- Certified Medical Device Reprocessing Technician High-Level Disinfection Questions and Answers Flashcards

What ventilation requirements exist for areas where high-level disinfectants are used?

Answer: Adequate ventilation including local exhaust ventilation to keep chemical vapour exposure below occupational exposure limits

High-level disinfectants like glutaraldehyde and OPA produce vapours that can cause respiratory sensitization and irritation. Engineering controls including local exhaust ventilation are required to maintain air concentrations below Canadian OELs.

What is the Spaulding classification of a laryngoscope blade, and what minimum reprocessing level does it require?

Answer: Semi-critical — requires at minimum high-level disinfection

Laryngoscope blades contact mucous membranes of the oropharynx and are therefore classified as semi-critical devices. They require at minimum high-level disinfection, though many Canadian facilities have moved to using sterilizable or single-use blades.

What are the occupational health risks associated with glutaraldehyde exposure during high-level disinfection?

Answer: Respiratory sensitization, skin dermatitis, eye irritation, and asthma-like symptoms

Glutaraldehyde is a known respiratory sensitizer and skin sensitizer. Repeated or acute exposure can cause occupational asthma, allergic contact dermatitis, eye irritation, headaches, and nose/throat irritation. Proper PPE and ventilation are essential.

A device labelled as 'single-use' by the manufacturer is being considered for reprocessing. What is the Canadian regulatory position?

Answer: Reprocessing of single-use devices is regulated by Health Canada and requires a licensed reprocessor to validate safety and effectiveness

In Canada, reprocessing of single-use devices (SUDs) is permitted only through licensed third-party reprocessors who must demonstrate that the reprocessed device meets the same safety and performance standards as the original. Individual facilities cannot reprocess SUDs independently.

What is the purpose of rinsing devices thoroughly after high-level disinfection?

Answer: To remove residual disinfectant that could cause tissue irritation or toxicity in patients

Residual high-level disinfectant on a medical device can cause chemical burns, irritation, or toxic reactions when the device contacts patient tissue. Thorough rinsing with appropriate quality water removes all chemical residue.

Which microorganisms are used as benchmark test organisms to validate the efficacy of high-level disinfection?

Answer: Mycobacterium species (such as M. terrae or M. bovis) because of their high resistance to chemical disinfectants

Mycobacteria are among the most resistant vegetative organisms to chemical disinfection. If an HLD agent can kill mycobacteria within the specified parameters, it is expected to be effective against less resistant organisms like bacteria, viruses, and fungi.