Current status of periodic accreditation of medical devices during use at medical facilities in some provinces

Abstract

The objective of this study is to describe the current status of periodic accreditation of medical devices during use at medical facilities in some provinces, thereby identifying some related difficulties, shortcomings and proposing appropriate solutions. The study used a cross-sectional descriptive research design, combining both quantitative and qualitative research methods, to collect the data from September 2022 to September 2023 in management agencies, 10 medical equipment testing service providers, and 29 medical facilities in Thai Nguyen province, Da Nang city, and Ho Chi Minh city. The results showed that: (1) None of the medical facilities has accredited the safety and technical features of 6 groups of medical devices; (2) Only 66.0% of medical devices belong to group II measuring equipment and 86.0% of medical devices of radiation safety accreditation have ensured the periodic accreditation on time; (3) Medical facilities have faced difficulties in financial resources and funding norms used for medical device accreditation as well as the operation plans of medical facilities during the period of accreditation.