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RF interference (RFI) of medical devices by mobile communications transmitters

Chapter
Part of the Telecommunications Technology & Applications Series book series (TTAP)

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.

Keywords

Medical Device Cellular Phone International Electrotechnical Commission Implantable Cardiac Pacemaker GTEM Cell 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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References

  1. 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.Google Scholar
  2. ANSI, American National Standards Institute C63.8 (1995) Draft Ad-Hoc Test Method for Medical Device Testing. ANSI, N.Y., U.S. November, 1995.Google Scholar
  3. 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.Google Scholar
  4. Bassen, H. (1986) Prom problem reporting to technological solutions. Med. Instrumentation, 20, 17–26.Google Scholar
  5. 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.Google Scholar
  6. 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.Google Scholar
  7. 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.Google Scholar
  8. Bassen, H., Moore, H. and Ruggera, P. (1995) Cellular phone interference testing of implantable cardiac defibrillators, in vitro. Circulation, 92(8), 3547.Google Scholar
  9. Biomedical Safety & Standards (1995) Ventilators Could Malfunction Under High EMI Exposure 25, 10: 1 and 75.Google Scholar
  10. Bostrum, U. (1991) Interference from mobile telephones — a challenge for clinical engineers. Clinical Engineering Update, 10.Google Scholar
  11. 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.Google Scholar
  12. Carrillo, R., Saunkeah, B., Pickels, M. et al. (1995) Preliminary observations on cellular telephones and pacemakers. PACE, 18(4), 863.Google Scholar
  13. 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.Google Scholar
  14. Casamento, J. Applying Standardized Electromagnetic Compatibility Testing Methods for Evaluating Radiofrequency Interference of Ventilators. Med. Instrumentation (in press).Google Scholar
  15. 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.Google Scholar
  16. Clemans, T. (1994) Electromagnetic compatibility. Biomedical Instrumentation, 28, 13.Google Scholar
  17. 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.MathSciNetCrossRefGoogle Scholar
  18. 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.Google Scholar
  19. ECRI, Emergency Care Research Institute (1993) Guidance article: Cellular telephones and radio transmitters — interference with clinical equipment. Health Devices, 22(8–9), 416–418.Google Scholar
  20. 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.Google Scholar
  21. 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.Google Scholar
  22. IEC, International Electrotechnical Commission (1992) Medical Electrical Equipment, Part 1: General requirements for safety; Collateral Standard: Electromagnetic Compatibility, IEC 601-1-2.Google Scholar
  23. 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.Google Scholar
  24. IEC, International Electrotechnical Commission (1995) Draft: 1st Edition of IEC 118-13, Hearing Aids, Part 13: Electromagnetic Compatibility (EMC) product standard for Hearing Aids.Google Scholar
  25. ISO, International Organization for Standardization (1994) Draft Revision of Standard 7176/1-1986, Wheelchairs, Part 1: Determination of Static Stability.Google Scholar
  26. 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.Google Scholar
  27. 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.Google Scholar
  28. 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.CrossRefGoogle Scholar
  29. RESNA, Rehabilitation Society of North America (1993) Draft Revision of Standard WC/01 Wheelchairs, Determination of Static Stability.Google Scholar
  30. 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.Google Scholar
  31. 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.Google Scholar
  32. 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 andGoogle Scholar
  33. 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.Google Scholar
  34. 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.Google Scholar
  35. 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.Google Scholar
  36. 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.Google Scholar
  37. Silberberg, J. (1993) Performance degradation of electronic medical devices due to electromagnetic interference. Compliance Engineering, Fall 1993, 25–39.MathSciNetGoogle Scholar
  38. 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.Google Scholar
  39. 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.Google Scholar
  40. 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).Google Scholar
  41. 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.Google Scholar
  42. 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.Google Scholar
  43. 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.Google Scholar

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