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Medical Devices Malfunction Due to Wireless Tracking Systems

Jun 25, 2008 | Parker Waichman LLP

The wireless systems which are used by many hospitals to track equipment may be creating potentially deadly breakdowns in lifesaving medical devices such as respirators, dialysis machines, and external pacemakers.  Apparently, some microchip-based "smart" systems, hyped for their improvements to patient safety, are doing just the opposite.  A Dutch study—123 tests at an Amsterdam hospital intensive care unit, without involving patients—reveals the systems could actually cause harm by sending out radio waves that can interfere with the equipment and warns hospitals to conduct safety tests on such systems.  A U.S. patient-safety expert said the study "is of urgent significance" and that hospitals should respond immediately to the "disturbing" results.

During testing, electromagnetic “glitches” occurred in nearly 30 percent of the tests when microchip devices similar to those in many types of wireless medical equipment were placed within about one foot of the lifesaving machines.  About 20 percent of the cases involved hazardous malfunctions that would likely harm patients, including respirators shutting off, mechanical syringe pumps ceasing to deliver medication, and external pacemakers malfunctioning.

Wireless systems monitor and track medical equipment like heart-testing machines, joint replacements, and surgical staplers, easily locating such devices throughout hospitals, aiding in theft prevention, and monitoring devices during surgery to prevent surgical errors.  The systems also help in drug counterfeiting prevention by embedding microchips in drug containers.

The study confirms that hospitals must test their wireless items before using them near life-saving patient equipment, said Dr. Erik Jan van Lieshout, a study co-author and critical care specialist at the University of Amsterdam's Academic Medical Center.  His study appears in Wednesday's Journal of the American Medical Association.  "Attention must be paid to these disturbing findings," Dr. Donald Berwick, president of the Institute for Healthcare Improvement, said in an editorial in the Journal.  "It seems that hospitals, regulators, and manufacturers certainly have some immediate work to do," including examining whether similar problems are occurring in hospital critical care units, Berwick said.

Meanwhile, earlier studies revealed that pacemakers and implanted heart defibrillators are susceptible to interference from cell phones and metal detectors outside hospital settings, according to FDA.  This Dutch study was only focused on devices and equipment used in hospitals.  "It is absolutely an issue, but you have to manage around it," said Dr. John Halamka, chief information officer at Beth Israel Deaconess Medical Center in Boston, which uses the wireless technology for identification and tracking, including microchips embedded in intravenous pumps and ventilators.  Halamka said the devices and the hospital's wireless system are compatible and all new machines are evaluated before being used near other electronic medical devices.

The JAMA piece suggests hospitals should consider surveillance for interference problems that employees haven't noticed or reported and that regulatory agencies should determine if new safety guidance is needed.  Peper Long, a spokeswoman for the Food and Drug Administration (FDA), said the FDA is testing some medical devices to "determine their vulnerability and to what extent such vulnerability may be a public health concern."


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