Office of Occupational Safety and Health (00S1)
Quarterly DASHO Conference Call Agenda
October 24, 2000
Time: 1 to 1:50 PM Eastern Time
Telephone Number (Bridge): 1-800-767-1750
Subject: Non-ionizing Radiation from Cell Phones
Audience: All Employees, Union Representatives, biomedical engineers, radiation safety officers, and Safety Officials
|1 - 1:03 PM
Director, Office of Occupational Safety and Health - Moderator
- Dental Water Lines IL -(includes attachment)
- Today's Subject -- non-ionizing radiation health effects and impact on medical devices.
|1:03 – 1:13
||Mr. Ron Peterson - email@example.com
- Bell Lab and Lucent Industries
- Non-ionizing radiation
- Research on effect of non-ionizing radiation on humans
|1:13 -- 1:23
||Dr. Lotz, William G. (Greg) [firstname.lastname@example.org]
- Health effects
- Studies - Canadian and UK
|1:23 – 1:33
||Dr. Joe Morrissey - email@example.com
- Research on effect on non-ionizing radiation on medical devices
- What can be done
|1:33 - 1:43
||Dr. Don Witter - dmw@cdrh.FDA.gov
- Food and Drug Administration
- Tests that have been done
- Other sources on non-ionizing radiation
|1:43 - 1:50
||Questions and Answers
- If you did not have time to ask your question you may e-mail it to firstname.lastname@example.org or call Frank Denny at 202 273-9743
Note: The Office of Occupational Safety and Health has contacted officials of agencies and/or organizations for this conference call that can represent their agency/organization's and/or are expects in their field. However, verbal statements and/or paraphrased questions and answers (found at the bottom of this agenda), are informational and have not been cleared as policy in-of-themselves. Links have been provided to this call that allow agency/organizational polices to be viewed. Questions and answers are viewed on the intranet only.
Links with additional information:
Questions and Answers:
Question: If I might ask the following questions pertaining to medical device > interference:
> is there any listing that would tell us which devices are more sensitive to interference (either specific models or generic classes such as infusion pumps, EEGs...) and if they failed would have serious consequences. Since most of the cell phones are very close to devices, does it seem that the E or H field is causing more problems in the NEAR field?
It would seem that any type of leads into the heart are potentially a problem. Has there been any research on the signal cables,....
Answer: Although there have been a handful of studies reporting the EMI effects of cell phone exposure on medical devices, no comprehensive analysis on all equipment make and model types has been performed. Further, testing is often performed on a single representative device, and the effects on other units of the same make and model might be different due to small variations in shielding side panels, position of the circuitry board, position of cords and leads, etc.. The test room environment can also have a strong influence on the effects observed. Finally, the effects of different cell phone signal types (analogue, iDEN/Nextel, CDMA-1900/Sprint PCS, TDMA-800/ATT, etc) can be drastically different for any single medical device. My advice for any hospital wanting to determine the immunity level of its equipment is to have a survey performed in their facility using specific cell phone signal type(s) of interest and testing multiple representative devices, especially in each of the general categories where interference has been found to occur from published reports (EEG & EKG monitors, defibrillators, ventilators, infusion pumps, dialysis machines, etc). I would not recommend putting TOO MUCH weight on extrapolations from published reports, although I have listed them below if you are interested in reviewing their findings. Concerning the issue of EMI with pacemakers and implantable defibrillators, as Don Witters mentioned in his talk this area has been investigated much more thoroughly, and a number of reports on this subject can be found in the literature.
References to studies related to hospital EMI:
1. Revision of the International Electrotechnical Commission (IEC) Standard (IEC 60601-1-2), 1993.
2. Robinson MP and Flintoft ID, Can Mobile Phones Interfere with Hospital Equipment, in EMC Engineering Europe, September 1998, pp 9-10
3. Sibakov V and Appelqvist M. Immunity of Medical Electronic Devices to Electromangetic Field of Cellular Mobile Phones, VTT Tiedotteit Research Bulletin 1998
4. Davis D, Segal B, and Pavlesek T. Can minimum Separation Criteria Ensure Electromagnetic Compatibility in Hospitals? An Experimental Study. Biomed Instrum Technol. 1999; 33(5):411-6.
5. Foster KE. Radiofrequency Field Surveys in Hospitals. Biomedical Instrumentation and Technology March/April 1999, pp155-159
6. Kimmel WD and Gerke DD. Electromagnetic Interference in the Hospital Environment. Medical Device & Diagnostic Industry May 1995, pp. 97-101
7. Segal B. Electromagnetic Environment in hospitals Proceedings of the Round Table on EMC in Health Care (Ottawa, Ontario, Sept. 1994) Care Technology, Alberta, Canada 1995, pp. 33-37
8. MDA Device Bulletin DB9702, Electromagnetic Compatibility of Medical Devices with Mobile Communications, March 1997.
9. Irnich WE, Tobisch R. Mobile Phones in Hospitals. Biomed. Instrum. Technol. 1999; 33(1):28-34.
10. Robinson MP, Flintoft ID, and Marvin AC, Interference to Medical Equipment from Mobile Phones. J. Med. Engineering Tech 1997, 21:141-148
11. Turcotte J, Witters D, A Practical Technique for Assessing Electromagnetic Interference in the Clinical Setting: Ad Hoc Testing, Biomed Instrum Technol 1998 May-Jun;32(3):241-52
12. Silbert J. Interference from Cellular Telephones in the Electroencephalogram. J Polysomnographic Technology 1994; volume X:20-22
13. American Association of Medical Instrumentation (AAMI) Technical Information Report (TIR) #18, 1997.
14. Bassen HI. Radiofrequency Interference with Medical Devices: A Technical Information Statement. IEEE Eng. Med. Biol. Mag. 1998; 17(3):111-114
15. American National Standard's Institute (ANSI) standard C63.18 "Recommended Practice for an On-site, Ad-Hoc Test Method for Estimating Radiated Electromagnetic Immunity of Medical Devices to Specific Radio Frequency Transmitters" 1999.
16. Morrissey JJ. Characterization of Electromagnetic Interference of Medical Devices in the Hospital from Cell Phone Signal Emissions. Health Physics (submitted).
Question: Mr. Witter of CDRH referred to a report, "AMI #18 Technical Information" can you expand on that reference? I'd like enough information to see about ordering it.
Answer: A Finish study was mentioned by somebody. I am not sure if it is the same > study or not but the most recent issue of "Health Physics" the > "Operational Radiation Safety" supplement, Nov 2000, has an article, "Safe > Use of Mobile Phones in Hospitals", Maila Kietmen, et al. There are 2 Finnish studies - a reportb by VTO (Finnish Institute of Technology) as well as the study in Health Physics by Maila Heitanen.
The AAMI publication TIR 18, detailed below, should be available from AAMI (I found this information on their website www.aami.org with the publication search feature). AAMI TIR18:1997 -- Guidance on electromagnetic compatibility of medical devices for clinical/biomedical engineers - Part 1: Radiated radio-frequency electromagnetic energy Final AAMI Technical Information Report Provides information and guidance on electromagnetic compatibility (EMC) of medical devices to assist clinical engineers and other biomedical personnel in evaluation of the radiated frequency (RF) electromagnetic environment in health care facilities and to minimize electromagnetic interference (EMI) problems. The report includes general recommendations regarding EMC with emphasis on radiated RF immunity; principles of electromagnetic energy and interference mechanisms; assessment of the radiated RF electromagnetic environment; management of the radiated RF electromagnetic environment, including site selection, design, and construction of new facilities; management of medical devices for EMC; investigation and reporting of EMI problems; selected case studies in radiated EMI problems; and guidance on developing a hospital EMC/EMI policy together with a model policy.
----------- my mention of some of the effects of cell phones on medical devices. My source was a study from Finland. It may also be the source of the paper he cites, I have not seen the most recent Health Physics issue, but the authors appear to be similar to the study I mentioned. If possible, I would appreciate copy of the Health Physics article (my fax is 301/827-4947).