Physicochemical, toxicological and hygienic aspects of ethylene oxide application for the sterilization of medical products. III. Setting hygienic norms in sterilized medical products.

Some of the drawbacks are discussed associated with hygienic norms for gaseous sterilizing agents in polymeric products for medical applications. A new approach is proposed for regulating ethylene oxide (EO) in such products. To this end, limiting types of biological effect and its pathways have been determined and substantiated as well as the reliability factor for establishing hygienic norms for EO in medical products. Daily threshold EO limit values were calculated for momentary and repeated exposure of humans. The duration of long-term and short-term exposure of the patient to sterilized products was evaluated on the basis of EO extraction kinetics from a variety of materials. Using daily threshold limit values, threshold residual values (TRV) of EO were calculated for different groups of polymeric products for medical applications.

Physico-chemical and toxico-hygienic aspects of using ethylene oxide for the sterilization of articles for medical use. Part 2. Toxicity and risk of ethylene oxide entering the organism by non-inhalation routes.

Results of investigation of toxicity of ethylene oxide (EO) entering the organism by routes other than inhalation (subcutaneous, intramuscular, intraperitoneal, intravenous) have demonstrated that the substance causes intoxication characterized by polytropic effect on many vitally important organs and systems. The changes in most of the indices under study show a phasic character and dose-time dependence. In both the acute and chronic effect, impairment of the state of the nervous system, the liver, kidney, blood and reactivity of the organism come to the foreground. After one single entrance, EO becomes manifest as a low-risk (class 4) compound (Limac for subcutaneous, intraperitoneal and intravenous routes being 5.0, 0.5 and 1.0 mg/kg, respectively); after repeated exposure as a high-risk (class 2) compound (Limchr for subcutaneous and intraperitoneal route being 1.0 and 0.1 mg/kg, respectively). In comparison with the subcutaneous route, the intravenous and intraperitoneal routes are more dangerous. The obtained parameters of EO toxicometry can be used as a basis for the calculation of safe levels of residual quantities of the compound in articles for medical use.