Medical Design Briefs - April 2021 - 6

Testing Strategies for
EUA Devices
eeping our spirits up during
a worldwide pandemic can
be challenging. However,
one bright spot on the horizon of our time is the
increased invention and ingenuity that
is coming into the medical device field
to deal with the COVID-19 crisis. From
3D printed ventilators to new designs
and materials for many mask types,
there has been an explosion of new
ideas and devices that are trying to
make it to the market right now.
However, with these new
designs comes the challenge
of how they will be assessed
for safety by regulatory agencies. While many devices
have received Emergency
Use Authorization (EUA) for
short-term use, supporting
the long-term use of these
devices becomes the subject in
question. Therefore, along with new
device ideas, new testing strategies need
to be considered to correctly assess these
new designs and ensure low patient risk.

K

6

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Cov

ToC

For all medical devices, the endpoints to be assessed are stated in ISO
1099-1 and are also elucidated in the
FDA guidance for Industry, Use of
International Standard ISO 10993-1.
However, gas pathway devices don't
have specific guidance for endpoints
to assess. While there is an ISO series
(18526) that has testing strategies for
gas pathway devices, it is challenging
to utilize these testing guidelines with
new devices and designs. When contemplating new testing strategies with
gas pathway devices, there are really
three areas that need to be considered
when assessing the safety of these
devices: Air volatile organic compounds (VOCs) and particulates,
chemical characterization, and toxicological risk assessments.
Breathing Devices
Air VOCs and Particulates. For many
breathing gas pathway devices, air
VOCs and particulates can be difficult
to assess. Many of the breathing gas
pathway devices (ventilators, CPAPs,
Medical Design Briefs, April 2021


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Medical Design Briefs - April 2021

Table of Contents for the Digital Edition of Medical Design Briefs - April 2021

Medical Design Briefs - April 2021 - Intro
Medical Design Briefs - April 2021 - Cov4
Medical Design Briefs - April 2021 - Cov1a
Medical Design Briefs - April 2021 - Cov1b
Medical Design Briefs - April 2021 - Cov1
Medical Design Briefs - April 2021 - Cov2
Medical Design Briefs - April 2021 - 1
Medical Design Briefs - April 2021 - 2
Medical Design Briefs - April 2021 - 3
Medical Design Briefs - April 2021 - 4
Medical Design Briefs - April 2021 - 5
Medical Design Briefs - April 2021 - 6
Medical Design Briefs - April 2021 - 7
Medical Design Briefs - April 2021 - 8
Medical Design Briefs - April 2021 - 9
Medical Design Briefs - April 2021 - 10
Medical Design Briefs - April 2021 - 11
Medical Design Briefs - April 2021 - 12
Medical Design Briefs - April 2021 - 13
Medical Design Briefs - April 2021 - 14
Medical Design Briefs - April 2021 - 15
Medical Design Briefs - April 2021 - 16
Medical Design Briefs - April 2021 - 17
Medical Design Briefs - April 2021 - 18
Medical Design Briefs - April 2021 - 19
Medical Design Briefs - April 2021 - 20
Medical Design Briefs - April 2021 - 21
Medical Design Briefs - April 2021 - 22
Medical Design Briefs - April 2021 - 23
Medical Design Briefs - April 2021 - 24
Medical Design Briefs - April 2021 - 25
Medical Design Briefs - April 2021 - 26
Medical Design Briefs - April 2021 - 27
Medical Design Briefs - April 2021 - 28
Medical Design Briefs - April 2021 - 29
Medical Design Briefs - April 2021 - 30
Medical Design Briefs - April 2021 - 31
Medical Design Briefs - April 2021 - 32
Medical Design Briefs - April 2021 - 33
Medical Design Briefs - April 2021 - 34
Medical Design Briefs - April 2021 - 35
Medical Design Briefs - April 2021 - 36
Medical Design Briefs - April 2021 - 37
Medical Design Briefs - April 2021 - 38
Medical Design Briefs - April 2021 - 39
Medical Design Briefs - April 2021 - 40
Medical Design Briefs - April 2021 - 41
Medical Design Briefs - April 2021 - 42
Medical Design Briefs - April 2021 - Cov3
Medical Design Briefs - April 2021 - Cov4
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