1. Cleaning Verification
Understanding
ATP, Protein, Hemoglobin
As Cleaning indicators
Presented By:

2. 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

3. 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.

4. Agenda Tools Available What ATP is and is NOT Pro’s and Con’s
Protein/Hemoglobin Swabs
Demo
Summary and Wrap up

5. Dirty Surgical Instruments:
Can you tell which one has residual blood left on it after cleaning?

6. 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:

7. 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

8. 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 ?

9. 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

10. 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

11. 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

12. 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.

13. 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

14. 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