Real-World Analysis of Ventilator-Associated Technical Adverse Events and Preventive Maintenance Deficiencies under Materiovigilance Surveillance
Authors: Jitendra Patidar, Anuja Jha, Mohammad Nadeem Khan, Rashmi Mahajan, Pooja Reddy
Keywords: Mechanical ventilator; Materiovigilance; Adverse events; Critical care; Patient safety; Preventive maintenance; Calibration; Medical device safety.
Abstract:
Background:-Mechanical ventilators are critical life-support medical devices extensively utilized in intensive care units for the management of critically ill patients requiring respiratory support. Despite technological advancements, ventilator-associated technical malfunctions, calibration deficiencies, alarm failures, and inadequate preventive maintenance may compromise patient safety and clinical outcomes. Continuous post-marketing surveillance through materiovigilance systems is therefore essential for the early identification, reporting, and prevention of device-associated adverse events in routine healthcare practice.
Objective:-To evaluate the frequency, pattern, severity classification, and technical characteristics of ventilator-associated adverse events reported under materiovigilance surveillance in a tertiary care teaching hospital.
Materials and Methods:-A prospective cross-sectional observational study was conducted at the Medical Device Monitoring Centre operating under the Materiovigilance Programme of India at Sri Aurobindo Medical College and Post Graduate Institute, Indore, India, between September 2022 and February 2023. Data were obtained from Medical Device Adverse Event reporting forms submitted to the Indian Pharmacopoeia Commission. Ventilator-associated adverse events were evaluated for demographic characteristics, severity classification, calibration status, preventive maintenance history, utilization duration, and technical malfunction patterns using descriptive statistical analysis.
Results:-Among 120 reported medical device adverse events, 27 (22.5%) were associated with mechanical ventilators. Low tidal volume was the most frequently reported technical abnormality (40.74%), followed by alarm failure (14.81%) and flow sensor malfunction (11.11%). All reported incidents were classified as near-miss events, with no serious adverse events observed during the study period. Calibration records were available for 85.15% of ventilators; however, preventive maintenance documentation was available for only 40.74% of devices, indicating potential deficiencies in routine maintenance practices and biomedical monitoring systems.
Conclusion:-The present study provides important real-world evidence regarding ventilator-associated technical adverse events under materiovigilance surveillance. The findings highlight the clinical importance of active materiovigilance reporting, routine technical evaluation, standardized calibration practices, and structured preventive maintenance strategies for improving ventilator safety and minimizing preventable device-related risks in critical care settings. Strengthening integrated biomedical engineering support and post-marketing surveillance systems may substantially enhance patient safety and operational reliability of mechanical ventilators.
