CIS CIS - Certified Instrument Specialist Regulatory Compliance and Standards Questions and Answers 3

Question 1

What is the primary purpose of the IAHCSMM Certified Instrument Specialist (CIS) credential?

Accepted Answer

To validate specialized knowledge in the care and handling of surgical instruments

Answer

The CIS credential, offered by IAHCSMM, validates that a sterile processing professional has demonstrated specialized knowledge in surgical instrument care, handling, and reprocessing.

Question 2

Which standard provides guidance for testing and performance requirements of rigid sterilization containers used to package surgical instruments?

Accepted Answer

ISO 11607

Answer

ISO 11607 establishes performance requirements and test methods for packaging systems, including rigid containers, intended to maintain sterility of medical devices.

Question 3

Under AAMI ST79, what is required before a facility can routinely use a new sterilization cycle or a new type of packaging material?

Accepted Answer

Cycle development and validation testing to confirm efficacy

Answer

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.

Question 4

What is the role of the chemical indicator (CI) placed inside a sterilization package?

Accepted Answer

It indicates that sterilant has penetrated into the package interior during the cycle

Answer

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.

Question 5

Which regulatory concept requires that all steps in the sterile processing workflow be documented to allow reconstruction of events following a patient infection?

Accepted Answer

Traceability

Answer

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.

CIS - Certified Instrument Specialist Practice Test

CIS - Certified Instrument Specialist Practice Test

CIS CIS - Certified Instrument Specialist Regulatory Compliance and Standards Questions and Answers 3