The National Evaluation System for health Technology (NESTcc) is seeking feedback on plans to add abilities to actively monitor the performance of medical devices in the real world.
FDA tasked NESTcc with developing active postmarket surveillance capabilities in its Medical Device Safety Action Plan in 2018, leading the group to start work on a system for detecting and refining signals through the proactive collection and analysis of data.
The resulting Active Surveillance Roadmap sets out plans for a cloud-based platform that will allow collaborators to keep patient-level data behind their existing firewalls while sharing the aggregated results.
NESTcc has looked to FDA’s Sentinel System for inspiration for the development of active surveillance capabilities for medical devices. Sentinel uses a multisite distributed database to give FDA the data it needs to proactively assess the safety of the medical products it regulates. NESTcc sees device safety as a "more challenging domain" but nonetheless thinks it can learn from Sentinel.
Initially, NESTcc will set up a centralized system that will bring de-identified, study-specific extracts of patient-level data into its cloud. NESTcc estimates the centralized, intermediate version of the system will be up and running in the third quarter. In Phase II of the project, NESTcc will move to a federated model that enables its collaborators to keep data in their own environments and share aggregated results data via its cloud.
Work on Phase II with a contractor is expected to start in the fourth quarter and deliver a federated active surveillance system in the third quarter of 2022. The move from Phase I to Phase II will see NESTcc start testing real scenarios of interest to FDA such as ventilators, robotic surgery, breast implants and fully disposable duodenoscopes, and work with far larger, more complex datasets.
NESTcc plans to initially apply the system to signal refinement studies as they "are expected to be the most straightforward due to their consideration of known or suspected adverse events with one or more medical devices." As NESTcc automates more of the data curation pipeline and adds analytical capabilities, it envisions the system being used in more challenging signal detection studies.
Ultimately, NESTcc wants to be able to set up recurring, automated signal detection projects.
NESTcc is accepting feedback until Oct. 11 and will hold a webinar to discuss the roadmap on Sept. 23. The consultation is intended to "ensure the stated capabilities and strategy meets the needs of the medical device ecosystem."