Healthcare Hygiene magazine November 2019 | Page 29

HHM Has there been any progress on removing the
barriers to improvement in sterile processing?
SK: The biggest barriers remain, such as limited
processing capacity due to shortages in staff, tools, equip-
ment and resources. Or unrealistic turnaround times. For
example, some IFUs mandate a 20-minute soak time, but
the operating room needs it faster than that. We must get
with the surgical services department and educate them
around the numerous steps in the average IFU, and that we
need adequate time from when the device or instrument
first lands in the decontamination department to when it
gets packaged and sent back to the OR. We must better
educate our customers in the OR so that they are not
pressuring us. Maybe the healthcare institution needs to
buy more equipment. When IFUs change, or involve things
like robotics, a lot of hospitals increase their instrument
inventory because it extended their processing time. We
need to communicate clearly with our OR customers because
they don’t understand all the complicated steps required to
process a medical device or instrument.
Researcher Cori Ofstead and her team conducted a study
that showed it takes about 74 minutes to clean a scope,
yet sterile processing is continually pressured to deliver in
half that time, despite complicated IFUs. We must educate
around IFU compliance and emphasize that the OR must
schedule patients differently or buy more scopes. We must
work with our OR customers better for them to understand
what is involved in processing these increasingly complex
medical devices and instruments.
HHM Speaking of Cori Ofstead; her recent survey of
IAHCSMM members revealed numerous challenges
that persist in CS/SPD.
SK: We are moving toward improvement, we just aren’t
getting there as fast as I wish we would and should. Barriers
to better practice are not being entirely eliminated and we
have a ways to go, but I don’t want to discourage anyone
because we have worked so hard to get where we are. We
need to keep going; to me, the survey results tell me we
are making progress but not as fast we wish we could go.
HHM Are manufacturers realizing they can help make
devices that are easier to process, and IFUs that might
be easier to understand, as part of the solution?
SK: The dial is moving slowly; there are some companies
that are providing better resources for sterile processing.
We’re moving slowly but we’re not quite there yet. The
problem with IFUs is that some lack information. In most
cases, it’s the older ones that lack critical information we
need, while others are so detailed that they are almost
impossible to follow completely, so we have both ends of
the spectrum. In 2015 the FDA published their latest labeling
guidance and that provided some help. We have the FDA’s
ear and they are trying to address these issues, and I think
they will help us move the needle. Manufacturers make the
www.healthcarehygienemagazine.com • november 2019
devices and we process them, but we both have the same
objective – we want that medical device to work perfectly
every time that it is used. And for that to happen we need
to partner with the manufacturers who must show us how
to process that device, walk us through every step, so that
every time we process it, we do it correctly and when the
surgeon uses it, it is perfect. And that’s good patient care.
HHM Can certification of sterile processing techs
boost compliance with IFUs?
SK: Certification has a bearing on IFU compliance
because it provides the “why” in what we do, so when we
talk about cleaning a certain way, and validation, etc. techs
who go through the certification program understand why
all of the steps in the IFUs are necessary. By understanding
the “why,” they are inclined to perform the steps correctly.
It also helps them to question the process; so if a tech is
performing a step in the reprocessing protocol, they can say,
“This doesn’t look quite right to me,” and report the issue
to their supervisor. In my experience, it’s usually the certified
techs who identify the problems and raise the issues; having
that additional knowledge that certification provides, they
function at a higher level.
HHM How is technology evolving the sterile pro-
cessing profession?
SK: Medical devices are so much more complex, and
as they continue to evolve, the tools we use in sterile pro-
cessing must evolve as well to keep up. It’s no longer the
flat, hinged, stainless steel instruments we used to process;
many more of them are now complex medical devices and
it’s not just a simple assemble and package process. There
is a great deal of inspection required for these devices –and
we must use cleaning validation tools like boroscopes. We
can use boroscopes on almost everything, and not just
flexible scopes. A lot of IFUs require lighted magnification
and inspection and outline what to look for, so whatever it
is we are doing, we must always check the IFUs and make
sure we are following them exactly.
A key issue is involving the sterile processing department
in the healthcare facility’s new product decision-making. A
sterile processing leader should look at the product and make
sure that the department has the equipment to process the
device, as well as adequate time and personnel to do so. We
are often not even considered in the product-procurement
process, and as a result, we find out too late that the IFU
may be difficult or impossible to follow. I
have heard many stories where a new medical device is
purchased by a hospital and it just sits there because techs
can’t process it, they don’t have the tools and equipment
specified in the IFU. Also, the cost of processing a new
medical device should be taken into consideration in the
purchase-related costs of the product.
We need the competency of staff as well, to make
sure they can process the device. Get us involved at the
very beginning.
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