I looked into the data that the FDA has available on MAUDE. A significant amount of time was spent getting the data into a single database so it could be searched for trends. There are lots of holes in it. The best I could do is collect the reports from 2000 -2011, rate the final patient outcomes and group the results by 21 CFR classification. There would need to be some correlation between the the FDA’s nomenclature and yours. In fact, 21 CFR has a different name for similar devices than the FDA Classification. The resulting summary, short description of methodology and a few opinions on how it can be used are available at: http://www.barrykohler.com/technical-projects/completed/maude-summary.
I would suggest it’s best use is to import into Excel, running a pivot table and seeing if the devices with the highest number of each kind of incident match your expectations. If not, adjust your risk scoring and the time you spend on planning your maintenance accordingly. You may also wish to search into those items that actually have the device problem filled out to see if any problems and maintenance solutions are applicable. It is possible to add individual manufacturer and model for such purposes but that is a little misleading when looking for statistical trends, could get one into hot water, and exceeded the space Google gave me. The website above refers to the original data sources so you could rebuild it yourself and get manufacturer info.
Contributed by: Barry Kohler
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About MAUDE from the FDA website:
MAUDE – Manufacturer and User Facility Device Experience
- MAUDE data represents reports of adverse events involving medical devices. The data consists of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. MAUDE may not include reports made according to exemptions, variances, or alternative reporting requirements granted under 21 CFR 803.19.
- The on-line search allows you to search CDRH database information on medical devices which may have malfunctioned or caused a death or serious injury. MAUDE is scheduled to be updated monthly and the search page reflects the date of the most recent update. FDA seeks to include all reports received prior to the update. However, the inclusion of some reports may be delayed by technical or clerical difficulties.
- MAUDE data is not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices. Please be aware that reports regarding device trade names may have been submitted under different manufacturer names. Searches only retrieve records that contain the search term(s) provided by the requester.
CLICK HERE to visit the FDA website.