Failure modes and effects analysis in clinical engineering.

Abstract

Failure modes and effects analysis (FMEA) is a proactive quality assurance procedure that has been commonly used to address potential design flaws and product misuses during the design stage of a product's life. FMEA is becoming commonplace among manufacturing companies but is relatively unknown outside of manufacturing circles. One potential new application of FMEA is by medical device end-users who could address design or functional concerns specific to their situation. The continued increase in the amount and complexity of medical instrumentation necessitates an aggressive stance towards safety in each hospital, such as is recommended in this paper.