Considerations for Establishing National Sentinel Hospitals for Medical Device Adverse Event Monitoring

doi:10.19803/j.1672-8629.20250281

Abstract

Abstract: Objective To explore the functions and ways of establishing sentinel hospitals for medical device adverse event surveillance, and to establish a scientific, efficient, and sustainable operational model for sentinel hospitals in order to provide data for enhancing China's surveillance system for medical devices. Methods By reviewing domestic and foreign literature, this article analyzed the status quo of spontaneous adverse event reporting in China and elucidated the role and value of sentinel hospitals by drawing on the experience of the FDA's MedSun program. Results and Conclusion National sentinel hospitals should be established to improve the quality of reporting, upgrade risk identification, and enhance active surveillance so as to provide data for medical device vigilance in China.

Key words: Medical Devices, Adverse Events, Spontaneous Reporting, Sentinel Hospitals, MedSun, Vigilance

CLC Number:

R951
R994.11

LI Dong, SONG Yana, WANG Ligang, BIAN Rongrong, ZHAO Yan. Considerations for Establishing National Sentinel Hospitals for Medical Device Adverse Event Monitoring[J]. Chinese Journal of Pharmacovigilance, 2025, 22(7): 780-785.

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https://zgywjj.magtechjournal.com/EN/Y2025/V22/I7/780

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