Mechanical hazards in clinical equipment.

Abstract

A wide variety of mechanical hazards are associated with clinical instrumentation containing mechanical components. Therefore, safety considerations for clinical equipment must be extended to include mechanical safety standards, maintenance programs, and operating procedures. Mechanical risk classes have been developed from the study of mechanical-mode failures of medical devices. To facilitate the development of priorities for clinical engineering involvement in mechanical safety programs, most mechanical devices which are commonly used in clinical practice have been assigned an appropriate risk classification. General recommendations for the development of such programs are also presented.