Members of Farm’s Human Factors team were featured in the Association for the Advancement of Medical Instrumentation’s Biomedical Instrumentation & Technology (BI&T) May/June 2020 journal.
In the article, “Using the FDA MAUDE and Medical Device Recall Databases to Design Better Devices,” contributing authors, Teresita C. Liebel, human factors engineer, Tara Daugherty, human factors engineer, Alexandra Kirsch, human factors engineer co-op, Sharifah A. Omar, human factors engineer, and Tara Feuerstein, head of device quality risk and usability at Takeda, explain how manufacturers can use the databases to design better products.
The article provides recommendations to manufacturers on using the Food and Drug Administration's MAUDE (Manufacturer and User Facility Device Experience) and Medical Device Recall databases to identify unknown use issues, discover design opportunities, and improve one's risk management file. These recommendations are based on the experiences of researchers who have spent time analyzing and working with both database systems and have developed a methodology for both. Manufacturers can leverage the suggested practices described in this article to address regulatory requirements.