Quality Assurance Flashcards
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Read the first 7 Quality Assurance flashcards as text
Which action should be taken first when a sterilizer load fails a biological indicator (BI) test?
Answer: Quarantine all items from that load and investigate the cause
When a BI fails, all items from that load must be recalled or quarantined immediately, and an investigation into the root cause must be initiated before any items are used.
What does 'D-value' mean in the context of sterilization quality assurance?
Answer: The time or dose required to reduce the microbial population by 90% (1 log)
The D-value (decimal reduction value) is the time or radiation dose required to reduce the number of microorganisms by 90%, or one logarithmic unit.
Which sterilization quality record must be retained to allow for instrument tracking in the event of a recall?
Answer: Load content records linking items to a specific sterilization cycle
Load content records that link specific instruments or implants to a sterilization cycle number are essential for effective traceability and recall management.
How often should mechanical/physical parameters (time, temperature, pressure) of a sterilizer be reviewed for each cycle?
Answer: For every sterilization cycle run
Mechanical monitoring of sterilizer parameters must be reviewed for every cycle to ensure the equipment is functioning within acceptable ranges before items are released.
What is the significance of the '12D concept' in sterilization?
Answer: Sterilization must achieve 12 log reductions of Clostridium botulinum spores
The 12D concept, originating from food canning, requires achieving a 12-log reduction of the most resistant organism (Clostridium botulinum) to ensure safety.
A package is found wet after a steam sterilization cycle. What quality concern does this represent?
Answer: Wet packs may compromise sterility and are considered non-sterile
Wet packs are considered a sterilization failure because moisture can wick microorganisms through packaging material, compromising the sterile barrier.
Which sterilization method is most commonly validated using Bacillus atrophaeus (formerly B. subtilis) spore strips as biological indicators?
Answer: Ethylene oxide (EtO) sterilization
Bacillus atrophaeus spores are the standard biological indicator for ethylene oxide sterilization due to their high resistance to EtO.