Medical device EMI: FDA analysis of incident reports, and recent concerns for security systems and wireless medical telemetry

摘要

FDA has evaluated reports of medical device malfunctions caused by electromagnetic interference (EMI), performed device testing, and developed standardized test procedures. Over 500 incident reports are suspected to be attributable to EMI affecting cardiac devices. More than 80 of these reports involve cardiac and other medical device interactions with electronic security systems. EMI presents a risk to patient safety and medical device effectiveness that is likely to continue as the use of electromagnetic energy in the medical device environment increases (e.g., cell phones, security systems). Developments can reduce these risks, such as the allocation of dedicated frequency bands for the new wireless medical telemetry service (WMTS) designed to protect transmissions of patient vital signs from interference by other intentional transmitters.