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

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.