Here is an interesting debate that's a bit "upstream" from medical translation.
The Economist recently featured an interesting article on medical technology. When code can kill or cure wonders if applying the "open source" model to the design of medical devices promises to increase safety and spur innovation?
Software has become a hugely important component of medical devices. It's one thing to hear that and kind of know that. It's a totally different thing, however, if your life depends on a medical device that's driven by software, as is the case for Karen Sandler:
The Economist mentioned that software is becoming more important. In fact, the article says that more than half the medical devices sold in America, for instance, rely on software. Yet despite this, there is little regulatory oversight of software.
Sure, the EU amended the MDD a couple of years ago to include software. Device manufacturers must now ensure that their software is validated, taking into account the principles of development lifecycle, risk management, and verification.
Nonetheless, plenty of safety issues remain. The following is from Wikipedia, referring to "Medical Device Recalls and the FDA Approval Process":
A 2011 study by Dr. Diana Zuckerman and Paul Brown of the National Research Center for Women and Families, and Dr. Steven Nissen of the Cleveland Clinic, published in the Archives of Internal Medicine, showed that most medical devices recalled in the last five years for 'serious health problems or death' had been previously approved by the FDA using the less stringent, and cheaper, 510(k) process. In a few cases the devices had been deemed so low-risk that they did not need FDA regulation. Of the 113 devices recalled, 35 were for cardiovacular issues.The Economist raises questions regarding bugs, crashes, and vulnerability to digital attacks. Overall, the article sounds a rather cautious tone, causing the medicaldeviceslegal blog to ask: Economist, why so pessimistic about open source medical devices software?
Erik Vollebregt, the post's author, points out that it "is a big misconception" to assume that currently no open source software is used in manufacturers' closed systems. Also, he opines that "the EU CE system is actually ideal for delivering open source software to the devices market, without compromising on safety or regulatory rigor in the least".
Whether or not open source software makes devices riskier or safer seems hart to ascertain. What everybody does agree on is the need for increased quality and scrutiny of medical device software. Hear hear!
For more on the intersection of software and regulation, take a look at:
- When is software a medical device?
- What's the fuss about IEC 62304?
- Introduction to software localization
- Software localization requirements in Japan
- Complying with EU Requirements for Medical Device Software
ForeignExchange's QMS is certified to ISO 9001, ISO 13485, EN 15038 and compliant with ISO 14971. For your next medical translation and software localization assignment, request a detailed proposal from ForeignExchange.