HOSPITAL ADVERSE EVENT REPORTING SYSTEM TO BE INTEGRATED INTO FDA NEST PROGRAM
Based on recent FDA statements, it looks as though the FDA would like to integrate hospital medical device reporting obligations into the National Evaluation System for health Technology (NEST) framework. The NEST system is a new model for “real world” evidence generation as the FDA looks to better identify problematic devices, accurately and transparently characterize and release data on device performance in clinical practice, and efficiently generate data to support premarket clearance or approval of new devices and new uses of currently marketed devices
Currently the FDA has a number of post marketing surveillance tools available to assist these goals. First, medical device reporting obligations require user facilities to report a wide range of defects and adverse events associated with medical devices. FDA does not tend to enforce this requirement in light of a 1997 law requiring the FDA to find a less burdensome post market surveillance approach. Second, the FDA can, although it does so infrequently, require post approval studies as part of the device approval process. Recently the FDA inspected 17 hospitals and found significant noncompliance with FDA medical device reporting regulations. This is clearly a wakeup call that the current system is not working as it should.
If you are following the development of NEST like we are, you know that the FDA, led by CDRH Director Jeffrey E. Shuren, is slowly implementing a massive data collection and analysis system to merge data from many stakeholders into a system the FDA can utilize for pre market and post market decisions. FDA desires to obtain and utilize real world data about devices and their performances as part of the scientific evidence the FDA reviews, both pre and post market.
Now that a coordinating center for NEST has been established, the Medical Device Innovation Consortium (MDIC), we know that the policy goal of moving away from reliance on MDR reporting by end users towards the use of device registries is beginning to be implemented. We hope that the upcoming December 5th Public Workshop: The Role of Hospitals in Modernizing Evidence Generation for Device Evaluation: Harnessing the Digital Revolution for Surveillance allows for further discussion of the many issues we have seen that may impact any transition from the current MDR system to the planned NEST approach. For example, complicated software licensing agreements and data transfer restrictions often make EHR data transfers to a device registry difficult and unreliable. This could lead to biased information in the registries that ultimately could impact how the FDA views the safety and effectiveness of the device.
We strongly encourage hospitals and device manufactures to participate in the December 5th public meeting. It is important that the FDA consider all aspects of these issues before implementing long term policies that affect post market device surveillance.