The regulatory environment regarding the usage of perfluoroalkyl and polyfluoroalkyl chemicals (PFAS) in medical devices and other products is evolving to include potential action on the state level. Colorado state legislators are drafting a proposal that would give the state authority to ban products containing intentionally added PFAS.

CBSA is committed to keeping our community updated on issues that impact life sciences. Our Policy + Advocacy team reviews newly proposed legislation that could directly affect life sciences companies and will evaluate whether to take a formal position at the appropriate time, in consultation with our Policy Committee and advocacy partners at the state level. This educational piece provides an overview of the current draft bill.

Colorado Proposal

The proposal would require that, starting in 2025, manufacturers of products sold in the state and containing intentionally added perfluoroalkyl and polyfluoroalkyl chemicals (PFAS):

• Provide notification to the Colorado Department of Public Health and Environment (CDPHE) with the trade name of the product and a description of the purpose that PFAS chemicals serve in the product, and
• Pay a fee to submit the notification to CDPHE
• The information contained in the notification would be publicly available online.

Also in 2025, CDPHE will identify by rule a list of priority products. And no later than 2027, CDPHE will promulgate rules prohibiting the sale of said priority products that contain intentionally added PFAS chemicals and have not been exempted by the department. A manufacturer or consumer may apply for an exemption for a priority product identified by the department that would last for five years. The applicant must also pay a fee as part of the application process.

Background

Perfluoroalkyl and polyfluoroalkyl (PFAS) chemicals are a group of thousands of chemical compounds with varying characteristics, properties, and environmental and safety profiles. One such compound is fluoropolymer which has applications across the medical device industry. Applications for the compound include:

• Surgically implantable medical devices: Fluoropolymers are used in implantable medical devices like vascular grafts, stent-grafts, and surgical mesh to reduce the risk of failure, infections, medical complications, and replacements as well as to increase the lifetime of implants.

• Heart patches: Fluoropolymers are used to make various layers of heart patches to reduce the risk of complications associated with tissue attachment and equipment failure.

• Catheters: Fluoropolymers are used to make low-friction and clot-resistant coatings for catheters to support patient safety and comfort.

• High Dielectric Insulators: Fluoropolymers make possible high dielectric insulators in defibrillators, pacemakers, and CRT, PET, and MRI imaging devices.

• COVID-19 testing and treatment: Fluoropolymers are used to make ventilators and COVID-19 test kits that are critical in fighting the global pandemic

While some alternative materials might match the selected properties of fluoropolymer compounds, the total combination of properties of fluoropolymers makes them ideal for many medical devices.

Call to Action

Please reach out to CBSA Vice President Michael Crews if your company currently uses PFAS in any products that are currently sold in the state.