Background: Medical devices are the vital part of healthcare system. The use of medical devices is higher in the intensive care units leading to increased exposure rendering the exponential rise in incidence of medical device associated adverse events (MDAEs). Timely detection and reporting of MDAEs can help reduce the disease and associated liabilities. Objective: To determine the rate, patterns, and predictors of MDAEs. Methods: An active surveillance was carried out in the intensive care units (ICUs) of a tertiary care teaching hospital located in southern India. The patients were monitored for MDAEs which were reported based on MvPI guidance document 1.2. The predictors were calculated using an odds ratio at 95% confidence interval. Results: A total of 185 MDAEs were reported amongst 116 patients, of which the majority [74 (63.7%)] were males. Most of the MDAEs were attributed to urethral-catheters [42 (22.7%)] among which a high majority of 34 were associated with urinary tract infections (UTI), followed by ventilators [35 (18.9%)] with all events causing pneumonia. Urethral catheters and ventilators are both classified as categories B and C respectively based on device risk classification provided by the Indian Pharmacopoeia Commission (IPC). Over 58% of MDAEs were reported among the elderly. The causality assessment was possible for 90 (48.6%) MDAEs whereas 86 (46.4%) were probable. The majority of the MDAEs reported were serious [165 (89.2%)] and only [20 (10.8%)] were found to be non-serious on the severity scale. Most [104 (56.2%)] of the devices attributed to MDAEs were single-use devices, of which [103 (55.6%)] were destroyed and only [81 (43.7%)] were retained in healthcare facilities. Conclusions: Despite the best possible care in the intensive care units (ICUs), MDAEs are inevitable, adding to the burden of patients in terms of suffering, disease, extended hospital stay, and increased costs. MDAEs require rigorous monitoring of patients, especially in the elderly population and patients with increased exposure to multiple devices.
Keywords: adverse drug reactions reporting/monitoring; drug/medical use evaluation; medication therapy management (MTM).
© The Author(s) 2023.