Endoscope washer disinfector

Introduction

An endoscope washer disinfector is a medical device used for the automated cleaning, the disinfection, and, in some models, the drying of the endoscopes, and it is used in the hospitals and the clinics for the reprocessing of the flexible and the rigid endoscopes. The endoscope washer disinfector consists of a chamber or a basin, the water supply and the circulation system, the detergent and the disinfectant delivery system, the nozzles and the connectors for the channels of the endoscope, the heating system, and the control system, and it performs the automated cycles of the pre-cleaning, the washing with the detergent, the rinsing, the disinfection with the chemical disinfectant or the thermal disinfection, the final rinsing, and the drying, with the monitoring of the parameters and the logging of the cycles; the endoscope washer disinfector is used for the reprocessing of the gastrointestinal, the bronchoscopic, and the other endoscopes, for the assurance of the disinfection and the safety, for the compliance with the reprocessing guidelines, and for many other applications, with features such as the programmable cycles, the leak testing, and the data management; the endoscope washer disinfector is an essential equipment in the endoscopy units, and it reduces the risk of the infections. Endoscope washer disinfectors are used in the hospitals, in the clinics, in the endoscopy units, and for many other applications. With their automated reprocessing, endoscope washer disinfectors are essential for the endoscope safety.

Endoscope Washer Disinfector LEWD-T2010

Endoscope Washer Disinfector is a fully automated disinfector with a highly cleaning efficiency of 10 minutes. It offers high cleaning efficiency with automatic washing, cleaning, disinf...

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Standards

ISO 15883-1:2024-Washer-disinfectors-General requirements, terms and definitions and tests

ISO 15883-2:2024-Washer-disinfectors-Requirements and tests for thermal disinfection of critical and semi-critical medical devices

Complies with the above standards, but is not limited to them.

Features

1. Endoscope washer disinfector for automated cleaning, disinfection and rinsing of flexible and rigid endoscopes.

2. Medical device reprocessing system that washes, disinfects (high-level) and dries endoscopes between patient uses.

3. Suitable for hospitals, endoscopy centers, clinics, surgical centers and medical device reprocessing departments.

4. Includes washer chamber, detergent/disinfectant dosing, water heating, filtration, drying, controls and manual.

5. Supports automated reprocessing of flexible endoscopes (gastroscope, colonoscope, bronchoscope) and rigid endoscopes.

FAQ

Q1: What testing scenarios is this washer disinfector mainly applied to?

A: The endoscope washer disinfector (EWD, also called automated endoscope reprocessor - AER) is used in hospitals, endoscopy centers, outpatient surgery centers, clinics, and medical device reprocessing departments to automatically clean, high-level disinfect, rinse, and dry flexible and rigid endoscopes after patient use, ensuring that endoscopes are safe for reuse by removing bioburden and inactivating microorganisms (bacteria, viruses, spores) to prevent cross-contamination and healthcare-associated infections (HAIs). It supports endoscope reprocessing (flexible endoscopes: gastroscopes (EGD), colonoscopes, sigmoidoscopes, duodenoscopes (ERCP - elevator channel, complex), bronchoscopes, ureteroscopes, cystoscopes, echoendoscopes (EUS); rigid endoscopes: laparoscopes, arthroscopes, cystoscopes, sinuscopes, hysteroscopes; endoscope accessories: biopsy valves, forceps, brushes, bottles, connectors - per device manufacturer instructions for use (IFU)), hospital endoscopy/GI labs (high-volume reprocessing (multiple scopes per day), standardized reprocessing per AAMI/ST91, SGNA, CMS, Joint Commission standards; documentation/traceability for each scope), outpatient surgery centers (same-day surgery endoscopy, rigid scope reprocessing), clinics (smaller volume, flexible endoscopes), and veterinary/animal hospitals (endoscopes for animal procedures). Process: After manual pre-cleaning (at point of use - flush channels, wipe insertion tube), leak testing (flexible endoscopes - verify no water ingress into internal channels), the endoscope is loaded into the AER. The AER automatically performs: pre-wash/flush (detergent cleaning of internal channels and external surface with enzymatic or alkaline detergent, pressurized flushing of all channels), rinse (water to remove detergent), high-level disinfection (chemical disinfectant (OPA - ortho-phthalaldehyde, glutaraldehyde, hydrogen peroxide, peracetic acid) circulated through channels and over surface at specified concentration/temperature/contact time), rinse (sterile or filtered water to remove disinfectant residue), alcohol rinse and forced air drying (to prevent moisture-related bacterial growth (e.g., Pseudomonas, Mycobacterium) in channels). The AER provides consistent, validated reprocessing with cycle documentation (critical for infection control and regulatory compliance).

Q2: What standards does the washer disinfector comply with?

A: The endoscope washer disinfector follows relevant ISO, AAMI, FDA, EN and GB/T standards including ISO 15883 (washer-disinfectors - parts 1-5: general requirements, requirements for washer-disinfectors employing thermal disinfection, evaluation of efficacy, requirements for washer-disinfectors employing chemical disinfection for thermolabile instruments including endoscopes), AAMI ST91 (flexible and semi-rigid endoscope processing in health care facilities - comprehensive guidance), AAMI ST58 (chemical sterilization and high-level disinfection in health care facilities), FDA 510(k) (medical device clearance - AERs and disinfectants are FDA-cleared/registered), EN ISO 15883, SGNA (Society of Gastroenterology Nurses and Associates) guidelines, CMS (Centers for Medicare & Medicaid Services) conditions of participation, and GB/T standards for medical washer-disinfectors. The hardware complies with IEC 60601-1 (medical electrical equipment safety), IEC 60601-1-2 (EMC), and is a registered medical device (FDA, CE MDR, NMPA). Disinfectants used must be FDA-cleared/registered for high-level disinfection (OPA, glutaraldehyde, hydrogen peroxide, peracetic acid) and used per label (concentration, contact time, temperature). For hospitals, follow accreditation standards (Joint Commission, AAAHC, DNV) and regulatory (CMS, state health dept, FDA). Calibration/validation includes installation qualification (IQ), operational qualification (OQ), performance qualification (PQ) per ISO 15883 and AAMI; routine monitoring of disinfectant concentration (test strips), water quality, cycle parameters, and biological monitoring (for sterilizers, not typically for AER high-level disinfection, but some facilities use).

Q3: What is the warranty period for the whole washer disinfector and key components?

A: The whole endoscope washer disinfector is covered by a 12-24 month warranty (medical devices often 1-2 years; some 3 years). The chamber, pumps, valves, heating system, dosing pumps, filters, controller/software, and housing are covered, while detergent/disinfectant (consumable - per-cycle cost), filters (HEPA/water filters - replace periodically), spray arms/nozzles (wear/clog - clean/replace), door seals/gaskets (wear - replace if leaking), and chemical containers are consumables/accessories. Damage from improper use, using non-approved disinfectants/detergents (can damage seals, tubing, chamber; void warranty - use only chemicals approved by AER and endoscope manufacturer), inadequate water quality (hard water causes scaling, damage to pumps/valves; use treated/RO water), clogging (bioburden, debris in channels/nozzles - clean filters/spray arms), chemical spill/corrosion, or unauthorized repair is excluded. Extended warranty and service contracts (preventive maintenance, calibration, software updates) are standard for medical devices and strongly recommended (AERs are critical for infection control; downtime requires backup reprocessing). Pumps/valves last 5-10 years; seals/filters need periodic replacement (6-12 months).

Q4: Is this device difficult to operate? Is professional training required?

A: Operation requires trained sterile processing/endoscopy reprocessing personnel (familiar with endoscope handling, infection control, chemical safety). We provide operation manuals, installation, and training (typically 1-3 days). Proper instrument setup (place AER in designated reprocessing area (separate from clinical/procedure areas; negative pressure if using glutaraldehyde; adequate ventilation for chemical fumes), connect utilities: water (treated/RO water for rinse, potable for wash - per AER IFU), drain, power (dedicated circuit, proper grounding), chemical supply (detergent, disinfectant, alcohol - connect to dosing pumps, verify levels), install/verify filters (water inlet filter, HEPA for air), verify door seal), pre-cleaning (CRITICAL: before AER, perform manual pre-cleaning at point of use (immediately after procedure): wipe insertion tube with detergent, flush/aspirate detergent through all channels (biopsy, air/water, suction, elevator) using syringe, flush air, place in transport container with damp towel; AER is NOT a substitute for manual cleaning - bioburden must be removed first; residual organic material protects microbes from disinfectant), leak testing (flexible endoscopes: perform leak test before immersion (per endoscope IFU) - pressurize channels, submerge, look for bubbles; a leak means water can enter internal components (damage scope, create biofilm niche); do NOT process leaking scope in AER - send for repair), loading (connect endoscope channels to AER connectors (ALL channels must be connected - biopsy, air/water, suction, elevator (duodenoscope); use adapters per scope model), place insertion tube in chamber (no kinks, coils appropriate size), attach accessories (valves, forceps - disassembled per IFU), close door, select cycle (choose cycle matching scope type and disinfectant; verify disinfectant concentration with test strip before each cycle (for glutaraldehyde/OPA - minimum effective concentration (MEC) test; if below MEC, replace disinfectant), start cycle), cycle monitoring (AER automatically runs: pre-wash (detergent, heated, pressurized channel flushing), rinse, disinfection (chemical at specified temp/contact time - e.g., OPA 12 min at 20 degrees C, glutaraldehyde 20-45 min at 20-25 degrees C, hydrogen peroxide per label), rinse (filtered/sterile water), alcohol rinse + forced air drying; cycle time 20-60 min depending on disinfectant; monitor cycle completion (AER displays pass/fail; if cycle fails (temperature, time, concentration error), do NOT use scope - reprocess or investigate), documentation (AER records cycle parameters (time, temp, disinfectant lot, operator, scope ID) - print or electronic log; maintain records per regulation (typically 3-5 years); traceability: link scope ID to patient (if reprocessing failure, can notify patients), unloading (wear gloves (disinfectant residue), remove scope, flush channels with alcohol and air (some AER do this automatically), hang to dry (vertical, in clean storage cabinet with forced air; ensure channels dry before storage - moisture promotes bacterial growth (Pseudomonas, Mycobacterium); store in clean, dry, designated cabinet), maintenance (daily: clean exterior, check chemical levels, verify water quality, inspect door seal, run cycle; weekly: clean chamber, spray arms, filters, inspect tubing; monthly: replace water filters, verify dosing pump calibration, check drain; semi-annually/annually: professional preventive maintenance (pumps, valves, heating, calibration, software update), disinfectant concentration testing (each use or daily - test strips; replace at MEC or per schedule (e.g., glutaraldehyde every 14-28 days, OPA per label)), water quality monitoring (RO water quality per AAMI/ST91: bacteria <10 CFU/100 mL, endotoxin <10 EU/mL for rinse water; test periodically), troubleshooting (cycle failure (temperature too low, time error, disinfectant low, pump failure - check chemical levels, water temp, filters; if persistent, service; do not bypass), scope not drying (alcohol/air step failed, channels blocked, filter clogged - check connections, clean channels, replace filter), leaking (door seal worn, chamber crack, loose fittings - replace seal, service), chemical odor (ventilation inadequate, door seal leak, spill - improve ventilation, PPE, clean spill), disinfection efficacy concern (bioburden outbreak (Pseudomonas, Mycobacterium, CRE) - common causes: inadequate manual cleaning, blocked channels, biofilm in channels, improper disinfectant concentration, moisture in storage; investigate with culture, review reprocessing process, scope maintenance (duodenoscopes with elevator are high-risk - follow FDA guidance for enhanced reprocessing, culturing), and safety (CHEMICAL HAZARD (disinfectants: glutaraldehyde (toxic, irritant, sensitizer; requires fume hood/ventilation, PPE; OSHA PEL 0.2 ppm; can cause asthma, dermatitis), OPA (stains skin/eyes, irritant; less toxic than glutaraldehyde but still requires PPE/ventilation), hydrogen peroxide (irritant, corrosive at high %), peracetic acid (corrosive, pungent) - wear PPE (gloves, goggles, mask/respirator if ventilation inadequate), use in ventilated area, have eyewash station, SDS accessible, dispose per regulations; do not mix chemicals), BIOLOGICAL HAZARD (used endoscopes carry patient bioburden (blood, mucus, bacteria, viruses including bloodborne pathogens (HBV, HCV, HIV)) - wear appropriate PPE (gloves, gown, eye protection, mask), handle as biohazard, clean spills with disinfectant, dispose sharps properly), ELECTRICAL (medical device, proper grounding, do not use with wet hands, do not spray liquid into vents), WATER QUALITY (use only water quality specified by AER/endoscope IFU (RO, filtered, sterile); improper water causes scaling, biofilm, ineffective rinsing), REGULATORY (AER and endoscope reprocessing are heavily regulated (FDA, CMS, Joint Commission, state health); follow IFU exactly, maintain records, report adverse events (infection linked to endoscope) to FDA MedWatch and manufacturer), do not use AER for sterilization (it is high-level disinfection, NOT sterilization; for sterilization use autoclave/ETO per scope IFU - most flexible endoscopes are heat-sensitive and cannot be autoclaved)) are critical for safe and effective endoscope reprocessing.

Q5: What is the typical lead-time for order delivery?

A: Standard models require 7-30 working days. In-stock units can ship within 3-7 working days. Custom configurations or large built-to-order systems may require additional time, and we confirm the exact schedule before order confirmation.

Q6: Is regular calibration required? What is the recommended calibration cycle?

A: Performance verification/calibration recommended every 6-12 months (or per quality system/regulatory) by manufacturer or certified biomedical technician: verify water temperature (wash and disinfection temps per cycle), cycle timing (contact time for disinfectant), chemical dosing (concentration of detergent/disinfectant delivered - compare to label), pump pressure/flow (channel flushing pressure), water quality (RO/filtered water bacteria/endotoxin per AAMI ST91), and alarm functions (cycle failure detection). Disinfectant concentration: test with test strips BEFORE EACH USE (or at least daily) for glutaraldehyde/OPA (MEC - minimum effective concentration); replace disinfectant when below MEC or at scheduled interval (per label, e.g., 14-28 days for glutaraldehyde). Water quality: test rinse water periodically (bacteria <10 CFU/100 mL, endotoxin <10 EU/mL per AAMI ST91; quarterly or per facility policy). Routine cycle verification: each cycle is self-monitored by AER (time, temp, chemical level) with pass/fail; maintain logs. Full annual preventive maintenance (pumps, valves, seals, filters, calibration, software) by manufacturer. For CMS/Joint Commission accreditation, follow applicable schedules and maintain records (calibration certificates, maintenance logs, disinfectant test logs, water quality results, cycle records). Endoscope reprocessing is critical for patient safety - regular maintenance and verification are essential; many facilities have service contracts for AERs (downtime is high-risk).

Q7: Are supporting consumables universal?

A: Detergent and disinfectant are often AER/endoscope-specific (use only chemicals approved by both AER manufacturer and endoscope manufacturer IFU; using non-approved chemicals can damage scope (glutaraldehyde can damage some endoscopes over time; hydrogen peroxide compatibility varies) or AER (seals, tubing) and void warranty; available from medical supply (Medivators, Steris, Olympus, CIVCO, Metrex)). Filters (water inlet, HEPA for air - specific to AER model), door seals/gaskets (specific), spray arms/nozzles (specific), endoscope adapters/connectors (specific to scope model and AER - must connect all channels; duodenoscope elevator adapter is specialized), chemical containers, PPE (gloves, goggles, masks - universal), and test strips (disinfectant concentration - specific to chemical type) are available from medical supply companies, though most are AER/scope-specific (use OEM or certified compatible to maintain efficacy and warranty). Long-term consumable cost is SIGNIFICANT (detergent + disinfectant per cycle: $2-$10+ depending on chemical; filters/seals replacement; service contract).

Q8: Can I customize parameters or supporting accessories?

A: Customization includes capacity (single-scope (one endoscope per cycle), double/twin (two scopes simultaneously), multi-scope (high-volume endoscopy centers)), disinfectant type (OPA (ortho-phthalaldehyde - fast (12 min), no activation, less toxic than glutaraldehyde, stains proteins; most common), glutaraldehyde (2% - cheap, effective, but toxic/irritating, requires activation, longer (20-45 min), ventilation), hydrogen peroxide (accelerated hydrogen peroxide - fast, low toxicity, but may not be compatible with all scopes), peracetic acid (fast, low residue, but corrosive, pungent) - AER must be compatible with chosen chemical; some AERs support multiple chemicals), cycle programs (flexible endoscope, rigid endoscope, accessories, custom cycles per scope IFU), drying (forced air, alcohol rinse, heated drying - important for preventing bacterial growth in storage), traceability/software (basic (cycle log) or advanced (scope ID tracking, patient linkage, electronic records, 21 CFR Part 11, barcode/RFID scanning, alerts for maintenance, integration with hospital IT), water treatment (integrated RO, filtration, or connection to facility RO; water quality monitoring), construction (stainless steel chamber, chemical-resistant materials, safety interlocks (door lock during cycle)), accessories (extra endoscope adapters (various scope models, duodenoscope elevator, EUS), detergent/disinfectant initial supply, test strips, water filters, PPE kit, validation package (IQ/OQ/PQ), training, service contract, certifications (FDA 510(k), CE MDR, NMPA, ISO 15883, AAMI ST91 compliance), language and accessories. Additional adapters, chemicals, and accessories can be ordered separately.

Q9: Does the purchase include on-site installation and commissioning service?

A: Standard delivery includes endoscope washer disinfector, basic adapters, hoses/connectors, power cord, and instruction manual. On-site installation, qualification (IQ/OQ), and operator training ARE typically included or strongly recommended for AERs (medical devices requiring professional installation (utility connections, water treatment), performance validation, and user training on endoscope handling, chemical safety, cycle operation, and regulatory compliance; installation by manufacturer or certified biomedical technician is standard, and many hospitals require IQ/OQ for accreditation). For self-installation (not typical for medical devices): connect utilities, install, but calibration/validation still needed. Always verify cycle performance with chemical indicators and follow endoscope manufacturer IFU before clinical use.

Q10: What types of samples are compatible with this equipment?

A: The endoscope washer disinfector reprocesses reusable endoscopes and accessories including flexible endoscopes (gastroscopes, colonoscopes, sigmoidoscopes, duodenoscopes (ERCP - with elevator channel, high-risk, requires specialized adapter and enhanced reprocessing per FDA), bronchoscopes, ureteroscopes, cystoscopes, echoendoscopes (EUS), enteroscopes, nasopharyngoscopes), rigid endoscopes (laparoscopes, arthroscopes, cystoscopes, sinuscopes, hysteroscopes, thoracoscopes - heat-sensitive, cannot autoclave; some rigid scopes can be autoclaved per IFU - check), and endoscope accessories (biopsy valves, air/water valves, suction valves, forceps, brushes, cleaning adapters, water bottles, connectors - disassembled per IFU). NOT compatible with: Single-use endoscopes/accessories (discard after use - do not reprocess), endoscopes with known leaks (do NOT process in AER - water ingress damages internal components and creates biofilm risk; repair first), endoscopes not approved for AER reprocessing (some older or specialized scopes require manual reprocessing only - check endoscope IFU), items that can be autoclaved (if scope is autoclavable per IFU, sterilization is preferred over high-level disinfection - but most flexible endoscopes are heat-sensitive), instruments with lumens that cannot be connected to AER (all channels must be flushed; if cannot connect, manual reprocessing required), and non-medical items. IMPORTANT: Endoscope washer disinfector (AER) fundamentals: (1) What it does: Automates reprocessing of heat-sensitive endoscopes: cleaning (detergent) -> rinse -> high-level disinfection (chemical) -> rinse -> drying. It does NOT sterilize (sterilization kills all microbes including spores; high-level disinfection kills most but not all spores - endospores of C. difficile may survive HLD; for critical/semi-critical devices per Spaulding classification: endoscopes are semi-critical (contact mucous membranes) -> high-level disinfection is acceptable; critical items (enter sterile tissue) need sterilization). (2) Spaulding classification: - Critical: Enters sterile tissue/vascular system (surgical instruments) -> sterilization. - Semi-critical: Contacts mucous membranes (endoscopes, laryngoscopes) -> high-level disinfection (HLD). - Non-critical: Contacts intact skin (BP cuffs, stethoscopes) -> low/intermediate disinfection. Endoscopes are semi-critical -> HLD is standard (AER provides HLD). (3) Key steps (per AAMI ST91, SGNA): 1. Pre-cleaning (point of use, immediately after procedure): wipe insertion tube, flush channels with detergent. DO NOT SKIP - AER cannot remove dried bioburden effectively. 2. Leak testing (flexible scopes): before immersion, pressurize and check for bubbles. Leaking scope = do not reprocess, send for repair. 3. Manual cleaning (if required by IFU, or after AER for complex channels): brush all channels with detergent, rinse. 4. AER processing: connect ALL channels, select cycle, run (wash -> rinse -> HLD -> rinse -> dry). 5. Drying and storage: alcohol flush + forced air, store vertically in clean, dry cabinet with forced air drying. Moisture in channels = bacterial growth (Pseudomonas, Mycobacterium). (4) High-level disinfectants: - OPA (ortho-phthalaldehyde, 0.55%): Fast (12 min at 20 degrees C for HLD), no activation, low odor, less toxic than glutaraldehyde, but stains proteins/skin gray, more expensive. Most common. MEC test strips. - Glutaraldehyde (2%): Cheap, effective (20 min at 25 degrees C for HLD), but toxic (OSHA PEL 0.2 ppm), irritant/sensitizer (asthma, dermatitis), requires activation, fumes need ventilation. Replaced by OPA in many facilities. - Accelerated hydrogen peroxide (AHP, 2-7%): Fast (5-10 min), low toxicity, breaks down to water/oxygen, but may not be compatible with all endoscopes (check IFU), expensive. - Peracetic acid: Fast, low residue, but corrosive, pungent, used in some AERs (e.g., Steris System 1E). (5) Critical issues/outbreaks: Endoscope-related infections (Pseudomonas, Mycobacterium, CRE, E. coli) have occurred due to: - Inadequate manual cleaning (bioburden protects microbes). - Duodenoscope elevator mechanism (complex, hard to clean; FDA issued safety communications, requires enhanced reprocessing, culturing, or disposable components). - Biofilm formation in channels (from incomplete cleaning/drying). - Improper disinfectant concentration/time. - Moisture in storage (bacterial proliferation). - AER design flaws (channel flushing inadequate). Facilities must follow IFU, maintain records, and have outbreak response plans. (6) Regulatory: - FDA: AERs are Class II medical devices (510(k)); disinfectants are registered/cleared. Endoscope reprocessing failures must be reported (MedWatch). - CMS: Conditions of Participation require manufacturer IFU compliance. - Joint Commission/AAAHC: Survey reprocessing practices, records, staff competency. - AAMI ST91: Comprehensive standard for flexible endoscope processing. - SGNA: Guidelines for reprocessing. - State health departments: May have specific requirements. (7) Common errors: - Skipping pre-cleaning (biggest cause of reprocessing failure). - Not connecting all channels (especially elevator channel on duodenoscopes - unflushed channel = contaminated). - Using wrong disinfectant or wrong concentration/time (not meeting HLD). - Not testing disinfectant concentration (using expired/degraded chemical). - Inadequate drying (moisture = bacterial growth in storage). - Storing scopes wet or in contaminated cabinet. - Not leak testing (processing leaking scope damages scope, creates risk). - Using non-approved chemicals (damages scope/AER). - Inadequate staff training/competency. - Poor record-keeping (cannot trace scope to patient if outbreak). (8) AER vs manual reprocessing: AER provides consistent, validated, documented cycles; reduces human error; but does NOT replace manual pre-cleaning. Manual reprocessing is backup (if AER down) but less consistent. Some complex scopes (duodenoscopes) may require both AER and enhanced manual steps per FDA.