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

What is the primary purpose of inspecting instruments before assembly into sets?

Answer: To verify that instruments are clean, functional, and free of damage that could compromise sterilization or patient safety

Inspection ensures that each instrument is thoroughly clean (no residual soil), properly functioning (hinges, ratchets, cutting edges), and free of defects (cracks, pitting, corrosion) that could harbour microorganisms or fail during surgery.

What types of packaging materials are acceptable for steam sterilization according to CSA standards?

Answer: Validated packaging materials such as sterilization wrap (SMS or crepe), peel pouches, rigid containers, and sterilization paper that allow steam penetration and maintain sterility

Packaging for steam sterilization must allow steam penetration during the sterilization cycle and maintain a microbial barrier during storage. CSA Z314.8 specifies that only validated packaging materials designed for sterilization should be used.

What is the sequential wrapping technique and why is it recommended?

Answer: Using two layers of sterilization wrap applied in separate, sequential steps to provide a double barrier and facilitate aseptic presentation

Sequential double wrapping creates two independent microbial barriers. If the outer wrap is accidentally compromised during handling or storage, the inner wrap maintains sterility. It also facilitates aseptic opening in the sterile field.

What information must be included on the label of a sterilized package?

Answer: Contents description, sterilizer number, cycle/load number, date of sterilization, and expiry date or event-related statement

Comprehensive labelling ensures traceability from the sterilized package back to the specific sterilization cycle. This is essential for quality assurance, recall management, and regulatory compliance.

What is the maximum recommended weight for a wrapped instrument tray to be sterilized?

Answer: 25 pounds (11.4 kg) as recommended by CSA and AAMI standards to ensure adequate steam penetration

Heavy trays can impede steam penetration to the centre of the package, resulting in sterilization failure. The 25-pound limit ensures that steam can reach all instrument surfaces within the standard sterilization cycle parameters.

Why should instruments with ratchets be sterilized in the open (unlocked) position?

Answer: To allow steam to contact all surfaces including the concealed areas under the ratchet and within the box lock

When ratchets are closed, the overlapping metal surfaces prevent steam from reaching the concealed areas beneath the ratchet and inside the box lock. Opening them ensures complete steam contact with all instrument surfaces for effective sterilization.