FDA Better Late Than Never: Mass Recall Largest Ever Recorded
September 3, 2014
The situation with medical device and the FDA is often thought of as a chicken/egg situation. Did device companies purposely set out to cut corners and save money first or was the FDA full of fuck ups that didn’t know how to do their jobs that promoted the largest mass recall of medical devices ever recorded last week? Well, it’s not so much a chicken/egg is the answer is both.
Medical Device Startups especially have a greater propensity for fraud in that their funding is limited and they must show profit quickly to VC’s who want to recoup their money. While the FDA’s 510 (k) (the process in which a device is approved which usually involves the device being similar to another) has often been scrutinized for being out-of-touch with real world application or understanding of the industry both medical device and the FDA are part of the problem.
And here’s a little known fact, the FDA does not actually test the devices, during the 510 (k) process. Well that certainly appears to be inconsistent and contradictory language to action from our government when it comes to devices that will be implanted into human beings. The FDA checks a box to see if one device is similar to another but doesn’t actually test to see if the device itself works. The other problem is that if a device is pulled (or a company decided) remove a product what happens to all the other devices that were approved using that device as the “Gold Standard” or benchmark on which all others were approved?
Medical Device Recalls are done in three classes:
According to FDA data, the agency typically recalls between 13 and 75 devices each day, though the overwhelming majority of those recalls are either Class II or Class III recalls, which reflect lesser (and non-deadly) safety risks than Class I. Since 2004, 86% of all recalls have been Class II recalls, while 7% have been Class III and 6% have been Class I.
Last week it was reported that Johnson & Johnson’s DePuy Synthes (in the headlines for billion dollar hip recalls) had a Class I recall for their CMF Distraction System used mainly in small children; but, on 29 August 2014, FDA posted to its website 233 Class I recalls, all for devices manufactured by Customed.
From the voluntary recall notices posted to FDA’s website, all of the devices were recalled for a single reason: Packaging flaws.
“Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots),” FDA explained in the notice. “This could result in an injury to the patient due to product contamination or loss of sterility condition.”
While it doesn’t look great for companies like Johnson & Johnson or the 233 Class I recalls from Customed it also doesn’t spark much confidence in the FDA’s ability to do their job to protect the people either.