Abstract No. 260: The MAUDE database: Friend, foe, or just misunderstood

Abstract

To illustrate the utility of the FDA-sponsored Manufacturer and User Facility Device Experience (MAUDE) database for post market surveillance of interventional devices using the Starclose (Abbott) device as an example. Post-market surveillance is an essential aspect of establishing the safety of new medicines or devices in clinical practice. Pre-market clinical trials may not reveal all the potential complications associated with a device without prohibitive large or lengthy trials. As such the FDA designed the MAUDE database for post-marketing surveillance of medical devices through voluntary reporting of device-related adverse events. As there is an ever-expanding array of devices approved by the FDA with a considerably lower threshold than for pharmaceuticals, the potential value of the MAUDE database is tremendous. The reality is that MAUDE provides a useful starting point for post-market evaluation of device complications, however there are significant shortcomings that limit the utility of this resource. In this educational exhibit we will describe the MAUDE database and illustrate how it can be used to track device complications using the Starclose vascular device as an example. The strengths and the limitations of this database for tracking device complications are reviewed. - Post-market evaluation of devices may increasingly impact interventional radiology practice given the proliferation of new devices.