Crowdsourcing a consumer safety issue — EMI interference and cardiac devices

What follows is a guest post from Dr. J Rod Gimbel, a cardiac electrophysiologist from Knoxville, TN. Dr. Gimbel has written extensively on the issue of electronic surveillance systems and electromagnetic interference (EMI) with cardiac implantable electronic devices, such as pacemakers and defibrillators.

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I’d like to express my appreciation for allowing me to guest post in this space.

This is about crowdsourcing a consumer safety issue; specifically the public safety of consumers who happen to have CIEDs (cardiac implantable electronic devices) such as pacemakers or implantable defibrillators (ICD).  Nearly 2 million such consumers (patients) have CIEDs in the U.S. alone.  As you know, these devices are susceptible to EMI (electromagnetic interference).  Simply put, the lead(s) act like antennas and can pick up stray EMI from any number of sources and cause the device to malfunction by either withholding therapy (no pacing or ICD rescue therapy) or through delivery of inappropriate therapy (delivering pacing output or shocks where none is needed).  Either situation can be life threatening.

One source of EMI that can affect a CIED patient is electronic article surveillance system (EAS).  Such systems are widely used by retailers (ref) to deter and prevent store theft, a problem commonly referred to as “shrinkage”.

About 8 years ago, an ICD patient that I was caring for received inappropriate shocks from his ICD after being near an EAS system located in a big box retailer.   A colleague of mine related a similar situation where a pacemaker dependent patient reported syncope in the proximity of an EAS system after her pacemaker inhibited in response to the EMI from the EAS system.  These were two disturbing, potentially life threatening events.  In hopes of raising awareness of this serious problem (EAS-CIED interaction), we generated a manuscript detailing the events that was published in 2007 in the Mayo Clinic Proceedings.  Notably, the New York Times picked up the story.  Others have published similar unfortunate misadventures between patients and EAS systems.

Several common sense recommendations have been made in this area; recommendations that preserve a retailer’s right to deter and reduce theft (a legitimate concern), but still protect CIED patients from adverse interactions with EAS systems.  For instance, after receiving reports of several adverse events caused by EAS systems the Food and Drug Administration (FDA) issued a “Safety Communication” and noted:

1) Be aware that EAS systems may be hidden/camouflaged in entrances and exits where they are not readily visible in many commercial establishments.

2) Do not stay near the EAS system or metal detector longer than is necessary and do not lean against the system.

Beyond this, we and others also suggested:

3) Retailers should not “camouflage” the EAS pedestals with advertising as this may prevent customers with devices from recognizing the threat and may actually draw device patients toward the EAS pedestal.

4) Retailers should not place goods and services near the EAS systems that effectively encourage the patients to violate the “don’t linger, don’t lean” dictum that physicians tell patients who have devices.

It seems entirely reasonable to suggest a shared responsibility between medical device professionals, device patients, retailers, and EAS system manufacturers.   It was hoped EAS manufactures and retailers would do their part and embrace these simple recommendations and help make retail spaces safe for those with implantable devices.  Unfortunately, this does not seem to always be the case.

Figure 1:  Bench to “relax” placed adjacent to camouflaged EAS pedestal at big box retailer.

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Figure 2:  Chair to “relax” adjacent to EAS pedestal while patient waits for prescription to be filled at retail chain pharmacy store.

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Figure 3:  Complementary coffee station where device patients might linger placed adjacent to EAS pedestal at big box retailer.

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These pictures were taken in the last several months around the country.  Clearly, the juxtaposition of EAS systems and consumer areas may undermine the dictum “don’t linger, don’t lean” and leave device patients in harm’s way.  Who then, is responsible for the safety of device patients in this situation?

Finally, perhaps in an attempt to thwart a determined and “informed shoplifter” who may employ several methods that might undermine the effectiveness of EAS systems, “there are also concerns that some installations are purposefully configured to exceed the rated specifications of the manufacturer, thereby exceeding tested and certified magnetic field levels.”  This may increase further the risk of adverse reactions experienced by device patients when near EAS systems.

Here’s the crowdsourcing part.  A presentation on this topic (CIED-EAS interactions) to an extra governmental regulatory group helping set standards for the device industry is to be given soon.  This presentation will be to a number of interested parties including representatives of the EAS manufactures, device manufactures, and the FDA.   As noted above, the “event rate” of these interactions is rather low, but as has been suggested significant under-reporting may obscure the true significance of the problem.  It is surely recognize that not everyone has the time or inclination to write up adverse events for publication or inclusion in a database.  Perhaps, some events go entirely unrecognized for what they really are, being passed off as “Oh, Mom passed out at the store today, but she’s OK now”.

With your help a strong presentation and case can be made emphasizing CIED-EAS interactions are an important public safety issue.  Your voice and concerns can be heard.  First off, send pictures where you see EAS systems placed in a manner that might endanger a device patient (like the ones shown above).  Cell phone pics are just fine.  Second, if you are a health care provider or patient, please send any “events” that you may have experienced describing an adverse interaction between an EAS system and pacemakers and or ICDs.   Please post the items here or send items of interest to J. Rod Gimbel, MD (gimbeljr@gmail.com).  Your response is of course appreciated and in confidence and any presentation of the material provided will be anonymized.  Upon completion of the presentation, a link will be posted here.

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My friend Dr. Wes Fisher also published this guest post. Wes said it well:

“This is an important effort that Rod is undertaking on behalf of patients with CIEDs. I hope patients and health care providers will come forward with examples of EAS systems or EAS interference in their locales to assist him in this important consumer safety effort.”

JMM

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