIC: medical embedded device for individualized care.

Science.gov (United States)

Wu, Winston H; Bui, Alex A T; Batalin, Maxim A; Au, Lawrence K; Binney, Jonathan D; Kaiser, William J

2008-02-01

Presented work highlights the development and initial validation of a medical embedded device for individualized care (MEDIC), which is based on a novel software architecture, enabling sensor management and disease prediction capabilities, and commercially available microelectronic components, sensors and conventional personal digital assistant (PDA) (or a cell phone). In this paper, we present a general architecture for a wearable sensor system that can be customized to an individual patient's needs. This architecture is based on embedded artificial intelligence that permits autonomous operation, sensor management and inference, and may be applied to a general purpose wearable medical diagnostics. A prototype of the system has been developed based on a standard PDA and wireless sensor nodes equipped with commercially available Bluetooth radio components, permitting real-time streaming of high-bandwidth data from various physiological and contextual sensors. We also present the results of abnormal gait diagnosis using the complete system from our evaluation, and illustrate how the wearable system and its operation can be remotely configured and managed by either enterprise systems or medical personnel at centralized locations. By using commercially available hardware components and software architecture presented in this paper, the MEDIC system can be rapidly configured, providing medical researchers with broadband sensor data from remote patients and platform access to best adapt operation for diagnostic operation objectives.

Medical applications for pharmacists using mobile devices.

Science.gov (United States)

Aungst, Timothy Dy

2013-01-01

Mobile devices (eg, smartphones, tablet computers) have become ubiquitous and subsequently there has been a growth in mobile applications (apps). Concurrently, mobile devices have been integrated into health care practice due to the availability and quality of medical apps. These mobile medical apps offer increased access to clinical references and point-of-care tools. However, there has been little identification of mobile medical apps suitable for the practice of pharmacy. To address the shortage of recommendations of mobile medical apps for pharmacists in daily practice. Mobile medical apps were identified via the iTunes and Google Play Stores via the "Medical" app categories and key word searches (eg, drug information, medical calculators). In addition, reviews provided by professional mobile medical app review websites were used to identify apps. Mobile medical apps were included if they had been updated in the previous 3 months, were available in the US, used evidence-based information or literature support, had dedicated app support, and demonstrated stability. Exclusion criteria included apps that were not available in English, had advertisement bias, used nonreferenced sources, were available only via an institution-only subscription, and were web-based portals. Twenty-seven mobile apps were identified and reviewed that involved general pharmacy practice, including apps that involved drug references, clinical references, medical calculators, laboratory references, news and continuing medical education, and productivity. Mobile medical apps have a variety of features that are beneficial to pharmacy practice. Individual clinicians should consider several characteristics of these apps to determine which are suitable to incorporate into their daily practice.

Developing medical device software in compliance with regulations.

Science.gov (United States)

Zema, M; Rosati, S; Gioia, V; Knaflitz, M; Balestra, G

2015-08-01

In the last decade, the use of information technology (IT) in healthcare has taken a growing role. In fact, the adoption of an increasing number of computer tools has led to several benefits related to the process of patient care and allowed easier access to social and health care resources. At the same time this trend gave rise to new challenges related to the implementation of these new technologies. Software used in healthcare can be classified as medical devices depending on the way they are used and on their functional characteristics. If they are classified as medical devices they must satisfy specific regulations. The aim of this work is to present a software development framework that can allow the production of safe and high quality medical device software and to highlight the correspondence between each software development phase and the appropriate standard and/or regulation.

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

Science.gov (United States)

2010-04-01

....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”. ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices for processing, repacking, or...

Handheld Diagnostic Device Delivers Quick Medical Readings

Science.gov (United States)

2014-01-01

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

Medical device problem reporting for the betterment of healthcare.

Science.gov (United States)

1998-08-01

Given that there are nearly 5,000 individual classes of medical devices, tens of thousands of medical device suppliers, and millions of healthcare providers around the world, device-related problems are bound to happen. But effective problem reporting can help reduce or eliminate many of these problems--not only within an institution, but also potentially around the world. In this article, we trace the problem reporting process from its beginnings in the hospital to its global impact in making critical information available throughout the healthcare community.

Medical technology in Japan the politics of regulation

CERN Document Server

Altenstetter, Christa

2014-01-01

Compared to its American and European counterparts, Japan lags in adopting innovative medical devices and making new treatments and procedures available. Christa Altenstetter examines the contextual conditions of Japan's medical profession and its regulatory framework. Altenstetter looks into how physicians and device companies connect to the government and bureaucracy, the relationships connecting Japanese patients to their medical system and governmental bureaucracy, and how relationships between policymakers and the medical profession are changing.

Home Healthcare Medical Devices: A Checklist

Science.gov (United States)

... not using it. Contact your doctor and home healthcare team often to review your health condition. * Check ... assurance of their safety and effectiveness. A home healthcare medical device is any product or equipment used ...

Review of early assessment models of innovative medical technologies

DEFF Research Database (Denmark)

Fasterholdt, Iben; Krahn, Murray D; Kidholm, Kristian

2017-01-01

INTRODUCTION: Hospitals increasingly make decisions regarding the early development of and investment in technologies, but a formal evaluation model for assisting hospitals early on in assessing the potential of innovative medical technologies is lacking. This article provides an overview of models...

Radiation sterilization of medical devices

International Nuclear Information System (INIS)

Kaluska, I.; Stuglik, Z.

1996-01-01

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

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

Science.gov (United States)

2012-04-02

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2012-N-0165] Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus Serological Reagents; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; correction...

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.

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.

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

Science.gov (United States)

2017-10-01

Award Number: W81XWH-09-1-0705 TITLE: “Medical Device Plug-and-Play Interoperability Standards and Technology Leadership” PRINCIPAL INVESTIGATOR...Sept 2016 – 20 Sept 2017 4. TITLE AND SUBTITLE “Medical Device Plug-and-Play Interoperability 5a. CONTRACT NUMBER Standards and Technology ...efficiency through interoperable medical technologies . We played a leadership role on interoperability safety standards (AAMI, AAMI/UL Joint

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.

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.

Cybersecurity and medical devices: A practical guide for cardiac electrophysiologists

Science.gov (United States)

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

2017-01-01

Abstract Medical devices increasingly depend on software. While this expands the ability of devices to perform key therapeutic and diagnostic functions, reliance on software inevitably causes exposure to hazards of security vulnerabilities. This article uses a recent high‐profile case example to outline a proactive approach to security awareness that incorporates a scientific, risk‐based analysis of security concerns that supports ongoing discussions with patients about their medical devices. PMID:28512774

Medical device registration, agreements on mutual recognition - a step forward to global harmonization?

International Nuclear Information System (INIS)

Eidenberger, R.Reiner

2000-01-01

The purpose of this article is to give a short overview of some different regulations in Europe and the United States with regard to the clearance of medical devices and to give an outlook of what the Agreements on Mutual Recognition will bring in terms of Global Harmonization. Recent European legislation, the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (Medical Device Directive, MDD), requires that all medical devices placed on the European market bear the CE marking. From 14 June 1998, medical devices fall under the scope of this European Medical Device Directive and there is a harmonization within the European market. Similar to this, but for another market, are the USA FDA requirements, Premarket Approval (PMA) and Premarket notification (510(k)). The same medical device, the same goal - a safe product - but different legislation and thus duplication of registration procedures. The European Commission is presently discussing a series of agreements with third countries, Australia, New Zealand, USA, Canada, Japan and Eastern European countries wishing to join the EU, concerning the mutual acceptance of inspection bodies and, ultimately, proof of conformity (for example reports on examination, certificates, licenses and marks of conformity) in connection with medical devices. Meanwhile agreements with Australia, New Zealand, USA and Canada came into force. (author)

77 FR 4252 - Additional Spectrum for the Medical Device Radiocommunication Service

Science.gov (United States)

2012-01-27

... licensed users in these frequency bands to continue providing service. Medical Micro-Power Networks (MMNs...). Under this approach, medical devices would operate in the band on a shared, non-exclusive basis with...Radio Service rules for devices operating in the 413-457 MHz band. These definitions were for a Medical...

Optical tests for using smartphones inside medical devices

Science.gov (United States)

Bernat, Amir S.; Acobas, Jennifer K.; Phang, Ye Shang; Hassan, David; Bolton, Frank J.; Levitz, David

2018-02-01

Smartphones are currently used in many medical applications and are more frequently being integrated into medical imaging devices. The regulatory requirements in existence today however, particularly the standardization of smartphone imaging through validation and verification testing, only partially cover imaging characteristics with a smartphone. Specifically, it has been shown that smartphone camera specifications are of sufficient quality for medical imaging, and there are devices which comply with the FDA's regulatory requirements for a medical device such as a device's field of view, direction of viewing and optical resolution and optical distortion. However, these regulatory requirements do not call specifically for color testing. Images of the same object using automatic settings or different light sources can show different color composition. Experimental results showing such differences are presented. Under some circumstances, such differences in color composition could potentially lead to incorrect diagnoses. It is therefore critical to control the smartphone camera and illumination parameters properly. This paper examines different smartphone camera settings that affect image quality and color composition. To test and select the correct settings, a test methodology is proposed. It aims at evaluating and testing image color correctness and white balance settings for mobile phones and LED light sources. Emphasis is placed on color consistency and deviation from gray values, specifically by evaluating the ΔC values based on the CIEL*a*b* color space. Results show that such standardization minimizes differences in color composition and thus could reduce the risk of a wrong diagnosis.

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

Science.gov (United States)

Gittard, Shaun D; Narayan, Roger J

2010-01-01

Laser-based direct writing of materials has undergone significant development in recent years. The ability to modify a variety of materials at small length scales and using short production times provides laser direct writing with unique capabilities for fabrication of medical devices. In many laser-based rapid prototyping methods, microscale and submicroscale structuring of materials is controlled by computer-generated models. Various laser-based direct write methods, including selective laser sintering/melting, laser machining, matrix-assisted pulsed-laser evaporation direct write, stereolithography and two-photon polymerization, are described. Their use in fabrication of microstructured and nanostructured medical devices is discussed. Laser direct writing may be used for processing a wide variety of advanced medical devices, including patient-specific prostheses, drug delivery devices, biosensors, stents and tissue-engineering scaffolds. PMID:20420557

Topological interface states and effects for next generation of innovative devices

International Nuclear Information System (INIS)

Kantser, Valeriu; Carlig, Sergiu

2013-01-01

Topological insulators (TI) have opened a gateway to search new quantum electronic phase of the condensed matter as well as to pave new platform of modern technology. This stems mainly on their unique surface states that are protected by time-reversal symmetry, show the Dirac cones connecting the inverted conduction and valence bands and exhibit unique spin-momentum locking property. Increasing the surface state contribution in proportion to the bulk of material is critical to investigate the surface states and for future innovative device applications. The way to achieve this is to configure topological insulators into nanostructures, which at the same time in combination with others materials significantly enlarge the variety of new states and phenomena. This article reviews the recent progress made in topological insulator nano heterostructures electronic states investigation. The state of art of different new scenario of engineering topologically interface states in the TI heterostructures are revealed, in particular by using polarization fields and antiferromagnetic ordering. Some of new proposals for innovative electronic devices are discussed. (authors)

Evaluating and Predicting Patient Safety for Medical Devices With Integral Information Technology

Science.gov (United States)

2005-01-01

323 Evaluating and Predicting Patient Safety for Medical Devices with Integral Information Technology Jiajie Zhang, Vimla L. Patel, Todd R...errors are due to inappropriate designs for user interactions, rather than mechanical failures. Evaluating and predicting patient safety in medical ...the users on the identified trouble spots in the devices. We developed two methods for evaluating and predicting patient safety in medical devices

Integrating mobile devices into nursing curricula: opportunities for implementation using Rogers' Diffusion of Innovation model.

Science.gov (United States)

Doyle, Glynda J; Garrett, Bernie; Currie, Leanne M

2014-05-01

To identify studies reporting mobile device integration into undergraduate and graduate nursing curricula. To explore the potential use of Rogers' Diffusion of Innovation model as a framework to guide implementation of mobile devices into nursing curricula. Literature review and thematic categorization. Literature published up until June 2013 was searched using EBSCO, PubMed, and Google Scholar. The literature was reviewed for research articles pertaining to mobile device use in nursing education. Research articles were grouped by study design, and articles were classified by: 1) strategies for individual adopters and 2) strategies for organizations. Rogers' Diffusion of Innovation theory was used to categorize reported implementation strategies. Fifty-two research studies were identified. Strategies for implementation were varied, and challenges to integrating mobile devices include lack of administrative support and time/funding to educate faculty as well as students. Overall, the use of mobile devices appears to provide benefits to nursing students; however the research evidence is limited. Anticipating challenges and ensuring a well laid out strategic plan can assist in supporting successful integration of mobile devices. Crown Copyright © 2013. Published by Elsevier Ltd. All rights reserved.

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.

77 FR 8260 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device...

Science.gov (United States)

2012-02-14

... will be used to evaluate risks associated with medical devices which will enable FDA to take...] Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Reporting... comment in response to the notice. This notice solicits comments on medical device reporting (MDR...

Medizinbibliotheken: Innovativ denken, strategisch planen, praktisch umsetzen / Medical libraries: think innovative, plan strategically, implement in practice

Directory of Open Access Journals (Sweden)

Bauer, Bruno

2011-12-01

Full Text Available The focus of the current issue 3/2011 of GMS Medizin – Bibliothek – Information is the annual conference 2011 of the German Medical Libraries Association in Cologne. The motto of the conference was “Think innovative, plan strategically, implement in practice”. Focal points of the meeting were innovation management, marketing and new applications in medical libraries.The authors in this issue are Bruno Bauer, Daniel Formanek & Helmut Dollfuß (E-Books at medical libraries: They came to stay, Ursula Georgy (Systematic innovation management, Maurizio Grilli (New library portal at Province College for Health-Care Professions Claudiana, Bozen, Sabine Köhrer-Weisser (Marketing in One Person Libraries, Roland Mumenthaler (Innovation Management at ETH-Bibliothek, Markus Schmiel (Performance-related bonuses at Hannover Medical School: practical experience report of the library, Guus van den Brekel (Mobile Computing & Semantic Web in Health & Medicine, Iris Reimann & Sonja Fräntz (Think innovative, plan strategically, implement in practice – Annual Meeting 2011 of the German MLA, 19th to 21th September in Cologne and Eike Hentschel (Aus der AGMB.

Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Microbial Pathogen Nucleic Acids in Cerebrospinal Fluid. Final order.

Science.gov (United States)

2017-10-20

The Food and Drug Administration (FDA or we) is classifying the device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid into class II (special controls). The special controls that will apply to the device type are identified in this order and will be part of the codified language for the device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid’s classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Innovative energy absorbing devices based on composite tubes

Science.gov (United States)

Tiwari, Chandrashekhar

Analytical and experimental study of innovative load limiting and energy absorbing devices are presented here. The devices are based on composite tubes and can be categorized in to two groups based upon the energy absorbing mechanisms exhibited by them, namely: foam crushing and foam fracturing. The device based on foam crushing as the energy absorbing mechanism is composed of light weight elastic-plastic foam filling inside an angle ply composite tube. The tube is tailored to have a high Poisson’s ratio (>20). Upon being loaded the device experiences large transverse contraction resulting in rapid decrease in diameter. At a certain axial load the foam core begins to crush and energy is dissipated. This device is termed as crush tube device. The device based upon foam shear fracture as the energy absorbing mechanism involves an elastic-plastic core foam in annulus of two concentric extension-twist coupled composite tubes with opposite angles of fibers. The core foam is bonded to the inner and outer tube walls. Upon being loaded axially, the tubes twist in opposite directions and fracture the core foam in out of plane shear and thus dissipate the energy stored. The device is termed as sandwich core device (SCD). The devices exhibit variations in force-displacement characteristics with changes in design and material parameters, resulting in wide range of energy absorption capabilities. A flexible matrix composite system was selected, which was composed of high stiffness carbon fibers as reinforcements in relatively low stiffness polyurethane matrix, based upon large strain to failure capabilities and large beneficial elastic couplings. Linear and non-linear analytical models were developed encapsulating large deformation theory of the laminated composite shells (using non-linear strain energy formulation) to the fracture mechanics of core foam and elastic-plastic deformation theory of the foam filling. The non-linear model is capable of including material and

Gaming science innovations to integrate health systems science into medical education and practice.

Science.gov (United States)

White, Earla J; Lewis, Joy H; McCoy, Lise

2018-01-01

Health systems science (HSS) is an emerging discipline addressing multiple, complex, interdependent variables that affect providers' abilities to deliver patient care and influence population health. New perspectives and innovations are required as physician leaders and medical educators strive to accelerate changes in medical education and practice to meet the needs of evolving populations and systems. The purpose of this paper is to introduce gaming science as a lens to magnify HSS integration opportunities in the scope of medical education and practice. Evidence supports gaming science innovations as effective teaching and learning tools to promote learner engagement in scientific and systems thinking for decision making in complex scenarios. Valuable insights and lessons gained through the history of war games have resulted in strategic thinking to minimize risk and save lives. In health care, where decisions can affect patient and population outcomes, gaming science innovations have the potential to provide safe learning environments to practice crucial decision-making skills. Research of gaming science limitations, gaps, and strategies to maximize innovations to further advance HSS in medical education and practice is required. Gaming science holds promise to equip health care teams with HSS knowledge and skills required for transformative practice. The ultimate goals are to empower providers to work in complex systems to improve patient and population health outcomes and experiences, and to reduce costs and improve care team well-being.

TU-C-BRF-01: Innovation in Medical Physics and Engineering

International Nuclear Information System (INIS)

Mohan, R; Pelc, N; Jaffray, D; Mackie, T

2014-01-01

We seek to heighten the awareness of the role of research and innovation that leads to clinical advances in the field of medical physics and engineering. Marie Curie (discovery and use of radium) and Harold Johns (Co-60 tele-therapy) in radiotherapy, and pioneers in imaging (Allan Cormack and Godfrey Hounsfield for the CT and Paul Lauterbur, Peter Mansfield for MRI, etc.) were scientists often struggling against great odds. Examples of more recent innovations that are clearly benefitting our patients include IMRT, Image Guided Radiation Therapy and Surgery, Particle Therapy, Quantitative imaging, amongst others.We would also like to highlight the fact that not all of the discovery and engineering that we benefit from in today’s world, was performed at research institutions alone. Rather, companies often tread new ground at financial and reputational risk. Indeed the strength of the private sector is needed in order to bring about new advances to our practice. The keys to long term success in research and development may very well include more public and private research spending. But, when more investigators are funded, we also need to recognize that there needs to be a willingness on the part of the funding institutions, academic centers and investigators to risk failure for the greater potential achievements in innovation and research. The speakers will provide examples and insight into the fields of innovation and research in medical physics from their own first hand experiences. Learning Objectives: To obtain an understanding of the importance of research and development towards advances in physics in medicine. To raise awareness of the role of interdisciplinary collaborations in translational research and innovation. To highlight the importance of entrepreneurships and industrial-institutional research partnerships in fostering new ideas and their commercial success. To recognize and account for the risk of failure for the greater potential achievements in

TU-C-BRF-01: Innovation in Medical Physics and Engineering

Energy Technology Data Exchange (ETDEWEB)

Mohan, R [UT MD Anderson Cancer Center, Houston, TX (United States); Pelc, N [Stanford University, Stanford, CA (United States); Jaffray, D [Princess Margaret Hospital, Toronto, ON (Canada); Mackie, T [University of Wisconsin, Madison, WI (United States)

2014-06-15

We seek to heighten the awareness of the role of research and innovation that leads to clinical advances in the field of medical physics and engineering. Marie Curie (discovery and use of radium) and Harold Johns (Co-60 tele-therapy) in radiotherapy, and pioneers in imaging (Allan Cormack and Godfrey Hounsfield for the CT and Paul Lauterbur, Peter Mansfield for MRI, etc.) were scientists often struggling against great odds. Examples of more recent innovations that are clearly benefitting our patients include IMRT, Image Guided Radiation Therapy and Surgery, Particle Therapy, Quantitative imaging, amongst others.We would also like to highlight the fact that not all of the discovery and engineering that we benefit from in today’s world, was performed at research institutions alone. Rather, companies often tread new ground at financial and reputational risk. Indeed the strength of the private sector is needed in order to bring about new advances to our practice. The keys to long term success in research and development may very well include more public and private research spending. But, when more investigators are funded, we also need to recognize that there needs to be a willingness on the part of the funding institutions, academic centers and investigators to risk failure for the greater potential achievements in innovation and research. The speakers will provide examples and insight into the fields of innovation and research in medical physics from their own first hand experiences. Learning Objectives: To obtain an understanding of the importance of research and development towards advances in physics in medicine. To raise awareness of the role of interdisciplinary collaborations in translational research and innovation. To highlight the importance of entrepreneurships and industrial-institutional research partnerships in fostering new ideas and their commercial success. To recognize and account for the risk of failure for the greater potential achievements in

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.

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

Science.gov (United States)

... to Create a Personal Emergency File My personal emergency file contains: □ Instructions for using the medical device and all device manuals. □ First aid kit □ Medical records □ Insurance cards □ Current home care doctor’s orders □ Plan of treatment □ What a family ...

Educational leadership during a decade of medical curricular innovation and renewal.

Science.gov (United States)

Pinder, Karen E; Shabbits, Jennifer A

2018-03-05

The past decade has witnessed successful expansion, distribution and curricular renewal at the University of British Columbia (UBC) medical school. The expansion and distribution of the medical program doubled enrollment and established the first North American medical school training students across multiple geographical locations. The more recent competency-based curriculum renewal demonstrates sustained innovation within UBC medicine. This paper describes that a significant contributor to these successes has been a team of teaching faculty whose exclusive roles have been providing curricular support. Over the past decade, this group has evolved into a vital component of the day-to-day operations and performance of the distributed medical curriculum; they now provide continuity in leadership and innovation across multiple educational facets of the program. This paper reports on the evolution and significance of these faculty members. The descriptions establish the success of an investment in teaching faculty and underscore the importance of engaging faculty whose primary commitments are to teaching, educational pedagogy, and student support. This efficacious model of supporting and advancing a complex distributed medical program over more than a decade of pivotal change will be of interest to faculties and programs that are contemplating or navigating similar pursuits.

Development of an innovative device for ultrasonic elliptical vibration cutting.

Science.gov (United States)

Zhou, Ming; Hu, Linhua

2015-07-01

An innovative ultrasonic elliptical vibration cutting (UEVC) device with 1st resonant mode of longitudinal vibration and 3rd resonant mode of bending vibration was proposed in this paper, which can deliver higher output power compared to previous UEVC devices. Using finite element method (FEM), resonance frequencies of the longitudinal and bending vibrations were tuned to be as close as possible in order to excite these two vibrations using two-phase driving voltages at a single frequency, while wave nodes of the longitudinal and bending vibrations were also adjusted to be as coincident as possible for mounting the device at a single fixed point. Based on the simulation analysis results a prototype device was fabricated, then its vibration characteristics were evaluated by an impedance analyzer and a laser displacement sensor. With two-phase sinusoidal driving voltages both of 480 V(p-p) at an ultrasonic frequency of 20.1 kHz, the developed prototype device achieved an elliptical vibration with a longitudinal amplitude of 8.9 μm and a bending amplitude of 11.3 μm. The performance of the developed UEVC device is assessed by the cutting tests of hardened steel using single crystal diamond tools. Experimental results indicate that compared to ordinary cutting process, the tool wear is reduced significantly by using the proposed device. Copyright © 2015 Elsevier B.V. All rights reserved.

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

Science.gov (United States)

2011-04-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2010-N-0026] Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass Assessment Score Test System; Correction AGENCY: Food and Drug Administration, HHS. ACTION...

Just a piece of equipment? The importance of medical device education.

Science.gov (United States)

Brand, Darren

2012-12-01

The use of medical devices is an increasingly important element of a healthcare professional's role. It is crucial that users receive regular teaching and education to ensure that they are competent in the use of devices. This is particularly relevant in the increasingly litigious society in which we live. This article focuses upon the importance of a medical device education.

Combining multi-criteria decision analysis and mini-health technology assessment: A funding decision-support tool for medical devices in a university hospital setting.

Science.gov (United States)

Martelli, Nicolas; Hansen, Paul; van den Brink, Hélène; Boudard, Aurélie; Cordonnier, Anne-Laure; Devaux, Capucine; Pineau, Judith; Prognon, Patrice; Borget, Isabelle

2016-02-01

At the hospital level, decisions about purchasing new and oftentimes expensive medical devices must take into account multiple criteria simultaneously. Multi-criteria decision analysis (MCDA) is increasingly used for health technology assessment (HTA). One of the most successful hospital-based HTA approaches is mini-HTA, of which a notable example is the Matrix4value model. To develop a funding decision-support tool combining MCDA and mini-HTA, based on Matrix4value, suitable for medical devices for individual patient use in French university hospitals - known as the IDA tool, short for 'innovative device assessment'. Criteria for assessing medical devices were identified from a literature review and a survey of 18 French university hospitals. Weights for the criteria, representing their relative importance, were derived from a survey of 25 members of a medical devices committee using an elicitation technique involving pairwise comparisons. As a test of its usefulness, the IDA tool was applied to two new drug-eluting beads (DEBs) for transcatheter arterial chemoembolization. The IDA tool comprises five criteria and weights for each of two over-arching categories: risk and value. The tool revealed that the two new DEBs conferred no additional value relative to DEBs currently available. Feedback from participating decision-makers about the IDA tool was very positive. The tool could help to promote a more structured and transparent approach to HTA decision-making in French university hospitals. Copyright © 2015 Elsevier Inc. All rights reserved.

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.

Protecting computer-based medical devices: defending against viruses and other threats.

Science.gov (United States)

2005-07-01

The increasing integration of computer hardware has exposed medical devices to greater risks than ever before. More and more devices rely on commercial off-the-shelf software and operating systems, which are vulnerable to the increasing proliferation of viruses and other malicious programs that target computers. Therefore, it is necessary for hospitals to take steps such as those outlined in this article to ensure that their computer-based devices are made safe and continue to remain safe in the future. Maintaining the security of medical devices requires planning, careful execution, and a commitment of resources. A team should be created to develop a process for surveying the security status of all computerized devices in the hospital and making sure that patches and other updates are applied as needed. These patches and updates should be approved by the medical system supplier before being implemented. The team should consider using virtual local area networks to isolate susceptible devices on the hospital's network. All security measures should be carefully documented, and the documentation should be kept up-to-date. Above all, care must be taken to ensure that medical device security involves a collaborative, supportive partnership between the hospital's information technology staff and biomedical engineering personnel.

Discovering Innovation at the Intersection of Undergraduate Medical Education, Human Factors, and Collaboration: The Development of a Nasogastric Tube Safety Pack.

Science.gov (United States)

Taylor, Natalie; Bamford, Thomas; Haindl, Cornelia; Cracknell, Alison

2016-04-01

Significant deficiencies exist in the knowledge and skills of medical students and residents around health care quality and safety. The theory and practice of quality and safety should be embedded into undergraduate medical practice so that health care professionals are capable of developing interventions and innovations to effectively anticipate and mitigate errors. Since 2011, Leeds Medical School in the United Kingdom has used case study examples of nasogastric (NG) tube patient safety incidents within the undergraduate patient safety curriculum. In 2012, a medical undergraduate student approached a clinician with an innovative idea after undertaking an NG tubes root cause analysis case study. Simultaneously, a separate local project demonstrated low compliance (11.6%) with the United Kingdom's National Patient Safety Agency NG tubes guideline for use of the correct method to check tube position. These separate endeavors led to interdisciplinary collaboration between a medical student, health care professionals, researchers, and industry to develop the Initial Placement Nasogastric Tube Safety Pack. Human factors engineering was used to inform pack design to allow guideline recommendations to be accessible and easy to follow. A timeline of product development, mapped against key human factors and medical device design principles used throughout the process, is presented. The safety pack has since been launched in five UK National Health Service (NHS) hospitals, and the pack has been introduced into health care professional staff training for NG tubes. A mixed-methods evaluation is currently under way in five NHS organizations.

21 CFR 892.2010 - Medical image storage device.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical image storage device. 892.2010 Section 892.2010 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED..., and digital memory. (b) Classification. Class I (general controls). The device is exempt from the...

[Impact of an automated dispensing system for medical devices in cardiac surgery department].

Science.gov (United States)

Clou, E; Dompnier, M; Kably, B; Leplay, C; Poupon, E; Archer, V; Paul, M

2018-01-01

To secure medical devices' management, the implementation of automated dispensing system in surgical service has been realized. The objective of this study was to evaluate security, organizational and economic impact of installing automated dispensing system for medical devices (ASDM). The implementation took place in a cardiac surgery department. Security impact was assessed by comparing traceability rate of implantable medical devices one year before and one year after installation. Questionnaire on nurses' perception and satisfaction completed this survey. Resupplying costs, stocks' evolution and investments for the implementation of ASDM were the subject of cost-benefit study. After one year, traceability rate is excellent (100%). Nursing staffs were satisfied with 87.5% by this new system. The introduction of ASDM allowed a qualitative and quantitative decrease in stocks, with a reduction of 30% for purchased medical devices and 15% for implantable medical devices in deposit-consignment. Cost-benefit analysis shows a rapid return on investment. Real stock decrease (purchased medical devices) is equivalent to 46.6% of investment. Implementation of ASDM allows to secure storage and dispensing of medical devices. This system has also an important economic impact and appreciated by users. Copyright © 2017 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.

[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.

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

Science.gov (United States)

2011-03-23

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2011-N-0026] Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian... of Food and Drugs, 21 CFR part 866 is amended as follows: PART 866--IMMUNOLOGY AND MICROBIOLOGY...

MO-DE-BRA-04: The CREATE Medical Physics Research Training Network: Training of New Generation Innovators

Energy Technology Data Exchange (ETDEWEB)

Seuntjens, J; Collins, L; Devic, S; El Naqa, I; Nadeau, J; Reader, A [McGill University, Montreal, QC (Canada); Beaulieu, L; Despres, P [Centre Hospitalier Univ de Quebec, Quebec, QC (Canada); Pike, B [University of Calgary, Calgary, Alberta (Canada)

2015-06-15

Purpose: Over the past century, physicists have played a major role in transforming scientific discovery into everyday clinical applications. However, with the increasingly stringent requirements to regulate medical physics as a health profession, the role of physicists as scientists and innovators has become at serious risk of erosion. These challenges trigger the need for a new, revolutionized training program at the graduate level that respects scientific rigor, attention for medical physics-relevant developments in basic sciences, innovation and entrepreneurship. Methods: A grant proposal was funded by the Collaborative REsearch and Training Experience program (CREATE) of the Natural Sciences and Engineering Research Council (NSERC) of Canada. This enabled the creation of the Medical Physics Research Training Network (MPRTN) around two CAMPEP-accredited medical physics programs. Members of the network consist of medical device companies, government (research and regulatory) and academia. The MPRTN/CREATE program proposes a curriculum with three main themes: (1) radiation physics, (2) imaging & image processing and (3) radiation response, outcomes and modeling. Results: The MPRTN was created mid 2013 (mprtn.com) and features (1) four new basic Ph.D. courses; (2) industry participation in research projects; (3) formal job-readiness training with involvement of guest faculty from academia, government and industry. MPRTN activities since 2013 include 22 conferences; 7 workshops and 4 exchange travels. Three patents were filed or issued, nine awards/best papers were won. Fifteen journal publications were accepted/published, 102 conference abstracts. There are now 13 industry partners. Conclusion: A medical physics research training network has been set up with the goal to harness graduate student’s job-readiness for industry, government and academia in addition to the conventional clinical role. Two years after inception, significant successes have been booked

MO-DE-BRA-04: The CREATE Medical Physics Research Training Network: Training of New Generation Innovators

International Nuclear Information System (INIS)

Seuntjens, J; Collins, L; Devic, S; El Naqa, I; Nadeau, J; Reader, A; Beaulieu, L; Despres, P; Pike, B

2015-01-01

Purpose: Over the past century, physicists have played a major role in transforming scientific discovery into everyday clinical applications. However, with the increasingly stringent requirements to regulate medical physics as a health profession, the role of physicists as scientists and innovators has become at serious risk of erosion. These challenges trigger the need for a new, revolutionized training program at the graduate level that respects scientific rigor, attention for medical physics-relevant developments in basic sciences, innovation and entrepreneurship. Methods: A grant proposal was funded by the Collaborative REsearch and Training Experience program (CREATE) of the Natural Sciences and Engineering Research Council (NSERC) of Canada. This enabled the creation of the Medical Physics Research Training Network (MPRTN) around two CAMPEP-accredited medical physics programs. Members of the network consist of medical device companies, government (research and regulatory) and academia. The MPRTN/CREATE program proposes a curriculum with three main themes: (1) radiation physics, (2) imaging & image processing and (3) radiation response, outcomes and modeling. Results: The MPRTN was created mid 2013 (mprtn.com) and features (1) four new basic Ph.D. courses; (2) industry participation in research projects; (3) formal job-readiness training with involvement of guest faculty from academia, government and industry. MPRTN activities since 2013 include 22 conferences; 7 workshops and 4 exchange travels. Three patents were filed or issued, nine awards/best papers were won. Fifteen journal publications were accepted/published, 102 conference abstracts. There are now 13 industry partners. Conclusion: A medical physics research training network has been set up with the goal to harness graduate student’s job-readiness for industry, government and academia in addition to the conventional clinical role. Two years after inception, significant successes have been booked

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

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.

Methodological considerations in observational comparative effectiveness research for implantable medical devices: an epidemiologic perspective.

Science.gov (United States)

Jalbert, Jessica J; Ritchey, Mary Elizabeth; Mi, Xiaojuan; Chen, Chih-Ying; Hammill, Bradley G; Curtis, Lesley H; Setoguchi, Soko

2014-11-01

Medical devices play a vital role in diagnosing, treating, and preventing diseases and are an integral part of the health-care system. Many devices, including implantable medical devices, enter the market through a regulatory pathway that was not designed to assure safety and effectiveness. Several recent studies and high-profile device recalls have demonstrated the need for well-designed, valid postmarketing studies of medical devices. Medical device epidemiology is a relatively new field compared with pharmacoepidemiology, which for decades has been developed to assess the safety and effectiveness of medications. Many methodological considerations in pharmacoepidemiology apply to medical device epidemiology. Fundamental differences in mechanisms of action and use and in how exposure data are captured mean that comparative effectiveness studies of medical devices often necessitate additional and different considerations. In this paper, we discuss some of the most salient issues encountered in conducting comparative effectiveness research on implantable devices. We discuss special methodological considerations regarding the use of data sources, exposure and outcome definitions, timing of exposure, and sources of bias. © The Author 2014. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

[Study on the reform and improvement of the medical device registration system in China].

Science.gov (United States)

Wang, Lanming

2012-11-01

Based on the theories of the Government Regulation and Administrative Licensure, aiming at the current situations of medical device registration system in China, some policy suggestions for future reform and improvement were provided as follows. (1) change the concepts of medical device registration administration. (2) perfect the regulations of medical device registration administration. (3) reform the medical device review organizational system. (4) Optimize the procedure of review and approval. (5) set up and maintain a professional team of review and approval staff. (6) reinforce the post-marketing supervision of medical devices. (7) foster and bring into play of the role of non-government organizations.

Managing Innovation Probabilities: Core-driven vs. Bottleneck-removing Innovations

OpenAIRE

Tsutomu Harada

2015-01-01

This paper provides a simplified framework of focusing devices that generate different patterns of innovation, i.e., core-driven and bottleneck-removing innovations, and discusses the managerial implications. We show that core-driven innovation should be undertaken when technology components are independent (independent technology system), while bottleneck-removing innovation should be pursued when they are interdependent (interdependent technology system). Different types of focusing device ...

Induced Innovation and Social Inequality: Evidence from Infant Medical Care.

Science.gov (United States)

Cutler, David M; Meara, Ellen; Richards-Shubik, Seth

2012-01-01

We develop a model of induced innovation that applies to medical research. Our model yields three empirical predictions. First, initial death rates and subsequent research effort should be positively correlated. Second, research effort should be associated with more rapid mortality declines. Third, as a byproduct of targeting the most common conditions in the population as a whole, induced innovation leads to growth in mortality disparities between minority and majority groups. Using information on infant deaths in the U.S. between 1983 and 1998, we find support for all three empirical predictions.

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

Science.gov (United States)

2010-11-17

.... FDA-2010-N-0513] Medical Devices; General and Plastic Surgery Devices; Classification of Non-Powered... risks. Adverse tissue reaction Material degradation Improper function of suction apparatus (e.g., reflux.... Material degradation Section 8. Stability and Shelf Life. [[Page 70113

Campaign to gather medical devices containing radium: results

International Nuclear Information System (INIS)

Pierre, J.P.; Vidal, J.P.; Martin, J.C.; Pasquier, J.L.

2002-01-01

Campaign to gather medical devices containing radium: results. On December 1, 1999, at the request of the French Health Ministry, OPRI and ANDRA launched a campaign to gather medical devices containing radium, formerly used in brachytherapy. This campaign addressed a public health issue because of the risks actually involved in a careless handling of these objects. Moreover the growing number of reported scattered radium medical devices in the last few years reinforced the necessity of the campaign. The gathering was initiated by a call of the owners (hospitals, caring centers, retired doctors or their heirs) to a toll free number. OPRI or ANDRA then appreciated the situation urgency. Priority was given to private people because most of them did not have suitable storage facilities. OPRI teams operated according a strict protocol guaranteeing their own safety, proper procedures and compliance with transport regulations for radioactive materials. 517 objects amounting to an activity of 1.32 x 10 11 Bq have been gathered in 90 operations. Properly packaged they were transported to and safely stored at the CEA Saclay site before their permanent storage in the ANDRA facilities. (author)

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. Copyright © 2017 Elsevier HS Journals, Inc. All rights reserved.

Accelerating medical innovation at USC: realizing the dream of Alfred E. Mann.

Science.gov (United States)

Gosset, Nathalie; Lasch, Jonathan G

2012-07-01

Alfred E. Mann's vision is to create organizations that will help medical innovations born in academic environments evolve into commercially fit solutions, without the risk of being abandoned under the financial pressures early stage start-ups often experience. In 1998, Mann worked with Stephen Sample, president of USC, to create the first AMI for Biomedical Engineering, an organization fueled by an endowment valued at approximately US$160 million today. Technology-acceleration centers come in different flavors. AMI USC's recipe has evolved since its creation, with edits that incorporate lessons learned and improvements brought by its expanding network of talented resource people. Its 15-member staff, consisting of three-fourths industry professionals, includes seasoned generalists and specialists in medical technology commercialization. Although the support varies with each invention, some recurring ingredients weave into the AMI approach to accelerating medical innovation.

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

Science.gov (United States)

2011-11-21

... Multiplexed Microbiology Devices: Their clinical application and public health/clinical needs; inclusion of...] Advancing Regulatory Science for Highly Multiplexed Microbiology/ Medical Countermeasure Devices; Public... Multiplexed Microbiology/ Medical Countermeasure Devices'' that published in the Federal Register of August 8...

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.

77 FR 6028 - Taxable Medical Devices

Science.gov (United States)

2012-02-07

... sold as part of an x-ray system. Commentators also requested information on the tax treatment of..., mitigation, treatment, or prevention of disease; or intended to affect the structure or any function of the... subject to an IDE is not a ``taxable medical device'' under the proposed regulations. VI. Dental...

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

Science.gov (United States)

2013-06-05

... after the public workshop on the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/Workshops..., compact, and mobile, the number of battery-powered medical devices will continue to increase. While many...] Battery-Powered Medical Devices Workshop: Challenges and Opportunities; Public Workshop; Request for...

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

Science.gov (United States)

2010-11-10

.... FDA-2010-N-0512] Medical Devices; General and Plastic Surgery Devices; Classification of Tissue... running to unintended areas, etc. B. Wound dehiscence C. Adverse tissue reaction and chemical burns D..., Clinical Studies, Labeling. Adverse tissue reaction and chemical Biocompatibility Animal burns. Testing...

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

Science.gov (United States)

2012-06-01

...] Medical Devices; Exemption From Premarket Notification: Wheelchair Elevator AGENCY: Food and Drug... elevator devices commonly known as inclined platform lifts and vertical platform lifts. These devices are... behalf of Bruno Independent Living Aids, Inc., for wheelchair elevator devices (commonly known as...

Views of patients and professionals about electronic multicompartment medication devices: a qualitative study.

Science.gov (United States)

Hall, Jill; Bond, Christine; Kinnear, Moira; McKinstry, Brian

2016-10-17

To explore the perceived acceptability, advantages and disadvantages of electronic multicompartment medication devices. Qualitative study using 8 focus groups and 10 individual semistructured interviews. Recordings were transcribed and analysed thematically. Strategies were employed to ensure the findings were credible and trustworthy. Community pharmacists (n=11), general practitioners (n=9), community nurses (n=12) and social care managers (n=8) were recruited from the National Health Service (NHS) and local authority services. Patients (n=15) who were current conventional or electronic multicompartment medication device users or had medication adherence problems were recruited from community pharmacies. 3 informal carers participated. Electronic multicompartment medication devices which prompt the patient to take medication may be beneficial for selected individuals, particularly those with cognitive impairment, but who are not seriously impaired, provided they have a good level of dexterity. They may also assist individuals where it is important that medication is taken at fixed time intervals. These are likely to be people who are being supported to live alone. No single device suited everybody; smaller/lighter devices were preferred but their usefulness was limited by the small number/size of storage compartments. Removing medications was often challenging. Transportability was an important factor for patients and carers. A carer's alert if medication is not taken was problematic with multiple barriers to implementation and no consensus as to who should receive the alert. There was a lack of enthusiasm among professionals, particularly among pharmacists, due to concerns about responsibility and funding for devices as well as ensuring devices met regulatory standards for storage and labelling. This study provides indicators of which patients might benefit from an electronic multicompartment medication device as well as the kinds of features to consider when

Fiber bundle probes for interconnecting miniaturized medical imaging devices

Science.gov (United States)

Zamora, Vanessa; Hofmann, Jens; Marx, Sebastian; Herter, Jonas; Nguyen, Dennis; Arndt-Staufenbiel, Norbert; Schröder, Henning

2017-02-01

Miniaturization of medical imaging devices will significantly improve the workflow of physicians in hospitals. Photonic integrated circuit (PIC) technologies offer a high level of miniaturization. However, they need fiber optic interconnection solutions for their functional integration. As part of European funded project (InSPECT) we investigate fiber bundle probes (FBPs) to be used as multi-mode (MM) to single-mode (SM) interconnections for PIC modules. The FBP consists of a set of four or seven SM fibers hexagonally distributed and assembled into a holder that defines a multicore connection. Such a connection can be used to connect MM fibers, while each SM fiber is attached to the PIC module. The manufacturing of these probes is explored by using well-established fiber fusion, epoxy adhesive, innovative adhesive and polishing techniques in order to achieve reliable, low-cost and reproducible samples. An innovative hydrofluoric acid-free fiber etching technology has been recently investigated. The preliminary results show that the reduction of the fiber diameter shows a linear behavior as a function of etching time. Different etch rate values from 0.55 μm/min to 2.3 μm/min were found. Several FBPs with three different type of fibers have been optically interrogated at wavelengths of 630nm and 1550nm. Optical losses are found of approx. 35dB at 1550nm for FBPs composed by 80μm fibers. Although FBPs present moderate optical losses, they might be integrated using different optical fibers, covering a broad spectral range required for imaging applications. Finally, we show the use of FBPs as promising MM-to-SM interconnects for real-world interfacing to PIC's.

Left to their own devices: medical learners' use of mobile technologies.

Science.gov (United States)

Ellaway, Rachel H; Fink, Patricia; Graves, Lisa; Campbell, Alanna

2014-02-01

Although many medical learners and teachers are using mobile technologies within medical education, there has been little evidence presented describing how they use mobile devices across a whole curriculum. The Northern Ontario School of Medicine (NOSM) introduced a new mobile device program in 2010. Incoming undergraduate medical learners received a laptop and an iPad and learners entering year three of the four-year program received a laptop and an iPhone. A survey was sent to all learners to gather information on their use of and attitudes toward these devices. A combination of quantitative and qualitative methods was used to analyze the data and to generate a series of themes that synthesized student behaviors, perceptions and attitudes. Context and learner autonomy were found to be important factors with learners using multiple devices for different purposes and adopting strategic approaches to learning using these devices. The expectation that school-issued devices would be regularly and enthusiastically used to replace more traditional study media was not reflected in practice. Learners' approaches to using mobile devices are heterogeneous as is the extent to which they use them. Learners adapt their use of mobile devices to the learning cultures and contexts they find themselves in.

Possibilities of radiation sterilization for re-usage of medical devices in the medical management

International Nuclear Information System (INIS)

Tabei, Masae; Kudo, Hisaaki; Katsumura, Yosuke

2004-01-01

The rule for re-usage of medical single-use devices was established in US in 2000 based on the concept of Managed Care (total management of medicare on cost, quality and patients' satisfaction) and 20-30% of those devices are re-used at present. The re-usage is conducted in not only US but also Canada, Denmark, UK, India, China etc. Standing on the viewpoint, this paper described and discussed the possibility of re-usage of the single-use devices now prohibited in Japan, possible re-sterilization, possible re-usage of hollow fiber-type hemodialyzer following γ-ray sterilization with consideration for D-values against bacteria and viruses, cost estimation of electron beam sterilization for re-usage, and radiation sterilization of waste water and plastic materials. Radiation sterilization for re-usage of medical devices was concluded possible if their materials and records for their usage processes are proper, and should be conducted in a large scale after sufficient examinations by industries/government/academia. (N.I.)

Third-year medical students' knowledge of privacy and security issues concerning mobile devices.

Science.gov (United States)

Whipple, Elizabeth C; Allgood, Kacy L; Larue, Elizabeth M

2012-01-01

The use of mobile devices are ubiquitous in medical-care professional settings, but information on privacy and security concerns of mobile devices for medical students is scarce. To gain baseline information about third-year medical students' mobile device use and knowledge of privacy and security issues concerning mobile devices. We surveyed 67 third-year medical students at a Midwestern university on their use of mobile devices and knowledge of how to protect information available through mobile devices. Students were also presented with clinical scenarios to rate their level of concern in regards to privacy and security of information. The most used features of mobile devices were: voice-to-voice (100%), text messaging (SMS) (94%), Internet (76.9%), and email (69.3%). For locking of one's personal mobile phone, 54.1% never physically lock their phone, and 58% never electronically lock their personal PDA. Scenarios considering definitely privacy concerns include emailing patient information intact (66.7%), and posting de-identified information on YouTube (45.2%) or Facebook (42.2%). As the ease of sharing data increases with the use of mobile devices, students need more education and training on possible privacy and security risks posed with mobile devices.

Early Innovative Immersion: A Course for Pre-Medical Professions Students Using Point-of-Care Ultrasound.

Science.gov (United States)

Smalley, Courtney M; Browne, Vaughn; Kaplan, Bonnie; Russ, Brian; Wilson, Juliana; Lewiss, Resa E

2016-12-01

In preparing for medical school admissions, premedical students seek opportunities to expand their medical knowledge. Knowing what students seek and what point-of-care ultrasound offers, we created a novel educational experience using point-of-care ultrasound. The innovation has 3 goals: (1) to use point-of-care ultrasound to highlight educational concepts such as the flipped classroom, simulation, hands-on interaction, and medical exposure; (2) to work collaboratively with peers; and (3) to expose premedical students to mentoring for the medical school application process. We believe that this course could be used to encourage immersive innovation with point-of-care ultrasound, progressive education concepts, and preparation for medical admissions. © 2016 by the American Institute of Ultrasound in Medicine.

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.

Stakeholder challenges in purchasing medical devices for patient safety.

Science.gov (United States)

Hinrichs, Saba; Dickerson, Terry; Clarkson, John

2013-03-01

This study identifies the stakeholders who have a role in medical device purchasing within the wider system of health-care delivery and reports on their particular challenges to promote patient safety during purchasing decisions. Data was collected through observational work, participatory workshops, and semi-structured qualitative interviews, which were analyzed and coded. The study takes a systems-based and engineering design approach to the study. Five hospitals took part in this study, and the participants included maintenance, training, clinical end-users, finance, and risk departments. The main stakeholders for purchasing were identified to be staff from clinical engineering (Maintenance), device users (Clinical), device trainers (Training), and clinical governance for analyzing incidents involving devices (Risk). These stakeholders display varied characteristics in terms of interpretation of their own roles, competencies for selecting devices, awareness and use of resources for purchasing devices, and attitudes toward the purchasing process. The role of "clinical engineering" is seen by these stakeholders to be critical in mediating between training, technical, and financial stakeholders but not always recognized in practice. The findings show that many device purchasing decisions are tackled in isolation, which is not optimal for decisions requiring knowledge that is currently distributed among different people within different departments. The challenges expressed relate to the wider system of care and equipment management, calling for a more systemic view of purchasing for medical devices.

[Software as medical devices/medical apps : Tasks, requirements, and experiences from the point of view of a competent authority].

Science.gov (United States)

Terhechte, Arno

2018-03-01

Software can be classified as a medical device according to the Medical Device Directive 93/42/EEC. The number of software products and medical apps is continuously increasing and so too is the use in health institutions (e. g., in hospitals and doctors' surgeries) for diagnosis and therapy.Different aspects of standalone software and medical apps from the perspective of the authority responsible are presented. The quality system implemented to establish a risk-based systematic inspection and supervision of manufacturers is discussed. The legal framework, as well as additional standards that are the basis for inspection, are outlined. The article highlights special aspects that occur during inspection like verification of software and interfaces, and the clinical evaluation of software. The Bezirksregierung, as the local government authority responsible in North Rhine-Westphalia, is also in charge of inspection of health institutions. Therefore this article is not limited to the manufacturers placing the software on the market, but in addition it describes the management and use of software as a medical device in hospitals.The future legal framework, the Medical Device Regulation, will strengthen the requirements and engage notified bodies more than today in the conformity assessment of software as a medical device.Manufacturers, health institutions, notified bodies and the authorities responsible are in charge of intensifying their efforts towards software as a medical device. Mutual information, improvement of skills, and inspections will lead to compliance with regulatory requirements.

Research on dose setting for radiation sterilization of medical device

International Nuclear Information System (INIS)

Zhang Tongcheng; Liu Qingfang; Zhong Hongliang; Mi Zhisu; Wang Chunlei; Jiang Jianping

2002-01-01

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

77 FR 32642 - Medical Devices; Exemption From Premarket Notification: Powered Patient Transport

Science.gov (United States)

2012-06-01

...] Medical Devices; Exemption From Premarket Notification: Powered Patient Transport AGENCY: Food and Drug... received a petition requesting exemption from the premarket notification requirements for powered patient... necessary to provide a reasonable assurance of safety and effectiveness. Under the Medical Device Amendments...

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

Science.gov (United States)

2011-03-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. FDA-2011-N-0002] Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Microbiology...

Innovation and entrepreneurship programs in US medical education: a landscape review and thematic analysis.

Science.gov (United States)

Niccum, Blake A; Sarker, Arnab; Wolf, Stephen J; Trowbridge, Matthew J

2017-01-01

Training in innovation and entrepreneurship (I&E) in medical education has become increasingly prevalent among medical schools to train students in complex problem solving and solution design. We aim to characterize I&E education in US allopathic medical schools to provide insight into the features and objectives of this growing field. I&E programs were identified in 2016 via structured searches of 158 US allopathic medical school websites. Program characteristics were identified from public program resources and structured phone interviews with program directors. Curricular themes were identified via thematic analysis of program resources, and themes referenced by >50% of programs were analyzed. Thirteen programs were identified. Programs had a median age of four years, and contained a median of 13 students. Programs were led by faculty from diverse professional backgrounds, and all awarded formal recognition to graduates. Nine programs spanned all four years of medical school and ten programs required a capstone project. Thematic analysis revealed seven educational themes (innovation, entrepreneurship, technology, leadership, healthcare systems, business of medicine, and enhanced adaptability) and two teaching method themes (active learning, interdisciplinary teaching) referenced by >50% of programs. The landscape of medical school I&E programs is rapidly expanding to address newfound skills needed by physicians due to ongoing changes in healthcare, but programs remain relatively few and small compared to class size. This landscape analysis is the first review of I&E in medical education and may contribute to development of a formal educational framework or competency model for current or future programs. AAMC: American Association of Medical Colleges; AMA: American Medical Association; I&E: Innovation and entrepreneurship.

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 where...

Health Care: Reprocessed Medical Single-Use Devices in DoD

National Research Council Canada - National Science Library

2002-01-01

... for decontamination and resterilization. The emergence of new materials and sterilization methods, and the increasing costs of health care, resulted in the development of medical single-use devices and the practice of reprocessing the devices...

Management information system of medical equipment using mobile devices

Science.gov (United States)

Núñez, C.; Castro, D.

2011-09-01

The large numbers of technologies currently incorporated into mobile devices transform them into excellent tools for capture and to manage the information, because of the increasing computing power and storage that allow to add many miscellaneous applications. In order to obtain benefits of these technologies, in the biomedical engineering field, it was developed a mobile information system for medical equipment management. The central platform for the system it's a mobile phone, which by a connection with a web server, it's capable to send and receive information relative to any medical equipment. Decoding a type of barcodes, known as QR-Codes, the management process is simplified and improved. These barcodes identified the medical equipments in a database, when these codes are photographed and decoded with the mobile device, you can access to relevant information about the medical equipment in question. This Project in it's actual state is a basic support tool for the maintenance of medical equipment. It is also a modern alternative, competitive and economic in the actual market.

Medical Devices; Obstetrical and Gynecological Devices; Classification of the Pressure Wedge for the Reduction of Cesarean Delivery. Final order.

Science.gov (United States)

2017-12-28

The Food and Drug Administration (FDA or we) is classifying the pressure wedge for the reduction of cesarean delivery into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the pressure wedge for the reduction of cesarean delivery's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

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

Science.gov (United States)

2010-07-01

... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false In-kind donations of medicine...-kind donations of medicine, medical devices, and medical services. (a) Effective July 6, 2006, nongovernmental organizations that are U.S. persons are authorized to provide in-kind donations of medicine...

Pricing and reimbursement of drugs and medical devices in Hungary.

Science.gov (United States)

Gulácsi, L; Dávid, T; Dózsa, Cs

2002-01-01

Similarly to other countries of Central and Eastern Europe, Hungary has witnessed massive diffusion of healthcare technology such as drugs and medical devices since 1990. While substantial new pharmaceuticals, medical devices, and procedures have been liberalized, there has been no proper evaluation or training in their use. Healthcare providers have come to find themselves as entrepreneurs in private practice, while patients are acquiring an increasing awareness as customers of healthcare,demanding services in return for their taxes and contributions. This has led to extremely irrational patterns of investment in technology, with most an obvious waste of resources, while leaving basic needs unmet. Both the National Health Insurance Fund and the Ministry of Finance believe that the current pharmaceutical and medical device bill is too high. However, introducing a more transparent and flexible pricing and reimbursement framework may enable a more efficient allocation of the limited resources to be achieved.

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

Science.gov (United States)

2010-01-11

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0606] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice...) is announcing an amendment to the notice of a meeting of the General and Plastic Surgery Devices...

Top five medical innovations in China mainland since Xinhai revolution [1911]: results of AME survey-002.

Science.gov (United States)

Wáng, Yì-Xiáng J; Xiao, Fan

2015-06-01

This survey aims to scrutinize important medical innovations in Chinese mainland since Xinhai (Hsin-hai) revolution in 1911, which marked the end of Manchurian imperial rule and the beginning of China's republican era. An online cross-sectional survey was carried out during the period of Dec 29, 2014 to Feb 5, 2015, totaling 37 days. The survey was conducted on the platform provided by DXY (www.dxy.cn), which is the largest medical and paramedical related website in China. An email was sent to all DXY registered users to invite them to participate in a 5-minute survey. The participants were asked to nominate up to four important medical innovations in China mainland since Xinhai revolution. The participant could select 'zero' which means he/she felt there was no important medical innovations, or he/she did not know important medical innovations. It was noted that important medical innovations refer to (I) those with practical and almost immediate significance to improve healthcare; (II) should not only be introducing western technique to China, but those involve major improvement of existing western techniques count; (III) should not be those with important theoretical discovery but did not have almost immediate significance to improve healthcare. In total 1,513 DXY users participated in the voting. Totally 489 (32.3%), 441 (29.1%), 342 (22.6%), 150 (9.9%), 91 (6.0%) participants provided 0, 1, 2, 3, 4 nominations respectively. (I) Artemisine (Qinghaosu) for malaria treatment (Project 523 team, 1972); (II) arsenic Trioxide (As2O3) for acute promyelocytic leukemia (APL) treatment (ZHANG Ting-Dong and colleagues, 1970s); (III) limb re-plantation (CHEN Zhong-Wei and colleagues, 1963); (IV) all-trans retinoic acid (ATRA) for APL treatment (WANG Zhen-Yi and colleagues, 1988); and (V) Wu's mask for plague prevention (WU Lien-The, 1910), were voted as the top five innovations in China mainland since Xinhai revolution, with 375, 96, 91, 53, and 8 votes respectively. In

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%.

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

Science.gov (United States)

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

2015-06-01

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

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

Science.gov (United States)

2010-07-01

... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false In-kind donations of medicine....515 In-kind donations of medicine, medical devices, and medical services. (a) Effective July 6, 2006, nongovernmental organizations that are U.S. persons are authorized to provide in-kind donations of medicine...

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

Science.gov (United States)

2010-07-01

... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false In-kind donations of medicine... Licensing Policy § 597.511 In-kind donations of medicine, medical devices, and medical services. (a... incident to the provision by nongovernmental organizations that are U.S. persons of in-kind donations of...

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

International Nuclear Information System (INIS)

Triani, Gerry; Doe, Simon

2005-01-01

The Australian Nuclear Science and Technology Organisation (ANSTO) and the Commonwealth Scientific and Industrial Research Organisation (CSIRO) have provided support to the Medical Devices and Sensors Industry in Australia for many years. In particular the Institute of Materials and Engineering Science at ANSTO and CSIRO Manufacturing and Infrastructure Technology have worked independently and jointly on a number of projects to provide technical services and support to small to medium sized companies. A recent venture to capture their capabilities in the WTIA's Medical Devices and Sensors Industry Sectoral Project, part of the WTIA National Diffusion Networks Project, has produced substantial technical and financial gains for its participants. The aim of this article is to highlight the infrastructure and capabilities that ANSTO and CSIRO can provide to component manufacturers and industry clusters that offer a range of manufacturing processes needed for medical devices and sensors. Several case studies illustrate how ANSTO and CSIRO have provided support to the medical devices industry

Sterilization and reprocessing of materials and medical devices--reusability.

Science.gov (United States)

Jayabalan, M

1995-07-01

Problems associated with reprocessing of disposable medical devices such as hemodialysers with resterilization for reuse and changes in material properties with resterilization of polymeric (PVC, polypropylene, polyester, polycarbonate) materials intended for development of disposable devices are reviewed. Reprocessing of hospital supplies, polystyrene microtiter plate and angiographic catheter for reuse is also discussed.

Using a framework to implement large-scale innovation in medical education with the intent of achieving sustainability.

Science.gov (United States)

Hudson, Judith N; Farmer, Elizabeth A; Weston, Kathryn M; Bushnell, John A

2015-01-16

Particularly when undertaken on a large scale, implementing innovation in higher education poses many challenges. Sustaining the innovation requires early adoption of a coherent implementation strategy. Using an example from clinical education, this article describes a process used to implement a large-scale innovation with the intent of achieving sustainability. Desire to improve the effectiveness of undergraduate medical education has led to growing support for a longitudinal integrated clerkship (LIC) model. This involves a move away from the traditional clerkship of 'block rotations' with frequent changes in disciplines, to a focus upon clerkships with longer duration and opportunity for students to build sustained relationships with supervisors, mentors, colleagues and patients. A growing number of medical schools have adopted the LIC model for a small percentage of their students. At a time when increasing medical school numbers and class sizes are leading to competition for clinical supervisors it is however a daunting challenge to provide a longitudinal clerkship for an entire medical school class. This challenge is presented to illustrate the strategy used to implement sustainable large scale innovation. A strategy to implement and build a sustainable longitudinal integrated community-based clerkship experience for all students was derived from a framework arising from Roberto and Levesque's research in business. The framework's four core processes: chartering, learning, mobilising and realigning, provided guidance in preparing and rolling out the 'whole of class' innovation. Roberto and Levesque's framework proved useful for identifying the foundations of the implementation strategy, with special emphasis on the relationship building required to implement such an ambitious initiative. Although this was innovation in a new School it required change within the school, wider university and health community. Challenges encountered included some resistance to

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

Science.gov (United States)

... Medical Procedures Home Health and Consumer Devices Brochure - Home Healthcare Medical Devices: Infusion Therapy - Getting the Most ... if needed. What is the role of your home healthcare provider and supplier in your infusion therapy? ...

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

Science.gov (United States)

2011-07-19

...] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice... announcing an amendment to the notice of meeting of the General and Plastic Surgery Devices Panel of the... INFORMATION: In the Federal Register of July 7, 2011, FDA announced that a meeting of the General and Plastic...

OR.NET: a service-oriented architecture for safe and dynamic medical device interoperability.

Science.gov (United States)

Kasparick, Martin; Schmitz, Malte; Andersen, Björn; Rockstroh, Max; Franke, Stefan; Schlichting, Stefan; Golatowski, Frank; Timmermann, Dirk

2018-02-23

Modern surgical departments are characterized by a high degree of automation supporting complex procedures. It recently became apparent that integrated operating rooms can improve the quality of care, simplify clinical workflows, and mitigate equipment-related incidents and human errors. Particularly using computer assistance based on data from integrated surgical devices is a promising opportunity. However, the lack of manufacturer-independent interoperability often prevents the deployment of collaborative assistive systems. The German flagship project OR.NET has therefore developed, implemented, validated, and standardized concepts for open medical device interoperability. This paper describes the universal OR.NET interoperability concept enabling a safe and dynamic manufacturer-independent interconnection of point-of-care (PoC) medical devices in the operating room and the whole clinic. It is based on a protocol specifically addressing the requirements of device-to-device communication, yet also provides solutions for connecting the clinical information technology (IT) infrastructure. We present the concept of a service-oriented medical device architecture (SOMDA) as well as an introduction to the technical specification implementing the SOMDA paradigm, currently being standardized within the IEEE 11073 service-oriented device connectivity (SDC) series. In addition, the Session concept is introduced as a key enabler for safe device interconnection in highly dynamic ensembles of networked medical devices; and finally, some security aspects of a SOMDA are discussed.

A laser induced breakdown spectroscopy (LIBS) based ion specific sensor for quantifying io levels in haemodialysis; an innovation of the Van 't Hoff program

NARCIS (Netherlands)

Amelink, A.; Westerlaken, A.C.

2014-01-01

The Van ‘t Hoff program is a new collaborative research and innovation program, initiated by TNO, in the field of biomedical optics. The Van ‘t Hoff program aims to improve medical diagnosis and therapy through development of innovative medical devices based on photonics and biomedical technologies.

Biophotonics-based strategies for improving Alzheimer’s and Parkinson’s disease diagnosis and monitoring: two innovative approaches by the Van ‘t Hoff program

NARCIS (Netherlands)

Amelink, A.; Westerlaken, A.C.; Boer, B.M. de

2015-01-01

The Van ‘t Hoff program is a new collaborative research and innovation program, initiated by TNO, in the field of biomedical optics. The Van ‘t Hoff program aims to improve medical diagnosis and therapy through development of innovative medical devices based on photonics and biomedical technologies.

Current status of the regulation for medical devices

OpenAIRE

Shah Anuja; Goyal R

2008-01-01

In the light of escalating use of medical devices, stringent regulatory standards are required to ensure that the devices are safe, well studied and have least adverse reactions. 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. India has emerged as one of the leaders in pharmaceutical industry. Like many other amendments in Drugs and Cosmetics Act that ...

A smart spirometry device for asthma diagnosis.

Science.gov (United States)

Kassem, A; Hamad, M; El Moucary, C

2015-08-01

In this paper an innovative prototype for smart asthma spirometry device to be used by doctors and asthma patients is presented. The novelty in this prototype relies in the fact that it is destined to subtend not only adults but offers an efficient and attractive manner to accommodate children patients as well thus, making it efficient for doctors, patients and parents to detect and monitor such intricate cases at stages as early as six years old. Moreover, the apparatus used enables us to integrate a vital parameter representing the Forced Expiratory Volume to the final diagnosis. Besides, the presented device will automatically diagnose those patients, assess their asthma condition, and schedule their medication process without excessive visits to medical centers whilst providing doctors with accurate and pertinent and comprehensive medical data in a chronological fashion. Zooming into under the hood of the device, a fully reliable hardware digital system lies along with a flowmeter detector and a Bluetooth emitter to interface with a user-friendly GUI-based application installed on smartphones which incorporates appealing animated graphics to encourage children to take the test. Furthermore, the device offers the capability of storing chronological data and a relevant resourceful display for accurate tracking of patients' medical record, the evolvement of their asthma condition, and the administered medication. Finally, the entire device is aligned with the medical requirements as per doctors' and telemedicine specialists' recommendations; the experiments carried out demonstrated the effectiveness and sustainable use of such device.

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.

Image Quality Characteristics of Handheld Display Devices for Medical Imaging

Science.gov (United States)

Yamazaki, Asumi; Liu, Peter; Cheng, Wei-Chung; Badano, Aldo

2013-01-01

Handheld devices such as mobile phones and tablet computers have become widespread with thousands of available software applications. Recently, handhelds are being proposed as part of medical imaging solutions, especially in emergency medicine, where immediate consultation is required. However, handheld devices differ significantly from medical workstation displays in terms of display characteristics. Moreover, the characteristics vary significantly among device types. We investigate the image quality characteristics of various handheld devices with respect to luminance response, spatial resolution, spatial noise, and reflectance. We show that the luminance characteristics of the handheld displays are different from those of workstation displays complying with grayscale standard target response suggesting that luminance calibration might be needed. Our results also demonstrate that the spatial characteristics of handhelds can surpass those of medical workstation displays particularly for recent generation devices. While a 5 mega-pixel monochrome workstation display has horizontal and vertical modulation transfer factors of 0.52 and 0.47 at the Nyquist frequency, the handheld displays released after 2011 can have values higher than 0.63 at the respective Nyquist frequencies. The noise power spectra for workstation displays are higher than 1.2×10−5 mm2 at 1 mm−1, while handheld displays have values lower than 3.7×10−6 mm2. Reflectance measurements on some of the handheld displays are consistent with measurements for workstation displays with, in some cases, low specular and diffuse reflectance coefficients. The variability of the characterization results among devices due to the different technological features indicates that image quality varies greatly among handheld display devices. PMID:24236113

"Joint Workshop on High Confidence Medical Devices, Software, and Systems (HCMDSS) and Medical Device Plug-and-Play (MD PnP) Interoperability"

National Research Council Canada - National Science Library

Goldman, Julian M

2008-01-01

Partial support was requested from TATRC, with joint funding from NSF, for a joint workshop to bring together the synergistic efforts and communities of the High Confidence Medical Devices, Software, and Systems (HCMDSS...

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

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.

A model of user engagement in medical device development.

Science.gov (United States)

Grocott, Patricia; Weir, Heather; Ram, Mala Bridgelal

2007-01-01

The purpose of this paper is to address three topical themes: user involvement in health services research; determining the value of new medical technologies in patient care pathways, furthering knowledge related to quality in health and social care; and knowledge exchange between manufacturers, health service supply chain networks and device users. The model is being validated in a case study in progress. The latter is a "proving ground" study for a translational research company. Medical devices play a pivotal role in the management of chronic diseases, across all care settings. Failure to engage users in device development inevitably affects the quality of clinical outcomes. A model of user engagement is presented, turning unmet needs for medical devices into viable commercial propositions. A case study investigating the perceptions of individuals with Epidermolysis Bullosa (EB), their lay and professional carers into unmet needs. EB is an inherited condition affecting the skin and mucosal linings that leads to blistering and wounds. Qualitative data are being collected to generate understanding of unmet needs and wound care products. These needs are being translated into new design concepts and prototypes. Prototypes will be evaluated in an n = 1 experimental design, generating quantitative outcomes data. There are generalisations from the case study, and the model outlined. New products for managing EB wounds can logically benefit other groups. The model is transferable to other clinical problems, which can benefit from research and technological advances that are integral to clinical needs and care.

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

Science.gov (United States)

2013-11-07

.... 66, rm. 2110, Silver Spring, MD 20993-0002, 301- 796-5750. For devices regulated by CBER: Stephen... the best clinical and statistical practices for investigational medical device studies. A medical...

NASA Johnson Space Center SBIR STTR Program Technology Innovations

Science.gov (United States)

Krishen, Kumar

2007-01-01

The Small Business Innovation Research (SBIR) Program increases opportunities for small businesses to participate in research and development (R&D), increases employment, and improves U.S. competitiveness. Specifically the program stimulates U.S. technological innovation by using small businesses to meet federal R&D needs, increasing private-sector commercialization of innovations derived from federal R&D, and fostering and encouraging the participation of socially disadvantaged businesses. In 2000, the Small Business Technology Transfer (STTR) Program extended and strengthened the SBIR Program, increasing its emphasis on pursuing commercial applications by awarding contracts to small business concerns for cooperative R&D with a nonprofit research institution. Modeled after the SBIR Program, STTR is nevertheless a separately funded activity. Technologies that have resulted from the Johnson Space Center SBIR STTR Program include: a device for regenerating iodinated resin beds; laser-assisted in-situ keratomileusis or LASIK; a miniature physiological monitoring device capable of collecting and analyzing a multitude of real-time signals to transmit medical data from remote locations to medical centers for diagnosis and intervention; a new thermal management system for fibers and fabrics giving rise to new line of garments and thermal-enhancing environments; and a highly electropositive material that attracts and retains electronegative particles in water.

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.

Exploring the possibility for business model innovation in Laerdal Medical using Virtual Reality

OpenAIRE

Ullestad, Freddie; Søndenaa, Thomas

2017-01-01

Master's thesis in Business administration: Executive MBA The purpose of this paper is to check how Virtual Reality patient simulation as a disruptive technology may give opportunities for established companies, such as Laerdal Medical, to create innovative business models in the nursing and healthcare education market. The goal of the new and innovative business model would be to maintain and further strengthen existing business, when faced with threats from established and potential new ...

Current challenges for clinical trials of cardiovascular medical devices.

Science.gov (United States)

Zannad, Faiez; Stough, Wendy Gattis; Piña, Ileana L; Mehran, Roxana; Abraham, William T; Anker, Stefan D; De Ferrari, Gaetano M; Farb, Andrew; Geller, Nancy L; Kieval, Robert S; Linde, Cecilia; Redberg, Rita F; Stein, Kenneth; Vincent, Alphons; Woehrle, Holger; Pocock, Stuart J

2014-07-15

Several features of cardiovascular devices raise considerations for clinical trial conduct. Prospective, randomized, controlled trials remain the highest quality evidence for safety and effectiveness assessments, but, for instance, blinding may be challenging. In order to avoid bias and not confound data interpretation, the use of objective endpoints and blinding patients, study staff, core labs, and clinical endpoint committees to treatment assignment are helpful approaches. Anticipation of potential bias should be considered and planned for prospectively in a cardiovascular device trial. Prospective, single-arm studies (often referred to as registry studies) can provide additional data in some cases. They are subject to selection bias even when carefully designed; thus, they are generally not acceptable as the sole basis for pre-market approval of high risk cardiovascular devices. However, they complement the evidence base and fill the gaps unanswered by randomized trials. Registry studies present device safety and effectiveness in day-to-day clinical practice settings and detect rare adverse events in the post-market period. No single research design will be appropriate for every cardiovascular device or target patient population. The type of trial, appropriate control group, and optimal length of follow-up will depend on the specific device, its potential clinical benefits, the target patient population and the existence (or lack) of effective therapies, and its anticipated risks. Continued efforts on the part of investigators, the device industry, and government regulators are needed to reach the optimal approach for evaluating the safety and performance of innovative devices for the treatment of cardiovascular disease. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

A model for training medical student innovators: the Harvard Medical School Center for Primary Care Abundance Agents of Change program.

Science.gov (United States)

Duong, David B; Sullivan, Erin E; Minter-Jordan, Myechia; Giesen, Lindsay; Ellner, Andrew L

2016-01-01

In 2013, the Harvard Medical School Center for Primary Care established the Abundance Agents of Change (AoC) program to promote interprofessional learning and innovation, increase partnership between 15 academic and community health centers (CHCs) in Boston's most under-served communities, and increase medical student interest in primary care careers. The AoC is modeled in the form of a 'grants challenge', offering $20,000 to interprofessional student teams to develop an innovative solution that addresses a healthcare delivery need identified by CHCs. The program's initial two years were characterized by a four-stage process which included working with CHCs and crafting a request for proposals, forming interprofessional 20 student teams comprising students from across and outside of Harvard University, training students using a systems-based innovation curriculum, and performing program evaluation. Our evaluation data from cohorts 1 and 2 of the AoC program demonstrate that we succeeded in training students as innovators and members of interprofessional teams. We also learned valuable lessons regarding creating better alignment with CHC priorities, extending the program cycle from 12 to 18 months, and changing the way funding is disbursed to 25 students, which will be incorporated in later versions of the program. Based on our experience and evaluation data, we believe that this program is a replicable way to train students as innovators and members of interprofessional teams to address the current complex healthcare environment.

Otolaryngology--head and neck surgery in undergraduate medical education: advances and innovations.

Science.gov (United States)

Fung, Kevin

2015-02-01

Medical students graduate with the knowledge and skills to be undifferentiated general physicians. Otolaryngology-head and neck surgery (OtoHNS) is an essential component of primary healthcare, but is disproportionately under-represented in undergraduate medical education (UME). Advances and innovations in educational technology may represent an exciting and creative solution to this important problem. Failure to meet this educational need will result in substantial downstream effects in primary healthcare delivery. The objectives of this study were to 1) demonstrate current deficits in OtoHNS teaching at the UME level; 2) develop, validate, and critically appraise educational innovations that may enrich OtoHNS teaching in medical school curricula; and 3) propose a process for standardization of learning objectives for OtoHNS in UME as it relates to development and deployment of such educational tools. A white paper, prepared as a Triological Society thesis, which consolidates a prospective 10-year investigation of the problem of and potential solutions for under-representation of OtoHNS in UME. Cited datasets include multicenter surveys, cohort studies, and prospective, randomized controlled trials. A series of published and unpublished data were synthesized that addresses the following: 1) the current state of OtoHNS teaching at the UME level with respect to content, volume, structure, and methods; and 2) educational innovations including e-learning and simulation with emphasis on validity and learning effectiveness. Educational innovations specific to postgraduate (residency) training were excluded. Data support the observation that there is uniformly disproportionate under-representation of OtoHNS within UME curricula. Medical school graduates, especially those pursuing primary care specialties, report poor overall comfort levels in managing OtoHNS problems. A series of novel teaching methods were developed and validated using e-learning and simulation

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 

What do you mean you can't sterilize it? The reusable medical device matrix.

Science.gov (United States)

Stephens, Anne; Assang, AnnMarie

2010-12-01

begins with proper cleaning and processing of the surgical instruments. Surgical site infections can increase the length of stay and the cost of the patients' hospitalization, as well as increased risk, morbidity and even mortality. 1 Today's patients are far more informed than they were in the past. They can gather information from the internet as well as from television, radio, and print media. This knowledge empowers the patient to expect that their healthcare providers are practicing due diligence. It is the ethical duty and responsibility of nurses to provide safe, competent care while protecting the rights of the patient and being accountable to the professional governing bodies. In other words, we are advocates for both our patients and the healthcare system.2 Using both new and innovative instruments in the OR was, in the past, as simple as a surgeon requesting an instrument, the perioperative nurse ordering the instrument and CPD processing it for use in the OR. That is no longer the case. With a wide range of more complex instrumentation and an increasing focus on sterilization strategies, healthcare facilities have had to adopt a more rigorous approach. There are many challenges in the world of sterile processing. A common one, faced on a regular basis, is the provision of vague, inaccurate reprocessing recommendations from the medical device manufacturer. Canadian centres are not able to meet European standards for reprocessing. European cycles, often referred to as "Fractionated Steam Cycles", are different than the pre-vacuum steam cycles run in Canada.

TU-AB-204-01: Device Approval Process

International Nuclear Information System (INIS)

Delfino, J.

2016-01-01

), Image Gently, and the Quantitative Imaging Biomarkers Alliance (QIBA) among others, to fulfill FDA’s mission will be discussed. Learning Objectives: Understand FDA’s pre-market and post-market review processes for medical devices Understand FDA’s current regulatory research activities in the areas of medical physics and imaging products Understand how being involved with AAPM and other organizations can also help to promote innovative, safe and effective medical devices J. Delfino, nothing to disclose

TU-AB-204-01: Device Approval Process

Energy Technology Data Exchange (ETDEWEB)

Delfino, J. [Food & Drug Administration (United States)

2016-06-15

), Image Gently, and the Quantitative Imaging Biomarkers Alliance (QIBA) among others, to fulfill FDA’s mission will be discussed. Learning Objectives: Understand FDA’s pre-market and post-market review processes for medical devices Understand FDA’s current regulatory research activities in the areas of medical physics and imaging products Understand how being involved with AAPM and other organizations can also help to promote innovative, safe and effective medical devices J. Delfino, nothing to disclose.

Mobile devices in medicine: a survey of how medical students, residents, and faculty use smartphones and other mobile devices to find information*

Science.gov (United States)

Boruff, Jill T.; Storie, Dale

2014-01-01

Objectives: The research investigated the extent to which students, residents, and faculty members in Canadian medical faculties use mobile devices, such as smartphones (e.g., iPhone, Android, Blackberry) and tablet computers (e.g., iPad), to answer clinical questions and find medical information. The results of this study will inform how health libraries can effectively support mobile technology and collections. Methods: An electronic survey was distributed by medical librarians at four Canadian universities to medical students, residents, and faculty members via departmental email discussion lists, personal contacts, and relevant websites. It investigated the types of information sought, facilitators to mobile device use in medical information seeking, barriers to access, support needs, familiarity with institutionally licensed resources, and most frequently used resources. Results: The survey of 1,210 respondents indicated widespread use of smartphones and tablets in clinical settings in 4 Canadian universities. Third- and fourth-year undergraduate students (i.e., those in their clinical clerkships) and medical residents, compared to other graduate students and faculty, used their mobile devices more often, used them for a broader range of activities, and purchased more resources for their devices. Conclusions: Technological and intellectual barriers do not seem to prevent medical trainees and faculty from regularly using mobile devices for their medical information searches; however, barriers to access and lack of awareness might keep them from using reliable, library-licensed resources. Implications: Libraries should focus on providing access to a smaller number of highly used mobile resources instead of a huge collection until library-licensed mobile resources have streamlined authentication processes. PMID:24415916

Mobile devices in medicine: a survey of how medical students, residents, and faculty use smartphones and other mobile devices to find information.

Science.gov (United States)

Boruff, Jill T; Storie, Dale

2014-01-01

The research investigated the extent to which students, residents, and faculty members in Canadian medical faculties use mobile devices, such as smartphones (e.g., iPhone, Android, Blackberry) and tablet computers (e.g., iPad), to answer clinical questions and find medical information. The results of this study will inform how health libraries can effectively support mobile technology and collections. An electronic survey was distributed by medical librarians at four Canadian universities to medical students, residents, and faculty members via departmental email discussion lists, personal contacts, and relevant websites. It investigated the types of information sought, facilitators to mobile device use in medical information seeking, barriers to access, support needs, familiarity with institutionally licensed resources, and most frequently used resources. The survey of 1,210 respondents indicated widespread use of smartphones and tablets in clinical settings in 4 Canadian universities. Third- and fourth-year undergraduate students (i.e., those in their clinical clerkships) and medical residents, compared to other graduate students and faculty, used their mobile devices more often, used them for a broader range of activities, and purchased more resources for their devices. Technological and intellectual barriers do not seem to prevent medical trainees and faculty from regularly using mobile devices for their medical information searches; however, barriers to access and lack of awareness might keep them from using reliable, library-licensed resources. Libraries should focus on providing access to a smaller number of highly used mobile resources instead of a huge collection until library-licensed mobile resources have streamlined authentication processes.

[Marketing approval and market surveillance of medical devices in Germany: Where does policy integration take place?].

Science.gov (United States)

Lang, Achim

2014-01-01

Since 2011 new regulatory measures regarding medical devices have been set up with the aim to eliminate obstacles to innovations and to find more coordinated ways to marketing authorisation and market surveillance. This essay investigates whether these new and existing coordination mechanisms build up to a Joined-up Government approach. The analysis shows that the regulatory process should be adjusted along several dimensions. First, many organisations lack awareness regarding their stakeholders and focus solely on their immediate organisational activities. Second, the regulatory process (marketing authorisation and market surveillance) is too fragmented for an effective communication to take place. Finally, the underlying strategy process is an ad-hoc approach lacking continuity and continued involvement of, in particular, the responsible federal ministries. Copyright © 2013. Published by Elsevier GmbH.

Implantable Medical Devices; Networking Security Survey

OpenAIRE

Siamak Aram; Rouzbeh A. Shirvani; Eros G. Pasero; Mohamd F. Chouikha

2016-01-01

The industry of implantable medical devices (IMDs) is constantly evolving, which is dictated by the pressing need to comprehensively address new challenges in the healthcare field. Accordingly, IMDs are becoming more and more sophisticated. Not long ago, the range of IMDs’ technical capacities was expanded, making it possible to establish Internet connection in case of necessity and/or emergency situation for the patient. At the same time, while the web connectivity of today’s implantable dev...

Framework conditions and requirements to ensure the technical functional safety of reprocessed medical devices.

Science.gov (United States)

Kraft, Marc

2008-09-03

Testing and restoring technical-functional safety is an essential part of medical device reprocessing. Technical functional tests have to be carried out on the medical device in the course of the validation of reprocessing procedures. These ensure (in addition to the hygiene tests) that the reprocessing procedure is suitable for the medical device. Functional tests are, however, also a part of reprocessing procedures. As a stage in the reprocessing, they ensure for the individual medical device that no damage or other changes limit the performance. When determining which technical-functional tests are to be carried out, the current technological standard has to be taken into account in the form of product-specific and process-oriented norms. Product-specific norms primarily define safety-relevant requirements. The risk management method described in DIN EN ISO 14971 is the basis for recognising hazards; the likelihood of such hazards arising can be minimised through additional technical-functional tests, which may not yet have been standardised. Risk management is part of a quality management system, which must be bindingly certified for manufacturers and processors of critical medical devices with particularly high processing demands by a body accredited by the competent authority.

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

Science.gov (United States)

2012-01-25

... devices. DATES: Submit either electronic or written comments by March 5, 2012. ADDRESSES: Submit.... Designing pediatric medical devices can be challenging; children are often smaller and more active than adults; body structures and functions change throughout childhood, and children may be long-term device...

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...... of the medical device sector. This paper reports on the development of a Maturity Grid to address this gap. This novel design tool was developed iteratively through application in five case studies. The tool captures principles of eco-design for medical devices in a simple form, designed to be used by a team...

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

Science.gov (United States)

2013-05-13

...] Dental Products Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Dental Products Panel of the Medical Devices Advisory Committee. General Function of the Committee: To... regulatory classification for dental devices known as Endosseous Dental Implants (Blade-form), one of the...

Nanomedical device and systems design challenges, possibilities, visions

CERN Document Server

2014-01-01

Nanomedical Device and Systems Design: Challenges, Possibilities, Visions serves as a preliminary guide toward the inspiration of specific investigative pathways that may lead to meaningful discourse and significant advances in nanomedicine/nanotechnology. This volume considers the potential of future innovations that will involve nanomedical devices and systems. It endeavors to explore remarkable possibilities spanning medical diagnostics, therapeutics, and other advancements that may be enabled within this discipline. In particular, this book investigates just how nanomedical diagnostic and

[Exhaustivity and critical tone of the news in print media reporting medical innovations].

Science.gov (United States)

Solans-Domènech, Maite; Millaret, Marta; Radó-Trilla, Núria; Caro-Mendivelso, Johanna; Carrion, Carme; Permanyer-Miralda, Gaietà; Pons, Joan M V

2017-11-24

To quantify how exhaustive and critical were stories reporting medical innovations published in print media and to analyze the characteristics that may be related. Content analysis of the newspapers stories related to the discovery, introduction or improvement of a medical innovation through a questionnaire with ten criteria that allows calculating an overall score of exhaustiveness. The critical view was also included. We analyzed 204 newspapers stories that on average obtained a comprehensiveness score of 4.5. Were optimistic 70% of the stories. The most valued criteria were: level of detail of the explanation of the innovation and the correct differentiation between facts and opinions. While the worst-valued criteria were: disclosure of financial conflicts of interest and the quantification of harms. The variables author, length of the story and classification of the innovation were related to both the comprehensiveness score and the critical view. The comprehensiveness score was also related to the pathology, number of sources of information and the critical tone of the story, while the critical view was also related to the newspapers diffusion and the relevance of the news. The analyzed stories presented inaccuracies, biases or an excess of optimism (either intentional or involuntary). Some aspects of the stories discussed in more detail would provide solutions to many of the identified shortcomings. Copyright © 2017 SESPAS. Publicado por Elsevier España, S.L.U. All rights reserved.

An investor perspective on forming and funding your medical device start-up.

Science.gov (United States)

Mas, Juan-Pablo; Hsueh, Brian

2017-06-01

Novel and transformative medical technologies of all forms have the potential to make a significant positive impact on the lives of patients and on the health care system, and one common pathway for guiding such innovations from concept through commercialization is via the formation of a company. For entrepreneurs looking to build a medical technology company, several common challenges await, including questions around how and where to raise funding. Here, we review key considerations for the formation of medical technology companies as viewed through the lens of an investor. We survey common sources of capital for early-stage companies, including grants, angel investors, and venture capital, and offer insights into how to differentiate among them to select the best partners for your start-up׳s needs. Finally, we discuss the critical components of pitching your ideas to potential investors, and offer guidance on best practices and common mistakes. We hope this primer on fundamental concepts and the various health care funding alternatives will prepare entrepreneurs to achieve their mission to improve patients׳ lives through commercialization of their medical innovations. Copyright © 2017 Elsevier Inc. All rights reserved.

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...

Additive Manufacturing for Robust and Affordable Medical Devices

OpenAIRE

Wolozny Gomez Robelo, Daniel Andre

2016-01-01

Additive manufacturing in the form of 3D printing is a revolutionary technology that has developed within the last two decades. Its ability to print an object with accurate features down to the micro scale have made its use in medical devices and research feasible. A range of life-saving technologies can now go from the laboratory and into field with the application of 3D-printing. This technology can be applied to medical diagnosis of patients in at-risk populations. Living biosensors a...

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

Science.gov (United States)

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

2017-02-01

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

An extended protocol for usability validation of medical devices : Research design and reference model

NARCIS (Netherlands)

Schmettow, M.; Schnittker, R.; Schraagen, J.M.

2017-01-01

This paper proposes and demonstrates an extended protocol for usability validation testing of medical devices. A review of currently used methods for the usability evaluation of medical devices revealed two main shortcomings. Firstly, the lack of methods to closely trace the interaction sequences

First Approval of Improved Medical Device Conditional on Use-Result Survey in Japan　- Regulatory Review of Polymer-Free Drug-Coated BioFreedom Coronary Stent.

Science.gov (United States)

Konishi, Akihide; Ho, Mami; Shirai, Yuko; Shirato, Haruki

2018-05-25

A prospective randomized clinical trial showed that the BioFreedom stent (Biosensors International), which is a polymer-free and carrier-free drug-coated stent, was significantly superior to a bare-metal stent (BMS) in patients at high bleeding risk who were receiving a 1-month course of dual antiplatelet therapy (DAPT). However, the stent thrombosis rate (2.01% for BioFreedom vs. 2.20% for BMS) was 4-6-fold higher than that of approved drug-eluting stents based on real-world data in Japan. Furthermore, the frequency of stent thrombosis at more than 1 month with the BioFreedom stent was slightly higher than that at less than 1 month. This result suggested that it would not be acceptable to stop DAPT universally at 1 month. Thus, the target patients for the BioFreedom stent are unspecified patients at high bleeding risk needing to continue DAPT for as long as necessary in Japan. Therefore, based on the pre- and post-marketing balance of medical devices regulations, regulatory approval was given for unspecified patients conditionally upon real-world data collection of 2,000 patients with a Use-Results Survey, instead of conducting additional pre-marketing clinical trial(s). The Use-Results Survey System is part of a strategy to expedite patients' access to innovative medical devices and to accelerate the development of medical devices.

Cybersecurity Regulation of Wireless Devices for Performance and Assurance in the Age of "Medjacking".

Science.gov (United States)

Armstrong, David G; Kleidermacher, David N; Klonoff, David C; Slepian, Marvin J

2015-08-27

We are rapidly reaching a point where, as connected devices for monitoring and treating diabetes and other diseases become more pervasive and powerful, the likelihood of malicious medical device hacking (known as "medjacking") is growing. While government could increase regulation, we have all been witness in recent times to the limitations and issues surrounding exclusive reliance on government. Herein we outline a preliminary framework for establishing security for wireless health devices based on international common criteria. Creation of an independent medical device cybersecurity body is suggested. The goal is to allow for continued growth and innovation while simultaneously fostering security, public trust, and confidence. © 2015 Diabetes Technology Society.

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

International Nuclear Information System (INIS)

Ito, Hitoshi; Ishigaki, Isao

1986-01-01

Radiation treatment is getting important position for sterilizing medical devices and for packaging films of foods. Recently, survey of bioburden is an important technique for evaluation of sterility doses for medical devices. However, many studies have been done mainly on the irradiation effects of spore-forming bacteria in medical devices. In this study, radiation sensitivity of spore-forming bacteria and fungi were examined after the survey on distribution of microorganisms in several kinds of medical devices. The main contaminant in disposable syringes, needles and conical flasks were consisted of Bacillus, with lesser amount of Micrococcus, Pseudomonas, Peptococcaceae and fungi as positive of 5 - 60 % in the medical devices which cultivated in thioglycolate broth. Bacillus group were identified as B. pumilus, B. sphaericus, B. coagulans, B. megaterium and etc. Fungi were isolated a lesser amounts compared with spore-forming bacteria and identified as Blastomyces, Penicillium, Haplosporangium, Euricoa and Audeobasidium. Peptococaceae were not isolated after irradiation with a dose of 0.1 Mrad even the samples were contaminated with high percentage. The D 10 values of dryed endospores of Bacillus-isolates which attached to the filter paper with pepton-glycerin were obtained to be 0.11 - 0.19 Mrad. The D 10 values of many isolates of fungi in dry condition were obtained below 0.08 Mrad. However, the isolate of Aureobasidium is radiation-resistant, and it's D 10 values was obtained as 0.28 Mrad under aerobic and anaerobic dry condition. (author)

Medical devices of the head, neck, and spine.

Science.gov (United States)

Hunter, Tim B; Yoshino, Mark T; Dzioba, Robert B; Light, Rick A; Berger, William G

2004-01-01

There are many medical devices used for head, neck, and spinal diseases and injuries, and new devices are constantly being introduced. Many of the newest devices are variations on a previous theme. Knowing the specific name of a device is not important. It is important to recognize the presence of a device and to have an understanding of its function as well as to be able to recognize the complications associated with its use. The article discusses the most common and important devices of the head, neck, and spine, including cerebrospinal fluid shunts and the Codman Hakim programmable valve; subdural drainage catheters, subdural electrodes, intracranial electrodes, deep brain stimulators, and cerebellar electrodes; coils, balloons, adhesives, particles, and aneurysm clips; radiation therapy catheters, intracranial balloons for drug installation, and carmustine wafers; hearing aids, cochlear implants, and ossicular reconstruction prostheses; orbital prostheses, intraocular silicone oil, and lacrimal duct stents; anterior and posterior cervical plates, posterior cervical spine wiring, odontoid fracture fixation devices, cervical collars and halo vests; thoracic and lumbar spine implants, anterior and posterior instrumentation for the thoracic and lumbar spine, vertebroplasty, and artificial disks; spinal column stimulators, bone stimulators, intrathecal drug delivery pumps, and sacral stimulators; dental and facial implant devices; gastric and tracheal tubes; vagus nerve stimulators; lumboperitoneal shunts; and temperature- and oxygen-sensing probes. Copyright RSNA, 2004

Innovating Healthcare Processes for Speed and Effectiveness

Directory of Open Access Journals (Sweden)

Maryline Margueritte

2013-12-01

Full Text Available For several years, health networks have developed devices enabling coordinated care of patients in France, regarding both medical plans as well as medico-psycho-social and human care. Some have developed computerized health records for sharing useful information for the coordination and continuity of care. Since the 2009 hospital reform, cooperative operating modes between health system professionals and users are being installed. The implementation of a health information system permits, on one hand, to ensure the transversality of the business process with the patient and, on the other hand, to measure the results of the medical and economic evolution of a complex system of information. The possibilities offered by new technologies of information and communication enable the development of applications supporting increased "on line" participation for citizens. The "ambulatory approach" exports healthcare outside hospital walls. This is an innovative medicine allowing the patient to stay at his home. In France, this re-engineering is based on four areas: a medical record, a collective ownership by the medical and paramedical professions, empowerment of patients and networking in the health sector.Keywords: Health; Networks; Information System; Innovation; Medicine; Patients; Science.

Socially responsible medical education: innovations and challenges in a minority setting.

Science.gov (United States)

Schofield, Aurel; Bourgeois, Daniel

2010-03-01

Distributed medical education sites help train, recruit and retain doctors, notably in rural and isolated areas, by providing education and training in these areas and adapting their curriculum to meet the host community's health needs. The Centre de Formation Médicale du Nouveau Brunswick (CFMNB; New Brunswick Medical Education Centre) was established by a partnership between two academic institutions, the Université de Sherbrooke (University of Sherbrooke), situated in the province of Quebec, and the Université de Moncton (University of Moncton), situated in the province of New Brunswick, in Canada. The CFMNB is specifically targeting a minority community (Acadians). Working to establish a high-quality medical education programme, the CFMNB has also set community objectives to meet not only the health needs of this population, but also its social and economic needs. This paper describes the overall objectives of this project, which are: to reduce the gap between community needs and academic institutional needs; to address ethno-cultural and language differences in a defined minority population, and to develop collaboration between the partners involved, including government and community entities which are often perceived as operating in isolation from one another. We also describe why and how the CFMNB developed community-focused objectives and the challenges that came with these innovations, and present lessons from the experience that may be relevant to other sites interested in the social responsibility of medical schools. The CFMNB has produced interesting work and innovations in the field of social responsibility and has encountered many challenges. Continuing interaction between medical education, health research and health services to better address the needs of the population has been established. The information obtained by this process has been used to build a strategic plan for the CFMNB in order to ensure that it is socially responsive and has

Early-stage valuation of medical devices: the role of developmental uncertainty.

Science.gov (United States)

Girling, Alan; Young, Terry; Brown, Celia; Lilford, Richard

2010-08-01

At the concept stage, many uncertainties surround the commercial viability of a new medical device. These include the ultimate functionality of the device, the cost of producing it and whether, and at what price, it can be sold to a health-care provider (HCP). Simple assessments of value can be made by estimating such unknowns, but the levels of uncertainty may mean that their operational value for investment decisions is unclear. However, many decisions taken at the concept stage are reversible and will be reconsidered later before the product is brought to market. This flexibility can be exploited to enhance early-stage valuations. To develop a framework for valuing a new medical device at the concept stage that balances benefit to the HCP against commercial costs. This is done within a simplified stage-gated model of the development cycle for new products. The approach is intended to complement existing proposals for the evaluation of the commercial headroom available to new medical products. A model based on two decision gates can lead to lower bounds (underestimates) for product value that can serve to support a decision to develop the product. Quantifiable uncertainty that can be resolved before the device is brought to market will generally enhance early-stage valuations of the device, and this remains true even when some components of uncertainty cannot be fully described. Clinical trials and other evidence-gathering activities undertaken as part of the development process can contribute to early-stage estimates of value.

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

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0142] Drug and Medical Device Forum on Food and Drug Administration Drug and Device Requirements and Supplier Controls; Public Educational Forum AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public...

Design of point-of-care (POC) microfluidic medical diagnostic devices

Science.gov (United States)

Leary, James F.

2018-02-01

Design of inexpensive and portable hand-held microfluidic flow/image cytometry devices for initial medical diagnostics at the point of initial patient contact by emergency medical personnel in the field requires careful design in terms of power/weight requirements to allow for realistic portability as a hand-held, point-of-care medical diagnostics device. True portability also requires small micro-pumps for high-throughput capability. Weight/power requirements dictate use of super-bright LEDs and very small silicon photodiodes or nanophotonic sensors that can be powered by batteries. Signal-to-noise characteristics can be greatly improved by appropriately pulsing the LED excitation sources and sampling and subtracting noise in between excitation pulses. The requirements for basic computing, imaging, GPS and basic telecommunications can be simultaneously met by use of smartphone technologies, which become part of the overall device. Software for a user-interface system, limited real-time computing, real-time imaging, and offline data analysis can be accomplished through multi-platform software development systems that are well-suited to a variety of currently available cellphone technologies which already contain all of these capabilities. Microfluidic cytometry requires judicious use of small sample volumes and appropriate statistical sampling by microfluidic cytometry or imaging for adequate statistical significance to permit real-time (typically medical decisions for patients at the physician's office or real-time decision making in the field. One or two drops of blood obtained by pin-prick should be able to provide statistically meaningful results for use in making real-time medical decisions without the need for blood fractionation, which is not realistic in the field.

3D-printing and the effect on medical costs: a new era?

Science.gov (United States)

Choonara, Yahya E; du Toit, Lisa C; Kumar, Pradeep; Kondiah, Pierre P D; Pillay, Viness

2016-01-01

3D-printing (3DP) is the art and science of printing in a new dimension using 3D printers to transform 3D computer aided designs (CAD) into life-changing products. This includes the design of more effective and patient-friendly pharmaceutical products as well as bio-inspired medical devices. It is poised as the next technology revolution for the pharmaceutical and medical-device industries. After decorous implementation scientists in collaboration with CAD designers have produced innovative medical devices ranging from pharmaceutical tablets to surgical transplants of the human face and skull, spinal implants, prosthetics, human organs and other biomaterials. While 3DP may be cost-efficient, a limitation exists in the availability of 3D printable biomaterials for most applications. In addition, the loss of skilled labor in producing medical devices such as prosthetics and other devices may affect developing economies. This review objectively explores the potential growth and impact of 3DP costs in the medical industry.

#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...

A service protocol for post-processing of medical images on the mobile device

Science.gov (United States)

He, Longjun; Ming, Xing; Xu, Lang; Liu, Qian

2014-03-01

With computing capability and display size growing, the mobile device has been used as a tool to help clinicians view patient information and medical images anywhere and anytime. It is uneasy and time-consuming for transferring medical images with large data size from picture archiving and communication system to mobile client, since the wireless network is unstable and limited by bandwidth. Besides, limited by computing capability, memory and power endurance, it is hard to provide a satisfactory quality of experience for radiologists to handle some complex post-processing of medical images on the mobile device, such as real-time direct interactive three-dimensional visualization. In this work, remote rendering technology is employed to implement the post-processing of medical images instead of local rendering, and a service protocol is developed to standardize the communication between the render server and mobile client. In order to make mobile devices with different platforms be able to access post-processing of medical images, the Extensible Markup Language is taken to describe this protocol, which contains four main parts: user authentication, medical image query/ retrieval, 2D post-processing (e.g. window leveling, pixel values obtained) and 3D post-processing (e.g. maximum intensity projection, multi-planar reconstruction, curved planar reformation and direct volume rendering). And then an instance is implemented to verify the protocol. This instance can support the mobile device access post-processing of medical image services on the render server via a client application or on the web page.

Technological Innovations from NASA

Science.gov (United States)

Pellis, Neal R.

2006-01-01

The challenge of human space exploration places demands on technology that push concepts and development to the leading edge. In biotechnology and biomedical equipment development, NASA science has been the seed for numerous innovations, many of which are in the commercial arena. The biotechnology effort has led to rational drug design, analytical equipment, and cell culture and tissue engineering strategies. Biomedical research and development has resulted in medical devices that enable diagnosis and treatment advances. NASA Biomedical developments are exemplified in the new laser light scattering analysis for cataracts, the axial flow left ventricular-assist device, non contact electrocardiography, and the guidance system for LASIK surgery. Many more developments are in progress. NASA will continue to advance technologies, incorporating new approaches from basic and applied research, nanotechnology, computational modeling, and database analyses.

Limitations of poster presentations reporting educational innovations at a major international medical education conference

Directory of Open Access Journals (Sweden)

Morris Gordon

2013-02-01

Full Text Available Background: In most areas of medical research, the label of ‘quality’ is associated with well-accepted standards. Whilst its interpretation in the field of medical education is contentious, there is agreement on the key elements required when reporting novel teaching strategies. We set out to assess if these features had been fulfilled by poster presentations at a major international medical education conference. Methods: Such posters were analysed in four key areas: reporting of theoretical underpinning, explanation of instructional design methods, descriptions of the resources needed for introduction, and the offering of materials to support dissemination. Results: Three hundred and twelve posters were reviewed with 170 suitable for analysis. Forty-one percent described their methods of instruction or innovation design. Thirty-three percent gave details of equipment, and 29% of studies described resources that may be required for delivering such an intervention. Further resources to support dissemination of their innovation were offered by 36%. Twenty-three percent described the theoretical underpinning or conceptual frameworks upon which their work was based. Conclusions: These findings suggest that posters presenting educational innovation are currently limited in what they offer to educators. Presenters should seek to enhance their reporting of these crucial aspects by employing existing published guidance, and organising committees may wish to consider explicitly requesting such information at the time of initial submission.

Limitations of poster presentations reporting educational innovations at a major international medical education conference.

Science.gov (United States)

Gordon, Morris; Darbyshire, Daniel; Saifuddin, Aamir; Vimalesvaran, Kavitha

2013-02-19

In most areas of medical research, the label of 'quality' is associated with well-accepted standards. Whilst its interpretation in the field of medical education is contentious, there is agreement on the key elements required when reporting novel teaching strategies. We set out to assess if these features had been fulfilled by poster presentations at a major international medical education conference. Such posters were analysed in four key areas: reporting of theoretical underpinning, explanation of instructional design methods, descriptions of the resources needed for introduction, and the offering of materials to support dissemination. Three hundred and twelve posters were reviewed with 170 suitable for analysis. Forty-one percent described their methods of instruction or innovation design. Thirty-three percent gave details of equipment, and 29% of studies described resources that may be required for delivering such an intervention. Further resources to support dissemination of their innovation were offered by 36%. Twenty-three percent described the theoretical underpinning or conceptual frameworks upon which their work was based. These findings suggest that posters presenting educational innovation are currently limited in what they offer to educators. Presenters should seek to enhance their reporting of these crucial aspects by employing existing published guidance, and organising committees may wish to consider explicitly requesting such information at the time of initial submission.

Pediatric medical device development by surgeons via capstone engineering design programs.

Science.gov (United States)

Sack, Bryan S; Elizondo, Rodolfo A; Huang, Gene O; Janzen, Nicolette; Espinoza, Jimmy; Sanz-Cortes, Magdalena; Dietrich, Jennifer E; Hakim, Julie; Richardson, Eric S; Oden, Maria; Hanks, John; Haridas, Balakrishna; Hury, James F; Koh, Chester J

2018-03-01

There is a need for pediatric medical devices that accommodate the unique physiology and anatomy of pediatric patients that is increasingly receiving more attention. However, there is limited literature on the programs within children's hospitals and academia that can support pediatric device development. We describe our experience with pediatric device design utilizing collaborations between a children's hospital and two engineering schools. Utilizing the academic year as a timeline, unmet pediatric device needs were identified by surgical faculty and matched with an engineering mentor and a team of students within the Capstone Engineering Design programs at two universities. The final prototypes were showcased at the end of the academic year and if appropriate, provisional patent applications were filed. All twelve teams successfully developed device prototypes, and five teams obtained provisional patents. The prototypes that obtained provisional patents included a non-operative ureteral stent removal system, an evacuation device for small kidney stone fragments, a mechanical leech, an anchoring system of the chorio-amniotic membranes during fetal surgery, and a fetal oxygenation monitor during fetoscopic procedures. Capstone Engineering Design programs in partnership with surgical faculty at children's hospitals can play an effective role in the prototype development of novel pediatric medical devices. N/A - No clinical subjects or human testing was performed. Copyright © 2017 Elsevier Inc. All rights reserved.

Design control considerations for biologic-device combination products.

Science.gov (United States)

Anderson, Dave; Liu, Roger; Anand Subramony, J; Cammack, Jon

2017-03-01

Combination products are therapeutic and diagnostic medical products that combine drugs, devices, and/or biological products with one another. Historically, biologics development involved identifying efficacious doses administered to patients intravenously or perhaps by a syringe. Until fairly recently, there has been limited focus on developing an accompanying medical device, such as a prefilled syringe or auto-injector, to enable easy and more efficient delivery. For the last several years, and looking forward, where there may be little to distinguish biologics medicines with relatively similar efficacy profiles, the biotechnology market is beginning to differentiate products by patient-focused, biologic-device based combination products. As innovative as biologic-device combination products are, they can pose considerable development, regulatory, and commercialization challenges due to unique physicochemical properties and special clinical considerations (e.g., dosing volumes, frequency, co-medications, etc.) of the biologic medicine. A biologic-device combination product is a marriage between two partners with "cultural differences," so to speak. There are clear differences in the development, review, and commercialization processes of the biologic and the device. When these two cultures come together in a combination product, developers and reviewers must find ways to address the design controls and risk management processes of both the biologic and device, and knit them into a single entity with supporting product approval documentation. Moreover, digital medicine and connected health trends are pushing the boundaries of combination product development and regulations even further. Despite an admirable cooperation between industry and FDA in recent years, unique product configurations and design features have resulted in review challenges. These challenges have prompted agency reviewers to modernize consultation processes, while at the same time, promoting

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.

Cybersecurity Regulation of Wireless Devices for Performance and Assurance in the Age of “Medjacking”

Science.gov (United States)

Armstrong, David G.; Kleidermacher, David N.; Klonoff, David C.; Slepian, Marvin J.

2015-01-01

We are rapidly reaching a point where, as connected devices for monitoring and treating diabetes and other diseases become more pervasive and powerful, the likelihood of malicious medical device hacking (known as “medjacking”) is growing. While government could increase regulation, we have all been witness in recent times to the limitations and issues surrounding exclusive reliance on government. Herein we outline a preliminary framework for establishing security for wireless health devices based on international common criteria. Creation of an independent medical device cybersecurity body is suggested. The goal is to allow for continued growth and innovation while simultaneously fostering security, public trust, and confidence. PMID:26319227

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.

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

Science.gov (United States)

2013-06-14

...] Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; Draft Guidance for... draft guidance entitled ``Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.'' This guidance identifies cybersecurity issues that manufacturers should consider in preparing...

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.

Innovative wave energy device applied to coastal observatory systems

Science.gov (United States)

Marcelli, Marco; Bonamano, Simone; Piermattei, Viviana; Scanu, Sergio; Paladini de Mendoza, Francesco; Martellucci, Riccardo; Maximo, Peviani

2017-04-01

Marine environment is one of the most promising sources of renewable energy, whose exploitation could have an effect on several application fields. This work presents the design of an innovative device based on the Oscillating Water Column (OWC), that allows to convert wave energy into electricity, suitable for the typical Mediterranean wave climate. The flexibility of the device permits its installation either in deep or shallow waters, with reduced costs of deployment, maintenance and connection to the grid. Furthermore, the replicability of the design allows the device to be installed in array of several number of similar units. The technical concept is to convey the sea water within a vertical pipe, in which the water movements activate a rotor connected to a generator that transforms the energy of the water motion into electricity. The hydrodynamic design of the pipe is built to minimize the losses due to friction and turbulence and to exploit the maximum possible energy from wave motion. The wave energy is directly absorbed by the rotational movement of the turbine blades located in the water itself allowing a further reduction of the energy losses associated with the transformation of the linear water motion into electrical generation in the air phase (typical configuration of the OWC devices). In this work the device components are described considering two possible configurations that use a Wells turbine or a Bulb type turbine. The system can be realized at a low cost, because of the modularity of the device project, which allows large freedom of sizes and placements, being able to be installed both individually and in arrays. The modularity, associated with the fact that the main elements of the system are available on the market, makes the device particularly attractive from the economic point of view. Finally, it is realized with a high constructive flexibility: the proposed system can be transported floating and moored to existing coastal structures or

The impact of intramural grants on educators' careers and on medical education innovation.

Science.gov (United States)

Adler, Shelley R; Chang, Anna; Loeser, Helen; Cooke, Molly; Wang, Jason; Teherani, Arianne

2015-06-01

The University of California, San Francisco (UCSF), Haile T. Debas Academy of Medical Educators Innovations Funding program awards competitive grants to create novel curricula and faculty development programs, compare pedagogical approaches, and design learner assessment methods. The authors examined the principal investigators' (PIs') perceptions of the impact of these intramural grants on their careers and on medical education innovation. At 12 months (project completion) and 24 months (follow-up), PIs submit a progress report describing the impact of their grant on their careers, work with collaborators, subsequent funding, project dissemination, and the UCSF curriculum. The authors analyzed these reports using qualitative thematic analysis and achieved consensus in coding and interpretation through discussion. From 2001 to 2012, the program funded 77 PIs to lead 103 projects, awarding over $2.2 million. The authors analyzed reports from 88 grants (85.4%) awarded to 68 PIs (88.3%). PIs noted that the funding led to accelerated promotion, expanded networking opportunities, enhanced knowledge and skills, more scholarly publications and presentations, extramural funding, and local and national recognition. They also reported that the funding improved their status in their departments, enhanced their careers as medical educators, laid the foundation for subsequent projects, and engaged an array of stakeholders, including trainees and junior faculty. These modest intramural education grants not only created innovative, enduring programs but also promoted educators' professional identity formation, fostered collaborations, supported junior faculty in finding their desired career paths, provided advancement opportunities, and raised the local and national profiles of recipients.

Understanding the adoption dynamics of medical innovations: affordances of the da Vinci robot in the Netherlands.

Science.gov (United States)

Abrishami, Payam; Boer, Albert; Horstman, Klasien

2014-09-01

This study explored the rather rapid adoption of a new surgical device - the da Vinci robot - in the Netherlands despite the high costs and its controversial clinical benefits. We used the concept 'affordances' as a conceptual-analytic tool to refer to the perceived promises, symbolic meanings, and utility values of an innovation constructed in the wider social context of use. This concept helps us empirically understand robot adoption. Data from 28 in-depth interviews with diverse purposively-sampled stakeholders, and from medical literature, policy documents, Health Technology Assessment reports, congress websites and patients' weblogs/forums between April 2009 and February 2014 were systematically analysed from the perspective of affordances. We distinguished five interrelated affordances of the robot that accounted for shaping and fulfilling its rapid adoption: 'characteristics-related' affordances such as smart nomenclature and novelty, symbolising high-tech clinical excellence; 'research-related' affordances offering medical-technical scientific excellence; 'entrepreneurship-related' affordances for performing better-than-the-competition; 'policy-related' affordances indicating the robot's liberalised provision and its reduced financial risks; and 'communication-related' affordances of the robot in shaping patients' choices and the public's expectations by resonating promising discourses while pushing uncertainties into the background. These affordances make the take-up and use of the da Vinci robot sound perfectly rational and inevitable. This Dutch case study demonstrates the fruitfulness of the affordances approach to empirically capturing the contextual dynamics of technology adoption in health care: exploring in-depth actors' interaction with the technology while considering the interpretative spaces created in situations of use. This approach can best elicit real-life value of innovations, values as defined through the eyes of (potential) users

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.

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

Directory of Open Access Journals (Sweden)

Maya Lyapina

2015-02-01

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

Communication during pediatric asthma visits and child asthma medication device technique 1 month later.

Science.gov (United States)

Sleath, Betsy; Carpenter, Delesha M; Ayala, Guadalupe X; Williams, Dennis; Davis, Stephanie; Tudor, Gail; Yeatts, Karin; Gillette, Chris

2012-11-01

This study investigated how provider demonstration of and assessment of child use of asthma medication devices and certain aspects of provider-patient communication during medical visits is associated with device technique 1 month later. Two hundred and ninety-six children aged 8-16 years with persistent asthma and their caregivers were recruited at five North Carolina pediatric practices. All of the medical visits were audio-tape recorded. Children were interviewed 1 month later and their device technique was observed and rated. If the provider asked the child to demonstrate metered dose inhaler technique during the medical visit, then the child was significantly more likely to perform a greater percentage of inhaler steps correctly 1 month later. Children with higher asthma management self-efficacy scores were significantly more likely to perform a greater percentage of diskus steps correctly. Additionally, children were significantly more likely to perform a greater percentage of diskus steps correctly if the provider discussed a written action plan during the visit. Children were significantly more likely to perform a greater percentage of turbuhaler steps correctly if they asked more medication questions. Providers should ask children to demonstrate their inhaler technique during medical visits so that they can educate children about proper technique and improve child asthma management self-efficacy. Providers should encourage children to ask questions about asthma medication devices during visits and they should discuss asthma action plans with families.

French Sizing of Medical Devices is not Fit for Purpose

International Nuclear Information System (INIS)

Kibriya, Nabil; Hall, Rebecca; Powell, Steven; How, Thien; McWilliams, Richard G.

2013-01-01

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

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

... drugs, devices, and medical treatments or procedures and adding the TRICARE definition of unlabeled or... labeling. We are now modifying the definition of ``unlabeled or off-label drug'' to ``off-label use of a... reference back to the definition of the term in 199.2. ``Off-label uses of drugs and devices'' includes off...

75 FR 20854 - Medical Device Use in the Home Environment: Implications for the Safe and Effective Use of...

Science.gov (United States)

2010-04-21

...] Medical Device Use in the Home Environment: Implications for the Safe and Effective Use of Medical Device... related to the safe and effective use of medical device technology in the home environment. The workshop... the home environment. FDA will solicit feedback on: 1. The agency's current working definition of...

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.

TU-AB-204-02: Device Adverse Events and Compliance

International Nuclear Information System (INIS)

Gonzales, S.

2016-01-01

), Image Gently, and the Quantitative Imaging Biomarkers Alliance (QIBA) among others, to fulfill FDA’s mission will be discussed. Learning Objectives: Understand FDA’s pre-market and post-market review processes for medical devices Understand FDA’s current regulatory research activities in the areas of medical physics and imaging products Understand how being involved with AAPM and other organizations can also help to promote innovative, safe and effective medical devices J. Delfino, nothing to disclose

TU-AB-204-02: Device Adverse Events and Compliance

Energy Technology Data Exchange (ETDEWEB)

Gonzales, S. [Food & Drug Administration (United States)

2016-06-15

), Image Gently, and the Quantitative Imaging Biomarkers Alliance (QIBA) among others, to fulfill FDA’s mission will be discussed. Learning Objectives: Understand FDA’s pre-market and post-market review processes for medical devices Understand FDA’s current regulatory research activities in the areas of medical physics and imaging products Understand how being involved with AAPM and other organizations can also help to promote innovative, safe and effective medical devices J. Delfino, nothing to disclose.

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

Directory of Open Access Journals (Sweden)

Sachin C. Deorukhkar

2016-01-01

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

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

78 FR 56719 - Challenging Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of...

Science.gov (United States)

2013-09-13

...] Challenging Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of Metabolic Diseases... announcing a public workshop entitled ``Changing Regulatory and Reimbursement Paradigms for Medical Devices... registration information on the AGA Web site. If you need special accommodations due to a disability, please...

Medical Device Integrated Vital Signs Monitoring Application with Real-Time Clinical Decision Support.

Science.gov (United States)

Moqeem, Aasia; Baig, Mirza; Gholamhosseini, Hamid; Mirza, Farhaan; Lindén, Maria

2018-01-01

This research involves the design and development of a novel Android smartphone application for real-time vital signs monitoring and decision support. The proposed application integrates market available, wireless and Bluetooth connected medical devices for collecting vital signs. The medical device data collected by the app includes heart rate, oxygen saturation and electrocardiograph (ECG). The collated data is streamed/displayed on the smartphone in real-time. This application was designed by adopting six screens approach (6S) mobile development framework and focused on user-centered approach and considered clinicians-as-a-user. The clinical engagement, consultations, feedback and usability of the application in the everyday practices were considered critical from the initial phase of the design and development. Furthermore, the proposed application is capable to deliver rich clinical decision support in real-time using the integrated medical device data.

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

International Nuclear Information System (INIS)

Ishizeki, Chuichi

1985-01-01

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

Limited Awareness of the Essences of Certification or Compliance Markings on Medical Devices.

Science.gov (United States)

Foo, Jong Yong Abdiel; Tan, Xin Ji Alan

2017-06-01

Medical devices have been long used for odiagnostic, therapeutic or rehabilitation purposes. Currently, they can range from a low-cost portable device that is often used for personal health monitoring to high-end sophisticated equipment that can only be operated by trained professionals. Depending on the functional purposes, there are different certification or compliance markings on the device when it is sold. One common certification marking is the Conformité Européenne affixation but this has a range of certification mark numbering for a variety of functional purposes. While the regulators and medical device manufacturers understand the associated significance and clinical implications, these may not be apparent to the professionals (using or maintaining the device) and the general public. With portable healthcare devices and mobile applications gaining popularity, better awareness of certification marking will be needed. Particularly, there are differences in the allowed functional purposes and the associated cost derivations of devices with a seemingly similar nature. A preferred approach such as an easy-to-understand notation next to any certification marking on a device can aid in differentiation without the need to digest mountainous regulatory details.

Feasibility of energy harvesting techniques for wearable medical devices.

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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.

Virtual reality, telemedicine, web and data processing innovations in medical and psychiatric education and clinical care.

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Hilty, Donald M; Alverson, Dale C; Alpert, Jonathan E; Tong, Lowell; Sagduyu, Kemal; Boland, Robert J; Mostaghimi, Arash; Leamon, Martin L; Fidler, Don; Yellowlees, Peter M

2006-01-01

This article highlights technology innovations in psychiatric and medical education, including applications from other fields. The authors review the literature and poll educators and informatics faculty for novel programs relevant to psychiatric education. The introduction of new technologies requires skill at implementation and evaluation to assess the pros and cons. There is a significant body of literature regarding virtual reality and simulation, including assessment of outcomes, but other innovations are not well studied. Innovations, like other uses of technology, require collaboration between parties and integration within the educational framework of an institution.

Dosimetric studies for gamma radiation validation of medical devices

International Nuclear Information System (INIS)

Soliman, Y.S.; Beshir, W.B.; Abdel-Fattah, A.A.; Abdel-Rehim, F.

2013-01-01

The delivery and validation of a specified dose to medical devices are key concerns to operators of gamma radiation facilities. The objective of the present study was to characterize the industrial gamma radiation facility and map the dose distribution inside the product-loading pattern during the validation and routine control of the sterilization process using radiochromic films. Cardboard phantoms were designed to achieve the homogeneity of absorbed doses. The uncertainty of the dose delivered during validation of the sterilization process was assessed. - Highlights: ► Using γ-rays for sterilization of hollow fiber dialyzers and blood tubing sets according to ISO 11137, 2006. ► Dosimetry studies of validations of γ-irradiation facility and sterilized medical devices. ► Places of D min and D max have been determined using FWT-60 films. ► Determining the target minimum doses required to meet the desired SAL of 10 −6 for the two products.

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

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Hannig, Jürgen; Siekmeier, Rüdiger

2015-01-01

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

Left Ventricular Assist Devices: The Adolescence of a Disruptive Technology.

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Pinney, Sean P

2015-10-01

Clinical outcomes for patients with advanced heart failure receiving left ventricular assist devices are driven by appropriate patient selection, refined surgical technique, and coordinated medical care. Perhaps even more important is innovative pump design. The introduction and widespread adoption of continuous-flow ventricular assist devices has led to a paradigm shift within the field of mechanical circulatory support, making the promise of lifetime device therapy closer to reality. The disruption caused by this new technology, on the one hand, produced meaningful improvements in patient survival and quality of life, but also introduced new clinical challenges, such as bleeding, pump thrombosis, and acquired valvular heart disease. Further evolution within this field will require financial investment to sustain innovation leading to a fully implantable, durable, and cost-effective pump for a larger segment of patients with advanced heart failure. Copyright © 2015 Elsevier Inc. All rights reserved.

Sri Lanka's national assessment on innovation and intellectual property for access to medical products.

Science.gov (United States)

Beneragama, Hemantha; Shridhar, Manisha; Ranasinghe, Thushara; Dissanayake, Vajira Hw

2016-09-01

In 2008, the Global strategy and plan of action on public health, innovation and intellectual property (GSPA-PHI) was launched by the World Health Organization, to stimulate fresh thinking on innovation in, and access to, medicines and to build sustainable research on diseases disproportionately affecting low- and middle-income countries. As part of the activities of the GSPA-PHI, Sri Lanka has been the first country to date to assess the national environment for medical technology and innovation. This year-long, multistakeholder, participative analysis facilitated identification of clear and implementable policy recommendations, for the government to increase its effectiveness in promoting innovation in health products through institutional development, investment and coordination among all areas relevant to public health. The assessment also highlighted areas for priority action, including closing the technology gap in development of health products, facilitating technology transfer, and building the health-research and allied workforces. The Sri Lankan experience will inform the ongoing independent external evaluation of the GSPA-PHI worldwide. The assessment process coincided with the passing of the National Medicines Regulatory Authority Act in 2015. In addition, there is growing recognition that regional cooperation will be critical to improving access to medical products in the future. Sri Lanka is therefore actively promoting cooperation to establish a regional regulatory affairs network. Lessons learnt from the Sri Lankan assessment may also benefit other countries embarking on a national GSPA-PHI assessment.

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.

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

Science.gov (United States)

Kim, Do-Hyun; Kim, Moon S.; Hwang, Jeeseong

2012-03-01

Contamination of the inner surface of indwelling (implanted) medical devices by microbial biofilm is a serious problem. Some microbial bacteria such as Escherichia coli form biofilms that lead to potentially lifethreatening infections. Other types of medical devices such as bronchoscopes and duodenoscopes account for the highest number of reported endoscopic infections where microbial biofilm is one of the major causes for these infections. We applied a hyperspectral imaging method to detect biofilm contamination on the surface of several common materials used for medical devices. Such materials include stainless steel, titanium, and stainless-steeltitanium alloy. Potential uses of hyperspectral imaging technique to monitor biofilm attachment to different material surfaces are discussed.

State of the art of medical devices featuring smart electro-rheological and magneto-rheological fluids

Directory of Open Access Journals (Sweden)

Jong-Seok Oh

2017-10-01

Full Text Available Recently, smart fluids have drawn significant attention and growing a great interest in a broad range of engineering applications such as automotive and medical areas. In this article, two smart fluids called electro-rheological (ER fluid and magneto-rheological (MR fluid are reviewed in terms of medical applications. Especially, this article describes the attributes and inherent properties of individual medical and rehabilitation devices. The devices surveyed in this article include multi-degree-of-freedom haptic masters for robot surgery, thin membrane touch panels for braille readers, sponge-like tactile sensors to feel human tissues such as liver, rehabilitation systems such as prosthetic leg, and haptic interfaces for dental implant surgery. The operating principle, inherent characteristics and practical feasibility of each medical device or system are fully discussed in details.

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

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

Science.gov (United States)

2016-10-01

death,” The Boston Globe, April 3 2010. 27. Arney D, Pajic M, Goldman JM, Lee I, Mangharam R, Sokolsky O, “Toward Patient Safety in Closed - Loop Medical ...becoming increasingly clear. We have been providing medical device interoperability domain expertise to assist the Veterans Administration in a...15. Wallroth C, Goldman J, Manigel J, Osborn D, Roellike T, Weininger S, Westenskow D, “Development of a Standard for Physiologic Closed Loop

Remote Access: A Vision for Mobile Medical Devices

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Herbert Ernst

2005-11-01

Full Text Available During the Symposium for Remote Engineering and Virtual Instrumentation held at Brasov in early July 2005 an outlook was presented regarding the future potential of remote engineering for mobile medical devices. It is the intention of this article to recapitulate the content of the initiated discussions and to stimulate work in this complex and until now largely neglected field of application.

How does the knowledge environment shape procurement practices for orthopaedic medical devices in Mexico?

Science.gov (United States)

Lingg, Myriam; Wyss, Kaspar; Durán-Arenas, Luis

2016-07-08

In organisational theory there is an assumption that knowledge is used effectively in healthcare systems that perform well. Actors in healthcare systems focus on managing knowledge of clinical processes like, for example, clinical decision-making to improve patient care. We know little about connecting that knowledge to administrative processes like high-risk medical device procurement. We analysed knowledge-related factors that influence procurement and clinical procedures for orthopaedic medical devices in Mexico. We based our qualitative study on 48 semi-structured interviews with various stakeholders in Mexico: orthopaedic specialists, government officials, and social security system managers or administrators. We took a knowledge-management related perspective (i) to analyse factors of managing knowledge of clinical procedures, (ii) to assess the role of this knowledge and in relation to procurement of orthopaedic medical devices, and (iii) to determine how to improve the situation. The results of this study are primarily relevant for Mexico but may also give impulsion to other health systems with highly standardized procurement practices. We found that knowledge of clinical procedures in orthopaedics is generated inconsistently and not always efficiently managed. Its support for procuring orthopaedic medical devices is insufficient. Identified deficiencies: leaders who lack guidance and direction and thus use knowledge poorly; failure to share knowledge; insufficiently defined formal structures and processes for collecting information and making it available to actors of health system; lack of strategies to benefit from synergies created by information and knowledge exchange. Many factors are related directly or indirectly to technological aspects, which are insufficiently developed. The content of this manuscript is novel as it analyses knowledge-related factors that influence procurement of orthopaedic medical devices in Mexico. Based on our results we

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

Directory of Open Access Journals (Sweden)

Ross JS

2015-05-01

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

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

Science.gov (United States)

2010-04-01

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

[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. Copyright © 2013 Société française de radiothérapie oncologique (SFRO). Published by Elsevier SAS. All rights reserved.

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. © 2013 The Authors. International Wound Journal © 2013 Medicalhelplines.com Inc and John Wiley & Sons Ltd.

Access to innovation - research, medical ethics, patient rights and financial resources

Directory of Open Access Journals (Sweden)

Maria Paula Leite Ribeiro de Faria

2016-12-01