Wireless systems at hospitals endanger dialysis/breathing ...

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Study: Wireless systems at hospitals could cause deadly glitch in dialysis,

breathing machines

By LINDSEY TANNER , Associated Press

June 24, 2008

CHICAGO - Wireless systems used by many hospitals to keep track of medical

equipment can cause potentially deadly breakdowns in lifesaving devices such as

breathing and dialysis machines, researchers reported Tuesday in a study that

warned hospitals to conduct safety tests.

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 U.S. 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.

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.

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. 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. 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.

Peper Long, a spokeswoman 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.

Halamka, chief information officer at Beth Israel Deaconess Medical Center in

Boston.

Beth Israel uses the technology for identification and tracking purposes,

including microchips embedded in intravenous pumps and ventilators.

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 Fleck said the sponges were designed not to interfere with

other hospital equipment and were approved by FDA last year.

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 shortsighted. "

___

On the Net:

JAMA: http://jama.ama-assn.org

FDA: http://www.fda.gov

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