Product Sustainability Review

The design stage offers a unique opportunity to shape a product's environmental, health and safety (EHS) performance across the life cycle. During this phase, decisions are made regarding materials selection, characteristics including energy use that influence carbon footprint, features that affect recyclability, and other factors.

For this reason, Baxter includes Product Sustainability Review (PSR) during the early stages of the product development process. PSR is a two-step assessment of a product’s projected EHS impacts. An initial screen at the product concept phase reveals high-level sustainability risks and opportunities in areas such as regulations and customer and other stakeholder requirements (see graphic).

The second step is a comprehensive review that identifies improvement opportunities across the life cycle. This process includes life cycle assessment-related computer modeling of a proposed product, and may involve comparison to existing products. Designers use this assessment to inform material choices and evaluate product end-of-life options and other factors. Baxter uses these results to confirm product feasibility, help establish product requirements and minimize potential product impacts to human health and the environment.

PSR has historically focused on medical devices, ranging from intravenous solution containers to dialysis machines, reflecting the greater potential environmental impact of these compared to other Baxter products. Since 2005, Baxter has used PSR to evaluate all new medical devices reaching the concept stage of development (more than 15 products so far), and currently has several devices under review.

In 2011, the company continued to expand use of PSR to therapeutics products in its BioScience business. Beginning in 2012, the product development process for these products will include a requirement to conduct a PSR. When fully implemented, nearly all new products Baxter introduces will complete the PSR process.

PSR also provides a process to integrate compliance considerations for existing and upcoming product regulations.¹ In 2008, Baxter enhanced the PSR screen for toxic chemicals, and updates this screen periodically to reflect changes in regulation and other factors. This enhancement helps the company meet growing customer demands to limit these substances and also helps Baxter prepare for potential chemical restrictions under the European Union REACH (Registration, Evaluation, Authorisation and Restriction of Chemical substances) regulation. Through the PSR process, requirements regarding materials selection are documented in the product design history file. See Case Study: Materials Restrictions for more information about Baxter’s approach related to product materials.

PSR has yielded positive results. Several reviews have influenced materials selection, and Baxter requires that all new machines under development meet the European Union Restriction of Hazardous Substances (RoHS) Directive restrictions regarding heavy metals. Even though these products are currently exempt, medical devices will fall under the scope of the revised RoHS Directive in 2014. Recent reviews also stipulate that new product designs should limit the use of "Substances of Very High Concern" as listed under REACH regulation.

Life Cycle Assessment

Supplementing PSR, Baxter also uses formal life cycle assessment (LCA) to evaluate the environmental performance of its products and determine ways to reduce environmental footprint. This may include decreasing the presence of chemicals of concern and reducing life cycle water or energy consumption, carbon footprint and waste generation.

During 2011, Baxter used LCA to take environmental impacts into account in the development of its next-generation home hemodialysis system.

In 2010, Baxter undertook a streamlined LCA that compared two generations of dialyzer products² to evaluate how material changes affect environmental performance. The company’s new family of XENIUM+ dialyzers is 13-22 percent lighter than earlier versions, which offers the potential for reduced fuel consumption in shipping and biohazard waste removal. XENIUM+ dialyzers also use approximately one-third less cardboard in their packaging, reducing natural resource use and waste removal requirements. Also, all materials used in XENIUM+ are free of bisphenol-A. In 2011, the product received certification from the Carbon Trust Footprinting Certification Company, the second medical product to receive this certification (FLEXBUMIN, see below, was the first).

In 2009, Baxter completed several externally verified LCAs demonstrating the significant environmental benefits of FLEXBUMIN [Albumin (Human)] - the first and only human albumin³ solution in a flexible, plastic container - compared to a similar product in a glass bottle. In addition to enhancing convenience for customers and users, the FLEXBUMIN container system has a 55-77% smaller carbon footprint, depending on product size and geography. (See Case Study: FLEXBUMIN Life Cycle Assessment for more detail).

Engaging with Customers

Customers in Europe and the United States increasingly require information related to product environmental performance in requests for proposal and consider that information in vendor selection. Baxter reflects these requirements in the PSR process, such as the need to avoid certain chemicals of concern. The company responds to targeted customer requests and engages with customers as appropriate to share information about products. Baxter also provides access to a searchable database of Materials Safety Data Sheets for all relevant products, in more than 25 languages.

Similarly, governments increasingly set environmental criteria for "greener" public procurement. For example, nearly all tenders in the United Kingdom include EHS-related questions. Throughout all of Europe, EHS-related questions can represent up to 20% of the total weighting of tenders.

Representatives from Baxter’s EHS and Supply Chain teams met with diverse audiences across the company during 2011 to provide background about the evolving customer landscape, as well as related regulatory trends, and how to best respond to these emerging information needs and legislation. Building on this, in 2012 meetings are planned on these issues with each Baxter franchise globally as well as the company’s Research and Development organization.

Baxter believes that leadership in this area will represent an increasing source of competitive advantage, and proactively communicates information about product environmental performance. Recent examples include:

• Baxter has continued the global marketing roll-out of FLEXBUMIN [Albumin (Human)], which is the world’s first medical product to receive Carbon Reduction certification from the Carbon Trust (in 2009, re-certified in early 2012).
• In 2011, Baxter also received Carbon Trust certification for Baxter’s new family of XENIUM+ synthetic dialyzers.

This year, Baxter plans to highlight the enhanced environmental performance of an additional new product at launch.

1	Such as the European Union's Restriction of Hazardous Substances (RoHS) Directive, REACH (Registration, Evaluation, Authorisation and Restriction of Chemical substances) Regulation, Energy-using Products (EuP) Directive, and Waste Electrical and Electronic Equipment (WEEE) Directive.
2	Dialyzers are filters used during hemodialysis to eliminate waste products from the blood of people with end-stage kidney disease.
3	Human albumin, which is an essential protein found in human plasma, is used to treat critically ill patients by replacing lost fluid and maintaining adequate blood pressure and volume.