Health-care Professionals' Perception toward Medical Device Postmarket Surveillance Practices: A Cross-sectional Study in India.

Autor:	Shukla S; Assistant Scientist, Department of Materiovigilance Programme of India (MvPI), Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Government of India, Uttar Pradesh, India., Meher BR; Assistant Professor, Department of Pharmacology, All India Institute of Medical Sciences, Bhubaneswar, Odisha, India., Mishra A; Assistant Professor, Department of Pharmacology, All India Institute of Medical Sciences, Bhubaneswar, Odisha, India., Arora S; Executive Director, Department of Hospital Administration and Management, Yashoda Super Speciality Hospital, Ghaziabad, Uttar Pradesh, India., Kalaiselvan V; Senior Principal Scientific Officer, Department of Materiovigilance Programme of India (MvPI), Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Government of India, Uttar Pradesh, India., Raghuvanshi RS; Secretory-Cum-Scientific Director, Department of Materiovigilance Programme of India (MvPI), Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Government of India, Uttar Pradesh, India.
Jazyk:	angličtina
Zdroj:	Indian journal of public health [Indian J Public Health] 2024 Jul 01; Vol. 68 (3), pp. 424-427. Date of Electronic Publication: 2024 Sep 24.
DOI:	10.4103/ijph.ijph_72_23
Abstrakt:	Summary: A cross-sectional, web-based survey was conducted to assess the health-care professionals (HCPs)' perception toward existing medical device postmarket surveillance (PMS) practices in India. A total of 1756 responses (medical practitioners [19.8%], nurses [22.5%], pharmacists [21.4%], and biomedical engineers [13.8%]) were recorded and analyzed. About 71.2% of participants were aware about the ongoing PMS program, 87.5% were aware that medical devices are under regulation in India, and 83.3% were aware about who can report medical device adverse event (MDAE). About 56.3% of participants agreed that they take regular feedback from patients after using high-risk medical device. Majority of participants (69.4%) were aware about tools for reporting MDAE and the online reporting form is the most preferable tool among users. About 76.2% of participants were agreeing that reporting of MDAE is their professional/ethical responsibility. This study reveals that Indian HCPs show a good understanding of PMS practices and a positive perception toward MDAE reporting. However, underreporting still remains a challenge in India. (Copyright © 2024 Copyright: © 2024 Indian Journal of Public Health.)
Databáze:	MEDLINE
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