Product liability aspects of bioengineering.

The introduction of the Consumer Protection Act 1987 brought the problems of product liability directly into hospital bioengineering and medical physics departments. This law makes great demands upon manufacturers, but also on suppliers and maintainers of medical equipment. Departments which manage medical equipment carry a responsibility for ensuring the requirements of product liability are known by all those whose actions may affect the potential of a piece of equipment to injure or damage a patient. This paper addresses these problems from a bioengineering, rather than a legal, viewpoint. The problems of design, manufacture, modification, maintenance and use are discussed and examples of potential problems are identified. The paper concludes that as long as good standards of quality control and professionalism are applied in bioengineering and medical physics departments then there is little to be feared from this piece of legislation.