Background: Medical devices play a vital role in health-care delivery. However, the usage of medical devices is not devoid of potential risks. It is critical to evaluate the risks of medical devices during their use with implementing a strong monitoring system to detect medical device-associated adverse events (MDAEs). Drugs Controller General India launched Materiovigilance Programme of India (MvPI) with the primary aim to monitor MDAEs. Spontaneous reporting of MDAEs by health-care professionals is the fundamental element for successful functioning of medical device surveillance system. Although the program was launched 7 years ago, no such study regarding knowledge, attitude, and practice among Nurses was found in Eastern India.
Aim and Objectives: This aimed to assess knowledge, attitude, and practice regarding MvPI and reporting of MDAEs among staff nurses posted in different departments of Medical College, Kolkata.
Materials and Methods: A cross-sectional, descriptive study among nurses was done. A self-administered, pre-tested, structured, pre-validated questionnaire was distributed to 230 nurses. A software called SPSS, version 21.0, was used to analyze the data.
Results: A total of 227 responses were received. About 44.9% (102) of the staff nurses had adequate knowledge about various aspects of materiovigilance and MvPI. 91.2% (202) of the participating nurses had a positive attitude toward reporting a MDAE. However, only 8.3% (19) have reported an event.
Conclusion: Among the study participants, there was a lack of transition from knowledge and a supportive attitude to practice of MDAE reporting. To improve spontaneous reporting of MDAEs, conducting various training programs such as workshops and CMEs may be beneficial.
Key words: Materiovigilance; Medical Device-Associated Adverse Events; Materiovigilance Programme of India
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