This article specifically relates to the “code” that is used by devices. As a coder myself I can tell you this is an area that is worked, reworked and then once more. It used to be you had a device that did one thing, and it went through the process over and over without change, however that is not the case today. I have had conversations with engineers who develop outside of health care and have tried my best to explain the complicated issues that are in health care, but almost every industry these days is going outside the standard code box as well with devices now connecting to the Internet, networks and so on, something that didn’t exist a few years ago.
I just started reading another book on “Writing Secure Code”, even though I am not currently still writing to create commercial products, it’s always a good idea to stay on top. We used to pretty much be a Windows world, but now many devices have a Linux operating system or combination there of, so it gets to be a bit more complicated. This article states the FDA trouble shooting system from 2004 was out of date, well yes…just the year says that much! Now there’s a new team with new systems performing the work. It’s always going to be a process of elimination too between software and hardware to drill down to find the culprit. I’ve had my days of this with just general computer networking issues and devices are no different. The hardware/software relationship is the key to any medical device today and getting the code to work correctly, sometimes this involves additional code to monitor and trouble shoot the actual working code, in other words more data trails and queries to double, triple and quadruple check and correct problems in less than a split second. It has to count when human lives are at risk! BD
WASHINGTON - 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.
"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."
“More often, though, 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. No human has the brain power - or patience - to perform that work. Indeed, powerful computers must, in effect, crunch all the moves that a piece of software might take.”