BOOK REVIEW

Gordon R. Higson: MEDICAL DEVICE SAFETY The Regulation of Medical Devices for Public Health and Safety
271 pages
Published by: Institute of Physics Publishing, IOP Publishing Ltd 2002,
Institute of Physics Publishing, Dirac House, Temple Back, Bristol BS1 6BE, UK
ISBN 0 7503 0768 4

As a consequence of rapid development of science in our days the acceleration of events and the progress towards more and more openness in space became typical. Information, news, people and objects arrive to any place of the world with surprising speed and frequency. This is part of the globalisation phenomenon and this situation influences the whole life including health care. Pharmaceuticals and health devices may be used in countries having different cultures and are far from the place of origin of the goods.

Regulations and laws controlling the safety and effectiveness of medical devices exist in many countries and their usefulness is accepted everywhere. This is why in the last three decades the necessity of harmonisation of regulations prepared by countries and regions came more and more to the front. This is why the complexity of the system of medical device safety and effectiveness became markedly apparent.

The book of G. R. Higson: Medical Device Safety provides orientation and helps in this complicated situation to those whose everyday work includes activity with devices. It helps successfully in the process starting from the individual testing of a device up to the analysis of quality systems.

As the author expresses: "This book has reviewed the development of regulations intended to ensure that public health and safety is maintained when medical devices are used. It is only 25 years since the world's first comprehensive and rational regulatory system for medical devices (the US Medical Device Amendments of 1976) was introduced and became the model for much national legislation." And concludes: "...but it must be remembered that these Amendments were made to the Food, Drug and Cosmetic Act and show evidence of their derivation from drug regulations which are, in some instances, inappropriate for medical devices. Much of this book has been devoted to the thesis that medical devices are engineered products which are better regulated if treated as such."

Following the US Medical Device Amendments of 1976 the most important step forward was the European Community Directive 93/42/EEC (medical devices) 1993, prepared by the EC.

Based on the European Community Directive 93/42/EEC (medical devices) the author gives the following definition of medical device:
"Medical device: Any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used on human beings for the purpose of:

• the monitoring, treatment or alleviation of disease,
• the diagnosis, monitoring, treatment, alleviation or compensation for an injury or handicap,
• the investigation, replacement, or modification of the anatomy or of a physiological process,
• the control of conception,

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means but which may be assisted in its function by such means."

The author starts the introduction of the regulatory systems of countries and regions by the one he indicated as the most important, the EC Medical Device Directive. This is followed by the regulatory praxis in USA and Japan, furthermore comes introduction of practises of other countries. Author explains besides the praxis in Australia and Canada the present one in countries that will become new members of the European Union from 1 May 2004. (PECA agreement). The practises in Latin-American region, in the countries in Far-East and in South Africa are introduced, too.

From these comparisons manifests that nowadays countries apply more or less the same principles in their regulatory systems. To achieve real harmonization the author rightly suggests that before finalising the regulatory procedures it would be practical to wait till the guidelines and suggestions under preparation by the Global Harmonization Task Force will be issued.

In paragraphs 6 - 9 the quality system, the product standards, the effectiveness, the adverse event recording and the post marketing control are dealt with. Several issues are discussed in details and the sometimes different opinions of countries are also thoroughly surveyed.

The idea of the global regulatory system for medical devices are discussed in a separate chapter. Here is introduced The Global Harmonization Task Force, established in 1992, and its work and results.

In the five Appendices information are given about practical steps towards global harmonization, safety questions, role of standards and the adverse event reporting guidance. In the last Appendix there is a list of some useful web sites.

Comprehensive references, bibliography and index makes the use of the book easier.

From the aforesaid one can feel that the reader will have a book of high complexity. From it one can learn a lot about the complex system requirements of the safe use of medical devices.

The book is not an easy reading. It has many facts and data. The character of such a book is that it strives for very precise wording, what requires high concentration from the reader. The topic, the history and the complexity of medical device safety is discussed in details. The reader gets a good picture of the complexity of the medical device safety and its present situation.

To those who are less familiar with these issues it would have been easier if the many phrases in the book - just to mention a few; assessment, certification, efficacy, effectivity, effectiveness, performance, quality, safety, validation, verification - would have been explained at the end of the book in a separate annex.

However, the language of the book, despite of many special words, is not too complicated, and from linguistic point of view is not a very difficult reading. The last remark should be emphasised because readers will find the book useful all over the world.

Who should read the book? Experts who deal with the safety and regulatory affairs of medical devices, and those who are present in the long process starting from the manufacture and ending with the use of the devices. The book is very informative to those who work with notified bodies and competent authorities and would like to get an overall picture about the present and future of medical device safety issue.

The book deals predominantly with the latest situation (up to 2001) but at the same time indicates that importance of this field will grow further. Therefore this book provides lasting assistance to experts dealing with medical device safety.

Details of the book indicate the author's excellent knowledge. In about thirty years of experience he acquired a difficult to surpass authentic overview.

Gordon Higson, after he finished in 2001 the final proof of his book, following a second stroke, died. Reading this book one can realise the great loss that the community which deals with the quality and safety of the health care suffered. He was active until the end of his life in strengthening the level of health care. This book will also help to preserve his memory.

Nandor Richter