US Standards Organization Targets Medical Device Interoperability Issues
The Association for the Advancement of Medical Instruments (AAMI), a US-based organization advocating standards for medical devices and technology, has partnered with life sciences firm Underwriters Laboratories to develop standards for medical device interoperability.
AAMI sought to address device interoperability issues as integrated diagnostic and therapeutic systems are more commonly utilized across the healthcare sector. The two organizations have agreed to a memorandum of understanding to design consensus-based standards; AAMI and UL will jointly draft the standards with the goal of assisting medical device manufacturers develop and register more safe and effective products in terms of interoperability. The standards may also prompt more attention from FDA reviewers to interoperability issues in US medical device registrations.
According to a press release issued jointly by AAMI and UL, the standard development effort will try to frame existing interoperability practices within larger risk management principles in order to improve safety.
The interoperability standards initiative is well timed, as issues such as wireless technology adoption among medical devices and use of electronic health records become more and more pertinent in the US and other markets. Significant buy-in from industry as well as healthcare providers will obviously be needed to ensure success of the proposed standards, but if AAMI and UL can convince enough stakeholders to implement their recommendations, the result will be a more efficient and robust medical technology infrastructure.