CSSD Module 9: Inspection, Assembly, and Packaging

Assembly Area

• A clean area in CSSD where surgical instruments are inspected for intactness, cleanliness, and functionality before being dispensed to OR rooms or clinics.
• This job must be carried out by trained decontamination specialists and technicians, following manufacturer's IFU.

Environmental Requirements for IAP

• Ventilation meets clean room standards according to ISO 14644-1: 1999 Class 8 or other internationally accepted equivalent standard.
• The room must be maintained under positive pressure to ensure air flows outward instead of into the work area.
• Temperature: 20–23°C, relative humidity: 30–60%.
• Furniture must be made of smooth, non-porous, easy-to-clean materials.

Environmental Cleaning

• Must follow policies and procedures approved by the hospital's infection control committee.
• Cleaning must be carried out daily in accordance with hospital policies and procedures.
• A dedicated cleaning room is located within the IAP room.

Manually Cleaned Device Acceptance

• Quality checks are carried out when accepting items not processed in a WD.
• Checks include:
• Soil or staining: rejected and sent back for reprocessing.
• Excessive wetness: items must be dry before moving to the IAP room.
• Damage: reported immediately to the line manager.
• Correct disassembly: adequate cleaning may not have occurred, so the item is returned for reprocessing.
• Documentation: completed and reported to the line manager.

Inspection and Function Testing

• All surgical devices unloaded from the washer-disinfector must be inspected for:
• Cleanliness, stains, corrosion, cracks, breakage, and stiffness of movable parts.
• Devices checked under magnification to detect small pieces of bioburden or debris.
• Each RMD set inspected separately.
• Critically inspected areas: box joints, serrations, crevices, hinges, jaws, and teeth.
• Function testing: telescopes, light cables, and cannulated devices.

Assembly of Devices into Trays

• Items arranged from left to right in the order required in a procedure.
• Items can also be arranged by size to prevent tangling or according to surgeon and OR nurse preferences.
• Accurate checklist followed to ensure consistency.
• Forceps placed on instrument pins to hold them together and reduce tangling.

Packaging and Sealing

• Peel-apart pouches used to pack small, lightweight single instruments.
• Pouches made of medical-grade paper/plastic or spunbond polyolefin-plastic (Tyvek).
• Choice of pouch type depends on sterilization method.
• Identification of packed devices made easy due to transparent plastic film.
• Recommended sealing temperatures and pressures followed carefully.

Package Labeling

• Labeling necessary before sterilization.
• Complete and accurate labeling helps the end user select the correct pack.
• Label includes:
• Package contents
• Lot number
• Sterilization date
• Pack complete name
• Assembler/packager name
• Requesting department
• Sterilizer number and used cycle.