HHM Compatibility Special Edition Feb/Mar 2020 HHM Compatibility Special Edition Feb:Mar 2020 | Page 13

robustly enough, and their inherent desire to not harm
patients by producing good products. Less stringent rules
protect profits, but at what cost, ultimately?
“We are at a crucial crossroads,” Turner emphasizes.
“Hospitals can no longer afford to accept the status quo.”
As we have seen, currently, there is no standard that tells
healthcare end users that a product’s materials have been
screened before they are incorporated in materials before
they enter the healthcare environment. That is, the materials
should be determined to be cleanable and durable before
they are even incorporated into a manufactured product.
This would be beneficial for healthcare designers and
architects, who often choose materials based on aesthetics
instead of performance.
“If you screen fabrics and building materials and find they
don’t hold up, they should be screened out early,” says Liu.
“Screening studies for materials up front need to be much
more rigorous to detect mechanical failures and show how
they translate to a fully-assembled surface.”
“Not only is there significant discrepancy in test method-
ologies, but materials are not being tested as assemblies,”
Lybert confirms. “Medical devices are tested as assemblies,
as required by the FDA, but there is still lingering confusion
as to what is required for surface materials. The issues of
testing and validation causes confusion in healthcare facilities
because there are no guidelines.”
Turner concurs. “We need better material-screening
studies and tests. Once materials are screened and selected,
only then is it appropriate to move into final product
design and testing. Currently, it’s a bit like the Wild West in
manufacturing plants – there is no good definition between
the screening studies to select the materials with which to
design, then the final screening to see if a product should
be introduced into the hospital environment.”
She adds, “There are no tests that exist which can
definitively prove that a medical device will last 10 years unless
you have waited 10 years to see the results, so screening
materials early by exposing them to drugs, disinfectants, etc.,
will weed out some that have a lesser chance of surviving
10 years of service. The assembled device must be tested as
well, but if adequate screening has been done, the chances of
passing full assembly testing is much higher. It will also reduce
time to market if you choose the right materials up front
and don’t have to rework the design later after a failure.”
Order can be restored to this Wild West, and manufac-
turers can become agents for change.
“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,” he continues. “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
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