The Baltimore Sun reports that the FDA with Computer Programmers and IT Experts have found the medical equipment malfunction my not be caused by poorly designed of badly made device, but rather due to faulty programmed code operating the device.
From the Baltimore Sun Article:
“After a routine piece of medical equipment started mysteriously killing hospital patients a few years ago, the federal government turned to a small team of its software experts in suburban Maryland for help.
The team’s discovery - a flaw in a computer code that caused a drug pump to administer heavy overdoses - led to a recall, warnings and rewriting of the equipment’s software. The discovery also illustrated a new threat behind some lifesaving medical devices.
Microprocessors run everything from patient monitors to artificial pancreases, and potential software flaws are a growing concern. A product might not malfunction because it was poorly designed or badly made - the traditional suspects - 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.
“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 Food and Drug Administration Office of Science and Engineering Laboratories, which oversees the team of software sleuths at White Oak in Montgomery County. “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.”
Of 23 recalls last year that the FDA classified as life-threatening, three involved faulty software.
Manufacturers test and inspect the software on their products, such as dialysis systems and patient monitors, before putting devices on the market. But they’ve been slow to follow the FDA in adopting new forensic technology because it is costly and still evolving, industry officials say. 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.”
The Baltimore Sun - Flaws in Medical Coding Can Kill
What often gets overlooked in analysis of patient safety are the unseen hazards from non-certified equipment in the workplace. Every week, our team travels to healthcare facilities to evaluate non-certified equipment (Certified is equipment listed or labeled by a Nationally Recognized Testing Laboratory such as UL, MET. ETL, TUV, etc). Often healthcare facility owners and managers get stuck with this equipment from unscrupulous or ignorant distributors, leaving them to deal with deaths and injuries afterwards. Much information is available at the IAEI site (International Association of Electrical Inspectors). A US National Healthcare “Engineering” association (ASHE) is attempting to strip equipment electrical safety testing requirements. http://www.iaei.org/magazine/?p=4561
Any questions or comments, contact information is in the IAEI Bio.