A comprehensive study in the Journal of the American Dental Association has found that 28,046 adverse events associated with dental devices, covering the years 1996 to 2011, were reported to the U.S. Food & Drug Administration (FDA). The study aimed to determine the frequency and type of these events in order to create a body of research for the dental industry on a similar level to that of the extensive patient safety literature as medicine and medical devices often do. Adverse events are defined by the FDA as an undesirable experience associated with the use of a medical product in a patient. These events can vary from malfunctions to serious injury and even death. Any such incidents must be reported to the FDA within 30 days, and it is from these reports that the research was compiled.
Using a unique, FDA database called the Manufacturer and User Facility Device Experience (MAUDE), researchers were able to identify adverse events relating specifically to dental devices, with each report containing detailed narratives concerning the incident, those involved and the device used.
The author of the study, Muhammad Walji, PHD, the associate dean for technology services and informatics and an associate professor of diagnostic and biomedical sciences at the University of Texas School of Dentistry at Houston, said: “By quantifying the frequency and type of dental [adverse events] reported into MAUDE since its inception, we aimed to update the dental profession's understanding of device-related threats to dental patient safety."
Of the nearly 2 million reports deposited into MAUDE, of which 28,046 were associated with dental devices. Of these, 66 reports involved deaths, 17,261 reported injuries, and 7,777 reported device malfunctions. A total of 26,691 of these reports were mandatory (23,583 manufacturers' reports, 2,968 distributors' reports, and 140 reports from user facilities), while 1,355 were voluntary. The authors presented the top 20 dental devices associated with adverse events, with endosseous dental implants being by far the most commonly represented. A total of 15,267 (53.5%) reports involved endosseous implants, which had 27 different types of problems associated with them.
However, the report is also quick to point out the limitations of the MAUDE system, due to the lack of extensive validation of reports or lack of severity expressed in some cases, but Walji hopes that this research will create a discourse around adverse events and ensure that they real solutions can be prescribed for common issues that arise.
"Dentists and their team members play a key role in reporting and recognizing these kinds of adverse events," he concluded. "Identification of dental adverse events is a critical first step before we can implement solutions to address them."