The document introduces the ProReveal fluorescence detection system, which can detect trace amounts of residual proteins on surgical instruments after cleaning. It describes the system's development in the UK and how it works with an easy 3-minute test. The system provides numerical and visual results, stores test data, and can be used to monitor cleaning processes and equipment over time through trend analysis. It is presented as a new tool that can help further the goal of ensuring surgical instruments are absolutely clean after reprocessing.

1. Greetings Everyone!
Welcome to the CAMDR Learning Annex on
New Technology for Protein Detection with the
ProReveal Fluorescence Detection System

2. Congratulations – It’s MDR Week!
It’s your week to b! e 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.

3. 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 Journey
Dialog: 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.

4. Getting to Zero The Journey
Dialog: 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!

5. 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.

6. 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.

7. The ProReveal
Today 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.

8. 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 London
Dialog: 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.

9. ❖ 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.
!
❖ 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.

10. Features
❖
❖
❖
❖
❖
❖
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.

11. 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’.

12. The Test
1. Place a sheet of black paper in the drawer.
2. Place the test instrument on the paper.
3. Spray the instrument with the
ProReveal spray.
(The reagent is non-toxic and
washes off easily.)
4. Close the drawer and press the
start 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.

13. 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.

14. Process Modes
Inspection Mode
The result is
displayed with
calculated amount
of residual protein
in micrograms.
A full report showing image
and test data is available
for printing out or to be
kept in a logbook or other
departmental record.
Place the surgical
instrument onto the paper.
Spray the surgical instrument
with the ProReveal spray,
from a distance of 30cm.
ProReveal displays the
amount of any residual
protein left on the
instrument. Eg:
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.
The ProReveal software waits
for the reagent to ‘develop’,
then uses fluorescence image
processing to detect and
measure tiny quantities of
contamination.
The
ProReveal
Process
Inspection
Mode
Select a surgical instrument
which has been through the
wash process.
Place a piece of ProReveal
black paper into the
ProReveal viewer drawer.
Click the Start button on
the ProReveal software,
then follow instructions
on the screen to test the
surgical instrument
Close the drawer to continue
the automatic sequence; a
timer on the screen shows
time to completion.
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.
ProReveal
Fluorescence Protein Detection Test
www.synopticshealth.com
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.

15. C! ontrol Mode
An ‘acceptable-value’
set in the system
renders either a pass
or fail result.
Process Modes
A label is printed to
record PASS or FAIL to
identify this test, to be
kept in a logbook or other
departmental record.
Place the surgical
instrument onto the paper.
Spray the surgical instrument
with the ProReveal spray,
from a distance of 30cm.
A green tick or a red cross
on the screen clearly
indicates whether the
washing process has
PASSED or FAILED this test.
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.
The ProReveal software waits
for the reagent to ‘develop’,
then uses fluorescence image
processing to detect and
measure tiny quantities of
contamination.
The
ProReveal
Process
Control
Mode
Select a surgical instrument
which has been through the
wash process.
Place a piece of ProReveal
black paper into the
ProReveal viewer drawer.
Click the Start button on
the ProReveal software,
then follow instructions
on the screen to test the
surgical instrument
Close the drawer to continue
the automatic sequence; a
timer on the screen shows
time to completion.
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.
ProReveal
Fluorescence Protein Detection Test
www.synopticshealth.com
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.

16. 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.

17. Data Collection
❖ Data transferrable to
a thumb-drive or
other storage device
via USB.
!
❖ 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.

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

19. The ProReveal can assist with the
following 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.
!
❖ Validation of AWDs in routine operation.
Dialog: The ProReveal can assist to Getting to Zero with these possible scenarios or actions.

20. The ProReveal can assist with the
following 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.

21. Please feel free to reach out to me:
!
Email: Tom.Overbey@UltraCleanSystems.com
Linked In: Thomas Overbey
Twitter: @UltraCleanSys

22. 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.

23. ❖ 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!

24. Thank you for your time!