A key component of life-saving medical devices has been placed in the crosshairs by government regulators, jeopardizing care for millions of Americans.
State and federal policymakers are targeting a class of 15,000 chemicals known as perfluoroalkyl and polyfluoroalkyl substances, or PFAS. Best known for waterproofing and nonstick treatments, these chemicals have been widely used because of their durability, friction resistance, and ability to withstand fire and other temperature extremes. Teflon and Scotchgard are two well-known products that contain PFAS.
The issue is that some of these chemicals have been linked to health concerns. As a result, certain state, federal, and European regulators have taken action to limit PFAS while others are considering sweeping bans on all 15,000 types of PFAS.
But these chemicals play an essential role in healthcare: they are crucial to the proper functioning of a broad range of medical devices such as stents, catheters, surgical mesh, pacemakers, heart patches, CPAP machines, prosthetics, surgical instruments, and asthma inhalers. Because there are not yet any clear alternatives to PFAS in the manufacturing and safe operation of many medical devices, regulators should carve out an exemption for the continued use of the chemical for healthcare.
A Brief History of PFAS
Discovered by accident in 1938 by a DuPont Company chemist in New Jersey, PFAS initially was used for the most urgent concern in the U.S. at that time -- helping to build the first atomic bomb for the Manhattan Project. After World War II, PFAS became a signature component of modern life, with widespread use in cooking pans, food packaging, clothes, carpet, furniture, sheets, pillows, mattresses, cosmetics, and sunscreen. The chemicals helped put humans on the moon via Apollo space missions, in the clouds via jet manufacturing, at sea through shipbuilding, and all across the Earth via cars, trucks, bicycles, and more. Products containing these chemicals became key ingredients in firefighters' foam, jackets, pants, and gloves.
One other major use was healthcare. A subset of PFAS made possible the development of medical devices for millions of people with no other alternative. Today, an estimated 32 million Americans live with an implanted medical device, and approximately one in every 10 Americans will have a device inside their bodies at some point in their lifetimes.
Over time, however, evidence mounted that various forms of PFAS were accumulating in the environment and posing health risks. What started as a miracle material is now referred to more often as a forever chemical and environmental hazard.
Scientists have detected these chemicals in the bodies of 98% of Americans. In 40 studies over 5 years, every mother's umbilical cord sample tested positive for PFAS -- nearly 30,000 samples -- meaning that humans begin their life today with the chemical in their bodies. The Environmental Working Group estimates that more than 200 million Americans are drinking water tainted with PFAS.
As a result, the Environmental Protection Agency has dramatically increased PFAS restrictions in the past two decades. The chemical behind Teflon was eliminated by 2014, and in recent years 30 states have approved 155 PFAS policies, with many banning once-common uses in clothing, cookware, cosmetics, and menstrual products. Last year, the federal government also imposed limits on PFAS in drinking water. Faced with mounting regulatory and courtroom pressure, 3M, one of the biggest U.S. manufacturers, has announced it is exiting the PFAS manufacturing business by the end of 2025.
PFAS in Medical Devices
The issue is that banning all PFAS from medical devices would threaten care for the Americans who receive 300,000 newly implanted pacemakers or defibrillators per year; 75 million annual endoscopies; 4.8 million laparoscopic procedures per year; as well as the 1.7 million Americans with amputated limbs who rely on prosthetics.
An outright ban on all PFAS would be a high-stakes case of throwing out the baby with the bathwater -- eliminating a clear medical good while trying to prevent an environmental bad.
Many of these medical devices are made possible with fluoropolymers, a chemically distinct subset of PFAS. Studies suggest fluoropolymers, when used in medical devices, are more biologically benign. Clinical studies of patients with implanted medical devices that used fluoropolymers have found no chronic toxicity or links to cancer, and no reproductive, developmental, or endocrine toxicity.
Other studies concluded fluoropolymers are nontoxic, do not bioaccumulate, and "have very different physical, chemical, environmental, and toxicological properties when compared with other PFAS." While research suggests emissions during fluoropolymer production, processing, and disposal may pose health or environmental risks, there is no evidence linking these substances in medical devices to adverse health effects.
Because sweeping PFAS bans would have such dire consequences for medical care, policymakers and public health regulators should include an exception that allows the crucial chemicals to continue to be used in medical devices -- at least until alternatives can be developed and tested.
The medical industry is researching chemical alternatives, but the process is lengthy and complicated. Many medical devices must be approved by the FDA, and replacement of PFAS with another substance may require extensive testing by the device manufacturer and detailed study by regulators.
The European Union (E.U.) considered a sweeping ban on PFAS, but scientists found that there currently are no feasible chemical alternatives for many types of equipment. As a result, E.U. regulators are weighing plans to enact a PFAS ban while carving out an exception of 5-12 years for implanted medical devices. That would give manufacturers and regulators more time to see if PFAS alternatives are possible.
Similar exceptions for medical devices have been approved by several states. Maine, for example, in 2021 announced the world's first sweeping PFAS ban covering all consumer goods, but amended it 2 years later to allow exemptions for medical devices. Minnesota and New Mexico also carved out exceptions for medical devices.
Patient safety should always be the overarching concern for medical devices. Regulators should focus PFAS restrictions on uses that pose the most robust risks to health and the environment, not the uses in medical devices that save lives.
Roberta Dressen, MBA, is CEO and president of Medical Alley, a Minnesota-based healthcare trade group that represents 800 partner organizations with more than 500,000 employees. Several of the partner organizations are medical device manufacturers.
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