HHM Compatibility Special Edition Feb/Mar 2020 HHM Compatibility Special Edition Feb:Mar 2020 | 页面 6
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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.
Test methods must include the evaluation of
surfaces for unseen damage caused by disinfec-
tants and rigorous disinfection protocols. Surfaces
can support and harbor microbes that cause
deadly infections. We must know what surfaces
support effective and efficient disinfection. How
can we address this foundational problem if we
don’t have any information other than we know
surfaces play a key role in the acquisition and
transmission of pathogens within the healthcare
environment? How can we prevent it if we don’t
completely evaluate and understand it?
Instructions for Use
Another problem that must be addressed are
the instructions for use (IFUs) that are inconsistent,
right down to the fact that not all manufacturers
provide IFUs. There are currently no requirements
for writing IFUs. Let me clarify this by stating that
the Food and Drug Administration (FDA) does
evaluate IFUs for medical devices that require
FDA clearance. Even with that, there are no clear
guidelines for writing the IFUs, which often leaves
healthcare professionals in a fog of confusion.
Manufacturers often don’t realize that
healthcare facilities face penalties and fines
during regulatory surveys when asked for IFUs to
verify that healthcare professionals are following
manufacturer recommendations. They not only
have to have IFUs readily available, they also
have to provide proof the IFU is being followed.
Challenges with IFUs include a manufacturer
requirement for the use of a proprietary disinfec-
tant product. There are times when a healthcare
facility uses completely different brands in the
same category of disinfectants. This puts the
healthcare facility in jeopardy of being fined,
and often, when damage occurs, warranties are
voided. Testing the categories of disinfectants will
eliminate this problem.
I have read many IFUs that don’t make sense;
for instance, the warning will state ‘do not use
bleach or peracetic acids; if used they may cause
severe damage,’ and then the manufacturer
recommends the use of soap and water. Soap and
water do not eliminate C. difficile. These types
of guidelines are not consistent with infection
prevention policies, products and processes.
The Challenge for Material Engineers,
Designers, General Contractors
I am grateful for several consulting clients
that have helped me understand that they,
too, are in the dark. While they are interested
in developing innovated products that support
patient care, there is a gap of knowledge and
understanding about patient care, unexpected
challenges and infection prevention strategies.
They are quick to state they want to support
healthcare professionals, not hinder them during
6
patient care. A question posed to me was, ‘Why or
how would we know about infection prevention,
as we are a medical device manufacturer with
a focus on several medical devices?’ Well said.
The expectation that they would simply know is
outrageous and I see great potential for a bridge
to be built that addresses this problem.
It is important to state that manufacturers do
test their products. In a 2018, a comprehensive
literature review of 65 different search terms
focused on surfaces, surface disinfection,
medical devices, environmental surfaces etc.,
was conducted by the Healthcare Surfaces
Institute. Expecting to find gaps in research and
understanding, we were not prepared for the
disparages between test methods and the types
of microbes used for testing.
When testing included patient rooms, they
often varied in size, location, and didn’t take into
consideration the often-unexpected infection
control requirements in any given setting.
Therefore, research results were inconsistent
and inconclusive.
There were significant inconsistencies when
identifying high-touch surfaces (HTS). It is
essential to observe the patient-care process
before determining what HTS to include in
research. I have done this several times and it
is fascinating to watch healthcare professionals
interact with surfaces and the patient. Clearly,
a lot of the behavior came from their training,
as most healthcare workers — no matter who
they were — exhibited the same behavior upon
entering the patient room. Even more interesting
was the behavior of the patient and their family
members. Visitors had a completely different form
of interaction with a wide variety of surfaces.
With a focus on what is believed to be high-
touch surfaces, it left an incredible amount of
highly touched surfaces completely overlooked.
An example would be the nurse call button that
spent a lot of time falling off the bed onto the
floor. I counted people, including the patient,
who came in contact with it in a two-hour time
frame. Not once in three days was it even cleaned.
Now is the time for a change, and change
is not easy. HAIs are a health-safety concern,
and the foundational issue of surfaces must be
addressed immediately if we are going to realize
sustainable reductions in HAIs. The Healthcare
Surfaces Institute understand the many aspects
of this foundational issue and are working to
develop a surface certification program that
will address many of these issues. If you are
interested in being involved, contact me at
[email protected]
Linda Lybert is founder and executive
director of the Healthcare Surfaces Institute.
Compatibility Special Edition February/March 2020 • www.healthcarehygienemagazine.com