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About What is a Medical Grade
Polymer?
In an interesting article as
published in the “Medical Plastic News (May – June 2018 ) ,
Siobhan Bastiansen, Velox, has explained why material suppliers as
well as Device Manufacturers would benefit from clarification and
shows how specialized medical polymer producers have risen to the
challenge to create indispensable value for processors and OEMs.
As per the article, “Polymers have
been used in the healthcare and medical industry for decades.
Today, an estimated 50% of all materials used in Medical Device
manufacturing consist of plastics. However, when it comes to the
right polymer choice for a specific medical or pharmaceutical
application, things can get complicated. Despite strict
international and national regulations as well as demanding
requirements for medical polymers, one extra difficulty in this
choice is the fact that there has been no universally accepted
definition of “medical grade” polymers so far.
She has further explained that,
“Medical device development is a long and complex undertaking,
with strict compliance regulations, long-term tests, quality
checks and certifications. However, the industry has yet to answer
one seemingly simple question: What is a “medical-grade” polymer?
The Association of German Engineers, VDI, has embarked on
defining a standard, with the first draft being presented at the
VDI congress in Friedrichshafen in April.”
It is believed that ,from a legal
perspective it is the company that brings the medical device onto
the market that is responsible for complying with any applicable
regulatory requirements, but medical grade polymers have no strict
definition, and very often such plastics are sold on the basis
their biocompatibility alone.
It is estimated that only about
three per cent of global plastics production is destined for the
healthcare industry. Considering this, it is clear that not every
polymer manufacturer will be willing or even able to meet the
healthcare OEM's stringent requirements in the medical and
pharmaceutical sectors. As such, the overall supply of plastics
for medical technology remains limited so that use of standard
polymers is still likely to continue in the future. This
represents a potential risk, since change management for standard
polymers often insufficiently addresses the high demands of
medical applications.
( References : 1. Medical Plastics News , May – June 2018 ; 2.
https://www.eppm.com/materials/the-medical-grade-polymer-dilemma/
)
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