CMDRT CMDRT - Certified Medical Device Reprocessing Technician Medical Device Classification and Regulation Questions and Answers 2

Question 1

Which Spaulding classification applies to items that contact only intact skin and require low-level disinfection at minimum?

Accepted Answer

Noncritical

Answer

Noncritical items contact intact skin and require low-level disinfection to remove most pathogens but are not required to be sterile.

Question 2

According to the Spaulding classification, which category requires sterilization because items enter sterile tissue or the vascular system?

Accepted Answer

Critical

Answer

Critical items, such as surgical instruments, penetrate sterile tissue or the vascular system and must be sterilized to prevent infection.

Question 3

IFU stands for 'Instructions for Use.' Why are IFUs critically important in sterile processing?

Accepted Answer

They provide manufacturer-validated reprocessing steps that must be followed to ensure safety and effectiveness

Answer

IFUs contain manufacturer-validated reprocessing instructions that must be followed to maintain device safety, efficacy, and regulatory compliance.

Question 4

What is the primary purpose of a medical device's 'unique device identifier' (UDI)?

Accepted Answer

To enable adequate identification and traceability of devices throughout their distribution and use

Answer

The FDA's UDI system enables standardized identification and traceability of medical devices through the supply chain and in patient records.

Question 5

Which type of regulatory standard is AAMI/ISO 17664 relevant to in sterile processing?

Accepted Answer

Information to be provided by the medical device manufacturer for the processing of medical devices

Answer

AAMI/ISO 17664 specifies the information that device manufacturers must provide to enable healthcare workers to safely reprocess medical devices.

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