MDRAO Introduction 2 — Questions and Answers
Question 1: Which federal agency in Canada is primarily responsible for regulating medical devices?
- Health Canada (Correct answer)
- Canadian Food Inspection Agency
- Public Health Agency of Canada
- Canadian Institute for Health Information
Correct answer: Health Canada
Health Canada regulates medical devices under the Medical Devices Regulations to ensure safety and effectiveness.
Question 2: What does the term 'reprocessing' refer to in the context of medical devices?
- The manufacturing of new devices
- The validated process of cleaning, disinfection, and/or sterilization of a used device for re-use (Correct answer)
- Disposing of single-use devices
- Packaging devices for first-time use
Correct 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.
Question 3: In the Spaulding Classification System, which category applies to items that contact only intact skin?
- Critical
- Semi-critical
- Non-critical (Correct answer)
- Sterile
Correct answer: Non-critical
Non-critical items contact only intact skin and require cleaning and low-level disinfection at minimum.
Question 4: What is the primary purpose of the MDRAO organization?
- To sell medical devices to Ontario hospitals
- To certify and support medical device reprocessing professionals in Ontario (Correct answer)
- To manufacture sterilization equipment
- To regulate pharmaceutical products in Ontario
Correct 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.
Question 5: Which document outlines the minimum standards for reprocessing of reusable medical devices in Ontario healthcare facilities?
- Ontario Hospital Association Manual
- CSA Z314 Standard (Correct answer)
- WHMIS Regulation
- Occupational Health and Safety Act
Correct answer: CSA Z314 Standard
CSA Z314 is the Canadian standard that outlines requirements for the reprocessing of reusable medical devices.
Question 6: What is the correct order of the reprocessing cycle for a reusable surgical instrument?
- Sterilize, clean, inspect, package
- Clean, inspect, package, sterilize (Correct answer)
- Inspect, clean, sterilize, package
- Package, sterilize, clean, inspect
Correct answer: Clean, inspect, package, sterilize
The correct reprocessing sequence is clean, inspect, package, then sterilize to ensure effective results.
Question 7: Which of the following best describes a 'critical' medical device according to the Spaulding Classification?
- A device that contacts only intact skin
- A device used only in administrative areas
- A device that enters sterile tissue or the vascular system (Correct answer)
- A device that contacts mucous membranes
Correct 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.
MDRAO Introduction 2
Which federal agency in Canada is primarily responsible for regulating medical devices?