Denice C.L. Stewart

The dangers of dental devices as reported in the Food and Drug Administration Manufacturer and User Facility Device Experience Database.

BACKGROUND The authors conducted a study to determine the frequency and type of adverse events (AEs) associated with dental devices reported to the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database. METHODS The authors downloaded and reviewed the dental device-related AEs reported to MAUDE from January 1, 1996, through December 31,2011. RESULTS MAUDE received a total of 1,978,056 reports between January 1, 1996, and December 31, 2011. Among these reports, 28,046 (1.4%) AE 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 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. Of the dental device-associated AEs, 53.5% pertained to endosseous implants. CONCLUSIONS A plethora of devices are used in dental care. To achieve Element 1 of Agency for Healthcare Research and Qualitys Patient Safety Initiative, clinicians and researchers must be able to monitor the safety of dental devices. Although MAUDE was identified by the authors as essentially the sole source of this valuable information on adverse events, their investigations led them to conclude that MAUDE had substantial 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 professions access to information about the safety of dental devices.

Original ContributionsPatient SafetyThe dangers of dental devices as reported in the Food and Drug Administration Manufacturer and User Facility Device Experience Database

BACKGROUND The authors conducted a study to determine the frequency and type of adverse events (AEs) associated with dental devices reported to the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database. METHODS The authors downloaded and reviewed the dental device-related AEs reported to MAUDE from January 1, 1996, through December 31,2011. RESULTS MAUDE received a total of 1,978,056 reports between January 1, 1996, and December 31, 2011. Among these reports, 28,046 (1.4%) AE 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 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. Of the dental device-associated AEs, 53.5% pertained to endosseous implants. CONCLUSIONS A plethora of devices are used in dental care. To achieve Element 1 of Agency for Healthcare Research and Qualitys Patient Safety Initiative, clinicians and researchers must be able to monitor the safety of dental devices. Although MAUDE was identified by the authors as essentially the sole source of this valuable information on adverse events, their investigations led them to conclude that MAUDE had substantial 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 professions access to information about the safety of dental devices.

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