Perspectives
By Damien Berg, CRCST
Instructions for Use, Inadequate Support
Pose Medical Device Cleaning Challenges for
Sterile Processing
S
terile processing (SP) professionals face many challenges
in today’s complex, ever-evolving instrument processing
landscape. One of the greatest obstacles involves complying
with manufacturers’ instructions for use (IFU) for cleaning/
disinfecting medical devices, as well as dealing with time
and resource constraints and difficult conditions in the
decontamination area.
The sterile processing department’s primary responsibility
remains the same: reprocessing a wide array of medical/surgical
devices that often include complex orthopedic instruments,
sophisticated power equipment, narrow-lumened laparoscopic
devices, and ever-challenging flexible endoscopes. Each of
these devices has specific, often confusing and even conflicting
cleaning instructions. SP technicians must navigate these IFUs
while also facing increasing demands from the operating room
(OR) or other end-user department. 1 Often, SP professionals
field requests to turn instruments around more quickly than is
safe, and those requests often don’t align with manufacturers’
IFUs. If the cleaning process is rushed or any missteps occur,
high-level disinfection (HLD) and sterilization will be negatively
affected, and patient safety becomes jeopardized; it’s a point
underscored in numerous studies, including a recent joint
study published by Ofstead & Associates. 2
When it comes to the confusion and frustration associated
IFU compliance and meeting the requirements of The Joint
Commission (TJC), the hospital and SP leadership must
understand the common challenges that can cause the
organization to become noncompliant during surveys. In 2017,
72 percent of surveyed hospitals and critical access hospitals
were found to be noncompliant with TJC’s infection control
standard, IC.02.02.011; 3 the standards require hospitals to
reduce infection risks associated with medical equipment,
devices and supplies, primarily as it related to steps of HLD and
sterilization. This high degree of noncompliance led TJC to revise
the standard to include more specific scoring that focuses on
areas of highest risk. The changes took effect Sept. 1, 2018.
TJC will continue to score IC.02.02.01 as noncompliant
whenever manufacturer IFUs are not followed to the letter
in the decontamination area. It is not only critical for SP
professionals to understand these tasks and details but also
to be able to speak to the IFU and how the medical device
is cleaned and disinfected prior to HLD and/or sterilization.
Unfortunately, challenges abound because the IFU are
not always clear or easy for the frontline SP technician to
understand. Technicians are also frequently pressed for time
and often lack adequate instrumentation inventories to meet
turnaround time requests from the OR and other patient-care
areas. Beyond that, some technicians/facilities don’t have
access to the correct processing equipment – or they may
8
lack enough equipment to meet the instrumentation and
turnaround demands.
All these gaps create the perfect conditions for failure. The
Association for the Advancement of Medical Instrumentation
(AAMI) has been working on its technical information report,
TIR12: Designing, testing, and labeling reusable medical
devices for reprocessing in healthcare facilities, which will
help manufacturers standardize their cleaning instructions
so the end user can better understand and follow them.
Developing this document required significant time as it
involved the review of more than 250 IFU and explored the
commonalities and complexities of cleaning. In doing so, the
end goal is to provide manufacturers with a blueprint and
understanding of what the modern SPD entails and how
it operates, so manufacturers can design their devices for
improved cleanability and develop realistic, easily understood
cleaning and disinfection instructions that can be performed
effectively in today’s instrument processing areas/departments.
Having regulatory agencies, standards-making bodies and
manufacturers of complex medical devices on the same page
in their understanding of the urgent need for safer, easier to
clean devices and easier to improved cleaning instructions
will bode well for compliance and patient safety. It is also
essential that healthcare facilities support reprocessing areas
with appropriate staffing levels; provide ongoing training;
ensurie instrumentation inventories are adequate to meet
procedure volume; and provide enough modern processing
equipment to meet the needs of the OR. Technology in the
procedural areas is becoming more complex and sophisticated
in order to provide the best and safest patient care; therefore,
it is imperative that those who perform instrument cleaning
and sterilization have the proper tools and training to ensure
that those devices are clean, sterile and ready when needed.
Today’s healthcare environment resides in a world of risk
assessments and a simultaneous push for cost containment;
however, it is critical that healthcare organizations do not
overlook the common factors that increase their own risks
and, most importantly, the patient’s. Among the greatest
risks are the human factors associated with cleaning and
disinfecting surgical instruments and complex medical
devices. This should be considered the foundation of any
successful clinical outcome.
References
1. The Joint Commission. Joint Commission Revises IC Devices Standard.
Oct. 1, 2018.
2. Ofstead et al. Endoscope Preprocessing: Current Practices and
Challenges in the Field. PROCESS. July/Aug 2019.
3. ECRI Institute. If It’s Not Clean, It’s Not Sterile: Reprocessing Contam-
inated Instruments. April 11, 2017.
january 2020 • www.healthcarehygienemagazine.com