Integrating Past Recall Information in Future Device Review

Executive Summary

The Center for Devices and Radiological Health within FDA is responsible for reviewing safety data prior to a medical device entering the marketplace to ensure that approved devices are safe and effective. Unfortunately, some approved devices result in patient injury and are recalled by the manufacturers. The current process for reviewing these failures is through examination of the manufacturer through the CDRH, Office of Compliance. These reviews typically result in finding error in the manufacturing process or software. However, there is no review process to determine whether FDA could have foreseen the error, or whether data was available to predict the failure. Answering these questions would allow FDA to update into the decision making process for future device review, provide feedback and closure to device reviewers involved in the approval of recalled devices, and guide updated policy for the center. Ultimately learning from past mistakes will allow FDA to improve decision making and have fewer device recalls in the future.

We want to reduce the number of patients that are unintentionally harmed by devices and explore ways to learn from past review decisions to improve future device review. We are proposing to use a Sentinel Event Review process to learn from past review decisions that led to device recall. In medicine, aviation, and criminal justice, this process has been developed to evaluate the errors and factors that may have contributed to a failure in complex systems. This review is non-blaming, all-stakeholder, and forward-looking examination of known errors allowing the organization to learn from past errors and minimize the risk of similar errors in the future.

A project supported by the: HHS Ignite Accelerator

Team Members

Cara Altimus (Project Lead), FDA
Victor Krauthamer, FDA

Milestones

January 2017: Project selected into the HHS Ignite Accelerator
February 2017: Time in the Accelerator began