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Cleaning Verification
Understanding ATP, Protein, Hemoglobin As Cleaning indicators Presented By:
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Disclosure I am an employee of Healthmark Industries Fraser, Michigan USA I am involved with the manufacture and distribution of medical products to healthcare facilities and healthcare professionals No compensation has been received for this presentation or for travel to and from the seminar All opinions are those of the presenter
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Healthmark Policy Healthmark’s Policy is to provide our customers and the healthcare community with the highest quality, state of the art medical products and support services in a timely and cost effective manner. This goal is supported by a staff committed to individual accountability, professionalism, mutual respect, collaboration and service excellence. This presentation is part of that commitment, educating our customers.
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Agenda Tools Available What ATP is and is NOT Pro’s and Con’s
Protein/Hemoglobin Swabs Demo Summary and Wrap up
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Dirty Surgical Instruments:
Can you tell which one has residual blood left on it after cleaning?
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What markers should users test for?
Literature supports using organic contaminants that are representative of the soils likely to be found on the device after clinical use (i.e., protein, hemoglobin, and carbohydrates) as markers.* Regulatory authorities (like the FDA) are looking for results from device manufactures for two clinically relevant markers of the test soil chosen (i.e., protein, hemoglobin, mucus,...).* Alfa has shown that for flexible scope that: protein; < 6.4 µg/cm2, carbohydrate; < 1.8 µg/cm2, hemoglobin; < 2.2 µg/cm2, are excellent markers for cleaning validation and verification.** Ask your self this question is ATP used by medical devices manufactures presently for their FDA submission for cleaning validation ? *The source for all of this information is taken from : A White Paper ;The New Scope of Reusable Device Cleaning Validations-By: Patrick Kenny;Microtest-2011 **Alfa MJ et al A Survey of reprocessing methods, residual viable bioburden and soil levels in patient-ready ERCP duodenoscopes used in Canadian centers. Infect Control Hosp Epidemiology 2002;23:
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Manual Cleaning Verification Monitors
Channel Sample Flush methods ATP Systems Swab methods Combination test strips Protein swabs Hemoglobin swabs Detects ATP Flush and swab methods Many systems available Carbohydrate, protein & hemoglobin
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Sterile Processing and Endoscopy Area have many Tools – ATP is one of them
Questions to ask? What is ATP ? Do I understand how it works? Why ATP ? Is ATP the right tool to use to monitor the cleaning process in a Sterile Processing Area, and / or Endoscopy departments ?
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What is ATP? ATP reacts with luciferase resulting in a light emission.
Origin: Greek biosfor "living" and the Latin lumen"light". The result of a chemical reaction - chemical energy is converted to light energy. Adenosine Triphosphate (ATP) Energy currency of all living cells Produced only by living cells ATP reacts with luciferase resulting in a light emission. History used in food service for surface testing Predominant molecule within cells. Thus can be used as an indicator for the presence of viable cells Reaction catalyzed by Luciferase enzyme found in fireflies Reaction forms Oxyluciferin. Light is emitted because “Oxyluciferin is formed” in an electronically excited state. ATP Oxyluciferin + Firefly Luciferase + AMP CO2 Light 560nm O2
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DETECTION OF ATP Luminometer- measures the amount of light emitted
Amount of light: proportional to the amount of ATP present, measured in Reflective Light Units (RLU). Method Testing surfaces Moisten the swab Swab the area to be tested Ideal is a 4 x 4 area test Insert the swab in the luminometer Fluid / solutions testing Place the honey comb type swab in the solution Some studies have established 100RLU as the threshold between clean/dirty. An instrument called the luminometer takes the measurement of light. Directly proportional Close, shake
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PROS of ATP Detects the ATP of living bacterial and human cells
Yields quick and easy to interpret results numerically Allows for on-site testing Yields a numeric result Swab method of testing surfaces Dip method for fluids Is one of many cleaning verification options shared in the various standards as a test method Computer tracing method of results
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CONS of ATP Degrades naturally; conditions of reprocessing
Sensitivity to physical and chemical conditions ( pH, detergents, temperature) ATP is short lived (only in living or very recently deceased cells) Variable degradation rates Specific area to swab(4 x 4 inches) No set regulatory limits on RLU’s for clean There isn’t an accepted defined measurement of clean with ATP. Zero is the only true number. Different brand readers can yield different RLU values for the same ATP load. No industry consistently.
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CONS of ATP ATP ≠ Bacteria*
Can have a very high count of bacteria with a low light reading Can have a high light reading with a low bacterial counts No correlation of bacterial surface counts to ATP Non-direct relation between RLU and bacterial colony forming units ( CFU/cm² ) Bacterial genus or species not known *Dr. Virginia Deibel;TRAC Microbiology, Inc.;3A Standards Meeting; May 20, 2008;High Tech Detection Methods: Hygiene Detection using ATP Bioluminescence
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CONS of ATP Readers are a capital purchased
Many companies offering the razor blade / razor handle purchasing concept Storage of swabs can be an issue Temperature sensitive (need to be refrigerated prior to use) Does not detect viruses and organic soils “ATP in NOT present in viruses nor is it present in components such as protein, carbohydrate, hemoglobin, lipids,..” Alfa-Chapter 4 –disinfection,Sterilization and Antisepsis ; page 66
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