HHM Compatibility Special Edition Feb/Mar 2020 HHM Compatibility Special Edition Feb:Mar 2020 | Page 22

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healthcare providers, or is the cost of device
failure built into the cost of the device itself?
Will liability for escalating healthcare costs move
upstream to OEMs? Manufacturers must consider
what materials are being used in their products
to avoid device failure due to premature polymer
breakdown as well as potential liability for adverse
patient outcomes.
¡
Manufacturers
must consider
what materials
are being
used in their
products to
avoid device
failure due
to premature
polymer
breakdown
as well as
potential
liability for
adverse
patient
outcomes.
22
Make no mistake, materials matter
Selecting the right polymer improves infection
prevention and control (IPC), because there’s a
direct link between cleaning hygiene failure and
healthcare associated infections (HAIs).
The road to better materials, fewer HAIs,
reduced exposures and a lower rate of device
failure is a top-down, bottom-up approach that
involves the whole value chain. From materials
manufacturers to quality and design engineers,
biomedical specialists, OEMs and healthcare value
analysts, there must be a concerted, holistic effort
to produce medical devices that are compatible
with disinfectants and designed without cracks
and crevices which could harbor pathogens.
And brands must be part of the solution by
sourcing disinfectant-compatible polymers
for their products.
For hospitals, being part of the solution means
focusing on improving health hygiene rather than
reducing the costs associated with device failure.
It’s a different way of looking at the problem to
achieve the same results. Implementing enter-
prise-wide sanitation and cleanliness protocols will
reduce the instances of HAIs. Using compatible
cleaning agents and insisting on chemical-resistant
materials will extend the life of medical devices
and equipment. This is important for OEMs to
understand, because it defines the true unmet
needs in healthcare.
For OEMs, eliminating device failure due
to chemical breakdown means using the right
materials from the get-go. Manufacturers should
independently evaluate polymer performance
and validate results in order to make informed
material selections. Eastman’s 4-step test is
designed to screen polymers for disinfectant
compatibility prior to selection and design, while
the simple drop test for electronic medical device
housings measures how high-stress areas perform
after being disinfected and dropped. By utilizing
Eastman’s simple test methodologies, OEMs can
produce more durable, chemically compatible
medical devices. Hospitals, in turn, can lower
environmental hygiene maintenance costs and
thereby reduce the incidences of HAIs through
greater freedom to choose effective disinfectants.
All of the above will enhance the patient
experience and ameliorate patient outcomes.
Awareness, advocacy and certification
To enable successful regulatory decision making
and better medical device evaluation, the FDA is
developing the National Evaluation System for
Health Technology (NEST). NEST will track the
entire product lifecycle of medical devices using
actual data and advanced analytics. In addition
to Eastman’s test methodologies which can be
implemented internally by OEMs, the FDA’s NEST
will guide device innovation from an independent
oversight and regulatory perspective.
In addition to NEST, the Healthcare Surfaces
Institute (HSI) has created a materials certification
process for OEMs. According to HSI’s website,
goals and objectives for the certification program
are as follows:
— Development of consistent test methods
that include compatibility testing of all
categories of EPA-registered disinfectants
as well as no-touch disinfection such as
UV and hydrogen peroxide vapor.
— The identification of the top four
microbes for all testing with the option
for additional microbial testing. The goal
is to have consistent measurable data
and information.
— Testing of products as assemblies–many
products are made using multiple types
of surface materials and/or textiles. When
combined on one product the ability to
efficiently and effectively disinfect all
materials can be compromised causing
degradation of surface materials.
— Evaluation of surfaces at a micro-level.
Damage is often unseen, creating micro-
bial reservoirs that support the growth
and proliferation of microbes.
— Evaluation of instructions for use
(IFU) to ensure they provide guidance
and recommendations pertinent to
active healthcare environments and that
support infection-prevention processes
and protocols.
HSI’s certification program provides guid-
ance for product development and testing
requirements, including screening methods for
material selection prior to finalizing product
design. Furthermore, HSI offers direction for the
creation of IFUs to support infection prevention
and control protocols.
Compatibility Special Edition February/March 2020 • www.healthcarehygienemagazine.com