Medical Design Briefs - November 2021 - 20

Reusable Device IFUs
reprocessing methods with patient safety,
end-user comprehension, and pro -
cess validations in mind. Planning ahead
can help manufacturers avoid potential
delays, additional costs, or lost revenue.
Developing or Refining the
Reprocessing Instructions
It is a manufacturer's responsibility
to ensure that the reprocessing in -
structions for reusable devices are
clear, comprehensive, and effective.
There are many points in a product's
life cycle when validation or revalidation
may be necessary, such as product
launch, design changes, produc tion
transfers, or remediation. When ap -
proaching validation testing, a crossfunctional
team generally unites to -
gether to review all design inputs and
develop, or possibly edit, the IFU.
Aligning different perspectives and
considering engineering, regulatory,
and clinical needs can be cumbersome.
Even when a team reaches
a compromise, gaps in the reprocessing
instructions can remain
until it is put to the test.
When drafting reprocessing
instructions for a new IFU, the
development team should factor
in various aspects of the device,
including:
* The device's geometry.
* The material makeup.
* Device durability expectations.
* Cleaning methods anticipated (manual,
automated, or both).
* Clinical applications.
* Device complexity.
* And more.
When device design is more intricate,
consider these device-specific challenges
in the reprocessing instructions.
Manufacturers should be aware that
certain device complexities
such as
unique surfaces, porous materials,
mated surfaces, narrow channels, and
occluded lumens may increase patient
safety risk. These design attributes may
warrant additional attention in the
development of comprehensive reprocessing
instructions.
Project teams may also review or
revalidate an existing set of reprocessing
instructions for projects such as
design change or remediation effort.
They will need to consider whether the
techniques described can yield passing
validation results that meet the current
standards, guidance, or latest scientific
20
Cov
trends. New design features or historical
testing results may not meet the current
expectations for validation testing.
Adding supplemental instructions may
be necessary to address unique design
features, or potentially executing a
comprehensive rewrite of the reprocessing
instructions. This can help to
better articulate the directions and
ensure a robust design that will result in
an effective method - even if not followed
exactly.
When validating the reprocessing
instructions, the testing laboratory will
construct an experimental design that
evaluates a worst-case scenario for
cleaning instructions, disinfection, and
sterilization. They will intentionally
expose the device to worst-case variables
that are specific to each validation.
The worst-case approach is a function
of U.S. Food & Drug Administration
(FDA) and AAMI literature guidance,
which exposes areas where repro "
Identifying
a master product
allows manufacturers to streamline
validation by testing one product to
minimize the entire family's testing.
the testing variables per validation and
then anticipate the expectations of the
agencies they will be providing the validation
data to.
Validation Principles. AAMI, ISO, and
the U.S. FDA provide direction for the
various types of reprocessing validations
required for reusable devices: cleaning,
disinfection, and sterilization. In reviewing
these documents, an initial and
foundational approach is for the manufacturer
to assign a master product or
products to represent a product family.
Identifying a master product allows
manufacturers to streamline validation
by testing one product to minimize the
entire family's testing. With proper justification,
grouping devices based on
materials, indications for use, product
design, reprocessing congruencies, and
other factors can help save time and
reduce costs.
"
cessing directions may fall short.
Manufacturers entering these evaluations
can minimize room for error by
reviewing even the smallest details in
their reprocessing procedures. For
example, if the instructions call for a
brush to be used in the cleaning of the
device, manufacturers should be prepared
to specify the important attributes
about the brush such as shape,
size, and material.
Factoring in Guidance Principles
to Meet Regulatory Expectations
Testing laboratories tailor the worstcase
approach to consider each product
and its unique properties. The guidance
documents provide principles to
consider when validating reprocessing
instructions in order to meet a worstcase
study design. However, they don't
specifically lay out a direct testing plan
for each device type or validation.
Companies should be familiar with the
applicable guidance documents and
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ToC
Applying the worst-case approach to
applicable variables in each type of validation
reveals the robustness of
the reprocessing instructions. In
steam sterilization, this is accomplished
by using a specific challenge
organism and reduced
exposure times. However, when
it comes to cleaning validations,
worst-case applies
to artificial
soils, their application, reduced
cleaning parameters, and more.
A visual inspection accompanied
with chemistry testing for specific
analyte residuals determine whether
the cleaning methods achieve the
acceptance criteria.
Applying Soils. Manufacturers must
act as informative partners and work
with qualified laboratories to instruct
them about the device and help them
understand clinical use. The selected
soils for testing should represent organic
components, inorganics, and viscosity
of the clinical use scenario. A clear
understanding of a device's clinical setting
is critical to this fundamental step.
This information then guides the selection
and application of a representative
artificial soil in order to accurately create
simulated use conditions.
The worst-case experimental design
must closely reflect the clinical use scenario,
so
the validation procedures
apply the soils correctly to the proper
locations in relevant quantities.
Without attention to detail, a test bias
can occur and skew results, for better or
worse. In some cases, device inoculaMedical
Design Briefs, November 2021
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Medical Design Briefs - November 2021

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