IAHCSMM Standards and Guidelines 2

Question 1

AAMI TIR34 primarily addresses reprocessing standards for:

Accepted Answer

Water quality for reprocessing medical devices in healthcare facilities

Answer

AAMI TIR34 provides guidance on water quality for the reprocessing of medical devices, addressing the impact of water purity on cleaning and sterilization efficacy.

Question 2

ISO 11135 is an international standard that specifically covers:

Accepted Answer

Sterilization of health care products using ethylene oxide (EO)

Answer

ISO 11135 covers requirements for the development, validation, and routine control of ethylene oxide (EO) sterilization processes for medical devices.

Question 3

According to ANSI/AAMI ST79, which type of sterilization monitoring provides the most direct measure of a sterilization process ability to kill the most resistant microorganisms?

Accepted Answer

Biological indicators (BIs)

Answer

Biological indicators directly challenge the sterilization process with a known population of highly resistant bacterial spores (Geobacillus stearothermophilus for steam), providing the most direct evidence of sterilization efficacy.

Question 4

The CDC Guideline for Disinfection and Sterilization in Healthcare Facilities is best described as:

Accepted Answer

An evidence-based guideline providing recommendations for disinfection and sterilization practices

Answer

The CDC Guideline is an evidence-based document providing recommendations for disinfection and sterilization practices, widely referenced by healthcare facilities and accrediting bodies.

Question 5

When a manufacturer IFU conflicts with a general AAMI standard, which should take precedence for reprocessing a specific device?

Accepted Answer

The manufacturer IFU takes precedence for the specific device, as it reflects validated reprocessing for that device

Answer

The manufacturer IFU takes precedence for reprocessing a specific device because it reflects testing and validation performed on that specific instrument design.

(IAHCSMM) International Association of Healthcare Central Service Material Manage Practice Test

(IAHCSMM) International Association of Healthcare Central Service Material Manage Practice Test

IAHCSMM Standards and Guidelines 2