Addressing FDA's Concerns about Electromagnetic Interference

July 1, 1997

2 Min Read
Addressing FDA's Concerns about Electromagnetic Interference

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

An MD&DI July 1997 Column


Along with the great strides in medical electronics in recent years come concerns on the part of medical device manufacturers and FDA about electromagnetic interference (EMI) with devices. Over the years, FDA has promoted electromagnetic compatibility (EMC), the solution to EMI, through several cooperative efforts with the device industry and clinical device users. Donald Witters, physicist and biomedical engineer with the Office of Science and Technology in FDA's Center for Devices and Radiological Health (CDRH), explains how device manufacturers can address FDA's concerns about device EMI in their submissions.

What is FDA's current policy on a manufacturer's responsibility to ensure that devices are adequately protected (i.e., shielded) from EMI and electrostatic discharge (ESD)?

Because of its concerns about EMI with medical devices, CDRH has performed research and developed some specific guidances to address this issue. For devices such as apnea monitors, cardiac pacemakers, and powered wheelchairs, industry is well acquainted with EMC and has been using appropriate recognized national and international standards.

As a general rule, testing devices to, and passing (with no failures), the IEC 601-1-2 EMC standard for medical electrical equipment can help satisfy FDA's concerns. Manufacturers may also have to address device labeling issues.

However, because approaches to IEC testing vary from manufacturer to manufacturer, device makers should make clear:

  • The type of EMC testing performed.

  • The test results, including pass/fail criteria and the device modes that were tested.

  • Descriptions of how EMI interactions were handled.

  • Device modifications made as a result of EMC test findings.

  • Any deviations from the standard.

Device manufacturers should also consult with the appropriate division of the Office of Device Evaluation, CDRH, for more specific information.

"Help Desk" solicits questions about the design, manufacture, regulation, and sale of medical products and refers them to appropriate experts in the field. A list of topics previously covered can be found in our Help Desk Archives. Send questions to Help Desk, MD&DI, 11444 W. Olympic Blvd., Ste. 900, Los Angeles, CA 90064, fax 310/445-4299, e-mail [email protected]. You can also use our on-line query form.

Although every effort is made to ensure the accuracy of this column, neither the experts nor the editors can guarantee the accuracy of the solutions offered. They also cannot ensure that the proposed answers will work in every situation.

Readers are also encouraged to send comments on the published questions and answers.

Copyright ©1997 Medical Device & Diagnostic Industry

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