Lessons from McKesson: Insight into FDA’s Stance on Clinical Decision-Support Software, in Medical Device and Diagnostic Industry

Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, wrote an article titled "Lessons from McKesson: Insight into FDA's Stance on Clinical Decision-Support Software."

Following is an excerpt:

On March 14, 2014, FDA notified healthcare professionals of a Class I recall that McKesson initiated in 2013 of its Anesthesia Care software. Because FDA rarely issues a recall notice of that nature with regard to standalone software—software that does not play a role in operating a medical device—there are some important insights about FDA's stance on clinical decision-support software (CDS) that we can derive from its action.

The recall classification gives us some clues as to what FDA considers to be high-risk clinical decision support software, and high-risk bugs that might be found in that CDS. More specifically, FDA considers software that helps highly trained anesthesiologists make clinical decisions with regard to such things as spotting the potential for adverse drug reactions to be in the moderate range of the risk scale. And when it comes to defects, FDA concludes that a bug that populates a patient's record with the wrong data, for example, creates significant risk. When you combine those two factors, you get a Class I recall.