FDA/CDRH Recommendations for EMC/EMI in Healthcare Facilities
CDRH receives many inquires from healthcare organizations, medical device manufacturers, clinicians, and the public seeking information about experiences with and prevention of electromagnetic interference (EMI) with medical devices. Of particular interest is the safe use of cellular and wireless communications equipment in the vicinity of medical devices. The following information is intended to help minimize the risks associated with medical device EMI and promote electromagnetic compatibility (EMC) in healthcare facilities.
CDRH EMC/EMI recommendations for healthcare facilities are as follows:
- Make use of available resources such as EMC professionals and publications and Internet web pages on the subject of medical device EMC;
- Assess the electromagnetic environment of the facility (e.g., identify radio transmitters in around the facility) and identify areas where critical medical devices are used (e.g., ER, ICU, CCU, NICU);
- Manage the electromagnetic environment, RF transmitters and all electrical and electronic equipment, including medical devices, to reduce the risk of medical device EMI and achieve EMC;
- Coordinate the purchase, installation, service, and management of all electrical and electronic equipment used in the facility to achieve EMC;
- Educate healthcare facility staff, contractors, visitors, and patients about EMC and EMI and how they can recognize medical device EMI and help minimize EMI risks;
- Establish and implement written policies and procedures that document the intentions and methods of the healthcare institution for reducing the risk of medical device EMI and achieving EMC;
- Report EMI problems to the FDA MedWatch program and communicate EMI/EMC experiences to colleagues in open forums such as medical/technical publications and conferences.
A comprehensive guidance document for EMC in healthcare facilities was developed, with CDRH participation, by the Association for the Advancement of Medical Instrumentation (AAMI):
See http://www.fda.gov/Radiation-EmittingProducts/RadiationSafety/ElectromagneticCompatibilityEMC/ucm116592.htm for a description of this document. To find out how to obtain AAMI TIR 18, go to the Standards Search page of the AAMI website and enter keyword "EMC."
For a better understanding of the concerns and issues of medical device EMI, particularly in healthcare institutions, CDRH recommends that AAMI TIR 18 be examined in its entirety. CDRH concurs with the summary recommendations that appear in AAMI TIR 18, which are reproduced below, and recommends that healthcare organizations consider them in reducing the risk of medical device EMI and achieving EMC in healthcare facilities.
Additional information and recommendations regarding medical device EMC in healthcare facilities can be found on the EMC pages of the CDRH website and the links that appear below. Of particular importance are the CDRH recommendations regarding medical telemetry, which were developed after TIR 18 was published.
Another important information resource for EMC assessment and management in healthcare facilities was developed by American National Standards Institute (ANSI) Accredited Committee C63 (EMC), also with CDRH participation:
See http://www.fda.gov/Radiation-EmittingProducts/RadiationSafety/ElectromagneticCompatibilityEMC/ucm116592.htm for a description of this document. To find out how to obtain C63.18, go to http://shop.ieee.org/store/default.asp and search for product code SH94556
- Association for the Advancement of Medical Instrumentation, http://www.aami.org
- American Medical Association Council on Scientific Affairs, "Report 4: Use of wireless radio-frequency devices in hospitals," http://www.ama-assn.org/ama/pub/article/2036-2918.html
- ANSI Accredited Committee C63, http://c63.ieee.org/
- ECRI, http://www.ecri.org
- FDA/CDRH EMC web page,
- FDA/CDRH recommendations for wireless medical telemetry,
- FDA/CDRH Safety Alerts, Public Health Advisories, and Notices, l
- FDA MedWatch safety information and adverse event reporting program,
- University of Oklahoma Center for the Study of Wireless EMC, http://www.ou.edu/engineering/emc/
- UK Medical Devices Agency, "Mobile Communications - Summary"
AAMI TIR 18 Summary Recommendations
Adapted from Association for the Advancement of Medical Instrumentation. Guidance on Electromagnetic Compatibility of Medical Devices for Clinical/Biomedical Engineers. AAMI TIR 18-1997. Arlington, Virginia: Association for the Advancement of Medical Instrumentation; 1997.