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Some of the microchip-based "smart" systems are touted as improving patient safety, but a Dutch study of equipment - without the patients -suggests the systems could actually cause harm.
A US patient-safety expert said the study "is of urgent significance" and said hospitals should respond immediately to the "disturbing" results. The wireless systems send out radio waves that can interfere with equipment such as respirators, external pacemakers and kidney dialysis machines, according to the study.
Researchers discovered the problem in 123 tests they performed in an intensive-care unit at an Amsterdam hospital. Patients were not using the equipment at the time.
Life-saving machinery can be affected
Electromagnetic glitches occurred in almost 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.
Nearly 20 percent of the cases involved hazardous malfunctions that would probably harm patients. These included breathing machines that switched off; mechanical syringe pumps that stopped delivering medication; and external pacemakers, which regulate the heart that malfunctioned.
The wireless systems are used to tag and keep track of medical equipment like heart-testing machines, joint replacements and surgical staplers.
They can help quickly locate devices that are elsewhere in the hospital and help prevent theft.
Microchips to stop drug counterfeiting
The technology also is viewed as a way to prevent drug counterfeiting, by embedding microchips in drug containers, and to prevent harmful medical errors by keeping tabs on 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, said Dr Erik Jan van Lieshout, a study co-author and critical care specialist at the University of Amsterdam's Academic Medical Centre.
His study appears in the 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.
FDA conducting own tests
Peper Long, a spokesman for the Food and Drug Administration, said 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.
She said the FDA is testing some medical devices to "determine their vulnerability and to what extent such vulnerability may be a public health concern."
Previous studies have shown that pacemakers and implanted heart defibrillators are susceptible to interference from cell phones and metal detectors outside hospital settings, according to the FDA's Web site. The Dutch study focused only 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 Centre in Boston.
Beth Israel uses the technology for identification and tracking purposes, including microchips embedded in intravenous pumps and ventilators.
New safety guidelines needed
Halamka said the devices are compatible with the hospital's wireless network and that all new machines are evaluated before being used near other electronic medical devices. He said there have been no examples of harmful interference at Beth Israel.
The JAMA editorial said hospitals should consider surveillance for interference problems that employees haven't noticed or reported. Regulatory agencies also should determine if new safety guidance is needed, the editorial recommended.
ClearCount Medical Solutions of Pittsburgh is marketing its new microchip-embedded surgical "smart" sponges. They respond to scanning wands to help doctors make sure sponges aren't left inside patients. Co-founder Steven Fleck said the sponges were designed not to interfere with other hospital equipment and were approved by FDA last year.
David Palmer, ClearCount's chief executive officer, said these systems can improve patient safety and that for hospitals to reject such technology because of the new study report "would be short-sighted." – (Sapa)
June 2008
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