STERILE PROCESSING
non-sterile/ non-high-level disinfected endoscope which is a health risk to the patient. The new standard to report and record leaks could assist a physician in the treatment of their patient and bring heightened awareness of monitoring those patients that were exposed to a non-sterile/non-high-level disinfected endoscope during a procedure. “Lastly, a much more difficult task for hospitals and endos- copy centers pertains to the need to separate endoscope decon- tamination from the sterilization process. Many GI endoscopy reprocessing departments perform all functions in one small room. While grandfathered in due to facilities constraints, due
to the high risk of cross contamination and the fact that the air flow is incorrect, hospitals and surgery centers should work to correct this critical flaw in the processing of GI endoscopes. This practice would never be allowed for an SPD, and it should not be allowed for GI endoscope reprocessing areas. Both contain biohazardous materials and have the risk of harm to staff and patients. For this reason, there should be no differ- ence in requirements between and SPD and a GI endoscope reprocessing area.”
Gregg Agoston, Vice President, Business Development, SPD Transformation Services, SpecialtyCare
Responsibility, accountability for pre-treating soiled devices finds a home
ANSI/AAMI houses the procedure at the point of use, in the OR immediately after a procedure by Rick Dana Barlow
ne of the hottest debates foment- ing tension between the Operating Room (OR) and Sterile Processing & Distribution (SPD) showed little sign of abating until the American National Standards Institute (ANSI) and the Association for the Advancement of Medical Instrumentation (AAMI) demon- strated steadfast and swift parenting skills. Few, if any, challenge one of the funda- mental and logical tenets of reprocessing: Clean first before high-level disinfecting or sterilizing anything because if something isnt thoroughly cleaned first it cannot be high-level disinfected or sterilized and ready for safe use on a patient. Acknowledging and accepting one of the
O
central tenets of reprocessing, OR and SPD professionals then move next to timing. Where does the process of reprocessing actually begin?
Until the revised ANSI/AAMI ST91:2021 standards were released by ANSI’s Endoscope Reprocessing Working Group in conjunction with AAMI’s Sterilization Standards Committee, the guidelines for reprocessing flexible and semi-rigid endo- scopes left the notion of “pre-cleaning,” which ST91 re-labeled as “pre-treating,” to circular finger-pointing. SPD professionals recognize the frustra- tion around pre-treating soiled devices. The longer that biological/organic material remained on soiled devices post-surgery, the faster the material dried, making it harder – and more time-consuming – for SPD techs to clean. This extended the overall reprocessing time in SPD as
well as the turnaround time to return devices to the OR. Logically, to prevent biological/organic material retained on soiled devices post- surgery from drying and hardening, it makes sense to apply some sort of pre- treatment material to the soiled devices earlier than in SPD to keep the biological/ organic material soft and therefore easier to remove during the cleaning process. From a timing standpoint, the ANSI/AAMI experts recognized the tenable solution to which Ron Banach, Director, Clinical Training, Ruhof Healthcare, emphasizes matter-of-factly. “The March 2022 release of the ANSI/ AAMI ST91:2021 update has made it very clear: Pre-treating needs to be carried out in the OR,” Banach told Healthcare Purchasing News. “The use of enzymatic products should start during the pre-cleaning process at the point of use immediately following pro- cedures,” Banach continued. “Enzymatic foams, gels and humectants designed for pre-cleaning aid in loosening soils and keeping instruments moist pending fur- ther cleaning until reprocessing begins. This discourages soils from drying and forming biofilms. Banach cites the direct, codified reference to remove any doubts on page 29 under the heading “7.2 Point of use treatment” and subheading “7.2.1 General considerations. “To prevent buildup of bioburden, devel- opment of biofilms, and drying of secretions, point of use treatment is performed immedi- ately after completion of use of the device. It is imperative that the written IFU from the
30 November 2022 • HEALTHCARE PURCHASING NEWS •
hpnonline.com
endoscope, cleaning equipment, and cleaning solution manufacturers are followed. When labelled for this purpose, commercially avail- able sponges or wipes can be used for point of use treatment. Also new automated sprayer delivery systems can add efficiency, compliance, and effectiveness.” Although OR nurses historically have mumbled and grumbled – and in some cases resisted – about their participation in what largely has been SPD’s responsibility, ANSI/AAMI threw down the gauntlet and clarified the matter once and for all. “Noncompliance by the OR staff is unac- ceptable,” Banach said. “When pathogens and micro-organisms are left on the medi- cal device, they begin drying in minutes. It is critical to keep the device moist long enough so the decontamination processing department can do their job effectively.” Ruhof makes Prepzyme Forever Wet with Bio-Clean Technology, a multi-tiered enzy- matic humectant spray for pre-treating soiled devices in the OR.
Other SPD experts quickly reinforce pre- treating soiled instruments in the OR. “We believe that pre-treating is crucial at point of use, immediately after a proce- dure and prior to transport,” said David Willoughby, Vice President, Marketing & Business Development, Medtrica Solutions Ltd. “Once instruments leave the proce- dure room there are too many variables that can and will delay pre-treating, so not using an enzymatic pre-cleaning agent at POU immediately after the procedure can become extremely problematic. Although pre-treating at POU can at times be per- ceived as an inconvenience in terms of time,
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