Medical Device Safety: The Regulation of Medical Devices for Public Health and Safety

Abstract

G R Higson Bristol: Institute of Physics Publishing (2001) 272pp, price: £65.00, ISBN: 0-7503-0768-4Starting with a brief historical overview of the regulation of medical devices tracing early beginnings from pharmaceutical regulations, the author settles on three main focal points for in-depth examination of the current situation: the USA, Europe and Japan. The situation elsewhere in the world is then briefly covered with reference to these systems. They have subtle differences in several areas and the key issues of quality systems, product standards, effectiveness and post-market controls are explored in seperate chapters. This is followed by a discussion of global harmonisation and appendices reproducing some related documents from the Global Harmonisation Task Force.The late Gordon Higson was perhaps uniquely placed to write such a book due to his personal perspective at the sharp end of many of the developments that he discusses. He has drawn together information which waspreviously scattered over asubstantial number of sources and often difficult to locate. Unlike the various papers which have been published previously, this book gives a fair and unbiased comparison of the strengths and weaknesses of various approaches. The overall result is an informed text written with a firm conviction that things are heading in the right direction and a clear vision of what that direction is. It is supported by copious references to source documents and the websites of key organisations.Anyone who has struggled to understand why apparently divergent approaches to medical device safety appear to have been taken in different countries or agonised over product import/export issues will find this an enlightening read. The style is such that what could have been a very dry topic is very flowing and informative. This book is an essential read for anyone involved with the design, marketing or regulatory affairs aspects of medical devices. It should be in the reference library of all medical device regulators and manufacturers (including university and hospital clinical engineering departments).