Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "McKesson Tagged with Rare Class I Recall for Clinical Decision Support Software."
Following is an excerpt:
McKesson Corp.'s recall of its McKesson Anesthesia Care clinical decision support system was categorized as class I by FDA March 14. It appears to be one of only a handful of standalone clinical decision support systems to be subject to a recall in this highest-risk category.
The 510(k)-cleared McKesson Anesthesia Care system is intended to help anesthesiologists make decisions by managing their data — that is, eliminating some manual data entry, inputting it into the hospital's electronic health record system and analyzing data to ensure proper care. A brochure distributed by McKesson also refers to the system's capabilities for medications, including avoiding adverse drug events and properly administering antibiotics. The brochure also boasts that the system can better ensure care integration, particularly during care handoffs. ...
Still, whatever the impact on the product itself, this recall is one that health information technology players may want to closely analyze, says Bradley Merrill Thompson, a lawyer and head of the Clinical Decision Support Coalition, an industry group. Class I recalls are rare for this type of product, Thompson explained in an email to "The Gray Sheet."
"This product seems to be pure clinical decision support software, that simply provides analytic decision-support, as opposed to software that controls the operation of another medical device or is specifically paired with a medical device to download data," he said. Thompson was able to identify two other recalls of pure clinical decision support software — one in December 2003 and another in May 2012. ...
Thompson suggests that the classification of the McKesson recall "gives us some clues" to what FDA considers to be high risk clinical decision support. In this case, that might include guiding clinical decision making by a highly trained anesthesiologist with regard to such things as spotting the potential for adverse drug reactions, he explained. The recall classification also provides insight, Thompson suggests, on what FDA considers to be the impact of bugs that might be found in that clinical decision support software, "a bug which, for example, populates a patient's record with the wrong data."
