Looking for a helpful tool / resource for your Sterile Processing onboarding, annual competencies, or training curriculum? Check out this quick Study Guide Tool (with Answer Key) focused on the ANSI/AAMI ST79:2017 document below:
Short-Answer Questions
Instructions: Answer the following questions in 2-3 sentences each.
Explain the difference between "shall" and "should" as used in AAMI ST79.
Define "biological indicator control, positive" and explain its purpose.
What is a dust cover, and why is it important in sterile processing?
Define "gravity-displacement cycle" and contrast it with a prevacuum cycle.
What criteria define a medical device as an implant according to AAMI ST79?
Outline the key components of a loaned instrumentation policy.
Describe acceptable containers for holding contaminated items during transport.
What factors should be considered when selecting sterilization wrap?
What information should be included in the lot control identifier for sterilized items?
List three types of PCDs (Process Challenge Devices) that can be used for routine release of loads containing nonimplantable items.
Answer Key
"Shall" indicates mandatory requirements for compliance with the recommended practice. "Should" signifies a recommended course of action, while allowing for alternative possibilities.
A "biological indicator control, positive" is a BI from the same lot as the test BI that is not exposed to sterilization. It is incubated to confirm the viability of the test BI and the growth-promoting capability of the media.
A dust cover, also known as a sterility maintenance cover, is a protective plastic bag used to shield sterile items from environmental contaminants like dust, moisture, and lint. It helps maintain sterility until the point of use.
A "gravity-displacement cycle" is a steam sterilization cycle where incoming steam forces out residual air through a drain at the bottom of the chamber. Prevacuum cycles actively remove air from the chamber before steam injection, resulting in faster penetration and shorter cycle times.
A medical device is classified as an implant if it is placed in a surgically or naturally formed body cavity and intended to remain there for 30 days or more. The FDA can designate devices placed for shorter durations as implants for public health protection.
A loaned instrumentation policy should include procedures for timely requests, detailed inventory upon receipt, pre-use logging, obtaining manufacturer IFUs, weight limitations, decontamination and sterilization at the receiving facility, implant quarantine until negative BI results, transport, post-procedure return for reprocessing, and return to the lender.
Acceptable containers for contaminated items should be made of decontaminable material or designated for single use and incinerable or disposable. Environmental and hazardous waste policies should guide the selection of single-use containers.
Sterilization wrap selection should consider device size, shape, and weight, healthcare facility guidelines, and wrap manufacturer IFUs. Ensure wrap is free of defects, non-fast dyes, and minimizes fiber shedding.
The lot control identifier should include the sterilizer ID, a detailed contents list, assembler name, sterilization date, cycle number, and expiration date.
Three PCD types for non-implantable items include: a PCD with a BI, a PCD with a BI and a Type 5 integrating CI, and a PCD with a Type 5 integrating CI or a Type 6 emulating CI.
Essay Questions
Discuss the importance of routine sterilizer efficacy monitoring as outlined in AAMI ST79, including the types of tests, frequency, and acceptance criteria.
Explain the different types of chemical indicators (CIs) described in AAMI ST79, their applications, and their role in sterilization process monitoring.
Analyze the potential causes of steam sterilization process failures and describe the appropriate investigation steps to be taken when a failure is suspected.
Evaluate the advantages and disadvantages of using rigid sterilization container systems compared to other packaging methods.
Elaborate on the key elements of a quality process improvement program for sterile processing departments, as recommended by AAMI ST79.
Glossary of Key Terms
Term /Definition:
Biological Indicator (BI) / A test system containing viable microorganisms (typically bacterial spores) that exhibit a defined resistance to a specific sterilization process. Used to assess the efficacy of sterilization cycles.
Bowie-Dick Test / A diagnostic test for dynamic-air-removal steam sterilizers, assessing their ability to remove air from the chamber and prevent re-entrainment. Performed daily before the first processed load.
Chemical Indicator (CI) / A device used to monitor one or more sterilization process parameters. Changes color or physical state upon exposure to sterilizing conditions. Several types exist, each designed to react to specific parameters.
Dust Cover / A protective plastic bag used to shield sterile items from environmental contaminants like dust, moisture, and lint. Helps maintain sterility until the point of use. Also known as a sterility maintenance cover.
Gravity-Displacement Cycle / A steam sterilization cycle where incoming steam displaces residual air by gravity through a port or drain at the bottom of the sterilizer chamber.
Implant/Implantable Device / A device placed in a surgically or naturally formed body cavity, intended to remain there for 30 days or more. The FDA can designate devices placed for shorter durations as implants.
Immediate-Use Steam Sterilization (IUSS) / A steam sterilization cycle used to sterilize cleaned patient-care items that will be used immediately. Specific criteria and meticulous adherence to procedures are essential.
Loaned Instrumentation Policy / A set of procedures governing the request, receipt, handling, processing, and return of loaned instruments and implants. Addresses inventory, decontamination, sterilization, quarantine, and transport to ensure safety and prevent cross-contamination.
Process Challenge Device (PCD) / A device designed to challenge a sterilization process. Typically contains a biological indicator and may include a chemical indicator. Used to monitor sterilizer efficacy, qualify sterilizers, and provide additional assurance for routine load release.
Rigid Sterilization Container System / A sterilization containment device designed to hold medical devices for sterilization, storage, transportation, and aseptic presentation. Composed of a lid, base tray, and potentially filters and locking mechanisms.
Sterility Maintenance Cover / Same as Dust Cover.
Purchase your department copy of the ANSI/AAMI ST79:2021 guidelines here https://www.aami.org/standards/featured-standards/ansi-aami-st79.
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