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. We strive to ensure our products are free from harmful substances. To do this, Edwards implements chemical safety procedures in our manufacturing and removes toxic materials from our product formulations.
Chemical Management and Reduction
Edwards complies with local regulations governing the use of chemicals in medical devices. In Europe this includes REACH, which prevents the impact of chemicals on human health and the environment. It also includes RoHS, which restricts chemicals used in electronic products. Our focus extends to our supply chain—where we require compliance with all applicable regulations for chemical and material use.
Hazardous material 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 Chemtrac, a comprehensive online application that provides notifications on new and updated 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, Edwards began developing our Material Compliance Module (MCM), an internal database to collect and manage information about product materials. The database will allow us to provide our customers with clear and complete reports on product composition.
Edwards is committed to ensuring all our products are free of conflict minerals. We use minerals 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 ensure that 100 percent of our products are conflict free by 2020.
In 2015, Edwards continued to build our Material Compliance Module database with supplier materials information. With tens of thousands of pieces of material disclosure documents, we aim to have 80 percent of applicable supplier responses entered by 2018. Our Product Stewardship department launched the module in 2015.
We also conducted two stages of Reasonable Country of Origin Inquiry (RCOI) as outlined by the Organisation for Economic Co-operation and Development (OECD). We identified 39 smelters that may have sourced from countries in question. Of these, we verified that 37 have been audited and determined conflict-free by the Conflict Free Smelter Program (CFSP). Our consultants identified that the remaining two smelters are not certified conflict-free, but are pursuing certification. We continue to maintain communications with these smelters to ensure they are on track.
In 2015, Edwards Lifesciences received FDA approval for use of our SAPIEN 3 heart valve in the United States. We designed the SAPIEN 3 for transcatheter aortic valve replacement (TAVR), an innovative and minimally invasive procedure. Clinical trials have shown that TAVR reduces patient risk of mortality and other post-operation complications.1