the device life

medical technology expands to younger generations

Device use expands through adaptation, innovation

  • Article by: JIM SPENCER , Star Tribune
  • Updated: December 2, 2013 - 3:50 PM

System enables new uses, but critics say this flexibility comes with risks.

hide

Sylvia Gonzalez showed her hip and pelvis replacements. She said she owes her life to medical device improvisation.

Photo: Tomas Ovalle • Special to the Star Tribune,

CameraStar Tribune photo galleries

Cameraview larger

The Mayo Clinic's Dr. Richard Marsh helps control brain seizures in epileptic patients with a fiber-optic laser first introduced to treat prostate tumors.

At the University of Minnesota, Dr. Ganesh Raveendran has figured out how to treat young stroke victims with a device designed for congenital heart defects.

It doesn’t matter whether the medical devices’ inventors, or the regulators who approved the products, ever considered such methods.

“It is common practice in the cardiology world,” said Raveendran, director of the U’s cardiac catheterization laboratory. “We expand the scope.”

Doctors have complete discretion to use medical devices in any way they think helps their patients — including “off-label” uses that were never envisioned. These adaptations are expanding the use of medical devices among U.S. patients of all ages.

But the flexibility this system enables comes with risks for patients.

The same kind of experimentation that transformed a prostate product into a promising brain probe led to the flawed use of surgical mesh as a treatment for women’s incontinence, injuring thousands.

“Frankly, the oversight is really quite relaxed and not accountable to the public,” said Lisa McGiffert, director of the Consumers Union Safe Patient Project.

The Food and Drug Administration reviews the safety and effectiveness of devices and how they can be sold. In recent years, criticism of the FDA has intensified, as device companies accuse the agency of stifling business and innovation through unnecessary review protocols. Consumer advocates argue the opposite, claiming the FDA fails to demand adequate product testing.

But the FDA’s oversight extends only to device makers, not doctors.

IT IS NOT OUR PLACE TO say, ‘Here is how you should treat that patient,’ ” said Christy Foreman, who directs evaluations at the FDA’s Center for Devices and Radiological Health.

The only way the FDA gets involved with the off-label use of a device is when a medical technology company seeks the agency’s approval for a popular adaptation to increase its sales. However, the typical process requires only that companies demonstrate that a new device is similar to an existing product, which means little human testing.

Often, device adaptations occur when doctors simply have no other options, or they are searching for a less-invasive treatment. The decision to adapt is never “cavalier,” said Marsh, a neurosurgeon.

At Nascent Surgical in Eden Prairie, Dr. Leonard Schultz is helping turn a surgical smoke control device into a product that can be used to reduce postoperative infections.

Schultz says he understands the concerns as devices are used in new ways, but there’s no such thing as risk-free medicine.

“Progress will never be done without risk,” Schultz said. “Every time technology changes, there is a chance that someone is going to get hurt.”

 

The (almost) bionic woman

  • related content

  • The Device Life: Medical technology expands to younger generations

    Monday July 28, 2014

    Hundreds of thousands of Americans are receiving medical devices that were once considered nearly exclusive to the elderly. The shift is profoundly changing patient care and expanding the fortunes of...

  • §Juvenile rheumatoid arthritis disfigured Sylvia Gonzalezís hands and forced her to start getting artificial joints implanted in her teens. --- Sylvia Gonzalez suffered from juvenile rheumatoid arthritis and ankylosing spondylitis which locked up her spine. She started getting artificial joints implanted at age 18. She has artificial hips, artificial knees, an artificial ankle, and artificial shoulder. Her spine has been fused so she can‚Äôt turn her head. She has a metal pelvis. With all of that and crippled hands, she teaches second grade at Yokomi Elementary in a poor neighborhood in Fresno, CA. Photo by...

  • An X-ray revealed the progress that young JunFen Freihammer has experienced from 12 operations. The bend in her spine has been reduced from 108 to 30 degrees.

  • Second-grade teacher Sylvia Gonzalez of Fresno, Calif., has juvenile rheumatoid arthritis. She credits doctors’ off-label uses of medical devices for her mobility and independence.

  • JunFen §plays with her dog, Daisy, as she stretches her spine with a halo gravity traction device. §§ --- JunFen Freihammer spent 44 days at the Mayo Clinic this summer having rods put in her back to straighten out the curvature from her scoliosis birth defect. Photo provided by family.]richard tsong-taatarii/rtsong-taataarii@startribune.com

  • JunFen Freihammer has been helped enough by her surgeries that she can now help her mother, Karin, in their Roseville yard. Doctors had to adapt existing medical devices for the girl’s scoliosis treatment.

  • About this series

    “The Device Life” is a Star Tribune four-part series examining the expanding use of medical devices in patients younger than 65 — a movement profoundly changing patient care and providing new markets for the med-tech industry. The previous installments are at startribune.com/devicelife.

    MEDICAL IMPLANTS TRENDING YOUNGER

    From 2000 to 2010, the percentage of medical devices for hips, knees, pacemakers and defibrillators among middle-age and younger patients has grown dramatically. Demand for hips and knees by those under 65 is expected to grow dramatically by 2030.

    Percent increase from 2000 to 2010 in medical device

    procedures by age group:

    Hips Knees

    18-44 years old +22% +113%

    45-64 years old +132% +213%

    65-84 years old +29% +97%

    85+ years old +15% +89%

    Projected growth in demand for artificial knees and hip implants:

    2011: 1.2 million

    2030: 4 million

    Estimated number of new requests from people under 65 from 2011-2030: 1.4 million

    Sources: Agency for Healthcare Research and Quality, U.S. Dept. of

    Health and Human Services, data on hospital discharges, Consumers Union Safe Patient Project

    BY THE NUMBERS

    Medical-technology industry

    $350 billion: Size of medical-technology industry across the globe.

    5,000: Medical device manufacturers in United States

    350: Med-tech companies in Minnesota

    Source: Medical Device and Diagnostic Industry

  • get related content delivered to your inbox

  • manage my email subscriptions

ADVERTISEMENT

Connect with twitterConnect with facebookConnect with Google+Connect with PinterestConnect with PinterestConnect with RssfeedConnect with email newsletters

ADVERTISEMENT

ADVERTISEMENT

ADVERTISEMENT

ADVERTISEMENT

ADVERTISEMENT

ADVERTISEMENT

 
Close