scholarly journals PMD52 MEDICAL DEVICES AND SUSTAINABILITY: CLAIMS AND EVIDENCE IN NICE MEDICAL TECHNOLOGIES EVALUATION PROGRAMME

2019 ◽  
Vol 22 ◽  
pp. S678
Author(s):  
F. Sheldon ◽  
P. Dimmock ◽  
L. Islam
Keyword(s):  
Medical Devices ◽  
Medical Technologies ◽  
Evaluation Programme

Regulating Medical Devices in the United States

2020 ◽  
Author(s):  
Patricia J. Zettler ◽  
Erika Lietzan
Keyword(s):  
United States ◽  
Medical Device ◽  
Medical Devices ◽  
Complete Information ◽  
The United States ◽  
Risk Level ◽  
Management Tools ◽  
Medical Technologies ◽  
The Us ◽  
Medical Device Regulation

This chapter assesses the regulation of medical devices in the United States. The goal of the US regulatory framework governing medical devices is the same as the goal of the framework governing medicines. US law aims to ensure that medical devices are safe and effective for their intended uses; that they become available for patients promptly; and that manufacturers provide truthful, non-misleading, and complete information about the products. US medical device law is different from US medicines law in many ways, however, perhaps most notably because most marketed devices do not require pre-market approval. The chapter explores how the US Food and Drug Administration (FDA) seeks to accomplish its mission with respect to medical devicecough its implementation of its medical device authorities. It starts by explaining what constitutes a medical device and how the FDA classifies medical devices by risk level. The chapter then discusses how medical devices reach the market, the FDA's risk management tools, and the rules and incentives for innovation and competition. It concludes by exploring case studies of innovative medical technologies that challenge the traditional US regulatory scheme to consider the future of medical device regulation.

PP206 Health Technology Assessment Guidance In The United Kingdom: Addressing Issues Specific To Medical Devices

2021 ◽  
Vol 37 (S1) ◽  
pp. 26-26
Author(s):  
Scott Gibson ◽  
Sita Saunders ◽  
Amanda Hansson Hedblom ◽  
Maximilian Blüher ◽  
Rafael Torrejon Torres ◽  
...  
Keyword(s):  
United Kingdom ◽  
Health Technology Assessment ◽  
Medical Devices ◽  
Technology Assessment ◽  
Healthcare Providers ◽  
Economic Assessment ◽  
Health Technology ◽  
Training Costs ◽  
Medical Technologies ◽  
The United Kingdom

IntroductionThe United Kingdom spends approximately GBP4.2 billion (USD5.6 billion; EUR4.7 billion) each year on medical devices, but healthcare providers receive little health technology assessment (HTA) guidance on cost-effective device procurement. Our objective was to assess the availability of HTA guidance for medical technologies and to identify key challenges related to the economic assessment of these technologies.MethodsNational Institute for Health and Care Excellence technology appraisal (TA) and Medical Technologies Evaluation Programme (MTEP) appraisals published online between November 2009 and October 2020 were identified. The “case for adoption” recommendation, type of devices, and critiques of economic analyses for each MTEP appraisal were extracted and categorized.ResultsIn comparison to 415 publicly available TAs for pharmaceuticals, only 45 medical technologies have been appraised through the MTEP. MTEP-submitted technologies can be categorized into diagnostic (7), monitoring (3), prophylaxis (5), therapeutic (28), and other (2). Furthermore, 11 were implants, seven were used by patients, and 27 had provider interaction. Major points of MTEP criticism were a failure to model cost consequences, training costs, and organizational impact. There was also the barrier of transferring costs across budgeting divisions.ConclusionsIn comparison to HTA guidance for pharmaceuticals, there is a dearth of medical device guidance. Therapeutic and implantable devices appear to be disproportionately overrepresented in the MTEP process. This may be because their appraisal is most akin to pharmaceuticals, for which HTA processes are well established. To encourage more HTAs of medical devices, HTA guidance should elaborate on issues specifically related to medical devices.

Introduction of emerging medical devices on the market: A new procedure in Belgium

2007 ◽  
Vol 23 (4) ◽  
pp. 449-454 ◽  
Author(s):  
Imgard Vinck ◽  
Mattias Neyt ◽  
Nancy Thiry ◽  
Marleen Louagie ◽  
Dirk Ramaekers
Keyword(s):  
Health Care ◽  
Decision Making ◽  
Health Insurance ◽  
Cost Effectiveness ◽  
Medical Devices ◽  
Clinical Effectiveness ◽  
Added Value ◽  
Scientific Evaluation ◽  
Medical Technologies ◽  
Organizational Issues

When new medical technologies enter the market, there is often uncertainty about the added value for the patient and for society, hampering well-considered decision making about reimbursement. Current Belgian legislation already offered opportunities for the managed uptake of possibly innovative emerging implants. However, it has also some shortcomings such as the lack of a clear research design, rendering the scientific evaluation of clinical effectiveness, cost-effectiveness, and patient or organizational issues more difficult. Against this background, a new procedure was elaborated by the Belgian health insurance institute and the Belgian Health Care Knowledge Centre.

scholarly journals Review of Economic Submissions to NICE Medical Technologies Evaluation Programme

2016 ◽  
Vol 14 (6) ◽  
pp. 623-634 ◽  
Author(s):  
Abualbishr Alshreef ◽  
Michelle Jenks ◽  
William Green ◽  
Simon Dixon
Keyword(s):  
Medical Technologies ◽  
Evaluation Programme

scholarly journals Review of the role of NICE in promoting the adoption of innovative cardiac technologies

Heart ◽  
2018 ◽  
Vol 104 (22) ◽  
pp. 1817-1822 ◽  
Author(s):  
Peter H Groves ◽  
Chris Pomfrett ◽  
Mirella Marlow
Keyword(s):  
Medical Devices ◽  
Medical Technology ◽  
Professional Community ◽  
Evidence Based ◽  
Medical Technologies ◽  
Professional Societies ◽  
Diagnostic Technologies ◽  
Improve Health

The National Institute for Health and Care Excellence (NICE) Medical Technologies Evaluation Programme (MTEP) promotes the adoption of innovative diagnostic and therapeutic technologies into National Health Service (NHS) clinical practice through the publication of guidance and briefing documents. Since the inception of the programme in 2009, there have been 7 medical technologiesguidance, 3 diagnostics guidance and 23 medtechinnovation briefing documents published that are relevant to the heart and circulation. Medical technologies guidance is published by NICE for selected single technologies if they offer plausible additional benefits to patients and the healthcare system. Diagnostic guidance is published for diagnostic technologies if they have the potential to improve health outcomes, but if their introduction may be associated with an increase in overall cost to the NHS. Medtechinnovation briefings provide evidence-based advice to those considering the implementation of new medical devices or diagnostic technologies. This review provides reference to all of the guidance and briefing medical technology documents that NICE has published that are relevant to the heart and circulation and reflect on their diverse recommendations. The interaction of MTEP with other NICE programmes is integral to its effectiveness and the means by which consistency is ensured across the different NICE programmes is described. The importance of the input of clinical experts from the cardiovascular professional community and the engagement by NICE with cardiovascular professional societies is highlighted as being fundamental to ensuring the quality of guidance outputs as well as to promoting their implementation and adoption.

scholarly journals Spending of medical devices in Slovakia

2014 ◽  
Vol 61 (2) ◽  
pp. 35-41
Author(s):  
I. Malovecká ◽  
J. Vidrová ◽  
D. Mináriková ◽  
V. Foltán
Keyword(s):  
Urinary Retention ◽  
Medical Devices ◽  
Public Health Insurance ◽  
Community Pharmacies ◽  
Supportive Treatment ◽  
Direct Sales ◽  
Medical Technologies ◽  
Insurance Funds ◽  
Health Insurance Funds ◽  
Reduced Risk

AbstractMedical devices (MD), together with pharmacotherapy are supportive treatment of many acute and chronic diseases. MD as a part of medical technologies lead to more effective treatment, faster patient recovery and a reduced risk of complications. Many MD are reimbursed from public health insurance funds entirely; for others, particularly advanced functional types of MD, there must be patient participation on price or they can buy them according own decision (direct sale). The target of this study is to analyze the data from paid databases of National Center for Health Information (NCHI) that collects the outputs of provided healthcare. The most recent data were from 1.1.2013 to 30.9.2013. According to NCHI, apart from community pharmacies, there are 226 registered establishments that sold MD until 30.9.2013. Their specialization included dispensing MD (n=163), dispensing orthopaedic devices (n=48) and dispensing audioprosthetic devices (n=15). In the observed period, average monthly spending on MD were 10.1 million packages and 14 million €. Average monthly spending on reimbursed MD were 8.8 million packages and 12.9 million €. The groups with the largest shares were MD for incontinence and urinary retention, 7.7 million packages (86.9%) and 3.9 million € (30.7%); plasters and bandaging materials, 0.5 million packages (6.0%) and 1.3 million € (10.1%); MD for ostomies, 0.4 million packages (4.5%) and 1 million € (8.0%); and the MD for diabetics group, 0.1 million packages (1.4%) and 1.6 million € (12.8%). Direct sales of MD per month on average reached 1.3 million packages and 1.1 million €. The groups with largest shares were MD for incontinence and urinary retention, 629,660 packages (50.3%) and 291,919 € (26.2%); plasters and bandaging materials, 388,111 packages (31.0%) and 227,119 € (20.4%); and MD for diabetics, 56,014 packages (4.5%) and 81,721 € (7.3%).

scholarly journals Improvement of the Procedure for the Introduction of New Medical Technologies in Kazakhstan Based on the Extracorporeal Membrane Oxygenation

2021 ◽  
Vol 1 (41) ◽  
pp. 48-53
Author(s):  
Kapyshev Timur ◽  
Keyword(s):  
Extracorporeal Membrane Oxygenation ◽  
Medical Devices ◽  
High Efficiency ◽  
Life Support ◽  
Extracorporeal Life Support ◽  
Health Technology ◽  
Medical Organization ◽  
Medical Technologies ◽  
Membrane Oxygenation ◽  
High Standards

The process of introduction of new medical technologies in Kazakhstan is regulated by a number of normative and legal acts, and is aimed at allowing the use of drugs and medical devices that meet high standards of safety, quality and efficiency. This article examines the process of such introduction based on the extracorporeal membrane oxygenation technology, with an analysis of all stages of the process and recommendations for its improvement. Given the high efficiency of new medical technologies (on the example of extracorporeal membrane oxygenation), when their limited use is due to the lack of funds of a medical organization, the involvement of additional intellectual resources seems expedient. Key words: Health Technology Assessment, Extracorporeal Life Support, Extracorporeal Membrane Oxygenation, Health Service Assessment

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