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Bureaucracy Stalls Defibrillator Solution

By DAVID WAHLBERG

Troy Betts was working in the emergency room of a Wisconsin hospital when paramedics brought in a man whose heart had been restarted by a defibrillator.

The paramedics' defibrillator was a different brand than the hospital's, so the man's chest pads had to be switched.

When nurses switched the pads, the man died. The incident occurred outside of Dane County five years ago; Betts wouldn't say where.

Betts thought about the incident two years ago when he was asked to write about a health-care problem for a class in the master's nursing program at Edgewood College.

Betts, 35, now a nurse manager at Meriter Hospital, teamed up with classmate Sue Olson, 51, an emergency services education coordinator at UW Hospital, to research incompatible defibrillator pads.

They learned that what they had seen was not unusual. Emergency workers they interviewed shared similar stories of patients who died after chest pads were switched, causing the patients to lose the electricity that had regulated their erratic heartbeats.

But the pads' likely role in the deaths generally isn't recorded or evaluated, Betts said. "Most reports just say the heart stopped," he said.

Heart-attack patients in Dane County - and elsewhere - frequently face two or three pad switches en route to the emergency room, Betts and Olson said.

Paramedics in Madison, Fitchburg and Verona, along with Madison's St. Mary's Hospital and Med Flight, use one brand of defibrillator. The other paramedics in Dane County and Meriter and UW hospitals, use a different brand.

Automated external defibrillators, or AEDs, found in businesses, schools, malls and other public places are often another brand, Betts said.

If AEDs, police, ambulances, community hospitals, Med Flight and Madison's hospitals are involved, "it's not unheard of to have four or five changes," Betts said.

Partial solutions exist. Adapters are available to make some pads compatible with other brands, but they don't exist for all combinations and are small and easily lost, said Dr. Darren Bean, a UW Health physician who works on Med Flight.

Emergency services and hospitals in Dane County could agree to use the same brand of defibrillator. But in referral centers such as Madison, patients are often transported from other counties.

Adapters and single-brand purchasing efforts "are band-aid solutions that don't solve the bigger problem," Betts said.

Defibrillator manufacturers could make pads that are compatible with other brands, engineers at some companies have told Betts and Olson. But that would require companies to share some of their proprietary electrical components.

The companies might lose significant profit: the pads cost $70 to $100, Olson said. Each use of a defibrillator requires a new set.

In 2005, as part of their class project, Betts and Olson approached U.S. Rep. Tammy Baldwin, D-Madison. In 2005, she wrote a letter on their behalf to Michael Leavitt, secretary of the U.S. Department of Health and Human Services. The letter urged universal defibrillator pads.

Leavitt referred the letter to Dr. Andrew von Eschenbach, commissioner of the U.S. Food and Drug Administration. He replied last year, saying manufacturers have several "disincentives."

Von Eschenbach said defibrillator companies make "significant revenue" from the pads, and some might resist having to redesign their defibrillators to make them compatible with universal pads.

This March, Betts and Olson wrote to the Association for the Advancement of Medical Instrumentation, which sets standards for medical devices. They asked AAMI to adopt standards for universal defibrillator pads.

AAMI wrote back, saying a committee might consider it. The nurses haven't heard anything else.

Olson said she and Betts are "just two nurses who are concerned about this, and we're struggling against big business."

Betts wonders how many patients continue to die like the man he saw in the emergency room.

"Would he have lived another two years? Five years?" Betts asked. "We'll never know."

dwahlberg@madison.com 608-252-6125



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