• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Medical Devices

  • Print
  • Share
  • E-mail

Important Information Regarding the Year 2000 Transition

This is an archived document and is no longer current information.

December 30, 1999

 

Healthcare facilities may make increased use of mobile communication products, such as cellular telephones and walkie-talkies, during the transition period to the Year 2000. Therefore, we call your attention to a Safety Notice that was developed by the Medical Devices Agency of the United Kingdom on the potential for these products to interfere with medical equipment.

The Safety Notice reminds healthcare staff that mobile communications equipment should be used with caution because of potential electromagnetic interference (EMI) with the operation of electronic medical devices. We bring this Safety Notice to your attention, so that you can pass it along to your staff.

This Safety Notice can be found at:

http://www.medical-devices.gov.uk/sn1999(39).htm

We do not intend this alert to override the existing policies of your facility on the use of mobile communications. However, we do want to remind you about this potential problem in case it was not considered in your Year 2000 contingency planning. If necessary, you may want to review your electromagnetic compatibility (EMC) policies and procedures to see if they adequately manage the risk of EMI with critical medical devices

Information on the general topic of electromagnetic interference with medical devices may be found on the FDA website at

Electromagnetic Compatibility (EMC)

Recommendations for managing EMC/EMI in healthcare facilities and a model EMC/EMI policy may be found in Technical Information Report (TIR) 18, Guidance on electromagnetic compatibility of medical devices for clinical/biomedical engineers -Part 1: Radiated radio-frequency electromagnetic energy, available from the Association for the Advancement of Medical Instrumentation (AAMI). AAMI’s website address is

http://www.aami.org.

Another source of information on this topic is the University of Oklahoma Center for the Study of Wireless Electromagnetic Compatibility. Their website address is

http://www.ou.edu/engineering/emc.

 

 

If you have questions about this Notification, please contact FDA's  Division of of Small Manufacturers, International and Consumer Assistance (DSMICA) by e-mail at dsmica@fda.hhs.gov or by phone at 1-800-638-2041 or 301-796-7100