From the May 2016 issue of HealthCare Business News magazine
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.Back to HCB News
