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The Role of Manufacturer and User Facility Database in Evaluating BPH and Prostate Cancer Procedures - Beyond the Abstract

In this paper, we clarify the intended role of the FDA’s MAUDE database and how its data should be interpreted. MAUDE collects reports of device-related problems, injuries, and malfunctions to help identify potential safety signals; not to measure event rates or compare devices.

MAUDE is best used as an early warning system to detect unusual patterns that warrant further investigation. When a potential signal is identified, it should be evaluated using more robust data sources, such as clinical trials, registries, or electronic health records. Interpreting MAUDE data in isolation can lead to incorrect conclusions about device safety.

Written by: Bilal Chughtai,1 Golnaz Venkatraman,2 Laura Gressler,3 Dean Elterman,4 Naeem Bhojani5

  1. Department of Urology, Northwell Health, Syosset, NY, USA.
  2. Urology Division, Boston Scientific Corporation, Minnetonka, MN, USA.
  3. College of Pharmacy, University of Arkansas for Medical Sciences, Little Rock, AR, USA.
  4. Division of Urology, University of Toronto, Toronto, ON, Canada.
  5. Division of Urology, University of Montreal, Montreal, QC, Canada.
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