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 "Recent FDA Software Recall Re-Ignites Debate Around HIT Legislation."
Following is an excerpt:
FDA made it clear with its class I recall of McKesson Technologies' anesthesia system -- clinical decision software that is the subject of recent legislative debate -- that it does not plan to just walk away from regulating CDS, Bradley Merrill Thompson, an attorney at Epstein, Becker & Green, said. ?...
Thompson, who leads industry coalitions and has participated in the development of the HIT framework, is urging lawmakers to consider FDA's recent recall of clinical decision support software as they move forward with legislation that would exempt clinical software from FDA oversight. ?...
Thompson said FDA's recent decision to upclassify a recall of McKesson's anesthesia care software system top class I -- the highest priority -- was significant since the software was approved as a class II moderate risk device. It clarifies the type of CDS defects the agency thinks have the potential to cause serious adverse events, he said. FDA rarely issues class I recalls for standalone devices, Thompson wrote in a March 20 blog for Medical Device and Diagnostic Industry. He added that lawmakers should study the event to get a clearer sense of what FDA considers high risk CDS before moving forward with legislation that would remove low-risk CDS from regulation from the agency's authority. ?...
"It would seem that FDA does not plan to simply walk away from regulating high risk CDS," Thompson noted. "FDA has to know that by placing this recall in the highest risk classification, members of Congress will take note. At this time when we are debating whether to remove by statute all CDS from FDA oversight, we need to decide as a society whether we want FDA to protect us from, for example, the risk that a physician could miss a drug interaction by relying on software that contains a bug, putting the patient's life at risk."
Thompson said given the high stakes involved with the issue, decisions about how CDS should be regulated should be made carefully.
