Industry Standards
The industry is rapidly approaching a point where an independent test and certification organization is required to provide verification testing of connectivity and interoperability (or semantic or syntactic interoperability) across multiple manufacturer's products and systems.
It's impractical for each individual manufacturer to do this verification testing themselves.
Unlike "plug-fests" or "connectathons" this test and certification must be in compliance with the FDA's Quality System regulation -- otherwise each manufacturer has to repeat the testing again themselves.
I asked Dick Moberg about the future of software libraries. He suggested that the military was a major factor in the adoption of DICOM. They made DICOM a requirement for imaging modality purchases, and manufacturers adopted. Moberg Research has a grant from the Army to develop an 11073 library. He noted that the military has let a number of grants around 11073 and other standards. The implication is that at some point the government, who buys a lot of medical devices, will mandate some standards.
Can you test to a standard or must you also to verification and validation testing of the system? This question was offered more as a statement that seems questionable, at best. Definite product management, design and regulatory strategy implications.
When asked about other standards (besides 11073) like DICOM or the HL7 RIM and their ability to either support vendor connectivity, or at minimum for use internally within a vendor's system. For example, many systems convert acquired data into an internal protocol for processing, storage and retrieval. Why not use the HL7 RIM as the internal data model rather than reinventing that wheel? John Harrington with Hill-Rom IT Solutions, suggested there'd be a lot of different standards that will end up being used.
Sudheer Matta with Cisco mentioned the need for connectivity to start with the physical layer -- Ethernet and Wi-Fi. He hits on two big issues here: the verification of medical device systems on specific vendor's infrastructure, and enabling coexistence among medical device systems on the same enterprise network.
Julian noted that we can't select or even create effective standards without knowing the requirements (he means the specific workflows and use cases that standards must support).
Great question about device association, when devices come on or off the network. Nat Sims volunteered a response: use a process like the 5 rights used in medication administration systems. Sudheer notes that medical devices also have quite a ways to go to become networked information appliances and supporting network authentication.
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