About a week and a half ago, I blogged about a Florida TV news report that took to task a radio amateur living a few doors down from a woman using an insulin pump. She claimed that his operation caused the pump to malfunction, putting her health at risk.
After hiring a consultant to look into the matter, the homeowner’s association ordered the ham to cease operation, even though the consultant’s findings were inconclusive. The report from Sublight Engineering, PLLC, of Arlington, VA, states, “It is possible that HF amateur radio operations described herein could create fields that exceed manufacturers (sic) limits.” (Italics are mine.)
In my original post, I wrote, “This report is troubling for many reasons. I hope that the ARRL is aware of this, and is looking into it.” Well, they did and reported on their findings. As expected, they wrote, “It also became apparent that there is no actual evidence connecting the amateur’s transmissions to operation of the insulin pump.”
Ria, N2RJ, the ARRL Hudson Division director, also produced a video on this situation:
What I don’t understand is why no one contacted the manufacturer, Medtronic. Wouldn’t they want to know if one of their devices was faulty, or if their manufacturing and testing procedures were faulty?
With no real conclusion to this story, it’s bound to pop up again. You know that someone somewhere is going to claim that a ham is interfering with his or her insulin pump and a Google search is going to turn up this story on the Florida TV station’s website. I think it would have been a good idea to completely debunk this story, so that when it does come up again, we can just point to this case and blow off the complainer. As it stands, however, we really can’t do that.
My ex-wife had a Medtronic insulin pump for about 15 years during our marriage, and three different models, if I recall correctly. I operated HF and 6 meters at 100 watts (CW), and VHF/UHF, about 50 watts. We never experienced an RFI problem with the pump.
I have a CardioMEMS unit implanted in my pulmonary artery. In reading the material, it detailed how my thoracic pressure was monitored via RF. My husband and I, both being Hams, quickly inquired about “what frequency?” and would operating our radios cause any problems.
(http://www.ellismedicine.org/heart/cardioMEMS.aspx#:~:text=The%20CardioMEMS%E2%84%A2%20device%20is%20implanted%20into%20the%20pulmonary,30%20minutes%20and%20is%20done%20with%20local%20anesthesia.)
The doctors were quite intrigued, as was the manufacturer. No one had ever asked about amateur radio before. After some research on their part, all is well. It’s just like pacemakers and microwave ovens and cell phones. As long as theirs a foot or so of distance from my chest, everything is fine. I never had any issues, even when using my HT. I just make sure I don’t put it in the chest pocket.
The pump in the news story is a 770G. The 5 series and 2 670G pumps involved in the interference were NOT involved in any recall. Medtronic was notified many times and the FDA has been investigating. There IS proof it was the ham transmissions, but Ed Hare hasn’t seen it, nor does he care. The engineers report was elaborate, gave calculated distances require for the electric fields to be below 10 volts per meter, which is the pumps immunity. The report ended with the engineer recommending that the HF transmissions NOT resume until interference issues had been resolved. The FDA notified Ed Hare that many complaints filed into the MAUDE reporting systems for medical device problems were from hams that had interference with their medical device from their own equipment.
Please send me the “proof.” I will publish it here. As I noted in my post, however, the part of the consultant’s report that was shown in the TV report says, “It is possible that HF amateur radio operations described herein could create fields that exceed manufacturers (sic) limits.” That’s hardly conclusive evidence. Also, the person complaining refused to do any actual testing, i.e. observing the operation of the pump while the amateur radio operator was transmitting. That would have certainly resolved the issue.
I’d also note that just because there have been “many complaints” doesn’t mean that hams actually caused any interference. It’s very easy to complain about something, but a lot harder to actually prove it.
Dan, the consultant that did the report is an electrical engineer specializing in RFI, and is also a ham radio operator. He used the equation for distance in the Medtronic manual, and came up with specific distances that the electric field would exceed the pump’s immunity limit of 10 volts per meter, and 3 volts per meter. His recommendation was for the HF transmissions to NOT resume until the interference issue could be resolved. Everything about the pump is uploaded into the Carelink system, and those documents were sent to the FDA. The pump is programmed to give a specific amount, and it did NOT during their transmissions (there were two hams living across the street from one another). Due to the way insulin works in the body, you cannot do an on/off transmissions test for this. The FDA told Mr. Hare this, and that there was documented proof of the interference. Why he chose to ignore that is unknown. The FDA reporting site is used mostly done by doctors to report interference and the specific reason is usually left out. However, ham operators themselves have reported interference with their medical device from their own equipment. Read that again please. Hams have complained about their own equipment interfering with their own medical device. Many hams have come forward and told me the problem most likely is that the ham is using an 800 watt amp (Ameritron) for HF transmissions in a zero lot line neighborhood.. He caused me severe highs for 8 months, and almost put me in a coma most nights for a month. It was terrifying. I did everything I was supposed to do-notify Medtronic and replace pumps, reservoirs, insulin/report to the FDA/ file with the State. He has done nothing but lie about me and insult me. A lot of other hams have been nasty as well, but I have done my best to give them the facts.
It seems to me that everyone involved in this case should be evaluating their own equipment and comparing the data with each other to determine where the real problem is and who’s problem it is. Has anyone conducted a station evaluation of the ham station in question? What are the actual numbers? And are those numbers in line with FCC Bulletin 65 and supplement B? Has the insulin pump been tested to see if its RFI shielding is adequate enough to withstand permissible RF that the ham is legally allowed to transmit at the distance in question?
Everyone has a complaint here and no one is getting to the root of the problem. Yes, the ham radio operator can live without his hobby. But he shouldn’t have to. Nor should Michelle Smith have a insulin pump that is affected by the ham operators transmissions “if” they are at permissible levels. But which is the case here? Is it that the ham signals are too strong or is it that the insulin pump is not manufactured to properly withstand legal radio transmissions without interference?
The engineer report does NOT answer these questions. Shutting down the ham station may be the easiest solution but it is not a fair solution. He’s not guilty until proven innocent. He has just as much right to his hobby as Michelle Smith has to a properly functioning insulin pump. Its not as simple as who’s dilemma is most important here. The real question is who does the problem belong to? Is it the ham operator or the manufacturer of the insulin pump? Because if its not the ham’s problem then he should be allowed to operate. Even if that means Michelle Smith must purchase a better quality insulin pump or move to another location if no acceptable insulin pump exist. Which I’m sure is not the case unless all insulin pumps are now made in China.
Another question, why is the ham operator banned from operating at all power levels? From what I understand, he isn’t allowed to operate all, not even at 1 watt. Would a one watt signal from his station cause her insulin pump to malfunction? And if not then why isn’t he allowed to operate at 1 watt? See, there’s too much bs going on here. There’s no working together to find a solution. And that’s just sad…,
This pump if I recall correctly is a Part 15 device which means that 1 it must not cause any intereference to any other device, and 2 it must accept any interference which may cause undesireable operation. The manual states this. I remember reading on another web site where people mentioned that this particular pump had dosage issues anyway even without any interference, so why blame the ham? There was no cause and effect shown but only an indication that the pump was malfunctioning was shown. I agree that the ham could reduce power, but at the same time the HOA doesn’t have any authority to impede on privileges granted by the FCC… the same agency that enforces the Part 15 rules mentioned earlier.
Well, unfortunately, none of that was part of the TV report. As I wrote above, the part of the consultant’s report that could be seen on TV was inconclusive. Also, just because some hams reported problems with their devices doesn’t mean that their amateur radio transmissions are at fault. It’s quite possible that the devices themselves are more susceptible than they are specified to be. You say that you notified Medtronic. What did they have to say about the problem?
Understand that amateur radio operators get blamed for all kinds of things and at least nine times out of ten, the problem turns out to be something other than an amateur radio transmission. The only way to ascertain who’s really at fault here is to test the device under controlled conditions. Being a former test engineer myself, I can tell you that a test can certainly be devised that will test a device’s susceptibility to electric fields.
I apologize for the hams that insulted you. It does seem that you have “done [your] best to give them the facts,” but It seems to me that there is still not enough information to make a clearcut determination of who’s at fault–the devices or the transmissions.
She said that she had proof. You asked for her to send it to you, and you would print it.
Another month has gone by, and I don’t see any proof.
It is time for her to ‘put up’ or ‘shut up’.
Bet the lady was just another What they call a Karen! Just wanted to complain and be a pain!!!