DOI: https://doi.org/10.22263/2312-4156.2025.4.100
U.S. Protasevich, V.A. Hrynchak, A.A. Kuzovkova, T.P. Krymskaya, D.V. Chernik, D.V. Chebotkova
Sanitary and chemical safety indicators of disposable medical products made of polyamide, polyorganosiloxane, metals and alloys
Republican Center for Hygiene, Epidemiology and Public Health, Mibsk, Republic of Belarus
Vestnik VGMU. 2025;24(4):100-107.
Abstract.
Objectives. To study sanitary and chemical safety indicators of medical products made from polyamide, polyorganosiloxane, metals and alloys after their accelerated aging.
The work studied the sanitary and chemical indicators of 16 disposable medical products made of polyamide and polyorganosiloxane and 19 made of metals and alloys. They were subjected to accelerated aging by incubation at the temperature of 80 to 95°C, which was increased by 50°C from the maximum storage temperature indicated on the label of each medical product. The incubation duration was 3.7, 11.2 and 18.7 days. The control groups were not subjected to accelerated aging. After incubation, for each medical device, its intended use conditions were simulated, and extracts from the products were prepared for this purpose. Subsequently, extracts from the control and experimental groups were studied according to sanitary and chemical indicators. The increase in the aging time of products to 18.7 days was established to contribute to a more pronounced statistically significant increase in migration of formaldehyde, acetaldehyde, lead, zinc, iron, nickel, pH, Δ pH, permanganate oxidizability and reducing impurities, and migration levels of formaldehyde, acetaldehyde, dibutyl phthalate, dioctyl phthalate, lead, iron, cadmium and nickel into the model medium from individual products exceeded hygienic standards.
Thus, it has been experimentally established that when determining the shelf life of disposable medical devices made of polyamide, polyorganosiloxane, metals and alloys, it is necessary to study sanitary and chemical safety indicators for human health.
Keywords: medical devices, sanitary and chemical indicators, polyamide, polyorganosiloxane, metals, alloys, accelerated aging, shelf life.
The sources of funding. The study was carried out within the framework of the task 02.15. “To develop and implement a method for determining the shelf life of single-use medical devices” of the State Scientific and Technical Program “Scientific and Technical Support for the Quality and Availability of Medical Services” for 2021-2025, subprogram “Safety of the Human Environment” (State registration No. 20231669 dated 11/13/2023).
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Submitted 16.04.2025
Accepted 22.08.2025
Information about authors:
Ulyana S. Protasevich ‒ researcher of the laboratory of applied toxicology and safety of medical devices, Research Institute of Hygiene, Toxicology, Epidemiology, Virology and Microbiology of the Republican Center for Hygiene, Epidemiology and Public Health, https://orcid.org/0009-0002-3783-7093, e-mail: Этот адрес электронной почты защищён от спам-ботов. У вас должен быть включен JavaScript для просмотра.;
V.A. Hrynchak ‒ Candidate of medical sciences, head of the laboratory of preventive and environmental toxicology, Research Institute of Hygiene, Toxicology, Epidemiology, Virology and Microbiology of the Republican Center for Hygiene, Epidemiology and Public Health, https://orcid.org/0000-0002-4119-1793
A.A. Kuzovkova ‒ Candidate of biological sciences, Head of the spectrometric research laboratory, Research Institute of Hygiene, Toxicology, Epidemiology, Virology and Microbiology of the Republican Center for Hygiene, Epidemiology and Public Health, https://orcid.org/0000-0003-1583-0536
T.P. Krymskaya ‒ head of the chromatographic research laboratory, Research Institute of Hygiene, Toxicology, Epidemiology, Virology and Microbiology of the Republican Center for Hygiene, Epidemiology and Public Health, https://orcid.org/0000-0002-7954-286X
D.V. Chernik ‒ leading chemist of the spectrometric research laboratory, Research Institute of Hygiene, Toxicology, Epidemiology, Virology and Microbiology of the Republican Center for Hygiene, Epidemiology and Public Health, https://orcid.org/0009-0003-2274-3104
D.V. Chebotkova ‒ junior researcher of the chromatographic research laboratory, Research Institute of Hygiene, Toxicology, Epidemiology, Virology and Microbiology of the Republican Center for Hygiene, Epidemiology and Public Health, https://orcid.org/0009-0002-9418-8632
