1.1本规程涵盖可重复使用、热稳定的内窥镜附属器械（EAI），其设计用于插入柔性内窥镜，并在用户说明中明确定义为用于患者之间重复使用的设备。本规程涵盖的EAI可能有或可能没有内腔或松散连接的表面，可能有或可能没有冲洗用的接入口，并且可能有或可能无法在重新处理之前完全拆卸。 1.2本规程不适用于制造商专门设计和标记的一次性EAI的再加工。 1.3本规程不旨在解决热敏EAI的再加工问题，例如，那些不能承受热灭菌的EAI。必须根据EAI和low制造商的具体说明，单独考虑每个热敏EAI的再加工- 温度灭菌装置。 1.4本规程旨在补充而非取代产品制造商提供的说明。EAI制造商应提供适当验证的说明和标签，以便用户了解特定附件的基本设计、规格、术语和组件，并正确检查、准备、使用、再加工和存储这些仪器。 1.5本规程不包括内窥镜技术和内窥镜的医学方面。 1.6本规程详细说明了重新处理热稳定EAI并使其为患者做好准备所需的基本步骤。 1.7为患者准备的EAI是指使用经验证的清洁程序彻底清洁、用水冲洗以去除残留洗涤剂、润滑（如有必要）并排空以去除多余润滑剂、干燥、包装、热灭菌和储存以防止在使用前影响无菌的EAI。 1.8本规程仅描述手动再处理，不涉及通过自动再处理设备清洁EAI。 1.9为确保正确遵守本规程，后处理人员应满足5.5至5.7中规定的某些要求。 1.10本实施规程不涉及柔性内窥镜再加工所需的步骤（见实施规程F 1518） ). 1.11 本标准并非旨在解决与其使用相关的所有安全问题（如有）。本标准的用户有责任在使用前制定适当的安全和健康实践，并确定监管限制的适用性。 ====意义和用途====== EAI可能具有一些设计特征，例如卷曲金属护套、旋转接头、相对表面和内腔或导线，这使得目视检查清洁度非常困难（如果不是不可能的话）。 由于其设计要求的性质，EAI比许多其他类型的医疗器械更难再加工。 由于EAI用于诊断和治疗免疫功能正常和免疫功能低下患者的疾病，因此必须注意确保仅使用患者准备好的设备进行检查。 在诊断或疑似感染如乙型肝炎、丙型肝炎或人类免疫缺陷病毒（HIV）的患者中使用EAIs并非禁忌。此外，EAI不需要仅用于这些患者。 负责再加工的人员必须了解EAIs的规格、术语、部件功能和内部设计，以便为患者做好准备。 负责再处理EAI的人员应在每次内窥镜手术后遵循本规程以及制造商提供的相关标签和说明，以确保EAI是患者- 准备好的 EAI的再处理应由经过适当培训的人员具体负责。未经必要培训的临时员工不应承担这些责任。 除非每个人都接受了相应的岗位培训，否则不应将EAI再处理的责任委派给每个人。 再加工人员应能够阅读、理解和执行制造商和监管机构发出的与EAI再加工相关的指示。 后处理人员应有机会完全熟悉设备的机械方面。他们可以通过研究制造商的信息和代表的演示来获得这些知识。 再加工人员应充分了解与EAI再加工相关的患者和医疗保健人员的潜在化学和感染危害。 培训应包括: 以书面的内部感染控制程序为基础，全面了解感染控制原则和概念。 关于因不遵守书面再处理指南而导致患者出现负面结果的可能性的全面背景， 熟悉职业安全与健康管理局（OSHA）关于适当和安全处理EAI后处理期间使用的化学后处理剂和设备的法规和内部政策，以及 使用后安全处理受患者组织和体液污染的EAI的信息，包括熟悉标准（通用）预防措施的原则和实践。 笔记 1-尽管医疗工作者和患者可能受益于遵守联邦和州OSHA机构发布的监管指南，但这些指南仅针对医疗工作者的安全和健康。 它们可能不足以实现患者的最佳安全和健康。因此，除了OSHA指南外，还应参考当代感染控制指南。 本规程的目的不是取代EAI制造商提供的再加工说明，也不是建议用于再加工的特定设备或化学试剂。相反，它将与制造商说明书一起使用，制造商说明书为特定产品提供了具体说明。见附录X1.1。 本规程不包括内窥镜技术、患者护理或柔性内窥镜的其他医学方面。 本规程不包括再加工柔性内窥镜的说明。

1.1 This practice covers reusable, heat-stable endoscopic accessory instruments (EAI) designed to be inserted into flexible endoscopes and clearly defined in the user instructions as devices intended for reuse among patients. The EAIs covered by this practice may or may not have lumens or loosely joined surfaces, may or may not have access ports for flushing, and may or may not be capable of being completely disassembled prior to reprocessing. 1.2 This practice is not intended to be applied to the reprocessing of single-use, disposable EAIs specifically designed and labeled as such by their manufacturers. 1.3 This practice is not intended to address reprocessing of heat-sensitive EAIs, for example, those not capable of withstanding heat sterilization. Reprocessing of each heat-sensitive EAI must be considered on an individual basis according to specific instructions from the manufacturers of the EAI and the low-temperature sterilization device. 1.4 This practice is intended to complement, not replace, the instructions provided by product manufacturers. EAI manufacturers should provide properly validated instruction and labeling necessary for users to understand the basic design, specifications, nomenclature, and components of specific accessories and to properly inspect, prepare, use, reprocess, and store these instruments. 1.5 Endoscopic technique and the medical aspects of endoscopy are not covered in this practice. 1.6 This practice details the basic steps necessary to reprocess a heat-stable EAI and render it patient-ready. 1.7 A patient-ready EAI is one that has been thoroughly cleaned using a validated cleaning procedure, rinsed with water to remove residual detergent, lubricated (if necessary) and drained to remove excess lubricant, dried, packaged, heat sterilized and stored to prevent from being compromised sterility before use. 1.8 This practice describes only manual reprocessing and does not address cleaning of an EAI by an automated reprocessing device. 1.9 To ensure the proper adherence to this practice, reprocessing personnel should meet certain requirements as specified in 5.5 to 5.7. 1.10 This practice does not address the steps necessary for the reprocessing of flexible endoscopes (see Practice F 1518 ). 1.11 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and to determine the applicability of regulatory limitations prior to use. ====== Significance And Use ====== EAIs may have design features such as coiled metal sheaths, pivoting joints, opposed surfaces, and internal lumens or wires which make visual inspection for cleanliness difficult if not impossible. By nature of their design requirements, EAIs are more difficult to reprocess than many other types of medical instruments. Because EAIs are used to diagnose and treat disease in both immunocompetent and immunocompromised individuals, care must be taken to ensure that only patient-ready devices are used for examination. The use of EAIs in patients having diagnosed or suspected infections such as hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) is not contraindicated. Further, EAIs need not be dedicated for use only in these patients. Persons responsible for reprocessing must understand the specifications, nomenclature, function of component parts, and interior design of EAIs in order to render them patient-ready. Persons responsible for reprocessing EAIs should follow this practice and associated labeling and instructions from manufacturers after each endoscopic procedure to ensure that the EAI will be patient-ready. Reprocessing of EAIs should be the specific responsibility of appropriately trained personnel. Temporary employees without the requisite training should not be given these responsibilities. The responsibility for reprocessing of EAIs should not be delegated from person to person unless each has the appropriate training for the position. Reprocessing personnel should have the ability to read, understand, and implement instructions from manufacturers and regulatory agencies as they relate to EAI reprocessing. Reprocessing personnel should have the opportunity to become completely familiar with the mechanical aspects of the devices. They may gain this knowledge through study of the manufacturer's information and demonstration by representatives. Reprocessing personnel should be made fully aware of the potential chemical and infectious hazards for patients and health care personnel associated with the reprocessing of EAIs. Training should include: A thorough background in infection control principles and concepts based on written in-house infection control procedures. A thorough background regarding the potential for negative patient outcomes resulting from lapses in compliance with written reprocessing guidelines, Familiarization with Occupational Safety and Health Administration (OSHA) regulations and in-house policies regarding the appropriate and safe handling of chemical reprocessing agents and equipment used during reprocessing of EAIs, and Information on the safe handling of EAIs contaminated with patient tissue and fluids after use, including familiarization with principles and practices of standard (universal) precautions. Note 1—Although healthcare workers and patients may benefit from adhering to the regulatory guidelines issued by federal and state OSHA agencies, these guidelines are directed only toward healthcare worker safety and health. They may not be sufficiently inclusive for optimum safety and health of patients. Therefore, contemporary infection control guidelines should be consulted in addition to OSHA guidelines. This practice is not intended to replace the reprocessing instruction provided by the manufacturers of EAIs or suggest specific equipment or chemical reagents to be used for reprocessing. Rather, it is to be used together with manufacturers' instructions that provide specific instructions for specific products. See Appendix X1.1. This practice is not intended to cover endoscopic techniques, patient care, or other medical aspects of flexible endoscopy. This practice does not include instruction for reprocessing flexible endoscopes.