Medical Design Briefs - April 2021 - 7

anesthesia machines, etc.) have different connections for the hoses, which
many times the testing labs do not have
adaptor for and, therefore, cannot
direct the air to analyze to only the
interior of the tubing. Assessing the
whole device, interior and exterior,
results in an increased level of air VOCs
detected, as the outside surface of the
device, which is not clinically relevant,
is assessed in conjunction with the
inside surface of the device. Being
aware of this situation up front can lead
to more appropriate testing. This issue
can also be addressed by coordination
with the testing laboratory and by providing appropriate connections so that
only the interior surface will be tested.
Another strategy is to use a surface area
calculation with the assumption that
the amount of air VOCs and particulates being shed can be scaled by the
ratio of interior surface area to exterior
surface area.
Chemical Characterization. Chemical characterization of breathing gas
pathway devices has been a perplexing
challenge. Questions arise regarding
what to test, how to test it, and what data
are needed to assess the device for safety in a way that makes scientific sense
and ultimately assesses patient safety in
the clinical setting. When conducting
chemical characterization of breathing
gas pathway devices or masks, the goal
is to understand what compounds could
be leaching from the device and reaching the patient. These leachables could
contact the patient via condensate.
Assessing this type of exposure is
fraught with difficulties such as how to
accurately extrapolate from a fully submerged device to what could contact the
patient during clinical use.
For example, a mask that is connected to a ventilator will only have one
side touching the patient's face.
Because it is impractical to cap off the
mask for extraction, the whole device
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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
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Medical Design Briefs - April 2021 - Cov3
Medical Design Briefs - April 2021 - Cov4
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