Before being put on the market, medicines undergo stringent evaluation of their efficacy and safety, satisfying the regulatory bodies of individual countries. The costs of these activities are borne by manufacturers or developers who may later be held responsible for subsequent shortcomings. By contrast, medical devices, as for example those used in endoscopic procedures, require no such prior assessment in many countries. In the United Kingdom, since June 1998, all new products must satisfy the requirements of the Medical Devices Agency,1 the UK Competent Authority, to be awarded the CE mark allowing use throughout the European Community. Endoscopists and assistants commonly learn of new products from commercial stands at exhibitions held alongside scientific meetings or from manufacturers' representatives or sales staff. The apparent virtues and novelty of products are exhorted whereas objective clinical evidence of efficacy or safety is usually not available. Phase III development is not a clearly defined prerequisite before device marketing. Why should devices be less well investigated and evaluated than drugs when offered for sale? The initiative and ingenuity of manufacturers in developing and producing new equipment is to be warmly commended, but enthusiasm for sales ahead of rigorous clinical evaluation must be seriously questioned.

Endoscopists are confronted with an overwhelming range of equipment from competing companies and at present choices …