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

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

Answer: Noncritical

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

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

Answer: Critical

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

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

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.

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

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.

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

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.

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

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.