This news is not surprising to anyone who pays attention to medical device recalls.
There has been a substantial jump in medical device recalls – up 97 percent over the last decade! This news comes from the division within the U.S. Food and Drug Administration (FDA) that regulates medical devices. The Center for Devices and Radiological Health (CDRH) takes in complaints through the MAUDE database which, in some cases, leads to product and device recalls.
The latest dramatic jump in recalls occurred from fiscal year 2002 to 2012, according to the CDRH.
Some of the problems leading to recalls include a defective design or components that fail, material that is not approved or software that doesn’t work.
Leave it to the FDA to put a good spin on this event. The agency says that this news may actually be a good sign because it shows manufacturers are increasingly aware of recalls and keeping an eye on devices.
“Concerted efforts to improve the quality and safety of medical devices on the part of both CDRH and the industry has resulted in greater numbers of recalls reported — and greater benefit for the public health,” the CDRH report notes.
Really? Could it be that the FDA allows medical devices on the market with virtually no oversight and there are actually more defective medical devices allowed on the market?
Take the 510(k) approval process, which is really more like a notification process that allows the manufacturers to be in the driver’s seat. Say a device maker wants to sell a device. It notifies the FDA and submits a 510(k) application. No clinical trials required. Paperwork is exchanged and in a couple months the device is approved.
The DePuy ASR Hip System, another total hip replacement (THR) with MoM components was recalled in August 2010 after patients had to have early revisions due to the prosthesis loosening, dislocating, pain, swelling and metal toxicity.
Even if one undergoes a PMA, file a supplemental application and you can revise the device ten different ways. No wonder with industry driving regulation there is a jump in recalls.