Quickly Approved Medical Devices Account for Most FDA Recalls
When the Food and Drug Administration pulls a medical device off the market because of safety concerns, the item recalled is likely to be one that didn’t get much scrutiny when it originally was approved by the agency.
That finding was documented in a new study appearing in The Archives of Internal Medicine. The researchers report that most of the medical devices that were recalled from 2005 to 2009 because they posed a high risk for users had been approved through a less stringent regulatory process.
The study highlights the two parallel paths to approval for medical devices. One track–usually employed for critical devices such as implanted heart defibrillators–requires extensive testing. The other track is a less exhaustive process permitted in cases when the company responsible for the device demonstrates that an equivalent product already is on the market.
Though far less reliant on testing, the class of devices given the green light in the less-demanding approval process includes such vital products as external heart defibrillators, mechanical ventilators and infusion pumps, along with artificial hips and knees.
The study’s authors conclude that these are the devices most likely to be pulled off the market by the FDA. Of the 113 recalls of high-risk medical devices carried out from 2005 to 2009, the study found that 80, or 71 percent, were originally approved through the light-testing path.
“This is an area where the FDA has failed the public,” Dr. Steven E. Nissen, a cardiologist from Ohio’s Cleveland Clinic and one of the study’s authors, told The New York Times. As the Times pointed out, thousands of patients have been hurt, and even died, because of flawed medical devices that went through little pre-approval testing.
In response, the FDA called the study’s conclusions unoriginal and suggested that they overlooked the benefits of the speedier approval process.
“Even one recall is too many,” FDA spokeswoman Karen Riley told the Washington Post in an e-mail. “But, considering that more than 19,000 devices were cleared via the . . . process between 2005 and 2009, it’s important to keep the 80 recalls in perspective. They represent a small number of the devices cleared via this program and don’t reflect the thousands of people who have benefited from these devices.”
The Advanced Medical Technology Association, a trade group for manufacturers of medical devices, said that the research was flawed, pointing out that since a majority of all devices are approved through the less-demanding process, it would make sense for such devices to constitute a majority of the recalls.
The study, conducted by Nissen with co-authors from the National Research Center for Women and Families, recommends changes that would subject all medical devices to the FDA’s more rigorous process. It also calls for the process to take into account the potential risk of a device’s failure.
That finding was documented in a new study appearing in The Archives of Internal Medicine. The researchers report that most of the medical devices that were recalled from 2005 to 2009 because they posed a high risk for users had been approved through a less stringent regulatory process.
The study highlights the two parallel paths to approval for medical devices. One track–usually employed for critical devices such as implanted heart defibrillators–requires extensive testing. The other track is a less exhaustive process permitted in cases when the company responsible for the device demonstrates that an equivalent product already is on the market.
Though far less reliant on testing, the class of devices given the green light in the less-demanding approval process includes such vital products as external heart defibrillators, mechanical ventilators and infusion pumps, along with artificial hips and knees.
The study’s authors conclude that these are the devices most likely to be pulled off the market by the FDA. Of the 113 recalls of high-risk medical devices carried out from 2005 to 2009, the study found that 80, or 71 percent, were originally approved through the light-testing path.
“This is an area where the FDA has failed the public,” Dr. Steven E. Nissen, a cardiologist from Ohio’s Cleveland Clinic and one of the study’s authors, told The New York Times. As the Times pointed out, thousands of patients have been hurt, and even died, because of flawed medical devices that went through little pre-approval testing.
In response, the FDA called the study’s conclusions unoriginal and suggested that they overlooked the benefits of the speedier approval process.
“Even one recall is too many,” FDA spokeswoman Karen Riley told the Washington Post in an e-mail. “But, considering that more than 19,000 devices were cleared via the . . . process between 2005 and 2009, it’s important to keep the 80 recalls in perspective. They represent a small number of the devices cleared via this program and don’t reflect the thousands of people who have benefited from these devices.”
The Advanced Medical Technology Association, a trade group for manufacturers of medical devices, said that the research was flawed, pointing out that since a majority of all devices are approved through the less-demanding process, it would make sense for such devices to constitute a majority of the recalls.
The study, conducted by Nissen with co-authors from the National Research Center for Women and Families, recommends changes that would subject all medical devices to the FDA’s more rigorous process. It also calls for the process to take into account the potential risk of a device’s failure.
http://www.fairwarning.org/2011/02/quickly-approved-medical-devices-account-for-most-fda-recalls/
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