Since 2008, medical devices have caused more than 80,000 deaths.
The United States Food and Drug Administration (FDA)’s Center for Devices and Radiological Health has the task of evaluating and approving or rejecting new medical devices based on safety and effectiveness.
Once a device earns FDA approval, post-market surveillance is supposed to gauge how well and how safely it performs in the real world. It is a mostly passive system in which manufacturers and users voluntarily report serious device-related adverse events.
The FDA is now collaborating with stakeholders in the medical device ecosystem to build the National Evaluation System for health Technology (NEST) - a better system for gathering evidence related to medical device evaluation and regulatory decision-making.
The FDA stated the goal of this new program to be: "NEST will generate evidence across the total product lifecycle of medical devices by strategically and systematically leveraging real-world evidence and applying advanced analytics to data tailored to the unique data needs and innovation cycles of medical devices."
Hopefully this will allow safer innovations in the development of medical devices, and decrease the number of medical device deaths.