This sample policy and procedure is being provided to help you write your own policy and
procedure for the use of this product in your facility. This sample should be edited as needed to
comply with each facility's policy, procedures and compliance needs. It is the responsibility of
each health care facility to develop policies and procedures that comply with its unique needs
and all applicable laws, rules, regulations, standards and industry recommended practices. For
more information on the recommended use of this product, refer to the Instructions for Use
provided with the product.
Department: Operating Room
Section:
Title:
Sterilization
Routine Sterilizer Efficacy Monitoring of Pre-Vacuum Immediate-Use Steam
Sterilization Cycles of 4 minutes at 270F/132C and 3 minutes at 275F/135C
Frequency: Daily plus Every Load Containing Implants
Date:
2/9/2016
POLICY:
Evidence of effective steam sterilization processes will be documented.
Rationale: Per AAMI ST79, all steam sterilizers should be routinely tested using Biological
Indicator Process Challenge Devices (BI PCDs). Biological indicators are test systems containing
viable microorganisms providing a defined resistance to a specified sterilization process.
Biological indicators containing spores of Geobacillus stearothermophilus provide a direct
measure of the lethality of the steam sterilization process. A quality control program that
includes a biological indicator that has tested negative in combination with physical monitors
(i.e., sterilizer printouts) that confirm specific time/temperature parameters and external and
internal chemical indicators with acceptable end-point responses provide an assurance that the
sterilization process was effective. They do not, however, guarantee the sterility of each
individual product within the load.
Procedure
1. A representative PCD containing a 3M Attest Super Rapid Readout Biological Indicator
1492V (1492V BI) and a 3M™ Comply™ SteriGage™ Steam Chemical Integrator 1243 is used
to conduct daily routine efficacy monitoring of 4 minute 270F/132C and 3 minute
275F/135C pre-vacuum immediate-use steam sterilization cycles.
2.
A PCD is made by placing a 1492V BI and a chemical integrator in an empty representative
test tray (e.g., 1492V BI + CI are placed in an empty rigid container cleared for IUSS). Each
type of tray configuration in routine use for IUSS is tested separately.
3.
The PCD is placed on the bottom shelf of the sterilizer, over the drain, in an otherwise
empty chamber.
4. The sterilization cycle is run.
5. When the cycle is complete, the representative PCD is retrieved and opened and the
monitoring products are removed. The 1492V BI is allowed to cool for 10 minutes. The BI
is then identified with the appropriate sterilizer and cycle information, activated, and
incubated in a 3M™ Attest™ Auto-reader 490 according to instructions provided in the IFU.
6. A positive control 1492V BI having the same lot # as the test BI is incubated in the 3M™
Attest™ Auto-reader 490 each day.
7. The result of the control BI is recorded. The Control BI must show a fluorescent positive
result (+ symbol on the Auto-reader 490 LCD display) within 1 hour to ensure the test BI
result is valid.
8. The final negative reading (- symbol on the Auto-reader LCD display) of the test BI is made
at 1 hour and indicates a successful sterilization process. The test BI result and chemical
integrator result are documented.
9. Any positive result for a test BI and/or failing chemical integrator result must be reported
to the OR Manager immediately for further investigation and/or action.
10. A 1492V BI PCD also containing a Class 5 Integrating Indicator (3M™ Comply™ SteriGage™
Steam Chemical Integrator 1243) is also used in all loads containing implants. All implants
are quarantined until the negative BI result is obtained after 1 hour of incubation.
References
1. ANSI/AAMI ST79:2010 &A1:2010 & A2:2011 & A3:2012 Comprehensive guide to steam
sterilization and sterility assurance in healthcare facilities. Section 10.7.4
2. Association of periOperative Registered Nurses. Perioperative Standards and
Recommended Practices, 2013 Edition. Recommended Practices for Sterilization,
Recommendations VII and XX.
3. 3M Attest Super Rapid Readout Biological Indicator 1492V – manufacturer’s written
IFU.