Bradley Merrill Thompson Quoted in “FDA Issues Recall Notice on McKesson Clinical Decision Support Software Product Food and Drug Administration Logo”

Bloomberg BNA

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 "FDA Issues Recall Notice on McKesson Clinical Decision Support Software Product Food and Drug Administration Logo."

Following is an excerpt:

The FDA March 14 released a class I (highest-risk) recall notice regarding McKesson's Anesthesia Care, an anesthesia information management system designed to monitor patients under anesthesia and notify providers of possible dangerous medication reactions and contraindications. Anesthesia Care "provides clinical decision support by communicating potential adverse drug event alerts proactively during the pre-anesthesia evaluation and at the point-of-care," the FDA said.

McKesson, located in San Francisco, is one of the largest developers of electronic health records (EHR) and clinical decision support (CDS) tools. Anesthesia Care was classified by the FDA as a class II medical device, meaning it is subject to special controls.

In the recall notice, the FDA said there was an occurrence of patient data mismatch caused by a software error that could "cause serious adverse health consequences, including death." ?...

"This case shows the high-risk portion of health IT that could in a very real way impact patients," attorney Bradley Merrill Thompson, with Epstein Becker Green in Washington, told Bloomberg BNA. "This is the kind of thing that we need to keep in mind when we consider legislation."

Thompson, who serves as general counsel for the mHealth Regulatory Coalition, a mobile health technology advocacy group, and the CDS Coalition, which focuses on CDS software, has actively opposed both bills, saying health IT oversight requires "a more complex framework" and FDA guidance.