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What about wireless phone interference with medical equipment?

Radiofrequency energy (RF) from wireless phones can interact with some electronic devices. For this reason, FDA helped develop a detailed test method to measure electromagnetic interference (EMI) of implanted cardiac pacemakers and defibrillators from wireless telephones. This test method is now part of a standard sponsored by the Association for the Advancement of Medical instrumentation (AAMI). The final draft, a joint effort by FDA, medical device manufacturers, and many other groups, was completed in late 2000. This standard will allow manufacturers to ensure that cardiac pacemakers and defibrillators are safe from wireless phone EMI.

FDA has tested hearing aids for interference from handheld wireless phones and helped develop a voluntary standard sponsored by the Institute of Electrical and Electronic Engineers (IEEE). This standard specifies test methods and performance requirements for hearing aids and wireless phones so that that no interference occurs when a person uses a “compatible” phone and a “compatible” hearing aid at the same time. This standard was approved by the IEEE in 2000.

FDA continues to monitor the use of wireless phones for possible interactions with other medical devices. Should harmful interference be found to occur, FDA will conduct testing to assess the interference and work to resolve the problem.

Electromagnetic Compatibility - Cellular Phone Interference - From FDA

November 1, 1995

UPDATE ON CELLULAR PHONE INTERFERENCE WITH CARDIAC PACEMAKERS
Background
Recently published studies performed on patients at the Mayo Clinic in Rochester, Minnesota and at the Mount Sinai Medical Center in Miami Beach, Florida, as well as laboratory studies in the U.S. and Canada, have shown that when some cellular phones are placed very close to implanted cardiac pacemakers, interference with the pacemaker's normal delivery of pulses can occur. Although FDA is not aware of any actual incidents in which cellular phones have caused people's pacemakers to malfunction, the agency is concerned about this possibility, and is conducting its own laboratory studies. So far, FDA's results agree with those of the other preliminary studies.

The nature of the problem
The type of interference under study is called "electromagnetic interference", or "Emi" If it were to occur, it could affect the pacemaker in one of three ways: by stopping the pacemaker from delivering the stimulating pulses that regulate the heart's rhythm; by causing the pacemaker to deliver the pulses irregularly; or by causing the pacemaker to ignore the heart's own rhythm and deliver pulses at a fixed rate.

This would pose a health hazard for the very small minority of pacemaker wearers who are "pacemaker dependent" -- that is, who depend heavily on their pacemakers to maintain the heart's rhythm. It would be of less concern for the vast majority of pacemakers wearers, who are not dependent.

What do we know so far?
EMI disruption of normal pacemaker function seems to occur only with cellular phones using digital technology, not those using analog technology. Most U.S.cellular phones are the analog type and thus would not affect pacemaker function. But digital phones are becoming more popular.

When the digital phone is turned off or moved outside the pacemaker's disturbance range, the interference stops and the pacemaker resumes its normal operation.

For most digital phones, and for most pacemakers now in use, EMI does not have an effect if the phone is more than about six inches from the implanted pacemaker. Thus the operation of these pacemakers would not be disturbed with the phone used in the normal talking position. However, some newly emerging pacemaker designs may be more sensitive to electromagnetic interference. FDA has tested these new designs,and has provided the results to pacemaker manufactures. FDA is also working with the manufactures to help assure that new products will be less susceptible to electromagnetic interference.

Precaution for pacemaker wearers !
Based on these preliminary findings, cellular phones would not seem to pose a significant health problem for the vast majority of pacemaker wearers. Still, people with pacemakers may want to take some simple precautions to be sure that their cellular phones don't cause a problem. For example, holding the phone to the ear opposite the side of the body where the pacemaker is implanted will add some extra distance between the pacemaker and the phone. And since cellular phones transmit electromagnetic energy whenever they are "on" (even when they are not being used), pacemaker wearers might want to avoid placing a turned-on phone next to the pacemaker implant - that means not carrying the phone in a shirt or jacket pocket directly over the pacemaker.

Federal Communications Commission (FCC) Seeking Information About Present and Future Uses of Radio Transmitters in Medical Devices

The FDA encourages all medical device manufacturers, designers, healthcare facilities and other users that utilize radio communications to respond to the Federal Communications Commission (FCC) Notice of Inquiry (NOI) released on July 18, 2006. [ http://hraunfoss.fcc.gov/edocs_public/attachmatch/FCC-06-103A1.pdf ] This NOI presents a unique opportunity to provide information to the FCC to help formulate future telecommunications plans and actions. The NOI includes questions about the present and future needs for medical device radio communications (which includes “wireless” technology). Information received by FCC will be coordinated with FDA to help address the issues surrounding wireless technology in and around medical devices and systems. The NOI comment period extends to October 31, 2006. Information about the NOI and filing comments can be found on the FCC web site: http://www.fcc.gov at http://wireless.fcc.gov/csinfo/comments.html. T he FCC News release on this topic can be found at http://hraunfoss.fcc.gov/edocs_public/attachmatch/DOC-266397A1.pdf.