AAMI and Underwriters Laboratories Inc. (UL) have together launched the first in a series of published standards they hope will support the medical device industry in its effort to achieve interoperability more effectively. The standard, ANSI/AAMI/UL 2800-1:2019, Standard for Safety for Medical Device Interoperability, covers “the safety, security and effectiveness of medical systems with interoperable elements throughout their development, deployment, assembly, and operation.” Diana Pappas Jordan, standards program manager at UL and co-chair of the 2800 Joint Committee, said that ANSI/AAMI/UL 2800-1 is the result of years of development and commitment by the committee and provides a critical set of requirements for medical device interoperability.
The standard employs a life cycle process approach to organizing requirements, providing a set of interoperability planning, realization, deployment, and monitoring activities that incorporate cross-cutting requirements for security and risk management. ANSI/AAMI/UL 2800-1 also provides supplementary guidance on key clinical and engineering properties essential for ensuring effective interoperability.
“Device interoperability remains a stubborn challenge, and we see this standard as a vital resource in achieving that goal,” Jennifer Padberg, senior vice president, standards program and policy at AAMI said.
Wil Vargas, standards director at AAMI and co-chair of the 2800 Joint Committee, noted that this standard was just the start of a bigger effort. “AAMI and UL have developed the foundational document that specifies a baseline set of requirements for assuring safe and secure medical device interoperability,” Vargas said. “This will serve as the cornerstone for a family of standards that will extend across different device families, as well as with different interoperability critical factors. We are excited to include this within the AAMI and UL portfolio.”
ANSI/AAMI/UL 2800-1 is available for purchase in the AAMI Store, www.aami.org/store. For more information on the development of this standard, contact UL’s Diana Pappas Jordan at [email protected] or AAMI’s Wil Vargas [email protected].
