“Manufacturers need to know that a certification is coming,”
Turner says. “Dig deeper to understand how the healthcare
environment is different from other environments. Test aggressively
with disinfectants that are commonly used. Pursue a certification
to accelerate adoption of new innovative solutions that reduce
cost and infection in the long-term for healthcare.”
Another potential solution, at least for equipment, UCSF’s
Fechter says, is for regulation by the FDA, and including standardized
compatibility testing in the agency’s 510k pre-market
approval process for equipment and devices.
“There is no entity that can mandate the manufacturers to do
anything except the FDA,” Fechter says. “So, if we can get this
agency to require compatibility testing as part of their process,
you might get some traction among the manufacturers. At the
rate the FDA does things, I would not bet on that happening
any time soon — it is a very slow process.”
“We need to better leverage reports of failures from incompatibility,”
Fechter adds. “I reported the syringe pumps breaking
apart and harming our patients, but that was just one report
and that means nothing to them unless they receive hundreds
of reports – then maybe they will take action. Fast-forward from
that 2004 syringe pump incident to 2010 or so, when one of our
other infusion pumps started experiencing problems — and not
just in our facility but in a lot of facilities. The door hinges were
breaking, potentially allowing medication to flow unregulated
into the patient that could result in a serious overdose. The
pump manufacturers acknowledged that the door hinges were
breaking, and they started their own journey to compatibility. It
probably took them more than a year to change their formulation
of plastics; they started making the same part out of different
material and the new and improved plastic was much more
compatible than the previous plastic and drastically reduced the
number of door hinge failures. Part by part, the manufacturers
had to upgrade other pieces of the pump with new plastics.
They didn’t do everything at once, they only re-manufactured
the parts that were breaking. It was a dangerous situation that
presented serious patient safety-related issues.”
Fechter continues, “We have no control over what materials
the manufacturers use but can choose from whom to buy. The
challenge is that our choices in the marketplace are limited.
What we can change is our cleaning products, choosing the ones
that are the most compatible with our equipment and surfaces.
I conducted testing on different cleaning products to sell our
infection control team on the one that I found to be the least
destructive. At the time I had estimated that our system was
facing at least $2 million worth of broken and failed equipment,
and my guess was that the real number was a lot higher than
that, but people don’t document these failures in a way that
allows you to conduct that analysis accurately. Instead, you walk
around the facility, look at how many devices broke and how
many are currently disintegrating. You soon discover that a piece
of equipment that might last five years is now lasting two years,
so we must replace that much more frequently or repair more
frequently. Just repairing parts alone can cost an astronomical
amount of money.”
Fechter looks to manufacturers to better address the problem.
“My opinion is that the entities who manufacturer the raw
materials know what they are doing, and they are able to present
viable options to their customers – the medical device and surface
manufacturers,” he says. “Medical device manufacturers often
don’t want to spend 20 cents more on
a better plastic to make a product more
durable, and I suppose they have their
reasons as to why they don’t want to use
the better-performing polymers. But if you
look at the cost of a medical device like an
infusion pump, which can run as much as
$10,000, and the cost of the raw material
for the plastic that goes into making the
pump is two or three dollars tops, so as
a percentage of the manufacturing cost,
that raw material is nothing. Even if they
pick a better-performing plastic that is
twice as expensive as what they are using,
it is insignificant in the total cost of that
infusion pump. So, I don’t think they have
a lot of excuses.”
Desired cosmetic finishes and aesthetics
are likely to dictate manufacturers’ decision-making,
Fechter adds. “In addition
to the look of a product, there may be
mechanical properties dictating function
over form. Some of the final materials
used in the finished product hold up
better than others, so you must convince
manufacturers to move away from their
Some of the final
materials used
in the finished
product hold
up better than
others, so you
must convince
manufacturers to
move away from
their favorite things
like polycarbonate
and ABS and use
more resistant and
durable formulas
and materials.”
favorite things like polycarbonate and ABS and use more resistant
and durable formulas and materials. it is going to increase the
cost of the product, yes, but not significantly.”
“Another aspect of the problem is not just the materials, but
the design of the product itself,” Fechter emphasizes. “If you
have a flat, smooth surface and you wipe it with disinfectant
and it dries off, those flat smooth surfaces tend to not suffer
damage. Where you see the damage is in the nooks, crannies,
corners, around fasteners or any kinds of seams where the liquid
disinfectant seeps into the cracks and crevices and stays wet a lot
longer than it would on that flat, smooth surface. From an overall
cleaning standpoint, and especially from an infection control
perspective, most devices are designed with far too many nooks
and crannies that invite body fluids and blood to get sucked in
and then contamination persists in these areas that are nearly
impossible to clean and disinfect properly. To be fair, we have
seen some improvement in recent years with the introduction of
more control panels manufactured from flat, smooth glass that
so much easier to clean. For example, in the old days, ultrasound
machines had a million knobs and switches, and now we are
seeing new machines out on the market that have simple glass
touchscreens. From a cleaning standpoint, these surfaces are
wonderful because there are fewer places for germs to hide, and
even a pretty poor disinfectant will address the microorganisms
on it. From a user standpoint, some clinicians still say they like the
feel of the old-fashioned knobs and buttons, but it is something
they’re going to have to get used to, and I don’t think it’s that
hard to use a glass touchscreen.”
Designing equipment so it is easier to clean is just part of the
issue; the benefits of improved device design can be lost if no one
actually cleans it. Healthcare facilities have been struggling with
ensuring accountability between clinicians and environmental
services when it comes to which party is responsible for cleaning
and disinfecting patient-care equipment.
www.healthcarehygienemagazine.com • august 2020
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