Cell phones and electromagnetic compatibility (EMC)
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Summary
The FDA's Center for Devices and Radiologic Health (CDRH) recently updated its Recommendations for Electromagnetic Compatibility in Healthcare Facilities (download guidelines below). These guidelines were prompted in part by the increased use of cellular and wireless communication equipment in healthcare facilities and the need to minimize risks associated with electromagnetic interference. CDRH recommendation include the assessment of the electromagnetic environment of the facility, identification of areas where critical medical devices are used, coordination of the purchase and management of all electronic equipment, and the reporting of problems to FDA MedWatch program.
The CDRH also maintains a Web site with resources and links to key documents from ECRI, (American National Standards Institute (ANSI), and the Association for Advancement of Medical Instrumentation (AAMI) on electromagnetic compatibility in healthcare facilities and other related issues. Resources include on-site testing for estimated radiated electromagnetic immunity of medical devices to radio frequency transmitters. For more information, visit www.fda.gov.
Key documents
- National Cancer Institute Fact Sheet
- FDA/CDRH EMC guidelines
- BMJ 2003; 326:460-1
- Lancet 2003; 9359:788
Resources
Controversy continues over association of cell phones and carcinogenicity
The controversy over risks of cancer has continued over a period of 30 years. Recently, several groups including the World Health Organization raised the issue again, as a "potential" risk. Others point to epidemiologic data that appear to minimize the risk. A resolution doesn’t appear to be on the immediate horizon but several representative reports are presented here. Note: Med Page Today links are available with free registration.
- 10 years later cell phone study inconclusive – May, 2010
- Download from Medpagetoday.com
- Download from Safety Institute
- WHO says cell phones may cause cancer - May, 2011
- Download from Medpagetoday.com
- Download from Safety Institute
- Group expands on possible cell phone cancer link - June, 2011
- Download from Medpagetoday.com
- Download from Safety Institute
- Researchers cast doubt on cell phone cancer risk – July, 2011
- Download from CNET
- Download from Safety Institute
Newer cell phone devices are safer; distance from
critical devices is key
Recent data have shown that newer cell phone technology has reduced the risk of electromagnetic interference (EMI) when used beyond approximately 3 feet (one meter) from critical medical equipment. Several sources updating current information and guidance on cell phones and electromagnetic interference indicate that although risks are reduced, they are not eliminated. Following is a recap of some current reports and findings:
ECRI Health Devices (December 2006)
The publication provides guidance on cell phones and electromagnetic interference. Hospital policies nationwide vary from no cell phone use to virtually unlimited use. Balanced against potential risks, hospitals are rethinking the use of cell phones because of improvements in cell phone technology, the benefits of using a cell phone for quicker communication among caregivers, and improvements made to the electromagnetic compatibility of newer medical devices. ECRI maintains that although evidence indicates risks may have diminished, cell phones continue to demonstrate a risk that EMI will affect medical devices. Consequently, ECRI advocates against the complete lifting of cell phone restrictions.
Journal of Critical Care
This 2006 study concludes that the majority of studies indicate that medical device malfunction is extremely rare if the distance from the transmitting device is greater than 1 meter or 39.37 inches.
Mayo Clinic
Cell phones - 2007 David Hayes, M.D., and colleagues reported in the "Mayo Clinic Proceedings" (March 12, 2007) that no phone problems were found during 300 tests run from February through June 2006. The cell or mobile phones were tested using two different technologies from different carriers, switching them on near 192 medical devices in 75 patient rooms. The incidence of clinically important interferences was 0 percent.
Other electronic devices 2007 The Mayo Proceedings also noted in two other articles that a CD player affected an electrocardiogram (ECG) reading and identified problems of malfunctioning devices in individuals with implanted heart devices (pacemakers or cardiac defibrillators) when in stores using an anti-theft device. These incidents would be prevented, however, by simply moving some distance from devices using magnetic fields, researchers noted.
Cell phones 2006 - One study conducted at the Mayo Clinic observed decreases in EMI events, most significantly in "clinically important" events, yet these events were not eliminated. Researchers reported on testing 15 devices with six cell phones and found a "clinically important interference" of 1.2 percent. Authors of this study conclude that the use of the newer technology must be closer to medical devices before any interference is noticed and suggest that cell phones be periodically tested to determine their effects on medical equipment.