In today’s wave of healthcare innovation, medical devices are becoming more complex.  As the intricacies of these products increase, the risks of failure and malfunction increase.  How do hospitals ensure patient safety for all approved medical technology? To help answer this question, we conducted a study with our hospital partners to find the current solutions to this modern day predicament.

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How Leading Hospitals Ensure Patient Safety for New Medical Devices

During an internal study of 30 hospital facilities utilizing GreenLight’s value analysis platform, we discovered that the majority of hospitals employ adverse event data to validate medical device safety.  While referencing the FDA MAUDE database, our hospital partners are able to analyze adverse event data to make informed procurement decisions around product introductions to their facilities.

From our interviews, we found that hospital systems commonly search for adverse events within the past twenty four months; the main focal points of the searches include deaths, injuries, and malfunctions associated with devices.  However, to ensure accurate search results, standardized product data is paramount. The first step in standardizing product information is to manage all new products from a single point of entry. Having a clean set of concise data from which to pull search criteria has equated to an increase in productivity through the Product Safety evaluation.  The next step in the process is converting the data into a useable report.

How to Make Sense of Adverse Event Data

With the sheer amount of adverse event information being utilized, data manipulation is critical in understanding the story being told by adverse events.  Only taking a single adverse event into consideration does not provide a full understanding of the risk associated with a device. In order to better predict the device’s state of operation during phases of its lifecycle, a comprehensive report of all adverse events will more easily illustrate trends and the risks devices pose to the patients’ safety.  Based on our findings, 85% of the interviewed health systems incorporate product recall information at the point of product introduction into the hospital to further ensure the quality of their approved devices. If a recall is identified, then value analysis teams may communicate with the medical representative regarding potential resolution of the recall.  This communication can give the value analysis team critical information about the device that could either make or break the procurement decision.

How GreenLight Supports Data-Driven Decision-making

To help the Value Analysis process work efficiently, GreenLight Medical makes collaboration with all stakeholders easier with our cloud-based software.  By integrating data from the current process into the GreenLight system, aggregation and standardization of new data will flow seamlessly into the portal allowing for a more complete review session.  GreenLight provides full transparency throughout the evaluation for doctors and other interested parties to follow along with the progress. To ensure product safety, GreenLight automatically collects new Adverse Events and notifies stakeholders of any current Recalls.  With the utilization of Adverse Event reports, committees can take proactive steps to ensure patient safety.


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