Application of SHERPA to Predict and Prevent Use Error in Medical Devices

Abstract

There is increased pressure from the FDA and European regulatory authorities to ensure that human factors issues are systematically addressed throughout the medical device design cycle. A particular area of interest is the risk analysis of medical devices to meet regulatory standards such as IEC 60601-1-6 for Usability Engineering and ISO 14971:2007 for Risk Assessment. Failure Modes and Effect Analysis (FMEA) is an important tool in these analyses. This paper describes the SHERPA (Systematic Human Error Reduction and Prevention Analysis) process, which has been applied in a wide range of safety critical industries, which provides an enhanced version of the FMEA process. SHERPA is supported by a software package called the Human Factors Risk Manager which supports Hierarchical Task Analysis, FMEA and other tools that can be applied during the medical device design and risk assessment.