The FDA receives thousands of reports each year detailing the deaths, serious injuries, and malfunctions associated with medical devices. This is in order to monitor the safety and performance of medical devices. As a service to device manufacturers, physicians, patients, and researchers, the FDA has collected the data retrieved in these reports. They have made it available through its Manufacturer and User Facility Device Experience, or MAUDE, database. The data can be complicated by the submission of incomplete or inaccurate information. As well as by the potential for events to go unreported. However, the database does offer some significant insights into the way medical devices are interacting with the patients they are made to help.
We took a look at MAUDE data with a leading medical device expert, as well as additional reports produced by the FDA. This was to obtain a snapshot of how the medical device industry has changed over the past decade. We discovered an increasing trend towards major negative events (such as death, injury, and disabilities). These are being caused by failures in medical devices.
About The Author
EXPERT WITNESS E-007962
This highly qualified expert specializes in engineering and regulatory affairs for medical device commercialization. She earned a BS in Mathematics from Oregon State University and an MS in Medical Device and Diagnostic Engineering from the University of Southern California. This expert currently owns and operates her own medical device company where she prepares and submits FDA regulatory documentation and applications.
BS, Mathematics, Oregon State University
MS, Medical Device and Diagnostic Engineering, University of Southern California
Certified, Quality Auditor
Former, Sales and Account Manager, IBM Data Network
Former, Insulin Pump Sales, Medtronic Diabetes
Current, President, Medical Device Consulting Firm