SELF-STUDY SERIES


cleaning solution and thereby help the cleaning chemistry work better. Fats/ lipids tend to interact with these hard water elements and become more rigid and harder to clean. Chelants also pull away ions that stabilize protein and lipid structures, allowing those soils to then be broken down and cleaned away more readily.


Sequestrants keep soils suspended in


solution and prevent them from rede- positing on devices. They also dissolve inorganic soils like patient preparation products and procedural flushing solu- tions.


It’s important to note that while mild sequestrants/chelants (i.e., citric acid) are beneficial to endoscope reprocessing, strong versions of these ingredients are not compatible with enzymes. Including strong chelants like EDTA in a formula- tion will degrade enzymes and render them ineffective after only a short shelf- life.


Surfactancy is also involved in soil breakdown and soil removal, particu- larly for fatty and lipid soils. Surfactants can penetrate lipid soils and emulsify or solubilize them, which breaks them down just as well, if not better than other mechanisms, including enzymes.


Checklist for choosing the right formulation Step One: assemble the team Endoscopy managers should work with material management, infection preven- tion and reprocessing professionals at their facility to assess and select the opti- mal cleaning chemistries for their devices. Each of these experts will have knowledge that contributes to an informed decision.


Step Two: research the IFU Access all endoscope manufacturers’ instructions for use. Device manufactur- ers typically test a variety of cleaning chemistries to ensure device material compatibility and efficacy with the clean- ing procedure they recommend for their device. Endoscope manufacturers most often recommend detergents and/or enzymatic cleaners that have neutral pH and are low-foaming and free-rinsing. These same recommendations are supported by industry standards and guidance. Cleaning chemistry labeling offers a wealth of information as well. Informa- tion about the formulation helps with determining whether a cleaning chem- istry will be effective and appropriate.


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For example, not all detergents contain enzymes, but a properly formulated enzymatic product includes both a detergent and enzyme(s). So, even if soil conditions don’t require the enzyme, the formula’s detergent will clean effectively. The choice is not detergent or enzyme, but a combination of ingredients that will result in optimal cleaning outcomes for all the endoscopes and accessories.


Step Three: list all anticipated procedures


The next step is to identify the types of procedures your endoscopes perform and the soils from those procedures. Remem- ber to also consider the procedures that may be performed in the future as the facility grows and changes. A cleaning chemistry formulated for a wide variety of soils will help accommodate future procedural expansion.


Step Four: investigate your water Water hardness can impact the effective- ness of a cleaning chemistry. Consider testing facility/department water quality to determine if water treatment is neces- sary to assure optimal cleaning.


Step Five: audit each chemistry’s test data and value


Evaluate the performance data and overall value of each cleaning chemistry formulation being considered. Evaluation criteria for a cleaning chemistry should include: • Verification of neutral pH • Verification that the chemistry is low- foaming and free rinsing


• Proven effective performance against hard-to-clean soils such as lipids and proteins


• Demonstrated compatibility with device materials


• Ability to protect devices from corro- sion during reprocessing


Cost is an important component of any product evaluation, but value is the ulti- mate indicator. Remember that a cheaper cleaning chemistry may not always be the most cost-effective choice in the long run. Be sure to consider: • The cost of instrument repairs due to poor chemistry performance


• The differences in chemistry dosing volumes (concentrations)


• The cost (in staff time, supplies and postponed procedures) of reclean- ing because of poorly performing chemistries


38 September 2021 • HEALTHCARE PURCHASING NEWS • hpnonline.com


Patient safety above all A facility’s choice of endoscope cleaning chemistry has implications beyond the department itself. Thoughtfully selecting a well-formulated, high-quality cleaning chemistry can certainly help improve the effectiveness and efficiency of the endoscope reprocessing function. But it also has the potential to enhance that department’s reputation for delivering consistent, reliable cleaning outcomes that support patient safety initiatives. Considering that these complex reusable medical devices pose a serious infection risk if improper cleaning leads to incom- plete disinfection or sterilization, the consequences could be dire for patients and the facility both. Keeping an eye on this bigger picture will lead to the optimal cleaning chemistry solution. HPN


Ann Kneipp is a senior scientist II in Research & Development for STERIS Corporation, based in St. Louis, Missouri. She has over 20 years of product formulation experience and holds 13 patents for healthcare consumer goods and instrument cleaning chemistries for surgical and endoscopic devices. Kneipp is a member of the International Association of Healthcare Central Service Materiel Manage- ment (IAHCSMM).


Nancy Kaiser is the scientific director for STERIS Corporation in St. Louis, Missouri with extensive expertise in formulation. She has more than 30 years of experience in devel- oping healthcare products and holds more than 20 patents (with additional patents pending) in hard surface cleaners, instrument cleaning chemistries, disinfectants, antimicrobial skin care, and wound management products. She has also written numerous published articles and book chapters on these subjects. Kaiser is a member of the Association for the Advance- ment of Medical Instrumentation (AAMI) and sits on several AAMI committees. She holds a degree in chemistry from Washington University. References:


1. American Society for Gastrointestinal Endoscopy Reprocess- ing Guideline Task Force. (2017) Multisociety guideline on repro- cessing flexible GI endoscopes: 2016 update. Gastrointestinal Endoscopy, Volume 85 (No. 2), 282-294.


2. Association for the Advancement of Medical Instrumentation and American National Standards Institute, Inc. (2015) Flexible and semi-rigid endoscope processing in health care facilities ST91:2015.


3. Association of periOperative Registered Nurses. (2016) Guideline for processing flexible endoscopes. Guidelines for Perioperative Practice, 675-758.


4. International Association of Healthcare Central Service Ma- teriel Management. (2017). Endoscope Reprocessing Manual (Workbook) (First).


5. Society of Gastroenterology Nurses and Associates, Inc. (2016) Standards of Infection Prevention in Reprocessing Flexible Gastrointestinal Endoscopes


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