CMDRT - Certified Medical Device Reprocessing Technician Quality Systems and Documentation Questions and Answers 2

Question 1

What is the purpose of a quality management system (QMS) in medical device reprocessing?

Accepted Answer

To provide a systematic framework for ensuring that reprocessing consistently meets defined standards, identifies and corrects problems, and continuously improves processes

Answer

To increase the speed of reprocessing

Answer

To manage employee payroll

Answer

To reduce chemical costs

Question 2

What types of records must be maintained for steam sterilization cycles?

Accepted Answer

Complete cycle records including mechanical printouts (time, temperature, pressure), chemical indicator results, biological indicator results, load contents, and operator identification

Answer

Only a log of how many cycles were run

Answer

Only biological indicator results

Answer

No records are required if the sterilizer is new

Question 3

What is a standard operating procedure (SOP) and why is it critical in reprocessing?

Accepted Answer

A detailed, written document that describes the step-by-step process for performing a specific task, ensuring consistency and compliance regardless of which staff member performs the work

Answer

A suggestion for how work might be done

Answer

A training manual read only once during orientation

Answer

A list of equipment in the department

Question 4

What is a recall process in medical device reprocessing, and when is it initiated?

Accepted Answer

A systematic process for retrieving and reprocessing devices when a sterilization failure or reprocessing breach is identified, to prevent potentially non-sterile items from being used on patients

Answer

A process for recalling employees from vacation

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A process for returning defective instruments to the manufacturer

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A recall only applies to pharmaceutical products

Question 5

What is the purpose of conducting routine audits in the reprocessing department?

Accepted Answer

To systematically evaluate compliance with standards, identify improvement opportunities, verify that SOPs are being followed, and ensure patient safety

Answer

To find reasons to discipline staff

Answer

Audits are only required for accreditation

Answer

To reduce department costs

Question 6

How should manufacturer's instructions for use (IFU) be managed in the reprocessing department?

Accepted Answer

Current IFU for every reusable device and chemical product must be accessible in the department, and reprocessing procedures must comply with them

Answer

IFU can be discarded after the first read

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Only IFU for sterilizers are needed

Answer

IFU are only relevant for new equipment