Identifying, Understanding, and Communicating Medical Device Use Errors: Observations from an FDA Pilot Program

摘要

The U.S. Food and Drug Administration (FDA) attempts to identify and understand new risks associated with medical device use; communicate information and recommendations to device users; help manage known risks by providing strategies to facilitate safe use; guide manufacturers to improve design, labeling, and training to address known risks; and guide users to make smart decisions about the acquisition and introduction of new technology. To identify the risks associated with medical devices, FDA has begun development of a device error reporting system, the Medical Product Surveillance Network (MedSun). The purpose of MedSun is to rapidly detect and understand previously unknown and serious problems, particularly close-call events. The heart of MedSun is its relationships with a relatively small, specifically trained and motivated group of workers who are focused on identifying device-related issues. This allows FDA to quickly react to the potential problems and identify the causes, contributing factors, and magnitude of a new risk. MedSun also serves as a virtual laboratory for problem research by focusing on certain devices, units, and users. This provides FDA with a better understanding of device problems, especially the human factors issues. This paper describes the development, implementation, and progress of the MedSun program.