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Evaluation of Rapid Readout Biological Indicators for 132°C Gravity and 132°C Vacuum-Assisted Steam Sterilization Cycles Using a New Automated Fluorescent Reader

Published online by Cambridge University Press:  02 January 2015

Michelle J. Alfa ,
Nancy Olson ,
Pat DeGagne  and
Michele Jackson
Michelle J. Alfa*
Affiliation:
St. Boniface Research Centre, Winnipeg, Manitoba, Canada Wayne State University, Detroit, Michigan
Nancy Olson
Affiliation:
St. Boniface Research Centre, Winnipeg, Manitoba, Canada
Pat DeGagne
Affiliation:
St. Boniface Research Centre, Winnipeg, Manitoba, Canada
Michele Jackson
Affiliation:
St. Boniface Research Centre, Winnipeg, Manitoba, Canada
*
Department of Clinical Laboratory Science, Wayne State University, Detroit, MI 48202
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Abstract

Objective:

The primary objective of this study was to evaluate fluorescent readout results of Attest 1291 Biological Indicators (Bis) (3M Health Care, St. Paul, MN) and Attest 1296 BI test packs (containing Attest 1292 Bis) using full and fractional cycles compared with the growth data when prolonged incubation (7 days) was included. Gravity displacement and vacuum-assisted steam sterilization cycles were evaluated. A secondary objective of this study was to evaluate the new automated rapid fluorescent reader (Attest 290 Auto Reader).

Design:

The rapid readout Bis for gravity displacement and vacuum-assisted steam autoclave cycles at 132° C were processed using full (4 minutes) and four fractional cycles that provided 30% to 80% positive results for growth after 24 hours of incubation (48 hours of incubation for Attest 1292 Bis from the Attest 1296 test packs). Sixty of each type of BI were tested for each cycle (300 of each BI type in total).

Results:

For all full steam sterilization cycles, results of the rapid fluorescent readout and the 24-hour, 48-hour, and 7-day growth tests were negative for all Attest 1291 and 1292 Bis tested. For all fractional cycles, the 24- and 48-hour growth results for the Attest 1291 and 1292 Bis, respectively, were the same as the 7-day growth results. The fractional cycle data indicated that fluorescent rapid readout was a more sensitive indicator than growth. There were rare (0.9%) false-negative results for Bis under fractional cycle conditions and these all correlated with short fractional cycle exposure times.

Conclusions:

The fluorescent rapid readout results of the 1291 Bis and 1296 BI test packs reliably predict both 24- and 48-hour and 7-day growth. These data support the value of rapid readout Bis for sterilizer monitoring for both the vacuum-assisted and the gravity displacement steam sterilization cycles. The new automated reader requires less manipulation of the BI and makes monitoring user friendly and less prone to user errors.

Type
Original Articles
Information
Infection Control & Hospital Epidemiology , Volume 23 , Issue 7 , July 2002 , pp. 388 - 392
Copyright
Copyright © The Society for Healthcare Epidemiology of America 2002

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References

1.Association of Operating Room Nurses. Proposed recommended practices for sterilization in the practice setting. AORNJ 1994;60:109–119.Google Scholar
2.Joint Commission on Accreditation of Healthcare Organizations. Accreditation Manual for Hospitals. Oakbrook Terrace, IL: Joint Commission on Accreditation of Healthcare Organizations; 1994.Google Scholar
3.American Society for Healthcare Central Service Personnel of the American Hospital Association. Recommended Practice for Central Service, Sterilization. Chicago, IL: American Hospital Association; 1989.Google Scholar
4.Association for the Advancement of Medical Instrumentation. Good Hospital Practice: Steam Sterilization and Sterility Assurance. Arlington, VAAssociation for the Advancement of Medical Instrumentation;1993.Google Scholar
5.Garner, JS, Favero, MS. Guidelines for Handwashing and Environmental Control. Atlanta, GA: Centers for Disease Control and Prevention; 1985. CDC Publication No. 85-923404.Google Scholar
6.Vesley, D, Langholz, AC, Rohlfing, SR, Foltz, WE. Fluorimetric detection of a Bacillus stearothermophilus spore-bound enzyme, alpha-D-glucosidase, for rapid identification of flash sterilization failure. Appl Environ Microbiol 1992;58:717–719.CrossRefGoogle Scholar
7.Albert, H, Davies, DJG, Woodson, LP, Soper, CJ. Biological indicators for steam sterilization: characterization of a rapid biological indicator utilizing Bacillus stearothermophilus spore-associated alpha-glucosidase enzyme. J Appl Microbiol 1998;85:865–874.Google Scholar
8.Vesley, D, Nellis, MA, Allwood, PB. Evaluation of a rapid readout biological indicator for 121°C gravity and 132°C vacuum-assisted steam sterilization cycles. Infect Control Hosp Epidemiol 1995;16:281–286.CrossRefGoogle Scholar
9.Rutala, WA, Jones, SM, Weber, DJ. Comparison of a rapid readout biological indicator for steam sterilization with four conventional biological indicators and five chemical indicators. Infect Control Hosp Epidemiol 1996;17:423–428.Google Scholar
10.Rutala, WA, Gergen, MF, Weber, DJ. Evaluation of a rapid readout biological indicator for flash sterilization with three biological indicators and three chemical indicators. Infect Control Hosp Epidemiol 1993;14:390–394.Google Scholar
11.3M Health Care. 3M Attest Rapid Readout Biological Indicators: Product Profile. St Paul, MN: 3M Health Care; 2001.Google Scholar
12.Isenberg, HD, ed. Clinical Microbiology Procedure Handbook. Washington, DC: American Society for Microbiology; 1994.Google Scholar
13.Center for Devices and Radiological Health. Pre-market Notifications [510(k)] for Biological Indicators Intended to Monitor Sterilizers Used in Health Care Facilities: Draft Guidance for Industry and FDA Reviewers. Rockville, MD: U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health; May 21, 2001. Available at www.fda.gov/cdrh/ode/guidance/1230.pdf.Google Scholar