The World Health Care Congress session on linking medical devices and equipment to a hospital's information technology showed that forging such a link is not a straightforward process, but the skeleton of an interoperability standard is emerging. Julian Goldman, MD, the standard-bearer for this effort at Partners Healthcare (Boston) noted in his Tuesday afternoon presentation that the draft of the IEC 80001 risk management document implicitly acknowledges "a number of potential problems."
This list includes lack of support from manufacturers, specifically "the non-availability or inadequacy of information provided by the manufacturer to the operator of the IT network." Goldberg's presentation also notes that "the mixing of medical devices and non-medical devices on the same network" is liable to create headaches in tying things together, as will be "the mixing of medical device software and non-medical software in the same network."
Still, the work proceeds apace toward an "ICE" (integrated clinical environment) standard under ASTM F-2761, and Golden's documents indicate that the standard will specify "the characteristics necessary for the safe integration of medical devices and other equipment, via an electronic interface, from different manufacturers into a single medical system."
The objective is to craft a system that will have "greater error resistance and improved patient safety, treatment efficacy and workflow efficiency than can be achieved with independently used medical devices." The work is expected to result in the publication of a standard this spring.
— Mark McCarty, Washington Editor