An article about the long-standing challenge of medical device interoperability concludes that this goal will not be realized until “basic systems engineering and risk management principles and practices” are fully embraced by all stakeholders in the healthcare community, with a full appreciation for the varied and often conflicting interests at play among manufacturers, regulators, and healthcare facilities.
The Association for the Advancement of Medical Instrumentation (AAMI) reports the authors warn that failure to take such an approach could open the door to “potentially catastrophic harm” to both patients and organizations. The commentary, titled “Confronting Systemic Challenges in Interoperable Medical Device Safety, Security & Usability,” will appear in the October issue of the Journal of Biomedical Informatics. An online version of the article has already been published.
In making their points, authors and human factors consultants Elizabeth Averill Samaras and George Michael Samaras quoted an AAMIBlog post written by AAMI President Mary Logan, who called for a “greater scientifically focused commitment to a systems approach” to address the complex challenges in healthcare technology. In this post, Logan also cautioned against implementing solutions developed “in our silos and comfort zones of expertise.”
A siloed approach is not likely to be successful as the safety and usability of interoperable medical devices lies at the intersection of healthcare delivery, regulations, and business practices. While all stakeholders want safe, reliable, and interconnected systems of medical devices, each “has its own overlapping requirements…, including points of vulnerability and … dissonance” that need to be taken into consideration, Samaras and Samaras wrote. For example, so-called “vendor-neutral interoperability” is usually attractive to healthcare delivery organizations but is seen by manufacturers as a threat to their business interests.
According to the authors, a balance needs to be struck whereby manufacturers are able to protect trade secrets and intellectual property while still providing the “requisite risk management and design information necessary to properly identify and mitigate potential hazards, as well as verify risk reduction efforts.” Such information is necessary because—when using a systems approach—the safety and usability of the entire connected system must be evaluated, in addition to that of each individual device, since “emergent properties and new risks arise at the interfaces” of system components.
Samaras and Samaras suggest an approach that would allow manufacturers to anonymously share their risk analyses so the entire system could be analyzed without disclosing any individual manufacturer’s confidential data. However, according to the authors, this “would not resolve all obstacles.”
Overall, the authors believe the “most responsible path forward” is “proceeding with caution, observing well-established safety, security, and usability principles and system validation, followed by (or in concert with) careful testing of new approaches (and re-testing for reproducible results).”