FDA Encourages Medical Devices Manufactures to Implement Forensic Tools
A report in the Baltimore Sun notes that the Food and Drug Administration has cited concerns about the use of microprocessors to run medical devices. One example occurred last year; a team of software experts from the FDA noted that a flawed code in some microprocessors was associated with an overdose from a drug pump. These errors resulted in a recall of the device and the manufacturer rewrote the device software.
In 2008, a total of 23 recalls were issued by the FDA that were classified as life threatening. Three of those were attributed to problems with software. The agency noted that the reliance on technology is improving care, but requires increased vigilance with respect to software and hardware mistakes. An increasing number of errors have been attributed to errors in computer codes.
The FDA has called on device manufacturers, both software and hardware, to adopt forensic technology. Companies complete tests and inspection of software before releasing such to the market, in addition to review and assessment by the FDA. Nevertheless, adoption of forensic systems has yet to become commonplace, in part because of the associated expense and the newness of this diagnostic technology.
The forensic software unit was initially created at the FDA in 2004. It was opened after the agency noted an increase in the number of recalls resulting from software issues. That group is conducting ongoing research with forensic technology. These efforts are intended, in part, to support the development of a cache of information for device manufacturers that will compel them to incorporate the tool.
July 2, 2008 Related topics: Quality, Safety, Errors, IT & software