Knowledge, attitudes and practices of Materiovigilance among physicians in a rural tertiary care teaching hospital in Puducherry- a cross sectional study

Authors

  • Sakthibalan M Department of Pharmacology, Sri Venkateshwaraa Medical College Hospital & Research Centre, Pondicherry https://orcid.org/0000-0002-7441-1545
  • Mangaiarkkarasi Adhimoolam Department of Pharmacology, Sri Venkateshwaraa Medical College Hospital & Research Centre, Pondicherry
  • Indumathi C Department of Pharmacology, Sri Venkateshwaraa Medical College Hospital & Research Centre, Pondicherry

DOI:

https://doi.org/10.18231/j.joapr.2024.12.1.10.15

Keywords:

Attitude and Practice, Knowledge, Materiovigilance

Abstract

Background: In India, medical devices are considered as drugs. A medical device may lead to problems either due to a defect during manufacture or transport, improper handling by health care professionals or patients, or failure to comply with recommendations. Aim & Objective: To evaluate the knowledge, attitude, and practice of Materiovigilance among health professionals at the Tertiary Care Hospital. Methods:  This was a Cross-Sectional Questionnaire Based study. The questionnaires were circulated among 100 medical professionals. The structured survey tool comprised of two parts. The first part contains demographic data, and the second part consists of 15 questions, with 5 each pertaining to the awareness, attitude, and practice domains. All the data were entered into a Microsoft Excel sheet and analyzed using GraphPad Instat software version 5.0. Results:  Medical professionals with above-average knowledge scores were 57 %, and the practice percentage of Materiovigilance was 60%, but there is a positive attitude (72%) towards Materiovigilance.  A significant difference was noted Between the knowledge scores of professors and residents (p-value - 0.0491). There was no significant difference in knowledge scores between medical, surgical, and pre/para specialties. However, there was a positive correlation between the knowledge and attitude scores of the medical professionals. Conclusion: We conclude that the Knowledge aspect and also the practice of Materiovigilance among Physicians in our tertiary care hospital is lacking. However, their positive attitude to reporting adverse events is reassuring.

Downloads

Download data is not yet available.

References

Coppa A, Bondioli L, Cucina A, Frayer DW, Jarrige C, Jarrige JF, Quivron G, Rossi M, Vidale M, Macchiarelli R. Palaeontology: early Neolithic tradition of dentistry. Nature 440, 755-6 (2006)

Johnson JA. FDA Regulation of Medical Devices. CRS Report for Congress Prepared for Members and Committees of Congress. June 25, 2012. (Accessed on August 2020)

Gupta SK. Medical Device regulations: a current perspective. Journal of Young Pharmacists 8, 6–11 (2016)

Huusko J, Kinnunen UM, Saranto K. Medical device regulation (MDR) in health technology enterprises - perspectives of managers and regulatory professionals. BMC Health Serv Res 23, 310 (2023)

Jefferys DB. The regulation of medical devices and the role of the Medical Devices Agency. Br J Clin Pharmacol 52, 229-35 (2001)

Heneghan C, Thompson M, Billingsley M, Cohen D. Medical-device recalls in the UK and the device-regulation process: retrospective review of safety notices and alerts. BMJ Open 1, e000155 (2011)

Hauser RG. Here we go again--another failure of postmarketing device surveillance. N Engl J Med 366, 873-5 (2012)

McGee RG, Webster AC, Rogerson TE, Craig JC. Medical device regulation in Australia: safe and effective. Med J Aust 196, 256-60 (2012)

Meher BR. Materiovigilance: An Indian perspective. Perspect Clin Res 9, 175-8 (2018)

Drugs and Cosmetics Act, 1940 and Rules, 1945. https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/acts_rules/2016DrugsandCosmeticsAct1940Rules1945.pdf (Accessed on December 2023)

Kalaiselvan V, Thota P, Singh GN. Pharmacovigilance Programme of India: Recent developments and future perspectives. Indian J Pharmacol 48, 624-8 (2016)

Saifuddin PK, Tandon M, Kalaiselvan V, Suroy B, Pattanshetti V, Prakash A, Medhi B. Materiovigilance Programme of India: Current status and way forward. Indian J Pharmacol 54, 221-5 (2022)

Sivagourounadin K, Rajendran P, Ravichandran M. Knowledge, Attitude, and Practice of Materiovigilance among Nurses at a Tertiary Care Hospital in South India: A Cross-Sectional Study. J Pharm Bioallied Sci 14, 162-7 (2022)

Shukla S, Gupta M, Pandit S, Thomson M, Shivhare A, Kalaiselvan V, Singh GN. Implementation of adverse event reporting for medical devices, India. Bull World Health Organ 98, 206-11 (2020)

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

Pandey N, Imran M. Materiovigilance: Current status in India analogous to its global status. Journal of Pharmacovigilance and Drug Research 1(2), 24-31 (2020)

Choi SJ, Nam KC, Choi S, Kim JK, Lee YK, Kwon BS. The establishment of the Korean medical device safety information monitoring center: Reviewing ten years of experience. Health Policy 125, 941-6 (2021)

Mirel, S. et al. (2014). Materiovigilance and Medical Devices. In: Vlad, S., Ciupa, R. (eds) International Conference on Advancements of Medicine and Health Care through Technology; 5th – 7th June 2014, Cluj-Napoca, Romania. IFMBE Proceedings, vol 44. Springer, Cham. https://doi.org/10.1007/978-3-319-07653-9_21

Polisena J, Gagliardi A, Urbach D, Clifford T, Fiander M. Factors that influence the recognition, reporting and resolution of incidents related to medical devices and other healthcare technologies: a systematic review. Syst Rev 4, 37 (2015)

Published

2024-02-29

How to Cite

M, S., Adhimoolam, M., & C, I. (2024). Knowledge, attitudes and practices of Materiovigilance among physicians in a rural tertiary care teaching hospital in Puducherry- a cross sectional study. Journal of Applied Pharmaceutical Research, 12(1), 10-15. https://doi.org/10.18231/j.joapr.2024.12.1.10.15

Issue

Section

Articles