Inspection, Assembly and Packaging (IAP) Zone After cleaning and disinfection, reusable medical devices are received in the Inspection, Assembly and Packaging zone to prepare for sterilization. Reusable medical devices are now safe for handling and extra care must be taken to ensure that they are not re-contaminated. Strict hand hygiene must be maintained and personal protective equipment must be used at all times.

1. ALL YOU NEED
TO KNOW ABOUT
CENTRAL
STERILE SUPPLY
DEPARTMENT

2. INSPECTION, ASSEMBLY
AND PACKAGING (IAP)
Presented by Talal Albudayri

3. Inspection, Assembly and Packaging (IAP)
Zone
After cleaning and disinfection, reusable
medical devices are received in the
Inspection, Assembly and Packaging zone
to prepare for sterilization. Reusable
medical devices are now safe for handling
and extra care must be taken to ensure
that they are not re-contaminated. Strict
hand hygiene must be maintained and
personal protective equipment must be
used at all times.

4. The IAP Room
The IAP room is usually the central point of CSSD and
where the crucial job of inspection, function testing
and appropriate maintenance of cleaned reusable
medical devices takes place.

5. Environmental Requirements for IAP
Temperature 21 to 24C
Humidity 30 to 60 %
Pressure positive ; 2,5 and above

6. Dress Code Requirement:

7. 1/A freshly laundered scrub suit Scrub suits are low-linting attire that minimize bacterial shedding
and provide comfort and a professional appearance. Freshly laundered attire is changed daily or
whenever it becomes visibly soiled or wet. Appropriate clothing is used by anyone entering this area,
including staff involved in the maintenance of reprocessing equipment, and visitors.
2/ Head/Hair Cover A clean, single-use, low lint surgical hat or hood that confines all hair is always
worn in IAP. The hat or hood must be designed so that microbial dispersal is minimized with all head
and facial hair confined as well as covered. After use, headgear and beard masks should be discarded
in the appropriate waste stream. Stud earrings may be worn as long as they are totally confined within
the head cover. Make-up and jewelry, apart from a wedding band, are not worn in the IAP.
3/ Shoes Dedicated sturdy shoes should be worn inside the IAP and never be used out-side. Those
shoes should be able to protect the feet from the items that may in an indeliberate manner fall from
work area. Shoes cover should be worn even if the shoes are dedicated to department use only to
protect shoes from contamination

8. Washer-Disinfector (WD) to Sterilizer :
we are now ready to unload the washer-disinfector containing clean,
disinfected surgical instruments and accessories.
Depending on your specific equipment this may be an automated process
using conveyor belt-type unloading mechanisms. If not automated, the
washer carriage can be manually removed from the chamber taking care to
wear heat-resistant gloves if necessary— remember the temperature in the
chamber can reach over 90c.
Be careful with utensils like gallipots or kidney dishes that may have turned
upside down during the washing process and contain hot water.

9. Correct cycle— for example, if a container cycle was inadvertently
used for instruments then the load should be rejected and sent back
for reprocessing.
Spray arms not blocked — If arms were blocked by RMD during cycle
the load must be rejected as correct cleaning and disinfection may
not have occurred.
When unloading, quality checks are carried out before
any further processing.
Quality checks consist of:

10. Soil or stain — any soil or staining seen on visual inspection is rejected and
items must be sent back for reprocessing.
Excessive wetness — excessive wetness could be caused by blocked arms,
incorrect loading or problems with the WD settings so should be investigated.
Damage due to configuration — for example if items were impacted by spray
arms or the the RMD was not compatible for WD processing.
Devices correctly disassembled — If items were not disassembled, adequate
cleaning would not have occurred so the full set should be returned for
reprocessing.

11. Completed documentation
load contents and any non-conformances and rejected loads must be
documented and reported to the line manager.
For example, you may notice a device that was not properly disassembled in
the wash area, so the entire tray must be considered contaminated and sent
back to the wash area via the transfer hatch or chamber.
A more serious issue may be where the specialist notices the spray arm
rotation has been hindered and therefore the whole load has been
compromised and must be returned for re-processing.
These non-conformances must be documented and reported to the line
manager immediately.

12. Local Policy Checks After Unloading (MUST BE DELETED DUE TO
REPETETION) What happens to the load next depends entirely
on local policies, procedures and guidelines.
These are some standard processes that should also take
place:

13. • Check that the chart record for the cycle conforms to the information established during
validation and that all recorded variables are within the parameters permitted.
• Check that the operating cycle selected is in accordance with the specification for the load
e.g. surgical instruments or anesthetic equipment would need different cycle types.
• Make a visual inspection of the load in order to ensure that there is no obvious damage,
staining or residue.
• If staining and/or residue are present, this may be due to the configuration of the load,
overloaded cart or malfunction in the washing cycle.
• Make a visual inspection of the load for dryness.
• Unless there is clear indication why a small percentage of RMD in a load were not cleaned
and/or dried effectively, the entire load should be returned for re-processing

14. Manually Cleaned Device Acceptance Quality checks must also be
carried out when accepting items that were not processed in a
WD.
These quality checks consist of:

15. Soil or staining— any visible soil or staining is rejected and items must be sent back for
reprocessing.
Excessive wetness— items that have been manually cleaned and disinfected must be dry
before moving to the IAP room.
Damage— if the item was handled incorrectly or immersed in fluid when it should not
have been it must be reported immediately to the line manager.
Correctly disassembled devices— if items were not disassembled, adequate cleaning
would not have occurred so the item is returned for reprocessing.
Documentation completed— manually cleaned items and any non-conformances and
rejected items must be documented and reported to the line manager.

16. Maryam: What should I do if a few items didn’t clean or dry effectively
but I can’t determine why?
Khaled: You should automatically reject the full cycle and return for
reprocessing as we don’t want to risk the safety of patients or our fellow
decontamination specialists when they handle them

17. 
Inspection and Function Testing
washer-disinfector must be inspected for
cleanliness, stains, corrosion, cracks,
Where possible, devices should be checked
under magnification because small pieces of
bioburden or debris can otherwise be
difficult to see.
All surgical devices unloaded from the
breakage, and stiffness of movable parts
before being placed in device sets.

18. Inspect each RMD from a set separately
closure and firm hold.
clamps) for ease of movement.
• Check jaws and teeth (such as found on
alignment.
• Critically inspect all areas of the devices
cleanliness.
• Check ratchets (Figure M6–10) for easy
e.g., box joints, serrations and crevices, for
• Check hinges (such as artery forceps and
Kocker-Mosquito forceps, Figure M6–9) for

19. • Reportany damaged, incomplete or
• Check cannulated devices to ensure channel is
patent (clear).
malfunctioning devices immediately to the
supervisor.

21. intact.
• Check insulated devices using a diathermy pin
bacteria to collect, and can also lead to a potential
• Function check telescopes and light cables as per
• Check each device set for completeness.
• Check cutting edges (such as scissors, rongeurs,
chisels, curettes) for sharpness, see device
sharpness testing, module 6.
• Devices that have an outer insulation coating, for
the manufacturer’s instructions.
point tester. Damaged surfaces allow dirt and
burn risk for the patient and/or the user.
example diathermy forceps , require close
inspection to ensure that the insulation remains

22. process.
• Check each device for free movement of all
part and non-sticking joints. A water-based
lubricant may be used if required (read IFU for
dilutions and application).
• Check that the edges of clamping RMD meet
with no overlap and that teeth mesh together
properly.
• Check all screws on jointed RMD for tightness
as they may become loose during the cleaning

23. 
Assembly and Checking
they are now ready to be assembled into their respective trays.
Once the devices have been inspected and function-tested

24. 
Many CSSDs today are switching to one
and trace systems on the market. These
modern CSSD. The system allows for the
device trays through the whole
decontamination process.
In the IAP room the track and trace
system usually consists of handheld barcode
readers connected to PC’s that log and store
the information for each tray .
of the many types of computerized track
systems are now accepted as one of the
most essential requirements in the
accurate tracking of the devices and

25. new unique unit number is produced
each and every time.
Once the barcode label is scanned by
the specialist preparing the tray it
and also generates a unique barcode
automatically produces a packing list
label which contains the serial number
specific to that tray and process.
Once a new processing cycle begins, a

26. For those CSSDs that do not
system may be used. This usually
consists of a pre-printed tray
checklist and a manual label gun
.
have such a computerized
system in place, a manual

27. There are some general rules when it comes to assembling
accordance to when they will be required in a procedure, for is
the first device on the left and the needle holders used to
close the wound are on the far right.
They can also be arranged by size so they don’t get tangled
or from Surgeon and OR Nurses preferences, but the most
specialists follow to ensure consistency.
checked and verified against it’s checklist.
together and reduce tangling. This can also be done using a
important aspect is to have an accurate checklist that all All
contents of a specific surgical instrument tray must be
Forceps should be placed on instrument pins to hold them
forceps but isn’t recommended.
devices into trays.
Most often items are arranged from left to right in
example, the scalpel handle used to make the initial incision

28. •Follow the manufacturer’s IFU for devices that should
Aim to leave all forceps with ratchets open but if
on the first ratchet only, to ensure that steam can
penetrate all surfaces.
place plastic items in the tray; avoid collecting them in
post-sterilization.
•Validated tip protectors (Figure M6–17) should be
M6–18) or silicone mats (Figure M6–19) may also be used
to protect delicate devices but placing them in a
devices, is also very important
•Spread devices evenly by weight over the tray surface to
help prevent condensate flowing together. Evenly
one area as this may also lead to moisture collection
be sterilized in a particular way or disassembled. This
ensures that all surfaces are presented to the sterilant.
stringers are not available close devices with ratchets
placed on delicate or sharp items. Tray liners (Figure
manner that protects them, especially away from heavy

29. •Any missing or extra devices found while assembling the tray should
be reported to the supervisorfor further action and a non-
an incorrect count may lead to long delays in the OR if an item is
conformance documented. This is an extremely important matter as
found to be missing before or after the case.

30. •Don’t create overcrowded or overweight trays as it leads to possible
trays is 25 pounds, this include the weight of the instruments and the
issues related to drying and sterility failure. in health care facility,
recommend that the maximum weight of surgical instrument sets
instruments containers .

31. •When processing metal basin, make sure you position them in a way
allows moisture to drain during sterilization. When steam touches
metal it cools down allowing water droplets to form. This can be
avoided by using wicking material such as surgical towels to facilitate
drainage and drying.

34. As a minimum, materials used must comply with EN ISO 11607-1 and EN ISO 11607-2, 2006
and EN 868 parts 2-10, inclusive. Regardless of the type of packaging chosen the main
requirements are that the packaging will:

35. Flat Wrapping Technique: Is made of nonwoven Spunbond-meltblown-spunbond (SMS) fabrics
and designed as single use product. They are available in a variety of sizes and weights.
1/ Sequential Wrapping Sequential wrapping refers to when two layers of wrap material are
wrapped individually using a fold technique. A single layer is folded completely and then
sequentially followed with a second sheet of wrap material and repeating the wrap sequence to
form a package within a package.
2/ Simultaneous Wrapping Simultaneous wrapping refers to when both layers of wrap material
are wrapped together simultaneously. Two single-layer wrappers or one bonded double-layer
wrapper can be used. Both methods are acceptable but sequential wrapping is the most
commonly used in CSSD.
Square Fold Technique The items to be wrapped are placed on the table parallel to the
wrapper. This method is generally preferred with heavier items.
Envelope Fold Technique The items to be wrapped are placed on the table in a diamond
shape to the wrapper. This method is frequently used for smaller items.
Both square and envelope fold techniques are used with the sequential and simultaneous
wrap method.

36. 2/ Containers Rigid reusable containers are making a comeback recently. Very
popular in the 70’s and 80’s they can be seen in many CSSDs today. The technology has
improved significantly and containers are far more user friendly and can be very
cost effective if used properly. As a barrier, rigid containers are almost
indestructible, providing sterility and customer reassurance if handled and
maintained as per the manufacturer’s instructions. Some things to consider when
using containers are that they are:
• 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 (Figure M6–27)
• Packed in a manner which allows for penetration of the sterilizing agent
• Able to remove contents without the risk of contamination of the contents

37. Rigid containers have filter and/or valve
systems that are secure and must be in proper
working order before sterilization.
Examine the filter plate for integrity both
before use and after the sterilization process.
If the filter is damaged or dislodged or has
holes, tears, or punctures, consider the
contents contaminated. Clean containers
between each use; preferably in an automated
process, and check the seal between the base
and the lid for possible damage.
Containers should be serviced regularly by
the manufacturer as per the IFUs.

38. 3/ Pouches and Reels There are a variety of packaging materials
available for individual surgical instruments, depending on the
item to be packaged.
Peel-apart pouches with a see-through front and paper backing
are often used for single devices or small loads. They come in reels
of various sizes where both ends need to be sealed or as single
form of various sizes for self-seal.
Sealing peel-apart pouches is essential to ensure that the product
remains sterile after autoclaving.
In self-sealing pouches, adhesive is 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. The see-through
peel packaging is a time-saving concept. It is fast and easy to pack
an item into a pouch and to close it with a heat sealer (Figure M6–
28) or self-seal. Recommended sealing temperatures and pressures
and other technical advice should be followed carefully. The
identification of packed device(s) is easy because of the
transparent plastic film.

39. Instruments should be packed inside the pouch with opened hinge to ensure complete
sterilant contact to surfaces of the surgical instruments. Leave about ¼’’ space on each side
of the package to facilitate air removal and sterilant penetration and avoid package
rupture during any of the sterilization phases. It’s important to remove excessive air from
the pouch before sealing since the trapped air interfere with proper sterilization. Pouch
labeling must be only on the plastic side using approved pen for the sterilization. It is
recommended to use tip protector to prevent instruments from puncturing the pouch during
sterilization or normal handling.
Double pouching is required for aseptic presentation of the items inside the sterile field. It
is created by placing an item inside a proper pouch then sealed. This pouch is then placed
inside another pouch that is slightly larger, then sealed. Avoid folding the inner pouch as it
affects air removal and sterilant penetration. Make sure to use a proper temperature when
sealing Tyvek or medical grade paper pouch.

40. Peel pouches are used to pack small lightweight single instruments.
They can be made of medical grad (kraft type) paper/plastic or
spunbond polyolefin- plastic (Tyvek pouch).
The choice of what type of pouch to use depends on the sterilization
method being used :
Paper pouches are used for Steam and Ethylene Oxide sterilization
methods while Tyvek pouches are used when sterilizing instruments by
hydrogen peroxide.
Peel pouches are available in rolls allowing the specialist to cut off
the desired length for each packed instrument. They are also available
in precut sizes.
Peel pouches can be heat sealed or contain self-adhesive seal that
does not require heat. The plastic side of the pouch allows for fast
and easy identification of the packed item.

42. Thank You
Presented by Talal Albudayri