Medical Device-Associated Adverse Events Reported from Intensive Care Units under the Materiovigilance Programme of India: A Descriptive Observational Study

Author : Padmashree Patil, Dr. Snigdha Misra

Abstract : Medical device-associated adverse events (MDAEs) can compromise patient safety, particularly in intensive care settings where multiple critical devices are used continuously. The Materiovigilance Programme of India (MvPI) provides a structured framework for monitoring and evaluating such events. This study characterized MDAEs reported from intensive care units in a tertiary care hospital. A hospital-based prospective observational study was conducted at MGM Medical College and Hospital, Kamothe, Navi Mumbai. ICU-associated MDAEs reported from October 2025 to March 2026 were analyzed using materiovigilance forms, biomedical engineering records, incident logs and device-use records. Events were assessed according to implicated device, MvPI/CDSCO risk classification, root cause, causality and corrective action. A total of 95 ICU-associated MDAEs were analyzed. Patient monitors were the most frequently implicated devices (38; 40.00%), followed by ventilators (22; 23.16%) and infusion pumps (14; 14.74%). Class B devices accounted for 48 (50.53%) events, followed by Class C devices (45; 47.37%). Software defects were the most frequent root cause (27; 28.42%), followed by mechanical (22; 23.16%) and electrical defects (20; 21.05%). Causality was predominantly classified as possible (45; 47.37%) and probable (41; 43.16%). Repair was the most common corrective action (44; 46.32%), followed by replacement (20; 21.05%) and notification to manufacturer (19; 20.00%). ICU-associated MDAEs predominantly involved monitoring and life support devices, highlighting the need for systematic reporting, preventive maintenance and timely corrective action to strengthen medical device safety in intensive care settings.

Keywords : Materiovigilance, Medical device-associated adverse events, Intensive care unit, Medical device safety, MvPI

Conference Name : International Conference on Pharmacy and Pharmacovigilance (ICPPV - 26)

Conference Place : Mumbai, India

Conference Date : 4th Oct 2026