Reprocessing of flexible endoscopes and endoscopic accessories - an international comparison of guidelines

Endoscopic examinations and procedures are essential for diagnosis and treatment of gastrointestinal diseases. As a result of poor reprocessing practice microorganisms can be transmitted via endoscope. The majority of infection transmissions is due to insufficient performance of cleaning and disinfection disregarding guidelines of societies of gastrointestinal endoscopy. A review of the literature and a comparison of European and American guidelines for reprocessing flexible endoscopes are given. Differences in the classification of endoscopic devices, on the possibility of prion transmission, recommendations on staff training and protection, quality assurance of reprocessing and evidence-based graduation of guidelines are stressed and discussed. With respect to the procedure of endoscope reprocessing, differences concerning the cleaning solution to choose, necessity of thoroughly manual cleaning and brushing of the accessible endoscope channels (even in the case of subsequent automatic reprocessing endoscopes in washers-disinfectors), disinfection solution, microbiological quality of water for final rinsing and rationale for alcohol flush of endoscope channels for better drying are mentioned. The need for experimental investigations of the cleaning and disinfection process is stressed. In contrast to recent guidelines of European and American societies of gastrointestinal endoscopy, the now updated recommendations of the Robert Koch-Institute for reprocessing flexible endoscopes and endoscopic accessories are evidence-based and graduated.     

Survey of gastrointestinal endoscope disinfection and accessory reprocessing practices in the Asia–Pacific region

Abstract Concern has been raised about the possibility of transmission of infection by gastrointestinal endoscope. This vexation may be related to reliability of the disinfecting techniques or to the compliance with the guidelines laid down for disinfection. There have been very few recent surveys examining the disinfection practices for gastrointestinal endoscopes and their accessories. This survey was undertaken to understand such practices in the Asia–Pacific region. A questionnaire was sent by post or electronic mail to 356 randomly selected endoscopy centres in the Asia–Pacific region. Responses were received from 38.7% of the centres. The survey showed that there were significant aberrations in the application of disinfection procedures. One-third of the respondents did not practise disinfection at the start of the day's session, 2.9% of the centres were not using a high-level disinfectant and 34.7% of the centres used a soak time in 2% glutaraldehyde of less than 10 min. At 40% of the centres, at the end of the day's session, forced air or alcohol was not used to dry the endoscopes. Reuse of accessories meant for single use was widely practised.     

Cleaning and disinfection of equipment for gastrointestinal flexible endoscopy: interim recommendations of a Working Party of the British Society of Gastroenterology.

1. All patients undergoing gastrointestinal endoscopy must be considered 'at risk' for HIV and appropriate cleaning/disinfection measures taken for endoscopes and accessories. 2. Thorough manual cleaning with detergent, of the instrument and its channels is the most important part of the cleaning/disinfection procedure. Without this, blood, mucus and organic material will prevent adequate penetration of disinfectant for inactivation of bacteria and viruses. 3. Aldehyde preparations (2% activated glutaraldehyde and related products) are the recommended first line antibacterial and antiviral disinfectant. A four minute soak is recommended as sufficient for inactivation of vegetative bacteria and viruses (including HIV and HBV). 4. Quaternary ammonium detergents (8% Dettox for two minutes for bacterial disinfection), followed by exposure of the endoscope shaft and channels to ethyl alcohol (70% for four minutes for viral inactivation), is an acceptable second-line disinfectant routine where staff sensitisation prevents the use of an aldehyde disinfectant. 5. Accessories, including mouthguards and cleaning brushes, require similarly careful cleaning/disinfection, before and after each use. Disposable products (especially injection needles) may be used and appropriate items can be sterilised by autoclaving and kept in sterile packs. 6. Closed circuit endoscope washing machines have advantages in maintaining standards and avoiding staff sensitisation to disinfectants. Improved ventilation including exhaust extraction facilities may be required. 7. Endoscopy staff should receive HBV vaccination, wear gloves and appropriate protective garments, cover wounds or abrasions and avoid needlestick injuries (including spiked forceps, etc). 8. Known HIV-infected or AIDS patients are managed as immunosuppressed, and require protection from atypical mycobacteria/cryptosporidia etc, by one hour aldehyde disinfection of endoscopic equipment before and after the procedure. A dedicated instrument is not required. 9. Increased funding is necessary for capital purchases of GI endoscopic equipment, including extra and immersible endoscopes with additional accessories to allow for safe practice. 10. Greater numbers of trained GI assistants are needed to ensure that cleaning/disinfection recommendations and safety precautions are followed, both during routine lists and emergency endoscopic procedures. 11. These recommendations are based on expert interpretation of current data on infectivity and disinfection; they may require future modification.     

Endoscopic disinfection: a worldwide problem.

Safety of endoscopic procedures has been a major issue over the last 10 years. Outbreak of new infectious diseases (type C) hepatitis, Creutzfeldt-Jakob disease) underlines the necessity for strengthening cleaning and disinfection guidelines. Patients should be ensured that all endoscopic procedures are carried out with high-level disinfection endoscopes and with sterile or single-use accessories. Improvements from a hygienic point of view of both endoscopes and washer-disinfectors are important goals for manufacturers. Adequate training of endoscopic staff is one of the most crucial points to achieve the highest quality control standards in digestive endoscopy.     

GI endoscopic reprocessing practices in the United States.

BACKGROUND: Patient infection from contaminated gastrointestinal (GI) endoscopes can generally be attributed to failure to follow appropriate reprocessing guidelines. Recently, the Food and Drug Administration recommended a 45-minute exposure of GI endoscopes to 2.4% glutaraldehyde solutions heated to 25 degrees C. Simultaneously, the American Society for Gastrointestinal Endoscopy (ASGE), the American Gastroenterological Association, and the Society of Gastroenterology Nurses and Associates endorsed a reprocessing guideline that emphasized manual precleaning and recommended a 20-minute exposure to a 2.4% glutaraldehyde solution at room temperature. Since then, little information has become available regarding actual reprocessing practices in the United States. METHODS: A previously developed questionnaire regarding endoscopic disinfection practices was mailed to randomly selected members of the ASGE. RESULTS: The survey was sent to 730 members and 294 responded (40.3%). Appropriate manual cleaning (suctioning detergent through the accessory channel and brushing the channel and valves) is performed by 90.7% of respondents; 69.9% then use automated reprocessors for disinfection or sterilization. Glutaraldehyde is the most widely used chemical disinfectant; 85.3% use glutaraldehyde as one of their primary disinfectants. The most commonly used disinfection time with 2.4% glutaraldehyde is 20 minutes (83.9%) followed by 45 minutes (11.4%). Only 23.8% of users of 2.4% glutaraldehyde heat their solution; 59.6% of centers test disinfectant concentration daily or more frequently; 74.0% sterilize nondisposable forceps before use; 29.2% of centers re-use disposable endoscopic accessories (which are more frequently disinfected rather than sterilized). Twelve respondents reported cases of endoscopic cross infection. CONCLUSIONS: A significant minority of endoscopy centers still do not completely conform to recent ASGE, American Gastroenterological Association, and the Society of Gastroenterology Nurses and Associates guidelines on disinfection, and they may not be appropriately disinfecting GI endoscopes. Rigid adherence to recommended guidelines is strongly encouraged to ensure patient safety.     

Disinfection of upper gastrointestinal fibreoptic endoscopy equipment: an evaluation of a cetrimide chlorhexidine solution and glutaraldehyde.

There is little information available on the bacteriological contamination of upper gastrointestinal fibreoptic endoscopes during routine use and the effects of 'disinfecting solutions'. A bacteriological evaluation was therefore made of cleaning an endoscope and its ancillary equipment with (1) water, (2) an aqueous solution of 1% cetrimide with 0.1% chlorhexidine, and (3) activated aqueous 2% glutaraldehyde. All equipment, but particularly the endoscope itself, was found to be heavily contaminated after use with a wide variety of organisms of which 53% were Gram positive. Cleaning the endoscope and ancillary equipment with water and the cetrimide/chlorhexidine solution alone or in combination was inadequate to produce disinfection but immersion in glutaraldehyde for two minutes consistently produced sterile cultures with our sampling technique. A rapid and simple method for disinfection of endoscopic equipment is therefore recommended and we think this is especially suitable for busy endoscopy units.     

Fifty years of digestive endoscopy: Successes,setbacks, solutions and the future

Flexible endoscopes became generally available 50 years ago and created a revolution in the practice of gastroenterology. They improved diagnosis enormously, enabled quicker, less invasive, and more cost-effective surgical treatment, while endoscopic screening has prevented many cancer deaths. The new technology stimulated research leading to a better understanding of gastrointestinal pathology, identifying new diseases and clarifying the etiology of others. Better-controlled clinical trials accelerated the use of newer and more effective drugs. National and international endoscopy societies supported nursing input, encouraged research, stimulated specialist journals, and devised guidelines that encouraged audit and quality assurance. Advances in instrument design and the manufacture of new accessories enhanced endoscopic technique, diagnostic ability, patient comfort, and safety. The risk of cross-infection inherent in the use of complex labile equipment that cannot be autoclaved remains a challenge. Endoscopy societies working closely with industry have established rigid protocols for high-level disinfection that minimize the risks, but strict adherence to guidelines and continued vigilance is essential, especially with the increasing prevalence of antibiotic-resistant commensals that can give rise to opportunistic infection. Government health departments have a responsibility to encourage and support research in this area by endoscopists, instrument manufacturers, and the pharmaceutical industry. Current trends suggest that in the future, artificial intelligence will greatly improve endoscopic diagnosis, and that therapeutic endoscopy will expand, encouraging endoscopists to subspecialize.     

Recent advances in epidemiology and prevention of gastrointestinal endoscopy related infections

PURPOSE OF REVIEW: This article reviews recent publications relevant to endoscope reprocessing and the potential for transmission of infection during gastrointestinal endoscopy. RECENT FINDINGS: There have been a number of established reprocessing failures of gastrointestinal endoscopes at various healthcare facilities across the US resulting in patient notifications. These episodes have been associated with user errors and reprocessing equipment failures, highlighting the need for increased compliance with established guidelines. Surveillance cultures may be useful to monitor the outcome of reprocessing, although their use is controversial. New technology to allow point-of-use monitoring is promising. Biofilm accumulation may be an issue when reprocessing gastrointestinal endoscopes. Although peracetic acid has been promoted as superior to aldehyde-type liquid chemical germicides with regard to soil fixation, it may only be a modest improvement. Electrolyzed acid water is an emerging liquid chemical germicide that may be equivalent to currently accepted disinfectants. There appears to be no benefit to an additional reprocessing cycle before use for endoscopes that have been appropriately cleaned, disinfected, and stored. SUMMARY: With the recent media attention on gastrointestinal endoscope reprocessing failures, despite the absence of documented transmission of infection, increased compliance with existing guidelines and new initiatives to enhance endoscope reprocessing are increasingly important to maintain public confidence.     

Multi-society guideline for reprocessing flexible gastrointestinal endoscopes

Summary  Flexible gastrointestinal endoscopy is a valuable diagnostic and therapeutic tool for the care of patients with gastrointestinal and pancreaticobiliary disorders. Compliance with accepted guidelines for the reprocessing of gastrointestinal endoscopes between patients is critical to the safety and success of their use. When these guidelines are followed, pathogen transmission can be effectively prevented. Increased efforts and resources should be directed to improve compliance with these guidelines. Further research in the area of gastrointestinal endoscope reprocessing should be encouraged. The organizations that endorsed this guideline are committed to assisting the FDA and manufacturers in addressing critical infection control issues in gastrointestinal device reprocessing.     

Safety of technology: infection control standards in endoscopy

Transmission of infection related to gastrointestinal endoscopy continues to be a subject of much discussion. The principles of infection control during endoscopy are reviewed. Guidelines set forth by a number of gastrointestinal endoscopy associations have emphasized the need for meticulous cleaning of endoscopes immediately after use, followed by appropriate disinfection, rinsing and drying. Most, if not all, episodes of transmission of infection during endoscopy are associated with lapses in cleaning and disinfection protocols. The need for universal compliance with infection control standards, and for the development of strategies to achieve such compliance, is highlighted.     

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.     

The occurrence and prevention of infections associated with gastrointestinal endoscopy

In the four decades since the introduction of flexible endoscopy into medical practice, nearly 300 cases of human infections or pseudoinfections involving bacteria, fungi, parasites, and viruses have been linked to endoscopic procedures. In the majority of such cases, inadequate cleaning and disinfection techniques during the reprocessing of the instruments or their accessories have been likely contributing factors. Working groups from major gastroenterology societies and infection control organizations have established standards of care for the routine maintenance of endoscopic equipment in order to decrease the rates of infection even further. Since the institution of these standards, rates of transmission of infections to patients have decreased, though have not been completely resolved. This article reviews the available literature on transmission of pathogenic agents through endoscopic procedures, summarizes the current guidelines for the care of endoscopic equipment, and discusses available preventive measures aimed at decreasing the risk of endoscopy-related infections.     

Biopsy forceps: Reusable or disposable?

Reusable and disposable biopsy forceps are both widely available for use in gastrointestinal endoscopy units. Biopsy forceps have design and material features that may interfere with cleaning, and reusable devices must be designed to function safely and effectively following sterilization in a healthcare setting. During the last decade, endoscopic accessories have evolved from reusable to disposable in many parts of the world. Although use of disposable devices helps reduce the potential risk of cross-contamination and spread of infection, there remains the factor of cost. Major concerns for reuse of endoscopic accessories center on two main areas: sterility, and the capability of the equipment to perform its function satisfactorily after repeated uses and sterilizations. Reusable biopsy forceps perform a designated number of procedures, thus becoming more cost-effective than disposable forceps, which are impossible to clean and sterilize. The potential risk of infectious disease transmission must be taken into account. There is also the consideration that reprocessing of disposable forceps may damage or destroy the fragile devices.     

新型便携式内镜系统用于上消化道内镜检查的实验研究

目的通过动物实验初步评估新型便携式内镜系统用于上消化道内镜检查的操作性能、有效性和安全性。方法采用平行对照、非劣效研究,选取10头健康巴拿猪作为研究对象,1名内镜医师使用日本Olympus内镜系统(型号GIF-Q260),另一名内镜医师使用新型便携式内镜系统,对10头健康巴拿猪按照先新型便携式内镜系统后Olympus内镜系统的顺序进行上消化道内镜检查,采用量化评分指标,对新型便携式内镜系统进行器械质量评价、图像质量评价和安全性评价。结果新型便携式内镜系统单人操作时,展开和收纳用时分别为(110.24±8.93)s和(91.33±11.59)s,戴内镜一次性保护套用时(233.48±17.06)s。器械质量评价方面,新型便携式内镜系统的水气吸引性能不如Olympus内镜系统,吸引400 mL生理盐水所需时间为(56.44±5.18)s,用时多于Olympus内镜系统(型号GIF-Q260)的(33.71±3.56)s,但本新型便携式内镜系统吸引仍符合医疗器械技术要求(吸引量>400 mL/min);其他性能(包括整机密封性、活检通道、镜身坚柔、旋钮操作、镜身弯曲度、视野范围)与Olympus内镜系统相当。图像质量评价方面,新型便携式内镜系统的性能(包括图像清晰度、图像变形及失真、图像颜色分辨率、图像照度、图像质量综合评价)与Olympus内镜系统相近。安全性评价方面,仅使用Olympus内镜系统操作时有1头猪出现恶心症状,使用新型便携式内镜系统操作时的10头猪未发生呕吐、咽喉部出血、心脏骤停等不良事件。结论新型便携式内镜系统展收方便,操作安全性好,内镜操作性能和有效性与临床常用内镜系统相当,不足之处在于水气吸引性能略差于临床常用内镜系统,但仍符合医疗器械技术要求,可以满足上消化道内镜检查。     

Current Practice of Duodenoscope Reprocessing

Numerous outbreaks of duodenoscope-associated transmission of multi-drug resistant bacteria have recently been reported. Unlike prior episodes of endoscope-transmitted infections, the latest outbreaks have occurred despite strict adherence to duodenoscope reprocessing guidelines. The current standard for all flexible endoscope reprocessing includes pre-cleaning, leak testing, an additional manual cleaning step, and high-level disinfection. When these steps are strictly followed, the risk of infection transmission during endoscopy is exceedingly rare. However, due to its complex design, the duodenoscope may not be able to be adequately disinfected using the current reprocessing standards. Supplemental measures to enhance scope reprocessing have subsequently been recommended to reduce the infection risk in patients undergoing endoscopic retrograde cholangiopancreatography. These methods are likely short-term solutions that have yet to be validated regarded their effectiveness. Additional approaches to monitor the quality of duodenoscope reprocessing may also be useful. Ultimately, a definitive, yet logistically feasible, method of duodenoscope reprocessing is required to ensure the safety of our patients.     

Aldehyde disinfectants and health in endoscopy unit: The report of a working party of the British Society of Gastroenterology Endoscopy Committee

Summary of main recommendations

(1) Glutaraldehyde, used in most endoscopy units in the United Kingdom for the disinfection of flexible gastrointestinal endoscopes, is a toxic substance being an irritant and a sensitiser; symptoms associated with glutaraldehyde exposure are common among staff working in endoscopy units.

(2) The Control of Substances Hazardous to Health Regulations 1988 (COSHH) obliges the employer to make a systematic assessment of risk to staff of exposure to glutaraldehyde and institute measures to deal effectively with exposure.

(3) At present glutaraldehyde remains the first line agent for the disinfection of flexible gastrointestinal endoscopes. Other agents are being developed; a standard means of assessment for flexible endoscope disinfectants should be devised.

(4) Equipment and accessories that are heat stable should be sterilised by autoclaving; disposable accessories should be used wherever possible.

(5) Flexible gastrointestinal endoscopes should be disinfected within automated washer/disinfectors; trays, bowls or buckets for this purpose are unacceptable.

(6) Local exhaust ventilation must be used to control glutaraldehyde vapour. Extracted air may be discharged direct to the atmosphere or passed over special absorbent filters and recirculated. Such control measures must be regularly tested and records retained.

(7) Endoscope cleaning and disinfection should be carried out in a room dedicated to the purpose, equipped with control measures to maintain the concentration of glutaraldehyde vapour at a level certainly below the current occupational exposure standard of 0·2 ppm and preferably below the commonly used working limit of 0·1 ppm. Sites other than the endoscopy unit where endoscopy is regularly performed, such as the radiology department, should have their own fully equipped cleaning and disinfection room.

(8) COSHH limits the use of personal protective equipment to those situations where other measures cannot adequately control exposure. Such equipment includes nitrile rubber gloves, apron, chemical grade eye protection, and respiratory protective equipment for organic vapours.

(9) Monitoring of atmospheric levels of glutaraldehyde should be performed by a competent person such as an occupational hygienist; the currently preferred method of sampling uses a filtration technique, the commercially available meters being less reliable.

(10) Health surveillance of staff is mandatory; occupational health records must be retained for 30 years.

(11) Endoscopy staff must be informed of the risks of exposure to glutaraldehyde and trained in safe methods of its control. Only staff who have completed such an education and training programme should be allowed to disinfect endoscopes.

(12) The unsafe use of glutaraldehyde has significant health and legal consequences; the safe use of glutaraldehyde may have revenue consequences that contribute significantly to the cost of gastrointestinal endoscopy.

     

新型冠状病毒肺炎疫情期间全国儿科消化内镜开展情况调查

目的总结新型冠状病毒肺炎（coronavirus disease 2019,COVID-19）疫情期间全国儿科消化内镜开展诊疗经验,为下一步临床诊疗工作提供防控指导。方法中华医学会消化内镜学分会儿科协作组对全国47所儿科消化内镜中心2020年1月24日—3月1日内镜诊治开展情况以问卷调查表的形式进行了调查。结果疫情期间,儿科消化内镜中心采用了停止常规内镜诊疗、严格术前流行病学排查、增加特殊术前检查、术前内镜医师会诊制度、候诊区管理、精简工作人员、不同岗位不同防护级别、特殊麻醉管理、重视诊疗区域消毒、加强内镜清洗消毒及医疗废物管理等防控措施。47所医院在2020年1月24日—3月1日38 d内共完成536例儿科消化内镜诊疗,其中治疗210例（39.2%）,诊断326例（60.8%）,未发生一例院内感染。结论COVID-19疫情期间,全国儿科消化内镜中心根据国家疫情防控政策及相关指南要求,结合儿科特点及医院实际情况,在严格把握内镜诊疗指征、严密防护的前提下,安全开展了儿科消化内镜诊疗。     

Failure of an engineered system: The gastrointestinal endoscope

Advances in endoscopic technology continue to expand the field of gastrointestinal endoscopy. However, there have been no parallel advances in general endoscope design, and gastroenterologists are at risk for musculoskeletal repetitive strain injury due to the repetition, high forces and prolonged, awkward postures required to perform endoscopy. The current endoscope design lacks a consideration of human factors, and due to the high risk of injury, represents a failure of an engineered system. This review will focus on a risk assessment and management strategy for the gastrointestinal endoscope. Risk assessment is the identification of potential flaws in the system. Risk management describes the steps taken to mitigate these flaws. Three different approaches to risk assessment and management, proactive, reactive, and interactive risk assessment and management, will be reviewed as they apply to the performance of gastrointestinal endoscopy.     

Advances in modern enteroscopy therapeutics

Advances in modern enteroscopy have been largely due to endoscope development but also through the improved availability of endoscopic accessories along with improved understanding in their application. Device assisted enteroscopy began with the double balloon system in 2001 and was quickly followed by single balloon enteroscopy and spiral enteroscopy. These tools revolutionised deep small bowel endoscopy and allowed for the delivery of virtually all known therapeutic endoscopy intervention to almost all segments of the small bowel. This review covers the types of interventions in regards to indications, methods and their safety profiles as well as reviewing the various device assisted endoscopes available and their attributes.     

Summary of guidelines for infection prevention and control for flexible gastrointestinal endoscopy

BACKGROUND:

High-quality processes to ensure infection prevention and control in the delivery of safe endoscopy services are essential. In 2010, the Public Health Agency of Canada and the Canadian Association of Gastroenterology (CAG) developed a Canadian guideline for the reprocessing of flexible gastrointestinal endoscopy equipment.

METHODS:

The CAG Endoscopy Committee carefully reviewed the 2010 guidelines and prepared an executive summary.

RESULTS:

Key elements relevant to infection prevention and control for flexible gastrointestinal endoscopy were highlighted for each of the recommendations included in the 2010 document. The 2010 guidelines consist of seven sections, including administrative recommendations, as well as recommendations for endoscopy and endoscopy decontamination equipment, reprocessing endoscopes and accessories, endoscopy unit design, quality management, outbreak investigation and management, and classic and variant Creutzfeldt-Jakob Disease.

DISCUSSION:

The recommendations for infection prevention and control for flexible gastrointestinal endoscopy are intended for all individuals with responsibility for endoscopes in all settings where endoscopy is performed.