HHM Compatibility Special Edition Feb/Mar 2020 HHM Compatibility Special Edition Feb:Mar 2020 | Page 12

manufacturers as discussed previously, and work with
surface fabrication vendors to identify materials that are
robust against a wider range of cleaners and disinfectants.
HHM Why is it so critical to screen/test materials
before they reach the end-user environment?
AS: The use of incompatible cleaners or disinfectants
can cause immediate damage to, or degradation of,
medical device/equipment surfaces. It is imperative for
healthcare facilities to determine safe and effective
cleaners and disinfectants prior to bringing medical
devices/equipment into their facility as well as to provide
those cleaners and disinfectants at the point of use.
HHM When it comes to ensuring better perfor-
mance by materials/surfaces/equipment in the
demanding healthcare environment, what should
healthcare institutions be requiring of designers?
Manufacturers? Themselves?
AS: ECRI Institute is aware of one facility that has
standardized low-level disinfection of non-critical
medical devices/equipment to one chemical wipe.
They achieved this by establishing a risk assessment for
low-level disinfection of non-critical devices/equipment
at their institution. As part of their risk assessment, they
developed a disinfectant review sheet for new devices/
equipment that is reviewed by their facility’s Medical
Device Committee. If they decide to purchase a new device
that does not recommend their standard disinfectant wipe
in the device instructions for use, then they require the
device manufacturer to write a letter that states that the
facility’s standard disinfectant wipe will not damage the
manufacturer’s device.
HHM Isn’t this issue included in a recent ECRI report?
AS: Improper cleaning and disinfection procedures can
also lead to medical device and equipment damage. In
the #9 report on ECRI Institute’s Top Ten Hazards List for
2019, we discussed that the use of cleaning or disinfectant
wipes that are dripping with excess fluid can cause fluid
penetration in electrical components that may result in
equipment damage or fires.
HHM How can hospitals look for chemicals that
won’t necessarily degrade surfaces/devices/
equipment in the interim?
AS: Review the instructions for use of your facility’s
medical devices and equipment to identify the manu-
facturers’ recommended cleaners, disinfectants, and
methods for cleaning and disinfection. If needed, add this
information to relevant environmental services checklists
(i.e., those for use while a room is occupied and those
for use after a patient is discharged). Keep a stock of the
recommended cleaners and disinfectants at the point of
use (e.g., dirty utility room). 
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mode and thus better predict material performance,” he
says. “Following just the broad ASTM protocols could cause
OEMs to inadvertently validate their materials incorrectly,
and the results may be misleading and misrepresent the
performance of the device in the field.” 
Eastman Chemical Company has developed a four-step
test method that can differentiate the performance of
different plastic materials under conditions commonly
found in a healthcare setting. This test can help predict the
reliability of a material after exposure to disinfectants, lipids,
drugs or drug carrier solvents. The test is simple and quick,
taking only 24 hours, compared to other test methods that
can take weeks or even months.
“The four-step test method is based on a
commonly used ASTM method and is an
excellent screening test for material selection,”
Turner says. “It takes 24 hours to complete,
Click to view
Eastman four- and it rules out materials which will be a risk
of failure after the final device assembly
step method
is disinfected.”
Turner explains the test: “Step one is to simply select a jig
with the appropriate strain level. In step two, load plastic flex
bars onto the jig. Remember to load some control samples
that will not be exposed to chemicals. For step three, apply
chemicals such as commonly used hospital disinfectants,
lipids, drugs, or drug carrier solvents to the flex bars using
a presoaked piece of cotton. Enclose the entire sample jig
in a plastic bag to prevent evaporation and leave at room
temperature for 24 hours. For the fourth and final step,
unload the samples and run a reverse side impact test on
the exposed and control samples.”
She continues, “To best interpret the results, record the
impact strength of exposed and control samples to calculate
the percentage of impact strength retention. Higher retention
translates to better reliability after exposure. The Healthcare
Surfaces Institute exists because there are not many standards
and test methodologies that can be followed and audited to
ensure that devices and equipment are designed appropriately
for healthcare to receive the best value from their purchase.”
Lybert says it would behoove industry to establish a
test such as this as a standard for equipment and device
manufacturers as well as disinfectant-makers who are united
in the desire to improve disinfectant chemistries to maintain
efficacy against pathogens while limiting damage to surfaces.
“In a recent panel discussion at the 2019 annual meeting
of the Society of Plastic Engineering, chemical compatibility
was being addressed, along with a call for a standard because
there is no agreement as to which method is to be used in
evaluating device performance,” Liu says. “If OEMs have
materials engineers with a limited understanding of how
to evaluate materials properly, imagine how difficult it is for
end users such as clinicians in the field to determine whether
a device or surface material has been validated properly,
and whether the best materials possible were used in the
manufacturing of that device. So, it is a long journey ahead
for those of us who want to see more appropriate testing
protocols for the industry.”
The tension continues between OEMs’ profitability by
continuing to sell products that may have not been validated
Compatibility Special Edition February/March 2020 • www.healthcarehygienemagazine.com