When Sustainability Meets Sterility
Inside SPMC®'s drive for smarter packaging policy
As lawmakers around the world pursue ambitious sustainability goals for packaging, an essential sector of the healthcare supply chain has found itself at the center of an unexpected policy collision.
For the Sterilization Packaging Manufacturers Council (SPMC®), the growing wave of legislation targeting plastics, recyclability, and recycled content isn’t just a matter of material choice. It’s a matter of patient safety.
The majority of SPMC®’s member companies produce the flexible materials that keep medical devices sterile. These materials must withstand rigorous sterilization methods, maintain sterile integrity for years, and remain traceable and free of contamination. That means any shift in their composition—particularly mandates on recycled content or restrictions on certain materials—can directly affect patient safety and regulatory compliance.
This issue came into sharp focus when the SPMC® recently released its first formal sustainability position paper, Sustainability of Medical Device Packaging. While supportive of environmental objectives, the paper posits that emerging packaging legislation, focused on recycling and recyclability, could unintentionally jeopardize and introduce significant challenges for sterile packaging.
The group cautions that the primary role of packaging
is product protection. Needs across sectors, such as fast-moving consumer goods versus medical packaging, require different approaches.
Recycled-content mandates, for example, may introduce unknown contaminants or compromise strength and seal consistency, inadvertently compromising patient safety. While most legislation carves out exemptions for highly regulated industries, the SPMC® cautions that material requirements that don’t differentiate between food packaging, medical packaging, and other sectors may risk removing materials with decades of validated performance under U.S. Food and Drug Administration and international standards.
Since the 1990s, the SPMC® has functioned primarily as a technical body, developing test methods, publishing guidance documents, and contributing to consensus standards that now define how medical-device packaging is evaluated. These efforts—such as early work that informed ASTM peel-strength methods and the long-standing guide for primary flexible packaging—helped unify expectations across manufacturers, suppliers, and regulators.
But as packaging legislation accelerates, SPMC® has stepped into a more strategic advocacy role. Through its Sustainability and Regulatory Committee, the council now translates technical realities into policy guidance to help lawmakers understand why sterile packaging cannot be governed by one-size-fits-all rules.
The council’s messaging emphasizes two complementary ideas. First, patient safety must remain the non-negotiable core of medical packaging policy. And second, sustainability progress is still achievable when regulations account for the unique demands of sterile healthcare products.
This pre-regulatory engagement marks a significant shift, turning SPMC® into a model for how niche technical organizations can influence government policy in a constructive, evidence-based way. Rather than reacting after legislation is drafted, the council is proactively offering frameworks, exemptions, and scientifically grounded considerations that help policymakers pursue environmental goals without creating unintended public health risks.
As the packaging industry faces increasing scrutiny over legislative sustainability goals, SPMC®’s approach underscores a broader truth: Meaningful progress depends not only on innovation but also on informed collaboration between industry experts and policymakers. In the push toward a more sustainable future, sterility and patient safety cannot be afterthoughts. Thanks to SPMC®’s evolving advocacy, they are less likely to be.
Lourdes Pogue is partner and creative director at Merakke. Reach her at lourdes@merakke.com.
