Abstract
In the early 1990s a significant increase in reports of medical device failures from electromagnetic interference (EMI) was noted worldwide (Silberberg, 1993; 1994; Segal et al., 1995). A primary cause of this EMI was identified as radiated radiofrequency (RF) fields emitted by mobile communications transmitter/receivers (transceivers). The increase in reports of medical device failures was due to several factors. These factors included (1) a great increase in the number of electronically-controlled medical devices and (2) a significant increase in the number of sources of RF in the environment. Throughout hospitals and medical facilities (‘the clinical environment’) new medical devices utilizing electronics were installed. Outside the clinical environment, there was and continues to be a great increase in the use of electronically-controlled medical devices. These devices are used in the home, attached to patients, or implanted in their bodies. Often, the newer medical devices were more sensitive to radiofrequency interference (RFI). This was due to the increasing use of low-power integrated electronic circuitry in medical devices. This circuitry can be much more susceptible to electromagnetic fields than its electrical and electromechanical predecessors. The terminology associated with electromagnetic interference is presented in the appendix for this chapter.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Preview
Unable to display preview. Download preview PDF.
References
Alpert, S. (1994) Dear Powered Wheelchair/Scooter or Accessory Component Manufacturer. Letter establishing minimum recommended immunity level to interfering electromagnetic energy, Food And Drug Administration, Center For Devices and Radiological Health, Rockville, MD 20850, U.S., May 26, 1994.
ANSI, American National Standards Institute C63.8 (1995) Draft Ad-Hoc Test Method for Medical Device Testing. ANSI, N.Y., U.S. November, 1995.
Barbaro, V., Bartolini, P., Militello, C. et al. (1995) Do European GSM mobile phones pose a potential risk to pacemaker patients? In vitro observations. PACE, 18(6), 1218–1224.
Bassen, H. (1986) Prom problem reporting to technological solutions. Med. Instrumentation, 20, 17–26.
Bassen, H., Ruggera, P. and Casamento, J. (1992) Changes in the susceptibility of a medical device resulting from connection to a full-size model of a human. Proceedings of the 14th Annual International Conference of the IEEE Engineering in Medicine and Biology Society, Nov. 1994, Baltimore MD, 2832–2834.
Bassen, H., Ruggera, P., Casamento, J. et al. (1994) Sources of radiofrequency interference for medical devices in the non-clinical environment. Proceedings of the 16th Annual International Conference of the IEEE Engineering in Medicine and Biology Society, Nov. 1994, Baltimore MD, 896–897.
Bassen, H. (1996) The FDA laboratory program, in Electromagnetic compatibility for medical device — issues and solutions (ed S. Sykes), Conference Report Published by the Association for the Advancement of Medical Instrumentation, Arlington VA, USA, 111–119.
Bassen, H., Moore, H. and Ruggera, P. (1995) Cellular phone interference testing of implantable cardiac defibrillators, in vitro. Circulation, 92(8), 3547.
Biomedical Safety & Standards (1995) Ventilators Could Malfunction Under High EMI Exposure 25, 10: 1 and 75.
Bostrum, U. (1991) Interference from mobile telephones — a challenge for clinical engineers. Clinical Engineering Update, 10.
CMDB, Canadian Medical Devices Bureau (1994) Use of Portable Telecommunication Devices in Hospitals. Policy statement from the Canadian Medical Devices Bureau, Health and Welfare, Ottawa, Ontario, Canada.
Carrillo, R., Saunkeah, B., Pickels, M. et al. (1995) Preliminary observations on cellular telephones and pacemakers. PACE, 18(4), 863.
Carillo, R. et al. (1996) Electromagnetic filters impede adverse interference of pacemakers by digital cellular phones. J. American College of Cardiology (Supplement), 27(2a), paper 901–22.
Casamento, J. Applying Standardized Electromagnetic Compatibility Testing Methods for Evaluating Radiofrequency Interference of Ventilators. Med. Instrumentation (in press).
CDRH, Center for Devices and Radiological Health (1993) Reviewer Guidance for Pre-market Notification Submissions. Anesthesiology and Respiratory Devices Branch, Division of Cardiovascular, Respiratory, and Neurological Devices, November 1993.
Clemans, T. (1994) Electromagnetic compatibility. Biomedical Instrumentation, 28, 13.
Durney, C., Iskander, M., Massoudi, H. et al. (1979) An empirical formula for broadband SAR calculations of prolate spheroidal models of humans and animals. IEEE Trans. Microwave Theory and Tech., 27, 758–762.
Eicher, B., Ryser, H., Knafl, U. et al. (1994) Effects of TDMA-modulated handheld telephones on pacemakers. Abstracts of the 16th Annual Meeting of the Bioelectromagnetics Society, Copenhagen, Denmark, June 1995, 67.
ECRI, Emergency Care Research Institute (1993) Guidance article: Cellular telephones and radio transmitters — interference with clinical equipment. Health Devices, 22(8–9), 416–418.
FDA Food and Drug Administration (1975) Draft: Pacemaker standard: Labeling requirements, performance requirements, and terminology for implantable artificial cardiac pacemakers. Association for the Advancement of Medical Instrumentation (AAMI). Report FDA/HFK-76-38, Aug. 1975.
Foster, K. (1995) Digital Cellular Phone Interference with Cardiac Pacemakers. Health Canada, Health Protection Branch Alert, Medical Devices Bureau, Ottawa, Ontario, Canada, Nov. 6, 1995.
IEC, International Electrotechnical Commission (1992) Medical Electrical Equipment, Part 1: General requirements for safety; Collateral Standard: Electromagnetic Compatibility, IEC 601-1-2.
IEC, International Electrotechnical Commission (1994) Electromagnetic Compatibility (EMC), Part 4: Testing and measurement techniques, Section 3: radiated, radio-frequency, electromagnetic field immunity test, IEC 1000-4-3.
IEC, International Electrotechnical Commission (1995) Draft: 1st Edition of IEC 118-13, Hearing Aids, Part 13: Electromagnetic Compatibility (EMC) product standard for Hearing Aids.
ISO, International Organization for Standardization (1994) Draft Revision of Standard 7176/1-1986, Wheelchairs, Part 1: Determination of Static Stability.
Joyner, K., Wood, M., Burwood, E. et al. (1993) Interference to Hearing Aids by the New Digital Mobile Telephone System, Global System for Mobile (GSM) Communications Standard. National Acoustic Laboratories, Australian Hearing Services, Sydney Australia.
Joyner, K., Anderson V. and Wood, M. (1994) Interference and energy deposition rates from digital mobile phones. Abstracts of the 16th Annual Meeting of the Bioelectromagnetics Society, Copenhagen, Denmark, June 1995, 67–68.
Kuster, N. and Balzano, Q. (1992) Energy deposition mechanism by biological bodies in the near field of a dipole antenna above 300 MHz. IEEE Trans. on Vehicular Tech., 41(1), 17–23.
RESNA, Rehabilitation Society of North America (1993) Draft Revision of Standard WC/01 Wheelchairs, Determination of Static Stability.
Ruggera, P. and O’Bryan, E. (1991) Studies of apnea monitor radiofrequency electromagnetic interference. Proceedings of the 13th Annual International Conference of the IEEE Engineering in Medicine and Biology Society, 1641–1643.
Ruggera, P. (1996) In-vitro testing of pacemakers for digital cellular phone electromagnetic interference. Proc. of the 31st Annual Meeting and Exposition of the Association for the Advancement of Medical Instrumentation, 92.
SBET, Society of Biomedical Equipment Technicians (1994) CMBE & SBET Recommend Cellular Phone Ban & RFI Standards Review. Society of Biomedical Equipment Technicians. Biomedical Safety and Standards, 24(8), 1 and
SBET, Society of Biomedical Equipment Technicians (1994) CMBE & SBET Recommend Cellular Phone Ban & RFI Standards Review. Society of Biomedical Equipment Technicians. Biomedical Safety and Standards, 24(8), 59.
Schlegal, R. et al. (1995) In-vitro study of the interaction of cellular phones with cardiac pacemakers. Proceedings of a Workshop on Electromagnetics, Health Care, and Health, 17th Annual International Conference of the IEEE Engineering in Medicine and Biology Society, 33–36.
Segal, B., Skulic, B., Liu-Hinz, C. et al. (1995) Preliminary study of critical-care medical device susceptibility to portable radiofrequency sources. Proc. Thirteenth Annual Meeting and Exposition of the Association for the Advancement of Medical Instrumentation, 83.
Segal, B. et al. (1996) Sources and victims: The potential magnitude of the electromagnetic interference problem. Conference report published by the Association for the Advancement of Medical Instrumentation, Arlington VA, USA, 24–39.
Silberberg, J. (1993) Performance degradation of electronic medical devices due to electromagnetic interference. Compliance Engineering, Fall 1993, 25–39.
Silberberg, J. (1994) Medical device electromagnetic interference issues, problem reports, standards, and recommendations. Proceedings of the Health Canada Medical Devices Bureau, Round-Table Discussion on Electromagnetic Compatibility in Health Care, Ottawa, Canada, September 22–23, 1994, 11–20.
Silberberg, J. and Witters, D. (1995) Recommendations for Mitigation of EMI in Health Care Facilities. American National Standards Institute, Committee C63, Subcommittee 8, May 20, 1995.
Skopec, M. (1996) Hearing Aid Electromagnetic Interference from Digital Cellular Telephones. Proceedings of the 18th Annual International Conference of the IEEE Engineering in Medicine and Biology (in press).
Tan, K.S. and Hinberg, I. (1995a) Malfunction in medical devices due to EMI from wireless telecommunication devices. Proceedings Thirteenth Annual Meeting and Exposition of the Association for the Advancement of Medical Instrumentation, 96.
Tan, K.S. and Hinberg, I. (1995b) Investigation of electromagnetic interference with medical devices in Canadian hospitals. Proceedings of a Workshop on Electromagnetics, Health Care and Health, held in association with the 17th Annual International Conference of the IEEE Engineering in Medicine and Biology Society, 20–23.
Witters, D. and Ruggera, P. (1994) Electromagnetic Compatibility (EMC) of Powered Wheelchairs and Scooters. Proceedings of the 16th Annual International Conference of the IEEE Engineering in Medicine and Biology Society, 894–895.
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 1997 Chapman & Hall
About this chapter
Cite this chapter
Bassen, H.I. (1997). RF interference (RFI) of medical devices by mobile communications transmitters. In: Kuster, N., Balzano, Q., Lin, J.C. (eds) Mobile Communications Safety. Telecommunications Technology & Applications Series. Springer, Boston, MA. https://doi.org/10.1007/978-1-4613-1205-5_3
Download citation
DOI: https://doi.org/10.1007/978-1-4613-1205-5_3
Publisher Name: Springer, Boston, MA
Print ISBN: 978-1-4612-8511-3
Online ISBN: 978-1-4613-1205-5
eBook Packages: Springer Book Archive