CL 7261 Cleaning Disinfection and Sterilization

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POLICY/PROCEDURE

CLEANING, DISINFECTION AND ORIGINAL DATE: VERSION:


TITLE:
STERILIZATION September 2004 2.0
IDENTIFICATION LAST REVISION NEXT REVIEW
NUMBER: CL 7261 DATE: DATE:
January 2019 January 2022
Sheet no. 1 of 20 Tracking History:
HOSPITAL(S) ALL HMC HOSPITALS / ENTITIES
sheet no. 20

1.0 POLICY STATEMENT AND PURPOSE:

1.1 This policy is formulated for all Hamad Medical Corporation staff on the process of
cleaning, disinfection and sterilization.

2.0 DEFINITIONS:

2.1 Cleaning - The removal of visible dust, soil, or any other foreign material.

2.2 Sanitizing - The reduction of microbial population in an inanimate object to a safe or


relatively safe level.

2.3 Decontamination - The process of removing disease-producing microorganisms


and rendering the objects safe for handling.

2.4 Disinfection - The process that kills or destroys nearly all disease-producing
microorganisms, with the exception of bacterial spores.

2.5 High-Level Disinfection – The process which uses a chemical or physical method
(Ultraviolet Disinfection) that kills vegetative bacteria, tubercle bacilli, fungi, lipid and
non-lipid viruses. This process does not necessarily kill high number of bacterial
spores:

2.5.1 Intermediate-Level Disinfection – The process that inactivates vegetative


bacteria, most fungi, mycobacteria, tubercle bacilli and most viruses
(particularly the enveloped viruses), but not bacterial spores.

2.5.2 Low-Level Disinfection – The process that kills most vegetative bacteria,
some fungi, some viruses. This process cannot be relied on to kill resistant
microorganisms such as mycobacterium or bacterial spores.

2.6 Sterilization - A process by which all forms of microbial life including bacteria,
spores, viruses and fungi are destroyed.

Prevention & Control of Infections (PCI) Regulatory, Accreditation & Compliance Services (RACS)
POLICY/PROCEDURE

CLEANING, DISINFECTION AND ORIGINAL DATE: VERSION:


TITLE:
STERILIZATION September 2004 2.0
IDENTIFICATION LAST REVISION NEXT REVIEW
NUMBER: CL 7261 DATE: DATE:
January 2019 January 2022
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2.7 Equipment Classification - Instruments and equipments employed for patient care
are divided into three general categories. This classification is based on the degree
of risk of infection involved with their use:

2.7.1 Critical Items - The devices that come into contact with a sterile human
tissue or the vascular system. These items require a high level of
sterilization.

2.7.2 Semi-Critical Items - The devices that come into contact with a non-intact
skin or mucous membranes, but ordinarily do not penetrate them. These
items require a high level of disinfection.

2.7.3 Non-Critical Items - The devices that come into contact with intact skin.
These items need to remain clean.

2.7.4 Flexible endoscope: An optic instrument that transmits light and carries
images back to the observer through flexible transparent fibers, and used to
inspect and treat interior portions of the body. Endoscopic devices includes,
but not limited, to the following:

2.7.4.1 Bronchoscopes
2.7.4.2 Gastrointestinal endoscopes
2.7.4.3 Nasolaryngoscopes
2.7.4.4 Cystoscopes and ureteroscopes
2.7.4.5 Cardiovascular Scope
2.7.4.6 Virginal scope
2.7.4.7 Ophthalmic endoscope

2.7.5 Vaginal Probes/Endocavitary Ultrasound Probes/Transducers are used


in sonographic scanning. A vaginal probe and all endocavitary probes are
semi critical devices because they have direct contact with mucous
membranes and should receive high level disinfection to destroy all
microorganisms with the exception of bacterial spores.

2.7.6 Probe Covers are barriers used to cover the transducer which are no
lubricated, no medicated and non-latex containing barriers (e.g. condoms).

Prevention & Control of Infections (PCI) Regulatory, Accreditation & Compliance Services (RACS)
POLICY/PROCEDURE

CLEANING, DISINFECTION AND ORIGINAL DATE: VERSION:


TITLE:
STERILIZATION September 2004 2.0
IDENTIFICATION LAST REVISION NEXT REVIEW
NUMBER: CL 7261 DATE: DATE:
January 2019 January 2022
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3.0 PROCEDURE / PROCESS:

3.1 General principles:

3.1.1 Hamad Medical Corporation shall provide general guidance on the approved
cleaning and disinfection products and methods for healthcare equipment
and environment, and outline cleaning responsibilities throughout the
Hamad Medical Corporation to allow Staff to correctly use the appropriate
product and cleaning and/or disinfection method.

3.1.2 Hamad Medical Corporation provides equipments, chemicals, and other


facilities needed for cleaning, disinfection and sterilization of medical
equipment.

3.1.3 The Central Sterile Supply Department of Hamad Medical Corporation shall:

3.1.3.1 Inspect and monitor on-site and off-site cleaning processes,


disinfection, and sterilization.
3.1.3.2 Participate in the evaluation and selection of appropriate
cleaning agents, disinfectants, equipment, and instruments
3.1.3.3 Educate the Staff responsible for receiving (at Reception of
CSSD), cleaning, disinfection, and sterilization, on-site and off-
site facility.

3.1.4 The Equipment used throughout the Hamad Medical Corporation shall be
decontaminated appropriately to ensure the minimization of cross infection.

3.1.5 The Clinical Environment shall be maintained safe and clean for delivering
patient care and services.

3.1.6 All Department Staff shall follow the appropriate cleaning processes for
Patient Care Supplies such as sorting, soaking, washing, rinsing, drying, or
draining.

3.1.7 The decision on equipment cleaning, disinfection, and/or sterilization shall


be based on the intended use of the equipment and not on the patient’s
diagnosis.

Prevention & Control of Infections (PCI) Regulatory, Accreditation & Compliance Services (RACS)
POLICY/PROCEDURE

CLEANING, DISINFECTION AND ORIGINAL DATE: VERSION:


TITLE:
STERILIZATION September 2004 2.0
IDENTIFICATION LAST REVISION NEXT REVIEW
NUMBER: CL 7261 DATE: DATE:
January 2019 January 2022
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3.1.8 The manufacturer’s information for all medical equipment/devices and


decontamination equipment shall be received and maintained.

3.1.9 The manufacturer’s recommendations for chemical disinfectants shall be


followed.

3.1.10 All reusable medical equipment/devices shall be reprocessed using


procedures that are effective against all human pathogens, including blood
borne pathogens.

3.1.11 Special procedures, including labelling, for specific microorganisms (e.g.,


MRSA, VRE) are not required. The exception is equipment/devices
potentially exposed to CJD (Refer to policy CL 7250, Management of
Patient with Suspected Prion Diseases).

3.1.12 Reusable medical equipment/devices shall be thoroughly cleaned before


disinfection or sterilization.

3.1.12.1 Vaginal probe and all endocavitary probes shall be thoroughly


cleaned before disinfection or sterilization even though they are
covered with a sterile sheath during procedure.

3.1.13 Environmental Requirements for Reprocessing Areas (refer to policy CL


7243, Infection Control for the Engineering and Bioengineering Department).

3.1.13.1 The environment where cleaning/decontamination is performed


shall:

3.1.13.1.1 Have adequate space for the cleaning process and


storage of necessary equipment and supplies

3.1.13.1.2 Be distinctly separate from areas where clean/


disinfected/ sterile equipment/devices are handled or
stored

3.1.13.1.3 Have easy access to hand hygiene facilities

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POLICY/PROCEDURE

CLEANING, DISINFECTION AND ORIGINAL DATE: VERSION:


TITLE:
STERILIZATION September 2004 2.0
IDENTIFICATION LAST REVISION NEXT REVIEW
NUMBER: CL 7261 DATE: DATE:
January 2019 January 2022
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3.1.13.1.4 Have surfaces that can be easily cleaned and


disinfected

3.1.13.1.5 Have slip-proof flooring that can withstand wet


mopping and hospital-grade cleaning and disinfecting
products

3.1.13.1.6 Have environmental controls in accordance with


requirements for reprocessing areas (e.g.,
temperature, ventilation, humidity)

3.1.13.1.7 Have restricted access from other areas in the setting


and ensure one-way movement by staff

3.1.13.2 Decontamination sinks:

3.1.13.2.1 Shall be designed and arranged to facilitate soaking,


washing and rinsing of equipment/devices with
minimal movement or delay between steps

3.1.13.2.2 Shall be adjacent to waterproof counter tops and a


backsplash

3.1.13.2.3 Shall not have an overflow

3.1.13.2.4 Shall be at a height that allows workers to use them


without bending or straining

3.1.13.2.5 Shall be large enough to accommodate trays or


baskets of instruments

3.1.13.2.6 Shall be deep enough to allow complete immersion


of larger devices and instruments so that aerosols
are not generated during cleaning

3.1.13.2.7 Shall be equipped with water ports for the flushing of


instruments with lumens, if appropriate

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POLICY/PROCEDURE

CLEANING, DISINFECTION AND ORIGINAL DATE: VERSION:


TITLE:
STERILIZATION September 2004 2.0
IDENTIFICATION LAST REVISION NEXT REVIEW
NUMBER: CL 7261 DATE: DATE:
January 2019 January 2022
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3.1.14 Eating/drinking, storage of food, smoking and application of cosmetics or lip


balm and handling contact lenses in the reprocessing area shall not be
permitted.

3.1.15 Personal belonging including foods or drinks shall not be allowed to store in
reprocessing area.

3.1.16 PERSONAL PROTECTIVE EQUIPMENT (PPE):

3.1.16.1 Staff involved in reprocessing shall be trained in the correct use


of PPE.

3.1.16.2 PPE shall include gloves appropriate to the task (e.g. Heavy
duty gloves), face protection (i.e., full face shield or fluid-
impervious face mask and protective eyewear) and
impermeable gown or waterproof apron.

3.1.16.3 When choosing gloves, the following points shall be


considered:

3.1.16.3.1 Gloves shall be long enough to cover wrists and


forearms.
3.1.16.3.2 Gloves shall be of sufficient weight to be highly tear
resistant.
3.1.16.3.3 Gloves shall be allowed adequate dexterity of the
fingers.

3.1.16.4 PPE shall be removed on completion of the task or before


leaving the reprocessing area.

3.1.16.5 Staff shall be trained in management of a blood or body fluid


spill.

3.1.16.6 Where there is the risk of exposure to biological and/or chemical


agents, eye wash stations shall be provided and staff shall be
trained in their use.

Prevention & Control of Infections (PCI) Regulatory, Accreditation & Compliance Services (RACS)
POLICY/PROCEDURE

CLEANING, DISINFECTION AND ORIGINAL DATE: VERSION:


TITLE:
STERILIZATION September 2004 2.0
IDENTIFICATION LAST REVISION NEXT REVIEW
NUMBER: CL 7261 DATE: DATE:
January 2019 January 2022
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3.1.17 Transportation and Handling of Contaminated Medical


Equipment/Devices:

3.1.17.1 If cleaning cannot be done immediately, gross soiling (blood,


tissue, and other residue) from items and devices shall be
removed prior to returning them for reprocessing (disinfection or
sterilization).

3.1.17.2 Appropriate Personal Protective Equipment shall be done while


removing gross soiling.

3.1.17.3 Ensure all used instruments are treated with enzymatic spray or
immersed (Presoaked) in the hospital approved enzymatic
solution prior to being transported to CSSD to prevent drying of
blood and tissue.

3.1.17.4 Heavily soiled instrument with feces, sputum, blood, or other


material such as surgical instruments shall be soaked in a
hospital approved enzymatic solution prior to being transported
to CSSD. These Instruments shall be kept wet in the transport
container by covering with towel soaked with enzymatic solution
or enzymatic spray.

3.1.17.5 The type of container used for transportation of soiled medical


equipment/devices shall depend on the items to be transported.
Types of recommended containers include :

3.1.17.5.1 Closed carts, bins with lids, rigid sterilization container


systems and impermeable bags that can be used in
combination.

3.1.17.5.2 The containers shall be leak-proof and puncture-proof


with a lid to prevent the spill of liquids, with easily
cleanable surfaces shall be used for handling and
transporting.

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POLICY/PROCEDURE

CLEANING, DISINFECTION AND ORIGINAL DATE: VERSION:


TITLE:
STERILIZATION September 2004 2.0
IDENTIFICATION LAST REVISION NEXT REVIEW
NUMBER: CL 7261 DATE: DATE:
January 2019 January 2022
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3.1.17.6 Soiled equipment/devices shall be transported by direct routes,


that avoid high-traffic, clean/sterile storage and patient care
areas, to areas where cleaning shall be done.

3.1.17.7 Containers or carts used to transport soiled medical equipment/


devices shall be cleaned after each use.

3.1.17.7.1 The external surfaces of bins with lids, closed carts and
other containers shall be decontaminated after each
use with a hospital approved intermediate-level
disinfectant.

3.1.17.7.2 The containers shall be thoroughly wiped down


externally and internally.

3.1.17.7.3 The use of a cart wash system shall recommend for


decontaminating closed carts.

3.1.17.7.4 Additionally, routine cleaning of the case cart wheels


shall be performed to remove string and other debris to
maintain the easy movement of the wheels.

3.1.17.8 Disposable sharps shall be disposed of in an appropriate


puncture-resistant sharps container at point-of use, prior to
transportation.

3.1.18 Selection of Product and Level for Reprocessing:

3.1.18.1 The reprocessing level and products required for medical


equipment/devices shall be depended on the intended use of
the equipment/device and the potential risk of infection involved
in the use of the equipment/device.

3.1.18.2 Reprocessing Level:

3.1.18.2.1 All Patient Care Equipment shall be categorized into


three (3) categories (Critical, Semi-Critical, and

Prevention & Control of Infections (PCI) Regulatory, Accreditation & Compliance Services (RACS)
POLICY/PROCEDURE

CLEANING, DISINFECTION AND ORIGINAL DATE: VERSION:


TITLE:
STERILIZATION September 2004 2.0
IDENTIFICATION LAST REVISION NEXT REVIEW
NUMBER: CL 7261 DATE: DATE:
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Non-Critical items) based on the potential risk of


infection involved in their use. (Refer to Table.1)

3.1.18.3 Table-1Spaulding's Classification of Medical Equipment/


Devices and Required Level of Processing/Reprocessing:
CLASSIFICATI ON DEFINITION LEVEL OF EXAMPLES
PROCESSING
/REPROCESSING
Critical Equipment/de Cleaning followed by - Surgical
Equipment/ vice that Sterilization instruments
Device enters sterile -Implants
tissues, - Biopsy
including the instruments - Foot
vascular care equipment
system •-Eye and dental
equipment
Semi critical Equipment/de Cleaning followed by -Respiratory
Equipment/ Device vice that High Level therapy equipment
comes in Disinfection OR -Anesthesia
contact with ULTRAVIOLET equipment
non-intact skin DISINFECTION) (as a -Tonometer
or minimum)
mucous Sterilization is
membranes preferred
but does not
penetrate
them
Noncritical Equipment/de Cleaning followed by -ECG machines
Equipment/ vice that Low- Level -Oximeters
Device touches Disinfection (in some -Bedpans, urinals,
only intact cases,
skin and not cleaning alone is
mucous acceptable)
membranes,
or does not
directly
touch the
client/patient/r
esident

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POLICY/PROCEDURE

CLEANING, DISINFECTION AND ORIGINAL DATE: VERSION:


TITLE:
STERILIZATION September 2004 2.0
IDENTIFICATION LAST REVISION NEXT REVIEW
NUMBER: CL 7261 DATE: DATE:
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3.1.18.4 Reprocessing of Non-critical medical equipment:

3.1.18.4.1 Non-critical medical equipment shall be disinfected


between patient and when visibly soiled

3.1.18.4.2 A hospital-approved disinfectant shall be used (e.g.


Alcohol wipes ,non-alcohol wipes or sodium
hypochlorite)

3.1.18.4.3 Appropriate cleaning/disinfection method shall be


practiced, that is cleaning from less to more soiled
and changing cleaning wipes between patient
equipment

3.1.18.4.4 To identify cleaned non–critical patient care


equipment, the equipment shall be covered with clear
plastic bag and shall be placed clean tag

3.1.18.4.5 The clear plastic bag and clean tag shall be removed
just prior to use of the equipment and discarded in to
waste bin

3.1.18.5 Reprocessing Product and Equipment:

3.1.18.5.1 Products used for any/all stages in reprocessing (i.e.,


cleaning, disinfection, sterilization) shall be:

3.1.18.5.1.1 Appropriate to the level of


reprocessing that is required for the
use of the medical equipment /device

3.1.18.5.1.2 Approved by the infection control


product evaluation team responsible
for product selection and an individual
with reprocessing expertise

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POLICY/PROCEDURE

CLEANING, DISINFECTION AND ORIGINAL DATE: VERSION:


TITLE:
STERILIZATION September 2004 2.0
IDENTIFICATION LAST REVISION NEXT REVIEW
NUMBER: CL 7261 DATE: DATE:
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3.1.18.5.2 The process and products used for cleaning,


disinfection and/or sterilization of medical
equipment/devices shall be compatible with the
equipment/devices:

3.1.18.5.2.1 The compatibility of the


equipment/device to be reprocessed
with detergents, cleaning agents and
disinfection/sterilization processes is
determined by the manufacturer of the
equipment/device.

3.1.18.5.2.2 The manufacturer shall be provided


written information regarding the safe
and appropriate reprocessing of the
medical equipment/device.

3.1.18.6 Duration and temperature of exposure to the product:

3.1.18.6.1 Use manufacturer's recommendations for


temperature and exposure time required to achieve
the desired level of disinfection/sterilization.

3.1.18.6.2 Do not exceed the manufacturer's maximum


exposure time, as some chemicals may cause
damage to the medical equipment/device if used for
extended periods of time.

3.1.18.6.3 Consult with an infection prevention and control


professional where the manufacturer’s
recommendations for minimum exposure time conflict
with those of Spaulding’s criteria for the intended use.

3.1.18.6.4 Ensure that all surfaces of the article are in direct


contact with the disinfectant/sterilant.

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CLEANING, DISINFECTION AND ORIGINAL DATE: VERSION:


TITLE:
STERILIZATION September 2004 2.0
IDENTIFICATION LAST REVISION NEXT REVIEW
NUMBER: CL 7261 DATE: DATE:
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3.1.18.6.5 Contact time shall be compromised by the complexity


of the article and the ability of the disinfectant to
penetrate lumens and other areas that are difficult to
reach.

3.1.18.7 High–level disinfection products and equipment:

3.1.18.7.1 High-level disinfectants shall include, hydrogen


peroxide, peracetic acid (ANIOXIDE1000 ) and
0.55% ortho-phthalaldehyde (OPA) (e.g. CIDEX
OPA)

3.1.18.7.2 Ultraviolet Disinfection (ANTIGERMIX S1 ,


ANTIGERMIX E1)

3.1.18.7.3 Guidelines for using these product (Refer to


Appendix-3)

3.1.18.7.4 Liquid Chemical Disinfection:

3.1.18.7.4.1 The process of high-level disinfection


shall be monitored and audited

3.1.18.7.4.2 Chemical test strips shall be used to


determine whether an effective
concentration of active ingredients is
present, despite repeated use and
dilution

3.1.18.7.4.3 The frequency of testing shall be


based on how frequently the solutions
are used (i.e., test daily if used daily);
at a minimum, test according to
manufacturer’s instruction

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CLEANING, DISINFECTION AND ORIGINAL DATE: VERSION:


TITLE:
STERILIZATION September 2004 2.0
IDENTIFICATION LAST REVISION NEXT REVIEW
NUMBER: CL 7261 DATE: DATE:
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3.1.18.7.4.4 Chemical test strips shall be checked


each time a new package/bottle is
opened to verify they are accurate,
using positive (e.g., full strength
disinfectant solution) and negative
(e.g., tap water) controls; see
manufacturer’s recommendations for
appropriate controls

3.1.18.7.4.5 Test strips shall not be considered a


way of extending the use of a
disinfectant solution beyond the
expiration date

3.1.18.7.4.6 A record shall be maintained and this


record shall include, but not be limited
to:

3.1.18.7.4.6.1 The identification of


the equipment/device
to be disinfected

3.1.18.7.4.6.2 Date and time of the


clinical procedure

3.1.18.7.4.6.3 Concentration and


contact time of the
disinfectant used in
each process

3.1.18.7.4.6.4 Results of each


inspection (and, for
endoscopes, each
leak test)

3.1.18.7.4.6.5 Result of each testing


of the disinfectant

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TITLE:
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NUMBER: CL 7261 DATE: DATE:
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3.1.18.7.4.6.6 The name of the


person completing the
reprocessing.

3.1.18.7.4.7 Disinfection practices shall be audited


on a regular basis

3.1.18.7.4.8 Prepared solutions shall not be topped


up with fresh solution

3.1.18.7.4.9 If manual disinfection is performed, the


container used for disinfection shall be
kept covered during use and washed,
rinsed and dried when the solution is
changed

3.1.18.7.4.10 The equipment or instrument shall be


subjected to adequate cleaning with
detergent and water treatment prior to
chemical sterilization, following proper
guidelines as to organic load, contact
time, temperature, and ph.

3.1.18.7.4.11 After chemical high-level disinfection,


rinse endoscopes and flush channels
with sterile water

3.1.18.7.4.12 After chemical sterilization, the


endocavitary probes shall be rinsed
with tap water

3.1.18.7.4.13 After rinsing, the equipment or


instrument shall be dried by a method
that does not re-contaminate the item
(e.g., filtered hot air)

3.1.18.7.5 The processes of High level disinfection for Flexible


endoscope (refer to Appendix-2) and (Appendix: 5)

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TITLE:
STERILIZATION September 2004 2.0
IDENTIFICATION LAST REVISION NEXT REVIEW
NUMBER: CL 7261 DATE: DATE:
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3.1.19 The Role of Pharmacy:

3.1.19.1 The Pharmacy should ensure that:

3.1.19.1.1 The disinfectant container shall be sterilized or


disinfected properly

3.1.19.1.2 The container shall be filled with the correct solution,


at the right dilution

3.1.19.1.3 The container shall be correctly labeled with:

3.1.19.1.3.1 Content
3.1.19.1.3.2 In-use dilution
3.1.19.1.3.3 Date of preparation and expiry date

3.1.19.1.4 The disinfectant shall not be exposed to inactivating


substances, such as cork, rubber, or incompatible
detergents

3.1.19.1.5 The disinfectant shall be diluted by a trained person,


in manageable single use quantities (e.g., 100 mL or
less), as this shall reduce wastage and minimize the
chance of partially filled bottles being left in the ward

3.2 Sterilization of Reusable Medical Equipment/Devices:

3.2.1 Steam Sterilization shall be performed on those equipment or instruments


that are not damaged by heat, pressure, or moisture.

3.2.1.1 Steam Sterilization is done by saturated steam under pressure

3.2.2 Dry heat sterilization shall be used for materials that cannot be steam
sterilized because of damage from steam.

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TITLE:
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NUMBER: CL 7261 DATE: DATE:
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3.2.3 Critical equipment/devices that cannot withstand heat sterilization, chemical


sterilization is required. Some examples of chemical sterilant include:

3.2.3.1 Liquid Peracetic acid


3.2.3.2 Hydrogen Peroxide Plasma Sterilization

3.2.4 Monitoring and INDICATORS:

3.2.4.1 The sterilization procedure shall be monitored routinely by a


combination of Mechanical or Physical, Chemical, and Biological
Parameters.

3.2.4.2 Monitoring shall be done when a sterilizer is first installed before


it is put into general use and to assess routine performance
thereafter.

3.2.5 A physical monitor is a device that monitors the physical parameters of a


sterilizer, such as time, temperature and pressure that are measured during
the sterilization cycle and recorded (as a printout or electronic record) on
completion of each cycle.

3.2.6 Each load shall be monitored with mechanical and chemical indicator.

3.2.6.1 If the mechanical or chemical indicator suggests inadequate


monitoring, the items shall not be used until adequately sterilized.

3.2.7 The Mechanical Technique for Steam Sterilization shall include the daily
assessment of cycle time, temperature by examining the temperature record
chart and an assessment of pressure.

3.2.8 Chemical Indicators (showing the package has been through a sterilization
cycle) shall be visible on each sterilized package.

3.2.8.1 Preferably, a Chemical Indicator shall also be placed inside


each sterilized package to verify steam penetration.

3.2.9 Chemical Indicator shall be used in the form of indicator tape, which change
color when exposed to heat or a particular sterilization.

Prevention & Control of Infections (PCI) Regulatory, Accreditation & Compliance Services (RACS)
POLICY/PROCEDURE

CLEANING, DISINFECTION AND ORIGINAL DATE: VERSION:


TITLE:
STERILIZATION September 2004 2.0
IDENTIFICATION LAST REVISION NEXT REVIEW
NUMBER: CL 7261 DATE: DATE:
January 2019 January 2022
Sheet no. 17 of 20 Tracking History:
HOSPITAL(S) ALL HMC HOSPITALS / ENTITIES
sheet no. 20

3.2.9.1 Chemical Indicator is not enough to guarantee the sterilization of


the product; however, it simply indicates that it has been
exposed to a process.

3.2.10 Bowie Dick Test shall be performed to test for air leaks in vacuum sterilizer.

3.2.11 The sterilizers shall be monitored at least once a week with commercial
preparations of spore intended, specifically for that type of sterilizer (i.e.,
Bacillus stearothermophilus for steam sterilizers and Bacillus sub tills for dry
heat sterilizers)

3.2.12 Every autoclave load, which contains an implantable device, shall be


monitored using biological indicators.

3.2.13 The sterilizer that fails to kill spores in routine spore test shall be
immediately shutdown, checked for proper use and function in conjunction
with Engineering, and the spore test should be repeated.

3.2.13.1 The sterilizer shall not be used until spore test is negative

3.2.13.2 If spore test remain positive, use of sterilizer shall be


discontinued until it is serviced

3.2.14 All monitoring and validation shall be properly documented and signed.

3.3 Preventive Maintenance: Manufacturer’s instruction shall be followed for use and
maintenance of mechanical cleaning equipment and sterilizer by engineering.
3.4 Storage and Use of Sterile Item: The Sterile Instrument or Equipment shall be
stored in a proper Storage Area:

3.4.1 This Storage Area shall provide clean and sterile items protection against
dust, moisture, insects, and temperature and humidity extremes, so that the
package is not compromised, punctured, or bent (Refer to policy CL 7234,
Infection Control In Central Sterile Supply Department (CCSD))

Prevention & Control of Infections (PCI) Regulatory, Accreditation & Compliance Services (RACS)
POLICY/PROCEDURE

CLEANING, DISINFECTION AND ORIGINAL DATE: VERSION:


TITLE:
STERILIZATION September 2004 2.0
IDENTIFICATION LAST REVISION NEXT REVIEW
NUMBER: CL 7261 DATE: DATE:
January 2019 January 2022
Sheet no. 18 of 20 Tracking History:
HOSPITAL(S) ALL HMC HOSPITALS / ENTITIES
sheet no. 20

3.5 Returning Items to Central Sterile Supply Department (CSSD) for Decontamination
and Re-Sterilization:

3.5.1 Rubber gloves shall be worn when washing contaminated equipment.

3.5.2 Personnel Protective Equipment shall be donned as required.

3.5.3 Non-sharp items shall be dried with a paper towel or cloth.

3.5.4 Gross soiling from Gauges or Electrical Equipment shall be wiped with a
damp towel and shall not be rinsed under running water.

3.5.5 All non-disposable reusable sharps shall be placed in a leak-proof covered


container for transportation to CSSD.

3.5.5.1 Sharp objects or needles shall not be wrapped in linen or


obscured from the view of CSSD personnel.

3.5.6 All other instruments or equipment shall be placed in an Orange Bag then
placed in closed container tightly knotted before it is removed from the
patient's room.

3.5.7 A Central Sterile Supply Department Requisition form shall be duly filled and
attached to the container.

3.5.8 All items shall be sent to Central Sterile Supply Department as early as
convenient.

3.6 Performance Improvement:

3.6.1 An audit shall be conducted to review the following information regarding the
process:

3.6.1.1 Method of sterilization used


3.6.1.2 The item being sterilized
3.6.1.3 The length and temperature of exposure
3.6.1.4 The date and time of sterilization
3.6.1.5 The patient’s file number

Prevention & Control of Infections (PCI) Regulatory, Accreditation & Compliance Services (RACS)
POLICY/PROCEDURE

CLEANING, DISINFECTION AND ORIGINAL DATE: VERSION:


TITLE:
STERILIZATION September 2004 2.0
IDENTIFICATION LAST REVISION NEXT REVIEW
NUMBER: CL 7261 DATE: DATE:
January 2019 January 2022
Sheet no. 19 of 20 Tracking History:
HOSPITAL(S) ALL HMC HOSPITALS / ENTITIES
sheet no. 20

3.6.1.6 The operating room number


3.6.1.7 Identification of the person performing the sterilization
3.6.1.8 The sterilizer being used
3.6.1.9 The results of validation procedures

3.6.2 The above data shall be analyzed to:

3.6.2.1 Make sure the correct method of sterilization is being used for
the instrument or material being sterilized.

3.6.2.2 Make sure the most cost effective method is being used for
sterilization.

3.6.2.3 Define the problem identified with particular sterilization or


technology, surgical case, operating room, particular shift, or
individual staff.

3.6.2.4 Decide whether validation method employed to identify problem


areas in an acceptable timeframe.

4.0 DOCUMENTATION: As stated in the Policy.

5.0 REFERENCES:

5.1 Association for Professionals in Infection Control (APIC) and Epidemiology, Inc.
Year 2016, 5th Edition Chapter 21: Cleaning, disinfection, and sterilization. In APIC
Text of infection control and epidemiology.

5.2 Infection control equipment cleaning and maintenance, Metro West Medical Center,
Year 2015.

5.3 Best Practices for Cleaning, Disinfection and Sterilization of Medical


Equipment/Devices In All Health Care Settings, Year 2013 3rd edition Provincial
Infectious Diseases Advisory Committee (PIDAC), Canada.

Prevention & Control of Infections (PCI) Regulatory, Accreditation & Compliance Services (RACS)
POLICY/PROCEDURE

CLEANING, DISINFECTION AND ORIGINAL DATE: VERSION:


TITLE:
STERILIZATION September 2004 2.0
IDENTIFICATION LAST REVISION NEXT REVIEW
NUMBER: CL 7261 DATE: DATE:
January 2019 January 2022
Sheet no. 20 of 20 Tracking History:
HOSPITAL(S) ALL HMC HOSPITALS / ENTITIES
sheet no. 20

5.4 Standards of Practice for the Decontamination of Surgical Instruments year 2018
http://www.ast.org/uploadedFiles/Main_Site/Content/About_Us/Standard_Decontamin
ation_%20Surgical_Instruments_.pdf

5.5 Guideline for Disinfection and Sterilization in Healthcare Facilities (2016)


https://www.cdc.gov/infectioncontrol/guidelines/disinfection/cleaning.html

6.0 TRACKING HISTORY OF CHANGES:


REVISION DATE: CHANGES:
Sheet No. 7
December 2018 Section 3.1.17.3 to 3.1.17.3.5 New Statement Added about
the transportation of soiled instrument to CSSD
Sheet No. 8
Section. 3.1.17.7 New Statement Added about the
container used for transportation of instrument to CSSD
Sheet No. 19
Section 3.5.6 The removal of soiled instrument from patient
room
Appendix :5
Added monitoring tool for flexible endoscope

SUBJECT MATTER EXPERT None


CONTRIBUTORS:

7.0 ATTACHMENTS:

7.1 Appendix: 1 Method of Sterilization and Disinfection of Inanimate Object Including


Medical Equipment By Alphabetical Order.
7.2 Appendix: 2 Reprocessing Flexible Endoscopes.
7.3 Appendix: 3 Guidelines for using Reprocessing products and equipment.
7.4 Appendix: 4 Protocol For Cleaning And Disinfection Of Endocavitary Ultrasound
Transducers
7.5 Appendix: 5 Monitoring tool for Reprocessing Flexible Endoscopes

Prevention & Control of Infections (PCI) Regulatory, Accreditation & Compliance Services (RACS)
APPENDIX -1

METHOD OF STERILIZATION AND DISINFECTION OF INANIMATE OBJECT INCLUDING MEDICAL


EQUIPMENT BY ALPHABETICAL ORDER:

ITEM PREFERRED ALTERNATIVE


Airways Disposable
Ampoules Wipe neck with 70% alcohol

Ambulance Refer to AS 9041 Infection control in


ambulance service and department
standard operational manual (SOP)

Anesthetic equipment - CIDEX OPA for 12


Tubing min
Face Mask Disposable (High Level Disinfection)
-Filters Steam Sterilization
-Laryngoscope blades

-Damp Dust with warm water and Refer to Manufacturer’s


- All Machines detergent guidelines
0.05% sodium hypochlorite for spot
cleaning of soiled surface.

Auriscope (ear piece) - Disposable Wash with soap and water,


rinse and dry then wipe
with 70% alcohol

Baby cot Wipe with warm water and detergent


followed by 0.05% hypochlorite
Baby feeding equipment, breast Sodium Hypochlorite 140 ppm (Milton Wash with detergent.
pump machine, shield and tubing solution)
Baby Scales Wipe with water and detergent 0.05% Sodium Hypochlorite
for spillage or soiling
Bath basins Send it to CSSD for low level Wash with soap and water,
disinfection then wipe with 70% alcohol.

-Store dry and inverted.

CL 7261 Cleaning, Disinfection And Sterilization Regulatory, Accreditation & Compliance Services (RACS)
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APPENDIX -1

ITEM PREFERRED ALTERNATIVE

Bath hoists -Clean with warm water & detergent. -Use 0.05% Hypochlorite for
soiling.
Bath & Immersion Trolley -Disinfect metal parts with 70% alcohol.
-Disinfect plastic parts with 0.05% hypochlorite
solution.

Bed frame and Mattress -Clean with detergent base tuberculocidal Clean with water and detergent
disinfectant followed by 0.05% Sodium
- Isolation rooms use 0.1% Sodium hypochlorite.
hypochlorite.

Bed pans & urinals - Disposable. - Automatic bedpan washer at


80.0°C

Blood pressure cuffs Wash with warm water and detergent or wipe -Disinfect with 0.05%
with Alcohol 70% hypochlorite if necessary

Blood sugar machines(Glucometer) Wipe with alcohol swab

Computer screens / Key boards Wipe with alcohol swab or non-alcohol wipes Disinfect with 0.05%
Avoid the use of cloths that are saturated with hypochlorite if visibly soiled with
fluid. Liquid disinfectants should never be blood
sprayed or poured directly on to IT devices
.Wipe with the disinfectant and surfaces should
be allowed to air dry before reuse.
Carpets -Vacuum daily
-Shampoo or use steam clean every 3 months

Coronary artery flow meter robe Sterilize by peracetic acid in HGH O R

Cystoscopes , Endoscopes Refer appendix-2


& Bronchoscopes
Crockery & Cutlery Dishwasher at 80 °C

Defibrillator paddles Follow manufacturers guideline

Dialysis machine Follow manufacturer’s guideline


dynamap machine Follow manufacturer’s guideline

ECG leads Follow manufacturer’s guideline

CL 7261 Cleaning, Disinfection And Sterilization Regulatory, Accreditation & Compliance Services (RACS)
2-5
APPENDIX -1

ITEM PREFERRED ALTERNATIVE


Fibro optic scope Refer to Appendix-2

Hydrotherapy tanks Hypochlorite at 140 ppm.


Infant incubator Follow manufacture's guideline OR
•Routine cleaning of exterior surface shall be done
every shift, and when surfaces are visibly soiled.
(Refer to CL 7242 Infection control in
Housekeeping) using hospital approved
disinfectant.
• The interior of the incubator should only be
cleaned if visibly soiled. Only use tap water for
interior cleaning, do not ever use odorous
solutions.
• Change incubator every 7 days
•Terminal cleaning & disinfection of incubators
after use: Refer to CL 7253 Infection control in
NICU, IMC and other units handling newborns.
•For Isolation cases use 0.1 % hypochlorite

IV stand Clean with detergent& water Alcohol wipes.


1.IVF Instruments
1.1Veress Needle 1.Disposable
1.2 Laparoscopic trocar
1.3 Cannula
1.4 Long grasping forceps

2. Hysteroscopy 2.High level disinfection in CSSD

3. Camera Head 3 .& 4. Use Sheath then disinfect with OOSAFE


4. Cables for light sources after use

5. Ultra sound transducer 5.Refer to Appendix-4

Kitchen work surface Clean surface with detergent 100 PPM Sodium
hypochlorite solution
Laboratory
Laboratory bench tops + - Disinfect with 0.1% Chlorine based disinfectant
Safety cabinets, hoods,
centrifuges etc
Laboratory glass- ware - Sterilize in autoclave before washing.
- Wash dry in a drying cabinet & sterilize in hot air
oven
Laboratory Equipment -Damp dust with detergent & hot water For spillage use
0.05% hypochlorite

CL 7261 Cleaning, Disinfection And Sterilization Regulatory, Accreditation & Compliance Services (RACS)
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APPENDIX -1

ITEM PREFERRED ALTERNATIVE


Mop buckets Clean with detergent
Monitors Wipe all parts that come in .
contact with patient with 70%
Alcohol wipes.
Nebulizer set Disposable.

Nail Cutter Use Alcohol wipe 70%.

Operative light Damp dust.

Ophthalmoscope Wipe with alcohol swab

Percussion Hammer Alcohol swab

Pillows Same as mattresses

Phototherapy machine Damp dust

Pulse oximeter. Wipe with alcohol swab

Respirators
- Detachable parts -Low heat Disinfection at CIDEX OPA for 5 - 12 min.
80°C for 30 minutes

- Pediatric humidifiers - Low heat disinfection at. CIDEX OPA for 5 -12min
80.0°C for 30 minutes.
Tubing's i.e., corrugated Disposable. -Low heat disinfection at
Tubes 80°C for 10 min.
.
-Fixed parts -damp dust body with
water and detergent
Speculum (vaginal) Disposable Send to CSSD for sterilization
Shaving
-Shaving razors - Disposable
-Clipper -Disposable head but the clipper
body to be cleaned with Alcohol70%

Spirometer Disposable

Stethoscopes, fetoscops Wipe bell & ear pieces with


70% alcohol
Stretchers - Treat top of stretchers as
mattresses
-Treat other parts as in furniture

Suction bottles -Disposable Low heat disinfection

CL 7261 Cleaning, Disinfection And Sterilization Regulatory, Accreditation & Compliance Services (RACS)
4-5
APPENDIX -1

ITEM PREFERRED ALTERNATIVE


Surgical instruments Autoclave

Syringe pump Damp dust Swab with 70% alcohol

Thermometer(Ivac) Wipe &disinfect with 70% Alcohol

Thoracoscope and forceps Manufacturer’s Recommendation


Camera and accessories Manufacturer’s Recommendation
thoracoscopy supplies Manufacturer’s Recommendation

Tracheostomy tube (metal) * Autoclave

Trolleys Wash with soap and water then 0.05 % hypochlorite


Swab with 70% alcohol wipe

Weighing scales water & detergent 0.05% hypochlorite


Solution
Wheelchair Clean all parts with water If soiled or contaminated
& detergent & dry with body fluids clean
with 0.05% hypochlorite

Work Surfaces Clean with hot water & detergent Disinfect with 0.05%
Hypochlorite
X-ray equipment Damp dust with detergent & For infected patients wipe
& X-ray Cassette 70% alcohol.

Note: For items not listed above, refer to the Manufacturer’s Guidelines

CL 7261 Cleaning, Disinfection And Sterilization Regulatory, Accreditation & Compliance Services (RACS)
5-5
APPENDIX-2

REPROCESSING FLEXIBLE ENDOSCOPES

1 The Following step shall be proceed while reprocessing flexible endoscopes

1.1 Pre-cleaning in procedure room (immediately after the procedure):

1.1.1 Wipe insertion tube using gauze saturated with enzymatic detergent/ any detergent solution.
1.1.2 Aspirate enzymatic detergent through the entire channel system.
1.1.3 Alternate suctioning of air and detergent until the internal channels are cleared from secretion/
blood.
1.1.4 Flush air and water channels by setting lever on air water bottle to “drain” position, turning air
pump “on” to highest pressure setting and using air/water valve to expel fluids/debris from air &
water channels.
1.1.5 Flush any special feature channel such as water jet, exposed elevator, etc.
1.1.6 Disconnect the scope from the video processor.
1.1.7 Detach removable components. Remove small rubber check valve and soak all items in
detergent solution.
1.1.8 Aspirate detergent solution for 30 seconds, water for 10 seconds and air for 10 Seconds.
1.1.9 Transport the contaminated scope to the decontamination area in a way that no contamination
of the door and other surfaces occur.

1.2 Leak Testing (in decontamination area) prior to immersion:

1.2.1 Detach removable components. Remove all valves, rubber inlet seals and forward adapter (and
suction selector mechanism, if available).
1.2.2 Attach soaking cap to the endoscope by aligning the green dot on endoscope with black arrow
on cap.
1.2.3 Lock soaking cap by pushing it in and turning it clockwise so that it locks into position.
1.2.4 Attach leakage tester to scope.
1.2.5 Tighten valve screw or set toggle switch to lock position (depending on the leak tester model)
and pump up tester until needle is aligned with a reference point (pressure marking) towards the
end of the green zone.
1.2.6 Perform “dry test” carefully. Check for trails of escaping air bubbles.
1.2.7 Deflect the scope distal tip in various directions by rotating the angulation controls.

1.3 Cleaning (in decontamination area):

1.3.1 Wear appropriate PPE before starting the cleaning procedure including full gown, gloves, foot
wear and goggles.
1.3.2 Transfer scope and previously detached components to cleaning basin.
1.3.3 Soak in fresh enzymatic detergent (according to manufacturer’s recommendations).
1.3.4 NOTE: AFTER THE 15 MINUTES SOAKING PERIOD:
1.3.5 Clean the external surfaces using clean cloth. Brush instruments/ suction channels, Cylinder
and instrument channel port. Repeat until the debris is removed.
1.3.6 Using cleaning brushes cloth, scrub clean all accessible endoscope channels and components/
surfaces.
1.3.7 Attach the channel cleaning adapters.

CL 7261 Cleaning, Disinfection And Sterilization Regulatory, Accreditation & Compliance Services (RACS)
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APPENDIX-2

1.3.8 Rinse all scope surfaces, individual components and internal channel with clean water to
remove residual detergent solution. Thoroughly dry all previously rinsed surfaces prior to
disinfection.

1.4 Disinfection of endoscopes:

1.4.1 Flexible endoscopes without internal channel (ej. nasolaringoscopes) could be reprocessed
using plasma sterilization or high level disinfection.
1.4.2 Flexible endoscopes with internal channel require at minimum high level disinfection with
peracetic acid or orthophthaldehide.
1.4.3 High level disinfection should be performed in automated reprocessors.

1.5 Drying:

1.5.1 Dry the exterior of the endoscope with a soft, sterile lint-free towel after each cycle

1.5.1.1 Purge all channels with air.


1.5.1.2 Flush all channels, including accessory channels, with 70% isopropyl alcohol or sterile water
until the alcohol can be seen exiting the opposite end of each channel.
1.5.1.3 Rinse the insertion tube and inner channels with alcohol and dry with forced air before storage.

1.6 Storage:

1.6.1 Ensure that all water has been removed from the scope and the scope/components are dry
1.6.2 A storage area shall be clean, well ventilated room or cabinet and dust free thus discouraging
any microbial contamination.
1.6.3 Hang the endoscope in a vertical position to facilitate drying (with caps, valves, and other
detachable components removed in accordance with the manufacturer’s instructions).
1.6.4 Avoid the contact of the endoscopes with wall, cabinet or other scopes.
1.6.5 Uncoil insertion tube.
1.6.6 Clearly label the reprocessed endoscopes with the date of reprocessing .
1.6.7 After 5-7 days of storing without being used the endoscope require a full reprocessing
procedure.

1.7 Post disinfection:

1.7.1 Handle the disinfected scopes carefully. Hold all parts of the scope when carrying. Do not let the
ends of the scope swing freely. The scopes should be handled in aseptic manner (using sterile
gloves) until it is used for the patient.

1.7.2 Before reuse:

1.7.2.1 Carefully inspect scope and ancillary equipments prior to subsequent use.
1.7.2.2 Use only sterile water for irrigation and inspection purposes.

CL 7261 Cleaning, Disinfection And Sterilization Regulatory, Accreditation & Compliance Services (RACS)
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APPENDIX-2

1.7.2.3 Transportation to other hospital suites:

1.7.2.3.1 Transportation of endoscope shall be performed in such way to prevent


against contamination or damage of the endoscope.
1.7.2.3.2 A contaminated carrying case shall be reprocessed.

1.8 Documentation ( Refer to CL 7261 (Central sterile supplies department):

1.8.1 As part of a quality control program, documentation may include, but is not limited to the
following:
1.8.1.1 The procedure date and time.
1.8.1.2 The patient’s name and medical record number.
1.8.1.3 The endoscope’s model and serial number or other identifier.
1.8.1.4 If the Automated Endoscope Reprocessors (AER) is used model and serial number or other
identifier shall be recorded.
1.8.1.5 The staff member(s) reprocessing the endoscope.

1.8.2 Report and document any suspected or identified infections probable related with endoscope
use, to those responsible for infection control in the endoscopy setting

1.9 Quality Control.( Refer to Appendix -3)

1.9.1 Daily quality control shallbe performed before the first cycle.

1.9.2 In each cycle of reprocessing:

1.9.2.1 Physical parameters and concentration of the disinfectant is monitored, including the
compliance with the quality the steps (rinse, washing, and rinse and drying)
1.9.2.2 Test strip to monitor achievement of the concentration of the disinfectant shall be performed as
per manufacturer recommendation.
1.9.2.3 Appropriate action shall be taken in case of failure during quality control.
1.9.2.4 A preventive maintenance plan shshall be in place for all automated reprocessing devices and
documented.

1.10 Education:

1.10.1 Supervisor personnel shall be familiar with the principles and practices of instrument
reprocessing.
1.10.2 Annual in service education shall be conducted.
1.10.3 The competency of each individual involved in reprocessing shall be evaluated and documented
at least annually

CL 7261 Cleaning, Disinfection And Sterilization Regulatory, Accreditation & Compliance Services (RACS)
3-3
APPENDIX-3
Guidelines for Using Reprocessing Products and Equipment

1. CIDEX OPA

1.1 CIDEX OPA shall be used for high-level disinfection of heat sensitive medical devices (e.g.,
scopes, vaginal probes, and other equipment)

1.2 Manufacturer’s instruction shall be followed for proper use of the product

1.3 This product shall be stored in its original sealed container between 59°F (15°C) and 86°F
(30°C) in a well-ventilated, low-traffic area.

1.4 Appropriate Personal Protective Equipment shall be donned, including but not limited to gloves,
eye protection, fluid-repellent apron or gown, face mask, gloves (latex, butyl, or nitrile rubber)

1.5 Cleaning:

1.5.1 To remove debris all instrument surfaces and the lumens of hollow instruments shall be
thoroughly cleaned prior to disinfection (e.g. endoscopes) with a mild protein dissolving
detergent such as Enzymatic Detergent .Because residual organic matter shall decrease
the effectiveness of the solution

1.5.2 Following cleaning, instrument surface and lumen of hollow instrument shall be rinsed
with adequate amount of fresh water to remove residual detergent

1.5.3 The instrument shall be dried prior to disinfecting to prevent excess water from diluting
the CIDEX OPA Solution below its Minimum Effective Concentration (MEC)

1.5.4 Instrument manufacturer’s pamphlet shall be referred to for additional instructions on


disassembling, cleaning, and leak testing of particular instruments

1.6 Disinfection:

1.6.1 Before using the solution, the end user shall be read the directions for use on the bottle
label and package insert.

1.6.2 The shelf life of an unopened bottle of CIDEX OPA Solution is 2 years. The solution
requires NO activation. After opening the bottle, pour CIDEX OPA Solution into a CIDEX
Solution Tray or appropriate container.

1.6.3 If there is still solution left in the bottle, the bottle can be stored up to 75 days.

1.6.4 The container shall be covered when not in use and during soaking time

CL 7261 Cleaning, Disinfection And Sterilization Regulatory, Accreditation & Compliance Services (RACS)
1-5
APPENDIX-3
1.6.5 The instrument for disinfection shall be exposed to:

1.6.5.1 Rapid 5-minute soak time at a minimum of 25°C in an automatic endoscope re-
processor and 12 minutes if the re-processor cannot maintain the disinfectant
temperature at a minimum of 25°C

1.6.5.2 Manual reprocessing shall be 12-minutes soak time at a minimum of 20°C


temperature

1.6.6 The date that the solution was poured out of the original container to a secondary
container shall be recorded

1.6.7 The solution in the secondary container shall be used for a period not exceeding 14 days

1.6.8 The clean and dry instrument shall be immersed completely into the CIDEX OPA
solution, to ensure that all instruments are completely submerged and the lumen of hollow
instrument is completely filled with the solution

1.6.9 Cover the CIDEX Solution Tray with a secure lid. Soak instruments for (12) minutes at
20ºC to achieve high level disinfection.

1.6.10 Following disinfection, the instruments shall be rinsed thoroughly, flushing all channels
and lumens

1.6.11 The instrument shall be soaked in clean water three times for a total submersion time of
one minute per soak or Rinse in running water for 1-2 minutes

1.6.12 The instrument shall be dried (Refer to manufacturer’s instructions for drying flexible
endoscopes)

1.6.13 Disinfected instruments shall be used immediately or stored in a manner to minimize


recontamination

1.6.14 CIDEX OPA Solution shall be tested prior to each use with CIDEX OPA Solution Test
Strips

1.6.14.1 Ensure that the solution to be tested has been dispensed according to
labeling instructions.

1.6.14.2 Always note the date the bottle was opened and label the date and time of
opening in the space provided on the bottle.

1.6.14.3 Ensure that appropriate safety precautions are observed when testing CIDEX
OPA Solution, refer to product labeling and the Material Safety Data Sheet
for CIDEX OPA Solution.

CL 7261 Cleaning, Disinfection And Sterilization Regulatory, Accreditation & Compliance Services (RACS)
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APPENDIX-3
1.6.14.4 Remove one Test Strip from the bottle and replace the bottle cap
immediately.

1.6.14.5 Use a watch or timer to monitor the following steps:

1.6.14.5.1 Timing control is critical to accurate reading.

1.6.14.5.2 Completely Submerge indicating pad at the end of the test strip
into the container of the solution being tested.

1.6.14.5.3 Hold for one second and remove. Do not leave the strip in the
test solution for longer than one second or “stir” the test strip in
the solution. Incorrect dipping technique, such as swirling the
test strip vigorously in the solution, shall wash off the reagents in
the test strip pad. This can cause a lack of purple color formation
(FAIL) when testing a solution that shall normally test as PASS.

1.6.14.6 Remove excess solution from the indicating pad by standing the strip upright
on a paper towel. Do not shake the strip after removal. When removing
excess solution, incorrect technique, such as violently shaking the test strip
and/or blotting the test strip with the pad face down against a paper towel,
can remove the reagents and solution. This can cause FAIL results for
solutions that shall normally test as PASS.

1.6.14.7 Read the results of the color reaction present on the indicating pad at (90)
seconds after the test strip is removed from the solution. If read in less than
(90) seconds, the color change may be incomplete and may be interpreted
incorrectly. If read past 90 seconds, color shall gradually change to indicate
“FAIL”.

1.6.14.8 To indicate an effective concentration of the solution, the indicating pad shall
be completely purple. Any shade of purple is acceptable; the intensity shall
vary due to concentration variation. If any blue appears on the indicating pad
apart from the top line, the solution is below the MEC of 0.3% and should be
discarded. Refer to the color chart on the test strip bottle for interpretation of
test results.

1.6.15 Result of the test shall be recorded on Cidex OPA solution Test Strip Log Sheet

1.6.16 Any failures shall be noted and a documentation should be established if the solution is
discarded, mentioning the date of occurrence on the Log Sheet

1.6.17 CIDEX OPA Solution Test strips shall be checked each time a new package/bottle is
opened to verify they are accurate, using positive (e.g., full strength disinfectant solution)
and negative (e.g., tap water) controls
CL 7261 Cleaning, Disinfection And Sterilization Regulatory, Accreditation & Compliance Services (RACS)
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APPENDIX-3

1.6.17.1 Preparation of Control Solutions:

1.6.17.1.1 To prepare positive and negative control solutions for testing,


first verify that the labeled expiration date for the solution is
appropriate. This solution may be used as a positive control.

1.6.17.1.2 To prepare a negative control, dilute one part of full strength


solution with one part of water. Label each control solution
appropriately.

1.6.17.2 Testing Procedure:

1.6.17.2.1 Following the Directions for Use, submerge three test strips in
each of the above freshly prepared solutions for one second
each and Remove

1.6.17.2.2 The three strips dipped in the full strength positive control
solution should exhibit a complete purple color on the indicating
pad at (90) seconds. The three strips dipped in the diluted
negative control should either remain completely blue or exhibit
an incomplete color change to purple when read at (90) seconds.
Refer to the color chart on the test strip bottle for interpretation of
results.

1.6.18 CIDEX OPA Solution shall be kept in a covered container in well-ventilated areas

1.6.19 CIDEX OPA Solution shall be discarded after (14) days, even if the Test Strips indicate a
concentration above the Minimum Effective Concentration

1.6.20 CIDEX OPA Solution shall be discarded down the Hospital and Office drain in
accordance with Local Regulations

2. ANIOXYDE 1000:

2.1 ANIOXYDE 1000 should be used for high-level disinfection of cold sterilant for instruments,
endoscopes, and medical equipment

2.2 ANIOXYDE 1000 should be used after Product Activation, which is at least 30 minutes

2.3 Personal Protective Equipment should be donned, including but not limited to, gloves, eye
protection gear, fluid-repellent apron or gown, face mask, or gloves

2.4 The instrument should be cleaned and rinsed thoroughly before soaking it in activated solution
of ANIOXYDE 1000

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2.5 The Soaking Time should be 5 minutes

2.6 The instrument should be rinsed thoroughly with sterile or filtered water

2.7 The Peracetic Acid level in ANIOXYDE 1000 should be tested with a Testing Strip to ensure the
disinfectant efficacy, properly following the directions for use on the Test Strips

2.8 This shall be done:

2.8.1 At the start of the session


2.8.2 When restarting after an interruption
2.8.3 Every four hours of consecutive activity

2.9 The result of the test should be recorded on ANIOXYDE 1000 solution Test Strip Log sheet

2.10 ANIOXIDE 1000 Solution Test strips shall be checked each time a new package/bottle is
opened to verify they are accurate, using positive (e.g., full strength disinfectant solution) and
negative (e.g., tap water) controls (Follow the same method of CIDEX OPA Control test )

2.11 Any failure shall be noted and a documentation should be established if the solution is
discarded, mentioning the date of occurrence on the Log Sheet

2.12 The solution shall be stored from +5 oC to +25 oC

2.13 The container shall be covered securely and the solution should be discarded after 14 days of
activation

2.14 The solution shall be discarded down the Hospital and Office drain in accordance with Local
Regulations

3. ULTRAVIOLET DISINFECTION ( ANTIGERMIX S1 and ANTIGERMIX E1):

3.1 ANTIGERMIX S1 unit shall be used for high-level disinfection of heat sensitive medical devices
(e.g., scopes, vaginal probes, and other equipment)

3.2 To remove debris all instrument surfaces and the lumens of hollow instruments shall be
thoroughly cleaned prior to disinfection .Make sure that the equipment is completely dry and
without gel residue.

3.3 Place the equipment in the ULTRAVIOLET Machin without disconnecting it.

3.4 Suspend the equipment in the ULTRAVIOLET Machin Chamber using the attachment ring
without disconnecting it and close to the door.

3.5 Press the “Cycle 1” button to start a high –level disinfection (HLD). At the end of the cycle,
which stops automatically, the probe is ready to be used again or may store.

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APPENDIX-4

PROTOCOL FOR CLEANING AND DISINFECTION OF ENDOCAVITARY ULTRASOUND TRANSDUCERS

1. The equipment included in endocavitary ultrasound transducers are:

1.1 Vaginal Probes


1.2 Endocavitary Ultrasound Probes
1.3 Transducers

2. Cleaning Procedure:

2.1 The vaginal probe should be cleaned and subjected to high level disinfection after each patient use.

2.2 After endocavitary examination, gloves should be used to remove the condom or other barrier from
the transducer and care should be taken not to contaminate the probe with secretions from the
patient.

2.3 After removal of the probe cover, wash the probe using running water to remove residual gel or debris
from the probe, if there is a designated sink for washing. Hand washing sink should not be used for
this purpose.

2.4 Use damp gauze or other soft cloth and a small amount of mild non-abrasive liquid soap (hospital
approved detergent) to thoroughly cleanse the transducer.

2.5 Consider the use of a small brush for crevices and areas of angulations depending on the design of
the transducer.

2.6 Rinse the transducer thoroughly with running water and then dry with a soft cloth.

2.7 If there is no designated sink for washing ,wipe the probe with wet gauze followed by disinfectant
solution compatible with manufacturer's guidelines

2.8 Wash hands after completion of the procedure.

3. Disinfection Procedure Using Glutaraldehyde User Station (GUS )System:

3.1 Place the electrical connector in the top compartment.

3.2 Place probe into the soak container with Cidex OPA, align mark on cable with top of spring clip. Push
in on the blue plastic tab and slide the cable into the spring clip to suspend probe.

3.3 Manual reprocessing should be with (12) minutes soak time at a minimum of 20°C temperature.

3.4 A clock timer should be available in the unit and soaking time should be documented in a log book.

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3.5 When removing the probe from the soak container, lift it up, shake it gently to remove large drops and
then place directly into the rinse container. While doing this, keep the probe in the air stream, which
shall prevent fumes from escaping into the room.

3.6 Rinse off the probe gently by swirling it around in the rinse container.

3.7 Remove the probe from the rinse container then give a final rinse with running water for 1-2 minutes
and air drying.

3.8 When GUS System is not in use, replace the screw caps on the soaking containers. Turn off the
machine when soaking containers caps are secured.

4. Quality Control:

4.1 Quality control check for the cidex OPA solution Test strips should be followed according to
Appendix-3

5. Disinfection Procedure using ANTIGERMIX S1 unit (Refer to Appendix- 3)

6. Storage of Endocavitary Probes:

6.1 Store the probe in a clean and dust-free environment with clean cover.

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INFECTION PREVENTION AND CONTROL
ENDOSCOPY REPROCESSING CHECK LIST

Elements YES NO Comment


1. Manufacturer’s guidelines for scopes are readily accessible by
Endoscopy staff
2. Manufacturer’s guidelines followed for endoscope cleaning processes
3. Manufacturer’s guidelines followed for selection of cleaning product
4. Manufacturer’s guidelines followed for selection of
disinfectant/sterilization products
5. Manufacturer’s guidelines followed regarding use of alcohol
6. Manufacturer’s guidelines followed related to the compatibility with
automatic endoscope reprocessors
Pre –cleaning of Endoscope
1. Pre-cleaning of the endoscope and accessories occurs at the point of
use.
2. External surfaces washed with an enzymatic detergent solution using
a soft cloth or sponge.
3. If the enzymatic detergent solution requires dilution, proper dilution
ratios are followed.
4. Internal suction/biopsy channels cleaned by suctioning copious
amounts of enzymatic solution and air
5. Air and water channels flushed with an enzymatic solution then low
pressure air or air filled syringes to the standard air, water, and suction
channels. Some scopes have additional channels in addition to the air,
water and suction. If so, each should also be flushed or purged by
following the scope manufacturer’s guidelines.
6. Additional complex design components (such as; forward water jet
channel, exposed elevator wire channels, balloon channels) flushed or
purged with water or enzymatic detergent solution according to
manufacturer’s guidelines.
7. Tip of endoscope is visually inspected for damage to surface or any
working part and for cleanliness.
8. Detachable parts (such as hoods, valves, water bottles) are removed
and immersed in an enzymatic detergent solution until transport to
decontamination.
9. Endoscopes accessories used on the sterile field are handed to the
circulator as soon as possible enabling steps 2 through 11 to be
accomplished.
10. Endoscope accessories used on the sterile field are wiped with a lint-
free cloth saturated with sterile water.
11. Endoscopes accessories used on the sterile field are alternately
suctioned through all channels with sterile water and air.
12. The enzymatic detergent solution is discarded after a single use.

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APPENDIX: 5
INFECTION PREVENTION AND CONTROL
ENDOSCOPY REPROCESSING CHECK LIST

Elements YES NO Comment


Transportation of Contaminated Endoscopes
1. Soiled endoscopes are transported (before remaining organic material
is able to dry on the surface or in the channels) to decontamination
area after pre-cleaning before remaining organic material dries on the
surface or in the channels.
2. During transport the soiled endoscope is contained (in plastic bag or in
a container with a lid).
3. The transport container is labeled to indicate bio-hazardous contents.
Cleaning
1. Leak testing (using clean water) is conducted according to
manufacturer’s guidelines and before cleaning in the decontamination rea.
Manual cleaning occurs after leak testing and before high-level
infection.
2. The endoscope is submerged in an enzymatic detergent solution
using roper dilution ratios determined by enzymatic detergent
manufacturer.
3. Ensure video cap is secure. Immerse the endoscope
4. ll internal channels are flushed thoroughly with an enzymatic
etergent using manufacturer provided channel cleaning adapters.
5. All components (shroud, valves) should be flushed thoroughly with
an enzymatic detergent.
6. The entire endoscope is submerged when the brush is inserted
and the bristles are wiped to remove excess moisture prior to
retracting the brush back through the channel.
7. Brushes are inspected prior to insertion to confirm appropriate size
in relation to the channel(s)
8. The brushes are not kinked, not missing bristles, and a protective
tip is present
9. After each brush passage, rinse the brush in the detergent
solution, removing any visible debris before any visible debris
before retracting and reinserting it
10. Continue brushing until there is no debris visible on the brush
11. All channels are flushed thoroughly and all exterior surfaces of the
endoscope and accessories are rinsed with potable tap water.
12. The endoscope is dried using low-pressure forced air through the
internal channels and surfaces are wiped with a soft cloth before
high-level disinfection.
High – Level Disinfection
1. HLD can be achieved either manually or automated by using an
automated endoscope repressor (AER)

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INFECTION PREVENTION AND CONTROL
ENDOSCOPY REPROCESSING CHECK LIST

Elements YES NO Comment


Manual Disinfection
2. Test strips are dated with new expiration date when opened, not
expired (according to the manufacturer’s expiration date, and the lid is
closed tightly
3. Quality control (at a minimum each new bottle of strips when opened)
has been conducted as strip manufacturer’s guidelines (if required) and
results documented
4. Solution is tested and results documented before each use
5. HLD solution is dated when opened with new expiration date and
solution is not expired based on new expiration date
6. Scopes are completely immersed as directed by the manufacturer
7. Timer is present
8. Temperature of solution is monitored and reaches manufacturer’s
recommended temperature
9. Flush disinfectant into all channels of the endoscope until it can be
seen exiting the opposite end of the channel. Take care that all
channels are filled with the chemical, and that no air pockets remain
within the channels.
10. Endoscope is completely submerged in the disinfectant solution
11. Soak time and temperature are met
12. Manufacturer’s recommendations for rinse time is followed
13. Rinse solution is changed between scopes
14. Alcohol flush is performed, scope dried and is lint free
15. High level disinfected scope is transported to storage area in manner to
prevent contamination
Automated Reprocessing
1. 1. Follow steps for manual cleaning of the endoscope
2. Prepare the endoscope reprocessor according to manufacturer’s
guidelines
3. Place the endoscope in the reprocessor and attach all channel
adapters according to manufacturer’s instructions
4. Place valves and other removable parts into the soaking basin of the
reprocessor. Unless the reprocessor has a dedicated space for
accessories, reprocess these items separately
5. If enzymatic detergent is used, ensure that the product is compatible
with the reprocessor and the endoscope
6. Set the appropriate time and temperature depending on the chemical
used
7. If the cycle(s) are interrupted, HLD cannot be ensured and full cycle
must be repeated

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INFECTION PREVENTION AND CONTROL
ENDOSCOPY REPROCESSING CHECK LIST

Elements YES NO Comment


8. If a final alcohol rinse cycle is not included in the automated
reprocessor cycle, manually purge all channels with air until dry. Refer
to manufacturer’s instructions
9. ERCP elevator and elevator channel must be manually perfused and
dried per manufacturer’s instructions
10. High level disinfected scope is transported to storage area in manner to
prevent contamination
Drying
1. Store endoscopes in a manner to prevent contamination
2. Store endoscopes in a closed cabinet and doors remain closed
3. Internal surfaces of the storage cabinet must be composed of
cleanable materials
4. Scopes must be hung in a vertical position to facilitate drying with caps,
valves, and other detachable components removed per manufacturer’s
instructions
5. The scope must not touch the sides or bottom of the space and not
touch other scopes
6. If the scope is too long for the space, a Christmas tree pattern can be
used
Storage
1. Storage area must be clean, well ventilated (positively pressured -
more positive than the processing room), and dust free
2. A separate room for clean scopes storage is preferred but not
required
3. Instruments must flow from the contaminated area to the clean
assembly area and then to storage without risk of cross
contamination.
4. A minimum of 3 feet should be maintained between clean scopes
and contaminated scopes at all time to assist in preventing cross
contamination
5. There must be work counters and accommodations for equipment,
including space and utility connections for the endoscope
reprocessor, sonic cleaner, and sterilizers (if required)
General guidelines
1.The endoscopy equipment processing room should contain the following:
• PPE
• Products required and not expired
• Timers
• Sinks to manually clean flexible endoscopes
• Hand washing facilities
• Eyewash station

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APPENDIX: 5
INFECTION PREVENTION AND CONTROL
ENDOSCOPY REPROCESSING CHECK LIST

Elements YES NO Comment


• Automated equipment consistent with the types of flexible
endoscopes to be decontaminated
• Leak testing equipment
• Low pressure air
• Closed storage facilities
• Proper ventilation
-Negative pressure to the surrounding spaces
-Air must exhaust directly outside
-Air changes at a minimum of 10 times per hour; 2 of
the 10 exchanges must be fresh outside air
-No temperature or humidity requirements
2.All staff have annual competencies on each type of scopes, accessories,
valves and automatic endoscope reprocessors as they are introduced in
the facility on hospital approved competency templates
3.Core components of an education program should cover the following
topics:
• Standard precautions
• Personal protective equipment
• OSHA rules on occupational exposure to blood-borne
pathogens
• Reprocessing procedures for endoscopes and accessory
equipment
• Mechanisms of disease transmission
• Maintenance of a safe work environment
• Safe handling of high level disinfectants and sterilants
• Procedures for waste management
4. On an ongoing basis, minimally every quarter, observe every
technician’s technique for cleaning and disinfecting endoscopes using the
checklist developed from manufacturer’s instructions. If there is a misstep,
notify the technician as it occurs. Repeat observations until there is 100%
compliance with following the steps without coaching.

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