Medical Design Briefs - October 2023 - 17

MDB Statek Ad 0621.qxp_1/3 Page Vertical 5/26/21 12:21 PM
result. Still, there are other companies,
like 3M, that are getting out of the PTFE
and PFAS business to avoid ongoing exposure
to lawsuits.
The quest to eliminate PFAS has more
than just the coatings and chemical industries
reeling. Engineers and medical
device designers are also undergoing a
paradigm shift and rethinking how to
produce devices using more sustainable
PTFE coatings, along with alternatives to
PTFE, that will comply with the new restrictions
while ensuring that their products
meet or exceed performance expectations.
It is a role reversal, to be sure.
OEM companies traditionally called the
shots about how their products should be
manufactured but are now in reactive
mode under the watchful eye of the EPA
and EU.
Answering Sustainability's Call
Strides have been made, some significant,
toward greatly reducing PTFE in
medical device coatings. For example,
through collaboration with functional
coating technology companies like Surface
Solutions Group (SSG), coatings
manufacturers are using established scientific
data to reformulate existing proven
coatings to create new versions that
reduce the use of restricted chemicals.
All this, while at the same time meeting
product performance standards and
working to fill the all-too-critical supply
chain gaps left by others.
With the growing concern over
PTFE use in medical devices, alternatives
are being examined to find lubricants
that can be added to coatings
that are not manufactured with PFAS
nor contain PFAS.
Companies are working hard to find
the right combination of resins and lubricants
that can work on medical devices.
One example of success occurred 10
years ago, when a coating was developed
for use on nitinol wire that comprised
only 5 percent PTFE. The new, low 5 percent
PTFE coating has a cure temperature
of 450 °F while the previously specified
PTFE coating had a cure
temperature of 700 °F. An additional,
welcome benefit was also revealed: At
the new, 450 °F cure temperature, the
coating did not change the Af
of the nitinol
wire.
With further R&D efforts, SSG recently
discovered that it was possible to remove
the remaining 5 percent PTFE and
Medical Design Briefs, October 2023
achieve the same frictional values that
customers required. Upon comparing
the frictional properties of this coating to
resin-bonded PTFE coatings, researchers
found it to be nearly equal.
SSG's R&D work created GlideMed™,
water-based, low-friction, biocompatible
medical device coatings that contain no
PTFE and one that is low PTFE. They are
free from any PFOA, PFOS, solvent, and
hex chrome compounds. These properties
make them sustainable and REACH
and RoHS compliant.
Where Do We Go from Here?
In terms of the medical device industry,
the quest continues for more sustainable
coatings. There is little doubt that
PTFE coatings that are made using PFAS
substances will eventually be eliminated,
but it is imperative that the industry continues
to educate and advocate for a cautious,
gradual approach.
As this article was being written, it
came to the industry's attention that
the EU MDR is reconsidering banning
fluoropolymers and, namely, PFAS.
This is due in large part to industry
pressure, according to a recent article.4
The final outcome remains to be seen,
but one thing is certain. Regulatory
changes will continue to occur, and industry
must be poised to respond.
References
1. Bloomberg Law News, " Ban on PFAS Use and
Production Proposed in European Union, "
Feb. 7, 2023, https://news.bloomberglaw.com/
environment-and-energy/ban-on-most-pfas-use
-and-production-proposed-in-european-union.
2. Agency for Toxic Substances and Disease Registry,
US Department of Health and Human Services,
" What are the health effects of PFAS? " November
1, 2022, https://www.atsdr.cdc.gov/.
3. Dechengwang Fluoropolymers, Blog, " What is
PTFE: Everything You Need to Know, " May 30, 2022,
https://www.ptfedf.com/what-is-ptfe-everything
-you-need-to-know/.
4. Arthur Neslen, " EU to drop ban of hazardous
chemicals after industry pressure, " The Guardian,
Tue 11 Jul 2023 01.00 EDT, https://www.theguardian.com/environment/2023/jul/11/eu-to-dropban-of-hazardous-chemicals-after-industrypressure.
This
article was written by George Osterhout,
Senior Advisor and past President
at Surface Solutions Group, LLC,
Chicago, IL. Osterhout holds two patents
and has 48 years of coatings industry
experience. For more information
about SSG or GlideMed™, visit www.
surfacesolutionsgroup.com or e-mail
techsales@surfacesolutionsgroup.com
or phone 773-427-2084.
www.medicaldesignbriefs.com
STATEK CORPORATION
ISO 9001
AS9100
512 N. Main St., Orange, CA 92868
Tel. 714-639-7810
Fax 714-997-1256
www.STATEK.com
17
Medical Grade Crystals,
Oscillators and Sensors
* High stability and precision
* Used in implantable devices
* Excellent long term aging
* Low power consumption
Ultra-Miniature - High Reliability
Quartz Crystals, Oscillators
and Sensors
UNSURPASSED QUALITY
THE MEDICAL INDUSTRY
COUNTS ON
UNSURPASSED QUALITY
THE MEDICAL INDUSTRY
COUNTS ON

http://info.hotims.com/84484-769 https://www.theguardian.com/environment/2023/jul/11/eu-to-drop-ban-of-hazardous-chemicals-after-industrypressure https://news.bloomberglaw.com/environment-and-energy/ban-on-most-pfas-use-and-production-proposed-in-european-union https://www.atsdr.cdc.gov/ https://www.ptfedf.com/what-is-ptfe-everything-you-need-to-know/ https://www.ptfedf.com/what-is-ptfe-everything-you-need-to-know/ https://www.theguardian.com/environment/2023/jul/11/eu-to-drop-ban-of-hazardous-chemicals-after-industry-pressure https://www.theguardian.com/environment/2023/jul/11/eu-to-drop-ban-of-hazardous-chemicals-after-industry-pressure http://www.surfacesolutionsgroup.com http://www.surfacesolutionsgroup.com http://www.medicaldesignbriefs.com

Medical Design Briefs - October 2023

Table of Contents for the Digital Edition of Medical Design Briefs - October 2023