Part V: Infection Prevention and Control Guideline for Flexible Gastrointestinal Endoscopy and Flexible Bronchoscopy – Recommendations for reprocessing flexible endoscopes

PART V. RECOMMENDATIONS FOR REPROCESSING FLEXIBLE ENDOSCOPES

1. Administrative Recommendations

1.1 Policies and Procedures

All healthcare settings where endoscopies are performed should have detailed written policies and procedures for the cleaning, reprocessing, and handling of flexible endoscopes that are based on current recognized standards and recommendations. Policies and procedures should include responsibilities of management and staff and the qualification, education and training of personnel involved in reprocessing^{Footnote 1} ^{Footnote 2} ^{Footnote 6} ^{Footnote 11} ^{Footnote 12} ^{Footnote 16} ^{Footnote 91} ^{Footnote 128}.
B II
All healthcare settings in which endoscopies are performed should have ongoing access to infection prevention and control expertise^{Footnote 176} ^{Footnote 177} ^{Footnote 178}.
B II
All healthcare facilities in which endoscopies are performed should have ongoing access to and collaboration with an Occupational Health and Safety Program^{Footnote 11}.
C II
All healthcare facilities where endoscopy is performed should have sufficient resources to support training and education programs for personnel assigned to reprocess endoscopes and accessories^{Footnote 6} ^{Footnote 9} ^{Footnote 11}.
B II
Policies and procedures for cleaning and reprocessing endoscopes, endoscope accessories, and related equipment should be reviewed at least annually, revised as necessary and readily available in the practice setting. Procedures/modifications should be documented and reviewed by the facility or organization’s Infection Prevention and Control Committee, infection prevention and control personnel or other individual(s) responsible for infection prevention and control in the setting^{Footnote 1} ^{Footnote 6} ^{Footnote 11} ^{Footnote 91}.
C II
A procedure should be established for the recall of improperly reprocessed equipment (e.g., incorrect reprocessing method was used on equipment). The recall procedure should include assessment of patient risk, and a procedure for subsequent notification of patients, other facilities, and/or regulatory bodies if indicated^{Footnote 2} ^{Footnote 12}.
C II
Healthcare settings where endoscopy is performed should have written policies regarding the use of single-use medical/equipment/devices^{Footnote 2} ^{Footnote 4} ^{Footnote 67} ^{Footnote 130} ^{Footnote 131} ^{Footnote 179}.
B II
The bronchoscopist is responsible for notifying those involved in the endoscopic procedure as well as those involved in equipment reprocessing as to whether a patient undergoing bronchoscopy may have tuberculosis.
C II

2. Recommendations for Endoscopy and Endoscopy Decontamination Equipment

Medical equipment/devices that cannot be cleaned and reprocessed according to the recommended standards should not be purchased^{Footnote 2}.
B I
All medical equipment/devices intended for use on a patient that are being considered for purchase should be assessed by infection prevention and control personnel and should meet established quality reprocessing parameters^{Footnote 2} ^{Footnote 11}. The manufacturer must supply the following:
1. Information about the design of the equipment/device and clearly indicate which parts need to be disassembled for reprocessing,
2. Manuals/directions for use,
3. Device-specific recommendations for cleaning and reprocessing of equipment/device,
4. Education for staff on use, cleaning and the correct reprocessing of the equipment/device,
5. Recommendations for auditing the recommended process.
  B II
The manufacturer’s recommendations regarding the installation, care, use, and maintenance of decontamination equipment should be followed including establishment of a preventive maintenance schedule. This includes but is not limited to cleaning, lubrication, checking for leaks, the changing of filters, and verification of settings and calibrations.
Qualified personnel only should perform equipment maintenance and repairs.
C II
Original Equipment Manufacturer (OEM) parts should be used to repair equipment^{Footnote 11} ^{Footnote 34} ^{Footnote 36}.
C II
Proper planning and assessment is necessary for the selection and purchase of automatic endoscope reprocessors (AERs) used to reprocess endoscopes and accessories^{Footnote 124}.
1. The AER must be licensed for sale in Canada^{Footnote 124}.
2. The manufacturer of the AER must identify by brand and model each endoscope that may be effectively reprocessed in the AER and the limitations of the AER in processing certain models of endoscopes and accessories^{Footnote 3} ^{Footnote 124} ^{Footnote 125}.
  
  B II
3. The reprocessing instructions provided by the endoscope manufacturer and the AER manufacturer’s instructions should be compared and any conflicting recommendations should be resolved prior to first reprocessing^{Footnote 3} ^{Footnote 85} ^{Footnote 125}.
  B I
4. The AER should effectively irrigate all channels of the endoscope. All channel connectors should be attached according to the AER manufacturer’s instructions to ensure exposure of all internal surfaces with the high-level disinfectant/chemical sterilant^{Footnote 3} ^{Footnote 85} ^{Footnote 124} ^{Footnote 126} ^{Footnote 127}.
  B I
5. The AER should have no potential reservoirs for microbial growth, i.e., areas in the AER where water or disinfectant can stagnate. For wash cycles, ensure that all wash fluids (water and chemicals) are completely drained and discarded following each cycle^{Footnote 6} ^{Footnote 124} ^{Footnote 180}.
  B I
6. If the AER uses a single-use disinfectant, the disinfectant should be completely drained between cycles.
  C II
7. If the AER uses a reusable disinfectant, the MEC should be monitored daily using test strips available from the supplier of the disinfectant^{Footnote 6} ^{Footnote 16}.
  B II
If an AER cycle is interrupted, high-level disinfection or sterilization cannot be ensured and the process should immediately be repeated^{Footnote 3} ^{Footnote 6}.
C II
Because design flaws have compromised the effectiveness of AERs, infection prevention and control personnel (or other appropriate personnel) affiliated with the facility should routinely review Health Canada’s advisories, warnings and recalls about marketed health products, Emergency Care Research Institute (ECRI) reports, manufacturer alerts, and the scientific literature for reports of AER deficiencies that may lead to infection^{Footnote 3} ^{Footnote 34} ^{Footnote 127} ^{Footnote 181}.
C II
If an automatic endoscope reprocessor manufacturer identifies a defect that may impact on effectiveness of the disinfection/sterilization process, it has an obligation to provide information to the user detailing the likely impact on disinfection/sterilization.
C II
If an endoscope requires repairs, proper disinfection should be performed prior to repair, or, if disinfection is not possible, then handling precautions as specified by the service vendor/equipment manufacturer should be followed when shipping a contaminated endoscope. Preparation and shipping of the endoscope should conform to the applicable jurisdictional requirements for the transportation of dangerous goods^{Footnote 1} ^{Footnote 11}.
C II

3. Recommendations For Reprocessing Endoscopes and Accessories

3.1 Preparing the Endoscope for Cleaning

Immediately after removal from the patient, the exterior surface of the endoscope should be wiped down with a soft lint-free cloth or endoscope sponge soaked in a freshly prepared enzymatic detergent solution^{Footnote 1} ^{Footnote 6} ^{Footnote 11} ^{Footnote 101} ^{Footnote 125}.
C II
The biopsy/suction and air/water channels should be flushed with an enzymatic detergent solution. For endoscopes with an elevator wire, manual flushing of this channel with an enzymatic detergent followed by rinsing is required^{Footnote 1} ^{Footnote 11} ^{Footnote 101} ^{Footnote 125}.
B II
The endoscope should be transported to the reprocessing area in an enclosed container. Do not transport contaminated and clean endoscopes in the same container at the same time^{Footnote 6} ^{Footnote 11} ^{Footnote 101}.
C II

3.2 Leak Testing

Pressure/leak testing should be performed according to manufacturer’s instructions after each use and prior to immersion of the endoscope in the reprocessing solution. Remove from clinical use any instrument that fails the leak test and have it repaired^{Footnote 1} ^{Footnote 3} ^{Footnote 4} ^{Footnote 6} ^{Footnote 11} ^{Footnote 60} ^{Footnote 85}.
C II

3.3 Manual Mechanical Cleaning in the Reprocessing Area

Non-immersible endoscopes should not be used^{Footnote 3} ^{Footnote 4} ^{Footnote 8} ^{Footnote 11} ^{Footnote 16} ^{Footnote 85}.
C II
The endoscope and its disassembled components (e.g., suction valves) should be completely immersed in a freshly prepared enzymatic detergent cleaner^{Footnote 1} ^{Footnote 3} ^{Footnote 6} ^{Footnote 11} ^{Footnote 15} ^{Footnote 59} ^{Footnote 85} ^{Footnote 182}.
C II
The entire endoscope, including valves, channels, connectors and all detachable parts should be meticulously cleaned with an enzymatic detergent compatible with the endoscope, according to the manufacturer’s instructions^{Footnote 1} ^{Footnote 3} ^{Footnote 5} ^{Footnote 6} ^{Footnote 9} ^{Footnote 11} ^{Footnote 12} ^{Footnote 15} ^{Footnote 43} ^{Footnote 54} ^{Footnote 85} ^{Footnote 90} ^{Footnote 100} ^{Footnote 153} ^{Footnote 183} ^{Footnote 184}.
B I
All accessible channels should be flushed and brushed to remove all organic (e.g., blood or tissue) and other residues. Repeatedly actuate the valves during cleaning to facilitate access to each surface^{Footnote 1} ^{Footnote 3} ^{Footnote 5} ^{Footnote 6} ^{Footnote 9} ^{Footnote 11} ^{Footnote 28} ^{Footnote 44} ^{Footnote 47} ^{Footnote 85} ^{Footnote 90} ^{Footnote 91} ^{Footnote 100} ^{Footnote 127} ^{Footnote 187}.
B I
Cleaning brushes appropriate to the size of the endoscope channel or port should be used (i.e., bristle should contact surfaces). Disposable cleaning items are preferred. Reusable cleaning items should be thoroughly cleaned, inspected for damage and subjected to, at a minimum, high-level disinfection after each use. Cleaning items should be discarded if worn or damaged^{Footnote 3} ^{Footnote 6} ^{Footnote 9} ^{Footnote 11} ^{Footnote 85} ^{Footnote 90} ^{Footnote 186}.
C II
The external surfaces of the endoscope and accessories should be cleaned using a soft, lint-free cloth, sponge or brushes. Use of a soft bristle toothbrush to clean the lens end is acceptable^{Footnote 6} ^{Footnote 11} ^{Footnote 101}.
C II
Enzymatic detergents should be discarded after each use as these products are not microbicidal and will not retard microbial growth^{Footnote 3} ^{Footnote 6} ^{Footnote 9} ^{Footnote 11} ^{Footnote 85} ^{Footnote 90}.
B II
The endoscope and all the channels should be rinsed thoroughly with copious amounts of tap water (minimum of three times the lumen volume) to remove residual enzymatic detergent. To decrease the possibility of diluting the disinfectant solution, excess water from the rinse should be removed from the channels by purging with forced air^{Footnote 1} ^{Footnote 6} ^{Footnote 11} ^{Footnote 12} ^{Footnote 93} ^{Footnote 101}.
C II

3.4 Sterilization and High Level Disinfection

Flexible gastrointestinal endoscopes and bronchoscopes and accessories that come in contact with mucous membranes are classified as semi-critical items and should receive, at a minimum, high-level disinfection after each use^{Footnote 1} ^{Footnote 3} ^{Footnote 5} ^{Footnote 7} ^{Footnote 9} ^{Footnote 11} ^{Footnote 12} ^{Footnote 21} ^{Footnote 85} ^{Footnote 90} ^{Footnote 187}.
B I
Endoscope accessories that penetrate mucosal barriers (e.g., biopsy forceps or other cutting instruments) are considered critical items and should be sterile before use^{Footnote 1} ^{Footnote 3} ^{Footnote 11} ^{Footnote 12} ^{Footnote 47} ^{Footnote 58} ^{Footnote 85} ^{Footnote 181} ^{Footnote 187} ^{Footnote 188} ^{Footnote 189}. See Section 3.5 Recommendations for Accessories.

B II
A Health Canada approved (possesses a drug identification number (DIN)) sterilant or high level disinfectant should be use for sterilization or high-level disinfection^{Footnote 1} ^{Footnote 11} ^{Footnote 12}.
For cleaning, disinfection and sterilization, only products that are confirmed by the manufacturer to be compatible with the endoscope and accessories should be used^{Footnote 3} ^{Footnote 4} ^{Footnote 5} ^{Footnote 9} ^{Footnote 11} ^{Footnote 12} ^{Footnote 85}.
C II
Formulations containing glutaraldehyde, glutaraldehyde with phenol/phenate, ortho-phthalaldehyde, hydrogen peroxide, peracetic acid and both hydrogen peroxide and peracetic acid can be used to achieve high level disinfection if the products are used as directed (e.g., proper concentration), and objects are properly cleaned, disinfected, rinsed and dried Refer to Table 5 for specific product recommendations for achieving high level disinfection and sterilization^{Footnote 1} ^{Footnote 3} ^{Footnote 15} ^{Footnote 43} ^{Footnote 85} ^{Footnote 102} ^{Footnote 118} ^{Footnote 190} ^{Footnote 191} ^{Footnote 192} ^{Footnote 193}.
B I
If manually reprocessed, the endoscope should be completely immersed in the high level disinfectant/sterilant and all channels should be filled with high level disinfectant. Non-immersible endoscopes should be phased out^{Footnote 1} ^{Footnote 3} ^{Footnote 6} ^{Footnote 11} ^{Footnote 15} ^{Footnote 16} ^{Footnote 28} ^{Footnote 85} ^{Footnote 90} ^{Footnote 126} ^{Footnote 127}.
C II
Endoscopes should not soak overnight. If cleaning and disinfection/sterilization cannot be performed immediately, soak the endoscope in enzymatic detergent until final reprocessing can be carried out. Consult the manufacturer’s instructions for delayed reprocessing^{Footnote 11} ^{Footnote 101}.
C II
The exposure time and temperature for disinfecting semi-critical patient care equipment varies among high level disinfectants. The label claim for high level disinfection should be followed unless several well-designed experimental scientific studies, endorsed by infection prevention and control, and/or regulators, and/or guidelines committees, demonstrate an alternative exposure time is effective for disinfecting semi-critical items^{Footnote 1} ^{Footnote 6} ^{Footnote 7} ^{Footnote 9} ^{Footnote 16} ^{Footnote 100} ^{Footnote 105} ^{Footnote 191}.
B I
If an automatic endoscope reprocessor (AER) is used, the endoscope and endoscope components should be placed in the reprocessor and all channel connectors should be attached to the AER according to the AER and endoscope manufacturer’s instructions to ensure exposure of all internal surfaces to the high-level disinfectant/sterilant. NB: See Recommendations Section 2. (f) for further AER recommendations^{Footnote 4} ^{Footnote 6} ^{Footnote 11} ^{Footnote 85} ^{Footnote 124} ^{Footnote 126} ^{Footnote 127}.
B I
If an automatic endoscope reprocessor (AER) cycle is interrupted, high-level disinfection or sterilization cannot be assured and the cycle should be repeated^{Footnote 3} ^{Footnote 6}.
After high-level disinfection, the endoscope should be rinsed and all channels flushed to remove the disinfectant/sterilant. The use of sterile or bacteria-free water is preferred but tap water can be used. If tap water is used, a subsequent 70-90% alcohol rinse is critical between each patient use. Discard the rinse water after each use/ cycle^{Footnote 3} ^{Footnote 5} ^{Footnote 9} ^{Footnote 11} ^{Footnote 15} ^{Footnote 32} ^{Footnote 36} ^{Footnote 66} ^{Footnote 85} ^{Footnote 93} ^{Footnote 100} ^{Footnote 194} ^{Footnote 195} ^{Footnote 196} ^{Footnote 197}. NB: If a final alcohol rinse is not included in an automatic endoscope reprocessor, this step should be done manually followed by forced air-drying prior to storage^{Footnote 37} ^{Footnote 181}.
B II
Prior to storage, flush the channels with 70%-90% ethyl or isopropyl alcohol^{Footnote 11} ^{Footnote 37} ^{Footnote 39}.
B II
After flushing all channels with alcohol, the channels should be dried using forced ‘medical grade’ air^{Footnote 1} ^{Footnote 3} ^{Footnote 4} ^{Footnote 9} ^{Footnote 11} ^{Footnote 12} ^{Footnote 15} ^{Footnote 29} ^{Footnote 85} ^{Footnote 93} ^{Footnote 198} ^{Footnote 199}.
C II
No recommendation can be made about the routine use of sheathed endoscopes^{Footnote 137} ^{Footnote 138} ^{Footnote 139} ^{Footnote 140} ^{Footnote 200}.
C II

3.5 Recommendations for Accessories

Ultrasonic cleaning should be used for reusable endoscopic accessories to remove soil and organic material from hard to clean areas^{Footnote 1} ^{Footnote 3} ^{Footnote 4} ^{Footnote 11} ^{Footnote 85} ^{Footnote 129} ^{Footnote 201}.
C II
Biopsy forceps are classified as critical items. If reusable, they must be steam sterilized after cleaning. Chemical sterilization does not penetrate the coils and is not effective. If disposable items are used, discard after use^{Footnote 1} ^{Footnote 3} ^{Footnote 4} ^{Footnote 47} ^{Footnote 58} ^{Footnote 85} ^{Footnote 129} ^{Footnote 189}.
B II
Other accessories that penetrate mucosal barriers (i.e., papillotomes, cytology brushes) should either be disposable or sterilized between patient use (high level disinfection is not appropriate)^{Footnote 3} ^{Footnote 4} ^{Footnote 11} ^{Footnote 85} ^{Footnote 129}.
B II
The water bottle used to provide intra-procedural flush solution and its connecting tubing should be sterilized or receive high-level disinfection at least daily. The water bottle should be filled with sterile water^{Footnote 1} ^{Footnote 3} ^{Footnote 4} ^{Footnote 11} ^{Footnote 36} ^{Footnote 85}.
B II
Each Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure requires a fresh sterile bottle filled with sterile water^{Footnote 1} ^{Footnote 11} ^{Footnote 33} ^{Footnote 101}.
B II

3.6 Storage and Transport

Valves and other components should be detached from the endoscope as per manufacturer’s instructions, thoroughly dried and stored separately^{Footnote 1} ^{Footnote 9} ^{Footnote 11} ^{Footnote 93} ^{Footnote 141}.
B II
Endoscopes should be stored uncoiled, hanging vertically in a clean, dry, ventilated area that prevents recontamination or damage^{Footnote 1} ^{Footnote 3} ^{Footnote 4} ^{Footnote 6} ^{Footnote 9} ^{Footnote 11} ^{Footnote 16} ^{Footnote 85}.
C II
The storage area should be cleaned weekly with an approved low level disinfectant/cleaner^{Footnote 1} ^{Footnote 11}.
C II
The maximum allowable storage time before reprocessing is required is 7 days^{Footnote 11} ^{Footnote 143} ^{Footnote 144} ^{Footnote 145} ^{Footnote 146} ^{Footnote 202}.
B II
A carrying case should be used exclusively to transport the used instrument and not used for storage. Once placed in the carrying case, the instrument will be considered not patient ready and will require reprocessing before being used^{Footnote 9} ^{Footnote 11} ^{Footnote 85}.
C II
If a case is needed to transport the processed endoscope, it should be designated for this purpose and well marked. Do not use the same case to transport used and reprocessed scopes^{Footnote 147}.
C II

4. Recommendations for Endoscopy Unit Design

All settings where endoscopes are used and disinfected should be designed to provide a safe environment for patients and healthcare workers. Design should accommodate proper workflow from dirty to clean with adequate separation to minimize risk of cross contamination^{Footnote 4} ^{Footnote 11} ^{Footnote 167}.
C II
Reprocessing areas should be physically separate from patient procedure rooms^{Footnote 6} ^{Footnote 8} ^{Footnote 11} ^{Footnote 16} ^{Footnote 167}.
C II
The procedure room should have a separate, dedicated hand-washing sink with hands-free controls. A separate hand washing station should be provided in the reprocessing area^{Footnote 11} ^{Footnote 67}.
C II
Air-exchange equipment (ventilation system, exhaust hoods) should be used to minimize the exposure of all persons to potentially toxic vapours and air quality should be monitored regularly^{Footnote 3} ^{Footnote 11} ^{Footnote 85}. See Recommendations Section 5.2 (e).
C II
The reprocessing area should be under negative pressure and have an air-exchange rate of, at minimum, 10 per hour^{Footnote 11}.
Bronchoscopy procedures and patient recovery post bronchoscopy must be performed in a negative pressure room with a minimu air-exchange rate of 12 per hour in newly constructed isolation rooms or 6 per hour in existing facilities^{Footnote 168} ^{Footnote 169} ^{Footnote 170}.
Clean storage space, which is physically separate from decontamination and cleaning areas, should be provided. Storage space should have adequate positive pressure ventilation^{Footnote 11} ^{Footnote 167} ^{Footnote 170}.
C II

5. Recommendations for Quality Management

5.1. Personnel Education and Training

All healthcare personnel in any setting where gastrointestinal endoscopy and bronchoscopy are performed should be trained in and adhere to Health Canada Guidelines: Routine Practices and Additional Precautions for Preventing the Transmission of Infection in Health Care^{Footnote 13}, which includes the correct use and requirement to wear personal protective equipment to protect both patients and healthcare workers, and Hand Washing, Cleaning, Disinfection and Sterilization in Health Care^{Footnote 12}. For detailed recommendations, refer to Health Canada Guidelines: Routine Practices and Additional Precautions for Preventing the Transmission of Infection in Health Care^{Footnote 13} and Hand Washing, Cleaning, Disinfection and Sterilization in Health Care^{Footnote 12}.
B I
Personnel assigned to reprocess endoscopes and accessories should receive hands-on training with written device-specific reprocessing instruction for every endoscope model and automatic endoscope reprocessor in their area of responsibility^{Footnote 3} ^{Footnote 4} ^{Footnote 6} ^{Footnote 7} ^{Footnote 11} ^{Footnote 85} ^{Footnote 91} ^{Footnote 125} ^{Footnote 127}.
B II
Personnel should meet the healthcare setting’s written endoscope reprocessing competency requirements. Documented competency testing should be carried out initially after completion of training and subsequently on a regular basis (e.g., at least annually). Additional training with documented competency should be provided for new models of endoscopes or automatic endoscope reprocessors as they are introduced into the practice setting^{Footnote 11}.
B II
Temporary personnel should not be allowed to reprocess endoscopes until competency has been established^{Footnote 3} ^{Footnote 4} ^{Footnote 6} ^{Footnote 8} ^{Footnote 11} ^{Footnote 16} ^{Footnote 85} ^{Footnote 91} ^{Footnote 125} ^{Footnote 127}.
B II
All personnel using chemicals should be educated about the biological and chemical hazards present while performing procedures that use disinfectants/sterilants. Occupational health and safety training should include the workplace hazardous materials information system (WHMIS)^{Footnote 13}.

5.2. Worker Health and Safety

Personal protective equipment (e.g., gloves, gowns, eye protection with visors or goggles, and respiratory protection devices) should be readily available and should be used routinely to protect workers from exposure to chemicals, blood or other potentially infectious material. For detailed recommendations, refer to Health Canada Guidelines: Routine Practices and Additional Precautions for Preventing the Transmission of Infection in Health Care^{Footnote 13} ^{Footnote 159} and CSA Standard Z314.8-08: Decontamination of Reusable Medical Devices^{Footnote 1} ^{Footnote 2} ^{Footnote 3} ^{Footnote 4} ^{Footnote 5} ^{Footnote 11} ^{Footnote 13} ^{Footnote 73} ^{Footnote 85} ^{Footnote 158} ^{Footnote 165}.
An N95 respirator should be used during an endoscopic procedure if pulmonary or laryngeal tuberculosis is suspected^{Footnote 5} ^{Footnote 101} ^{Footnote 165} ^{Footnote 203} ^{Footnote 204}.
C II
All susceptible personnel should receive immunizations as recommended by the National Advisory Committee on Immunization (NACI)^{Footnote 164} and receive tuberculin skin testing in accordance with Public Health Agency of Canada guidelines^{Footnote 11} ^{Footnote 168}.
B I
Established written protocols, in accordance with the healthcare facility’s Occupational Health and Safety Program, should be in place to prevent and manage worker exposure to infectious agents (e.g., HBV, TB) and toxic chemicals^{Footnote 3} ^{Footnote 4} ^{Footnote 12} ^{Footnote 85} ^{Footnote 124} ^{Footnote 128}.
B I
Wherever chemical disinfection/sterilization is performed using products that produce toxic vapours (e.g., glutaraldehyde), work areas need to be properly ventilated to ensure levels are below threshold limit values (TLVs) specified in provincial and federal Occupational Health and Safety (OH&S) regulations. Recirculation of air in the area where the product is used is prohibited by OH&S regulation and ventilation must be to the exterior)^{Footnote 11} ^{Footnote 34} ^{Footnote 65} ^{Footnote 101} ^{Footnote 114} ^{Footnote 121} ^{Footnote 128}.

5.3. Reprocessing Program

Manufacturer’s written recommendations for use of sterilants/chemical disinfectants and instructions for reprocessing should be followed^{Footnote 11} ^{Footnote 101} ^{Footnote 125} ^{Footnote 128}.
B I
All manufacturer’s written recommended maintenance schedules and services for endoscopes and automatic endoscope reprocessors used in the facility should be adhered to^{Footnote 3} ^{Footnote 4} ^{Footnote 9} ^{Footnote 11} ^{Footnote 15} ^{Footnote 16} ^{Footnote 85} ^{Footnote 91} ^{Footnote 101}.
C II
Visual inspections of equipment should be conducted to ensure that it is in proper working order in accordance with the endoscope manufacturer’s recommendations and to identify conditions that may affect the cleaning or disinfection processes^{Footnote 3} ^{Footnote 11}.
B II
Routine testing of the liquid sterilant/high-level disinfectant should be performed to ensure minimum effective concentration (MEC) of the active ingredient. Product-specific test strips should be used. The solution should be checked at the beginning of each day of use (or more frequently) and the results documented. If the chemical indicator shows that the concentration is less than the MEC, the solution should be discarded. A log of test results should be maintained^{Footnote 3} ^{Footnote 4} ^{Footnote 6} ^{Footnote 11} ^{Footnote 85} ^{Footnote 101}.
B II
The liquid sterilant/high level disinfectant should be discarded at the end of its reuse life (which may be single-use), regardless of the minimum effective concentration^{Footnote 6} ^{Footnote 11} ^{Footnote 23} ^{Footnote 205}.
B II
Healthcare facilities should develop protocols to ensure that users can readily identify whether an endoscope is contaminated or is ready for patient use^{Footnote 3}.
C II
A permanent record of reprocessing shall be completed and retained according to the policy of the facility. The record shall include but not be limited to the patient’s name and medical record number, the endoscopist, identification number and type of endoscope (and automatic endoscope reprocessor, if used), date and time of the clinical procedure, results of each individual inspection and leak test and the name of the person reprocessing the endoscope^{Footnote 3} ^{Footnote 4} ^{Footnote 6} ^{Footnote 9} ^{Footnote 10} ^{Footnote 11} ^{Footnote 85} ^{Footnote 101} ^{Footnote 135} ^{Footnote 136} ^{Footnote 153} ^{Footnote 154} ^{Footnote 172} ^{Footnote 205} ^{Footnote 206} ^{Footnote 207} ^{Footnote 208}.
B I
A surveillance system capable of detecting clusters of infections or pseudo-outbreaks associated with endoscopic procedures should be established^{Footnote 76} ^{Footnote 205}.
B I
Routine microbiologic testing of endoscopes for quality assurance purposes is not recommended. If endoscope cultures are indicated (e.g., outbreak investigation), see Appendix D for sample collection method and interpretive criteria^{Footnote 3} ^{Footnote 4} ^{Footnote 85} ^{Footnote 124} ^{Footnote 172}.
C II

6. Recommendations for Outbreak Investigation and Management

If a cluster of suspected or confirmed endoscopy-related infections occurs, an investigation should be initiated to determine the potential routes of transmission (e.g., person-to-person, common source) and reservoirs. Use standard methods for outbreak investigation. Refer to Appendix H, Guideline for Outbreak Investigation Related to Endoscopic Procedures^{Footnote 76}.
B I
If a breach in protocol is recognized, a risk assessment should be initiated to determine if patient notification is required^{Footnote 5} ^{Footnote 80} ^{Footnote 82} ^{Footnote 83} ^{Footnote 174}.
B I
If a breach in protocol is recognized, an assessment and investigation should be performed to determine why this happened and how to prevent a recurrence^{Footnote 174}.
B I
Outbreaks of endoscope-related infections should be reported to persons responsible for infection prevention and control, risk management and all involved department heads. If there are public health implications, notify local public health authorities and Health Canada. Where appropriate, notify the manufacturer(s) of the endoscope, disinfectant/sterilant, and automatic endoscope reprocessor^{Footnote 3} ^{Footnote 4} ^{Footnote 5} ^{Footnote 9} ^{Footnote 11} ^{Footnote 23} ^{Footnote 80} ^{Footnote 85} ^{Footnote 101} ^{Footnote 122} ^{Footnote 205}.
B I

7. Recommendations for Classic and Variant Creutzfeldt-Jakob Disease (CJD and vCJD)

Refer to Health Canada/Public Health Agency of Canada Infection Prevention and Control Guideline, Classic Creutzfeldt-Jakob Disease in Canada-Quick Reference-2007^{Footnote 75} and “Classic Creutzfeldt-Jakob Disease in Canada”^{Footnote 209} for definitions of high risk patient, high and low infectivity tissues, risk assessment tools and special recommendations for cleaning and decontamination of instruments and surfaces that have been exposed to tissues considered infective for CJD. The recommendations for gastrointestinal and bronchoscopic endoscope reprocessing found in this section are updated from those in the earlier Canadian CJD guidelines. The general procedures for reprocessing endoscopes already outlined in this guideline should be followed. In addition, the following are recommended for CJD.

Channel cleaning brushes and, if a biopsy has been taken, the valve on the endoscope biopsy/instrument channel port should be disposed of as clinical waste after each use. Single use biopsy forceps should be used^{Footnote 7}.
C II
Disinfectants with fixative properties (e.g., aldehyde disinfectants) should not be used on flexible scopes used for any procedure on patients with a diagnosis of definite, probable, or possible CJD/vCJD, or where the diagnosis of CJD/vCJD is unclear^{Footnote 7}.
B I
Following the decontamination of the endoscope, the automatic endoscope reprocessor (AER) should be run through an empty cycle. Any solid waste or tissue remaining in the AER should be removed together with the outlet strainer and disposed of by incineration. Liquid waste should be disposed of safely by normal direct discharge from the AER. The usual self-disinfection cycle should be run as per recommended routine. Endoscopic accessories and cleaning aids should be disposed of by incineration^{Footnote 7}.
C II
Endoscopes used for invasive (e.g., biopsy) procedures in individuals with definite, probable, or possible vCJD, or where the diagnosis of vCJD is unclear, should be removed from use or quarantined to be re-used exclusively on that same individual if required. The endoscope should be fully cleaned and decontaminated alone using an automatic endoscope reprocessor immediately after use, before being quarantined^{Footnote 7}.
C II
If there is a risk that the endoscope could become contaminated with olfactory epithelium, a single use endoscope should be used if possible. If this is unavailable the endoscope should be removed from use^{Footnote 7}.
C II
If it has been found retrospectively that an invasive endoscopic procedure was performed on a patient suspected to have vCJD, endoscopy equipment should be managed as in 7d. The instrument should be stored in a dated, leak proof, puncture-resistant container, labelled “biohazardous”. The container should then be stored in a secure area and a monitoring system should be in place to ensure that the instrument is not re-circulated into the system until the diagnosis has been confirmed by neuropathological examination. If the diagnosis is positive for vCJD, the instrument should be incinerated. If an alternative diagnosis (i.e., not vCJD) is made, the instrument does not require CJD precautions, and routine cleaning and sterilization/disinfection may be initiated^{Footnote 7} ^{Footnote 210}.
C II
If it has been found retrospectively that an invasive endoscopic procedure was performed on a patient suspected to have vCJD, reusable cleaning brushes that are still in use should be disposed of by incineration.
C II
A record should be kept of each endoscope used for each patient. Refer to Recommendation 5.3 (g) for details. This is important for any future contact tracing when possible endoscopic disease transmission is being investigated.
C II
Outbreaks of endoscope-related prion infections should be reported to persons responsible for infection prevention and control, risk management, all involved department heads and the Public Health Agency of Canada CJD Surveillance Unit (phone 1-888-489-2999). If patient and physician notification and follow-up are required, refer to Appendix H, Guideline for Outbreak Investigation Related to Endoscopic Procedures.
C II

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Date modified:: 2011-02-14

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