Edwards Lifesciences’ work to manage our Chemical and Materials Stewardship serves our Aspiration to Excel as a Trusted Partner and Global Leader Through the Quality of Our Work.
Edwards Lifesciences is committed to the long-term health of patients. Our goal is to ensure that our products are fully compliant with chemical regulations and requirements. We have procedures in place to monitor the toxicity of materials in our products and make continuous improvements to remove those materials. Safety procedures protect our employees by limiting exposure to potentially harmful chemicals.
Chemical Management and Reduction
Edwards complies with materials regulations governing the use of certain hazardous substances in medical devices. In Europe this includes REACH, which reduces the potential impact of chemicals on human health and the environment. It also includes RoHS, which restricts hazardous substances used in electrical and electronic equipment. Our focus extends to our supply chain, where we require compliance with all applicable regulations for chemical and materials use.
Hazardous materials regulations can evolve quickly. For example, REACH adds new substances of very high concern to its list every six months. Edwards monitors these changes using various applications and sources that provide notifications on new and updated materials regulations. When Edwards becomes aware of a pending restriction that might impact our business, we act. We brief our Steering Committee for Product Stewardship and begin assessing our products immediately.
Supplier Materials Database
While Edwards already screens suppliers for hazardous substances, we know customers increasingly demand full transparency about materials in their products. In 2015, we began developing our Material Compliance Module (MCM), an internal database to collect and manage information about product materials. During 2016, we made considerable progress in collecting and uploading supplier materials disclosures for REACH, RoHS and Conflict Minerals to the database. The MCM allows us to assess current regulatory compliance and can be easily updated to monitor future materials regulations as needed. The database will enable us to provide our customers with clear and complete reports on product composition.
Edwards’ goal is to ensure that all our products are free of conflict minerals. We use 3TG (tantalum, tin and tungsten) for the functionality and production of certain of our Critical Care products. Our Conflict Minerals Policy Statement describes our support of the Security and Exchange Commission (SEC) disclosure requirement for conflict mineral sourcing. Since 2013, we have also published an annual Conflict Minerals Report highlighting our progress.We include a clause in all supplier contracts prohibiting the use of conflict minerals. For every new part ordered, we require suppliers to submit written disclosure of compliance to this standard. Each year, we work with a third-party consultant to monitor our progress, analyze data and identify strategies to improve our performance. Our goal is to strive to ensure that 100 percent of our products are conflict free by 2020.
Supplier Materials Database
During 2016, Edwards continued to build our Material Compliance Module database with supplier materials information and have approximately 20 percent of supplier responses included. With tens of thousands of pieces of materials disclosure documents, we aim to have 80 percent of applicable supplier responses entered by 2018.
We also conducted two stages of Reasonable Country of Origin Inquiry (RCOI) and due diligence as outlined by the Organisation for Economic Co-operation and Development (OECD). In 2016, we identified 37 affected suppliers (or smelters) that sourced, or there is reason to believe they may have sourced, from the covered countries of origin. Of these, 89 percent responded to our request for smelter information. Each year, we follow a risk mitigation and improvement program to work with the suppliers that have not responded to our requests, have no conflict minerals program or may source from smelters that may not be certified as conflict-free.
We have strengthened our engagement with suppliers, by:
- Directly engaging suppliers during the RCOI process;
- Reviewing supplier responses as part of the RCOI process;
- Incorporating conflict minerals compliance into new supplier quality and manufacturing agreements; and,
- Implementing a plan to improve the quantity and quality of supplier responses year over year.
We continue to work toward our goal of ensuring that 100 percent of our products are conflict mineral free by 2020.
Edwards also has a company- and mine-level grievance mechanism in place. We recognize the Conflict Free Smelter Program’s three audit protocols for gold, tin/tantalum and tungsten as valid sources of smelter- or mine-level grievances. A company-wide grievance mechanism is available, through which our employees and suppliers can confidentially report a violation of our policies without fear of retaliation. The Edwards Integrity Helpline is available 24/7 for both United States and international employees. The Integrity Helpline is hosted by a third party. Callers can self-identify when making a report or can report anonymously, where permitted by law. We also maintain an e-mail address (firstname.lastname@example.org) for suppliers and employees to ask questions and voice concerns.
Since 1958, Edwards has led the medical technology industry in patient-focused innovation for therapies that treat structural heart disease. We’ve pioneered developments in surgical, transcatheter and critical care products that enhance and save patient lives. Innovation not only drives our bottom line, but also enables us to continually improve our impacts on society and the environment.