The role of manufacturer and user facility database in evaluating BPH and prostate cancer procedures

To understand the utility and limitations of using the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database to evaluate rates of adverse events (AEs) for devices used in benign prostatic hyperplasia (BPH) and prostate cancer (PCa) procedures.

A systematic literature review was performed in Embase, MEDLINE, and Google Scholar to identify literature published between 1991 and August 2024 using the MAUDE database to analyze complications reported for BPH and PCa procedures.

A total of 11 full text articles (6 BPH articles and 5 PCa articles) met the inclusion criteria, citing use of a variety of BPH and PCa devices. The majority of articles (9 out of 11) used the number of AEs, events, or device failures/malfunctions as the denominator for determining incidence rates. Top author-reported advantages of MAUDE were anonymity of the system and ability to detect more unusual AEs. Top author-reported disadvantages of MAUDE were inability to determine AE rate/incidence and under-reporting.

The MAUDE database is useful in identifying previously unknown AEs occurring in BPH and PCa medical device procedures. However, the database should not be used to calculate adverse event/malfunction rates. Safety signals found via MAUDE should be further studied prior to reporting AE rates.