MAKING SURE THAT MEDICAL DEVICES WORK.

The reliability of equipment is a function of certain controls exerted by designers, producers, and consumers. In a systems engineering context it is necessary that these controls be delineated and that responsibilities for their implementation be clearly assigned. For purposes of reliability planning, hospitals can be thought of as factories analogous to facilities that manufacture complex equipment (e. g. , computers). Manufacturers of medical instruments and devices can be envisioned as subsystem producers not unlike producers of subsystems for communication, aerospace, and other high technology industries. Each has specific responsibilities for achieving the ultimate objective - safe and reliable equipment.