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recommendations;
e) Following pasteurization, medical equipment/devices should be inspected for wear, cracks
or soil. Damaged equipment/devices should be handled according to facility procedures.
Soiled equipment/devices should be reprocessed;
f) Following pasteurization, medical equipment/devices shall be handled so as to prevent
contamination. Equipment/devices shall be transported directly from the pasteurizer to a
clean area for drying, assembly and packaging.
11.9 A preventive maintenance program for pasteurizing equipment must be implemented and
documented.
11.10 Following the pasteurizing cycle, medical equipment/devices shall be thoroughly dried in a
drying cabinet that is equipped with a HEPA filter and that is used exclusively for the drying
of pasteurized equipment/devices.30
A preventive maintenance program for drying cabinets must be implemented and documented.
11.11 A logbook of contents, temperature and time is to be maintained for pasteurizing
equipment.
30
Canadian Standards Association. CAN/CSA Z314.8-00. Decontamination of Reusable Medical Devices: A National
Standard of Canada. Toronto, Ont.: Canadian Standards Association; 2000. (R2005).
25
Best Practices for Cleaning, Disinfection and Sterilization in Health Authorities March 2007
If the pasteurizer produces printed records of the parameters of each cycle, these records shall be
retained in accordance with the facility s requirements.
12. Reprocessing Endoscopy Equipment/Devices
For the purposes of this document, endoscopes will be considered to be of two types:
Critical Endoscope: Endoscopes used in the examination of critical spaces, such as joints and
sterile cavities. Many of these endoscopes are rigid with no lumen. Examples of critical endoscopes
are arthroscopes, laparoscopes and cystoscopes.
Semicritical Endoscope: Fiberoptic or video endoscopes used in the examination of the hollow
viscera. These endoscopes generally invade only semicritical spaces, although some of their
components might enter tissues or other critical spaces. Examples of semicritical endoscopes are
laryngoscopes, nasopharyngeal endoscopes, transesophageal probes, colonoscopes,
gastroscopes, duodenoscopes, sigmoidoscopes and enteroscopes.
Opinions differ regarding the reprocessing requirements for bronchoscopes; a minimum of high
level disinfection is required.
Due to the complexity of their design, flexible fibreoptic and video endoscopes ( semicritical
endoscopes ) require special cleaning and handling.30,31
12.1 Individuals responsible for reprocessing endoscopes shall be specially trained and shall
meet the facility s written endoscope processing competency requirements, including
ongoing education and training.30
a) Staff assigned to reprocess endoscopes must receive device-specific reprocessing
instructions to ensure proper cleaning and high-level disinfection or sterilization.
b) Competency testing of personnel reprocessing endoscopes must be performed on a
regular basis.31
c) Temporary personnel must not be allowed to reprocess endoscopes until competency has
been established.31
12.2 Each health care setting in which endoscopic procedures are performed shall have written
detailed procedures for the cleaning and handling of endoscopes.30
12.3 Ventilation shall be such as to remove toxic vapours 30 generated by, or emitted from,
cleaning or disinfecting agents.
a) The vapour concentration of the chemical disinfectant used shall not exceed allowable
limits 31 (e.g. 0.05 ppm for glutaraldehyde).
b) Air-exchange equipment (e.g. ventilation system, exhaust hoods) should be used to
minimize the exposure of all persons to potentially toxic vapours.31
c) In-use disinfectant solutions must be maintained in closed, covered, labeled containers at
all times.
d) Air quality should be monitored on a scheduled basis to ensure control of vapours.
12.4 Endoscopic cleaning shall commence immediately following completion of the clinical
procedure.32
Soil residue in endoscope lumens dries rapidly, becoming very difficult to remove. Initial cleaning
includes:
a) The manufacturer s recommendations for cleaning and cleaning products shall be
followed;
31
American Society for Gastrointestinal Endoscopy. Multi-society guideline for reprocessing flexible gastrointestinal
endoscopes. Gastrointest Endosc. 2003;58: 1-8.
32
Canadian Standards Association. CAN/CSA Z314.8-00. Decontamination of Reusable Medical Devices: A National
Standard of Canada. Toronto, Ont.: Canadian Standards Association; 2000. (R2005).
26
Best Practices for Cleaning, Disinfection and Sterilization in Health Authorities March 2007
b) Soaking and manual cleaning of all immersible endoscope components with water and a
recommended cleaning agent shall precede automated or further manual disinfection or
sterilization;
c) Endoscope components (e.g. air/water and suction valves) must be disconnected and
disassembled as far as possible and the endoscope and components must be completely
immersed in enzymatic detergent;33
d) All channels and lumens of the endoscope shall be flushed and brushed while submerged
to remove debris while minimizing aerosols;
e) Brushes used for cleaning lumens shall be of an appropriate size, inspected before and
after use, and discarded or cleaned, high-level disinfected and dried following use;
f) Irrigation adaptors or manifolds shall be utilized to facilitate cleaning;
g) Damaged endoscopes shall be identified and immediately removed from service.
h) Enzymatic detergent shall be discarded after each use;
i) Cleaning items shall be disposable or thoroughly cleaned and disinfected/sterilized
between uses.32
12.5 Patency and integrity of the endoscope sheath should be verified through leak testing,
performed after each use.32,33
a) The leak test is performed prior to, and during, immersion of the endoscope.
b) An endoscope that fails the dry leak test should not undergo the immersion leak test.
12.6 Endoscopic equipment/devices shall be rinsed and dried prior to disinfection or
sterilization.32
a) Sterile water is recommended for rinsing and flushing.
12.7 Semicritical endoscopes and accessories (excluding biopsy forceps and brushes) must
receive at least high-level disinfection after each use.33
a) Choose a disinfectant that is compatible with the endoscope.33
b) Completely immerse the endoscope and endoscope components in the high-level
disinfectant/sterilant and ensure all channels are perfused.33
c) Maintain a written log of monitoring test results.
d) Monitoring of the disinfectant must be carried out before each use with test strips available
from the product manufacturer.
e) Disinfectants must not be used past the expiry date.
f) Manufacturer s directions must be carefully followed regarding the ambient temperature
and duration of contact for disinfectant (e.g. 2% glutaraldehyde = 20 minutes at 20°C).
g) Following disinfection, rinse the endoscope and flush the channels with water (preferably
sterile water).
12.8 Endoscopic accessories (e.g. biopsy forceps and brushes) that break the mucosal barrier
must be sterilized after each use.33
a) Because of the difficulty cleaning biopsy forceps/brushes, it is strongly recommended
that disposable items be used.
b) If biopsy forceps/brushes are not disposable, they must be meticulously cleaned prior to
sterilization using ultrasonic cleaning.
12.9 If an automated endoscope reprocessor (AER) is used, ensure that the endoscope and
endoscope components are compatible with the AER.34
a) Follow the manufacturer s instructions for use of the AER.
b) Ensure that the endoscope to be reprocessed is compatible with the AER used.
c) Ensure that channel connectors and caps for both the AER and the endoscope are
compatible.
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