CIS - Certified Instrument Specialist Regulatory Compliance and Standards Questions and Answers Flashcards
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What is the primary purpose of the IAHCSMM Certified Instrument Specialist (CIS) credential?
Answer: To validate specialized knowledge in the care and handling of surgical instruments
The CIS credential, offered by IAHCSMM, validates that a sterile processing professional has demonstrated specialized knowledge in surgical instrument care, handling, and reprocessing.
Which standard provides guidance for testing and performance requirements of rigid sterilization containers used to package surgical instruments?
Answer: ISO 11607
ISO 11607 establishes performance requirements and test methods for packaging systems, including rigid containers, intended to maintain sterility of medical devices.
Under AAMI ST79, what is required before a facility can routinely use a new sterilization cycle or a new type of packaging material?
Answer: Cycle development and validation testing to confirm efficacy
AAMI ST79 requires that any new sterilization cycle or packaging material undergo validation testing to confirm that the process achieves sterility assurance before routine use.
What is the role of the chemical indicator (CI) placed inside a sterilization package?
Answer: It indicates that sterilant has penetrated into the package interior during the cycle
Internal chemical indicators confirm that the sterilant (steam, EO gas, etc.) penetrated into the package interior, but they do not confirm biological kill or full sterility.
Which regulatory concept requires that all steps in the sterile processing workflow be documented to allow reconstruction of events following a patient infection?
Answer: Traceability
Traceability requires documentation of every step in the sterilization process so that events can be reconstructed and specific patients, instruments, and sterilization loads identified during infection investigations.
Under AAMI ST79, what corrective action is required when a biological indicator (BI) test result returns positive (growth) from a routine steam sterilization load?
Answer: Quarantine all items from that load, investigate the failure, and reprocess before release
A positive BI result indicates a potential sterilization failure; all items from the affected load must be immediately quarantined, retrieved if possible, and reprocessed while a thorough investigation is conducted.