This week, MET’s Product Safety Lab Director Rick Cooper is attending a meeting of a newly-convened standards committee in Long Beach, CA to discuss the creation of a new medical equipment safety of interoperability standard(s) tentatively known as AAMI/UL 2800. The meeting is well attended by interested parties consisting of certification agencies like MET Labs, and manufacturers, consultants, researchers, and medical professionals.
The topic is a very complex one, but essentially a need has been determined that medical equipment shall be designed, tested and certified to be interoperable while maintaining a specified level of safety.
The problem of interoperability is significant. There are so many different makes and models of so many different types of products to consider – e.g. pulse oximeters, blood pressure monitors, EKGs, and on and on. Each has its own unique needs and features. For example, with EKG filter settings, how do you assure this is communicated to connected equipment? What protocol is to be used? This is just one example of many possible scenarios.
This initial meeting will move into a standards development process jointly managed by AAMI and UL via UL’s Collaborative Standards Development System (CSDS).
No firm deadline exists for when this process might result in a standard or set of standards, but everyone in attendance agrees it needs to be as soon as possible. Any resulting standard will be voluntary and not mandatory.
Official minutes of the meeting are due to be released to participants in early July.
For more information, contact Rick Cooper at firstname.lastname@example.org with “AAMI/UL 2800” in the subject line.
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