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RFID Devices Can Interfere With Hospital’s Lifesaving Medical Equipment

Posted on: Wednesday, 25 June 2008, 06:00 CDT

Dutch researchers reported Tuesday that radio frequency identification chips (RFID) used by many hospitals to keep track of medical products and equipment could cause the breakdown of critical medical care devices such as ventilators, pacemakers and kidney dialysis machines. 

One U.S. patient-safety expert called the study "of urgent significance", and urged hospitals to immediately respond to the “disturbing” results. In their report, the researchers called on hospitals to conduct further safety tests.

"We wanted to investigate the safety of RFID in healthcare because it hasn't been tested," Van Lieshout, the study’s co-author, told Reuters. "This is the first study ever done on RFID interference within the hospital."

The researchers found that Electromagnetic interference (EMI) from the so-called “smart chips” produced 22 problems that could jeopardize patients, such as completely shutting down syringe pumps and switching off ventilators, according to Van Lieshout, a critical care physician at University of Amsterdam’s Academic Medical Center.

The researchers discovered the problem in 123 tests they conducted in an Amsterdam intensive-care unit. Electromagnetic interference occurred in close to 30 percent of the tests when devices similar to those used in many types of wireless medical equipment were placed within a foot of the critical care machines.  Patients were not using the lifesaving equipment at the time.

Nearly one-in-five of the cases involved hazardous malfunctions that would likely harm patients, the researchers said. These included mechanical syringe pumps that stopped administering medication, breathing machines that shut off and pacemakers that malfunctioned.

The wireless systems are typically employed identify and track medical supplies and equipment, such a joint replacements, heart-testing machine and surgical staplers.   These procedures assist staff in locating the devices and help prevent theft. The technology is also seen as a way to prevent drug counterfeiting and medical errors by tracking devices used during surgery.

“The results show that it's crucial for hospitals to test their wireless items before using them around equipment essential for keeping patients alive,” Dr. Van Lieshout told the Associated Press.

"Attention must be paid to these disturbing findings," wrote Dr. Donald Berwick, president of the Institute for Healthcare Improvement, in an editorial about the study in the Journal of the American Medical Association (JAMA).

"It seems that hospitals, regulators, and manufacturers certainly have some immediate work to do," he said.

U.S. Food and Drug Administration spokeswoman Peper Long told the AP the agency is aware of the potential problem but has not received any reports of injuries directly caused by electronic interference with hospital medical devices.

The agency is testing some of the devices to "determine their vulnerability and to what extent such vulnerability may be a public health concern," she said.

According to the agency’s website, previous research has shown that equipment such as implanted heart defibrillators and pacemakers are vulnerable to EMI from cell phones and metal detectors outside hospital settings.  

But the current study focused exclusively on equipment and devices used in hospitals.

"It is absolutely an issue, but you have to manage around it," Dr. John Halamka, chief information officer at Beth Israel Deaconess Medical Center in Boston, told the AP. Beth Israel implemented technology for identification and tracking applications, including microchips embedded in IV pumps and ventilators.

Halamka said there have been no examples of harmful interference at Beth Israel, and that the devices are compatible with the hospital's wireless network.   New machines are evaluated before being used in the vicinity of other electronic medical devices, he said.

The JAMA editorial urged hospitals to contemplate surveillance for unreported interference problems, and said regulatory agencies should decide if new safety guidelines are required.

ClearCount Medical Solutions in Pittsburgh, PA, developed a new microchip-embedded surgical "smart" sponge, which responds to scanning wands to help doctors ensure sponges aren't left inside patients during surgery.

Steven Fleck, the firm’s co-founder, said the sponges were awarded FDA approval last year, and that they do not to interfere with other hospital equipment.
CEO David Palmer said hospitals "would be shortsighted” to reject such technology.

Retailers have long embraced RFID technology, which is now gaining ground in healthcare settings.  Experts estimate sales of RFID products will grow to $2 billion annually in the next ten years, from a current $90 million.

Applications include marking drug containers to prevent counterfeiting, monitoring temperature-sensitive blood products and tracking and tracing important medical equipment and devices, Van Lieshout said.

The study appears in Wednesday's Journal of the American Medical Association. An abstract can be viewed here.

Source: redOrbit Staff & Wire Reports

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