FDA warns that spread of computers creates new dangers for medical devices
A federal team of software experts discovered a flaw in a computer code that caused a drug pump to administer heavy overdoses, which led to a recall, warnings and rewriting of the equipment's software. Of 23 recalls last year that the FDA classified as life-threatening, three involved faulty software, according to The Baltimore Sun.
"The world of technology is allowing us to do things we never thought possible, and it's largely a great advance," said Larry G. Kessler, who directs the FDA Office of Science and Engineering Laboratories, which oversees federal software investigators. "Where it gets to be scary is, we used to have more human intervention. With software doing more now, we need to have a lower tolerance for mistakes."
A product might not malfunction because it was poorly designed or badly made but because the computer code running it includes a mistake. The impact of that glitch can be increasingly serious because the latest automation is removing the doctors and nurses who watched for machine mix-ups, reported The Sun.
While manufacturers test and inspect the software on products, such as dialysis systems and patient monitors, before putting devices on the market, they have been slow to follow the FDA in adopting new forensic technology because it is costly and still evolving, according to The Sun.
As a result, FDA software specialists are amassing evidence to show companies the value of the new testing. Meanwhile, traditional software checks, while good at detecting some flaws, are not thorough enough to find every mistake, according to computer scientists.
Brian Fitzgerald, who heads the FDA's software specialists, told The Sun that clues are scarce and answers far from immediate. The team must pore over the entire code, looking for tiny flaws in the logic that, on the rare occasions it is summoned into action, could have “disastrous consequences.”
The Sun reported that the FDA established its forensic software unit in 2004, after noticing that device makers were issuing more and more software-based recalls. The FDA's team employs about 10 mathematicians, computer scientists and a physicist who once designed military satellites.