Surveillance and assessment of medical device-associated adverse events in a tertiary care hospital: An observational study.

Background and objectives Medical devices are essential in hospitals for diagnosis and treatment but may also cause unintended adverse events. Materiovigilance plays a crucial role in detecting, reporting, and preventing such events to safeguard patients. This study aimed to monitor, assess, and report medical device-associated adverse events (MDAEs) in a tertiary care hospital and to identify the devices most frequently implicated. Methods A prospective observational study was conducted at a tertiary care hospital in Bengaluru, India, from May 2023 to January 2024. Daily ward rounds were carried out in collaboration with the biomedical team to identify device-related issues. Confirmed MDAEs were documented using the standard reporting forms of the Materiovigilance Programme of India (MvPI). Results Among 1,100 medical devices in use, 31 (2.81%) were associated with adverse events. Most affected patients were females, with an average age of 61 years. Frequently implicated devices included disposable syringes and intravenous (IV) cannulas. The common events included thrombophlebitis, blocked or damaged needles, and elevated serum creatinine following contrast use. Most adverse events involved Class B devices. Causality assessment classified the majority as probable or possible. Interpretation and conclusions The overall frequency medical device associated of adverse events associated was low. However, the findings underscore the importance of continuous device surveillance. Strengthening awareness and structured reporting under MvPI can improve early detection, timely intervention, and long-term patient safety in clinical practice.