The Food and Drug Administration on March 14 issued a Class 1 recall notice to healthcare professionals for the Anesthesia Care software of McKesson Corp. The software collects, processes, and records data both through manual entry and from monitors which are attached to patients, such as in an operating room environment. San Francisco-based McKesson had initiated a voluntary Class II recall of the product last year.
The Class I recall is in the FDAs highest risk category which is reserved for defects where there is a reasonable probability that the use of or exposure to the product will cause serious adverse health consequences or death. It is not often that the regulatory agency issues this kind of recall notice for standalone software that does not play a role in operating a medical device. However, the software 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 in the notice.
There was an occurrence where the patient case data did not match the patient data when the case was recalled in the Anesthesia Care Record in that it included data from another case, states the FDA notice. Use of this affected product may cause serious adverse health consequences, including death.
Asked to comment on the FDA notice, McKesson says that its corrective measures were thorough--as the agency has outlined--and questions the move to now categorize the recall as Class 1. In a written response to Health Data Management, Leslie White, vice president of marketing communications for McKesson Technology Solutions, stated that: In compliance with FDA regulations, McKesson filed a voluntary Class II recall for McKesson Anesthesia Care with the FDA on March 28, 2013. There was no patient impact, and there was only one customer report associated with the issue. We promptly issued a corrective patch to the 10 customers with the involved version of product installed and have been closely monitoring product performance. In FDAs review of the case in early March 2014, the recall was reclassified to Class I, resulting in posting of the issue on the FDA website. We have requested the recall be terminated.
According to the FDA, McKesson has initiated a clinical alert which was distributed to potentially affected customers. In addition, the agency said that phone calls were placed to each customer that was followed up by emails. Moreover, McKesson provided their customers with written copies of the communication and clinical alert and obtained acknowledgement that they read and understood the issue and preventive action to take.
The FDA did not respond in time for publication to inquiries about its decision to re-categorize the recall as Class 1.
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