Study on the impact of sensitization on materiovigilance programme among pharmacy and dental postgraduate students

ABSTRACT

Background

Medical devices play a crucial role in patient care but entail inherent risks, necessitating the presence of materiovigilance to monitor and prevent medical device adverse events (MDAEs). The primary objective of our study is to evaluate the impact of an awareness and sensitization program regarding medical devices among participants.

Methods

A self-administered, validated knowledge, attitude, and practice (KAP) questionnaire consisting of 15 questions was distributed to study participants, and their responses were collected. The data were analyzed using SPSS software version 18.

Results

Out of the 182 responses received, 56% were from the Pharmacy, while 44% were from the Dental field. 64.8% of the participants were unaware of the Materiovigilance Programme of India (MvPI). However, an overwhelming 97.5% displayed a positive attitude towards reporting MDAEs. Only 5% of the participants had received training on how to report MDAEs. Furthermore, 85.71% of participants had not seen the MDAE reporting form.

Conclusion

To improve the reporting of MDAEs, it is essential to implement educational interventions and provide training to Pharmacy and Dental postgraduate students. These measures will increase awareness and promote better understanding and implementation of materiovigilance practices.

KEYWORDS:

• Medical devices
• Materiovigilance
• medical device associated adverse events
• Materiovigilance Programme of India
• healthcare professionals

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewers disclosure

Peer reviewers on this manuscript have no relevant financial relationships or otherwise to disclose.

Ethical approval

This study was performed in line with the principles of the Declaration of Helsinki. The study protocol was approved by Ramaiah Medical College, Human Ethics Committee and Institutional Scientific Committee (Ethics committee approval number- EC-22/35-PG-FP)

Author contributions

Conception and design contributions were made by Pramod Kumar A and Jyothi S. Analysis and interpretation of data were performed by Pramod Kumar A and Jyothi S. The manuscript was drafted by Kavya A V. Critical revision of the article for important intellectual content was done by Jeesa George. Final approval of the article was given by Pramod Kumar A. Provision of study materials for patients was carried out by Pramod Kumar A, and statistical expertise was provided by Jyothi S. Collection and assembly of data were performed by Kavya A V.

Acknowledgments

The authors thank all the staffs of department of Pharmacy Practice, Ramaiah University of Applied Sciences who made this research possible.

Data availability statement

The data that support the findings of this study are available from the corresponding author upon reasonable request.

Additional information

Funding

This paper was not funded.