FDA Recall Epidemic
FY 2017 will be worst year ever.
A Medical Device and Diagnostic Industry magazine cover article, titled "Medtech’s Recall Epidemic" reported a record high number of FDA medical device recalls in Fiscal 2015. FY2016 had a dip, but 2017 is on track to be the most terrible year in FDA's history.
This might seem to be a more pressing problem than compliance. But, more research needs to be done. The FDA and ISO 13485 for risk management do not require the use of a third risk factor for 'detectability'. That's the likelihood a failure mode is detectable by current controls. I don't believe it is covered by regular risk likelihood (aka. occurrence), like some 'gurus' say.
In the FDA's Medical Device Recall Report FY2003 to FY2012 it previously found, from FY2010 to FY2012, 36% of recalls were due to design related failures. This was the largest cause of recalls.
That can be a very dangerous misunderstanding. Especially in the case of medical devices. I am writing a paper on that to submit to a professional journal. As part of my research I am surveying how common is the practice of Failure Mode and Effects Analysis, and Fault Tree Analysis. And, how often detectability is used in the calculations.