Regulatory Framework in the Field of Medical Personal Protective Equipment against Infectious Disease Pathogens

Relevance. The sanitary and epidemiological emergency caused by COVID-19 has revealed a number of problems in the readiness of the healthcare system to respond, which was expressed, among other things, in the resource base. In the context of the unfolding epidemiological crisis, a number of changes have occurred in the regulatory framework, including updates to documents related to sanitary and epidemiological regulation and circulation of medical devices, as well as the release of a huge number of new personal protective equipment (PPE). During these processes, contradictions arose in the documents regulating the use of PPE, in the terminology used, in the trade names and characteristics of PPE. These contradictions complicate the selection of PPE of a certain level of protection and corresponding to certain provisions of mandatory documents and can lead to an increase in the terms of purchase and delivery of products to organizations, as well as the purchase of products that do not provide the required level of protection and do not comply with certain provisions of mandatory documents. To establish compliance or identify contradictions between the provisions of sanitary and epidemiological standardization documents, nomenclature classification of medical devices, state and interstate standards in terms of terminology and description of certain types and characteristics of PPE registered as medical devices against infectious disease pathogens. Materials and methods. A study of the regulatory and legal documentation governing the use of PPE and circulation of medical devices, the terminology base, including state and interstate standards, was conducted. Starting from 2020, information was collected on the personal protective equipment against biological factors offered for purchase, the presence of registration certificates for PPE and the relevance of their validity were checked according to the state register of medical devices, information was searched in the registry records, and the type of medical device was determined according to the corresponding nomenclature classification. A comparison of the descriptions of the types of medical devices and trade names with the nomenclature classification, provisions of sanitary rules and state/interstate standards was carried out. Results. The nomenclature classification, state and interstate standards (GOST) do not include such types of medical products as "anti-plague suit" (set, device, adaptation), anti-plague gown, anti-plague scarf (large, small), while their use is regulated by sanitary legislation. A significant number of GOSTs do not apply to PPE used for medical purposes and for protection against biological factors. There are contradictions in the sanitary rules regarding the use of PPE, as well as discrepancies with the provisions of GOST and the nomenclature classification of medical products. These contradictions complicate the processes of providing organizations with PPE due to the complexity of choosing the necessary products and purchasing them. It is necessary to revise, eliminate contradictions, systematize individual provisions of regulatory documents governing the use and handling of PPE used for medical purposes. Conclusion. It is necessary to carry out work aimed at: eliminating contradictions in regulatory documents of different levels; harmonizing regulatory documents issued by various departments, including those related to worker safety. In the context of current and potential sanitary and epidemiological emergencies, it is necessary to ensure the adaptation of medical organizations to crisis phenomena, form unified approaches in the legal field, facilitate work in the areas of epidemiological support for medical activities and improve the system of protecting medical personnel from biological threats.

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