Abstract

Materiovigilance is a systematic technique for detecting, gathering, reporting, and analyzing medical device-related adverse events to protect patient health by preventing recurrence. In order to ensure patient safety and improve device performance, it is crucial to identify gaps in current considerations and reporting processes. These experts' knowledge, attitude, and practice (KAP) are vital for effective adverse event reporting. The study's objective was to appraise health care workers' acquaintance and familiarity, attitude or approach, and practice or application (KAP) of materiovigilance. This was a cross-sectional, observational, questionnaire-based study conducted among MBBS students, postgraduate students, interns, pharmacy students, faculty members, technicians and nurses. The study was done between May 2024 and August 2024. A structured questionnaire in the English language was prepared, containing a total of 15 questions related to the knowledge (5 questions), attitude (4 questions) and practice (6 questions) aspects of materiovigilance. Statistical analysis was done using the R language. The questionnaire was distributed to 350 health professionals, out of whom 321 participated. Female contribution was more than that of males. The majority of healthcare personnel did not have sufficient knowledge; however, the majority of participants, 75%, believed that medical devices can cause adverse events. The results showed that healthcare authorities need to improve their skills in recognizing and comprehending persuasion and orientation for the application or practice of materiovigilance. The transition of medical device-related adverse events (MDAE) reporting was lacking among the study contributors, and more awareness programs and continuous professional development need to be addressed regularly.

Key words: Healthcare, Materiovigilance, Medical device adverse events (MDAE)