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

Assembly Area and Environmental Requirements

• Assembly area is a clean area in the CSSD where surgical instruments are inspected for intactness, cleanliness, and functionality.
• The area must be designated and controlled to optimize the effect of the sterilization process and minimize the risk of contamination of the RMD sets.
• Ventilation in the inspection, assembly, and packing room 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 that the air flows outward instead of into the work area.
• The room must be maintained at a comfortable working temperature of 20–23°C and a relative humidity within the range 30–60%.
• All furniture in the area 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.

Rigid Containers

• Rigid containers are almost indestructible, providing sterility and customer reassurance if handled and maintained according to the manufacturer's instructions.
• Containers must be:
  • Easily disassembled for cleaning, drying, and storage
  • Suitable for the method of sterilization being used
  • Compatible with the cleaning method and cleaning agent being used
  • Suitable for the storage configuration
  • Lockable, tamperproof, and non-resealable
  • Packed in a manner that allows for penetration of the sterilizing agent
• Containers have filter and/or valve systems that are secure and must be in proper working order before sterilization.
• Filter plates must be examined for integrity before and after the sterilization process.

Disadvantages of Using Rigid Containers

• Create ergonomics challenge to those who lift them due to heaviness
• Require additional space to store them as they are larger than wrapped trays
• Longer cycle time may be required to avoid issues associated with excessively wet packs
• Entail extra effort since the containers must be cleaned between uses
• Potential risk of filter dislodge leading to instruments contamination

Packaging Materials

• Peel-apart pouches with a see-through front and paper backing are often used for single devices or small loads.
• Pouches come in reels of various sizes where both ends need to be sealed or as single forms of various sizes for self-seal.
• Peal pouches are used to pack small lightweight single instruments.

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 before being placed in device sets.
• Devices should be checked under magnification because small pieces of bioburden or debris can otherwise be difficult to see.
• Each RMD from a set should be inspected separately.
• Critically inspect all areas of the devices, including box joints, serrations, and crevices, for cleanliness.

Packing and Sealing

• Peal pouches are used to pack small lightweight single instruments.
• Sealing peel-apart pouches is essential to ensure that the product remains sterile after autoclaving.
• Self-sealing pouches have an adhesive manufactured into the open end of the bag or plain top and either a heat sealing machine or autoclave tape is then required to create a seal.
• Recommended sealing temperatures and pressures, and other technical advice should be followed carefully.
• Identification of packed devices is easy because of the transparent plastic film.