Cleaning and Sterilization of Instruments and Supplies
Instruments are cleaned as soon as possible after use
in an enzyme solution so that organic
material will not dry and cling to the object. Organic
materials interfere with the sterilization or disinfecting
process and must be completely removed before sterilization
procedures are initiated.
The following is based on Federal Drug Administration
guidelines, Center for Disease Control and The Association of
Peri-operating Room Nurses guidelines.
Factors, which interfere with sterilization and disinfecting,
1. Organic material, such as mucus, blood, pus, feces, and
saliva on uncleaned instruments
2. Microbial contamination and the nature and number of
3. Incorrect dilution (improper mixing) of disinfectant
4. Inadequate exposure (contact) time between instruments
and the sterilant/disinfectant
5. Excessive dilution of the sterilant/disinfectant,
usually from the addition of wet instruments. Use a
solution test strip according to the manufacturer's
6. Loss of sterilant/disinfectant strength due to expired
7. Inadequate penetration of the sterilant/disinfectant
into the instrument, such as into endoscope channels
8. Incorrect pH or temperature of the disinfectant
9. Water hardness
10. Incompatible detergents
11. Presence of materials such as rubber and plastic
After a pre-soak in an enzyme detergent, instruments should
then be cleaned manually with detergent and water according to the manufacturer's
Enzymatic detergent preparations are recommended for a
pre-soak because they contain various proteinase and
propylene glycol additives that enhance the cleaning
procedure in the pre-soak phase.
CLASS OF INSTRUMENTS
1. Critical instruments, scissors, implants or any
instrument which enters sterile areas of the body or
vascular system should have instrument cleaning
followed by sterilization
2. Semi-critical instruments, endoscopes, endotracheal tubes or instruments which come in contact
with intact mucous membranes or non-intact skin should have instrument cleaning followed by steam sterilization
or high level disinfecting. Endotracheal tubes, if used, are disposed of after use.
3. Non-critical instruments, stethoscopes, ear syringe
tips, tabletops or instruments which come in contact
with intact skin should have instrument cleaning
followed by low level disinfecting
The nature of the procedures performed at our organization precludes the use of sterile processing. However, the elements of sterilization are included. Staff are not trained in sterile processing.
1. Steam sterilization shall be conducted in accordance
with the manufacturer's directions.
2. The efficiency of the sterilization process shall be
monitored by all of the following methods:
A. Sterilizer tape used in securing wrappings on
the packs is an indicator of exposure to the
B. Chemical indicators placed in the center of each
pack indicates that the necessary conditions for
sterilization to occur have been reached in that
portion of the pack/package.
C. Biological monitor (spore testing; e.g. Attest, or
an out-sourced system) shall be run, at least, weekly
for the detection of heat resistant spores. A
record of these tests will be kept near the
3. Any one of the above indicators may be used to denote
failure of proper completion of the sterilization
process; all loads affected by the failure will be
considered non-sterile and will not be used until re-
processed. The equipment will be repaired and re-
4. Preparing articles for sterilization:
A. Instruments and other items for sterilization must
be decontaminated and cleaned prior to being laid
out for inclusion in the packs.
B. Articles to be steam sterilized must be double-
wrapped or in a peel-pack. Steam sensitive tape is
used to secure each package to be sterilized; a
steam indicator is placed inside each package at the
thickest portion of the pack.
C. Packs should be securely packaged but the contents
must not be crowded in the package.
D. The size of each package must be appropriate to the
E. Layers should be cross-hatched to minimize bulk in
F. Rubber tubing should be carefully placed so that no
kinks are allowed to form.
G. All locking instruments must be left UNLOCKED for
H. Articles must be clean and free of grease.
I. Steam must have direct contact with all surfaces of
If any question exists as to how to sterilize an item,
the manufacturer of the autoclave or of the item in
question should be consulted.
5. Wrapping packages for sterilization:
A. All items are to be double wrapped; wrapping
material should be clean and free of holes.
B. Articles must be completely covered with the corners
of wrapper turned in.
C. Packages should be loosely packaged and securely
wrapped before closing with steam sensitive autoclave
D. Peel pack must be large enough to hold the item
while allowing for sealing.
E. All packs and pouches must contain an internal
6. High Level Decontamination Chemical sterilization:
High-level chemical disinfectants kill most microbes
except bacterial spores. If the contact time is long
enough, glutaraldehyde, a powerful disinfectant can
achieve complete sterilization (usually 24 hours).
Such disinfectants are call 'sterilants' and are
approved by the FDA. Cold sterilization performed at
this facility for suture removal instruments only.
Some examples of high-level disinfectants are:
Glutaraldehyde, Cidex OPA, Sodium hypochlorite (bleach)
Gluteraldehyde (2%) requires substantial ventilation.
Gluteraldehyde can be used to disinfect/cold sterilize a wide
variety of medical instruments that cannot be subjected to
heat. Gluteraldehyde must be prepared and used according to
manufacturer's instructions. Thorough rinsing of instruments
with clean water is imperative to remove potential toxicity
of Gluteraldehyde residue.
1. Is toxic, irritating to skin, eyes and nasal passages,
and can cause breathing problems. Employees may be
exposed to elevated Gluteraldehyde vapor levels if
equipment is soaked in rooms with inadequate
ventilation, when spills occur, or where there is an
open immersion bath. Therefore monitoring badges must be
worn periodically; see policy MC.11 in the Infection
2. Staff must wear protective clothing, gloves, and eye
protection when handling.
3. Activated Gluteraldehyde is unstable and germicidal
potency tends to decrease after storage and use.
Manufacture's expiration date should be followed after
activation and the solution must be kept in a covered
container, and concentrations need to be monitored;
utilizing a dip stick and documenting results of
4. The placement of a cautionary sign warning pregnant
women; placed in the area where this product is used is
Intermediate-level disinfectants do not kill large numbers of
bacterial spores, but can kill most of the surface organisms
in an exam room. A 1:100 (1 teaspoon of bleach in 2 cups of
water) bleach solution or a brand such as Cavicide, germicidal wipes
Envirocide, Madacide can be used to kill surface germs.
Equipment that does not touch mucous membranes and only
touches intact skin, e.g., stethoscopes, blood pressure cuffs.
A. Articles approved for high level disenfecting must
be chemically disinfected by glutaraldehyde (e.g.,
Cidex) after having been cleaned,
inspected and dried before immersion; time of
soaking is per manufacturer's directions (at least,
20 minutes at room temperature).
B. The cycle of chemical disinfectants shall be changed
per manufacturer's directions.
7. Flash Sterilization:
Flash sterilization should be used when there is an
immediate need for an instrument item or instrument set.
Flash sterilization shall be restricted to unplanned or
emergency situations. Flash sterilization shall never
be used as a convenience to compensate for inadequate
inventories of instruments or implantables. Flash
sterilization of implantables shall be restricted to
only the most dire circumstances.
A. Flash sterilization is used only according to the
standards of the equipment manufacturer.Flash
sterilization is used only according to the
standards of the equipment manufacturer. (usually 3
minutes at 270 degrees F at 27 to 28 lbs. of
B. The surgeon is aware of the use of the flash
C. Items which are to be flash sterilized shall be
cleaned and decontaminated before the sterilization
D. All items to be flashed whether in a closed
container or on a perforated tray must have an
indicator placed in the container or on the tray.
E. There will be a log kept of items that are flash
sterilized in relation to date, time, instrument,
patient and case.
The circulating personnel may remove small items and single
instruments from the sterilizer with care to prevent
Large instrument trays require the individual to reach over
the tray which would preclude the circulating personnel from
this task. Also to avoid back injury, the tray needs to be
carried close to the body. Since circulating personnel are
not in a sterile gown and gloves this action would
contaminate the instruments.
Therefore the scrub person must remove the larger trays from
the sterilizer. The following should be noted:
A. The scrub person should avoid leaving the sterile
field when the procedure is in progress, attention
should be on the field and assisting with the
B. The circulating personnel should accompany the scrub
person to the sterilizer to help monitor possible
contamination to the scrub person.
C. The scrub person should avoid accidental contact
with the doorways, edges of the sterilizer doors,
and other equipment.
D. Traffic in the area leading to the sterilizer and
back to the OR should be restricted to the scrub and
circulating personnel during the retrieval process.
When the circulator accomplishes the retrieval, the following
should be noted:
i. Avoid reaching over the top of the item while
pulling the tray out of the sterilizer
ii. Do not allow the bottom of the perforated tray to
come in contact with the un-sterile tray.
iii. Traffic in the area leading to the sterilizer and
back to the OR should be restricted to the
circulating personnel during the retrieval
1. Always check expired dates of sterile supplies.
2. Rotate supplies as they are stocked.
3. All sterile supplies must be inspected for damaged
packaging before opening onto sterile field.
The person responsible for the processing of instruments can
and should become certified. Please see The CBSPD
Certification Program – located in the Web Resource Link of
the Forms Repository.
For further information please see the CDC Guideline for
Disinfection and Sterilization in Healthcare Facilities. A
link to this document is located in the Forms Repository, Web
Resource Link Section.
Approved By Governing Board