Healthcare Hygiene magazine November 2019 | Page 28

IFUs: The Challenges and Opportunities
for Compliance
By Kelly M. Pyrek
Healthcare Hygiene magazine
spoke with Susan Klacik, BS, CRCST,
CHL, CIS, ACE, FCS, clinical educator
with the International Association of
Healthcare Central Service Materiels
Management (IAHCSMM), about the
importance of following manufacturers’ instructions for
use (IFUs) as part of the overall strategy for proper med-
ical device reprocessing and upholding patient safety. Labs inoculate the device, and they know exactly what it
takes to clean it and sterilize it, and if we aren’t following
the IFUs, we can harm patients. Also, we risk damaging the
device if we don’t follow the IFUs. The bottom line is, we
don’t want to have any debris remaining on or in the device
because we don’t want to give our patients infections, and
that’s why we must follow the IFUs.
HHM Talk to us about the importance of following IFUs. SK: The challenge around educating continues. It’s
always best to explain the “why” behind why we do what
we do; because then CS/SPD personnel perform their jobs
better when they understand more about the “why.” So, I
think the “why” is very important. Techs must understand
that validation is based on the science, which drives every-
thing that we do.
SK: IFUs share with us the key details about how to
properly process a medical device or instrument. IFUs are
developed based on the scientific validation on that specific
medical device; the devices are soiled with a certain kind of
soil that is reflective of soil it will be exposed to. There are
measurements taken around the level of soil and how this
soil is eradicated from the device, and how exactly to do so.
Testing labs determine the cleaning and disinfection protocol,
and manufacturers list out these steps for removing the soil.
IFUs are becoming so detailed now, that manufacturers
are even indicating what kind of brushes to use. This is
especially good information, especially if a facility is going
to buy a new medical device – that’s the information we
need up front so that when we have the medical device in
front of us, we don’t say, ‘Oops, we don’t have the right
brush on hand.”
HHM With more detailed IFUs comes new challenges
of compliance, right?
SK: Right, and the IFUs do change, compounding the
challenge even more. We must keep them updated but it
is a challenge because some of them are very, very detailed
and they are difficult for techs to follow. We often must use
our critical thinking skills. For much more complex medical
devices, we really must follow IFUs to the letter because
that’s where all the validation information is contained.
HHM Can healthcare facilities do a better job of
explaining these imperatives and improving techs’
comprehension of the science?
HHM Is the onus on the manager?
SK: Yes, sterile processing leaders are responsible for the
education and training of their personnel. We need to hold
a lot of in-services as new medical devices and instruments
come into the healthcare facility, and the manufacturer
must help in-service staff as well. These new devices and
instruments shouldn’t be used until the sterile processing
staff is in-serviced, period. The sterile processing leader can
also identify their problem items and start in-serving techs
on those IFUs. Many manufacturers offer online resources,
as does IAHCSMM, which provides instructional resources
including webinars and now podcasts. Time is also a factor
because we are so busy.
HHM Could providing techs with feedback about
HAIs and facility infection rates could help?
SK: We need to educate them around why we must
process based on scientific validation – it’s not just infections,
it’s overall patient safety.
Medical devices are so much more complex, and as they
continue to evolve, the tools we use in sterile processing
must evolve as well to keep up.
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november 2019 • www.healthcarehygienemagazine.com