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

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What is the primary purpose of the assembly area in the CSSD?

To inspect, assemble, and package surgical instruments

Who should carry out the job in the inspection, assembly, and packaging area?

Trained decontamination specialists and technicians

What is the primary purpose of maintaining a positive pressure in the IAP?

To reduce the risk of airborne bacteria introduction to the IAP

What is the required temperature range for the IAP?

20-23°C

What is the purpose of environmental cleaning in the IAP?

To follow policies and procedures approved by the hospital's infection control committee

What type of materials should furniture in the IAP be made of?

Smooth, non-porous materials

What is the required ventilation standard for the IAP?

ISO 14644-1: 1999 Class 8

What is the relative humidity range required for the IAP?

30-60%

Why is it recommended to inspect devices under magnification?

To detect small pieces of bioburden or debris

What should be checked in devices with hinges, such as artery forceps and clamps?

Ease of movement

What is the purpose of checking cannulated devices?

To ensure channel patency

Why is it essential to inspect devices with outer insulation coatings?

To ensure insulation remains intact

What is the recommended method for inspecting insulated devices?

Using a diathermy pin point tester

What is the purpose of function checking telescopes and light cables?

To follow manufacturer's instructions

What is the consequence of damaged surfaces on insulated devices?

Dirt and bacteria collection, and potential burn risk

What is the main purpose of checking the devices for free movement of all parts and non-sticking joints?

To ensure proper assembly

What is the recommended lubricant to use on devices if required?

Water-based lubricant

Why is it important to check the edges of clamping RMD for overlap?

To ensure proper assembly

What is the purpose of checking all screws on jointed RMD for tightness?

To prevent loose screws during cleaning

What is the purpose of the track and trace system in CSSD?

To track and trace devices and device trays

What is produced each time a new processing cycle begins in the track and trace system?

A new unique unit number

What is scanned by the specialist preparing the tray in the track and trace system?

The barcode label

What is used in CSSDs that do not have a computerized track and trace system?

A manual system

What is a potential consequence of introducing lint to the sterile field?

Increased risk of infection

Why is daily environmental cleaning essential in the hospital?

To prevent the spread of infection

What is the purpose of microbiological monitoring in the IAP room?

To serve as an early warning system for environmental quality

What is the significance of comparing testing results to baseline counts?

To determine if the environment is within accepted levels of contamination

Why is it essential to conduct part of the sampling program when the facility is unoccupied?

To establish a baseline contamination level prior to occupied sampling

What is the purpose of using contact or settle plates in microbiological monitoring?

To culture microorganisms for further analysis

What is the significance of having a dedicated cleaning room within the IAP room?

To ensure that only the IAP room is cleaned from this location

Who determines the accepted levels of contamination in the IAP room?

The microbiologist or a contracted specialist

What is the primary purpose of wearing shoes cover in the department?

To protect the shoes from contamination

What is the maximum temperature that can be reached inside the washer-disinfector chamber?

90°C

Why is it necessary to wear heat-resistant gloves when unloading the washer-disinfector?

To protect hands from hot water

What is the purpose of quality checks during the unloading process?

To verify the correct cycle and cleanliness of instruments

What should be done if the utensils show soil or staining during visual inspection?

Reject the utensils and send them back for reprocessing

What happens if the spray arms were blocked by RMD during the cycle?

The load is rejected and sent back for reprocessing

What should be done if a container cycle was inadvertently used for instruments?

Reject the instruments and send them back for reprocessing

Why should utensils like gallipots or kidney dishes be handled carefully during unloading?

They may have turned upside down during the washing process and contain hot water

What could be the cause of excessive wetness during the WD process?

Blocked arms or incorrect WD settings

What should be done if a device was not properly disassembled in the wash area?

Return the entire tray for reprocessing

What should be reported to the line manager in case of nonconformances?

Load contents, non-conformances and rejected loads

Why should the specialist document nonconformances?

To maintain quality control

What determines what happens to the load next after unloading?

Local policies and guidelines

What should be checked during the unloading process?

The chart record and recorded variables

What is the consequence of a blockage in the spray arm rotation?

The entire load must be reprocessed

Why is it necessary to document nonconformances and rejected loads?

To maintain quality control

Why is it necessary to make a visual inspection of the load after the washing cycle?

To inspect the load for dryness

What should be done if a small percentage of RMD in a load were not cleaned and/or dried effectively?

The entire load should be returned for reprocessing

What is the purpose of manually cleaning and inspecting devices that were not processed in a WD?

To check for any visible soil or staining

What should be reported immediately to the line manager?

Damage to items due to incorrect handling

Why is it necessary to document manually cleaned items and any nonconformances?

To track the quality of manually cleaned devices

What is the consequence of not properly disassembling devices?

Items may not be properly cleaned

What should be done if items were not processed in a WD?

They should be manually cleaned and disinfected

What is the purpose of checking items for excessive wetness?

To ensure items are dry before moving to the IAP room

What is the primary purpose of maintaining a controlled environment in the IAP?

To optimize the effect of the sterilization process

What is the primary consequence of introducing lint to the sterile field in the IAP room?

Infection to the patients' wounds

What is the significance of using smooth non-porous easy to clean materials for furniture in the IAP?

To minimize the risk of contamination of the RMD sets

What is the purpose of ventilation in the IAP?

To reduce the risk of airborne bacteria introduction to the IAP

Why is it essential to carry out environmental cleaning on a daily basis in the IAP room?

To reduce the risk of infection to patients' wounds

What is the primary purpose of microbiological monitoring in the IAP room?

To serve as an early warning system for environmental quality

What is the requirement for environmental cleaning in the IAP?

Follows policies and procedures approved by the hospital infection control committee

What is the significance of maintaining a positive pressure in the IAP?

To ensure that the air flows outward instead of into the work area

What is the significance of comparing testing results to baseline counts in microbiological monitoring?

To ensure that testing results are within acceptable limits

Why is it essential to conduct part of the sampling program when the facility is unoccupied?

To achieve a baseline contamination level prior to sampling when occupied

What is the requirement for the inspection area in the IAP?

Must be designated and controlled

What is the purpose of using contact or settle plates in microbiological monitoring?

To detect the presence of microbiological contaminants

What is the purpose of having a controlled temperature range in the IAP?

To provide a comfortable working environment for the staff

What is the requirement for the relative humidity range in the IAP?

Must be within the range of 30-60%

What is the significance of having a dedicated cleaning room within the IAP room?

To provide a separate area for cleaning and disinfection

Who determines the accepted levels of contamination in the IAP room?

The microbiologist or a contracted specialist

What is the primary consideration when arranging devices in a tray?

The order of requirement in a procedure

Why should forceps be placed on instrument pins?

To hold them together and reduce tangling

What should be done with devices that have ratchets after assembly?

Close them on the first ratchet to prevent accidental opening

Why is it important to follow the manufacturer's IFU for devices?

To ensure all surfaces are presented to the sterilant

What is the primary purpose of the checklist in a tray?

To ensure consistency and accuracy in device assembly

How should devices be arranged in a tray according to the surgeon's preference?

In a specific pattern to ensure easy access

Why should devices be arranged in a specific order in a tray?

To ensure they are used in the correct order during the procedure

What is the purpose of verifying the contents of a tray against the checklist?

To ensure all devices are present and accounted for

Study Notes

Inspection, Assembly, and Packaging (IAP)

  • IAP area is a clean area in CSSD where surgical instruments are inspected for intactness, cleanliness, and functionality.
  • The job in this area is critical as surgical instruments will be handled for the last time before being dispensed to OR rooms or clinics.
  • The area where inspection takes place is designated and controlled to optimize the effect of sterilization process and minimize the risk of contamination.

Environmental Requirements for IAP

  • Ventilation for 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 air flows outward instead of into the work area whenever the doors are opened.
  • All rooms in the department are ventilated and controlled to provide a comfortable working environment of 20-23°C and a relative humidity within the range 30-60%.
  • Environmental cleaning must follow policies and procedures approved by the hospital infection control committee.
  • Furniture in this area must be made of smooth, non-porous, easy-to-clean materials.

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 to detect small pieces of bioburden or debris.
  • Each RMD from a set should be inspected separately.
  • Critically inspect all areas of devices, including box joints, serrations, and crevices, for cleanliness.
  • Check hinges, jaws, and teeth for ease of movement and alignment.
  • Report any damaged, incomplete, or malfunctioning devices immediately to the supervisor.

Assembly and Checking

  • Once devices have been inspected and function-tested, they are ready to be assembled into their respective trays.
  • A track and trace system allows for accurate tracking of devices and device trays through the decontamination process.
  • The system consists of handheld barcode readers connected to PCs that log and store information for each tray.

Microbiological Monitoring

  • Microbiological monitoring is carried out in the IAP room according to hospital infection control policies.
  • Monitoring is used as an early warning system to alert staff when environmental quality is drifting out of control.
  • One method of monitoring involves placing contact or settle plates in pre-planned locations in the room and sending them to the lab for culturing and analysis.

Washer-Disinfector (WD) to Sterilizer

  • Quality checks are carried out when unloading the washer-disinfector, including correct cycle, spray arms not blocked, and no soil or staining.
  • Fine fibers that compose lint can be carried by air currents and settle on clean surgical instruments, causing infection to patients' wounds.

Manually Cleaned Device Acceptance

  • Quality checks must also be carried out when accepting items that were not processed in a WD, including soil or staining, excessive wetness, damage, and correctly disassembled devices.
  • Documentation must be completed for manually cleaned items, including non-conformances and rejected items.

Test your knowledge of the CSSD's critical inspection, assembly, and packaging area where surgical instruments are prepared for use in OR rooms and clinics. Learn about the importance of trained specialists and adherence to manufacturer's instructions.

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