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Key Updates to ‘Guideline on Reprocessing Flexible GI Endoscopes and Accessories’

By Susan Klacik, BS, CRCST, CIS, CHL, ACE, FCS

The American Society for Gastrointestinal Endoscopy (ASGE) – along with all organizations and members of the American Society for Gastrointestinal Endoscopy Quality Assurance in Endoscopy and Standards of Practice committees – have updated the “Multisociety Guideline on Reprocessing Flexible GI Endoscopes and Accessories.” This article highlights some of the key changes.

The updated guideline states that staff training and competency of endoscope reprocessing skills are important aspects of infection prevention. It is recommended that reprocessing staff be trained on all the endoscope models they are expected to process and shown to have documented competency before being assigned to process them. The health care organization should then perform competency evaluations of endoscope processing personnel on a scheduled basis, as defined by the organization (typically, this occurs when one first assumes endoscope processing duties; at least annually; anytime a breach is identified; when a major technique or new endoscope or reprocessing accessory is introduced; and in the context of local quality control efforts).

The delayed processing of endoscopes has become an area of greater focus. The updated guideline recommends that manual cleaning begin according to the instructions for use (IFU), which is usually within one hour after the endoscope is released from the procedure. If cleaning is delayed beyond this time period, the manufacturer’s IFU for delayed processing must be followed. It is recommended that soiled endoscopes be transported immediately to the reprocessing area in a fully enclosed, puncture-resistant, leak-proof containers with a biohazard label.

It is also recommended that only clean cleaning implements are used; if reusable cleaning implements are used, they must be cleaned and disinfected between uses. Additionally, the guideline recommends the use of fresh cleaning solution for each endoscope. If the cleaning solution falls outside the recommended temperature and dilution range, it is recommended that it be replaced.

If an endoscope undergoes high-level disinfection, it is recommended to perform this disinfection step in an automated endoscope reprocessor (AER) using a high-level disinfectant or sterilant that is compatible with the AER and sterilizer IFU. The importance of adhering to the endoscope manufacturer’s IFU for high-level disinfection was also emphasized. Some duodenoscopes contain an elevator wire channel that may not effectively be disinfected by some AERs and that this step should be performed manually. In addition, the endoscope and components should be attached using only approved connectors, per the AER and endoscope manufacturer’s IFU to ensure contact of all internal surfaces with the high-level disinfectant solution. If the AER cycle is interrupted, the entire cycle should be repeated.

Recent research links incomplete endoscope drying to multiple outbreaks of waterborne organisms (data shows a reported endoscope contamination rate of 80%). This research signifies that the methods of drying flexible endoscopes need to change – and this multisociety guideline includes new drying recommendations. Prior to this newfound information, 70% to 90% ethyl or isopropyl alcohol was injected into the endoscope channels to dry the channels. Alcohol was recommended because it purged and promoted the evaporation of residual water within endoscope channels, thereby decreasing the chances for bioburden buildup. Little data exists regarding possible benefits of alcohol flushes. Based on research, this guideline recommends drying the endoscope channels and areas not dried with a cloth with forced, pressure-regulated filtered air – with a sufficiently prolonged flow of medical air through all accessible channels. For best results, it is ideal for this step to occur simultaneously for all channels and for a duration of at least 10 minutes. Flexible endoscopes should be completely dried after processing and before use. Note: This guideline recommends following manufacturers’ IFU regarding the use of ethyl or isopropyl alcohol for drying endoscopes. There was a case report that switched to suctioning 70% alcohol through a duodenoscope working channel, followed by compressed air during the drying phase. It was reported that this helped contain an outbreak of Pseudomonas aeruginosa. In addition, a conclusion from the pulmonary literature suggests that using alcohol for drying purposes significantly reduces bronchoscope contamination rates; however, the fixation properties of alcohol could lead to the retention of organisms within the endoscope. At this time, there is no data to strongly support or refute the use of alcohol flushes for the drying of endoscopes.

Proper storage of endoscopes is essential for preventing contamination. This updated guideline includes information on proper endoscope handling, including the need for personnel to perform hand hygiene and wear clean gloves during all phases of endoscope handling. Endoscopes may be stored in drying cabinets or conventional cabinets, and always in a way that does not allow for moisture to collect on or within the endoscope. Drying cabinets have connectors that force air through each endoscope channel. The endoscopes can be stored either vertically or horizontally. These storage cabinets use forced irrigation of endoscope channels with warm, filtered air during storage to achieve complete drying of the channels. Conventional cabinets require endoscopes to hang vertically, and active or passive ventilation with filtered air helps prevent moisture from forming on or within endoscopes. Passive cabinets without airflow directed into all channels are not sufficient for drying the endoscope from a wet state.

Endoscope cabinets should be in a secure location that is near but not in the procedure rooms. Care and maintenance of the cabinet should be performed according to the cabinet IFU and the cabinets should be routinely inspected for damage and cleaned on a routine basis (and when soiled) with an Environmental Protection Agency-registered hospital disinfectant. This guideline does not provide a specific amount of time that endoscopes can be stored before being considered contaminated. It is recommended that endoscopy units evaluate the available literature, perform an assessment regarding benefits and risks around the optimal storage time for endoscopes, and then develop a policy and procedure specific to their unit on endoscope storage time.

The multisociety guideline also addresses recommendations regarding the use of simethicone. It is recommended that the endoscopy unit follow the manufacturer’s IFU on its addition in water bottles and irrigation devices, including cleaning and disinfection of endoscopes after its use.

The guideline also recommends that documentation be put into place to provide traceability of endoscopes, including those that are loaned.

The complete guideline is available on the ASGE website at www.asge.org.

Susan Klacik, BS, CRCST, CIS, CHL, ACE, FCS, serves as a Clinical Educator for the International Association of Healthcare Central Service Materiel Management (IAHCSMM). IAHCSMM provides certification, education and support to nearly 40,000 Sterile Processing professionals.

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