OR Manager August 2023 - 12

Navigating challenges of connecting recalls to patients, inventory
PROCESS IMPROVEMENTS
ealthcare facilities face challenges
in the recall process of
tissue, non-biologic implants,
and medical devices because of to their
time-sensitive nature and inherent risks
to patient safety and compliance. Hospitals
often use secondary sources for recall
notifications. These lists, however,
do not include two critical pieces-the
identification of affected patient cases
and inventory item's storage location.
A lack of system-wide visibility forces
perioperative nurses and staff to combine
siloed data from multiple sources.
But recall management involves multiple
departments. In the absence of
interoperability, connecting recalls to
patients and inventory puts hospitals
and patients at risk.
This article examines the challenges
facilities face in recall matching, the difficulty
in managing recalls using siloed
data from multiple sources, and the importance
of leveraging a data-integrated
software to eliminate these barriers, resulting
in effective recall management.
Recall matching
Connecting recalls to patients and inventory
is a challenging task for several
reasons. Multiple departments can be
involved in managing recalls. Perioperative
nurses are responsible for entering
case information into the patient's
electronic health record (EHR), while
materials management teams enter inventory
before surgery, and supply chain
teams order the inventory, trying to balance
what surgeons use with what is
in stock. Working with fragmented data
only hinders operational efficiency and
informed decision-making, resulting in a
delayed response to recalls.
With the support of the Unique Device
Identifier (UDI) initiative, barcodes
were standardized to require UDI for all
tissue and non-biologic implant devices.
The goal was to simplify the process of
identifying individual pieces and improve
data to make recall identification easier.
To leverage this, hospitals need technol12
OR
Manager | August 2023
H
ogy that integrates multiple data sources
into one centralized system.
In the current market, thousands of
non-biologic implantable devices are
available, and approximately 95% of
recalls involve non-biologic implants. Because
only 5% involve tissue, software
that is only capable of tracking tissues
is not an effective tool. It is necessary
to close the gaps between missing data
links to overcome this barrier. A centralized
solution that manages tissue and
implant devices, and integrates data
from all key players, solves this issue.
Data integration
Healthcare organizations can mitigate
these challenges by implementing an
effective solution that enables systemwide
visibility across all departments involved
in recall management. Data from
the Food and Drug Administration Recall
Database, EHR, and manufacturer systems
can be consolidated. Incorporating
these key players into a cohesive
system enables data to be captured
and automated for connecting recalls to
patients and inventory, eliminating the
need for manual cross-checking and any
associated errors or oversights.
A culture of transparency must be
maintained between all involved parties,
including perioperative nurses, materials
management, supply chain, finance,
risk management, and executives within
the healthcare system. It is more beneficial
for modern healthcare settings
to take a holistic approach to recall
management rather than to concentrate
solely on a microsystem level.
UDI management software
A UDI tracker may address these challenges.
Tissue and implant software is
now available as a solution for simplifying
recall management. This process is
exemplified by the seamless data integration
within such a tracker that makes
it easier to manage recalls among the
stakeholders involved.
When a recall occurs, software can
BY: TRACEY BERKOWITZ
pull data from the aforementioned databases.
Recalls can be listed based
on product codes, lot numbers, or affected
serial numbers, and those get
matched to implanted patient cases. An
alert appears on the software's dashboard
when a match occurs, and one
is emailed in the event of an urgent recall.
It is also crucial that each recall instance
is equipped with all the required
information regarding the affected case.
Having access to this level of realtime
visibility is essential for healthcare
organizations that wish to see and
pursue opportunities to reduce spend,
increase revenue, avoid compliance
risk, and make informed decisions that
affect the bottom line. Specialized software
solutions can provide end-to-end
management and tracking capabilities
for tissue, implants, explants, warranty
claims, and recalls.
There are several obstacles that prevent
successful recall management.
To address the complexity of connecting
recall notifications to affected patient
cases and inventory items, effective
measures should be put into
place. Healthcare organizations need
to manage recalls with a macrosystem
approach for optimal microsystem efficiency.
Perioperative nurses play an
integral role in ensuring patient safety
and complying with regulatory agency requirements,
whether in a hospital, medical
center, or orthopedic facility. Having
access to necessary data quickly and
accurately is essential. Tissue and implant
management software that provides
advanced cross-functionality and
data integration is the ideal solution
for streamlining the recall process and
mitigating risks associated with it. ORM
-Tracey Berkowitz is division
marketing lead at InVita
Healthcare Technologies, a
software solutions provider
of end-to-end management
of tissue, implants, explants, warranty
claims, and recalls.
www.ormanager.com
http://www.ormanager.com
OR Manager August 2023

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