CMDRT CMDRT - Certified Medical Device Reprocessing Technician Medical Device Classification and Regulation Questions and Answers 2 — Questions and Answers
Question 1: Which Spaulding classification applies to items that contact only intact skin and require low-level disinfection at minimum?
- Critical
- Semi-critical
- Noncritical (Correct answer)
- Sterile
Correct answer: Noncritical
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?
- Noncritical
- Semi-critical
- Critical (Correct answer)
- Environmental
Correct answer: Critical
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?
- They list the purchase price of the device
- They provide manufacturer-validated reprocessing steps that must be followed to ensure safety and effectiveness (Correct answer)
- They describe how to market the device to clinicians
- They are optional guidelines that can be replaced by facility protocols
Correct answer: They provide manufacturer-validated reprocessing steps that must be followed to ensure safety and effectiveness
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)?
- To track reimbursement billing codes
- To enable adequate identification and traceability of devices throughout their distribution and use (Correct answer)
- To indicate the sterilization method required
- To certify that a device has passed quality inspection
Correct answer: To enable adequate identification and traceability of devices throughout their distribution and use
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?
- Packaging material strength testing
- Information to be provided by the medical device manufacturer for the processing of medical devices (Correct answer)
- Environmental air quality in sterile processing departments
- Biological indicator performance requirements
Correct answer: Information to be provided by the medical device manufacturer for the processing of medical devices
AAMI/ISO 17664 specifies the information that device manufacturers must provide to enable healthcare workers to safely reprocess medical devices.
Question 6: A loaner instrument set arrives without accompanying IFUs. What is the most appropriate action for the sterile processing technician?
- Process it using standard protocols since all instruments are similar
- Return the set without processing until IFUs are provided (Correct answer)
- Ask a surgeon how they want it processed
- Use the IFUs from a similar set in the department
Correct answer: Return the set without processing until IFUs are provided
Without validated IFUs, the technician cannot confirm the correct reprocessing method; the set must not be processed until proper documentation is obtained.
CMDRT CMDRT - Certified Medical Device Reprocessing Technician Medical Device Classification and Regulation Questions and Answers 2
Which Spaulding classification applies to items that contact only intact skin and require low-level disinfection at minimum?