Medical Design Briefs - October 2023 - 16

The Truth About PTFE
tomed to. Imagine delicate vascular
procedures being performed before
PTFE coatings were applied to the guidewires.
Yet the PFAS substances that are
used to make PTFE are being targeted
for elimination.
While coatings
manufacturers
currently
use PFAS to make PTFE, they are
not turning a blind eye to its eventual
elimination and are working to stay
ahead of the curve. For example, the use
of PFAS in processing PTFE coatings
must be closely controlled by the processor.
All water used in the process must be
filtered before exiting a plant and flowing
into the sewer system. The fumes
produced during polymerization must
be incinerated prior to being released to
the atmosphere.
SSG's sustainable GlideMed™ coating on electromyography needles. (Credit: SSG)
Once again, chemical and coatings
manufacturers in the EU and United
States are working to help regulating organizations
make important distinctions
between PFAS substances that probably
should be eliminated and those that can
and should be used. There must not be a
broad-brush-stroke elimination.
Myth: PTFE is dangerous if ingested
or inserted into the body.
Truth: PTFE has a unique chemical
structure that happens to fall under the
PFAS class of substances. However, the
PTFE molecule is inert and thermally
stable so that if it were put into water,
nothing would happen to it; and if you
put it into the body, it passes through unaltered
because it does not biodegrade.
It is not absorbed into the body as are
some PFAS chemicals.3
In the medical industry, there is a
very low amount of PTFE coating applied
on medical devices. For example,
consider the guidewires used for cardiac
procedures like angioplasties and the
placement of stents in very small veins
and arteries. The guidewires measure
between 0.0065 and 0.015 in. in diameter
(about five times thicker than a human
hair), and the wire is 5-6 ft. long.
The uniform thickness of most PTFE
coatings that are applied to these and
other medical devices ranges from 5 to
15 µm, which is extremely thin. Specifically,
the amount of coating used on a
guidewire is less than 0.013 oz. of coating
per guidewire.
Myth: PTFE will be eliminated completely.
Truth:
No one wants to completely
eliminate PTFE. It is just too important
to too many industries, from cookware
to packaging to electric-powered cars
and airplanes.
SSG's sustainable GlideMed™ coating on preform
guidewires.
16
If PTFE were eliminated, the medical
device industry would be set back decades
because PTFE, with its unprecedented
low coefficient of friction, is what
makes it possible for surgeons to perform
procedures with the ease and degree
of safety we have all become accuswww.medicaldesignbriefs.com
These
preventive measures were not
done previously, but many PTFE manufacturers
such as Chemours and Daikin
have implemented these procedures.
Most other PTFE manufacturers have
moved quickly in that direction.
The Drive for Sustainable Coatings
Here in the United States, the EPA is
looking at the best available technology,
working cooperatively with the chemical
and coatings industries to learn what can
be done to eliminate PFAS in favor of
more sustainable, functional coatings
and set a time limit to reach that goal.
The process used in 2015 for the elimination
of PFOA in manufacturing is a
good example of industry and the EPA
working together to achieve mutual success.
The EPA realized that it could not
eliminate PFOA all at once, and taking
valuable input provided by chemical
manufacturers, set a timeline to use the
best available technology back in 2010 to
eliminate its use. We see the same type of
collaborative process being initiated for
other PFAS in the United States.
This is pretty common practice in the
United States, whereas in the EU, mandates
often are handed out using governmental
power to say " PFAS will be eliminated
by this time and that is just how it
is going to be. "
Interestingly, the EU has instead
opened this issue for input from the
manufacturing industry, so numerous
companies are contacting the European
Commission to provide data supporting
their need to responsibly use PFAS substances
in products. Time will tell whether
future EU regulations will ease as a
Medical Design Briefs, October 2023
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Medical Design Briefs - October 2023

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