Do Retail Anti-Theft Systems Interfere With Implanted Medical Devices?

By Chuck Seegert, Ph.D.

The growing number of medical electronic implants prompted the Association for the Advancement of Medical Instrumentation (AAMI) to revisit the effects that common electronic article surveillance (EAS) gates may have on those devices. People with pacemakers and implanted defibrillators have been affected by EAS gates, and recommendations are being developed with input from the FDA.

Just about every store in a modern mall has EAS gates, which serve as electronic guardians at exits to prevent shoplifting. They’ve become so commonplace that they blend into the background in many cases, a state of affairs that may be encouraged by store owners. It is not unusual for the gates to be used at a convenient location for advertising, consequently leading to the gate’s concealment by posters and other promotional material.

With the increased number of implanted electronic devices, however, the chance for EAS gates to alter the performance of pacemakers and defibrillators has become greater. To address this concern, the AAMI’s Cardiac Rhythm Management Device Committee met recently to discuss the risks patients may encounter with EAS gates, according to a recent press release.

Historically, EAS gates have been known to cause adverse effects in patients, most often in patients with spinal cord neurostimulators, according to the press release. Additional adverse effects have been recorded in the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database, where an elderly patient with a defibrillator was shocked when he came in close proximity to an EAS gate. In another incident, a woman with a pacemaker passed out near a gate. When she sat against the gate to recover, she passed out again. In all, she lost consciousness five times before the store’s employees finally moved her away from the gate, according to an article in the New York Times.

In 2000, the FDA recognized this concern and issued a guidance document on Labeling for Electronic Anti-Theft Systems. The guidance recommended an approach called “don’t lean, don’t linger,” which encouraged people with electronic implants to avoid EAS gates and other electronics. While only a few people are at risk, posting labeling or signage would help decrease the risk even further.

The discussion of the committee was centered on how this guidance may now be ineffective, since many retailers are now concealing the gates or making them less noticeable, according to the press release. Examples include the placement of coffee stations near the gates, and even the placement of lounge chairs in close proximity. These scenarios are compounded by the fact that warning signs are generally quite small — sometimes only 3 by 5 inches.

In the future, it seems that EAS gates may be more prevalently placed in the floors of stores, according to the press release. While these new locations may mitigate the concerns for electronic implant effects, it hasn’t been shown conclusively to be the case. To understand these changes, the FDA suggested human factors research be conducted to understand if patients were in fact aware of the presence of EAS gates.