Technical Data Monograph

Transcription

1 CLEAN STARTS HERE POINT OF USE PROCESSING GEL Technical Data Monograph Minimized Product Waste By Using PRE-KLENZ Point Of Use Processing Gel Versus Other Commercially Available Pretreatment Products

2 Table of Contents 1. Introduction Purpose Method Results Conclusion

3 1Introduction Pretreatment of soiled surgical instrumentation at point of use is recommended by multi-industry guidelines 1,2,3,4 to begin and facilitate the decontamination process. Moistening and removing gross soil at the point of use can help prevent organic material and debris from drying on instruments. 3 For this critical step to be most efficacious and cost effective, the pretreatment product selected needs to dispense with controlled application that limits hazardous splashing and wasteful overspray and must remain on instruments for extended periods of time without running off. 2Purpose PRE-KLENZ Point of Use Processing Gel is a ready-to-use, neutral ph gel designed to keep soils moist and initiate the cleaning process on reusable surgical instruments at the point of use. The gel technology allows PRE-KLENZ Point of Use Processing Gel to cling to instrument surfaces longer than products dispensed as liquids or foams, and the easy-dispense package enables controlled instrument coverage with the simple push of a button, at any angle. This study evaluated PRE-KLENZ Point of Use Processing Gel along with a variety of other commercially available pretreatment products for product waste generated through routine use. 3Method Overspray Method: Run-off Method: Products were applied to a flat tray in an even, complete coating. Preweighed papers placed around the tray caught product overspray and splashing. These papers were reweighed immediately after application and the amount of wasted product was calculated. Products were applied to a perforated instrument tray containing two layers of hemostat instruments. The tray sat undisturbed for 30 seconds to allow for run-off onto the preweighed absorbent towels underneath the tray. After 30 seconds, the towels were reweighed and the amount of product run-off was calculated. 3

4 4Results Overspray Most commercially available pretreatment products are sold in packages with trigger spray dispensing systems. Drawbacks to these traditional trigger sprayers include splattering, splashing, and overspray which are generated by the mechanical pumping/pulling action required to operate as well as the designs of the nozzle. PRE-KLENZ Point of Use Processing Gel Bag-on-Valve (BOV) dispensing technology resulted in the least amount of product lost to overspray. Using this technology, product dispenses in a broad yet controlled pattern from a single open setting, while the one-touch button actuator helps the operator keep the can steady during application. The gel formulation also prevents splashing and kick-back off surfaces, further limiting overspray and product loss. Five of the pretreatment products evaluated also have single setting nozzles. ProEZ foam Foaming Enzymatic Spray 5 and Blu62 Pretreatment Foam 6 yielded limited overspray due to tighter dispensing patterns. However, trade-offs of this more limited coverage area are that more product is required per tray to achieve complete coverage, which leads to additional time and ergonomic fatigue. Bio-Zolve Instrument Presoak Spray Gel 7 and OptiPro Gel Instrument Pre-Cleaner 8 created more significant amounts of overspray, 12 times and 23 times respectively the amount generated by PRE-KLENZ Point of Use Processing Gel. Of the pretreatment products with single nozzle settings, by far the worst amount of overspray was generated by EmPower Foam 9 which propelled product out at erratic angles. This created an enormous amount of product waste and created a product exposure hazard to all surrounding surfaces, including personnel. See Figure 1. Figure 1: Amount of pre-cleaner overspray of single setting nozzles times the amount of overspray from PRE-KLENZ Gel BOV 4

5 Four of the pretreatment products evaluated utilize trigger sprayers that offer various setting options or configurations, yet provide no guidance for selection in the directions for use on the label, even though these options greatly impact the way the product dispenses. Prepzyme Forever Wet Instrument Transport Pre-Cleaner Enhanced with Bio-Clean Technology 10,11 and Prepzyme Multi-Tiered Enzymatic Foam Spray 10,11 have nozzles with removable screens. The differences in dispensing pattern using the screen versus not resulted in significant differences in the amount of overspray generated. Through the screen, Prepzyme Forever Wet Pre-Cleaner with Bio-Clean Technology generated 38 times more overspray than PRE-KLENZ Point of Use Processing Gel. However, Prepzyme Forever Wet Pre-Cleaner with Bio-Clean Technology dispensed as a broad mist without the screen, making application harder to control and generating double the amount of overspray with the screen 78 times that of PRE-KLENZ Point of Use Processing Gel. Similar results were demonstrated with Prepzyme Multi-Tiered Enzymatic Foam Spray. Through the screen, Prepzyme Multi-Tiered Enzymatic Foam Spray dispensed in a tight, controlled pattern, though yielding six times more overspray than PRE-KLENZ Point of Use Processing Gel. Prepzyme Multi-Tiered Enzymatic Foam Spray also dispensed as a broad mist without the screen, yielding 149 times more overspray than PRE-KLENZ Point of Use Processing Gel. Prepclean Forever Wet Instrument Transport Pre-Cleaner 10 has a choice of spray and stream nozzle settings, with spray yielding less product loss than stream. While Prepclean Forever Wet Pre-Cleaner generated 21 times the amount of overspray than PRE-KLENZ Point of Use Processing Gel using the spray setting, the stream setting generated 188 times the amount due to both overspray and significant splashing. Renuzyme Foam Spray 12 has a choice of foam and stream settings, with foam yielding less product loss than stream. Renuzyme Foam Spray has a tight dispensing pattern on the foam setting, generating only 12 times the amount of overspray as PRE-KLENZ Point of Use Processing Gel. However, this comes with the aforementioned trade-offs of requiring more product per tray to achieve complete coverage, leading to additional time and ergonomic fatigue. Renuzyme Foam Spray using the stream setting dispensed forcefully as a thin liquid resulting in a large amount of radiant splashing, and creating an enormous amount of product waste (310 times more than PRE-KLENZ Point of Use Processing Gel) and a product exposure hazard to all surrounding surfaces, including personnel. See Figure 2. Figure 2: Amount of pre-cleaner overspray of multi-setting nozzles times the amount of overspray from PRE-KLENZ Gel BOV 300% 275% % 225% 200% 175% 150% 125% % 75% 50% 25% PRE-KLENZ GEL PREPZYME W/BIO-CLLEAN PREPZYME PREPCLEAN RENUZYME NOZZLE SETTING 1 NOZZLE SETTING 2 5

6 Run-Off To be efficacious, a pretreatment product must remain on instruments for extended periods of time without running off instrument surfaces and out of perforated trays. Yet it must not adhere so tightly that it prevents spreading and flow into instrument crevices and to lower layers of stacked instruments within trays. PRE-KLENZ Point of Use Processing Gel provided thorough coverage that was not readily forced through tray perforations during dispensing. The gel formulation effectively clings to surfaces, and yielded minimal product loss from run-off. Conversely, at least half of the pretreatment products evaluated created greater than double the amount of run-off as PRE-KLENZ Point of Use Processing Gel. This product loss was attributed to several factors. Prepzyme Multi-Tiered Enzymatic Foam Spray, Renuzyme Foam Spray, and EmPower Foam are liquid-thin foam products that spray with enough force that they readily penetrated the perforations in the tray during application. Bio-Zolve Presoak Spray Gel, Blu62 Pretreatment Foam, and Prepzyme XF extreme Foam Multi-Tiered Enzymatic Foam Spray 10 are thicker products that did not readily breach the perforations in the tray during dispensing yet they did not cling effectively to the instrument and tray surfaces, thus resulting in large amounts of measured run-off. See Figure 3. Figure 3: Amount of pre-cleaner run-off times the amount of run-off for PRE-KLENZ Gel BOV PREPZYME RENUZYME BLU62 PREPZYME XF EMPOWER FOAM BIO-ZOLVE GEL PROEZ FOAM PREPZYME W/BIO-CLEAN OPTIPRO GEL

7 5Conclusion The routine use of many commercially available pretreatment products results in a significant amount of product waste from overspray and run-off. Comparison tests indicate PRE-KLENZ Point of Use Processing Gel with BOV dispensing technology reduces product waste from overspray and the gel formulation reduces product loss from run-off. REFERENCES 1 Association for the Advancement of Medical Instrumentation (AAMI). ANSI/AAMI ST79:2010/ A4:2013: Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. Section 6.4. AAMI, Arlington, VA; Association for the Advancement of Medical Instrumentation (AAMI). AAMI TIR30:2011: Compendium of Processes, Materials, Test Methods, and Acceptance Criteria for Cleaning Reusable Medical Devices, Section AAMI, Arlington, VA; Association of perioperative Registered Nurses (AORN). Guideline for cleaning and care of surgical instruments, Recommendation III G. In: Guidelines for Perioperative Practice. AORN, Inc, Denver, CO; U.S. Food and Drug Administration. Center for Devices and Radiological Health. Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. Guidance for Industry and Food and Drug Administration Staff. Center for Biologics Evaluation and Research, Silver Spring, MD; March 17, ProEZ foam is a trademark of Certol International, LLC 6 Blu62 is a trademark of Stryker Instruments 7 Bio-Zolve Instrument Presoak Spray Gel is distributed by Medline Industries, Inc. 8 OptiPro is a trademark of Ecolab USA, Inc. 9 EmPower Foam is a trademark of Metrex Research, LLC 10 Prepzyme and Prepclean are registered marks of The Ruhof Corporation 11 Multi-Tiered and Bio-Clean Technology are trademarks of The Ruhof Corporation 12 Renuzyme Foam Spray is distributed by Getinge USA, Inc. 7

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