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

Critical

Answer

Semi-critical

Answer

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

Noncritical

Answer

Semi-critical

Answer

Environmental

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

They list the purchase price of the device

Answer

They describe how to market the device to clinicians

Answer

They are optional guidelines that can be replaced by facility protocols

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

To track reimbursement billing codes

Answer

To indicate the sterilization method required

Answer

To certify that a device has passed quality inspection

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

Packaging material strength testing

Answer

Environmental air quality in sterile processing departments

Answer

Biological indicator performance requirements

Question 6

A loaner instrument set arrives without accompanying IFUs. What is the most appropriate action for the sterile processing technician?

Accepted Answer

Return the set without processing until IFUs are provided

Answer

Process it using standard protocols since all instruments are similar

Answer

Ask a surgeon how they want it processed

Answer

Use the IFUs from a similar set in the department