Special Edition on Sterile Processing Imperatives Special Edition- Sterile Processing Imperatives | Page 25

IFU steps may have in the organization. Leadership
support providing adequate resources to perform
the reprocessing tasks leads to a culture of reliability
and risk prevention.
JW: In some cases, the IFU are not written with the
end-user processing technicians reading skills in mind,
being written by experts and not in a way that the users
can understand in a straightforward manner. In some cases,
the instruments are very complicated and difficult to clean,
with time-consuming aspects to the processing that can
be hard to execute repeatedly and thoroughly. Also, access
to IFU may be limited, so the end-user technician may not
be able to have ready access to the IFU.
HHM How can institutions remove these barriers
and empower their SPD technicians?
CC: Two great ways to empower our front-line staff are
to make IFUs available in the department as a whole, and
at each workstation throughout it. A subscription to an IFU
document site, which technicians are trained to efficiently
use, is critical when novel instruments are introduced to
the department. Additionally, modern instrument tracking
programs have the functionality to attach links to the docu-
ment site or actual IFUs to count sheets, so that technicians
in the decontamination, inspection and sterilization areas
can immediately access them in the course of their work.
MO: There must be collaboration between the SPD, the
OR, infection prevention and control, purchasing and the
administrative leadership. Stringent processes for medical
device acquisition which includes a clinical review of the
IFU prior to purchasing the equipment to ensure the SPD
has all required tools to reprocess the device. This process
will enable the organization to decide whether to invest
in the medical device or provide the necessary resources
and equipment for SPD to be able to adhere to the IFU.
SPD must be encouraged and empowered to bring forth
the needs without fear of retaliation. 
JW: Training and access to IFUs. If the IFUs are
not comprehensible, get the manufacturer to provide
in-service training.
HHM How can manufacturers address complex,
difficult-to-follow IFUs?
CC: An example of how manufacturers can solve this
problem can be found in global chemical safety protocols. In
2003, the United Nations adopted the Globally Harmonized
System of Classification and Labeling of Chemicals (GHS).
OSHA began the process of adopting GHS in 2009, and
it is now fully implemented in all workplaces. (source:
https://www.osha.gov/dsg/hazcom/) The GHS is a unified
and standardized 16 point method of labeling chemical
containers for critical health and safety instructions at point
of use, and providing detailed information in the form of
Safety Data Sheets which employers are required to make
freely available to their workers.
Safety Data Sheets are now written in the same format,
with the same icons, and with standard, non-technical
terminology throughout the world. Training for workers is
on the format and universal symbology of the standard form,
enabling us to read necessary safety and health information
easily and quickly.
In the GHS, national and international organizations
concerned with public health, such as the WHO, ISO, ANSI,
FDA and others, have an established example of what form
IFU standardization could take, and should proceed with
regulatory actions to bring standardized IFUs to the industry,
for the benefit of our patients.
MO: Manufacturers must partner with hospitals SPD and
perform on-site validations for reprocessing to ensure the steps
listed in the IFU can be replicated in a real SPD environment.
These trials should be conducted in sample facilities using
categories of small, medium and large hospital size.
JW: Rethink the process. Rewrite the IFU with the input
of end-user technicians. Require that the user obtain proper
processing equipment, like ultrasonic baths with lumen
cleaning capability, lumen flush devices, lumen racks for
washer disinfectors. If any particular step of the processing
was not completed, the use of “overkill” cleaning using
these cleaning accessories and machines will help to make
up for the incomplete processing.
HHM How can technology assist with IFU compliance?
CC: The most impactful way that we can use technology
to assist with IFU compliance is found in instrument tracking
systems. As healthcare facilities move towards electronic track-
ing of surgical instruments, we are subscribing to instrument
tracking systems as a good way to protect our patients, track
our funds, and manage our inventory. A common feature of
instrument tracking programs is the “red screen,” a warning
screen that appears at a technician’s workstation when an
instrument is scanned to an inappropriate process, such as
an instrument that must be manually cleaned being scanned
into an automated washer/disinfector, or an instrument that
requires low-temperature sterilization being scanned into a
steam sterilizer. A “red screen” feature is an effective way
to warn technicians before they subject an instrument to a
damaging process.
MO: All new devices should be marked with incorporated
bar code that automatically uploads the IFU. The predeter-
mined code in the bar code prevents errors in choosing the
wrong IFU and/or following dated IFUs. The barcode should
also incorporate a video application for complex steps.
Software applications can be suited to read those barcodes.
JW: Ready access to the IFU using PC workstations or
other viewing platforms. Also, addition of videos to the online
IFU showing disassembly and reassembly of the devices and
how they are cleaned and packaged for sterilization. 
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