《多学会指南：软式胃肠内镜及附件再处理（2020）》解读：胃肠内镜再处理部分

2021年美国胃肠内镜学会（American Society for Gastrointestinal Endoscopy,ASGE）联合多家学会组织共同更新发布了《多学会指南：软式胃肠内镜及附件再处理（2020）》（以下简称“2020指南”）。2020指南针对22个临床问题提出建议,问题涵盖员工培训和内镜再处理技能的能力、胃肠内镜再处理流程、内镜科室布局和流程、内镜维护、内镜科室感染控制小组、内镜附件再处理及内镜微生物监测等方面,同时对清洗、干燥和储存等再处理关键步骤的相关内容进行了详细的拓展,并纳入了与改善胃肠内镜再处理相关的最新证据。本文仅对胃肠内镜再处理流程部分的指南进行了解读和分析,内容供胃肠内镜医护人员参考,以期提高再处理质量,降低院内感染发生率。     

Variability in reprocessing policies and procedures for flexible fiberoptic endoscopes in Massachusetts hospitals

BACKGROUND: Concern is increasing regarding the risk of transmission of blood-borne pathogens by means of improperly reprocessed medical devices. METHODS: On-site surveys of policies and practices were performed in 18 reprocessing areas in eight randomly selected hospitals in Massachusetts to assess current practices for reprocessing of flexible fiberoptic endoscopes. Manufacturers' and internal written protocols, were reviewed, employees were interviewed, and procedures were observed. Reprocessing included high-level disinfection in 17 of 18 areas, with 16 areas using 2% glutaraldehyde; ethylene oxide gas sterilization was used in one area. RESULTS: Considerable interhospital and intrahospital variability was found in high-level disinfection procedures, including equipment, contact time (range 10 to 45 minutes), disinfectant testing, and rinsing. Disinfection of internal channels was inadequate in three areas, recommended sterilization of biopsy forceps was not performed in five, and written protocols were unavailable in three. Ad hoc deviation from established written or verbal protocols occurred in eight areas during reprocessing of flexible fiberoptic endoscopes from patients known to have AIDS; ethylene oxide sterilization was used in seven areas and a separate device was used in one. Interviews with personnel revealed that lack of knowledge of high-level disinfection contributed to the discrepancies between policy and practice. CONCLUSIONS: We conclude that reprocessing of flexible fiberoptic endoscopes is inconsistent and potentially ineffective. Knowledge that a flexible fiberoptic endoscope was used for a patient with AIDS influences practice.     

Real-time monitoring in managing the decontamination of flexible gastrointestinal endoscopes

OBJECTIVES: To evaluate the efficacy of endoscope reprocessing using bacteriologic methods and adenosine triphosphate (ATP) bioluminescence and to evaluate the potential benefits of the latter in managing the process. SETTING: An endoscopy unit in each of 2 acute district general hospitals in the United Kingdom. METHODS: Following visual observation, 8 locations important in the decontamination of gastrointestinal (GI) endoscopes were monitored during reprocessing by bacteriologic sampling (paddle method) and ATP bioluminescence. RESULTS: Endoscope reprocessing was conducted in accordance with British Society of Gastroenterology guidelines. Bacteriologic tests required 24 hours for results to be obtained; ATP tests were completed within 2 minutes. Of the 504 sites tested throughout the decontamination process, bacterial growth was recorded on 32 occasions, 3 from the end product. Throughout the decontamination process, ATP tests obtained 95 results above benchmark values and 1 from the end product. CONCLUSIONS: The bacteriologic results after terminal disinfection indicated that the reprocessing was carried out effectively overall. ATP results prior to disinfection indicated that manual cleaning might not have always been performed adequately and that this could have impaired the disinfection process. ATP provided a rapid means of assessing the efficacy of cleaning steps prior to terminal disinfection.     

HYGEA (Hygiene in gastroenterology--endoscope reprocessing): Study on quality of reprocessing flexible endoscopes in hospitals and in the practice setting

The quality of reprocessing gastroscopes, colonoscopes and duodenoscopes in daily routine of 25 endoscopy departments in hospitals and 30 doctors with their own practices was evaluated by microbiological testing in the HYGEA interventional study.In 2 test periods, endoscopes ready for use in patients were found contaminated at high rates (period 1: 49 % of 152 endoscopes; period 2: 39 % of 154 endoscopes). Culture of bacterial fecal flora (E. coli, coliform enterobacteriaceae, enterococci) was interpreted indicating failure of cleaning procedure and disinfection of endoscopes. Detection of Pseudomonas spp. (especially P. aeruginosa) and other non-fermenting rods - indicating microbially insufficient final rinsing and incomplete drying of the endoscope or a contaminated flushing equipment for the air/water-channel - pointed out endoscope recontamination during reprocessing or afterwards. Cause for complaint was found in more than 50 % of endoscopy facilities tested (period 2: 5 in hospitals, 25 practices). Reprocessing endoscopes in fully automatic chemo-thermally decontaminating washer-disinfectors with disinfection of final rinsing water led to much better results than manual or semi-automatic procedures (failure rate of endoscopy facilities in period 2 : 3 of 28 with fully automatic, 8 of 12 with manual, 9 of 15 with semi-automatic reprocessing). The study results give evidence for the following recommendations: 1. Manual brushing of all accessible endoscope channels has to be performed even before further automatic reprocessing; 2. For final endoscope rinsing, water or aqua dest. should only be used disinfected or sterile-filtered; 3. Endoscopes have to be dried thoroughly using compressed air prior to storage; 4. Bottle and tube for air/water-channel flushing have to be reprocessed daily by disinfection or sterilization, and in use, the bottle have to be filled exclusively with sterile water.The HYGEA study shows that microbiological testing of endoscopes is useful for detection of insufficient reprocessing and should be performed for quality assurance in doctors' practices, too. The study put recommendations for reprocessing procedures in more concrete terms.     

Reprocessing of flexible endoscopes

Abstract Proper reprocessing of endoscopes prevents the risk of transmission of infection between patients. Meticulous mechanical cleaning is the most important step as it removes the majority of the contaminating bacteria. It should be performed before manual or automatic disinfection. High-level disinfection involves total immersion of the endoscope in a liquid chemical germicide (LCG) at a preset temperature and concentration for a pre-determined period of time. Subsequent rinsing and drying are essential steps to remove the chemical solution and prevent bacterial colonization during storage. Endoscopy units that are used for more than 50 procedures per week may benefit from cleaning in an automatic endoscope reprocessor (AER). This allows automated exposure of the endoscope to the LCG with subsequent flushing and drying of the channels, and minimizes staff exposure to the LCG. Reprocessing should be performed by trained and accredited personnel according to written guidelines or standards of practice as defined by professional societies. Regular monitoring of the reprocessing process is important for quality control and in ensuring patients' safety.     

Efficacy of high-level disinfectants for reprocessing GI endoscopes in simulated-use testing

BACKGROUND: There has been recent public concern regarding the adequacy of current practices for flexible endoscope reprocessing. High-level disinfection is defined by the Food and Drug Administration (FDA) as a minimum of 6-log reduction of mycobacteria under a worst-case scenario. Several agents are currently approved by the FDA, but published data on their relative efficacies against mycobacteria are lacking. The objective of this study was to determine the efficacy of these agents for high-level disinfection. METHODS: In simulated-use testing, video endoscopes (5 colonoscopes and 5 duodenoscopes) were each inoculated with 9.0 x 10(7) colony-forming units of Mycobacterium chelonae. Cleaning was performed by using a standardized protocol. Each endoscope was then subjected to chemical disinfection with Cidex (2.0% glutaraldehyde) at 20 degrees C for 20 minutes, Sporox (7.5% hydrogen peroxide) at 20 degrees for 30 minutes, and Steris 20 (0.2% peracetic acid) at 50 degrees C to 56 degrees C for 12 minutes using the Steris System 1 processor. Although not FDA-approved, tests were also conducted by using 70% isopropyl alcohol at 20 degrees C for 20 minutes. These results were compared with disinfection with ethylene oxide gas. All channels were sampled for M chelonae before and after manual cleaning and after disinfection. RESULTS: Cleaning alone resulted in an average log reduction of 3. Cidex, Sporox, Steris 20, ethylene oxide gas, and isopropyl alcohol, in combination with manual cleaning, each achieved a 6-log or greater reduction of the mycobacterial inoculum. No organisms were recovered from any channel after reprocessing with ethylene oxide and Steris 20. CONCLUSIONS: Commercially available high-level disinfectants are equally efficacious for reprocessing flexible GI endoscopes when used in conjunction with cleaning and in accordance with recommended guidelines.     

Efficacy of electrolyzed acid water in reprocessing patient-used flexible upper endoscopes: Comparison with 2% alkaline glutaraldehyde

BACKGROUND AND AIM: Two percent glutaraldehyde, the most widely used liquid chemical germicide (LCG), may be hazardous to patients and medical personnel. Alternatives to glutaraldehyde, such as electrolyzed acid water (EAW), are being developed, but data from well-controlled studies with patient-used endoscopes are rare. The purpose of the present paper was to evaluate the high-level disinfection capability of EAW and compare it with glutaraldehyde. METHODS: A random sample of 125 endoscopes was collected immediately after upper endoscopic examination. After careful manual cleaning, endoscopes were divided into a glutaraldehyde and EAW group. After the disinfection procedure, samples from working channel (S-1), insertion tube (S-2), umbilical cord (S-3), and angulation knob (S-4) were taken and cultured. Another twenty endoscopes were experimentally contaminated with hepatitis B virus (HBV) and samples were collected after contamination (T-1), after manual cleaning (T-2), and after final disinfection (T-3). Polymerase chain reaction (PCR) for HBV-DNA was performed. RESULTS: In the EAW group, culture-positive rates were 3.2% in S-1, 9.5% in S-2, 3.2% in S-3, and 27.0% in the S-4 samples. There was no significant difference between the EAW and glutaraldehyde groups for all sampling sites. However, in both groups, disinfection of the angulation knobs (S-4) was less efficient than the others. For the T-1 site, HBV-DNA was detected from all of them, and in 95% (19/20) of T-2. However, HBV-DNA was not detected from T-3 samples. CONCLUSIONS: Electrolyzed acid water is as efficient as glutaraldehyde in eliminating bacteria from patient-used endoscopes. After disinfection procedures using both methods, HBV-DNA was not detected from any endoscopes experimentally contaminated with HBV-positive mixed sera. However, some bacteria may remain on the surface of the endoscopes. Therefore, more careful precleaning of the endoscopes may help achieve high-level disinfection in the clinical setting.     

Guidelines for standardizing cleansing and disinfection of gastrointestinal endoscopes

As part of the activities toward standardizing endoscopy procedures, the Japan Gastroenterological Endoscopy Society has prepared guidelines for cleansing and disinfection of gastrointestinal endoscopes. The environment of gastrointestinal endoscopy differs between Japan and advanced Western countries. In advanced Western countries, gastrointestinal endoscopy is performed almost exclusively at specialized facilities, where strict provisions are observed for cleansing and disinfecting endoscopes. In Japan, however, gastrointestinal endoscopy is performed even in small clinics, and the annual number of gastrointestinal endoscopy cases is enormous. In addition, the method for cleansing and disinfecting endoscopes differs among hospitals. Although there is a distinct lack of evidence for how gastrointestinal endoscopes are cleaned and disinfected, it is necessary to standardize the method for doing so to advance the field of endoscopic medicine.