Medical equipment regulation and the role of the test house

Abstract

This chapter sets out the need for increased regulatory action for medical equipment brought about by a number of factors, including its complexity, its ever-increasing quantity, and the requirements for it to be able to cross frontiers in international trade by being acceptable in each country. The history of the regulatory processes is covered, as this is not only important for its understanding but will serve to show new or potential manufacturers in this field the need for such regulation. The development of international standards and the means by which equipment is tested to them is also set out in some detail, so that those users of medical equipment unacquainted with the steps taken to ensure its safety may become aware of the tremendous international effort, sustained over many years, being made to achieve very high safety levels. Two major concepts contained in the international safety standard are also described: that of safety in single fault condition, and that of the electrically isolated patient. Further measures are described in which the manufacturing processes themselves are examined to ensure continuing quality of equipment, although the inspection itself is not covered in depth. Apart from ensuring that safe and reliable equipment is available, it is also essential to see that such equipment is indeed bought and used in preference to less satisfactory products. The schemes that have been set up to this end are explained, namely, the equipment evaluation programme to publicize safe and reasonably priced products, and the manufacturer's declaration of compliance with current safety standards. Work in all these spheres will continue as medical equipment not only diagnoses and treats but carries out more and more physiological functions on a long-term basis, and is used in greater numbers.