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Electromagnetic Compatibility - Medical Device EMI Problems and Solutions

A copy of the full article is published in COMPLIANCE ENGINEERING, Vol. XIII, No. 4, May - June 1996, pp.41-57.

Between 1979 and 1995, the Center for Devices and Radiological Health (CDRH) of the US Food and Drug Administration (US FDA) has received over one hundred reports alleging that electromagnetic interference (EMI) resulted in malfunction of electronic medical devices. Verifying individual incidents is difficult. However, these reports have stimulated investigation of the susceptibility of specific devices, recognition of EMI as a potential problem for electronic medical devices, and development of a CDRH action plan to work toward assurance of medical device electromagnetic compatibility (EMC). For several reasons, EMI problems appear to be under-reported. Derivation of statistical inferences from the number of problem reports received is not recommended. Clinical engineers have expressed interest in an on-line version of the FDA problem reporting database, so that they can attempt to determine if their equipment is subject to reported problems and take appropriate action in their facility in a more immediate manner. Development of such a capability is presently under consideration at CDRH. Meanwhile, EMI problem reports can best serve to: 1) raise the awareness of the medical device community regarding the kinds of malfunction that can result from EMI, and 2) identify the medical devices and use environments for which further investigation and/or mitigation of EMI is needed.

Updated September 9, 1996