Standards and Guidelines Flashcards
6 cards from real IAHCSMM practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 Standards and Guidelines flashcards as text
AAMI TIR34 primarily addresses reprocessing standards for:
Answer: Water quality for reprocessing medical devices in healthcare facilities
AAMI TIR34 provides guidance on water quality for the reprocessing of medical devices, addressing the impact of water purity on cleaning and sterilization efficacy.
ISO 11135 is an international standard that specifically covers:
Answer: Sterilization of health care products using ethylene oxide (EO)
ISO 11135 covers requirements for the development, validation, and routine control of ethylene oxide (EO) sterilization processes for medical devices.
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?
Answer: Biological indicators (BIs)
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.
The CDC Guideline for Disinfection and Sterilization in Healthcare Facilities is best described as:
Answer: An evidence-based guideline providing recommendations for disinfection and sterilization practices
The CDC Guideline is an evidence-based document providing recommendations for disinfection and sterilization practices, widely referenced by healthcare facilities and accrediting bodies.
When a manufacturer IFU conflicts with a general AAMI standard, which should take precedence for reprocessing a specific device?
Answer: The manufacturer IFU takes precedence for the specific device, as it reflects validated reprocessing for that device
The manufacturer IFU takes precedence for reprocessing a specific device because it reflects testing and validation performed on that specific instrument design.
OSHA Bloodborne Pathogen Standard (29 CFR 1910.1030) applies to CS workers primarily because:
Answer: CS decontamination staff have occupational exposure to blood and potentially infectious materials on used instruments
CS decontamination workers have occupational exposure to blood and potentially infectious materials on used surgical and procedural instruments, making them subject to OSHA Bloodborne Pathogen Standard.