To help manufacturers navigate the MAUDE (Manufacturer and User Facility Device Experience) and Medical Device Recall databases for post-market surveillance, we gave a presentation at this year’s International Symposium on Human Factors and Ergonomics in Health Care (Virtual Conference).
In the presentation, MAUDE & Recall Data for Usability - Helping Manufacturers Use Event Reporting Effectively for Medical Device Risk Mitigation and Design Improvement, we explained how to use MAUDE and Recall event data sets to identify use issues, design opportunities, and improve risk management documentation. With this presentation, we provided medical device manufacturers with ways to leverage best practices to address regulatory requirements.
To access additional information related to using the MAUDE and Medical Device Recall databases, please see below:
- MAUDE and Recall Event Analysis Methodology, Case Studies, and Applications: Refer to “Using the FDA MAUDE and Medical Device Recall Databases to Design Better Devices,” featured in the Association for the Advancement of Medical Instrumentation’s (AAMI) Biomedical Instrumentation & Technology (BI&T) May/June 2020 journal.
- Decision Trees for Analyzing and Classifying Human Factors Issues: Refer to “Classifying Medical Device Human Factors Issues for the MAUDE and Recall Databases,” featured in the AAMIBlog.