Medical devices and public policy: the pharmaceuticals analogy

Article type: Review Article

Authors: van Gruting, C.W.D.

Note: [] Correspondence to: Drs C.W.D. van Gruting, Vogelenzangseweg 27, 2114 BB Vogelenzang, The Netherlands.

Abstract: In much of the world, public health policy regarding medical devices and the need to ensure their safety is poorly defined and much less developed than that regarding pharmaceuticals. A small number of countries have now established systems to monitor risk and to ensure some form of assessment and approval of medical equipment, at least where an element of risk could be involved. In view of the very large number of medical devices and current evidence of their unwanted effects there is a reason for the extension of such monitoring and licensing systems, complemented by self-regulatory mechanisms. Measures are also needed to ensure that when they enter the field devices are properly used and maintained. In various respects, the close analogy of pharmaceutical regulation can be applied.

Keywords: Medical device, Safety, Epidemiology of risk, Regulation, Pharmaceutical law

DOI: 10.3233/JRS-1990-1205

Journal: International Journal of Risk and Safety in Medicine, vol. 1, no. 2, pp. 123-133, 1990