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

What is the purpose of a Medical Device Reporting (MDR) under FDA regulations?

Answer: To notify the FDA when a device may have caused or contributed to serious injury, illness, or death

MDRs are mandatory reports to the FDA when a device malfunction, serious injury, or death occurs that is associated with a medical device.

Which document must a sterile processing department maintain to demonstrate that a sterilizer has been properly validated for a specific load configuration?

Answer: Load qualification or validation records

Load qualification/validation records document that a sterilization process has been tested and confirmed to achieve sterility for specific device types and load configurations.

In the U.S., which standard provides guidance on the validation and routine control of moist heat (steam) sterilization for healthcare facilities?

Answer: ANSI/AAMI ST79

ANSI/AAMI ST79 is the comprehensive U.S. guideline for steam sterilization and sterility assurance in healthcare facilities.

Which FDA database allows sterile processing professionals to search for recalls, safety alerts, and cleared devices?

Answer: MAUDE (Manufacturer and User Facility Device Experience)

The FDA's MAUDE database contains reports of adverse events involving medical devices and is a key resource for patient safety research.

What does 'lot traceability' require in sterile processing?

Answer: Linking processed items to specific patients, loads, and cycle parameters so events can be traced if a recall or failure occurs

Lot traceability requires that processed items can be linked back to specific sterilization runs and patients, enabling effective recalls and investigations.

A newly purchased robotic surgical instrument arrives at the sterile processing department. What is the first step before reprocessing it?

Answer: Obtain and review the manufacturer's IFUs to determine the validated reprocessing method

Before reprocessing any device, the technician must obtain and follow the manufacturer's validated IFUs to ensure safe and effective reprocessing.