Clinical Evaluation of Medical Devices: Principles and Case Studies (2nd edn)

Abstract

From the outset, it must be made clear that this book has been written entirely for the American market and hence deals with American legislation. First published in 1997, rapid development of medical devices has stimulated the need for a second edition. Bearing in mind that the American legislation and workings of the Food and Drug Administration (FDA) are quite different from those encountered in the UK (where the responsible body is the Medicines and Healthcare products Regulatory Agency), the contributors are all North American apart from one Norwegian. Despite this, there are as always chapters that are worthy of note, some of which are particularly helpful. Chapter 1 deals entirely with clinical trials and having dealt with definition of a medical device then provides an important overview of considerations to be taken into account when organising an appropriate clinical trial. This is a helpful section with a lot of practical advice on the standards required and the sources of potential hazards and pitfalls. It looks to pre-market testing, clinical outcomes and the postmarket surveillances while addressing the statutory requirements of the FDA. The debate as to whether emerging technologies are covered by the medicines or the devices side of the Agency is addressed in a single chapter. This is not an unfamiliar situation and is becoming an increasingly pointed debate in the UK. As such, the role of the National Institute for Health and Clinical Excellence raised within this chapter does give some indication of the attempt to look internationally. The second part of the chapter largely covers cost, which is of no direct relevance to the UK situation. Chapter 4 exposes the difference between the British and American systems, with the UK singularly focused on postmarketing surveillance. However, the reporting systems do appear to be markedly similar. Chapter 5 is especially useful, looking at the statistics associated with the Bayesian method in clinical trials. This fundamental mathematical approach to clinical trials answers many of the difficulties associated with small trial numbers, particularly with multiple end-points. The development of emerging technologies and the combination of drug/device combinations is examined in chapter 9. Many of the issues discussed, particularly the nature of principal action of the device, are looked at in detail. Systematic exposure to drugs from devices such as drug-eluting stents and the discussion on their toxicology (and hence their relevance as a device or a medicine) are illustrated. Chapter 10 is especially interesting and revealing as it discusses the issues of the production of new devices on the stock market: a sensitive area often overlooked. Part 2 of the book deals with a series of clinical examples. As such it is particularly useful, covering many of the problems anyone involved in the development of medical devices will encounter, for example, the use of randomised controlled trials and how difficult it is to apply them to devices. In summary, as with so many that have a specialised audience, this book does have value on an international basis. However, readers do need to be highly selective in what they take note of since so much of it is directly applicable to the FDA and the American process of achieving licence for the use of devices. It is useful as a reference book for those involved in the development of clinical trials but is of little value when applied to the UK regulatory system.