- Certified Medical Device Reprocessing Technician Instrument Assembly and Packaging Questions and Answers Flashcards

What is event-related sterility, and how does it differ from time-related sterility?

Answer: Event-related sterility means a package remains sterile until an event compromises the barrier (such as damage or moisture), while time-related sterility assigns a fixed expiry date regardless of conditions

Event-related sterility recognizes that a properly stored, undamaged package maintains sterility indefinitely. The sterility is compromised by events (tears, moisture, handling damage) rather than the passage of time alone.

What is a chemical indicator (CI) and what types are placed inside sterilization packages?

Answer: A device that uses chemical reactions to indicate exposure to one or more sterilization parameters such as temperature, time, and steam presence

Chemical indicators change colour or appearance when exposed to specific sterilization conditions. Internal CIs placed inside packages verify that the sterilant penetrated the packaging and reached the instruments.

What precautions should be taken when packaging sharp instruments for sterilization?

Answer: Sharp tips and cutting edges should be protected with tip protectors or guards to prevent puncture of the packaging and injury during handling

Unprotected sharp instruments can puncture sterilization wrap or peel pouches, compromising the sterile barrier. Tip protectors also prevent injury to staff handling the packages and protect the instrument's cutting edge.

What is the correct procedure for sealing peel pouches for sterilization?

Answer: Seal using the heat sealer at the validated temperature with an adequate seal width, ensuring no channels or wrinkles in the seal

Heat sealing creates a continuous, airtight seal that maintains the sterile barrier. Staples, clips, and non-sterilization tape create holes or inadequate seals that allow microbial ingress. The seal must be wrinkle-free to prevent channels.

How should heavy instruments be positioned in a sterilization tray during assembly?

Answer: Placed on the bottom of the tray with lighter instruments on top to prevent damage and ensure even weight distribution

Placing heavy instruments on the bottom prevents them from crushing lighter, more delicate instruments. Even weight distribution also ensures stable stacking in the sterilizer and proper steam circulation throughout the tray.

What should a reprocessing technician do if an instrument set is missing a component during assembly?

Answer: Document the missing item, attempt to locate a replacement, and if unavailable, communicate the shortage to the OR team before the set is needed

Missing instruments can impact surgical procedures. Documenting the shortage, seeking a replacement, and communicating with the surgical team ensures they can prepare alternatives or adjust their approach before the procedure begins.