HHM Compatibility Special Edition Feb/Mar 2020 HHM Compatibility Special Edition Feb:Mar 2020 | Page 11

what test method(s) you used to prove it.’ The current testing
methods don’t relate to the failure mechanisms involved.
And because there is not a high-level entity calling for and
monitoring standards and test methods, we are not seeing
robust-enough products in healthcare.”
“Facilities cannot accept this,” asserts Linda Lybert,
founder and executive director of the Healthcare Surfaces
Institute, which is addressing the compatibility issue head
on through its education and research programs. “Plenty
of organizations, including ASTM and ANSI, have created
test methodologies that manufacturers follow, but they
aren’t evaluated further. In a literature review conducted
by the Healthcare Surfaces Institute, we found great
inconsistency in test methods to validate a product, as well
as a shocking lack of scientific data, and inconsistency in
the type of microorganisms used in the testing. I believe
that surface compatibility testing needs to be EPA-registered
so hospitals can select products and materials based on
their performance.”
Lybert adds that their literature review revealed inconsis-
tencies in the definitions of the processes of cleaning and
disinfecting. “This means that when determining validation,
manufacturers weren’t considering the same definitions
and criteria that should have been standardized across the
board and that they most likely validated these variable
methods and passed them down to the end user. Many
manufacturers use only a visual inspection to tell if a product
works; this is a BIFMA (Business and Institutional Furniture
Manufacturers Association) test method involving a 4-inch
by 4-inch square piece of material that is looked at in order
to validate disinfectant damage to a textile. This is flawed,
because in the real world, the healthcare environment
doesn’t function as a single textile in an area of 16 square
inches, and the test only determines if the textile discolors,
and that’s all.
Instead, manufacturers must look at a product as an
assembly, and the impact that the disinfectant has on the
entire surface, device or textile. Microphotography needs
to be conducted during the validation process, instead of
looking at the material on a macro level.”
One materials manufacturer, Eastman Chemical Company,
leveraged current testing methods to create an entirely new
test that could demonstrate a failure mechanism, in essence
reverse-engineering a testing method to better understand
the resistance and durability of the materials when exposed
to chemicals commonly used in the healthcare environment.
According to Eastman, “Understanding chemical resis-
tance is complex because observations are often dependent
on the nature of chemical contact (composition or chemistry,
time and temperature) and the level and type of stress found
in the part.”
While ASTM methods provide a general overview for
how to conduct testing methods, original equipment manu-
facturers (OEMs) have different interpretations of how they
conducted their tests, explains Yubiao Liu, global technical
lead for medical applications at Eastman Chemical Company.
“It is advisable for quality and design engineers to better
understand the failure modes and how the device cracks
after disinfection, in addition to visual inspection, a tensile
test, and an impact test, as the best way to mimic the failure
Q
& A
Materials Compatibility:
A Q&A With
Amanda Sivek, PhD
Healthcare Hygiene magazine spoke with
Amanda Sivek, PhD, principal project officer
for the Health Devices Group at ECRI Institute,
about surface and equipment material
compatibility issues.
HHM What is your perception of the overall
awareness (or lack thereof) of the surface materials
compatibility issue in hospitals?
Amanda Sivek (AS): ECRI Institute has received nu-
merous reports of medical device damage (e.g., infusion
pump components cracking, compromised mattresses
oozing body fluids onto patients) as a consequence of
improper cleaner or disinfectant use. It is likely that most
clinicians are aware of this issue.
HHM Similarly, is this issue on the radars of
purchasing managers and healthcare institution
leadership, and are they fully understanding the
issue at play when they need to keep replacing
failing surfaces and equipment?
AS: Similarly to point-of-care clinicians, it is likely that
most facilities’ purchasing departments and executives
are aware of this issue. It may only take one or two
costly device replacements (e.g., physiological monitoring
systems) to realize that a problem with their facility’s
cleaning and disinfection procedures exists.
HHM What do manufacturers of chemical disin-
fectants need to know to become an agent for
change in this arena?
AS: Chemical disinfectant manufacturers have likely
conducted surface compatibility testing for various mate-
rials/surfaces used in medical device fabrication. Medical
device manufacturers should specify compatible products
that can safely and effectively reprocess their device
after use. Collaboration between chemical disinfectant
manufacturers and manufacturers of non-critical medical
devices may be necessary to address this issue.
HHM What do manufacturers of surfaces for the
built environment need to know to become an
agent for change in this arena?
AS: Manufacturers of non-critical medical devices
and equipment should specify compatible cleaners and
low-level disinfectants that can safely and effectively
clean and disinfect their device/equipment after use.
Manufacturers may need to work with healthcare
facilities to sign off on the use of a facility’s standard
low-level disinfectant, work with chemical disinfectant
www.healthcarehygienemagazine.com • Compatibility Special Edition February/March 2020
11