美国食品和药品监督管理局（FDA）正在就指导原则草案收集反馈信息，该草案为减少柔性胃肠道内窥镜及冲洗部件带来的的交叉感染提供了建议。

在该文件中，FDA强调了把同一个液瓶在未经处理的情况下给不同的患者使用的危险性，而这种情况时有发生。根据该指导原则草案，“这种情况增加了病人交叉感染的风险，因为液瓶和连接件可能被通过内窥镜管道和通路的血液或粪便污染（一种被称为’回流’的现象）”。

其他可能的交叉感染源来自于冲洗管路。比如：存在于柔性内窥镜上的气/液道，该通道指引液体到达设备的透镜。其中包括一个防止回流的阀，这个阀应该在每次被使用后都被标记为回收或置换以确保患者安全。

该文件也描述了把器械设计，标签及正确处理相结合的方式如何确保避免源自内窥镜连接件的交叉感染。例如，在冲洗过程中防止回流，”在液体通道内部应该至少有一个器械零件有单向阀或其他配置。

另外，FDA为生产商提供了在标签和市场前通知中使用的定义来确保使用中的一致性和这些器械的检查。

来自于内窥镜的可能存在的交叉感染风险是一项许多医疗机构都面临的风险。比如，该草案指导原则的发布于一家加拿大的英国哥伦比亚医院报道了一项柔性内窥镜预清洗过程中的错误之后的几天。

北不列颠哥伦比亚大学医院通知患者说在2012至2014年12月间，用于检查结肠、胃上部范围的内窥镜，以及内窥镜逆行没有按照制造商的指示进行清洁处理。该医院在一个声明中称，其已经更正了这一错误，并且正在对医疗机构专业人员就清洁过程进行额外培训。

该机构称存在一项“极小的”疾病传播风险并且没有推荐病人接受进一步治疗。

FDA Outlines Risk Mitigation Strategies for Flexible Endoscopes

The U.S. Food and Drug Administration (FDA) is seeking feedback on draft guidance that provides recommendations for reducing cross-contamination from flexible gastrointestinal endoscopes and accompanying irrigation accessories.

In the document, the agency highlights the dangers of using a single water bottle for multiple patients without reprocessing between procedures—a practice that occurs frequently. “This practice raises the risk of cross-contamination between patients, because the water bottle and associated tubing/connectors can become contaminated with blood or stool that travels up through the endoscope channels and tubing (a phenomenon referred to as ‘backflow’),” according to the draft guidance.

Other possible sources of cross-contamination are irrigation channels. For example, air/water channels, which are present on most flexible gastrointestinal endoscopes, direct water to the device’s lens. They include a valve to prevent backflow that should be labeled for reprocessing or replacement after every use to ensure patient safety.

The document also describes how using a combination of device design, labeling, and proper handling can guard against cross-contamination from endoscope connectors. For example, to prevent backflow during irrigation, “there should be at least one device component within the fluid pathway that has a one-way valve or other feature.”

In addition, the agency provides definitions for manufacturers to use in labeling and premarket notifications to ensure consistency in the utilization and review of these devices.

The challenge of possible contamination from endoscopes is one that many healthcare facilities have faced. For example, the release of the draft guidance comes days after a hospital in British Columbia (BC), Canada, reported an error in the precleaning process for flexible endoscopes.

The University Hospital of Northern BC informed patients that between 2012 and December 2014, endoscopes used in colonoscopies, upper gastric scopes, and endoscopic retrograde cholangiopancreatograms were not cleaned according to manufacturers’ instructions for use. The hospital said in a statement that it has corrected the error and is providing additional education on the cleaning process to healthcare professionals.

The facility said there is an “extremely minimal” risk of disease transmission and is not recommending patients receive follow-up treatment.