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.

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.

The ability to extract data and translate it to a system of record is part of what the FDA considers to be a medical device data system (MDDS). The FDA requires that MDDS solutions carry an FDA Class I status for general documentation. Other aspects, such as alarms and active patient monitoring, are beyond the scope (transfer, storage, conversion and display) of standard MDDS capabilities. According to the rule, if an MDDS is used beyond its intended use, this shifts the burden for oversight and compliance onto hospitals that will subsequently be classified as a manufacturer.

A Class II clearance can be achieved by a middleware vendor that demonstrates from a risk perspective that it has successfully mitigated the hazards of the data for use in live interventions, which would be consistent with alarm communication or creation of new data from raw data collected from medical devices.

For a middleware vendor to claim clearance for active patient monitoring, it must have all the checks and balances in place to ensure the receipt and delivery of all active patient data for intervention purposes from end to end — from collection point (medical device) to delivery point (the clinician). Again, the ability to deliver on the timing and receipt of data necessary for interventions and active patient monitoring is an important distinction.

Universal medical device standards won’t happen overnight, though it has been interesting to note manufacturers’ slow migration to a more standardized approach. Logistics and practicality rule the day in a world with steep costs in investment, development, acquisition and regulation. This reinforces the need to have a comprehensive and forward-looking approach to selecting an MDI and middleware provider that can support the technical and clinical needs of your health care organization.

About the author: John Zaleski, Ph.D., CPHIMS, is executive vice president and chief informatics officer of Bernoulli, a leader in real-time connected health care. Dr. Zaleski brings more than 25 years of experience in researching and ushering to market devices and products to improve health care. He received his Ph.D. from the University of Pennsylvania, with a dissertation that describes a novel approach for modeling and prediction of postoperative respiratory behavior in post-surgical cardiac patients. Dr. Zaleski has a particular expertise in designing, developing and implementing clinical and non-clinical point-of-care applications for hospital enterprises. Dr. Zaleski is the named inventor or co-inventor on seven issued patents related to medical device interoperability.