MDRAO Introduction 2

Question 1

Which federal agency in Canada is primarily responsible for regulating medical devices?

Accepted Answer

Health Canada

Answer

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?

Accepted Answer

The validated process of cleaning, disinfection, and/or sterilization of a used device for re-use

Answer

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?

Accepted Answer

Non-critical

Answer

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?

Accepted Answer

To certify and support medical device reprocessing professionals in Ontario

Answer

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?

Accepted Answer

CSA Z314 Standard

Answer

CSA Z314 is the Canadian standard that outlines requirements for the reprocessing of reusable medical devices.

MDRAO - Medical Device Reprocessing Association of Ontario Practice Test

MDRAO - Medical Device Reprocessing Association of Ontario Practice Test

MDRAO Introduction 2