DOI: https://doi.org/10.22263/2312-4156.2026.1.59
V.A. Hrynchak, U.S. Protasevich, T.P. Krymskaya, D.V. Chebotkova
Sanitary and chemical indicators of degradation of medical polymer products
Republican Center for Hygiene, Epidemiology and Public Health, Mibsk, Republic of Belarus
Vestnik VGMU. 2026;25(1):59-66.
Abstract.
Objectives. To evaluate the sanitary and chemical indicators of degradation of medical polymer products made from polyvinyl chloride, styrene, and methylene styrene after aging under the aggravated conditions.
Material and Methods. Accelerated aging of medical devices was simulated using 15 products made from polyvinyl chloride and 13 products made from styrene and methylene styrene, both domestically and internationally. Aggravated aging conditions were created by thermostating the products at 75-95°C for 3.7, 11.2, and 18.7 days. After thermostating, clinical conditions were simulated for each medical device by preparing extracts from the devices. The chemical content of the extracts was subsequently analyzed.
Results. Chemical migration from medical devices was found to depend on the accelerated aging time. Increasing the aging period to 18.7 days resulted in the most pronounced increase in the migration capacity of formaldehyde, styrene, acrylonitrile, alpha-methylstyrene, vinyl chloride, and dibutyl phthalate, as well as changes in the quantitative values of permanganate oxidizability, pH, and ΔpH. The levels of some parameters exceeded hygienic standards.
Conclusions. The study results showed that during the aging process, polymer medical devices made from polyvinyl chloride, styrene, and methylene styrene undergo migration of degradation products, including toxic formaldehyde, styrene, acrylonitrile, alpha-methylstyrene, vinyl chloride, dibutyl phthalate, dioctyl phthalate, and others, posing significant health risks to patients. The migration rate of harmful chemicals from polymer medical devices can be used to estimate their shelf life.
Keywords: medical devices, shelf life, aging, aggravated conditions, permissible migration amount, polyvinyl chloride, styrene, methylene styrene.
Sources of funding. The assessment was carried out within the framework of the subprogram “Safety of the Human Habitat” of the State Scientific and Technical Program “Scientific and Technical Support for the Quality and Availability of Medical Services” – task 02.15. “Develop and implement a method for determining the expiration dates of single-use medical devices” (state registration number 2023166).
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Submitted 12.12.2025
Accepted 16.02.2026
Information about authors:
Vitaly A. Hrynchak ‒ Candidate of Medical Sciences, associate professor, 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, e-mail: Этот адрес электронной почты защищён от спам-ботов. У вас должен быть включен JavaScript для просмотра.;
U.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
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. 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
