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 bios for "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

15. Other Cleaning Verification Tools
Optical inspection/Enhanced Optical Inspection
Performed with Lighted Magnification, Digital Microscopes or a Borescope
Protein or Hemoglobin Swabs
Lumen/Cannula Sterile Water Flush

16. Enhanced Optical Inspection
Magnification
Handheld
Desktop
Bench or Table mounted
Microscope
Traditional
Electronic
Borescope
Allows visualization of the cannula or lumen
Rigid or Flexible
Manual or Camera

17. Surface Testing Can be performed using a swab
Tip is wetted with Sterile water and the surface is swabbed or it is inserted into a lumen to collect a surface sample.
Results are quick (30sec to 5 min) but does not yield a numerical result
Looks for a specific marker and is typically more sensitive (can detect down to .1µg)

18. Protein Test: A colorimetric result that is easy to interpret.
Works for both soluble insoluble proteins
Detection limit of 1.0µg within minutes for protein
Swab method
(ProCheck II™)

19. Hemoglobin Sensitive down to 0.1ug hemoglobin.
Colorimetric result - easy to interpret.
Limited chance for false positives (e.g., oxidizing agents which might be in cleaners or disinfectants).
Swab method
(HemoCheck™)

20. Pros: Protein/Hemoglobin Swabs
Ability to pick up denatured Protein
Sensitive. Can detect down to .1µg
Fast. Protein yields typical results in under 5 minutes, Hemoglobin in 30 seconds
Like ATP, a swab can be used to have friction contact with a surface.
Detects soils found in instrument reprocessing

21. Cons: Protein/Hemoglobin Swabs
Sometimes too sensitive for manufacturers
Does not yield a numeric value when soil is detected. Pass/Fail
Cost. No initial equipment cost but each test can run between $5 and $8.

22. Remember this picture from the start of the program
Remember this picture from the start of the program? Both look visibly soiled. Using a spot residual soil test can help differentiate between blood and rust in this case.
Blood

23. A Simple test to show what ATP can and cannot detect.

24. Which Organic Parameters to monitor?
Flexible endoscope biopsy channel: (Alfa et al 2002)
Protein; < 6.4 µg/cm2
Carbohydrate; < 1.8 µg/cm2
Hemoglobin; < 2.2 µg/cm2
Endotoxin; <2.2 EU/cm2

25. Cleaning verification recommendations
Current recommendations support testing of the manual cleaning process at pre-established regular intervals:
AAMI ST91: Regular intervals, i.e. Weekly or preferably daily
AORN: Regular intervals such as with EACH reprocessing cycle or daily
SGNA: Confirm the adequacy of manual cleaning by using a rapid cleaning monitor. If the tool results are positive, this allows for the re-cleaning of the endoscope prior to disinfection. Frequency determined by facility.

26. Microbial Surveillance
Options include:
Traditional culturing
Gram negative test kits
AAMI - No recommendation is made in the current version because of the timing of release.
Studies have identified the nature of microbial contamination likely to be found in improperly reprocessed endoscopes and have demonstrated the value of surveillance testing
AORN: Base decision on a risk assessment
Not ATP or cleaning verification tests

27. Guidance on culturing
CDC Interim Guidance on culturing duodenoscopes updated 4/3/15
Sites to be cultured?
Instrument channel (suction/biopsy channel)
Distal end (elevator mechanism, elevator recess)
Elevator channel (on older, unsealed)
Frequency: Every 30 days or 60 cycles
Mail back service for endoscope samples are now available

28. Monitoring for Gram-negative organisms in reprocessed scopes
Enzymes specific to Gram-negative bacteria hydrolyze the substrate in the reagent vial
This generates fluorescence, which is read by the fluorometer, which then gives a reading.
ST91: Types of verification testing may include enzyme based tests
Such as the gram negative test kit

29. PATIENT The circle of life Pre-Cleaning at point of use
Proper Biohazard transport
Patient Use
PATIENT
Cleaning per device IFU and Cleaning Verification
Proper Transport-Storage
Visual Inspection-Enhansed Optical Inspection
DOCUMENTATION
HLD or Sterilization

30. Thank You!
Questions?
On behalf of Healthmark, I am grateful for the opportunity to be here today.
THANK YOU!

31. Contact information:
Fred Alston Cell: Mary Ann Drosnock Cell: /Ext