Hospital Surveillance Logged Device-Related Adverse Events in 2.2% of Dental Patients

Posted: September 25, 2026

Hospital Surveillance Logged Device-Related Adverse Events in 2.2% of Dental Patients

Edited by Dentaltown staff

A 13-month surveillance program at a tertiary care dental hospital recorded 1,024 adverse events associated with medical devices among 47,241 patients, a prevalence of 2.2%, according to a prospective observational study published Sept. 18 in the Journal of Dentistry.

Causality assessment classified 55.9% of the events as device-related. About 35.3% met regulatory criteria for serious events, and 92.3% occurred within 24 hours of device use.

Therapeutic devices were implicated in 48.4% of events. Most involved devices that were non-implantable, at 98.4%, invasive, at 52.3%, non-sterile, at 82.7%, and Class B, at 56.0%.

Women accounted for 57.8% of cases. Pediatric patients represented 23.8% of events and geriatric patients 6.0%.

Investigators at M.S. Ramaiah University of Applied Sciences in Bengaluru, India, conducted the study, drawing on faculty from pharmacy practice, prosthodontics, periodontology, conservative dentistry and endodontics, and pediatric dentistry. Events were categorized under India’s Medical Device Rules 2017, and chi-square tests examined associations with demographic and clinical variables.

The authors concluded that device-associated adverse events are an important patient safety concern in dental practice and called for strengthened materiovigilance and systematic surveillance of the devices dentistry uses.

The study was conducted at a single tertiary care hospital under India’s device classification and reporting framework, and the 2.2% figure reflects that setting. It does not describe an adverse event rate for U.S. dental practices.

Sources:
Journal of Dentistry, “Patient safety in dentistry: Surveillance of adverse events associated with medical devices,” published online Sept. 18, 2026:
doi.org/10.1016/j.jdent.2026.107053
PubMed record, PMID 42759921:
pubmed.ncbi.nlm.nih.gov/42759921


Hospital Surveillance Logged Device-Related Adverse Events in 2.2% of Dental Patients

Views: 8
Sponsors
Townie Perks
Townie® Poll
How many labs do you use on a regular basis?