The MAUDE Reports

Sept. 22, 2022

Q

 I keep hearing the term MAUDE. What does it mean, is it a report, and why would a medical device reprocessing professional want to know this term?

A

Last month, I briefly mentioned the MAUDE Reporting System. Let’s focus on that. Simply put, it means Manufacturer and User Facility Device Experience (MAUDE). This searchable database (within the U.S. FDA’s site) represents reports of adverse events involving medical devices. Many professionals think it is just for manufacturers but that is not true; anybody can fill out a MAUDE report.

“Each year, the FDA receives several hundred thousand medical device reports (MDRs) of suspected device-associated deaths, serious injuries, and malfunctions. The FDA uses MDRs to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products. The MAUDE database houses MDRs submitted to the FDA by mandatory reporters (manufacturers, importers, and device user facilities) and voluntary reporters such as health care professionals, patients, and consumers.”1

Customers often tell me about various equipment not working properly (malfunction of the device) and they feel companies are not listening to them. By filing a MAUDE report, the user (you and your facility) is not identified in anyway in the public data base, thus protected. I also believe before a user submits a MAUDE report, they should in good faith and effort work with the manufacture to try and resolve the issue of concern.

Here are just a few examples I have found in the MAUDE data base. Please note, for this article, I have redacted the reports’ information for dates using “xx” and specific companies’ names and products with em dashes.

“It was reported initially that the — mono cable had failed. Additional information received on 11/2019 indicated that the incident occurred on xx/xx/xx. It was reported that the nurses stated that the product failure was the plug in the generator, the cord separated and then arced. A 10-minute surgery delay was noted. The patient was prepped for surgery, and the device was in contact with the patient, however, there was no injury reported.”2

“xx/xx/2019, — company became aware of an issue with one of the washer-disinfector: —. As it was stated, a wrong detergent was used during washing disinfection procedure. There was no injury reported, however with the information available we were not able to confirm how long a wrong detergent was used. We decided to report this issue based on the potential and in abundance of caution as incorrect detergent was used and could affect the final effect of the process.”3

“— multi-level sonic does not pass efficacy tests when enzymatic detergent is used and dosed at 1 ounce per gallon. Efficacy test and active enzyme test not passing with — enzymatic detergent and check valve on detergent lines were plugged with debris. Once check valves were replaced, efficacy tests were still not passing in all levels, however active enzyme test strip passed. A specific product to test for cavitation did not pass in all levels consistently. Based on the efficacy tests and cavitation test device, this multi-level sonic machine design doesn’t have enough sonication power to reach every level when all lumen baskets are tested together.”4

In all my years of doing Critical Practice Review (CPR), I have seen so many issues that should be reported, and facilities just will not file a MAUDE report. If you have an issue (e.g., malfunction of your equipment) and have tried to work with the manufacture without resolve, using the MAUDE report to share your issue it is one way you can make a change (i.e., a difference in a positive way, not punitive toward any manufacture); at least in this author’s opinion. Manufactures are and should be our partner in making a difference, and the better ones are.

References
1. MAUDE - Manufacturer and User Facility Device Experience. (Last Updated: 2022, June 30). U.S. Food and Drug Administration (FDA). Retrieved July 19, 2022, from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm.
2. MAUDE - Manufacturer and User Facility Device Experience. (2019). Report #2523190-2019-00146. U.S. Food and Drug Administration (FDA). https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=10276825&pc=GEI.
3. MAUDE - Manufacturer and User Facility Device Experience. (2019). Report #9616031-2019-00012. U.S. Food and Drug Administration (FDA). https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=8619061&pc=MEC.
4. MAUDE - Manufacturer and User Facility Device Experience. (2020). Report # MW5097780. U.S. Food and Drug Administration (FDA). https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=10828979&pc=FLG.  

Original photo courtesy Bayhealth SPD, HPN's 2021 SPD of the Year, with affects added by generative AI.
64770523 © Win Nondakowit | Dreamstime.com
25375493 © Scanrail, 37586544 © Sudok1 | Dreamstime.com
244332651 © Auremar | Dreamstime.com