AAMI Releases White Paper on Interoperability
AAMI has released a white paper that details what the association can do to help make interoperability in healthcare a reality.
Medical Device Interoperability was developed by the AAMI Ad Hoc Group on Health Information Technology and Interoperability (HITI). It provides recommendations on how AAMI can contribute to interoperability, and an overview of current standards efforts by various groups.
“Our conclusion is that AAMI should develop standards for individual clinical scenarios that define specific clinical functional requirements and non-functional requirements, such as QoS, quality of measurement (precision and accuracy), and, most importantly safety,” the paper reads. ”These standards would describe the essential performance requirements for such a composite system.”
The white paper defines interoperability as “the ability of medical devices, clinical systems, or their components to communicate in order to safely fulfill an intended purpose.”
AAMI has already invested some resources in helping healthcare facilities with interoperability. It will host a two-day summit on interoperability alongside the U.S. Food and Drug Administration (FDA) Oct. 2-3 in Herndon, VA. Nearly 200 healthcare and technology experts will discuss issues and challenges surrounding interoperability, and identify “clarion themes” or priorities to tackle. In another development, the association reached an agreement earlier this month with Underwriters Laboratories to develop a suite of safety interoperability standards.
HITI recommends that AAMI not duplicate other interoperability standards efforts from organizations such as the Institute of Electrical and Electronics Engineers, Integrating the Healthcare Enterprise, or the International Organization for Standardization (ISO).
The white paper calls for a family of AAMI standards, each targeting a specific, important clinical use.
The white paper cites patient-controlled analgesia (PCA) as an example of a clinical use that could be improved through interoperability. It pointed to a study of the FDA’s Manufacturer and User Facility Device Experience database from 2007 to 2009 that found a third of infusion-related adverse events involved a PCA.
“Better interoperability of pumps should help to reduce medication delivery errors by allowing more automated verification of pumps and the systems to which the pumps connect,” the paper reads.
An AAMI standard on PCA interoperability would describe “the essential performance requirements for such a composite system,” the paper reads. “Standards like these might be recognized by regulatory bodies (e.g., the U.S. FDA), creating a uniform approach for ensuring the safety of composite systems.”
To read the white paper, click here (PDF). For more information on the interoperability summit, including how to register, click here.
Posted: September 26, 2012