HHM Compatibility Special Edition Feb/Mar 2020 HHM Compatibility Special Edition Feb:Mar 2020 | Page 4

perspectives
By Linda Lybert
Making the Case for Required Testing and
Validation of Surface Materials and Products
S
urfaces materials, surface structure, and surface chemis-
tries that create products are entirely overlooked within
the healthcare setting. Change must happen to reduce the
risk of healthcare-acquired infections (HAIs) for patients,
staff and members of the community.
The problem begins in the design phase, long before
products are purchased and put into service — or before
the new operating room or emergency department opens.
The selection of surface materials for the design of products,
medical devices, and instruments and the environment are
made, while two issues exist. There is a gap of knowledge
and understanding of real-life healthcare scenarios and
surface material requirements.
The selection of surface materials often comes down to
cost without first evaluating and validating that materials
can be effectively and efficiently be cleaned, disinfected,
and — when required — sterilized, without damage.
I have been challenged in the past when making this
statement because all surfaces most definitely can be cleaned
and disinfected with soap and water. I want to be very
clear that we are talking about healthcare, not your home.
Household cleaners such as soap and water, 409, Fantastic,
and other products are not typically used in the healthcare
setting. Moreover, the microbes are not the same in your
home as within the healthcare setting. Rigorous cleaning
and hospital-grade disinfectant requirements can completely
destroy surface materials and take equipment entirely out of
service. Unseen damage from these products creates a perfect
environment for the proliferation of microbes. This creates
a risk to patients and costs healthcare facilities hundreds of
thousands of dollars for repair and replacement of damaged
products as a result of surface/disinfectant incompatibility.
This problem must be addressed now, and it begins with
education. Engineers, architects and design professionals
must first understand the real-life challenges healthcare
professionals face. Next, they must understand more about
infection prevention products and protocols that subject
surface materials to rigorous use and disinfection. Surface
material manufacturers and product manufacturers must
test and validate their products for compatibility with all
categories of Environmental Protection Agency (EPA)-registered
hospital-grade disinfectants as well as no-touch technologies
such as UV and hydrogen peroxide vapor. The first question
must be: Will this material withstand required disinfection
processes using required disinfection products?
Makes sense, right? Then why are there no requirements
or guidelines?
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Currently, the evaluation of surfaces is done at a macro
level with visual inspections noticing discoloration or rough-
ness. It does not tell us what we can’t see at a micro-level.
Therefore, it is critical that an evaluation also is conducted
with scanning electron microscopy. Microbes cannot be seen
and quite often surface, texture, seams and damage provide
these microorganisms with a safe harbor. Also important is
the realization that a safe harbor can exist in seams, cracks,
and textures of surfaces that are combined with others on
any one product or in the environment. Brushed stainless
steel, often used in many healthcare settings for items such
as patient bathroom grab bars around the toilet, come with
grooves in the surface that require friction in the direction
of the grooves to remove pathogens and soil.
More and more continues to be revealed about biofilm and
the difficulty it presents when trying to remove pathogens.
Providing a surface that supports attachment and biofilm
formation can create a nightmare when trying to remove
pathogens. In some cases, the depth of the damage to
a surface can provide a location that is unreachable by
disinfectants. This issue may account for the microbial
rebound often referenced in research papers.
It is important to note here that different areas of the
hospital, such as the emergency department, with its high
levels of contamination and turn-overs, require a more
frequent and rigorous infection prevention process and
protocol. This reality supports the need for test methods
that challenge the materials and disinfection process of
high-contamination, high-turnover areas.
No Guidelines and No Requirements
It is hard to believe that there are no validation require-
ments for surfaces that are used in the healthcare setting:
— No testing requirements that validate that surfaces
and products can be effectively cleaned and disinfect-
ed with hospital-grade EPA-registered disinfectants.
— No testing guidelines or recommendations that
provide critical information about the way surfaces
either inhibit or support infection prevention policies
and procedures.
— No test methods that evaluate surfaces at a microbial
level for damage when disinfectants are used and
at the level where the problems exist.
— No guidelines for consistency in test methods
— No guidelines for microbes being tested
Compatibility Special Edition February/March 2020 • www.healthcarehygienemagazine.com