Endotoxin levels in steam and reservoirs of table-top steam sterilizers.

Abstract

To document endotoxin levels in "Statim" cassette sterilizer reservoirs and in steam delivered to the cassette in the unwrapped instrument cycle. To document endotoxin levels in sterilizer reservoir water using different management protocols. Endotoxin levels were determined using the Limulus Amebocyte Lysate test. Endotoxin preparations were from Escherichia coli and Ralstonia pickettii. All samples were collected in depyrogenated glassware and stored at -20 degrees C until assayed. The majority of water samples contained < 1.0 Endotoxin Unit (EU)/ml. The highest level found in sterilizers in clinical use was 5.3 EU/ml. Endotoxin was not detected in steam condensate within the limits of the assay. When the endotoxin level in the reservoir water was experimentally enhanced to 200 EU/ml, cassette steam condensate endotoxin levels were from 0.5% to 5% of the reservoir level. Daily and weekly emptying of the cassette reservoir consistently yielded low endotoxin levels as did monthly emptying, but with the latter there was a trend toward higher levels that favors weekly emptying as a precautionary measure. Endotoxin levels in the reservoirs of 23 sterilizers involving 240 samplings were never high enough to yield detectable endotoxin levels in steam in the sterilizer cassette. Regular weekly emptying of sterilizer reservoirs would eliminate the risk of endotoxin transfer during steam sterilization.