Computerized Medical Devices: Trends, Problems, and Safety

Virtually all of the medical devices utilizing electronics will contain a micro or minicomputer by 1990. These devices accounted for $7 billion in U.S. sales in 1984. Their capabilities can provide the means for new or greatly improved medical procedures, and ensure greater patient safety. However, these benefits can easily be compromised if ``computer safety'' is not practiced in the design, manufacturing, testing and clinical use of these devices. Along with a trend to wider usage, the number of recalls of medical devices due to computer-related problems has approximately doubled in the last five years. ``Computer-caused'' problems are often not recognized or reported as such, resulting in an underestimation of the prevalence of this type of problem. Our study of technical factors causing problems in computerized devices revealed that software quality assurance (SQA), the quality of the ac power, and electromagnetic interference are primary factors. Selected design and QA techniques that are well-known in military-aerospace industries can be used to prevent the most prevalent problems occurring in computerized medical devices, without significantly affecting overall device manufacturing costs.