Interoperable Medical Device Safety Standards Making Headway

It may be a stretch to compare the medical device market of the early 21st century to the market for electrical wiring and appliances in the early 20th century, but the goal of Underwriters Laboratories is essentially the same in both instances.

"Our goal is public safety. People recognize our brand because of our focus on that," said Anura Fernando, principal engineer for eHealth Medical Systems Interoperability and mHealth at UL. "In some cases, like electrical safety, people often don't even notice the UL mark on the back of products. In some respects it becomes very much taken for granted. But regardless of public perception and branding and so forth, we try to find areas where we can continue to grow and evolve the mission."

In evolving the organization's mission, Fernando says a fundamental difference between the "old" UL and the present-day UL is the time in a product's life cycle when it lends its expertise.  For many years, UL acted more as a gatekeeper between producers and consumers, testing both simple and complex electrical products after they had been designed and manufactured. Today, however, UL gets involved from the very first steps of design conceptualization—and through its standards-setting partnerships, sometimes even before a product is dreamt of.

One such effort is the collaborative effort UL is undertaking with the Association for the Advancement of Medical Instrumentation (AAMI) to create a suite of consensus-based standards for interoperable medical device interface safety. The effort, dubbed AAMI/UL 2800, has been underway since 2013, according to Fernando.

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In essence, the effort is intended to fill a gap the organizations saw in the safety assurance ecosystem of the burgeoning medical device market: as Fernando explained in a presentation prepared for a recent Software Certification Consortium conference, safety-focused architecture standardization work had already begun under ASTM efforts. However, testing and certification of conformance was missing.

"UL decided to partner with AAMI to develop the AAMI/UL 2800 standards because we noticed a global problem having to do with risks related to the lack of interoperability where it is much needed," he said. Examples include closed-loop control for patient-controlled analgesia, as well as risks that may arise when devices are interconnected, such as communication faults.

AAMI and UL are not alone in the standards efforts pertaining to device communication. The 2800 joint committee is looking at how best to harmonize their work with HL7 and ASTM specifications as well as with the group crafting IEEE 11703 personal health device communications standards.

"Putting all these existing pieces together to create an aligned and unified approach to make the case for safety in the marketplace is what we are really hoping to do, instead of reinventing the wheel," Fernando said.

While there is no firm timeline for the AAMI/UL 2800 standard to emerge, Fernando said he is optimistic that something will be produced by 2016.

"Standards development timelines can be very difficult to predict due to the nature of the consensus process," he said. "However, based on the high level of commitment of the joint committee members, who meet multiple times each week in smaller working groups and task groups, we are hopeful that documents in the AAMI/UL 2800 series will begin to be published next year."