Safe Standard of Aeration for Ethylene Oxide Sterilized Supplies

Matsumoto, Teruo; Hardaway, Robert M.; Pani, K. C.; Sater, Corinne M.; Bartak, Duane E.; Margetis, Peter M.

doi:10.1001/archsurg.1968.01330210142028

Cited by 20 publications

(6 citation statements)

References 18 publications

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“…In other reports, histological assessment of subcutaneous tissue in rats implanted with materials sterilized with EO and aerated for various times indicated that histopathological effects were similar to that of steam sterilized control materials when the aeration period was between 48 and 72 h. 9 Shorter aeration times elicited severe effects, including edema, cellular infiltration, and thrombus formation. Aeration times of 48-72 h correlated to EO content of 460 and 420 g/g in a cardiac catheter device and 80 and 170 g/g in a urinary Foley catheter.…”

Section: Discussionmentioning

confidence: 75%

“…Several studies have been conducted to assess the hemolytic effects of EO sterilized materials. [9][10][11][12][13][14][15] Some have also reported assessment of direct EO in solution added to the hemolysis test system. [12][13][14] It is clear from these studies that extraction of EO varies with type of material.…”

Section: Discussionmentioning

confidence: 99%

“…Several studies have been conducted to assess the hemolytic effects of EO sterilized materials 9–15. Some have also reported assessment of direct EO in solution added to the hemolysis test system 12–14.…”

Section: Discussionmentioning

confidence: 99%

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Reevaluation of ethylene oxide hemolysis and irritation potential

Anand

Cogdill

Klausner

et al. 2003

J Biomedical Materials Res

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The in vitro hemolytic and in vivo mucosal irritation potential of ethylene oxide (EO) was investigated with standard procedures used to determine the biocompatibility of medical devices. Test solutions containing EO at concentrations of 25, 50, 100, 250, 500, 1,250, 2,500, 5,000, or 10,000 microg/mL were prepared in saline to simulate a worst-case aqueous extraction of standard medical devices containing 125, 250, 500, 1,250, 2,500, 6,250, 12,500, 25,000, or 50,000 microg/g of EO, respectively. Concentrations of EO up to 500 microg/mL were not hemolytic ( < 5% hemolysis after a 4-h exposure), whereas > or =1250 microg/mL of EO resulted in significant hemolysis. Hamster cheek pouches exposed to cotton pellets saturated with EO at concentrations of up to 2500 microg/mL for 4 h with a recovery period of 14 days were without effects attributable to EO. However, at > or =5000 microg/mL of EO, significant histomorphological alterations of the buccal mucosa were observed and attributed to EO exposure. It was concluded that solutions of EO of up to 500 microg/mL representing an aqueous extract of a general medical device containing at least 2500 microg/g of EO residue do not result in significant hemolysis and irritation.

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Section: Discussionmentioning

confidence: 75%

Section: Discussionmentioning

confidence: 99%

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Reevaluation of ethylene oxide hemolysis and irritation potential

Anand

Cogdill

Klausner

et al. 2003

J Biomedical Materials Res

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“…Studies of elimination of ethylene oxide by aeration have led to a variety of recommendations for aeration times, but the wide variations in the suggested aeration times even for the same polymer indicate continued difficulty in standardizing the procedure (Matsumoto et al 1968;Roberts & Rendell-Baker, 1972;Andersen, 1971Andersen, , 1973Sterilization Systems Group, 1970). An Ethylene Oxide Aeration Index is now suggested as a possible solution to this problem.…”

Section: Introductionmentioning

confidence: 99%

Standard aeration for gas-sterilized plastics

White

1977

J. Hyg.

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SUMMARYIn an effort to provide guidelines for standardizing aeration times for plastics sterilized with ethylene oxide, an Aeration Index has been developed. Based on the rate of diffusion of ethylene oxide in selected polymers, the Index provides an indication of the aeration time at ambient temperature (23°C) for the ethylene oxide concentration in freshly sterilized plastics to drop to 50 parts/106.

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“…Little evidence is available to indicate the levels of ethylene oxide at which toxic reactions occur, but the level of 200 ppm has been accepted as a safe maximum limit (Weymes and Robertson, 1972). Matsumoto et al (1968) obtained no haemolysis or histological change from a cardiac catheter having a level of ethylene oxide of 460 ppm 48 hours after sterilization. Andersen (1971) obtained no tissue reaction using polyvinyl chloride tubing and also natural rubber tubing containing 2000 ppm or less.…”

Section: Residual Toxicitymentioning

confidence: 92%