Make us your home page
Instagram

Today’s top headlines delivered to you daily.

(View our Privacy Policy)

FDA medical device system under scrutiny

WASHINGTON — Government investigators say the Food and Drug Administration is putting patients at risk by approving sensitive medical devices such as hip joints and heart defibrillators under the same streamlined system intended for power wheelchairs, stitches and catheters.

The Government Accountability Office told a Senate committee on Wednesday that the approvals remain a serious issue — more than two years after the watchdog agency first cited the problem to the FDA.

In 2009, the GAO faulted the FDA for not reclassifying more than 26 types of devices so they receive more stringent reviews. Since then, the agency has cleared 67 individual, high-risk devices through the so-called 510(k) system, which is used to clear the majority of devices.

Wednesday's hearing came as the FDA faces complaints from medical device manufacturers that the speed of U.S. device reviews lags behind other countries. The Institute of Medicine is reviewing the device approval process at FDA request.

The industry's chief trade association, AdvaMed, has spent hundreds of thousands of dollars lobbying against new device regulations that they say would slow down innovation.

But Senate Aging Committee chairman Herb Kohl, D-Wis., warned Wednesday that swift approvals must not compromise safety.

"Faulty medical devices, especially those implanted in the body, can have a disastrous impact on the health of those who use them," he said.

The committee heard testimony from Katherine Korgaokar, a patient who had to have her Johnson & Johnson hip implant removed because of a defect that caused it to release metals into her body. Korgaokar told senators that the metals, cobalt and chromium, could damage a fetus and make it difficult for her to have children.

"I had no idea how these metals would affect my body," Korgaokar said.

The FDA's Dr. William Maisel told lawmakers that the FDA will reclassify the 26 types of high-risk devices cited by GAO before the end of 2012.

Medical devices include everything from tongue depressors to silicone breast implants and pacemakers. In 1976, Congress set up a three-tiered classification system for the devices.

Low-risk devices like crutches and hospital beds do not require FDA review. Moderate-risk devices such as mercury thermometers and power wheelchairs could be cleared by the speedy 510(k) method. If the FDA doesn't object to a manufacturer's 510(k) application within 90 days, the device is automatically approved for marketing.

High-risk devices such as pacemakers and heart valves have to go through tighter scrutiny, and their manufacturers are required to provide studies demonstrating their safety and effectiveness. Devices classified as high-risk tend to be ones that are implanted in the body or could spell the difference between life and death.

But an exception was made for new versions of high-risk devices that were already on the market in 1976, such as certain types of defibrillators and orthopedic implants. These devices could go through the faster 510(k) system if manufacturers could show they were "substantially equivalent" to their precursors. In 1990, Congress told the FDA to end the practice, but it has continued.

According to the GAO, the FDA has reclassified only one group of devices since 2009, leaving 26 remaining.

FDA medical device system under scrutiny 04/13/11 [Last modified: Wednesday, April 13, 2011 5:54pm]
Photo reprints | Article reprints

Copyright: For copyright information, please check with the distributor of this item, Associated Press.
    

Join the discussion: Click to view comments, add yours

Loading...
  1. Hit-run driver who refused to leave van threatened to shoot them, Hillsborough deputies say

    Public Safety

    TAMPA — Sheriff's deputies negotiated with a driver for about 90 minutes before taking him into custody after he refused to leave his van and threatened to shoot them near the scene of a hit-and-run crash in north Tampa.

    The driver of this van tried to flee the scene of a crash in north Tampa Thursday morning until he could travel no farther, the Hillsborough County Sheriff's Office said. Then he refused to leave the van and threatened sheriff's deputies, they said. [TONY MARRERO   |   Times]
  2. Get the latest Tampa Bay Buccaneers news delivered daily to your email inbox

    Bucs

    They narrowly missed the playoffs by thismuch.

    Bucs wide receiver Mike Evans (13) celebrates with quarterback Jameis Winston (3) after they connected for a touchdown during a win over the Seattle Seahawks in November in Tampa. [LOREN ELLIOTT | Times]
  3. Police release name of man found dead in north Tampa vacant lot

    Crime

    TAMPA — Authorities have released the name of a man found dead in a vacant lot in north Tampa on Tuesday and have confirmed his death is a homicide.

  4. Gov. Scott backs off boycott of companies doing business in Venezuela

    State Roundup

    TALLAHASSEE — Gov. Rick Scott will ask the Florida Cabinet next month to prohibit the state's investment managers from doing something they already do not do: invest in companies or securities owned or controlled by the Venezuelan government.

    Florida Governor Rick Scott interacts with people as he holds a Venezuelan Freedom Rally at El Arepazo 2 restaurant on July 10 in Miami. [Joe Raedle | Getty Images]
  5. Muslim leader endorses Kriseman

    Blogs

    Abdul Karim Ali, president of the Tampa Bay Area Muslim Association, announced his support of Mayor Rick Kriseman on Thursday.

    Abdul Karim Ali endorsed Mayor Rick Kriseman Thursday