The Use and Utility of Food and Drug Administration Adverse Event Data from the Manufacturer and User Facility Device Experience Database in Otology: A Systematic Review.

Abstract

To review otology-related studies using the US Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database to identify the opportunities and limitations of using MAUDE. PubMed, Science Direct, Web of Science, SCOPUS, and EMBASE. All studies reporting otology-related adverse events extracted from MAUDE were included from June 20, 2002, to 2022. Two reviewers independently screened abstracts, selected articles for exclusion, extracted data, and appraised studies. Critical appraisal was done according to the National Institutes of Health quality assessment tool for case series. The search yielded 5,645 studies, of which 8 studies met the inclusion criteria. All eight studies were case series; three evaluated cochlear implants, two evaluated osseointegrated hearing implants, and one evaluated illuminated operating microscope use. Quality assessment revealed all studies to be of poor quality. The most common domains contributing to these ratings included unclear study population, lack of consecutive participants, comparability of participants, clear and consistent outcome measures, and appropriate statistical analysis. Otology studies using the MAUDE database are of poor quality. This was primarily due to MAUDE's structural limitations as a passive surveillance system using nonstandardized free-text reports. The quality of studies also suffered from inappropriate analysis of MAUDE data, given its design. The utility of MAUDE could be improved by implementing case report best practices and converting the free fields to allow controlled and adaptive responses wherever possible to help standardize adverse event reporting.