CLINICAL AND ECONOMIC BURDEN OF MEDICAL DEVICE-RELATED ADVERSE EVENTS IN INDIA: A PROSPECTIVE MATCHED NESTED CASE-CONTROL STUDY
Author(s)
JEESA GEORGE, MPharm, Pursuing PhD1, Adusumilli Pramod Kumar, PhD2, Vivekanandan Kalaiselvan, PhD3, Vibha Shetty, PhD4.
1Assistant Professor, Faculty of Pharmacy, M S Ramaiah University of Applied Sciences, M S Ramaiah University Of Applied Sciences, Bangalore, India, 2M S Ramaiah University Of Applied Sciences, Bangalore, India, 3Indian Pharmacopoeia Commission, Ghaziabad, India, 4M S Ramaiah University Of Applied Sciences, bangalore, India.
1Assistant Professor, Faculty of Pharmacy, M S Ramaiah University of Applied Sciences, M S Ramaiah University Of Applied Sciences, Bangalore, India, 2M S Ramaiah University Of Applied Sciences, Bangalore, India, 3Indian Pharmacopoeia Commission, Ghaziabad, India, 4M S Ramaiah University Of Applied Sciences, bangalore, India.
OBJECTIVES: Adverse events (AEs) associated with medical devices may adversely affect patient safety, treatment outcomes, healthcare utilization, and costs; however, evidence regarding their clinical and economic impact in dental settings remains limited. This study aimed to assess the clinical and economic impact of medical device-related AEs among dental patients.
METHODS: A prospective matched nested case-control study was conducted among dental patients from January 2025 to January 2026. Patients were selected from 47,241 admissions using systematic random sampling and followed for the occurrence of medical device-related AEs. A total of 1,024 patients who experienced AEs were identified and matched 1:1 with 1,024 controls without AEs based on age, sex, clinical condition, comorbidities, and medication history. Causality assessment was performed using the European Union and Indian medical device causality assessment scales. Clinical and economic outcomes were compared using Chi-square, McNemar, and paired t-tests, with p<0.05 considered statistically significant.
RESULTS: Patients with AEs experienced significantly poorer clinical outcomes than controls. Serious adverse events occurred in 28.7% of cases compared with 6.4% of controls (p<0.001). Additional dental procedures were required in 62.5% of cases versus 18.3% of controls (p<0.001), while complications developed in 54.1% and 14.7%, respectively (p<0.001). Patients with AEs had more dental visits (5.8±2.1 vs 2.6±1.4; p<0.001) and longer treatment durations (41.3±12.6 vs 24.8±9.7 days; p<0.001). Economic analysis showed significantly higher direct medical costs among patients with AEs (₹18,740±4,860 vs ₹10,920±3,540; p<0.001) and higher direct non-medical costs (₹4,680±1,420 vs ₹1,950±890; p<0.001). Causality assessment indicated that 55.9% of reported events were related to the device.
CONCLUSIONS: Medical device-related adverse events impose substantial clinical and economic burdens in dentistry by contributing to complications, additional procedures, prolonged treatment, increased health care utilization, and higher costs. Strengthening materiovigilance and active surveillance systems may help mitigate these burdens and enhance patient safety.
METHODS: A prospective matched nested case-control study was conducted among dental patients from January 2025 to January 2026. Patients were selected from 47,241 admissions using systematic random sampling and followed for the occurrence of medical device-related AEs. A total of 1,024 patients who experienced AEs were identified and matched 1:1 with 1,024 controls without AEs based on age, sex, clinical condition, comorbidities, and medication history. Causality assessment was performed using the European Union and Indian medical device causality assessment scales. Clinical and economic outcomes were compared using Chi-square, McNemar, and paired t-tests, with p<0.05 considered statistically significant.
RESULTS: Patients with AEs experienced significantly poorer clinical outcomes than controls. Serious adverse events occurred in 28.7% of cases compared with 6.4% of controls (p<0.001). Additional dental procedures were required in 62.5% of cases versus 18.3% of controls (p<0.001), while complications developed in 54.1% and 14.7%, respectively (p<0.001). Patients with AEs had more dental visits (5.8±2.1 vs 2.6±1.4; p<0.001) and longer treatment durations (41.3±12.6 vs 24.8±9.7 days; p<0.001). Economic analysis showed significantly higher direct medical costs among patients with AEs (₹18,740±4,860 vs ₹10,920±3,540; p<0.001) and higher direct non-medical costs (₹4,680±1,420 vs ₹1,950±890; p<0.001). Causality assessment indicated that 55.9% of reported events were related to the device.
CONCLUSIONS: Medical device-related adverse events impose substantial clinical and economic burdens in dentistry by contributing to complications, additional procedures, prolonged treatment, increased health care utilization, and higher costs. Strengthening materiovigilance and active surveillance systems may help mitigate these burdens and enhance patient safety.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
CO2
Topic
Clinical Outcomes, Economic Evaluation, Epidemiology & Public Health
Topic Subcategory
Clinical Outcomes Assessment
Disease
Alternative Medicine, No Additional Disease & Conditions/Specialized Treatment Areas