Despite being hugely expensive, medical gear is packed full of software that doesn’t sing or dance.
While hospital administrators love to spend millions on a machine that goes ping they do not look at the software particularly closely.
Data from the US Food and Drug Administration (FDA) show that software failures were behind 24 percent of all the medical device recalls in 2011.
The FDA, which famously jailed Wilhelm Reich for coming up with something less expensive than drugs, wants to gearing up its labs to spend more time analysing the quality and security of software-based medical instruments and equipment.
The FDA’s Office of Science and Engineering Laboratories (OSEL) released the data in its 2011 Annual Report just after the news that a Web site used to distribute software updates for hospital respirators was hacked.
The report said that the “absence of solid architecture and principled engineering practices” in software development affects a wide range of medical devices, with life-threatening consequences.
According to Wired, the FDA is developing tools to test medical device software and locate security problems and weak design.
It said that the Agency is also acquiring expertise in areas like “detecting malware inside device designs” and reverse engineering certain types of malware to best identify the specific protective practices which manufacturers should be using.
It is the first time that the FDA has said that it is shifting focus to make software quality an area of interest rather than if Orgone Boxes are being shipped over state lines.