Medical Device Interoperability Workshop
There is a FDA (CDRH) Workshop on Medical Device Interoperability scheduled for January 25 – 27 at the FDA’s White Oak Campus in Silver Springs, MD. Here’s a link to the meeting’s official web site, which includes a number of downloadable files on the agenda, meeting logistics and background.
There is little question the workflow automation and intelligence offered by interconnecting medical devices can improve patient safety. There’s also little doubt that there is significant market demand for such solutions. For example, if hospitals could purchase PCA pumps and SpO2 monitors that were interoperable, i.e., the monitor could suspend drug delivery at the first indication of respiratory arrest, such a capability would quickly become a standard of care. Interoperability is a huge opportunity.
There is no doubt that there are unintended — and in some respects, unregulated by the FDA — systems of systems made up of medical devices sold and in use by health care providers. At the most basic level, there are medical devices with serial ports that were never intended to provide connectivity (or Medical Device Data Systems as the FDA called them in a draft rule issued almost 2 years ago). At the other extreme, you have systems like closed loop infusion therapy delivery, made up of components that are both regulated and unregulated, and that were originally developed with little or no thought to the demands of interoperability. This is a problem.
The FDA’s been interested in this area for some time. Way back in 2005, the FDA held a workgroup to discuss the system of systems issue regarding networked medical devices (see the blog posts here, here and here). The outgrowth of this meeting was IEC 80001, which is scheduled to be completed this year. In 2007, the FDA published an excellent draft guidance on wireless medical devices (posts here and here) on how to apply the Quality System regulation to wireless medical devices. (I can’t help but wonder why this is still a “draft” guidance.) Also back in 2007, the FDA provided a rather limp statement on interoperability at the 2007 conference on Medical Device Interoperability and High Confidence Software (see the posts in this search). (Offered as the first example of the FDA’s interest in interoperability is their dubious buy-in to the questionable patient safety benefits of new medical device unique device identification requirements was not inspiring — more here.)
