PFAS or perfluoroalkyl and polyfluoroalkyl substances (of which there are thousands of different types) are long-lasting, synthetic chemicals whose components break down very slowly over time, earning them the nickname “forever chemicals”. They have been widely used across various industries since the 1940s and, because of their persistent nature, have been detected in the blood of people and animals worldwide. Like nearly every other industry, PFAS has made its way into the medical device industry over the last few years.
People can become exposed to PFAS merely by touching, drinking, eating, or breathing in materials that contain PFAS, and researchers have been working diligently to uncover the different levels of risk associated with exposure to one’s health. Links have been established between PFAS exposure in humans and adverse effects on the immune, metabolic, endocrine, and reproductive systems, as well as an increased risk for cancer.
And yet, PFAS usage within medical devices and implants provides a variety of beneficial properties, such as resistance to infections, friction, and blood clots.
These advantages have also made them an attractive solution for coatings on medical devices such as sutures, nebulizers, and various pharmaceutical products. Without PFAS, the potential risks range from devastating to frustrating — some medical devices are at higher risk for implant failure or clogging, while others would need to be replaced more often. It is also integral in maintaining a sterile environment across the medical field.
PFAS are also essential in maintaining the supply chain of ingredients necessary to create life-saving pharmaceutical medications. For example, in packaging, PFAS are used to create a strong barrier against humidity to keep medications efficacious with an extended shelf-life.
And yet, despite the understanding that PFAS are essential to medical devices and their manufacturing processes, many manufacturers have to adopt a solution to protect their supply chains in light of rising regulations globally.
Supply chains will be challenged as some chemicals and materials manufacturers have announced that they will discontinue PFAS manufacturing, including medical lines and equipment that will cease to be available in the coming years. This will fundamentally disrupt medical manufacturers significantly in the coming years, and action must be taken proactively.
It’s just a matter of time before the testing standards and regulatory requirements for pharmaceuticals and medical devices evolve to address the growing concerns surrounding PFAS. Manufacturers should consider proactively mitigating potential PFAS-related risks and finding alternatives before these new rulings come into play and permanently upset the supply chain. It would be prudent for these organizations to identify these risks and develop a plan of action to address them head-on for both the chemical component and the corresponding changes across the industry — namely, increased regulations and a disrupted supply chain.
About Mercury
Mercury is a global logistics company specializing in time- and temperature-sensitive shipping for biotech and life science research, clinical trials, diagnostics, and medical device companies. Mercury’s Navigent℠ portal provides a holistic view of the client organization’s shipping and enables them to drive operational efficiencies.
Our clients get individual attention rather than a 1-800 number for their critical shipments. Mercury’s support teams proactively track shipments and troubleshoot issues so our clients can focus on their businesses, not shipping. For over 40 years, our dependability has allowed our clients to grow their business more efficiently, given Mercury’s flexible pickups, customized invoices, and reports – a single source for all their shipping needs.
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