Thursday, April 03, 2014

Here Is How The USA Manages The Issue Of Software Errors In Clinical Software. Interesting.

These reports appeared a few days ago:

FDA issues recall of McKesson Anesthesia Care Record

Author Name Kyle Murphy, PhD   |   Date March 20, 2014   |  
Nearly a year after McKesson notified its customers about flaw in one of its health IT systems, the Food and Drug Administration (FDA) has moved to applying a Class I recall. The product in question is McKesson’s Anesthesia Care Record (ACR), a clinical decision support system aimed at helping anesthesiologists identify potential adverse drug events.
“The system is generally indicated in the anesthetizing environment when the anesthesia provider decides to perform a patient assessment, to generate a paper and/or electronic record of the administration of anesthesia to a patient, and to document care,” the FDA notes.
According to the FDA notice, McKesson began alerting ACR users of a danger posed by the system on March 15, 2013. “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 (ACR) in that it included data from another case. Use of this affected product may cause serious adverse health consequences, including death,” the recall states.
The recall notice makes clear that McKesson actively engaged via a series of phone calls, written statements, and a “Clinical Alert” as well as verified that customers “read and understood the issue and preventive action to take.” Voluntarily McKesson filed a Class II recall near the end of March 2013.
Apparently, those efforts weren’t enough to dissuade the FDA from slapping the Class I recall tag on McKesson’s ACR product, a designation applying to “situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.” It is the highest level of all recalls.
More here:
Here is the second one:

FDA Again Issues Recall Notice for McKesson Anesthesia Care Software

MAR 19, 2014
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 FDA’s 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.”
Lots more here:
What interested me were two things. The big one is that clinical software can be monitored and tracked for issues and if problems arise there are substantial powers to have the issues remedied. Having such protections which are actively enforced can only be a good thing.
My other point is that action seemed to be taken rather slowly - not sure why. I wonder how our TGA would handle all this?
In passing I note medical device safety is also being carefully monitored.

FDA Surveillance System Leverages Databases to Monitor Medical Products for Adverse Events

MAR 19, 2014
The Food and Drug Administration is actively searching more than 100 million health insurance records to uncover possible adverse events, rather than relying on doctors and patients to report them, according to Michael Nguyen, M.D., Acting Director of the Division of Epidemiology in FDA’s Center for Biologics Evaluation and Research.
The surveillance system, called Sentinel, is the result of a partnership between FDA and the Harvard Pilgrim Healthcare Institute, who are using the system to determine whether a certain type of immune therapy is associated with heart attacks or strokes, and to better define the true rate of acute lung injury after transfusions of certain blood components. 
Lots more here:
David.

No comments: