patient safety & quality
By Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, PLNC, AS-BC,
IP-BC, VA-BC™, CFER, CPPS, NREMT, FACDONA, FAAPM, FNAP
Human Factors and Medical Device Safety:
A Clinical Perspective to Improve Patient Safety and
Reduce Cross-Contamination
W
ith recent outbreaks associated with reprocessed
medical devices, both the Food and Drug Administration
(FDA) and the Centers for Disease Control and Prevention
(CDC) have placed tremendous emphasis on improving medical
device safety. Medical devices are routinely used in clinical
settings for both diagnostic and therapeutic purposes. Medical
devices must be reprocessed according to the manufacturer’s
instructions for use (IFU).
The FDA regulates high-level disinfection and sterilant
products, while the Environmental Protection Agency (EPA)
regulates low- and intermediate-level disinfectants. Medical
devices are categorized into three classifications: noncritical,
semi-critical, and critical items. Noncritical items are those
most frequently used in healthcare settings and include blood
pressure cuffs, stethoscopes, etc. These items are used on
intact patient skin and include environmental surfaces as well.
Noncritical items require the use of a low or intermediate level
disinfectant for reprocessing. Semi-critical items are those
that contact mucous membranes of the patient and include
examples such as laryngoscopes and endoscopes. Semi-critical
items must undergo a minimum of high-level disinfection.
Finally, critical items are those that enter sterile body cavities
such as surgical instruments. Critical items require sterilization.
Recent guidance from the FDA requires many medical
manufacturers to conduct human factors validation of their IFU
and demonstrate the ability for users to safety and consistently
reprocess these medical devices to ensure patient safety and
reduce the risk for cross transmission. Reprocessing steps
must be concise, easy to follow for users, and validated to
be reliability achieved with all user populations.
For example, if a flexible endoscope is going to be used
in a gastroenterology setting, then all users, which would
include nurses, technicians, physicians, and reprocessing
professionals, would need to be properly trained on their
roles in reprocessing. This validation must be performed under
strict clinical research controls to ensure the integrity of the
process. This rigorous process validates that properly trained
clinical users can reliably reprocess reusable medical devices.
Incorporating human factors-validated clinical training in
healthcare facilities is a critical element for ensuring patient
safety and reducing the risk for outbreaks associated with
medical devices.
Healthcare facilities should focus on a three-step process
that addresses people, processes, and products across the entire
continuum of care. This unique approach begins with intense
focus on personnel and ensuring that the entire healthcare
team involved in the process has received standardized and
role-specific training for all associated tasks. In addition, training
does not equate to competency with healthcare professionals.
Healthcare Leaders must take the necessary responsibility to
www.healthcarehygienemagazine.com • april 2020
ensure proper competency management of their direct reports
so that breaches in medical device reprocessing are mitigated.
While many processes can be automated to reduce the risk
for error in reprocessing, some processes still require human
interaction, and these can introduce variability and result in
patient-safety risk. This is evidenced by the multiple outbreaks
associated with breaches in medical device reprocessing.
Recent advancements in human factors engineering has
demonstrated a high reliability in validated and standardized
reprocessing efforts for flexible endoscopes with properly
trained reprocessing personnel and appropriate resources to
execute the overall reprocessing process. If healthcare medical
device reprocessing processes are highly reliable, then errors will
be tremendously reduced. Processes should be independent
of specific individuals and the outcomes must be replicated
to document success.
Finally, healthcare facilities should have rigorous processes
in place to evaluate commercial products prior to them being
introduced into the healthcare facility. This process must include
disposable and reusable devices and items. Training on new
products should be conducted at the time of conversion and
then annually thereafter to ensure that each product is correctly
used and reaches its desired state of efficacy.
While medical devices are used millions of times daily
across the U.S. healthcare system, they are not without risk.
Healthcare executives must ensure staff competency with all
associated reprocessing processes. Regulators must screen
new medical device applications carefully to ensure that the
product can be appropriately used by the intended users.
This is validated by conducted human factors studies with
the input of actual simulated clinical users.
Finally, medical product manufacturers play a pivotal role
in collaboration and own the product development pipeline
to address healthcare’s complex needs. Patients deserve the
opportunity to receive healthcare in a safe environment that
is free of preventable harm. Interprofessional collaboration is
a strategic imperative for all stakeholders in healthcare and
requires an intense and ongoing focus on patient safety,
infection prevention and control, and ensuring healthcare
staff competency.
Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, PLNC,
AS-BC, IP-BC, VA-BC™, CFER, CPPS, NREMT, FACDONA,
FAAPM, FNAP, is president and CEO of Community Health
Associates, LLC. He also is an adjunct assistant professor of
medicine in the Division of Infectious Diseases at the University
of Louisville School of Medicine. Garrett is a frequent lecturer
globally on patient safety, infectious diseases, and medical
device reprocessing and safety. He may be reached at: Hudson.
[email protected]
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