False positive spere strip sterlity tests with steam sterilization

Epstein, Beverly; Lattimer, Joan M.; Metsen, John M.; Garibaldi, Richard A.

doi:10.1016/0196-6553(83)90103-7

Cited by 6 publications

(3 citation statements)

References 3 publications

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“…In contrast, Epstein et al encountered frequent false-positive tests with the same spore-strip indicator when used for monitoring flash sterilizers in actual use. 18 Biological indicators specifically designed for monitoring flash sterilization are now available. Except for a small study by Tornello et al, 30 which prompted complaints from several manufacturers, 31 and an analysis of four indicator systems published by one of the manufacturers, 32 evaluations of commercial biological indicators designated for monitoring flash sterilizers have not been published.…”

mentioning

confidence: 99%

Flash Sterilization: Carefully Measured Haste

Maki

Hassemer

1987

Infect. Control

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mentioning

confidence: 99%

Flash Sterilization: Carefully Measured Haste

Maki

Hassemer

1987

Infect. Control

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“…Two of four studies deal with positive biological indicators. In 1983, one author reported false positive biological indicators (ie, spore strips) that were documented intermittently between December 1977 and April 1978 22 . Intensive investigation failed to uncover evidence of equipment malfunction.…”

Section: Flash Sterilization Methodsmentioning

confidence: 99%

A Process for Improving Flash Sterilization

Huggins

Mood²,

Koch³

2002

AORN Journal

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In reviewing OR policies and procedures for flash sterilization, staff members at Presbyterian Hospital of Dallas discovered that their process of biological monitoring and flash sterilization needed improvement, and they implemented changes to correct the process. These changes led to questions regarding biological indicators and the flash sterilization container systems being used. As a result, the overall time required for flash sterilization was increased to validate the sterilization process.

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“…Thus, these simulations are generally difficult to apply to actual situations. Although many authors have reported isolated events, 1 we were unaware of any comprehensive study examining the frequency of and reasons for "false-positives" that could not be attributed to manufacturing variations in spore populations. Therefore, we undertook an extensive in-use evaluation utilizing two types of commercially available Bis.…”

Section: Introductionmentioning

confidence: 99%

Biological Sterilization Monitors: A Four-Year In-Use Evaluation of Two Systems

Kotilainen

Gantz

1985

Infect. Control

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Biological monitors (BI) are considered to be the best monitor of the sterilization process yet false positives may result in recalls and quality assurance difficulties. To assess the frequency, type and reasons for questionable results, we undertook a 4-year in-use study of two commonly used BI types--spore strips (Spordi) and a self-contained crushable ampule (Attest)--for both steam and ethylene oxide (EO). After laboratory verification of time/kill ratios for a portion of each involved lot, 2 BI of each type were placed in test pack within a randomly selected load run at standard time and temperature. All resulting positive BI were subcultured. Steam cycle positives were uncommon (32/1,1710 positive Spordi, 1.9%; 20/1,710 positive Attest, 1.2%) and could be related to chamber temperature or steam quality. All of the 4 BI per load were positive in only three loads; physical monitors indicated gross malfunction. Five positive Spordi were due to either contaminants or a malfunctioning incubator. EO-related positives were more common (53/1,109 positive Spordi, 4.8%; 25/1,109 positive Attest, 2.3%). One-half of the Spordi tests became positive after 48 hours of incubation. Organisms other than B. subtilis were recovered from 49.1% of the positive tests (26/53). The Attest was remarkable for its lack of contamination; 1/25 was positive for Pseudomonas stutzeri only. More positives were observed during the winter months when relative humidity was below 20%. This finding was more commonly observed with the EO Attest. In summary, we found no significant difference in the performance of either BI.(ABSTRACT TRUNCATED AT 250 WORDS)

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False positive spere strip sterlity tests with steam sterilization

Cited by 6 publications

References 3 publications

Flash Sterilization: Carefully Measured Haste

Flash Sterilization: Carefully Measured Haste

A Process for Improving Flash Sterilization

Biological Sterilization Monitors: A Four-Year In-Use Evaluation of Two Systems

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