BOCA RATON, Fla.--(BUSINESS WIRE)--November 4, 1998--Cardiac patients should not be alarmed by a case report and a letter to the editor published this week in The New England Journal of Medicine about the possible effects of electronic anti-theft systems on implanted cardioverter defibrillators (ICDs) and pacemakers.
The fact is that the medical community, implant manufacturers, and the anti-theft industry have long been aware that a variety of anti-theft systems, including those that employ both acoustomagnetic and swept radio frequency technology, can interact with implanted medical devices - and all agree, as the U.S. Food and Drug Administration stated in a recent advisory letter to physicians, that these interactions "are unlikely to cause clinically significant symptoms in most patients." As FDA's spokesperson told the Associated Press, there is no reason for heart patients to become anxious about electronic anti-theft systems.
The New England Journal of Medicine case report, written by Dr. Peter A. Santucci and three colleagues, related a 1997 incident involving a single ICD patient who said his defibrillator was triggered inappropriately after he had lingered for an extended period of time next to anti-theft equipment manufactured by Sensormatic Electronics Corporation. The letter to the editor, written by Dr. Michael McIvor and Dr. S. Sridhar, also concerned a 1997 incident, this one involving a single pacemaker patient who claimed to have been affected by an anti-theft system.
Such claims do surface occasionally, involving all types of anti-theft equipment, but they are extremely rare. The FDA emphasized that over the past 10 years - during which, it is worth noting, pacemaker and ICD patients have passed through anti-theft security gates literally hundreds of millions of times - the government has received just 18 so-called medical device reports involving electronic security systems and pacemakers, and just two involving electronic security systems and inappropriate firings by defibrillators.
After considering the matter at a public session in September, the FDA concluded that anti-theft systems do not pose a public health problem for pacemaker or ICD wearers. Shortly after that public session, the FDA distributed its physicians' advisory that stated, "Interactions with (anti-theft) systems and metal detectors are unlikely to cause clinically significant symptoms in most patients."
The FDA went on to recommend that physicians simply advise patients with pacemakers and ICDs to avoid lingering near or leaning directly on anti-theft equipment - precisely the same advice implant manufacturers and the anti-theft industry have been offering for years.
Dr. Santucci's case report describes an incident involving a 72-year-old man who said his defibrillator fired inappropriately when he lingered next to a Sensormatic anti-theft system for a prolonged period of time. ICD patients are routinely warned, however, that their devices are sensitive to outside electrical or magnetic fields and that, as a result - they should, as the leading ICD manufacturer says in its patient manual - "avoid standing near anti-theft devices in doorways of department stores and public libraries."
Inappropriate ICD firings like that described in Dr. Santucci's report can actually result from a wide variety of causes - and are not uncommon. Experts say that, depending on the ICD model, as many as 20 percent of all ICD firings are triggered in error. Since the FDA has received only a few reports of such firings tied to anti-theft systems, it seems clear that anti-theft systems are not a significant source of these inappropriate firings. (It is worth noting that the relatively few reports FDA has received have involved both acoustomagnetic and swept RF anti-theft systems.)
Fortunately, inappropriate ICD firings, while uncomfortable, are usually well tolerated by patients. In fact, Dr. Santucci's report notes that the patient it describes recovered from the effects of his inappropriate firing as soon as he was no longer next to the anti-theft equipment.
More importantly, the most extensive research study of its type ever undertaken confirms that ICD patients should not be concerned at all about shopping in stores equipped with anti-theft systems. Led by renowned cardiologist Dr. Douglas Zipes, tests underway since March at the Indiana University School of Medicine's Krannert Institute of Cardiology demonstrate that anti-theft systems pose no hazard to ICD patients who interact with them normally - that is, pass through the gates at an ordinary pace, without leaning on or lingering near the EAS pedestals longer than necessary.
Dr. Zipes, a former president of the North American Society of Pacing and Electrophysiology (NASPE) - the leading organization of physicians who treat ICD patients - is a Distinguished Professor of Medicine, Pharmacology and Toxicology at Indiana University as well as director of both the university's Cardiology Division and the Krannert Institute. He currently serves on the boards of NASPE, the American College of Cardiology, and the American Board of Internal Medicine, and he is editor-in-chief of the Journal of Cardiovascular Electrophysiology, Cardiology in Review, and Contemporary Treatments of Cardiovascular Disease, three of the field's leading journals.
Over the course of 1998, Dr. Zipes and his team have evaluated more than 160 ICD patients as they are exposed to electromagnetic and acoustomagnetic anti-theft systems in a variety of ways.
Sensormatic is sponsoring Dr. Zipes' study as part of the company's continuing effort to expand scientific knowledge and ensure that its products pose no health hazards to anyone.
The letter to the editor by Dr. McIvor and Dr. Sridhar published in this week's New England Journal of Medicine describes a 30-year-old Phoenix, Arizona, woman who claimed to have suffered adverse reactions, over a year ago, after being exposed to an acoustomagnetic anti-theft system manufactured by Sensormatic. What appears to have happened is that the woman's pacemaker - a model known as a "minute ventilation rate-adaptive system" that is designed to help younger, more active cardiac patients by increasing their heart rates as their respiration rates rise - shifted to its preprogrammed upper tracking rate. This sort of interaction is extremely rare and poses no hazard to patients, physicians say that's because the upper tracking rate is a safe preprogrammed rate set by the patient's own doctor.
In their letter, Dr. McIvor and Dr. Sridhar do not mention that shortly after the reported incident the Phoenix woman had both her pacemaker and its leads replaced. According to the woman's physician, the reason her pacemaker had to be replaced had nothing to do with any exposure to anti-theft systems. Since the replacement, Sensormatic has not been advised of any similar incidents involving this patient.
Dr. McIvor, who is author of a study principally funded by a competitor of Sensormatic, has been on a campaign for more than a year now to convince pacemaker patients that they should be concerned about exposing themselves to anti-theft systems - and in particular to acoustomagnetic systems as opposed to swept RF systems. These notions have been studied and decisively rejected by one leading expert after another - including the FDA, which has drawn no distinctions whatsoever between different anti-theft technologies. As an FDA spokesperson told the New Jersey Courier-Post, "We do not make a distinction between EAS technologies."
Sensormatic Electronics Corporation (NYSE:SRM) is the leading supplier of electronic security systems to the retail, commercial, and industrial marketplaces. Sensormatic is also the leader in source tagging, a process in which consumer-goods manufacturers insert anti-theft tags into products during manufacturing.
For more information on Sensormatic, visit its home page on the World Wide Web at http://www.sensormatic.com.
CONTACT:
Sensormatic Electronics Corporation, Boca Raton
Debbie Coller
Director, Corporate Communications
(561) 989-7035
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