AAMI and Underwriters Laboratories Inc. (UL) have jointly published the first in an expected series of standards intended to help the medical device industry achieve greater success with interoperability—a long-desired and sometimes elusive goal in health technology.
The standard is AAMI/UL 2800-1, Standard for Safety for Medical Device Interoperability. It addresses the safety, security and effectiveness of medical systems with interoperable elements throughout their development, deployment, assembly, and operation.
“UL is pleased to partner with AAMI on this joint standards development effort for the interoperability of medical devices,” said Phil Piqueira, vice president, UL Global Standards.
Jennifer Padberg, senior vice president, standards program and policy at AAMI, also hailed the collaborative effort. “We’re excited by this partnership with UL. By working together, we’ve created a standard that we believe will be valuable to the medical device industry. Device interoperability remains a stubborn challenge, and we see this standard as a vital resource in achieving that goal,” Padberg said.
Diana Pappas Jordan, standards program manager at UL and co-chair of the 2800 Joint Committee, said that 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. AAMI/UL 2800-1 also provides supplementary guidance on key clinical and engineering properties essential for ensuring effective interoperability.
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.”
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 Diana.Pappas.Jordan@ul.com or AAMI’s Wil Vargas WVargas@aami.org.
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