Technical Support - FAQs

ANSI/AAMI ST79:2006, Section 10.6.1 Process monitoring devices, states:
Rationale: "A Class 5 CI or an enzyme-only indicator should be included with the BI in the PCD so that if an implant must be released on an emergency basis, additional information about the critical parameters of the sterilization process will be available and documented."

As referenced in ANSI/AAMI ST79: 2006, Section 10.7.2.3 Test procedure:
Each day that a processed (sterilized) BI is incubated, incubate at least one non-processed (not sterilized) BI to use as a positive control. (Write a "C" [for "control"] and a date on the label.) The positive control should be from the same manufacturing date and lot number as the processed BI in the incubator.

Incubate the positive control for a visual color change. This helps ensure:

• correct incubation temperatures are met;
• viability of spores have not been altered due to improper storage temperature, humidity, or proximity to chemicals; and
• capability of media to promote growth.

AORN:2007, Section 3:Recommended Practices for Selection and Use of Packaging Systems for Sterilization Recommended Practice IX – A chemical indicator/integrator should be placed inside each package and an external chemical indicator affixed outside each package to be processed, states:
"The length of time that records must be retained varies throughout the country. Each health care facility is responsible for determining its record- retention policy based on state and local regulations, legal considerations (e.g., statutes of limitation for lawsuits), and its individual situation. Sterilization records should be retained according to the policy and procedure established by the individual health care facility."

"5. Two chemical indicators/integrators should be placed inside rigid containers, one in each of two opposite corners of the inside basket.
Multi-level containers should have a chemical indicator/integrator placed in two opposite corners (e.g., one in each of two corners) of each level."
"6. A chemical indicator/integrator should be placed on each level of multi-level wrapped sets."

ANSI/AAMI ST79:2006, Section 10.5.2.2.2 Internal chemical indicators, states:
"The CI should be placed in that area of the package, tray, or container system considered to be least accessible to steam penetration. This location might or might not be the center of the package, tray, or container system."

ANSI/AAMI ST79:2006, Section 10.3.2 Sterilizer records, states:
"The length of time that records must be retained varies throughout the country. Each health care facility is responsible for determining its record- retention policy based on state and local regulations, legal considerations (e.g., statutes of limitation for lawsuits), and its individual situation. Sterilization records should be retained according to the policy and procedure established by the individual health care facility."