CMDRT - Certified Medical Device Reprocessing Technician Quality Systems and Documentation Questions and Answers

Question 1

A key component of a quality management system (QMS) in a Medical Device Reprocessing Department (MDRD) is the ability to link a specific reprocessed device to a patient.
What is this documented process called?

Accepted Answer

Traceability

Answer

Sterilization log

Answer

Quality audit

Answer

Inventory management

Question 2

During a routine audit of steam sterilization records, a quality assurance manager notices that a technician's initials are consistently missing from the load documentation. According to quality system principles, what is the most appropriate first step to address this non-conformance?

Accepted Answer

Document the finding and discuss the importance of complete records with the technician.

Answer

Immediately suspend the technician from sterilization duties.

Answer

Discard all loads processed by the technician that day.

Answer

Report the issue to the hospital's risk management department.

Question 3

Which of the following documents provides the most detailed, step-by-step instructions for MDRTs to perform a specific task, such as operating the ultrasonic cleaner?

Accepted Answer

A Standard Operating Procedure (SOP)

Answer

The department's quality manual

Answer

The hospital's infection control policy

Answer

The equipment's purchase order

Question 4

A Medical Device Reprocessing Department is preparing for an external audit by an accreditation body. The auditor will most likely want to review which of the following records to verify the effectiveness of the sterilization process?

Accepted Answer

Equipment maintenance logs and sterilization cycle printouts

Answer

Staff vacation schedules

Answer

Purchase orders for new surgical instruments

Answer

Minutes from the last departmental staff meeting

Question 5

A new type of rigid container system is purchased. According to the CSA Z314-18 standard, what must be documented before this container is put into routine use?

Accepted Answer

Validation and verification of the manufacturer's instructions for use (IFU) within the facility's equipment.

Answer

The cost of the container system compared to the old one.

Answer

The date it was received from the vendor.

Answer

Staff preference survey results for the new container.

Question 6

If a technician discovers that a chemical indicator from a processed load shows a failure, but the load has already been sent to the sterile storage area, what does the quality system require them to do immediately?

Accepted Answer

Initiate a recall of the entire sterilization load.

Answer

Wait until the next shift to see if anyone else notices.

Answer

Document the failure in their personal notes for future reference.

Answer

Reprocess the next load using a longer cycle time.