Special Edition on Sterile Processing Imperatives Special Edition- Sterile Processing Imperatives | Página 22

Instructions for Use:
Q
& A
Insights and Advice from the Experts
Healthcare Hygiene magazine turned to experts in
the field for their insights on the importance of following
instructions for use (IFU).
Our experts are:
Casey Czarnowski, sterile processing educator
at Stanford Health Care and oneSOURCE
speakers’ bureau expert
Mary Olivera, MHA, CRCST, CHL, FCS, president
and CEO of OSPECS Consulting, LLC and
oneSOURCE speakers’ bureau expert
Jonathan Wilder, PhD, managing director
at  Quality Processing Resource Group and
oneSOURCE speakers’ bureau expert
HHM How critical is it to follow manufacturer IFUs
and why?
Mary Olivera (MO): Medical device manufacturers
conduct tests and validations to ensure the device can be
reprocessed safely. It is uncertain if after deviating from
the written steps or not using the listed equipment for
reprocessing the device is rendered clean or sterile. Therefore,
the medical device can potentially harm the patient.
HHM What are some examples of the consequences
of failure to follow manufacturers’ IFUs?
Casey Czarnowski (CC): A great example of the
consequences of not following a manufacturer’s IFU is an
ultrasound probe. Ultrasound probes can cost $15,000 to
$20,000, and the damage done by incorrect leak testing is
often not repairable. The IFU shows the process, which must
be carefully trained and strictly followed to avoid having to
replace the instrument. If technicians are not trained to the
IFU, great cost may be incurred by the facility, and patient
care may be impacted by instruments being down for repair.
MO: Failure to follow the appropriate steps listed in the
IFU can have a negative outcome to the patient and to the
organization. Processing medical devices without knowing
how the device is disassembled, cleaned and sterilized is
like placing a blind over your eyes being unable to see
what you are doing. The goal is to provide a device that is
microorganism free and that is not going to cause harm to
a patient. Just to name a few failures to not follow IFUs can
result in patient contamination and possibly death, hospital
reputation is damaged, and litigation.
Jonathan Wilder (JW): For instruments that have
complex structures, not following IFUs will result in improper
cleaning and potential patient-to-patient soil transmission.
In addition, the instrument may be ruined by soil remaining
Expert Casey
Czarnowski
says that an
example of
the conse-
quences of
not following
a manufac-
turer’s IFU is
an ultrasound
probe.
Ultrasound
probes can
cost $15,000
to $20,000,
and the
damage done
by incorrect
leak testing
is often not
repairable.
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Sterile Processing Imperatives 2020 • www.healthcarehygienemagazine.com