the device life

medical technology expands to younger generations

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Continued: Boomers' embrace of devices gives rise to new med-tech age

‘You gave me my life’

Peter Quimby of Plymouth likes to say that he’s “the healthiest dying person you’ll ever know.”

Quimby is waiting for a heart transplant. He received an implanted defibrillator and a left ventricular assist device in 2011 to help his weakened heart pump blood. Doctors told him not to overexert himself — don’t run, just shuffle.

To hell with that, Quimby says. The former paratrooper and college baseball player who graduated from West Point uses the devices to get in a good workout — and prove a point.

Six days a week, he sweats through intense workouts. He teaches a spinning class at the Andover YMCA. Recently, he finished the Minneapolis Duathlon, which combines a 15-kilometer bike race with two 5K runs — all while wearing a cumbersome device with wires that extend from his abdomen and batteries tucked into a shoulder holster.

Nobody knows whether the devices will hold up. Quimby said he won’t stop. “You didn’t give me a life,” he tells doctors and device makers. “You gave me my life.”

Federal regulators say their primary mission is to determine whether a technology is safe and saves lives — not address longevity or durability, said Christy Foreman, who directs the Office of Device Evaluation in the Center for Devices and Radiological Health at the Food and Drug Administration (FDA).

“The pacemakers that we had in 1976 were often times implanted in the abdomen because they were so big. And their battery didn’t last as long,” Foreman said. “We wouldn’t say no to the pacemaker … because we thought it was too big or didn’t last the entire patient life because we know that it is lifesaving technology. So we have to review it for what it is.”

The FDA also doesn’t regulate how physicians use medical devices. By law, doctors are allowed to use devices in any way they think will benefit their patients, even if the FDA never approved or cleared the device for that purpose.

Ralph Hall, a University of Minnesota law professor who has worked as a liaison between medical technology companies and the FDA, said the current regulatory approach will have to change as the trend toward younger patients builds momentum. It may not have been critical to assess how long a device would last in an older patient population, he said, but a wave of younger patients requires new ways of determining the life span of devices. The marketplace will demand it.

“This is going to require changes in testing methodology — less on human clinical study and more on bench testing and computer simulations and other types of tools assessing long-term performance,” Hall said.

Ultimately, it is up to the patient to decide whether to follow a doctor’s orders or the manufacturer’s recommended ways to use the device.

Dr. David Feldman, Quimby’s cardiologist, is seeing more young patients who need heart devices. Many want a treatment that will last forever.

Feldman explains that medical devices don’t work that way.

“What electronic piece of equipment that you buy now do you expect to last more than five years?”

 

Staff writer Glenn Howatt contributed to this report.

jwalsh@startribune.com • 612-673-7428

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