OR Manager - November 2019 - 23

ECRI Institute Perspectives
safety officers can improve the quality
of event reports in two ways.
First, update reports as new information
is obtained. For example, an
event that is initially classified as a
stapler " malfunction " (without injury)
should be updated if an associated
injury manifests days later. Second,
establish an investigation plan. Risk
management and frontline clinicians
should know what to sequester, and
should implement measures such
as labeling disposables according to
the chronology of their use and saving
loose and malformed staples.
* Consider the user when making purchasing
decisions. Anyone involved
in purchasing surgical staplers, especially
the OR manager, should
consider user familiarity when making
a large purchasing decision,
such as switching an entire suite of
endo-mechanicals from one manufacturer
to another. Lack of user
familiarity continues to be a contributing
factor in adverse incidents.
Involve the user in purchasing decisions
to bring potential use issues
to light before devices are placed
into service.
* Recognize risks and plan ahead.
Surgeons who use surgical staplers
should be especially aware of the
risk of immediate and serious hemorrhage
in vascular applications.
ECRI Institute recommends that the
entire OR team have a back-up intervention
planned in case of hemorrhage.
Such planning can dramatically
reduce patient harm.
* Improve user training. Ensure that
surgeons are knowledgeable and experienced
with the specific stapler
model that will be used. Unexpected
outcomes are less likely if the surgeon
is knowledgeable about and
experienced with the device before
use. Develop appropriate training
criteria for staplers with the manufacturer,
including contraindications
and what can go wrong, and verify
that these are met before stapler
use.
Reclassification by the FDA and the
identification of special controls is a
step in the right direction. But it is just
a step, and the FDA is just one of the
stakeholders with a role to play. Manufacturers
can continue to improve device
designs, and healthcare facilities
can implement measures like those
outlined above to prevent patient harm.
To learn more, contact ECRI Institute
at (610) 825-6000, ext. 5891, clientservices@ecri.org,
or visit www.ecri.
org. To download the executive brief of
ECRI Institute's Top 10 Health Technology
Hazards for 2020, visit www.ecri.
org/2020hazards. ✥
SPECIAL REPORT
Top 10 Health Technology
Hazards for 2020
Expert Insights from Health Devices
Unexpected health technology hazards can blindside
hospitals and harm patients. Our top 10 hazards
report can help you prioritize efforts and
reduce risks to patients.
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www.ecri.org/2020hazards
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OR Manager | November 2019
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OR Manager - November 2019

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