Knowledge attitude and practice of materiovigilance among healthcare professionals in tertiary care hospitals

Authors

  • Sindhu Selvam Department of Pharmacy Practice, Sri. Ramachandra Faculty of Pharmacy, Sri. Ramachandra Institute of Higher Education and Research, Chennai, Tamil Nadu, India
  • Rahul Prassath Department of Pharmacy Practice, Sri. Ramachandra Faculty of Pharmacy, Sri. Ramachandra Institute of Higher Education and Research, Chennai, Tamil Nadu, India
  • Ishwaryaa Jothi Babu Department of Pharmacy Practice, Sri. Ramachandra Faculty of Pharmacy, Sri. Ramachandra Institute of Higher Education and Research, Chennai, Tamil Nadu, India
  • Sneha Raja Department of Pharmacy Practice, Sri. Ramachandra Faculty of Pharmacy, Sri. Ramachandra Institute of Higher Education and Research, Chennai, Tamil Nadu, India
  • Narmatha Rajarathinam Department of Pharmacy Practice, Sri. Ramachandra Faculty of Pharmacy, Sri. Ramachandra Institute of Higher Education and Research, Chennai, Tamil Nadu, India

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20240992

Keywords:

Mv, Medical devices, Medical equipment, Adverse events

Abstract

Background: Materiovigilance (Mv) refers to the systematic monitoring and evaluation of medical devices in order to assess their performance and safety during all stages of their life. The purpose of Mv is to identify and avoid any potential hazards or issues linked with medical equipment. In brief, Mv plays an important role in ensuring the performance and safety of medical equipment. It consists of the systematic observation, the collection, and analysis of data on occurrences and adverse events related to medical equipment. The study was conducted to assess knowledge, attitude, and practice regarding Mv among healthcare professionals in tertiary care hospitals.

Methods: Self-prepared and validated questionnaires were distributed among healthcare Professionals in India through online forms from December 2022 to July 2023, a cross-sectional questionnaire-based survey was used, with convenience sampling utilized. Responses from 220 subjects were analyzed.

Results: The primary objective of this study was to assess the demographic details of the Healthcare Professionals as well as the distribution of knowledge, Attitude, Practice on Mv, in a list of 220 responses, 40% of them know about the Mv. Remaining 60% of them they don’t know about the Mv. Total 220 responses, 76.8% of the Healthcare professionals suggested to thought about the Mv, remaining 23.1% were disagreed. 75 out of 220 healthcare professionals acknowledged to seeing the reporting form and experiencing AE in their patients, while the remaining 145 denied it.

Conclusions: This study determined the knowledge, attitude and practice of Mv among healthcare professionals in tertiary care hospitals. According to the current study, the majority of healthcare professionals were knowledgeable and supportive of Mv, however they are not as effective in practice.

References

Maisel WH. Medical device regulation: An introduction for the practicing physician. Ann Intern Med. 2004;140:296 302.

Meher BR. Mv: An Indian perspective. Perspect Clin Res. 2018;9:175 8.

Gagliardi AR, Ducey A, Lehoux P, Turgeon T, Ross S, Trbovich P, et al. Determinants of reporting adverse medical device events: Qualitative interviews with physicians about higher-risk implantable devices. BMJ Qual Saf. 2018;27:190-8.

WHO to Develop Essential Diagnostic List. Available at: https:// www.who.int/me dical_devices/en/. Accessed on 20 December 2023.

Kalaiselvan V, Saxena R. Intraocular devices associated adverse events reporting system in India. Indian J Ophthalmol. 2020;68:2343 5.

Mirel S. Knowledge about Mv in Cluj-Napoca, Romania. Available at: http://origin.who.int/ medical_de vices/global_ forum/3rd_gf md/3rd_gf_ Posters/en/index 14.html. Accessed on 20 December 2023.

Guidance Document, Mv Programme of India (MvPI). Available at: file:///D:/New%20folder% 20 (8)/mate riovigilance/materiovigilan ce%20 programme%20of%20india.pdf. Accessed on 20 December 2023.

Coyle YM, Mercer SQ, Murphy-Cullen CL, Schneider GW, Hynan LS. Effectiveness of a graduate medical education program for improving medical event reporting attitude and behavior. Qual Saf Health Care. 2005;14:383-8.

Teow N, Siegel SJ. FDA regulation of medical devices and medical device reporting. Pharmaceut Reg Affairs. 2013;2:110.

Meher BR. Mv: An Indian perspective. Perspect Clin Res. 2018;9:175-8.

Alsohime F, Temsah MH, Hasan G, Al Eyadhy A, Gulman S, Issa H, et al. Reporting adverse events related to medical devices: A single center experience from a tertiary academic hospital. PLoS One. 2019;14: e0224233.

Yusoff MS. ABC of content validation and content validity index calculation. Educ Med J. 2019;11:49 54.

Kurien S, Satapathy S, Gupta SK, Arya SK, Sharma DK. Study of reporting system for adverse events related to common medical devices at a tertiary care public sector hospital in India. World Acad Sci Eng Technol Int J Health Med Eng. 2014;8:448-53.

Mirel S, Colobatiu L, Fasniuc E, Boboia A, Gherman C, Mirel V, et al. Mv and medical devices. In: Vlad S, Ciupa R, editors. International Conference on Advancements of Medicine and Health Care through Technology, Cluj Napoca, Romania. Available at: http://doi org 443.webvpn.fjmu.edu.cn/ 10.1007/978 3 319 07653 9_21. Accessed on 20 December 2023.

Mattox E. Medical devices and patient safety. Crit Care Nurse. 2012;32:60 8.

Sivagourounadin A. Knowledge, attitude, and practice of Mv among nurses. JPBS. 2022;17:54-9.

Indushree T, Narasimha MKM, Siddeswaraswamy P, Meghana D, Nandini T, Naveen K. Knowledge and attitude of Mv among doctors in a tertiary care teaching hospital: A cross-sectional survey. Natl J Physiol Pharm Pharmacol. 2022;13:32-9.

Meher BR, Padhy BM, Srinivasan A, Mohanty RR. Awareness, attitude, and practice of Mv among medical professionals at a tertiary care institute of national importance: A crosssectional study. Perspect Clin Res. 2022;13:94-8.

Downloads

Published

2024-04-25

How to Cite

Selvam, S., Prassath, R., Jothi Babu, I., Raja, S., & Rajarathinam, N. (2024). Knowledge attitude and practice of materiovigilance among healthcare professionals in tertiary care hospitals. International Journal of Basic & Clinical Pharmacology, 13(3), 358–363. https://doi.org/10.18203/2319-2003.ijbcp20240992

Issue

Section

Original Research Articles