Health Technology Assessment of Medical Devices in Low and Middle Income Countries: study design and preliminary results
Health Technology Assessment (HTA) of Medical Devices (MDs) remains an open challenge in particular for Low and Middle Income Countries (LMICs). Wide literature investigated how economical constrains may affect HTA in LMICs. Much less has been done in ana
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Abstract— Health Technology Assessment (HTA) of Medical Devices (MDs) remains an open challenge in particular for Low and Middle Income Countries (LMICs). Wide literature investigated how economical constrains may affect HTA in LMICs. Much less has been done in analyzing systematically how MDs safety and efficacy depend from environmental conditions (e.g., users, plants, and operational spaces) and how this affect HTA. After recalling the main differences among MDs and drugs, in order to highlight dependencies from environments that can diminish MD safety or efficacy, this paper explicates the main minimum requirements that are assumed as granted in Europe and that may affect MD safety and efficacy if not met in LMICs. Keywords— HTA, LMIC, medical devices.
I. INTRODUCTION
Health Technology Assessment (HTA) on Medical Devices (MDs) remains an open challenge in both developed and less developed countries. One of the main reasons is that HTA methods have been widely tested for drugs, but much less for medical devices. HTA of LMICs can be even more challenging due to the luck of standardization of operational environments from which MDs are far more dependent than drugs. For instance, when a MD is designed for the European market, researchers, designers and developers can assume that the medical locations in which the device will be operationalized meet a set of minimum standards regarding the structures, the plants (e.g. electrical, water and air), and organizations (e.g. minimum number of specialized healthcare personnel for each clinical setting). Accordingly, European studies on the HTA of a medical device will assume as granted those operational conditions, which guarantee minimum levels of safety and standard conditions for the MD efficacy. When a MD developed for the European market is moved to LMICs or regions, those environmental conditions are not guaranteed and therefore MD safety and efficacy should be reconsidered. HTA reports should capture relevant environmental dependencies that may diminish MD safety and efficacy and explicate them, so that when an assessment is performed for a LMIC, those conditions can be explored with heuristic methods.
© Springer Nature Singapore Pte Ltd. 2018 H. Eskola et al. (eds.), EMBEC & NBC 2017, IFMBE Proceedings 65, DOI: 10.1007/978-981-10-5122-7_57
This paper reports on the work done by the International Federation of Medical and Biological Engineering (IFMBE) HTA Division (HTAD) in order to develop a framework aiming to help decision-makers in considering MD dependencies from operational environments, which may affect their safety, efficacy and costs. After recalling the main differences among MDs and drugs, this paper explicates those European minimum requirements that may affect MD safety and efficacy if not met in LMICs.
II.
METHOD
A systematic literature review was performed in order to identify the most relevant papers highlighting relevant differences between MDs and drugs that may affect HTA conclusions. Minimum requirements were identified searching relevan
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