Quality Assurance Flashcards
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Read the first 7 Quality Assurance flashcards as text
Which document provides written evidence that a sterilization process has been validated to consistently produce a sterile product?
Answer: Process qualification report
A process qualification report provides written evidence that the sterilization cycle consistently delivers the required lethality and produces sterile products.
A sterility assurance level (SAL) of 10⁻⁶ means there is no more than a 1 in how many chance that a single item remains non-sterile after processing?
Answer: 1,000,000
SAL 10⁻⁶ means there is a 1 in 1,000,000 (one in a million) probability that a viable microorganism is present on a processed item.
Which type of sterilization monitoring detects the presence of living spores after a sterilization cycle?
Answer: Biological indicator monitoring
Biological indicator monitoring uses highly resistant bacterial spores (e.g., Geobacillus stearothermophilus) to directly challenge and confirm sterilization efficacy.
In quality management, what does the term 'corrective action' refer to?
Answer: Steps taken to eliminate the cause of a detected nonconformity
Corrective action involves identifying the root cause of a detected nonconformity and implementing steps to prevent its recurrence.
Which organization publishes the ANSI/AAMI standards most commonly referenced for sterilization quality assurance in U.S. healthcare facilities?
Answer: AAMI
AAMI (Association for the Advancement of Medical Instrumentation) publishes ANSI/AAMI standards such as ST79, which govern steam sterilization and sterility assurance.
A Class 5 integrating indicator is designed to react to all critical parameters of sterilization. How does it differ from a Class 6 emulating indicator?
Answer: Class 5 reacts to all critical variables; Class 6 is calibrated to specific cycle parameters
Class 5 integrating indicators react to all critical sterilization variables across a range, while Class 6 emulating indicators are calibrated to specified values of a particular sterilization cycle.
What is the primary purpose of conducting a Bowie-Dick test in prevacuum steam sterilizers?
Answer: To test air removal and steam penetration in the chamber
The Bowie-Dick test is performed daily in prevacuum sterilizers to verify that air is adequately removed and steam can fully penetrate porous loads.