Perspectives on Materiovigilance Among Nurses in a Tertiary Care Hospital: A Cross-Sectional Study

Abstract

Objective: Medical devices are essential in healthcare, but their increasing use has
led to a rise in reported adverse effects globally. This study aims to assess nurses'
awareness and behavior regarding MDAE reporting, identify training gaps, and
improve reporting practices. By evaluating knowledge, attitude, and practice, the
study aims to guide targeted interventions to enhance reporting and improve patient
safety.
Methods: A cross-sectional questionnaire-based study was conducted among nurses
at a tertiary care teaching hospital from May to July 2023. The final 21-question
questionnaire included sections on personal details and consent, knowledge of MV
(10 questions), attitude toward MV (5 questions), and practice (5 questions). The
survey was distributed via Google Form, and responses were analyzed.
Results: Of 500 nurses, 419 responded (83.8% response rate), with 75% female and
a mean age of 38.72 ± 7.1 years. Most nurses (83-86%) correctly identified medical
devices, but knowledge of India's adverse event monitoring program was lower (61-
65%), with overall basic knowledge at 73.16%. While 71-80% believed medical
devices could cause adverse events and supported reporting (70-78%), only 5%
reported MDAEs. Despite 93% receiving training, the reporting rate was low. Senior
Nursing Officers had the highest scores in knowledge, attitude, and practice.
Conclusion: While nurses demonstrated awareness of medical devices and adverse
events, the low MDAE reporting rate points to a gap in practice. Despite training,
underreporting remains an issue. However, the positive attitude and willingness to
participate in Materiovigilance workshops, particularly among Senior Nursing
Officers, indicate a proactive approach that, with further reinforcement, could
improve MDAE reporting and enhance patient safety.