The Dangers of Dental Devices as reported in the FDA MAUDE Database
Link: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4313571/
The Dangers of Dental Devices as reported in the FDA MAUDE Database
Nutan B Hebballi, BDS, MPH,1,* Rachel Ramoni, DMD, ScD,2,* Elsbeth Kalenderian, DDS, MPH, PhD,2,*Veronique F. Delattre, DDS,3 Denice C.L. Stewart, DDS, MHSA,4 Karla Kent, PhD,5 Joel M White, DDS, MS,6Ram Vaderhobli, DDS, MS,6 and Muhammad F Walji, PhD.1
J Am Dent Assoc. 2015 Feb; 146(2): 102–110. doi: 10.1016/j.adaj.2014.11.015
PMCID: PMC4313571
NIHMSID: NIHMS643672
PMID: 25637208
Abstract
Objectives
To determine the frequency and type of adverse events (AEs) associated with dental devices reported to Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database.
Methods
We downloaded and thoroughly reviewed the dental device-related AEs reported to MAUDE from January 01, 1996 – December 31, 2011.
Results
MAUDE received a total of 1,978,056 reports between January 01, 1996 and December 31, 2011. Among these reports, 28,046 (1.4 percent) AEs reports were associated with dental devices. Within the dental AE reports that had event type information, 17,261 reported injuries, 7,777 reported device malfunctions, and 66 reported deaths. Among the 66 entries classified as death reports, 52 actually reported a death in the description; the remaining were either misclassified or lacked sufficient information in the report to determine whether a death had occurred. 53.5 percent of the dental device associated AEs pertained to endosseous implants.
Conclusion
There is a plethora of devices used in dental care, and to achieve Element 1 of AHRQ’s Patient Safety Initiative, we must be able to monitor the safety of dental devices. While MAUDE is essentially the single source of this valuable information, our investigations led us to conclude that it currently has major limitations that prevent it from being the broad-based patient safety sentinel the profession requires.
Practical Implications
As potential contributors to MAUDE, dental care teams play a key role in improving the profession’s access to information about the safety of dental devices.
Keywords: Dental Equipment, Dental Public Health, Dental Records, Informatics, Quality of Care, Safety Management
