Better health care with quality medical devices: FDA on the cutting edge of device technology

2002 ◽  
Vol 8 (3) ◽  
pp. 89-90
Author(s):  
Suzanne Rich
2021 ◽  
pp. 0272989X2110190
Author(s):  
Ilyas Khan ◽  
Liliane Pintelon ◽  
Harry Martin

Objectives The main objectives of this article are 2-fold. First, we explore the application of multicriteria decision analysis (MCDA) methods in different areas of health care, particularly the adoption of various MCDA methods across health care decision making problems. Second, we report on the publication trends on the application of MCDA methods in health care. Method PubMed was searched for literature from 1960 to 2019 in the English language. A wide range of keywords was used to retrieve relevant studies. The literature search was performed in September 2019. Articles were included only if they have reported an MCDA case in health care. Results and Conclusion The search yielded 8,318 abstracts, of which 158 fulfilled the inclusion criteria and were considered for further analysis. Hybrid methods are the most widely used methods in health care decision making problems. When it comes to single methods, analytic hierarchy process (AHP) is the most widely used method followed by TOPSIS (technique for order preference by similarity to ideal solution), multiattribute utility theory, goal programming, EVIDEM (evidence and value: impact on decision making), evidential reasoning, discrete choice experiment, and so on. Interestingly, the usage of hybrid methods has been high in recent years. AHP is most widely applied in screening and diagnosing and followed by treatment, medical devices, resource allocation, and so on. Furthermore, treatment, screening and diagnosing, medical devices, and drug development and assessment got more attention in the MCDA context. It is indicated that the application of MCDA methods to health care decision making problem is determined by the nature and complexity of the health care problem. However, guidelines and tools exist that assist in the selection of an MCDA method.


2021 ◽  
pp. 70-75
Author(s):  
Viktor Yurievich Kozlov ◽  
Larisa Arkadyevna Karaseva

A safe hospital environment should fully provide the patient and healthcare professional with the comfort and safety conditions that effectively address vital health needs. To this end, medical devices are manufactured for the healthcare industry to ensure the safety of the hospital environment for patients and medical workers [2, 3].


2017 ◽  
Vol 33 (S1) ◽  
pp. 116-117
Author(s):  
Jana Hemmerling ◽  
Karolin Eberle ◽  
Sara Hogger ◽  
Maike Gupta ◽  
Anna Ullraum ◽  
...  

INTRODUCTION:National Health Technology Assessments (HTAs) for medical devices are crucial to regulate the quality and costs of healthcare systems. However, there is diversity in several aspects among European countries. Consequently, controversial results might arise, generating contrary reimbursement decisions. The European Network for Health Technology Assessment (EUnetHTA) is an interface platform for the harmonization of HTA information across Europe. The European Commission expects national uptake of a European HTA. Thus, European HTAs might overcome the diversity of national HTA requirements.METHODS:We aimed to compare German and European HTAs for medical devices regarding processes, methods, timelines, and involvement of medical device companies. Therefore we analyzed guidelines, requirements, and output of EUnetHTA and compared those aspects with the German G-BA (Federal Joint Committee, Gemeinsamer Bundesausschuss) standard and IQWiG (Institute for Quality and Efficiency in Health Care, Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen) methods.RESULTS:We found differences between the European and German HTAs for medical devices regarding timelines, involvement of medical device companies, body of evidence, use of surrogate endpoints, and methodology. European HTAs for medical devices reflect the clinical reality by integrating the existing evidence (including real world data) and by using comprehensive statistical methods for medical devices. In contrast, German HTAs for medical device-based technologies are long lasting and are often restricted to a small body of evidence.CONCLUSIONS:As a conclusion, similar to pharmaceuticals, the European HTA framework might also become a worldwide platform for HTAs of medical device-based technologies with the potential to harmonize reimbursement decisions and patients health care across countries on the basis of clinical reality.


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