Section 4A: Safety Guidelines 159What about wireless phone interference with medical equipment?Radiofrequency energy (RF) from wireless phones can interact with someelectronic devices. For this reason, FDA helped develop a detailed test methodto measure electromagnetic interference (EMI) of implanted cardiacpacemakers and defibrillators from wireless telephones. This test method isnow part of a standard sponsored by the Association for the Advancement ofMedical instrumentation (AAMI). The final draft, a joint effort by FDA, medicaldevice manufacturers, and many other groups, was completed in late 2000.This standard will allow manufacturers to ensure that cardiac pacemakers anddefibrillators are safe from wireless phone EMI.FDA has tested hearing aids for interference from handheld wireless phonesand helped develop a voluntary standard sponsored by the Institute ofElectrical and Electronic Engineers (IEEE). This standard specifies test methodsand performance requirements for hearing aids and wireless phones so thatthat no interference occurs when a person uses a “compatible” phone and a“compatible” hearing aid at the same time. This standard was approved by theIEEE in 2000.FDA continues to monitor the use of wireless phones for possible interactionswith other medical devices. Should harmful interference be found to occur,FDA will conduct testing to assess the interference and work to resolve theproblem.Which other federal agencies have responsibilities related to potentialRF health effects?Certain agencies in the Federal Government have been involved in monitoring,researching or regulating issues related to human exposure to RF radiation.These agencies include the Food and Drug Administration (FDA), theEnvironmental Protection Agency (EPA), the Occupational Safety and HealthAdministration (OSHA), the National Institute for Occupational Safety andHealth (NIOSH), the National Telecommunications and InformationAdministration (NTIA) and the Department of Defense (DOD).By authority of the Radiation Control for Health and Safety Act of 1968, theCenter for Devices and Radiological Health (CDRH) of the FDA developsperformance standards for the emission of radiation from electronic productsincluding X-ray equipment, other medical devices, television sets, microwaveovens, laser products and sunlamps. The CDRH established a productperformance standard for microwave ovens in 1971 limiting the amount of RFleakage from ovens. However, the CDRH has not adopted performancestandards for other RF-emitting products. The FDA is, however, the lead federalhealth agency in monitoring the latest research developments and advisingother agencies with respect to the safety of RF-emitting products used by thepublic, such as cellular and PCS phones.The FDA's microwave oven standard is an emission standard (as opposed to anexposure standard) that allows specific levels of microwave leakage (measured atfive centimeters from the oven surface). The standard also requires ovens to havetwo independent interlock systems that prevent the oven from generatingmicrowaves the moment that the latch is released or the door of the oven is
