At last week’s AAMI/FDA interoperability summit in Herndon, VA, I had a first-row view of the evolving issues and concerns swirling around medical device integration. The integration of medical devices with health IT systems has many potential benefits and is starting to see increased adoption.
However, as this adoption grows, one major theme of the summit was the difficulty of planning and documenting the safety of an integrated set of devices or systems. Especially when a single integration project can include an amalgam of cleared class II medical devices (both as data sources and as secondary alarm notification systems); Medical Device Data Systems to transfer information; and currently unregulated technologies such as information systems, clinical decision support algorithms, and communication devices. Who would have the information to create a safety case during an integration planning stage, and who would be responsible for establishing and maintaining the safety of the integrated system over time? FDA staffers went out of their way to be non-prescriptive, asking the industry to establish a common set of practices to guide FDA’s consideration of integration safety. Some attendees who hailed from ”Industry” replied, essentially, that they’d been hoping FDA would figure it out.
It doesn’t have to be this way.
In the infusion world, I’ve seen fierce competitors band together to work with FDA to clarify and develop best practices for following FDA’s new requirements for using the assurance case model for organizing new infusion pump submissions. Through AAMI’s Health Technology Safety Institute’s Infusion Safety Steering Council, these same suppliers are working together with clinical and independent experts like ECRI to support research and dissemination of best practices for infusion safety issues like multiple-line management, integration, and training materials. Instead of competing on basic safety features or trying to figure out how well a regulatory department could intuit FDA’s intentions, these suppliers are instead competing on ease of use, contracting, and feature sets.
My challenge to those involved with integration, whether medical device suppliers, electronic health record suppliers, third-party integrators, or independent consultants: please don’t compete on whether your system can connect. Please don’t try to out-do the competition with another unique and proprietary plug-and-socket set. Please do agree to implement existing IHE standard messaging and commit to moving towards open information exchange across a standardized set of interfaces. Please do compete on providing better quality of information, better analytics, better ease of use, and better enabling of workflows.
I, and the hospitals I work with, would be so grateful.
(This post was originally published by ECRI Institute’s Patient Safety Blog. It’s been reposted here with the permission of ECRI. For more posts, go to: https://www.ecri.org/blog/Pages/HomePage.aspx)
Senior Project Engineer
Health Devices Group