Last week (Oct 2-3), I attended a meeting addressing the challenges and issues related to the interoperability of medical devices hosted jointly by the Association for the Advancement of Medical Instrumentation (AAMI) and the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH). The purpose of the meeting was to discuss challenges, share best practices, and develop ideas for moving forward to address the issues raised.
Human factors and usability issues were raised throughout the meeting, as you would expect when discussing the design and development of a complex system made up of many other systems, and all the systems have many and varied users. There are several factors that increase system design challenges, and they all arise when addressing medical device interoperability as the design of a large system made up of all inter-related and interfacing systems. Examples include:
- defining and documenting the functions and attributes of each system to the extent necessary
- coordinating data and information across systems (e.g., one of the challenges discussed several times was that of having the clocks on all the systems synched to the same time)
- understanding potential interactions between systems and their impact
- ensuring that the right people (administrators and users) know about system limitations, impact on other systems, and reduced performance
- defining roles and responsibilities for designing, operating, training, maintaining, modifying, and overseeing systems
Two critical questions posed at this meeting underline the challenges and are going to take a lot of effort to answer:
- Where does the boundary of a “medical device” end when looking at a system within a system of systems?
- How do you validate the interoperability claim of a medical device?
Many of the safety-related projects that we’ve worked on are based on helping to create a definition and clear documentation of the system being designed or modified. Most of those systems have designs that are controlled by one company or small set of companies, and the designs stay fairly stable throughout their operational life. It has been shown with these systems that failures often are a result of poorly defined initial requirements. The more complex a system is, the more important documentation of functions and interactions becomes. When the systems are designed through many different companies and methods, they have the characteristics of such complex system and these challenges become much more difficult.
I look forward to following this work as it progresses and continuing to be involved. Check out the meeting page to learn more about the Medical Device Interoperability Summit including the agenda and links to presentations.