Two Organizations Join to Set Standards for Medical Device Interoperability

The Association of Medical Instrumentation (AAMI) and Underwriters Laboratories (UL) have joined forces to develop a suite of standards on medical device interoperability, which industry experts say is one of the biggest challenges facing the healthcare industry.

This is a first time collaboration between AAMI and UL, and comes at a time when many healthcare facilities and manufacturers are grappling with how to achieve interoperability. In its broadest terms, interoperability has the potential to improve patient care by enabling clinicians to work with integrated systems of diagnostic and therapeutic devices and sharing data with electronic health records (EHRs), thus providing enhanced clinical decision support safely and effectively.

“Interoperability is a huge space still under development,” said AAMI President Mary Logan. “It will take multidisciplinary commitment and collaboration to achieve meaningful management of the space and the issue.”

That is why AAMI and UL have signed a memorandum of understanding to develop the suite of consensus-based standards, which will be drafted to help manufacturers design safer interoperable products and aid healthcare facilities in implementation.

“This suite of standards is not intended to replace or supplant existing interoperability implementation standards or profiles,” said Terenzio Facchinetti, D.Pharm., business development manager for UL’s life and health business unit. “This family of standards instead aims to map existing implementation practices into a risk management framework and to address further safety issues where applicable.”

AAMI, a standards development organization, and UL, a testing, certification, and standards development organization, are well suited for the task, said Carol Herman, AAMI senior vice president for standards policy and programs. 

“What makes this particular collaboration between AAMI and UL unique is that we each have deep experience with medical devices, and yet the two organizations bring different expertise to the table, so that the sum truly will be greater than the parts,” Herman said.

UL writes standards on products such as video cameras and tests new medical devices for manufacturers, and organization officials have expressed that safety is paramount to success in the emerging interoperability market.

“The medical device interoperability sector is a new development with extraordinary expectations. Its success is linked to the quality and the safety of the products and their interoperability. This agreement will support the achievement of these targets,” Robert Williams II, vice president of standards, and Anil Patel, vice president of the life and health business unit at UL, said in a joint statement.

AAMI is headquartered in Arlington, Va., while UL is based in Northbrook, Ill.