Managing Chemicals of Concern in Medical Devices and Equipment

Key Factors to Understand Risk and Liability for Manufacturers

Medical implants and devices are subject to rigorous regulations and quality control processes to ensure patient safety and reduce contamination potential. When an implanted medical device becomes the subject of adverse media coverage or a recall, the effects ripple far beyond the immediate issue. Manufacturers and companies across the supply chain may face revenue losses, legal and regulatory costs and reputational damage that can translate into sharp declines in market value. It is noteworthy that the decision to recall a device does not necessarily mean a hazard is or was present or that a regulatory safety standard was violated. Additionally, this kind of proactive recall often does not protect a company against potential litigation.

Thoughtful and scientifically sound risk assessment and proper communication of the risks are pivotal for arriving at sound decisions, regardless of the stakeholder. While the Food and Drug Administration (FDA) has established regulations for medical devices (Class I-III, depending on specific type/function), a thorough understanding of toxicology, risk assessment, and epidemiological research is necessary for the sustainable use of products.

The industry benefits and builds a more detailed understanding of potential risks when consultants like TRC investigate, publish research, and testify as expert witnesses in matters involving the health implications of medical device contamination, wear particles and other chemical releases in the body, and the sterilization of medical devices. Common types of contamination include biological (e.g., viruses, bacteria, and endotoxins), chemicals (e.g., gases, detergents, and oils), or physical agents (e.g., fibers and chips), although this is far from an exhaustive list.

Litigation in the medical-device sector is both frequent and far-reaching. One study of 45 leading firms from 1995 to 2020 found 37 unique multidistrict litigations encompassing more than 215,000 individual cases. On average, active litigation in a product category was associated with a 40 percent decline in new product introductions, with cases lasting around seven years.

As the field evolves, device-related litigation has become increasingly complex, extending beyond design and manufacturing defects to include questions about chemical composition, material safety and supply chain responsibility. It is important to recognize that many chemicals used in medical devices are essential to their performance and present minimal risk when properly evaluated and controlled. Fluoropolymers, for example, offer chemical stability and biocompatibility that are critical to device safety and longevity, and many plasticizers and coatings have well established records of safe clinical use.

Chemicals of Concern in Medical Devices

The challenge, and opportunity, for manufacturers lies in demonstrating and effectively communicating that their materials are well understood, have been appropriately tested and are responsibly managed through every stage of the product lifecycle.

TRC understands this well by having a team of biomedical engineers, epidemiologists, toxicologists, and other health scientists trained in risk communication and human health risk assessment methods to evaluate potential hazards posed by medical devices and translate technical information to address misperceptions of risk. Here are some of the more common chemicals of concern:

1. Per- and Polyfluoroalkyl Substances (PFAS) in Numerous Products

Many medical devices, including catheters, guidewires, surgical gloves and implants, incorporate PFAS or fluoropolymers because of their desirable properties, such as low friction, chemical and heat resistance, durability and biocompatibility. Although the FDA has recently granted exemptions that permit PFAS use in specific medical devices, our team has evaluated risk and engaged in regulatory advocacy related to PFAS on a number of occasions. What we have learned is that manufacturers continue to face significant and evolving supply chain challenges due to supplier exits and state bans of the chemical intermediates that support the product of exempted PFAS. As a result, manufacturers of PFAS-containing products should prioritize tracking emerging PFAS regulations and supply chain changes and, as appropriate, conduct alternatives assessments and advocate for continued access to the materials needed to manufacture exempted devices. 

2. Volatile Organic Compounds (VOCs)

Ethylene Oxide (EtO) is one VOC that is widely used to sterilize medical devices. Litigation and regulatory scrutiny surrounding EtO exposures with the potential to affect workers, nearby communities, and, by extension, device and sterilization supply chains, continues to intensify. We continue to see major class action lawsuits alleging breast, blood and lymph cancers in communities surrounding hospitals, sterilization facilities and chemical manufacturers, potentially expanding future liability for similar operations. TRC has evaluated occupational and community exposures to ethylene oxide and medical device user exposures for other VOCs on a number of litigation-related matters. For example, we were previously retained to investigate concerns that certain continuous positive airway pressure (CPAP) machines release VOCs following the alleged breakdown of polyester-based polyurethane (PE-PUR) foam in these devices. Generally, we’ve found that the plausible exposure scenarios that we have evaluated presented a de minimis human health risk.

3. Metals in Implants and Inhalers

Metals may be present in implants, such as orthopedic prostheses, cardiovascular stents and dental implants, as well as in certain medical device coatings. As we have evaluated metal wear particles in the body related to litigation matters, including a recent risk assessment involving small metal particles from an aerosol-generating medical device, we understand the concerns firsthand. Historically, concerns have focused on whether cobalt, chromium and nickel released from metal hip implants during normal wear could induce sensitization or other adverse health effects in patients. For manufacturers, proactively characterizing potential metal release and associated patient risks can strengthen product stewardship, support regulatory submissions, and reduce downstream liability. 

4. Phthalates in PVC Devices

Phthalate plasticizers, such as di(2-ethylhexyl) phthalate (DEHP), have long been used in flexible PVC medical devices, including tubing, blood bags and catheters. While the toxic and carcinogenic effects of DEHP have been demonstrated in experimental animals, its potential to cause harmful effects in humans remains a subject of debate. Companies need to take a defensible approach by characterizing potential exposures. Our experts have conducted exposure assessments of phthalates released from the tubing of certain fluid delivery pumps. We conducted a study using human blood and relevant pharmaceutical agents to quantify phthalate loss from the tubing over time and subsequently evaluated the potential health risks associated with the observed exposure levels.

5. Endotoxins

Endotoxins are the residual toxic constituents remaining from the cell membranes of gram-negative bacteria. They may be introduced through contamination during manufacturing, handling, washing, or packaging of medical devices and be present on the surfaces of implants and other devices. Our experts have been retained to assess whether potential endotoxin exposures may lead to adverse health effects, and we encourage organizations to prioritize evaluating these potential health risks.

6. Formaldehyde

Formaldehyde is commonly used for sterilization, preservation and disinfection in the medical industry. In 2024, TSCA released a final risk evaluation that suggested a greatly reduced occupational exposure value (OEV) for formaldehyde, a shift that has sparked both support and backlash and renewed attention for its use in consumer and industrial products. TRC experts have evaluated the controversy surrounding formaldehyde’s carcinogenic and sensory irritation potential and the recent OEV recommendations. In an independent review of the weight of scientific evidence, TRC practitioners have published a recommended exposure level that is several orders of magnitude greater than the 2024 TSCA proposed OEV. In recent news, on December 3^rd, 2025, EPA released an Updated Draft Risk Calculation Memorandum that more closely aligns with the occupational exposure limits that TRC experts have recommended. The EPA is allowing for public comment on this proposal until February 2, 2026.