Hello Dan, on https://www.bfarm.de/DE/Medizinprodukte/Aufgaben/Risikobewertung-und-Forschung/Wissenschaftliche-Aufarbeitung/EMV-Studie_Herzschrittmacher.html you may find a press release from the German Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM; Federal Institute for Drugs and Medical Devices) on a "Study on the immunity of implantable pacemakers of the Institut für Rundfunktechnik GmbH, Munich". In this study, the EMC immunity of 274 pacemaker devices was tested according to European standard EN 45502-2-1 (CENELEC - CEN/CLC/JTC 16 (cencenelec.eu)<https://standards.cencenelec.eu/dyn/www/f?p=CENELEC:110:::::FSP_PROJECT,FSP_ORG_ID:20265,2401823&cs=1B2A778F33C4A9FE02D07532CE3EAC191>) and American standard ANSI/AAMI PC69 (ANSI/AAMI PC69:2007 (ANSI/AAMI PC 69:2007) - Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators (Includes Erratum)<https://webstore.ansi.org/Standards/AAMI/ANSIAAMIPC692007PC69>). The press release is in German only, but here is a translation of the summary:
"Through the use of a standard-compliant measurement setup and the automated measurements of PM, which in their model diversity represent about 95% of the market for active pacemakers as of 2004, the study offers the most comprehensive overview to date of device behavior under the influence of electromagnetic interference at different frequencies. In the area of mobile radio frequencies, no failures were observed in the study, but often in the frequency range below 450 MHz. Should electromagnetic interference occur in practice, the device would automatically be switched to safe mode (backup mode), where further operation is possible. In theBfArM's reporting system, there is no accumulation of pacemaker events due to EMC influences, and the BfArM has not reported any individual cases of high error severity that show a fatal pacemaker failure caused by interference. An event that comes into question for this, such as the coincidence of an electromagnetic disturbance and the stimulation in the vulnerable phase, is theoretically possible, but unlikely and this justifies the very low statistical relevance of such exceptional cases from the point of view of the BfArM." With respect to warnings in the instructions, the press release contains the following statement: "Many instructions for use contain not only an indication of the risks of electromagnetic interference, but also a list of sources of interference with appropriate warnings for the patient. If there is not even a general indication of the possibility of interference by external electromagnetic fields, it is necessary from the point of view of the BfArM to include a corresponding warning in the device description in accordance with Annex 2.4 of AIMD 90/385/EEC." Kind regards, Bernd Von: Chas Grasso <[email protected]> Gesendet: Montag, 7. November 2022 16:16 An: [email protected] Betreff: Re: [PSES] Magnetic fields, human exposure standards, and pacemakers Hello Dan, Dont you think that (irrespective of the warning ) the magnet on the DC cord is *much* weaker than a magnet used to penetrate through the thickness of the human body and then trigger the reed switches? My first thought is that the warning is there as a CYA? Perhaps? On Sun, Nov 6, 2022 at 2:06 PM Dan Roman <[email protected]<mailto:[email protected]>> wrote: This message originated outside of DISH and was sent by: [email protected]<mailto:[email protected]> ________________________________ Thank you everyone for the responses. Contacting the customer support number gets you to someone who basically reads back what is on the website and the user manual, so it was not particularly helpful when trying to get to the specifics. In a roundabout way through a friend of a friend I managed to arrange a phone call with someone from Boston Scientific that had technical engineering knowledge and could answer my questions. The device in question is a pacemaker/defibrillator. It happens to be MRI compatible but I didn't get into what that means with respect to magnetic fields, I think it probably has a lot to do with not getting ripped out of your chest if you get an MRI. Anyway, it has two sets of reed switches embedded in it. One reed switch will react to a lower level magnet placed over it and that puts it into a fixed pacing mode. This is used for diagnosing in the doctor's office. The magnet in a fitness tracker is not likely to be strong enough or to get close enough to turn on the fixed pacing mode during normal wear, but they still will tell you not to wear it to bed in case you contort in such a way when sleeping to cause an issue. The second reed switch reacts only to a much stronger magnetic field and this is used to disable the defibrillator if you go in for an operation. The anesthesiologist will apply a strong magnet over the device to disable it for the duration of the operation. Makes sense that as that is easier than connecting up a programming device to disable it and then re-enable it and it can be easily turned off in an emergency situation with no need for a make/model specific programming set. So the relative is going to keep the fitness tracker and not wear it to bed (most of the time). They lose the sleep tracking but that is not of as much interest to them and they don't have it when sleeping every few days to charge it overnight anyway. Not sure if all devices work the same way but sounds like for simplification reasons this might be a standardized practice to make surgeon's and other health care work easier. I should have asked about how "MRI compatible" works! Now I'm curious. Dan From: MIKE SHERMAN [mailto:[email protected]<mailto:[email protected]>] Sent: Thursday, November 03, 2022 8:52 PM To: [email protected]<mailto:[email protected]> Subject: Re: [PSES] Magnetic fields, human exposure standards, and pacemakers Dan -- I'd suggest that you have your relative call Support at the pacemaker/defib manufacturer. On a slightly different project, I found a lot of on-line information about device immunity, and I think we even called Support and got additional clarifying information. Go to the source! Mike Sherman Sherman PSC LLC Product Safety and Compliance Consulting On 11/03/2022 11:32 AM Dan Roman <[email protected]<mailto:[email protected]>> wrote: Hello list! I have a relative with an implanted pacemaker/defibrillator who recently got a fitness tracker that has a magnet for attachment/alignment of the charging cord. There are warnings in the user manual advising against people with pacemakers using this product because of the magnets, which I assume are fairly strong rare earth types. I looked up the DoC for the tracker and the EM field human exposure standards EN 50663 and EN 62479 are listed on the DoC. My question is do these standards and the similar IEC 62233 give a reasonable assurance that a pacemaker would not be interfered with or are these standards purely concerned with biological effects on the human body only? I would expect the pacemaker to be immune to a certain extent if it is FDA listed and complies with IEC 60601-1-2. I don't know the model number of their device but I would expect them all to be similar. Do they need to send back their fitness tracker? Or is the warning just thrown in because the lawyers wanted it? Although products I work on need to meet these types of standards, I don't have much familiarity with these exposure standards because my products have never failed Regards, Dan ______________________________________________________ Dan Roman, N.C.E. Senior Member IEEE Product Safety Engineering Society mailto:[email protected] - ---------------------------------------------------------------- This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. 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