1988 Improving the Utility of The Manufacturer and User Facility Device Experience (MAUDE) Database: Using Categorization of Device Events to Compare Uterine Endometrial Ablation Devices

Abstract

Study Objective Categorize 13 years of FDA MAUDE reports on endometrial ablation devices to assess its utility as an improvement to the database. Design The MAUDE database was reviewed from 2005 to 2018 using brand name searches: Genesys HTA, HerOption, Minerva, Novasure, and Thermachoice. Events related to device malfunction with and without patient injury were categorized: Type I: non-injury equipment malfunction event, Type II: an injury event not requiring hospitalization and, Type III: an injury event requiring hospitalization. Setting 13-year FDA MAUDE database review (2005-2018). Patients or Participants N/A Interventions N/A Measurements and Main Results 1518 MAUDE reports were categorized as follows: Genesys HTA: Type I: 131/432(33.41%), Type II: 259/432 (58.1%), Type III: 42/432 (9.49%); HerOption: Type I: 4/14 (28.57%), Type II: 0 (0%), and Type III:10/14 (71.43%); Minerva: Type I: 13/56 (23.21%), Type II: 9/56 (16.07%), and Type III: 34/56 (60.71%); Novasure: Type I: 92/550 (16.7%), Type II: 273/550 (49.6%), Type III: 185/550 (33.6%); Thermachoice: Type I: 315/466 (67.60%), Type II: 78/466 (16.74%), and Type III: 73/466 (15.67%). Large differences in reported category type were noted between brands of instruments. Conclusion The MAUDE database serves as a valuable tool for physicians to evaluate the safety of medical devices. Patient injuries, minor and serious, are critical information physicians need when considering new device use. Categorizing MAUDE reports into 1) instrument malfunction, 2) minor patient injury & 3) major patient injury (i.e., hospitalization) is a potential way to make the database more useful. While the MAUDE system was not design to compare devices, the categorization proposed here demonstrates a potential method to do this and improve the utility of the database. Additionally, the absence of sales or use volume data on devices use is a serious limitation to the utility of the database. This data can and should be incorporated into the MAUDE reporting system.