CSSD Module 9: Inspection, Assembly, and Packaging (IAP)

Study Notes

The IAP area is a clean area in the CSSD where surgical instruments are inspected for intactness, cleanliness, and functionality.
Trained decontamination specialists and technicians handle the instruments in this area according to the manufacturer's IFU.
The area is designated and controlled to optimize sterilization and minimize contamination risk.

Ventilation meets clean room standards according to ISO 14644-1:1999 Class 8 or equivalent international standards.
The room is maintained under positive pressure to ensure air flows outward when doors are opened.
The environment is kept at 20-23°C with a relative humidity of 30-60%.
Environmental cleaning follows approved hospital policies and procedures.
Furniture is made of smooth, non-porous, easy-to-clean materials.
Shoes must be worn with protective covers to prevent contamination.

Clean, disinfected surgical instruments and accessories are unloaded from the washer-disinfector.
Automated or manual unloading processes are used, depending on the equipment.
Quality checks are performed before further processing, including:
- Correct cycle selection
- Spray arms not blocked
- No soil or staining
- Correct operating cycle
- Visual inspection for damage, staining, or residue
- Visual inspection for dryness

Surgical devices are inspected for cleanliness, stains, corrosion, cracks, breakage, and stiffness of movable parts.
Devices are inspected under magnification where possible.
Each RMD is inspected separately, including:
- Box joints, serrations, and crevices
- Hinges and movable parts
- Jaws and teeth alignment
- Ratchets and easy closure
- Cannulated devices for patent channels
- Function testing of telescopes and light cables
- Completeness of device sets
- Cutting edges for sharpness
- Insulated devices for intact insulation
- Free movement of all parts and non-sticking joints
- Water-based lubricant use (if required)

Devices are assembled into their respective trays after inspection and function testing.
Computerized track and trace systems are used to track devices and device trays through the decontamination process.
The system includes handheld barcode readers, PCs, and packing lists with unique barcode labels.
A manual system may be used in the absence of a computerized system.