There have been a few (including those here, here and here) Class I product recalls of medical devices in the past month or so, particularly in regards to infusion devices having a higher flow rate than specified.
The financial repercussions are relatively obvious, but what’s less obvious are the root causes for these device failures, especially since they come from several different manufacturers. What kind of evaluation processes would a quality engineer have to run through in order to determine the reason for failure? How would his or her team have to prove the strength of their design, particularly since 2010 the FDA has been focused on preventing problems with infusion pumps due to a perceived deficiency in design and engineering? What kinds of test data would they have to show to the FDA to validate the quality of their product, and more importantly, ensure patient health and safety?