Greetings Everyone!

Welcome to the CAMDR Learning Annex on New Technology for Protein Detection with the

ProReveal Fluorescence Detection System

Congratulations – It’s MDR Week!

!It’s your week to be honored for the lives of patients

you are keeping safe!

Dialog: Congratulations – It’s MDR Week, making it your week to be honored for the lives of patients you are keeping safe with the special work you do. Departments everywhere are opening up and inviting people from other departments to see the specialized work that you do.

How is your Journey?

Wouldn’t you agree, it’s been an interesting one?

Rapid changes in your profession as the medical industry continues to change.

The JourneyDialog: How is everyone’s journey? Wouldn’t you agree it’s been an interesting one? You’ve seen a lot of changes within your profession and as rapidly as the medical profession advances, you will continue to see changes.

Getting to Zero The JourneyDialog: From the past to present, it has been a long and yet interesting journey. The real goal for Medical Device Reprocessing is Getting to Zero – or in other words absolute clean, every time; making the MDR cycle the safest and best that it can be for everyone!

The MDR Cycle

Dialog: Before standards were established and the tools were available to do the best job possible, we experienced many gaps in the reprocessing process.

The MDR Cycle

It’s Getting Better!All the Time!

Dialog: Over time, we’ve seen gaps in the cleaning process become closed with new techniques and tools to enable you to eliminate risk and keep instruments very clean. Like for example, keeping surgical instruments wet right in the OR continuing on to the MDR making them easier to process. As professionals in the MDR arena, you have to assess which tools to use with any task or issue with regards to reprocessing surgical Instruments. The process is getting better all the time! Today I bring you a new tool to add to your toolbox to assist with closing those gaps.

The ProRevealToday we are looking at the ProReveal which is an Ultra-Sensitive Florescence Protein detection testing system.

Dialog: Today we are looking at the ProReveal Testing System, which is an Ultra-Sensitive Florescence Protein detection testing system. The evolution of the system came about through a rather large grant from the Department of Health in the UK for the research and development of what ultimately became the ProReveal System.

David Perrett, Professor of Bioanalytical Science, Nanda K. Nayuni, Post-doctoral Researcher Bioanalysis,

William Harvey Research Institute, Barts & the London School of Medicine and Dentistry,

Queen Mary University of LondonDialog: The ProReveal was born out of a large gratin by the United Kingdom Department of Health. The inventors of this marvelous machine are Dr. David Perrett and Dr. Nanda Nayuni at the Barts & the London School of Medicine and Dentistry.

❖ Major concern - CJD (Creutzfeldt–Jakob disease),or Mad Cow Disease.

!❖ According to the Canadian Alzheimer Society,

there are about 35 cases in Canada reported annually.

❖ CJD - a malformed prion.

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❖ A prion is a normally occurring protein found in the brain. ❖ ProReveal test will include the evidence of this in the result. ❖ Proteins have a strong bond to stainless-316. ❖ Can require the destruction of the entire set surgical instruments in question.

Dialog: From the perspective of the United Kingdom’s Department of Health, a major concern of course is with CJD, (Creutzfeldt–Jakob disease), or mad cow disease. Although the outbreaks of this terrible disease has been predominately felt in the UK, there is always a real threat of this occurring anywhere in the world.According to the Canadian Alzheimer Society, there are about 35 cases reported annually.

Features❖

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ProReveal test is highly protein specific. Low cost /easy to use. Results provide both qualitative and quantitative information. Protein amount is numerically displayed. Visual image of instrument with protein areas overlaid.3-D representation of protein display for close-up viewing.

Dialog: The ProReveal test is highly protein specific. Each test is low cost and the results are very effective as it provides both qualitative and quantitative results. The total amount of protein is numerically displayed as well as a visual image of where and in what concentration the protein resides on an instrument. Even more interesting, there is a 3-D mode, which shows a representation of the residual protein allowing you to zoom in to see the results better.

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Benefits

❖ No swabbing or guesswork involved. ❖ Test performed in about three minutes. ❖ Images the whole instrument. (Single side)

Dialog: The test is completed in about three minutes with no swabbing or guesswork involved. You test the entire instrument, (one side). This is called in-situ protein detection – basically referring to ‘at the site of’.

The Test1. Place a sheet of black paper in the drawer.

2. Place the test instrument on the paper.

3. Spray the instrument with theProReveal spray.(The reagent is non-toxic andwashes off easily.)

4. Close the drawer and press thestart test button.

Dialog: The test starts by placing the instrument on a sheet of black non-reflective paper in the drawer and spray the instrument with the ProReveal spray, a reagent that is specifically formulated to produce fluorescent reactivity with regards to proteins, not just basic amino acids. This is the beauty of this testing method because it is so easy to perform. The reagent is non-toxic and washes off easily.

The Results

Test Results as shown on touch-screen

3D Display Mode !Dialog: The image on the left shows residual protein detected by the ProReveal System. The right image shows the left finger-ring and serrated clasps of a pair of forceps as a 3D visualization of the amount of residual protein. Note: The forceps were photographed following the test and showed no apparent protein on visual inspection.

Process Modes

Inspection Mode The result is displayed with calculated amount of residual protein in micrograms.

Dialog: With this system, there are two methods or modes in which you can operate. The first is called the Inspection Mode in which you see the result with a display of the calculated residual protein in numerical form. In this mode, the test is performed with the results showing the amount of residual protein in numerical form.

A full report showing image and test data is available for printing out or to be kept in a logbook or other departmental record.

Spray the surgical instrument with the ProReveal spray, from a distance of 30cm.

The ProReveal software waits for the reagent to ‘develop’, then uses fluorescence image processing to detect and measure tiny quantities of contamination.

The ProReveal software displays a detailed image of the surgical instrument under test, highlighting the exact location of any detected contamination which might remain after the washing process.

Select a surgical instrument which has been through the wash process.

Click the Start button on the ProReveal software, then follow instructions on the screen to test the surgical instrument

Place a piece of ProReveal black paper into the ProReveal viewer drawer.

Place the surgical instrument onto the paper.

Close the drawer to continue the automatic sequence; a timer on the screen shows time to completion.

ProReveal displays the amount of any residual protein left on the instrument. Eg:

The ProReveal viewer ejects the drawer automatically on completion of the test.

The surgical instrument, having been sprayed and tested, must now be returned to the wash process.

TheProRevealProcessInspectionMode

ProRevealFluorescence Protein Detection Test

www.synopticshealth.com

!Control Mode An ‘acceptable-value’ set in the system renders either a pass or fail result.

Process Modes

Dialog: In Control Mode mode, a hospital can establish an amount of protein that is considered acceptable. Let’s say for example one microgram of residual protein as acceptable on an instrument. In Control Mode, you set the value into the system and each test performed will conclude on either a pass or fail basis.

A label is printed to record PASS or FAIL to identify this test, to be kept in a logbook or other departmental record.

Spray the surgical instrument with the ProReveal spray, from a distance of 30cm.

The ProReveal software waits for the reagent to ‘develop’, then uses fluorescence image processing to detect and measure tiny quantities of contamination.

The ProReveal software displays a detailed image of the surgical instrument under test, highlighting the exact location of any detected contamination which might remain after the washing process.

Select a surgical instrument which has been through the wash process.

Click the Start button on the ProReveal software, then follow instructions on the screen to test the surgical instrument

Place a piece of ProReveal black paper into the ProReveal viewer drawer.

Place the surgical instrument onto the paper.

Close the drawer to continue the automatic sequence; a timer on the screen shows time to completion.

A green tick or a red cross on the screen clearly indicates whether the washing process has PASSED or FAILED this test.

The ProReveal viewer ejects the drawer automatically on completion of the test.

The surgical instrument, having been sprayed and tested, must now be returned to the wash process.

TheProRevealProcessControlMode

ProRevealFluorescence Protein Detection Test

www.synopticshealth.com

Data Collection❖ Data is stored in the

system with the results along with date and time of test.

❖ Generate data-plots over time to reveal trends in you cleaning process.Especially beneficial for optimizing the Automatic Washer Disinfector.

Dialog: The ProReveal represents a huge data collection tool. Each test is stored in memory with the date along with the results both numerically and visually. From there, the data can be collected over time to reveal trends in you cleaning process especially with the Automatic Washer Disinfector. This plot chart shows a set of 400 tests performed. This clearly shows that there is a upward shift in amount of protein measured. This is a tremendous aid in showing where the MDRD needs optimization.

Data Collection❖ Data transferrable to

a thumb-drive or other storage device via USB.

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❖ Data files created in Excel compatible or PDF formats.

Dialog: The data is transferrable via a thumb drive or other storage device when connected to one of the USB ports. Detailed test results may be downloaded from the system in an Excel compatible file as well as in PDF format.

Data Collection

❖ Network connectivity - data may be kept on permanent record on a local server or cloud based storage service.

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❖ Optional label printer provides a label with the test results for logging and reviewing.

Dialog: Since the system and has network connectivity, all the data may be kept on permanent record on a server elsewhere at the facility or within a cloud based storage service. Additionally, an optional label printer may be connected to the ProReveal and print a label with the test results, which can be kept in a logbook for retracing if and when necessary.

The ProReveal can assist with thefollowing possible scenarios or actions:

❖ Routine Quality Control and Quality Assessment in your reprocessing departments.

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❖ Performance testing of AWDs and/or detergents before purchase.

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❖ Validation of AWDs in routine operation.

Dialog: The ProReveal can assist to Getting to Zero with these possible scenarios or actions.

The ProReveal can assist with thefollowing possible scenarios or actions:

❖ Manufacturers of AWDs or detergents could use ProReveal for developing improved systems and chemistries.

❖ Methods for evaluating novel prion removing detergents.

❖ Surgical instrument manufacturers to improve their designs.

❖ General research applications.

Please feel free to reach out to me: !

Email: Tom.Overbey@UltraCleanSystems.com Linked In: Thomas Overbey Twitter: @UltraCleanSys

Thanks to: !

Candace Johnson President and COO Valumed Professional Products LTD !

The ProReveal will be on display in Valumed’s booth #52.

Please come by and see the system up close and ask any questions you may have.

❖ As MDR professionals, please stay involved with your cause for patient safety. !

❖ If you are not in a professional organization such as CSA, enroll and be vigilant toward continuing the journey toward Getting to Zero!

Thank you for your time!