现有软式内窥镜再处理技术存在不足
现有软式内窥镜再处理技术存在不足
翻译：周超群 审核：陈志锦
（SIFIC热点团队）
根据在感染控制和流行病学专业协会(APIC)官方杂志《美国感染控制杂志》（American Journal of Infection Control）二月版上发表的一项研究发现，目前用于清洁内窥镜以重复使用的技术并不总是有效。 本研究结果证实需要仔细地目视检查和清洁验证测试，以确保所有内窥镜在高水平消毒或灭菌和用于另一个患者之前都没有损伤和碎片。
2017年在任感染控制和流行病学专业协会主席 Linda Greene说：“感染控制和流行病学专业协会(APIC) 关注内窥镜感染的风险，本研究强调了在所有机构中由受过专业化培训的感染预防专家领导下建立强有力的内窥镜感染预防控制方案的重要性，以确保所有机构遵循最新的基于循证的指引。”
目前，软式内窥镜，包括胃肠镜、泌尿系内镜和呼吸道内镜，在清洁和高水平消毒后重复使用。然而，由Ofstead ＆ Associates有限公司进行的近期研究的结果表明，即使是最严格的内窥镜再处理技术也不是始终有效的，并且常常残留着有机残余物。
这一研究的主要作者Ofstead ＆ Associates有限公司的公共卫生学硕士Cori L. Ofstead说：“因为医疗机构需要寻找方法来提高内窥镜清洁消毒的质量，所以了解内窥镜再处理技术的有效性问题是至关重要的。即使使用了一流的方法，研究中的内窥镜还是有明显的损坏和碎片迹象，并且试验结果表明，大部分内镜仍然受到污染”。
Ofstead ＆ Associates有限公司在本研究中使用了纵向设计，在七个月内对20条内窥镜进行了三次评估。评估内容包括使用微型相机进行检查、微生物培养和蛋白质与三磷酸腺苷（ATP）生化检测，后者由于鉴定有机物的标记物。这些评估用于识别需要进一步清洁和维护的内窥镜。这些评估可用于识别需要进一步清洁和维护的内窥镜。
在最后评估期间，研究人员发现，所有的20条受检内窥镜都存在影像不规则的问题，例如通道中有流体、变色和碎片。此外，来自20条再处理内窥镜中的12条样品具有微生物生长，表明消毒过程失败。值得注意的是，内窥镜的再处理是按照现行推荐指南进行的，在高水平消毒前至少清洗过两遍，但最终还是表现出相似的培养结果。
进一步研究结果表明，每组中约20％的内窥镜超过了ATP和蛋白质残留的清洗后基准。此外，用于胃肠道手术的胃镜的ATP水平高于用于结肠检查的内窥镜。Ofstead ＆ Associates有限公司称：“因为相同的技术人员使用相同的技术来清洁和消毒这些内窥镜，所以这些发现和观察表明，在处理过程中发生了某些事情使胃镜表面发生改变因而导致再处理的失败。”
所测试的内窥镜中95％存在残余液体的发现具有重大意义，因为水分能促进微生物生长和生物膜的发展，这可能是内镜再处理的难题。换句话说，这证实了为确保患者的安全，内窥镜清洁、消毒和干燥的重要性。
来源：感染控制和流行病学专业协会(APIC)
原文：Existing Reprocessing Techniques Prove to be Insufficient for Flexible Endoscopes
Current techniques used to clean endoscopes for reuse are not consistently effective, according to a study published in the February issue of the American Journal of Infection Control, the official journal of the Association for Professionals in Infection Control and Epidemiology (APIC). The findings of this study support the need for careful visual inspection and cleaning verification tests to ensure that all endoscopes are free of damage and debris before they are high-level disinfected or sterilized and used on another patient.
“APIC is concerned about the risk of infections related to endoscopic procedures, said Linda Greene, RN, MPS, CIC, FAPIC, 2017 APIC president. “This study reinforces the importance of having strong infection prevention and control programs at all types of facilities, led by highly trained infection preventionists, to ensure that facilities are following the latest evidenced-based guidance.”
Currently, flexible endoscopes, including gastrointestinal, urological, and respiratory endoscopes, are reused following cleaning and high-level disinfection. However, results from the new study conducted by Ofstead & Associates, Inc., suggest that even more rigorous reprocessing techniques of endoscopes are not consistently effective, and organic residues often remain.
“Understanding issues with the effectiveness of reprocessing techniques is critically important as institutions seek to improve the quality of endoscope cleaning and disinfection,” said lead study author Cori L. Ofstead, MSPH, of Ofstead & Associates, Inc. “Even though top-notch methods were used, the endoscopes in this study had visible signs of damage and debris, and tests showed a high proportion were still contaminated.”
Using a longitudinal study design, Ofstead, et al. performed three assessments of 20 endoscopes over a seven-month period. The assessments involved visual inspections with a tiny camera, microbial cultures, and biochemical tests to detect protein and adenosine triphosphate (ATP) – a marker that identifies organic matter. These assessments were used to identify endoscopes that required further cleaning and maintenance.
During the final assessment, the researchers found that all 20 endoscopes examined had visual irregularities, such as fluid, discoloration and debris in channels. Furthermore, samples from 12 of 20 reprocessed endoscopes (60 percent) had microbial growth, indicating a failure of the disinfection process. Of note, endoscopes reprocessed using current recommended guidelines and those that were cleaned at least twice before high-level disinfection exhibited similar culture results.
Further results indicated that about 20 percent of endoscopes in each group exceeded post-cleaning benchmarks for ATP and protein residue. Moreover, ATP levels were higher for gastroscopes, which are used for upper GI procedures, than the endoscopes used for colonoscopy. “Since the same technicians used the same techniques to clean and disinfect these scopes, the findings and our visual observations suggest that something is happening to gastroscopes during procedures that changes the surfaces and causes reprocessing failures,” says Ofstead.
This study comes on the heels of a 2015 report of Carbapenem-resistant Enterobacteriaceae (CRE) infections related to Endoscopic Retrograde Cholangio-Pancreatography (ERCP) duodenoscopes - devices that are threaded through the mouth, throat, and stomach into the top of the small intestine (duodenum) for examinations and treatment. No breaches in reprocessing were identified and yet infections related to the duodenoscopes were uncovered, raising concerns that current reprocessing techniques were ineffective, and illuminating the challenges in reprocessing of such intricate medical devices.
“The finding of residual fluid in 95 percent of endoscopes tested was significant because moisture fosters microbial growth and the development of biofilm—which can be difficult or impossible to remove,” said Ofstead. “This confirms the importance of cleaning, disinfecting, and drying to ensure patient safety.”
“Longitudinal assessment of reprocessing effectiveness for colonoscopes and gastroscopes: Results of visual inspections, biochemical markers, and microbial cultures,” Cori L. Ofstead; Harry P. Wetzler; Otis L. Heymann; Ellen A. Johnson; John E. Eiland; and Michael J. Shaw appears in the American Journal of Infection Control, Volume 45, Issue 2 (February 2017).
Source: APIC
翻译：周超群 审核：陈志锦
（SIFIC热点团队）
根据在感染控制和流行病学专业协会(APIC)官方杂志《美国感染控制杂志》（American Journal of Infection Control）二月版上发表的一项研究发现，目前用于清洁内窥镜以重复使用的技术并不总是有效。 本研究结果证实需要仔细地目视检查和清洁验证测试，以确保所有内窥镜在高水平消毒或灭菌和用于另一个患者之前都没有损伤和碎片。
2017年在任感染控制和流行病学专业协会主席 Linda Greene说：“感染控制和流行病学专业协会(APIC) 关注内窥镜感染的风险，本研究强调了在所有机构中由受过专业化培训的感染预防专家领导下建立强有力的内窥镜感染预防控制方案的重要性，以确保所有机构遵循最新的基于循证的指引。”
目前，软式内窥镜，包括胃肠镜、泌尿系内镜和呼吸道内镜，在清洁和高水平消毒后重复使用。然而，由Ofstead ＆ Associates有限公司进行的近期研究的结果表明，即使是最严格的内窥镜再处理技术也不是始终有效的，并且常常残留着有机残余物。
这一研究的主要作者Ofstead ＆ Associates有限公司的公共卫生学硕士Cori L. Ofstead说：“因为医疗机构需要寻找方法来提高内窥镜清洁消毒的质量，所以了解内窥镜再处理技术的有效性问题是至关重要的。即使使用了一流的方法，研究中的内窥镜还是有明显的损坏和碎片迹象，并且试验结果表明，大部分内镜仍然受到污染”。
Ofstead ＆ Associates有限公司在本研究中使用了纵向设计，在七个月内对20条内窥镜进行了三次评估。评估内容包括使用微型相机进行检查、微生物培养和蛋白质与三磷酸腺苷（ATP）生化检测，后者由于鉴定有机物的标记物。这些评估用于识别需要进一步清洁和维护的内窥镜。这些评估可用于识别需要进一步清洁和维护的内窥镜。
在最后评估期间，研究人员发现，所有的20条受检内窥镜都存在影像不规则的问题，例如通道中有流体、变色和碎片。此外，来自20条再处理内窥镜中的12条样品具有微生物生长，表明消毒过程失败。值得注意的是，内窥镜的再处理是按照现行推荐指南进行的，在高水平消毒前至少清洗过两遍，但最终还是表现出相似的培养结果。
进一步研究结果表明，每组中约20％的内窥镜超过了ATP和蛋白质残留的清洗后基准。此外，用于胃肠道手术的胃镜的ATP水平高于用于结肠检查的内窥镜。Ofstead ＆ Associates有限公司称：“因为相同的技术人员使用相同的技术来清洁和消毒这些内窥镜，所以这些发现和观察表明，在处理过程中发生了某些事情使胃镜表面发生改变因而导致再处理的失败。”
所测试的内窥镜中95％存在残余液体的发现具有重大意义，因为水分能促进微生物生长和生物膜的发展，这可能是内镜再处理的难题。换句话说，这证实了为确保患者的安全，内窥镜清洁、消毒和干燥的重要性。
来源：感染控制和流行病学专业协会(APIC)
原文：Existing Reprocessing Techniques Prove to be Insufficient for Flexible Endoscopes
Current techniques used to clean endoscopes for reuse are not consistently effective, according to a study published in the February issue of the American Journal of Infection Control, the official journal of the Association for Professionals in Infection Control and Epidemiology (APIC). The findings of this study support the need for careful visual inspection and cleaning verification tests to ensure that all endoscopes are free of damage and debris before they are high-level disinfected or sterilized and used on another patient.
“APIC is concerned about the risk of infections related to endoscopic procedures, said Linda Greene, RN, MPS, CIC, FAPIC, 2017 APIC president. “This study reinforces the importance of having strong infection prevention and control programs at all types of facilities, led by highly trained infection preventionists, to ensure that facilities are following the latest evidenced-based guidance.”
Currently, flexible endoscopes, including gastrointestinal, urological, and respiratory endoscopes, are reused following cleaning and high-level disinfection. However, results from the new study conducted by Ofstead & Associates, Inc., suggest that even more rigorous reprocessing techniques of endoscopes are not consistently effective, and organic residues often remain.
“Understanding issues with the effectiveness of reprocessing techniques is critically important as institutions seek to improve the quality of endoscope cleaning and disinfection,” said lead study author Cori L. Ofstead, MSPH, of Ofstead & Associates, Inc. “Even though top-notch methods were used, the endoscopes in this study had visible signs of damage and debris, and tests showed a high proportion were still contaminated.”
Using a longitudinal study design, Ofstead, et al. performed three assessments of 20 endoscopes over a seven-month period. The assessments involved visual inspections with a tiny camera, microbial cultures, and biochemical tests to detect protein and adenosine triphosphate (ATP) – a marker that identifies organic matter. These assessments were used to identify endoscopes that required further cleaning and maintenance.
During the final assessment, the researchers found that all 20 endoscopes examined had visual irregularities, such as fluid, discoloration and debris in channels. Furthermore, samples from 12 of 20 reprocessed endoscopes (60 percent) had microbial growth, indicating a failure of the disinfection process. Of note, endoscopes reprocessed using current recommended guidelines and those that were cleaned at least twice before high-level disinfection exhibited similar culture results.
Further results indicated that about 20 percent of endoscopes in each group exceeded post-cleaning benchmarks for ATP and protein residue. Moreover, ATP levels were higher for gastroscopes, which are used for upper GI procedures, than the endoscopes used for colonoscopy. “Since the same technicians used the same techniques to clean and disinfect these scopes, the findings and our visual observations suggest that something is happening to gastroscopes during procedures that changes the surfaces and causes reprocessing failures,” says Ofstead.
This study comes on the heels of a 2015 report of Carbapenem-resistant Enterobacteriaceae (CRE) infections related to Endoscopic Retrograde Cholangio-Pancreatography (ERCP) duodenoscopes - devices that are threaded through the mouth, throat, and stomach into the top of the small intestine (duodenum) for examinations and treatment. No breaches in reprocessing were identified and yet infections related to the duodenoscopes were uncovered, raising concerns that current reprocessing techniques were ineffective, and illuminating the challenges in reprocessing of such intricate medical devices.
“The finding of residual fluid in 95 percent of endoscopes tested was significant because moisture fosters microbial growth and the development of biofilm—which can be difficult or impossible to remove,” said Ofstead. “This confirms the importance of cleaning, disinfecting, and drying to ensure patient safety.”
“Longitudinal assessment of reprocessing effectiveness for colonoscopes and gastroscopes: Results of visual inspections, biochemical markers, and microbial cultures,” Cori L. Ofstead; Harry P. Wetzler; Otis L. Heymann; Ellen A. Johnson; John E. Eiland; and Michael J. Shaw appears in the American Journal of Infection Control, Volume 45, Issue 2 (February 2017).
Source: APIC
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