Medical Design Briefs - September 2023 - 42

tion, called for continued cooperation
between the industry and the
agency as the regulations covering
medical device sterilization using
ethylene oxide (EtO) move forward.
AdvaMed said if the proposals are finalized
as written, the United States
will see a massive interruption in patient
care and access because of a 30-
50 percent reduction in sterilization
capacity for life-saving devices.
" As we review these EPA proposals,
Some elements of the two proposals
are conflicting or make implementation
technically impossible. Careful
analysis is needed of the interplay between
EPA's proposed rule and its proposed
interim registration decision to
ensure workable rules that can be reasonably
implemented.
No consideration of background levels
of EtO. Ethylene oxide is in the air
from many sources, but neither EPA
action takes this into account. Backit's
important to remember that we
come to these discussions as partners,
not as adversaries, " said Scott Whitaker,
AdvaMed president and CEO.
" The medtech industry and EPA must
continue working together to improve
these two proposals because as written, we
could see significant shortfalls and a risk
to patient access resulting from a device
sterilization capacity reduction of 30-50
percent nationwide. "
AdvaMed pointed to specific policies
that EPA must address in the proposals
to preserve patient access to the medtech
necessary for timely care, including:
Capacity reduction. The proposals as
drafted will result in an estimated total
capacity reduction at sterilization facilities
of 30-50 percent per site and even
upwards of 70 percent or more for some
facilities. This will likely result in a significant
disruption to patient care and risk
Molecule of ethylene oxide. (Credit: Alexey Novikov/AdobeStock)
a public healthcare crisis. AdvaMed conducted
an industry gap analysis to meaningfully
assess impact and the risk to critical
sterile infrastructure of the proposals.
Sterilization facilities are not uniform
operations. There is no one-size-fits-all
approach to the medtech industry and
sterilization. Any final determination
must allow for flexibility to prevent any
delays in lifesaving, life-enhancing, and
timely patient care.
Revalidation. Millions of products
would require revalidation, including
extensive testing and change management
with U.S. and worldwide regulatory
submissions. This in turn would also cut
capacity sharply and disrupt the supplies
of critical medical technology needed
for patient care.
ground concentration must be considered
in meaningful risk assessment.
Flawed risk assessment. EPA's risk
assessment model is fundamentally
flawed, relies on a single study, and ignores
recommendations by the National
Academies of Science, among others.
Technical feasibility. The EPA proposals
in certain cases call for technology
that either does not exist or is in limited
supply, exacerbating capacity decreases
and patient care and access delays to
sterile medtech.
Timeframe is not feasible. The proposed
rules' implementation timeframe
of 18 months is impossible to meet and
will exacerbate critical infrastructure
shortages.
For more information, visit www.
advamed.org. AdvaMed's comments
can be viewed at https://tinyurl.com/
advamed-EPA-comments.
Customizable Spun-Fiber Heart Valve Grows with Children
The valve can be
manufactured in less than
10 minutes.
Harvard Wyss Institute
Boston, MA
Strep throat is a common and treatable
childhood disease in the United
States, but in less wealthy countries, children
afflicted with strep can develop
rheumatic fever, in which runaway inflammation
attacks the body's tissues.
Rheumatic fever often damages the
valves of the heart, causing rheumatic
heart disease that can lead to serious
health problems, including heart failure.
Heart valves can be surgically replaced,
but children whose bodies are
still growing may need multiple, highly
invasive surgeries to replace their valves
42
with larger ones, putting them at risk.
Kevin Kit Parker's team at the Wyss Institute
and Harvard's John A. Paulson
School of Engineering and Applied Sciences
(SEAS) vowed to fix this problem
by creating an implantable heart valve
that grows with a child, minimizing surgical
complications and suffering.
They are now a big step closer to that
goal, as described in a new paper published
in Matter. Their next-generation
synthetic heart valve, called FibraValve,
can be manufactured in less than 10 minutes
using a new method called focused
rotary jet spinning (FRJS), which allows
the researchers to customize the shape
and properties of the valve's delicate
flaps down to the nanoscale. This new
valve was readily colonized by living cells,
both in vitro and in large animal model
studies conducted by collaborators led by
www.medicaldesignbriefs.com
Wyss Associate Faculty member Simon
Hoerstrup at the Wyss Zurich Translational
Center in Zurich, Switzerland.
This international collaboration was supported
by Wyss Institute Project funding.
" This study illustrates FibraValves' potential
as a solution for children suffering
from valve diseases. Our goal is for
the patient's native cells to use the device
as a blueprint to regenerate their own
living valve tissue, but FRJS also has potential
as a platform to fabricate other
medical devices in the future, " says Parker,
PhD, who is an associate faculty member
at the Wyss Institute as well as the
Tarr Family Professor of Bioengineering
and Applied Physics at SEAS.
n From " Good " to " Great "
Parker and Hoerstrup's quest to create
a living, growing heart valve has been unMedical
Design Briefs, September 2023
http://www.advamed.org https://tinyurl.com/advamed-EPA-comments http://www.medicaldesignbriefs.com
Medical Design Briefs - September 2023

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