Protecting Americans from Defective Medical Devices: Is the FDA Doing Enough?
According to a report in the Archives of Internal Medicine, there are questions as to whether the Food and Drug Administration is doing a good enough job of protecting Americans from defective medical devices. This is obviously an issue of concern for patients, as well as for our Charlotte, North Carolina defective medical devices attorneys who are familiar with how dangerous faulty/malfunctioning devices can be for patients.
Researchers looked at 113 devices that the FDA recalled between 2005 and 2009. The recalls were issued because of the health risks the devices posed. It now appears that 71% of these devices were approved without ever being tested on people—primarily because they were considered similar enough to at least one other product already in the marketplace. Just 19% of the products had to go through tougher review.
The FDA’s less strict approval process, which attempts to get medical devices out there sooner rather than later, is hurting patients. Yet, according to the Washington Post, seeing as over 19,000 medical devices were approved during those four years, there really weren’t that many recalls issued. FDA spokeswoman Karen Riley noted that many people have benefited from the approval of many of these medical devices. She did also say, however, that the researchers’ findings show a need for better safeguards. The agency is making 25 changes to ensure this.
While it is true that medical devices can save lives, defective ones have also been a source of serious injury and death. It is important that manufacturers make sure their products are safe before releasing them into the market and that the government does its job by checking to make sure a medical device is safe before placing its stamp of approval on it.
Examples of defective medical devices:
• DePuy Hip Replacement Systems
• Guidant Cardiac Defibrillator
• Medtronic Defibrillators
• Duragesic Pan Patch
• Nuvaring
• Knee Implants
• Guidant Pacemakers
Study of recalled medical devices faults lax FDA testing methods, The Washington Post, February 15, 2011
Medical Device Recalls and the FDA Approval Process, Archive of Internal Medicine, February 14, 2011
Related Web Resource:
US Food and Drug Administration
Related Blog Posts:
Banning Defective Medical Devices: Report Raises Questions About Whether FDA is Doing Enough to Protect People, North Carolina Injury Lawyer Blog, November 24, 2010
Medical Device-Related Complications Send Over 70,000 Children to the ER Every Year, North Carolina Injury Lawyer Blog, November 24, 2010
Supreme Court Places New Limits on Products Liability Lawsuits Filed Against Medical Device Manufacturers, North Carolina Injury Lawyer Blog, February 20, 2008
