Endoscope reprocessing is a critical healthcare procedure to ensure reusable flexible and rigid endoscopes are safe for patient use by thoroughly cleaning, disinfecting, and/or sterilizing them to eliminate pathogens and prevent infections. The complex design of endoscopes, with intricate channels and delicate components, demands careful handling and strict adherence to manufacturer instructions for use (IFUs) to prevent damage and ensure effective reprocessing. The process involves a series of essential steps—point-of-use treatment, leak testing, manual cleaning, high-level disinfection (HLD) or liquid chemical sterilization (LCS), drying, storage, and transportation—each vital to patient safety and device functionality.
With over 250 million endoscopic procedures performed globally each year, and this number steadily increasing due to the rise of minimally invasive techniques, proper reprocessing is essential to mitigate infection risks. Contaminated endoscopes can transmit pathogens, leading to healthcare-associated infections (HAIs) with serious consequences, including prolonged hospital stays and increased costs. Regulatory bodies like the Association for the Advancement of Medical Instrumentation (AAMI), the Association of periOperative Registered Nurses (AORN), and the Society of Gastroenterology Nurses and Associates (SGNA) have established stringent guidelines to ensure patient safety, device longevity, and compliance with standards, making robust reprocessing protocols critical in healthcare settings.
The reprocessing of flexible and semi-rigid endoscopes involves a meticulous workflow to ensure safety and efficacy. Below is a detailed explanation of the essential steps, presented in a streamlined, paragraph format.
Immediately after an endoscopic procedure, point-of-use treatment is performed in the procedure room to remove organic material like blood or mucus and reduce bioburden. This step prevents soils from drying, which would make them harder to remove and compromise subsequent disinfection. Using a non-linting cloth, non-abrasive sponge, or pre-cleaning kits like the Revital-Ox™ Bedside Complete Pre-Cleaning Kit with pre-diluted detergent, the endoscope’s exterior is wiped, and channels are flushed with enzymatic detergent. Prompt action and adherence to the manufacturer’s IFU for compatible cleaning agents are crucial to ensure effective cleaning and protect staff using appropriate personal protective equipment (PPE).
Upon arrival in the reprocessing area, leak testing is conducted to detect damage to the endoscope’s external surfaces or internal channels, ensuring its watertight integrity. This can involve a dry leak test, where the endoscope is pressurized and sensors detect pressure drops, or a wet leak test, where the pressurized endoscope is submerged in water to check for bubbles indicating a leak. If damage is found, the endoscope is sent for repair per facility protocols. Following the manufacturer’s IFU for manual or automated leak testing is essential to prevent fluid ingress, which could lead to microbial growth or device failure.
Manual cleaning, the most critical reprocessing step, involves thoroughly cleaning the endoscope at a dedicated sink using a compatible enzymatic detergent, such as Revital-Ox™ Enzymatic Detergents. All removable parts are detached, the endoscope is immersed, channels and ports are brushed to remove debris, and flushed with detergent, followed by rinsing and air purging. This process, which must follow the manufacturer’s IFU for solution concentration, water quality, and timing, can reduce pathogen levels by up to 99.9%. After cleaning, visual inspection, magnified inspection, or borescope use verifies the absence of debris, with qualitative protein detection tests confirming no residual organic material. If debris or damage is detected, recleaning or repair is required.
Following manual cleaning, the endoscope undergoes high-level disinfection (HLD) or liquid chemical sterilization (LCS) to eliminate viable microorganisms or achieve sterility, depending on the device’s intended use and manufacturer IFU. HLD can be performed manually or using an Automated Endoscope Reprocessor (AER), like the ADVANTAGE PLUS™ Pass-Thru AER, which ensures consistent disinfectant exposure and minimizes cross-contamination. LCS, performed with systems like the SYSTEM 1™ endo Liquid Chemical Sterilant Processing System, eliminates all microorganisms, including bacterial endospores. The choice between HLD and LCS depends on the endoscope’s classification as a semi-critical device, with AERs recommended for efficiency and consistency.
Drying and storage are crucial to prevent microbial growth and maintain endoscope readiness. Residual moisture is removed using forced air or other IFU-specified methods, as moisture can foster biofilm formation, allowing microorganisms to multiply rapidly. Endoscopes are then stored in dedicated drying cabinets, either vertically or horizontally, designed to ensure air circulation and channel purging per ANSI/AAMI ST91:2021 standards. Proper drying and storage prevent recontamination and damage, ensuring the endoscope remains patient-ready. Regular cabinet maintenance and adherence to IFU drying protocols are essential for compliance and safety.
The final step involves transporting the reprocessed endoscope to the procedure room without recontamination or damage. Staff perform hand hygiene, wear fresh gloves, and place the endoscope in a clean, covered transport container designed to accommodate a single endoscope without over-coiling. Unless transported through a controlled corridor, these containers protect against environmental contaminants. Proper handling and transport protocols ensure the endoscope remains safe for patient use, avoiding the need for repeat reprocessing.
Endoscope reprocessing is governed by standards from AAMI, AORN, and SGNA, with ANSI/AAMI ST91:2021 providing a comprehensive guide for flexible and semi-rigid endoscope processing. These guidelines emphasize meticulous adherence to all reprocessing steps, staff training, and competency verification based on manufacturer IFUs and reprocessing equipment protocols. Documentation of each step, from leak testing to disinfection, ensures traceability and compliance. Regular monitoring with tools like borescopes and protein detection tests is recommended to verify cleaning efficacy, ensuring patient safety and regulatory adherence.
Endoscope reprocessing faces challenges like complex device designs, time-sensitive cleaning requirements, human error, emerging pathogens, and evolving regulations. Innovations addressing these include Automated Endoscope Reprocessors for consistent disinfection, advanced verification tools like borescopes and protein tests, single-use endoscopes to eliminate reprocessing needs (though limited by cost), and advanced drying cabinets with HEPA filtration. Digital tracking systems further enhance compliance by providing audit trails. These advancements help healthcare facilities meet the growing demand for endoscopic procedures while ensuring safety and efficiency.
Endoscope reprocessing is a vital process to ensure the safety of reusable endoscopes, critical for the 250 million endoscopic procedures performed annually. By meticulously following the essential steps—point-of-use treatment, leak testing, manual cleaning, HLD or LCS, drying, storage, and transportation—healthcare facilities can prevent infections, maintain device integrity, and comply with standards like ANSI/AAMI ST91:2021. Investment in advanced equipment, staff training, and adherence to manufacturer IFUs are essential to meet the rising demand for endoscopy while prioritizing patient safety and operational efficiency. For specific details on any step or reprocessing tools, feel free to ask!
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Endoscope reprocessing is a critical healthcare procedure to ensure reusable flexible and rigid endoscopes are safe for patient use by thoroughly cleaning, disinfecting, and/or sterilizing them to eliminate pathogens and prevent infections.
From October 13 to 16, 2021, Jiajing proudly participated in the China International Medical Equipment Fair (CMEF) Autumn 2021, held in Shenzhen City, at booth 13D03.
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