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

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

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.

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

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

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;23:198-206

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

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 ?

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

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

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

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.

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

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

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

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

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)

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™)

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™)

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

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.

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

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

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

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.

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

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 http://www.cdc.gov/hai/organisms/cre/cre-duodenoscope-surveillance-protocol.html

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

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

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

Contact information: Fred Alston Cell: 724-448-4121 falston@hmark.com Mary Ann Drosnock Cell: 586-536-5322 1-800-521-6224/Ext.6005 Mdrosnock@hmark.com www.hmark.com www.healthmarkgi.com