DocuSign Envelope ID: 6556CCBB-104E-4C14-ACED-F32EB8D36FAA Medivators Technical White Paper Advances in Disinfection Technologies RAPICIDE OPA/28 used as a high level disinfectant with endoscopes RAPICIDE® OPA/28 Unique Properties as a High-Level Disinfectant (HLD) INTRODUCTION RAPICIDE OPA/28 contains a dual surfactant package that is patent pending. This addition to the high-level disinfectant gives RAPICIDE OPA/28 unique properties which result in many benefits for the user, patient and purchaser. One must understand what a surfactant is first to realize how this can be such an enormous advantage to the cleaning/disinfection process. Surfactants are compounds that lower the surface tension, or interfacial tension, between two liquids or between a liquid and a solid. Surfactants may act as detergents, wetting agents, emulsifiers, foaming agents and dispersants. Surfactants will diffuse in water and adsorb at interfaces between air and water or at the interface between oil and water. This reduces the adhesion of organic material and debris (dirt) from the surface it is attached and allows for a faster manual disinfection time. TERMINOLOGY Aldehyde: organic chemical compound formed by the oxidation of alcohols, contains a –CHO group Anaphylaxis: a severe, potentially life threatening, allergic reaction Cleaning Agent: An agent for the removal from facility and equipment surfaces of product residues that may inactivate sanitizing agents or harbor microorganisms Decontamination: The removal of microorganisms by disinfection or sterilization. Dermatitis: general term meaning inflammation of the skin, may present in multiple forms Dyspnea: difficult or labored breathing High-Level Disinfectant: a chemical or physical agent that destroys all microorganisms, including Mycobacterium tuberculosis, with the exception of high numbers of bacterial spores Residuals: any substance remaining on an endoscope after high-level disinfection and rinsing Respiratory sensitization: hypersensitivity of the airways induced by inhalation of a substance Adv Disinfect Tech 2015: 50098-751/A Surfactant: a compound that reduces surface tension between two liquids or between a liquid and a solid; often used as a cleaning agent or detergent; surface active agent Type-1 hypersensitivity response: an allergic reaction that causes the body to produce antibodies DISCUSSION Prolonged exposure to ortho-phthalaldehyde (OPA) vapors can cause respiratory sensitization, as shown by studies conducted on mice that exhibited a type-1 hypersensitivity immune response after repeated exposure to OPA.1 After eight months of exposure to OPA vapors while cleaning endoscopes, a nurse at a Japanese hospital experienced dyspnea and a dry-cough along with dermatitis.2 RAPICIDE OPA/28 requires only a ten-minute manual disinfection period whereas other available OPA disinfectants require 12 minutes exposure for manual disinfection. Reduction in manual cleaning time means a reduction in worker exposure to potentially harmful OPA fumes. Surfactants are effective cleaning agents3 because of their ability to reduce surface tension in water, which causes the water to wet items or surfaces more uniformly. Also, surfactants have a hydrophobic (water-fearing) end and a hydrophilic (water-loving) end. The hydrophobic end of the molecule is attracted to oil and dirt while the hydrophilic end is attracted to water. Because of this unique property, surfactant molecules help water molecules to grab dirt and oils and remove them from surfaces. With the addition of two surfactants to RAPICIDE OPA/28, this product is especially successful at removing soil from endoscopes. These same properties are also thought to remove any debris barriers between the active agent in the disinfectant (OPA) and the microbial targets; this makes RAPICIDE OPA/28 among the fastest and most efficacious high-level disinfectants on the market. Also, due to the 2015 Medivators Inc. All rights reserved. 1 DocuSign Envelope ID: 6556CCBB-104E-4C14-ACED-F32EB8D36FAA nature of the surfactants in RAPICIDE OPA/28, it is easily removed from endoscopes with a requirement of only two water rinses after disinfection. Other OPA products on the market require three water rinses. Previous cases show residual OPA found on cystoscopes caused anaphylaxis in four patients after a urology practice starting using OPA for endoscope disinfection.4 Using RAPICIDE OPA/28 can lower the risk of residuals to the patient because surfactants decrease adhesion to the scope. With twice the reuse life offered by competing OPAs, RAPICIDE OPA/28 minimizes the frequency in which healthcare workers need to change the solution. Frequent high-level disinfectant changes could lead to staff injury due to ergonomic issues, chemical spills or increased respiratory stress. By offering an up to 28 day use life RAPICIDE OPA/28 minimizes this type of exposure. Also, RAPICIDE OPA/28 achieves 84 cycles during reuse life, which benefits the purchaser when analyzing cost per cycle. Also, RAPICIDE OPA/28 has been tested to archive around 84 cycles during reuse life, per EPA Reuse Test Protocol Specifications. Purchasers will see this benefit when analyzing cost per cycle. CONCLUSION RAPICIDE OPA/28 has multiple benefits over traditional OPA products. RAPICIDE OPA has a dual surfactant package that removes soil from endoscopes more readily. RAPICIDE OPA only needs a 10 minute disinfection, as opposed to a 12 minute disinfection with other OPA products. This decreases the amount of exposure for health workers. RAPICIDE OPA also only needs two water rinses as opposed to three because of the surfactants present, therefore decreasing the risk of patient exposure. With a 28 day reuse life and high cycle counts, the purchaser realizes a lower cost per cycle. These breakthrough properties of RAPICIDE OPA/28 make it stand apart from other OPA High-Level Disinfectant (HLD)s on the market. REFERENCES 1. Johnson, V. J., Reynolds, J. S., Wang, W., Fluharty, K., & Yucesoy, B. (2011). Inhalation of Ortho-Phthalaldehyde Vapor Causes Respiratory Sensitization in Mice. Journal of Allergy, 2011, 751052. doi:10.1155/2011/751052 2. Fujita, H., Ogawa, M., & Endo, Y. (2006). A Case of Occupational Bronchial Asthma and Contact Dermatitis Caused by ortho-Phthalaldehyde Exposure in a Medical Worker. Journal of Occupational Health, 48(6), 413-416. 3. Hashiguchi, M., Nishi, Y., Kanie, T., Ban, S., & Nagaoka, E. (2009). Bactericidal efficacy of glycine-type amphoteric surfactant as a denture cleaner and its influence on properties of denture base resins. Dental Materials Journal, 28(3), 307314. Comparison of the leading brands of OPA and RAPICIDE OPA/28 Reuse Life 90 Number of AER Cycles 80 84 74 4. Sokol, W. (2004). Nine episodes of anaphylaxis following cystoscopy caused by Cidex OPA (ortho-phthalaldehyde) highlevel disinfectant in 4 patients after cytoscopy. Journal of Allergy and Clinical Immunology, 114(2), 392-397. Sensitization in Mice. Journal of Allergy, 2011, 751052. doi:10.1155/2011/7510 70 60 50 42 40 30 20 10 0 Leading Brand 1 Leading Brand 2 Rapicide OPA/28 Figure 1: Comparison of the reuse life of the leading OPA brands versus RAPICIDE OPA/28. RAPICIDE OPA/28 can be reused up to ten more cycles than the leading brand of OPA. Adv Disinfect Tech 2015: 50098-751/A ® RAPICIDE is a registered trademark of Medivators Inc. 2015 Medivators Inc. All rights reserved. 2
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