System Theoretic Process Analysis (STPA) Recommended Practices for Evaluations of Safety-Critical Systems in Healthcare APPENDIX – STPA and Medical Devices J-3187-5

This recommended practice supplements existing SAE guidance on the application of the System Theoretic Process Analysis (STPA) to safety critical systems in healthcare with a focus on medical devices. The expanded guidance provides a concise set of proven techniques practitioners have successfully applied when using STPA on safety-critical, human-interfacing healthcare systems. The practice is not meant as a stand-alone document but is expected to be used in conjunction with other SAE guidance involving STPA. This recommended practice does not repeat aspects of the STPA process captured in other documents. Rather, this document includes healthcare-specific considerations not captured in other documents. The document is meant to provide broad and generalized guidance and is meant to be applicable across any domain.