Safety Issues in Computerized Medical Equipment

Abstract

Computers now are being used increasingly in safety-critical systems like nuclear power plants and aircraft and, as a consequence, have occasionally been involved in deadly mishaps. As microcomputer technology continues to proliferate, computers are also now increasingly being used in medical equipment such as ventilators and pacemakers, sometimes with safety-critical results. This chapter discusses some of the special concerns that arise when computer technology is introduced into medical equipment, using two case studies as examples: the Therac-25 radiation therapy unit and Abbott’s patient controlled analgesia machine. Also discussed are some of the regulations that have been proposed by the (American) Food and Drug Administration (FDA) to help tackle the special problems that can arise when developing software-based medical equipment.