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 In 2007, the FDA published an excellent draft guidance on wireless medical devices (posts here and here) on how to apply the Quality System regulation to wireless medical devices.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.)
Last year the FDA was one of several organizers in a series of workshops on wireless medical devices. Oh, and I almost forgot the FDA’s proposed rule on Medical Device Data Systems (MDDS) it was published so long ago (2 years ago next month). You can read more about the draft MDDS rule here, here, here, and here. Finally, the FDA has participated in a number of standards and test and certification efforts, such as the IHE’s Patient Care Device workgroup.
In many ways, the FDA’s regulatory framework is based on the concept of medical devices as stand alone black boxes controlled by manufacturers and used by health care providers. With stand alone medical devices, a regulatory framework that only applies to manufacturers is fine. But when medical devices become components in wider systems that are designed and implemented by sometimes unregulated third parties and maintained by customers, things can break down. As a result, the efficacy of this long standing regulatory framework is called into question. The blog post Medical Device Networks Trouble Industry, offers another example of the potential gaps resulting from limiting regulatory requirements to manufacturers. Medical device networking was also the subject of my presentation proposal for the workshop.
So what’s the purpose or desired outcome of this workshop? From the workshop web page:
The purpose of the workshop is to facilitate discussion among FDA, industry, academia, professional societies, clinical investigators and other interested parties on issues related to safe and effective interoperable medical devices.
This is an uninspiring, or more accurately, overly broad objective. In fact, anyone who attends is likely to have more substantive objectives they’d like to see realized. For example:
- A desire to be educated, either industry’s interests in the regulatory requirements for medical device interoperability, or regulators interests in the kinds of interoperable solutions offered or under consideration by manufacturers
- A goal of convincing the FDA to adopt a new and less onerous regulatory framework within which to realize interoperability
- The objective to gain specific regulatory guidance from the FDA on how to apply current regulations to specific products incorporating interoperability
- As always, there will be some health care providers in attendance who simply want to know how they can go about buying or creating the interoperable solutions they’ve been waiting for so long
After chairing last September’s inaugural Medical Device Connectivity Conference in Boston, I’m just glad to be an attendee.
UPDATE: A revised agenda (dated January 20, 2010), including descriptions of all the presentations, has been released. You can download it here.