Introduction Flashcards
7 cards from real MDRAO practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Introduction flashcards as text
Which federal agency in Canada is primarily responsible for regulating medical devices?
Answer: Health Canada
Health Canada regulates medical devices under the Medical Devices Regulations to ensure safety and effectiveness.
What does the term 'reprocessing' refer to in the context of medical devices?
Answer: The validated process of cleaning, disinfection, and/or sterilization of a used device for re-use
Reprocessing is the validated process that renders a used medical device safe for its intended use through cleaning, disinfection, and/or sterilization.
In the Spaulding Classification System, which category applies to items that contact only intact skin?
Answer: Non-critical
Non-critical items contact only intact skin and require cleaning and low-level disinfection at minimum.
What is the primary purpose of the MDRAO organization?
Answer: To certify and support medical device reprocessing professionals in Ontario
MDRAO supports the professional development and certification of medical device reprocessing personnel in Ontario.
Which document outlines the minimum standards for reprocessing of reusable medical devices in Ontario healthcare facilities?
Answer: CSA Z314 Standard
CSA Z314 is the Canadian standard that outlines requirements for the reprocessing of reusable medical devices.
What is the correct order of the reprocessing cycle for a reusable surgical instrument?
Answer: Clean, inspect, package, sterilize
The correct reprocessing sequence is clean, inspect, package, then sterilize to ensure effective results.
Which of the following best describes a 'critical' medical device according to the Spaulding Classification?
Answer: A device that enters sterile tissue or the vascular system
Critical items enter sterile body cavities or the vascular system and must be sterile before use.