From the May 2016 issue of HealthCare Business News magazine
By John Zaleski
Despite myriad public and private guidelines, reforms and standardization initiatives, many medical devices still require that their proprietary semantics and messaging format be translated to something more standardized to health IT systems.
For the foreseeable future, medical device data system (MDDS) middleware will continue to be necessary to pull data from certain classes of medical devices using vendors’ specifications, then translate and communicate it to a system of record.
The breadth and scope of MDDS middleware’s capabilities facilitates ways in which hospitals, health systems and other provider organizations can uncover means to leverage the data that flows from a device into a system of record. The use of the data to improve patient care management and clinical decision making comes immediately to mind — but that only scratched the surface of what is possible.
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Critical distinctions in middleware will define how that data can be used. While the capabilities of different middleware products overlap, there are key aspects of note for any enterprise deploying MDDS middleware to capture medical device data for operational charting and research. Minimally, MDDS middleware needs to be able to retrieve episodic data from a medical device and translate it to a standard format. Additionally, middleware should be able to retrieve data at variable speeds to meet the requirements of various clinical operational settings.
For example, clinical charting intervals normally vary based on clinical requirements from 30 seconds up to several hours. The ability to retrieve data at variable rates, including at the sub-seconds level, requires technical capability on the part of the middleware vendor, but it also requires regulatory capabilities in the form of FDA clearances, which indicates that the middleware has mitigated the risk associated with communicating higher frequency data for alarms and analysis — even patient monitoring and intervention.
In the health IT space, FDA 510(k) clearance governs medical device connectivity and communication to medical device data systems. One of the distinctions between medical device data systems that are intended for the use of charting and active monitoring is that those systems cleared for active monitoring have demonstrated the capability to reliably communicate data and alarms that are required for patient assessment and intervention.