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Present
Enhanced Visual
Inspection
Today’s Presenters
Mary Ann Drosnock
Steve Kovach
Manager, Clinical Education for Endoscopy
Healthmark Industries
Director of Education
Healthmark Industries
Company Mission
To provide innovative and cost effective
products that aid our Healthcare Industry
customers in meeting their sterilization,
decontamination, storage, distribution and
security needs.
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 webinar is part of that
commitment, educating our customers.
Who is attending today
•Please answer the following questions
–What department do you primarily work in at
your facility (medical facility)?
•Sterile Processing
•Operating Room
•Infection Control
•Endoscopy
•Environmental Services
•Other department in a medical facility
•Non-Hospital (distributor/manufacture/sales
person)
Where are you from ?
•United States
•Canada
•United Kingdom
•Mexico
•South America
•Central America
•Asia
•Europe
•Middle east
•Africa
•Pacific area
•Australia
•New Zealand
Objectives
• Define visual clean
• Define enhanced visual inspection
• Site
• Surface
• Review the latest information from various organizations on
enhanced visual inspection
• Define best practices for enhanced visual inspection of medical
devices
• Examples
•
Lumen items
•
Orthopedic shaver
•
Doppler
•
Endoscopes
•
Other medical devices
Dirty medical device
• "A problem analysis should be
completed for any problem with
any aspect of decontamination
that can pose a risk to personnel
or patients. The problem
analysis should define and
resolve the problem and the
system should be monitored to
ensure that the problem has
been corrected”
• Dirty medical device
–Investigate
•Visual inspection
–Site
–Surface
ANSI / AAMI ST 79
• Visual inspection is described
–Verification of the Cleaning process
•Section – 7.5.5
– After completing the cleaning process, personnel should
visually inspect each item carefully to detect any visible soil.
–Inspection using magnification might identify residues more
readily than the unaided eye.
–Visual inspection alone may not be sufficient for assessing the
efficacy of cleaning processes; the use of methods that are
able to measure organic residues that are not detectable
using visual inspection should be considered in facility
cleaning policy and procedures (see Annex D for available
methods).
2014 - Survey on Visual Inspection
3
Do you presently test/check/swab any of your instruments after cleaning for
residual organic soil?
55
29
6
Do you presently visually inspect the housing/barrel of your art. shavers with any
type of scope?
66
15
N/A
8
Presently do you think you are following the IFU for cleaning & inspecting art.
shavers properly?
55
NO
24
YES
Before this workshop did you know of the issues associated with visual inspection
of art. shavers?
39
48
14
Do you presently clean arthroscopic shavers in your dept?
73
0
20
40
60
80
Results of 2014 Survey
• This basic survey showed that even with new IFU stressing
the importance of visually inspecting shavers with some type
of scope that only 7% of respondents are doing this
important step.
• This survey, while not a scientific one, does correlate with
what was presented at the FDA workshop in 2011 by Smith
& Nephew Endoscopy that showed staff are not following
the IFU and not performing visual inspection on each
medical device.
• It is not just shavers. It is any lumened device as described in
the article “Uphill Grime: Process Improvement in Surgical
Instrument Cleaning” that dealt with the difficulty of
cleaning these types of medical devices.*
*
DOI: http://dx.doi.org/10.1016/j.aorn.2012.03.018
Visual Inspection
•Definition:
–The process of using the unaided eye, alone or in conjunction
with various aids (borescope, stain identification) to inspect
medical devices for defects in functionality, pitting, stains,
imperfections on the medical device during its processing
cycle and rejecting the medical device according to the
medical devices IFU if any of these imperfections are found.
•First the Standard “is it visual clean”
–First and foremost if it is visual dirty, you must re-clean it
•Second, the Magnifying glass
•Third is enhanced visual inspection
–The IFU gives us direction
–The Shaver story
–Endoscope
Visual Inspection
• Technology is evolving and allows us to look inside devices and
in places we can not see with the naked eye
–Borescope (flexible inspection scope)
–Enhanced computer-aided
• Fourth step - Once you see it is dirty you should try and identify
the stain
–Stain identification
–IFU
–Standards and Guidelines
• Last step is make the inspection part of your quality process
–Document results
Basic visual inspection
• The most basic verification of the performance of a
cleaning process is by carefully inspecting the
cleanliness of instruments and materials with your eyes.
• All objects should be free of any remaining soils,
deposits, pitting etc.
• Take special care for checking pivots, box joints,
instrument serrations.
Visual Inspection
Visual Inspection Close-up
Magnified versus unaided eye
USB Microscope lets you document what
you see
SPD/CPD now has a Shaver Issue
The FDA has become aware of
events in which tissue has
remained within certain
arthroscopic shavers, even
after the cleaning process was
believed to have been
completed according to the
manufacturer's instructions
(April 2009).
Reports submitted to the FDA
suggested that the tissue
retained was not evident to the
naked eye.
Multiple manufacturers of these
devices recently informed their
customers of this situation and
reiterated the importance of
proper cleaning procedures.
Video Solutions
•Change in cleaning instructions by
device manufactures
•They added an inspection step
–….Visually inspect the handpiece…we recommend
using a scope to visually inspect the lumens of the
hand piece…
IFU Support for using a Flexible
Inspection Scope
• Arthrex - Adapteur Power
System™ II (APS II)
Shaver Hand pieces -DFU0154r10*
• INSPECTION AND
MAINTENANCE
–Step 4 in the DFU (IFU)
•“…Check device for visible soil. It
is recommended that the
cannulation be inspected with
an illuminated, magnifying
scope. Clean the device using
the guidelines for manual
cleaning if any soil is visible….”
*www.arthrex.com
• STRYKER Shaver HandPiece
- 1000400638 R-2012/10 *
–INSPECTION – EN 21
–Step 9
•“…Visually inspect the hand
piece, including all internal
surfaces, for remaining soil.
Use an endoscopic camera
and endoscope if necessary to
see the inner surface of the
lumen. If soil remains, repeat
the manual cleaning
procedure, focusing on those
areas…”
* www.stryker.com
Enhanced view
inside of a shaver.
You must clean
inside the fork
drive area using
special brushes
and then inspect
to make sure it is
clean inside.
A shaver that was presumed to be
clean
Flexible Inspection Scope
• USB 2.0 Cable: A standard,
RoHS Compliant
–USB2.0 Cable, with Type A to
Mini B connections, is the
only device accessory.
–Standard cable length is 6ft
(2m).
• Flash drive with installation
software
• Field of view: 100 degrees
• Nominal working distance:
5mm Degree of
magnification: 17X at 5mm
• Illumination max: 400 Lux at
2mm and 100%
• Resolution: 2.4 lp/mm USAF
Resolution Target
Survey question on visual inspection
• Please answer the following 2 questions on
visual inspection:
• Do process orthopedic shavers? Yes No
Survey Question part 2
• If you answered yes do you visually inspect
the shaver with a borescope like a flexible
inspection scope before final assembly? Yes
No
Lumens / Suctions
A new Suction:
Notice how we do not see
any red or dark colors.
Inspected new, right out
of the package.
These are pictures of used suctions, notice the red and
brown. This should not be inside the suction, this is organic
soil and other bio-burden not removed after cleaning. We
do not know how long they have been used.
But what we do know is that they are visually dirty.
Inside A Suction
Pictures supplied by Jahan Azizi of the University of Michigan
Endoscope Visualization
• AAMI
– ST 79
– ST 91
•
•
•
•
AORN
SGNA
Others
All support the practice
of using some type of
visual inspection to
unaided eye
Verifying Clean per AAMI and AORN
 Visual inspections and testing of the equipment
• Inspecting organic residues
• Testing for any cracks in the devices
• Bending section
• Checking integrity of fiber optic bundles
• Use of magnification
 Consider inspection with borescope
• ST91 and AORN recommendations
 Methods to measure organic and other residues found on scopes
• Protein
• Hemoglobin
• Carbohydrates
• Other
Best practices for verification and monitoring AAMI ST91
• Cleaning verification is performed following cleaning to
verify the effectiveness of a cleaning process PRIOR TO
DISINFECTION
• Cleaning verification should include:
– Visual inspection
– Testing of the cleaning efficacy of mechanical equipment
– Monitoring of key cleaning parameters
• Use of methods to detect organic residue should be
considered
Endoscope visual inspection
ST 91 - Cleaning Verification – 12.4.2
“…Inspection using magnification and additional
illumination might identify residues more readily than
the unaided eye… tools such as video borescopes of an
appropriate dimension (length and diameter) may be
used to visually inspect the internal channels of some
medical devices…the use of methods that are able to
quantitatively or chemically detect organic residues that
are not detectable using visual inspection should be
considered and included in facility policies and
procedures on device cleaning...”
SGNA Visual Inspection
• Time out
– Visually inspect for conditions that could affect the
disinfection process (e.g., cracks, corrosion,
discoloration, retained debris)
– Use magnification and adequate lighting to help assist
in visual inspection
– Repeat manual cleaning step(s) if not clean
• It is impossible to visualize internal channels.
– to confirm the adequacy of manual cleaning, a rapid
cleaning monitor for residual organic soil can be used
prior to high-level disinfection
– If positive, reclean scope
Where to inspect
•Instrument channel
•Distal tip
•Elevator
•Connection points
Endoscope enhanced inspection and
verification methods
• Infections tied to duodenoscopes:
FDA data shows as many as 350
patients at 41 medical facilities
world wide have been infected or
exposed to contaminated scopes
from January 2010 to the end of
October 2015.*
• Building quality into reprocessing
of flexible endoscope through
enhanced visual inspection and
cleaning verification testing
* http://www.latimes.com/business/la-fi-olympus-scope-pasadena20160504-snap-story.html
Support for using enhanced visual
inspection – Poster at AORN
http://www.ofsteadinsights.com/?p=2303
Lighted Visual Inspection Tools for
Endoscopes
Flexible Inspection Scope
Instrument channel
Lighted Visual Inspection Tools
Borescope Examination Showing a
Cracked Water Jet
The crack in the weld at the water jet nozzle not picked up by a leak
test
Cleaning monitoring is part of visual inspection
• 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.
Manual Cleaning Verification Monitors
Channel Sample
Flush methods
Combination test
strips
ATP Systems
Swab methods
Protein swabs
Hemoglobin swabs
Detects ATP
Carbohydrate, protein
& hemoglobin
Flush and swab
methods
Many systems
available
Surface Testing – Stain Identification
• Type of surface
• Commercially available products
– Swab or Flush method
• Hemoglobin specific
• Protein Specific
• Other organic soils
– Color change over time
• Clean / Dirty
• Pass / Fail
• Number
• Important what do you want a test to tell you
Stain Identification
•Why this step of stain identification
–“…Visual detection alone does not allow one to
detect residual bioburden that may remain on
cleaned devices…”
http://www.accessdata.fda.gov/ScienceForums/forum06/B-48.htm
•
In 1996, Michele Alfa PhD informed us that there was already a
growing concern about the effectiveness of decontamination
technique for reusable medical instrumentation in healthcare
facilities. Studies at that time had already shown the ability of
sterilization technologies, which under normal conditions;
achieve acceptable sterility assurance levels, to be greatly
impaired by the presence of residual soil containing serum and
salt. (Alfa,M.,et al, Comparison of Ion Plasma, Vaporized Hydrogen Peroxide, and 100% Ethylene oxide Sterilization to the
12/88 Ethylene oxide gas Sterilizer, Infection Control and Hospital epidemiology, 1996; 17:92-100)
Stain identification –Surface
•You want to know what
is that stain composed of
–Organic soil
–Blood
–Protein
–other
•That knowledge helps
you correct the concern
of a dirty medical device
Is this really hard water ?
•There has been a growing concern about the effectiveness of
decontamination technique for reusable medical
instrumentation in healthcare facilities. Studies have shown
the ability of sterilization technologies, which under normal
conditions, achieve acceptable sterility assurance levels, to be
greatly impaired by the presence of residual soil containing
serum and salt.*
*Alfa,M.,et al, Comparison of Ion Plasma, Vaporized Hydrogen Peroxide, and 100% Ethylene oxide Sterilization to the 12/88 Ethylene oxide gas Sterilizer, Infection Control and Hospital
epidemiology, 1996; 17:92-100
Yellow film on the wall
Documentation of your inspection
• "In court, the medical record is the care
rendered," they say. "Jurors view good record
keeping as an indicator of good care — poor
documentation can create an aura of poor
care and damage the credibility of the
healthcare providers.“
• Thus, if it wasn't documented, it wasn't done.
• Record your finds of your inspection
•
http://www.outpatientsurgery.net/surgical-facility-administration/avoid-medical-malpractice/how-to-survive-a-med-malsuit--orx-proceedings-13?utm-source=tod&utm-medium=email&utm-campaign=tips
Question
• Are you presently using any type of
magnification for inspection of any medical
devices in your department ? Yes No
• If you answered yes what type ?
– Hand held magnifier
– Bench type magnifier mounted to work table
(swing arm type)
– Flexible inspection scope (borescope)
– Other
Question
• Do you use magnification on the dirty
(decontamination) side for visual inspection of
medical devices of any type ? Yes or No
• Do you use magnification on the clean
(assembly) side for visual inspection of
medical devices of any type ? Yes or No
If you answered yes please answer this question
– At each work station ? Yes No
Questions
• If you are using any type of a flexible inspection scope
(borescope )for inspection of medical devices what
type of devices are you looking at ( check all that
apply) ?
•
•
•
•
•
Orthopedic shavers
Flexible endoscopes
Suctions
Reamers
Other devices
• Do you feel the use of the enhanced visual inspection
(like a borescope) helps improve the quality of your
departments work ?
– Yes No
Questions
• Do you presently test/check/swab any of your
instruments after cleaning for residual organic soil as
part of your quality plan in your department? Yes No
• If you answered Yes, what do you use?
Check all that apply
– Hemoglobin
– Protein
– Other
• Before this presentation, did you know the issues
associated with visual inspection of arthroscopic
shavers? Yes No
Review
•First the Standard “is it visual clean”
–Thus first and foremost if it is visual dirty re-clean it
• Try to identify the stain to improve process to find reason for the stain
•Second Magnifying glass
•Third is enhanced visual inspection
–The IFU gives us direction
–The Shaver story
•Technology is evolving and allows us to look inside and in places we can not see
with the naked eye
–Borescope ( flexible inspection scope )
–Enhanced computer aided
•Fourth step - once you see it is dirty you should try and identify the stain
–Stain identification
–IFU
–Standards and Guidelines
•Last step is make the inspection part of your quality process
–Document results
Helpful charts on Enhanced Visual
inspection
Remember this picture
References
• HPN (5/15) – Are you meeting the correct
manufactures requirements*
* http://www.hpnonline.com/inside/2015-05/1505-PnP.html
• AAMI ST 79
• AAMI ST 91
Healthmark
Visual Inspection Products
Helping you see where the naked eye cannot
CEU Information
•To receive your CEU you must go to this link
and fill out the form and a CEU certificate will
be emailed to you.
• This is approved for 1.0 CEU from both
–IAHCSMM
–CBSPD
Here is the link
http://www.hmark.com/becker_june2016.php
Questions
Mary Ann Drosnock
1-800-521-6224/Ext.6005
Cell: 586-536-5322
Mdrosnock@hmark.com
Stephen M Kovach
1-800-521-6224/Ext.6621
cpdguy@hmark.com