Urologic Endoscope Reprocessing Guidelines

Point‑of‑Use Treatment (Immediately After Procedure)

Flush the air/water channel with water for at least 15 seconds before detaching the endoscope to expel blood, mucus, and debris. 1
Connect the auxiliary washing pipe to the biopsy port and depress the suction button for 15 seconds with the distal tip immersed in clean water. 1
Wipe the outer surface of the insertion tube with a lint‑free cloth to remove organic material. 1
Transport contaminated endoscopes in puncture‑resistant, leak‑proof, clearly labeled containers. 2, 3
Avoid tight looping of the endoscope during transport to prevent puncture or penetration damage. 2, 3

Leak Testing

Immerse the endoscope in water for ≥ 60 seconds and watch for continuous air bubbles to detect leaks. 2
If a leak is identified, stop reprocessing immediately and return the device to the manufacturer for repair. 4
Perform leak testing before any immersion in detergent solution. 2, 3

Manual Cleaning (Critical Step)

Inadequate manual cleaning is the primary cause of endoscope‑related infections. 5
Detach all removable parts and assemble channel connectors exactly as specified by the manufacturer’s IFU. 4
Prepare fresh enzymatic detergent in a clean sink or basin for each endoscope. 2, 3
Clean the exterior surface with a soft, lint‑free sponge saturated with enzymatic detergent. 2, 3
Manually brush every accessible channel with appropriately sized brushes until the brush appears visually clean at both ends. 2
Brush all removable parts (suction valve, air/water valve, working‑channel inlet/outlet). 2, 3
Pay particular attention to the control section, angulation controls, distal end (especially the air/water nozzle), and bridge mechanism of duodenoscopes. 1
Rinse the brush in detergent solution after each passage and remove visible debris before reinsertion. 2, 3
Immerse the endoscope in enzymatic detergent solution using an ultrasonic cleaner. 4

Rinsing After Cleaning

Flush all channels with filtered or sterile water to eliminate residual detergent. 4
Purge all channels with air to remove remaining fluid. 4

High‑Level Disinfection (HLD)

Orthophthalaldehyde (OPA) does not require ventilation systems like glutaraldehyde. 2
Glutaraldehyde (GA) requires adequate ventilation due to respiratory and skin irritation potential. 2
Contact time for GA: 10 minutes for routine disinfection; 20 minutes if mycobacterial infection is suspected. 1
Completely immerse the endoscope and all detachable parts in undiluted high‑level disinfectant. 4
Ensure all channels are filled with disinfectant—no air pockets. 1
Verify that the disinfectant’s minimum effective concentration (MEC) meets manufacturer specifications before each use. 4
Use a timer to guarantee the prescribed contact time is achieved. 1

Final Rinsing

Flush all channels with filtered or sterile water (not tap water) to remove any residual disinfectant. 4
Change rinse water frequently to avoid buildup of toxic disinfectant residues. 1

Drying (Essential to Prevent Microbial Growth)

Flush channels with 75 % alcohol to facilitate drying. 4
Use compressed air to ensure complete drying of all channels. 4
Thorough drying prevents subsequent microbial proliferation during storage. 1

Storage Requirements

Hang endoscopes vertically or place them horizontally as instructed by the manufacturer. 1
Never store endoscopes in their transit cases. 1
Maximum storage time: 7 days for regular endoscopes and 3 days for high‑risk endoscopes (e.g., duodenoscopes, linear ultrasound endoscopes). 4
If storage exceeds these periods, perform a second HLD cycle before the next patient use. 4

Automated Endoscope Reprocessors (AERs)

AERs automate and standardize critical reprocessing steps, reducing the risk of omitted procedures. 4
AERs decrease personnel exposure to disinfectants. 4
Manual cleaning remains an essential prerequisite even when using an AER. 5

Advanced Sterilization for Critical Accessories

Ethylene oxide (EtO) processing requires 1–7 days for sterilization, incubation, and aeration to remove residual gas. 6, 5
EtO sterilization demands specially trained staff, strict environmental controls, and biological indicators for monitoring. 6, 5

Critical Pitfalls to Avoid

Never skip or abbreviate the manual cleaning step; it is the most common cause of endoscope‑related infections. 5
Never store endoscopes in transit cases; always use designated ventilated cabinets. 1
Ensure adequate ventilation when using glutaraldehyde to mitigate respiratory and skin irritation risks. 2
Always follow the manufacturer’s IFU for each specific endoscope model; deviations can damage equipment or compromise disinfection. 2
Do not exceed maximum storage times (7 days for regular, 3 days for high‑risk endoscopes) without repeating HLD. 4
Worn or damaged brushes are ineffective and may damage endoscope channels; inspect and replace brushes regularly. 2, 3

Urologic Endoscope Reprocessing and Sterilization Guidelines

Classification and Processing Requirements

Standard urologic endoscopes (rigid and flexible cystoscopes) contact mucous membranes and are classified as semi‑critical; they require at least high‑level disinfection (HLD). 7, 8
These instruments are heat‑sensitive and cannot undergo steam sterilization. 9
Endoscopic accessories that penetrate blood vessels or tissues (e.g., biopsy forceps, injection needles) are critical items and must be sterilized. 7
Single‑use accessories should be preferred; reusable accessories must be sterilized according to the manufacturer’s instructions. 10
When available, prioritize autoclavable accessories such as biopsy forceps, dilators, and guidewires. 10

Leak Testing

Immerse the endoscope in water for ≥ 60 seconds and watch for continuous air bubbles to detect leaks. 8, 11, 12
If a leak is identified, halt reprocessing immediately and return the device to the manufacturer. 8, 12

Cleaning (Most Critical Step)

Detach all removable parts and attach channel connectors exactly as specified by the manufacturer. 11, 13
Immerse the endoscope in an enzymatic or neutral detergent solution using an ultrasonic cleaner. 11
Manually brush every accessible channel until the brush appears visually clean. 10

Rinsing

Flush all channels with filtered or sterile water to eliminate residual detergent. 8, 11
Purge the channels with air to remove remaining fluid. 11, 13

High‑Level Disinfection (HLD)

Completely immerse the endoscope and all detachable parts in an undiluted high‑level disinfectant. 11, 13, 14
Verify that the disinfectant’s minimum effective concentration (MEC) meets the manufacturer’s specification. 11, 13

Disinfectant Preference

Peracetic acid (PAA) is the most practical solution—more potent and faster‑acting than alternatives—and is FDA‑approved as a liquid chemical sterilant. 7, 13, 9
Orthophthalaldehyde (OPA) offers better microbiological efficacy than glutaraldehyde, with lower toxicity and reduced vaporization. 13, 14
Glutaraldehyde (GA) requires adequate ventilation because of its respiratory and skin irritation potential. 13, 14

Final Rinsing

Flush all channels again with filtered or sterile water to remove any residual disinfectant. 8, 11, 13

Drying

Flush channels with 75 % alcohol to facilitate drying. 8, 11, 14
Use compressed air to ensure complete drying of all channels. 11, 14
Thorough drying prevents subsequent microbial proliferation. 10

Storage Requirements

Store endoscopes in a designated, well‑ventilated cabinet with controlled temperature and humidity. 13, 14
Follow the manufacturer’s guidance for orientation—hang vertically or place horizontally as instructed. 13, 14, 15
Endoscopes must not touch each other while stored. 13, 14
When hanging vertically, ensure the distal end does not rest on the cabinet floor. 13, 14
Maximum storage time is 7 days for regular endoscopes and 3 days for high‑risk endoscopes; beyond these periods, perform a second HLD cycle before the next patient use. 8, 11, 12

Advanced Sterilization Methods (When Required)

Liquid chemical sterilization with PAA is the most practical solution for flexible endoscopes and is FDA‑approved as a liquid chemical sterilant. 7, 9, 13
PAA provides more rapid bactericidal effects against biofilms compared with OPA or GA. 13
Ethylene oxide (EtO) sterilization is effective and compatible with flexible endoscopes, but it has drawbacks including long turnaround time, flammability, high toxicity, and carcinogenicity. 7, 9
Steam sterilization is not recommended because flexible endoscopes are heat‑labile and cannot be autoclaved. 7, 9
Vaporized hydrogen peroxide is not recommended; it cannot adequately fill long, narrow, and bent internal channels. 7, 9

Automated Endoscope Reprocessor (AER) Advantages

AERs automate and standardize critical reprocessing steps, reducing the risk of omitted procedures. 11, 13, 12
Use of an AER decreases the likelihood of missing essential steps. 11, 12
AERs lower personnel exposure to disinfectants. 11, 12

Critical Pitfalls to Avoid

Never store endoscopes in transit cases. 10
Do not reuse single‑use accessories without proper validation and acceptance of legal liability. 10
Ensure adequate ventilation when using glutaraldehyde to mitigate respiratory and skin irritation risks. 13, 14
Always follow the manufacturer’s instructions for use (IFU) for each specific endoscope model. 8, 11, 13

Optimal Reprocessing and Handling of Flexible Urologic Endoscopes

Reprocessing Method Selection

Liquid chemical high‑level disinfection (e.g., Cidex OPA or peracetic acid) is the most practical and least damaging method for flexible urologic endoscopes, preserving instrument integrity over many cycles. 16, 17, 18, 19

Sterilization Technique Limitations

Ethylene‑oxide sterilization is compatible with flexible endoscopes but is limited by a 1–7 day turnaround, flammability, high toxicity, and carcinogenic potential. 16, 17, 18, 19
Steam (autoclave) sterilization is absolutely contraindicated because flexible endoscopes are heat‑labile and cannot withstand high‑temperature autoclaving. 16, 17, 18, 19
Hydrogen‑peroxide vapor sterilization is not recommended; vapor cannot effectively penetrate the long, narrow, and bent internal channels of flexible endoscopes. 16, 17, 18, 19

Process Standardization and Quality Assurance

Automated endoscope reprocessors (AERs) standardize critical reprocessing steps and reduce variability, although manual cleaning must still be performed before high‑level disinfection. 20
Performing meticulous leak testing before each reprocessing cycle helps detect instrument damage early. 20
Skipping manual cleaning before high‑level disinfection is the most common cause of reprocessing failure. 20
Storing endoscopes in transit cases should be avoided; designated ventilated cabinets must be used for storage. 20

Storage and Handling Recommendations

Endoscopes should be stored for a maximum of 7 days (regular) or 3 days (high‑risk); if storage exceeds these limits, a second high‑level disinfection cycle is required. 21, 20

Cystoscope Reprocessing Guidelines

Device Classification and Processing Requirements

Flexible cystoscopes are classified as semi‑critical devices because they contact mucous membranes but do not normally penetrate sterile tissue; they therefore require at least high‑level disinfection between patients. 22
Rigid cystoscopes and reusable accessories that penetrate tissue (e.g., biopsy forceps, injection needles) are critical items and must be sterilized, preferably with autoclavable instruments when available. 22
Flexible cystoscopes cannot tolerate steam sterilization because their components are heat‑labile and cannot withstand temperatures > 60 °C. 23

Preferred High‑Level Disinfection (HLD) Method

Peracetic acid (PAA) is the preferred disinfectant for flexible cystoscopes: it is FDA‑approved as a liquid chemical sterilant and achieves more rapid bactericidal activity against biofilms than glutaraldehyde or orthophthalaldehyde. 22
PAA is more powerful and faster‑acting than alternative high‑level disinfectants. 22

Alternative High‑Level Disinfectants

Glutaraldehyde (GA) requires a contact time of 20–45 minutes (depending on pre‑cleaning thoroughness) and mandates adequate ventilation to prevent respiratory and skin irritation. 23

Sterilization Options When Sterilization Is Required

Liquid chemical sterilization with PAA is the most practical method for flexible cystoscopes when sterilization rather than HLD is indicated. 22
Ethylene oxide (EtO) sterilization is effective and compatible with flexible cystoscopes because it operates at temperatures < 60 °C and uses appropriate venting caps. 23
Major drawbacks of EtO include a 1–7 day turnaround time for processing, incubation, and aeration to eliminate residual toxic gas. 23
EtO processing demands specially trained staff, strict environmental controls, biological indicators for monitoring, and carries flammability, toxicity, and carcinogenicity concerns. 23

Methods Contra‑Indicated for Flexible Cystoscopes

Hydrogen peroxide vapor sterilization is contraindicated because vapor cannot effectively penetrate the long, narrow, and bent internal channels of flexible cystoscopes. 22
Steam autoclaving is absolutely contraindicated for flexible cystoscopes due to heat sensitivity. 22

Process Controls and Quality Assurance

A timer should be used to ensure the prescribed contact time for the chosen high‑level disinfectant is achieved. 23
After disinfection, all channels must be flushed with filtered or sterile water to remove residual disinfectant. 23
Even when using automated endoscope reprocessors (AERs), manual cleaning remains an essential prerequisite to ensure effective reprocessing. 23