Risks associated with diagnostic devices

Therapeutic medical devices alter patients' physiological functions. Diagnostic devices are for information gathering, manipulation, and display. Despite this difference in purpose, both types of medical equipment have potential risks associated with their use that must be recognized and subjected to the principles of risk management. For diagnostic equipment, special concerns include direct side effects, clinical misinterpretation of results, malperformance, obvious non-function, and inherent limitations. The role of clinical engineering in diagnostic risk management must be consistent with its general obligations in equipment acquisition, training, maintenance, and hazard identification. Since sharp lines of distinction often cannot be drawn between equipment, operator, and clinical issues, clinical engineering has the opportunity and responsibility to extend its contributions into an integrated systems approach to medical device safety and effectiveness.