Patient safety in dentistry: Surveillance of adverse events associated with medical devices.

OBJECTIVES: Medical devices are integral to modern dental care; however, their use is associated with risks. This study estimated the prevalence of medical device-associated adverse events (MDAEs) in a tertiary care dental hospital and examined their distribution across patient demographics, dental specialties, and device-related characteristics. METHODS: A 13-month prospective observational study was conducted at a tertiary care dental hospital. Patients were monitored for MDAEs. Each event was assessed for causality, classified for seriousness according to regulatory criteria, and categorized according to the Medical Device Rules 2017. Descriptive statistics were used to estimate the prevalence and distribution of MDAEs, and chi-square tests were used to examine associations with demographic and clinical variables. RESULTS: Among 47,241 patients, 1,024 MDAEs were identified, yielding an overall prevalence of 2.2%. Females accounted for 57.8% of cases, whereas paediatric and geriatric patients represented 23.8% and 6.0% of events, respectively. Therapeutic devices were implicated in 48.4% of the MDAEs. Most events involved non-implantable (98.4%), invasive (52.3%), non-sterile (82.7%), and Class B devices (56.0%). Overall, 92.3% of the MDAEs occurred within 24 hours of device use. Causality assessment classified 55.9% of the events as device-related, and 35.3% of the events were serious. CONCLUSION: MDAEs are an important patient safety concern in dental practice, emphasizing the need for strengthened materiovigilance and systematic surveillance of medical devices used in dentistry. CLINICAL SIGNIFICANCE: Routine monitoring and structured reporting of MDAEs can improve patient safety and provide evidence for regulatory decision-making and safer dental practices.