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

2. 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

3. 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

4. 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)

5. 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™)

6. 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™)

7. 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

8. 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.

9. 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

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

11. 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

12. 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.

13. 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

14. 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

15. 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

16. 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

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

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