TABLE 42A List of Automated Endoscope Reprocessors Used to Reprocess Flexible Gastrointestinal Endoscopes in the United States
Manufacturer
Trade Name
FDA Label Claim
Compatibility
Advanced Sterilization Products Custom Ultrasonics, Inc.
MediVators, Inc.
Steris Corporation
ASP Automatic Endoscope Reprocessor
System 83 Plus Washer-Disinfector (features a number of different models)
DSD Endoscope Disinfector (features a number of different models
MV-1/MV-2 Endoscope Reprocessor
Steris System 1
Disinfector Washer-disinfector
Disinfector
Disinfector
Advertised for sterile processing
Can be used with most liquid chemical sterilants Can be used with most liquid chemical sterilants
Can be used with most liquid chemical sterilants
Can be used with most chemical sterilants
Can be used with only one liquid chemical sterilant (0.2% peracetic acid)
FDA = Food and Drug Administration.
these tests more challenging, the FDA does not permit the soiled complex instruments to be manually cleaned before exposure to the LCS. Based on these challenging conditions, most 2% (alkaline) glutaraldehyde formulations, which are LCSs commonly used to reprocess GI endoscopes, list on their labels an exposure time of 45 minutes (at 25°C) to achieve high-level disinfection. This 45-minute exposure time for 2% glutaraldehyde is controversial, because it is arguably not applicable to the clinical setting, where, unlike during simulated in-use premarket testing, cleaning before high-level disinfection is the standard of care. Several studies have shown that manual cleaning, which is required by all endoscope reprocessing guidelines, reduces the amount of bioburden on the endoscope by 3 to 5 logs. Some of these studies have demonstrated that as a result of this log reduction achieved during manual cleaning, although ignored by the FDA, 2% glutaraldehyde should be labeled to achieve high-level disinfection in 20 minutes (at 20°C ). This shorter, more desirable, and clinically relevant exposure time is advantageous because without jeopardizing patient safety it lowers reprocessing costs by reducing overall reprocessing times, exposure of any personnel to LCSs, and the number of expensive GI endoscopes required in inventory to meet patient demand. Labels of LCS that indicate an immersion time and temperature for sterilization are also controversial. Indeed, the ability of an LCS or other low-temperature agent to sterilize flexible endoscopes, as opposed to high-level disinfect them, will be debated for some time.
Confusion and controversy surrounding the use and application of LCSs in the clinical versus the laboratory setting, although academically of interest, do little to facilitate or simplify the challenging task of endoscope reprocessing. Other factors that can further complicate endoscope reprocessing include a lack of standardization. In general, manufacturers of endoscopes and AERs provide different reprocessing instructions and equipment, such as the adapters, "irrigators," fittings, and connectors. Failure to resolve discrepancies between the endoscope's and the AER's disparate and sometimes contradictory reprocessing instructions has been reported to have caused an outbreak. The complex internal design of GI endoscopes can also pose a formidable challenge to endoscope reprocessing. Because of their different therapeutic applications, different models of GI endoscopes may feature a different number of internal channels. Moreover, some models may feature a specialized channel that is used to, for instance, manipulate an elevator forceps raiser at the endoscope's distal tip during ERCP. Keeping track of all of the different models in inventory, and the unique and specialized internal channels and reprocessing instructions that some GI
endoscope models require, can be demanding. As a result, it is essential to routinely review the reprocessing instructions and schematics of every endoscope model in inventory to ensure that after each procedure all of the endoscope's internal channels, including the endoscope's valves and other removable components, are accounted for and reprocessed, even if all of the channels were not used during the procedure. Efforts by the manufacturers of endoscopes and AERs to redesign their respective devices to simplify and further improve endoscope reprocessing are encouraged.
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