Medical Device Manufacturer Undertakes Proactive PFAS Compliance

Client Profile

Our client, a global leader in the medical device industry, is at the forefront of innovations in surgical care, surgical equipment, health technologies, and healthcare solutions.

Market Overview

In February 2023, the European Chemicals Agency (ECHA) proposed a sweeping ban on Per- and polyfluoroalkyl substances (PFAS) in the European Union.

Among the broadest chemical bans in modern history, the pending restrictions will prohibit the use and production of more than 10,000 PFAS.

ECHA's intent is to reduce the cumulative health and environmental dangers of "forever chemicals."

The ECHA ban is expected to take effect within two to three years. Once enacted, the deadline to comply will vary; some companies will have 18 months while others could have 12 years. How long a company has to comply will depend on how critical their product is to public health and well-being. For instance, medical device makers will have more time than cosmetics manufacturers to find non-PFAS replacements.

First developed in the 1940s, PFAS today are used in a multitude of consumer, commercial, and industrial products. Examples include but are not limited to cosmetics, cook-wear, clothing, food packing, fire-protective materials, and medical devices.

Currently, PFAS-free alternatives with the same exceptional properties as PFAS — durability, heat resistance, water resistance, non-stick — aren't available at a one-to-one ratio, meaning viable replacement options are far less by comparison. Although it is expected that the market for PFAS-free materials will grow, developing an ample supply of those materials with properties on par with PFAS could take years.

Thus, given the time, effort, expertise, and resourcefulness required to successfully find and replace PFAS with safe but scarce alternatives, even the longest deadline for ECHA compliance is still tight.

Therefore, companies that aren’t proactive could risk non-compliance, lost revenue, and lost access to large markets regardless of product type.

The Challenge

As a preventive measure, our client initiated proactive compliance with ECHA's forthcoming PFAS ban and other region-specific PFAS regulations, including the EPA's new reporting requirements in the U.S.

The client's plan was to identify and evaluate the presence of PFAS in their medical device products, equipment, and manufacturing processes. The undertaking necessitated comprehensive, meticulous assessments of more than 25,000 materials, including coatings, adhesives, and water-resistant components. It also necessitated exploring viable PFAS replacement options, which included the potential for reformulating or substituting longer-chain PFAS with shorter-chain chemicals.

The tedious yet exacting nature of this work poses a significant challenge to manufacturers worldwide — even more so when it’s on a tight deadline. For our client, who was already lacking the internal bandwidth to run these operations themselves, the challenge was no different.

Beyond bandwidth, their greatest difficulty was finding experts with material, chemical, and regulatory backgrounds. Without qualified experts to identify and assess the thousands of raw materials they used in medical device manufacturing — including direct materials, indirect materials, and manufacturing chemicals — the client risked not only losing the advantage of proactive compliance but possibly falling behind.

The Actalent Approach

Actalent was hired to direct the identification and assessment of more than 25,000 raw materials used across the client’s various manufacturing sites, including North America, China, India, Germany, and Brazil.

Actalent deployed a Material Specialist to coordinate these efforts with the client’s regulatory affairs (RA) team, supply-chain teams, and in-house experts.

Here's a rundown of the project scope as follows:

• Data Collection: 
  Bill of Materials were collected through (enterprise resource planning?) ERP systems and by contacting procurement teams at various manufacturing sites. The data was then differentiated into direct materials, indirect materials, and manufacturing chemicals.
• Identification and Assessment of Data:
  Raw Material documents like Material Specifications (MS), Technical Data Sheets (TDS), and Safety Data Sheets (SDS) were collected to help in Raw Material Assessment and PFAS identification using the chemical formula or structure.
• Tracking of PFAS Substances:
  All the affected PFAS materials and components were identified. Their use and weight percentage in the final product was roughly analysed. PFAS-susceptible materials were also identified to track and confirm their presence by actively involving the suppliers in exploring PFAS-free solutions.
• Comprehensive Reporting and Documentation:
  All materials containing PFAS, PFAS-susceptible materials, and PFAS free materials were identified and reported in a master-datasheet with different color codes based on their risk category and the level of attention needed for finding replacements or alternatives.
• Continuous Regulatory Surveillance:
  The finalized PFAS master-datasheet was submitted to the client’s RA team and stored in centralized documentation repository. Given the evolving landscape of PFAS regulations, stakeholders in the medical industry must maintain unwavering vigilance. This involves actively monitoring regulatory changes, engaging with industry associations, and participating in discussions on best practices for achieving PFAS compliance.

The Results

Given the emerging health risks, liabilities, and growing public concern associated with forever chemicals, integrating PFAS compliance into medical device manufacturing and a host of other industries has not only become a regulatory requirement but also a moral and ethical obligation.

Toward helping the client fulfill those obligations, Actalent played a leading role in completing the initial and important step of assessing and identifying PFAS in their devices.

Moving forward, the client’s RA team can ensure their unwavering compliance to the ECHA ban and other restrictions with full confidence while gaining a head start on exploring safer alternatives that offer equivalent performance to PFAS.

This project demonstrated that with the right knowledge and resources, manufacturers can navigate the complex world of PFAS regulations effectively, ensuring the highest standards of compliance, patient care, environment sustainability, and public health are upheld.