Analysis of endoscopy room standards and medical device codes, highlighting impacts on safety and quality.
Goal. To analyze the changes in standards for equipping endoscopic rooms introduced by the Order of the Ministry of Health of Russia No. 206n dated April 14, 2025, with an emphasis on the importance of using medical device codes, and to assess the impact of these changes on the quality, safety, and control of medical equipment in healthcare organizations. Materials and methods. The study is based on the analysis of regulatory documents: the Order of the Ministry of Health of the Russian Federation dated 14.04.2025 No. 206n, the Order dated 31.05.1996 No. 222, and sanitary rules SP 2.1.3678-20. A comparative analysis was conducted to assess the impact of standardization on procurement processes, technical maintenance, and patient safety, as well as an analysis of equipment requirements for endoscopic rooms before and after the introduction of the order. A review of practical recommendations and potential risks associated with the use of equipment with different codes was also performed.
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A. L. Avdyugina (2025) studied this question.
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