It’s often said laws can have unintended consequences. When it comes to certain proposed environmental legislative initiatives, the consequences could severely compromise the safety of sterile medical device packaging. The Sterilization Packaging Manufacturers Council (SPMC®) is tracking these initiatives closely, and its Sustainability and Regulatory Committee is developing a position paper that will be released soon.
“Environmental legislative efforts regarding plastics tend to focus on two particular areas: mandating that packaging contain recycled content and requiring that the package be recyclable at its end of life,” says Nick Packet, SPMC®’s Sustainability and Regulatory Committee chair and industry vertical manager with DuPont™ Tyvek® Healthcare Packaging.
SPMC®’s new position paper examines these environ- mental requirements and details the potential risks they could pose to sterile medical packaging. The committee hopes the paper will inform lawmakers and stakeholders on how these mandates would clash with the U.S. Food and Drug Administration’s (FDA’s) regulatory and biocompatibility requirements for sterile packaging, the sterilization process, and the product protection and stability of medical packaging.
“Sterile medical packaging affects everyone and our industry places patient safety above all else. I believe we can improve medical packaging’s sustainability while maintaining patient protection.”
Nick Packet, SPMC®’s Sustainability and Regulatory Committee chair and industry vertical manager with DuPont™ Tyvek® Healthcare Packaging
Protecting patients has been the core mission of sterilized packaging since the industry was founded. Currently, medical device packaging is designed and tested to meet FDA Regulatory Requirements (CFR 820) using consensus standards for packaging sterility (ISO 11607) and biocompatibility (ISO 10993). Records demonstrating compliance must be maintained. Failure to do so can deter products from being marketed, sold, or used.
SPMC®’s new position paper details how these FDA requirements cannot be met when using post-consumer recycled (PCR) plastics. At issue are the dangers posed by the lack of traceability of PCR plastics and the potential for chemical and other contaminants they could introduce into the packaging materials of medical products shipped to healthcare providers across the country.
In fact, as it currently stands, recycled content and PCR content do not have the needed traceability and are, there- fore, prohibited from use in sterilization packaging for med- ical devices in the United States. Mandating their use would be at direct odds with the FDA’s stringent requirements.
Also at odds is that PCR plastics do not exhibit the same protective properties, performance, or durability as plastics derived from virgin feedstock. This is a critical issue for sterilized packaging, which relies on material selections that must withstand the sterilization process and must hold up to the potential hazards and varying environmental conditions of shipping, distribution, storage, and use.
Concerning possible environmental legislation regarding the recyclability or recycled content requirements of sterile medical packaging, SPMC®’s position paper explains why mechanical recycling could place severe limitations on the materials used in these packaging systems. Instead, SPMC® encourages the industry to look at the use of advanced recycling technologies such as purification, depolymerization, and conversion. These processes are better suited to recycling healthcare plastics and producing materials more comparable to virgin stock in terms of performance, thus creating opportunities for circularity in the healthcare space.
Packet is hopeful that SPMC®’s position paper will raise awareness for the unique and stringent requirements of the sterile packaging industry and will mitigate conflicts between FDA and recycling and sustainability mandates.
“Sterile medical packaging affects everyone and our industry places patient safety above all else,” Packet says. “I believe we can improve medical packaging’s sustainability while maintaining patient protection.”
Lourdes Pogue is partner and creative director at Merakke. Reach her at lourdes@merakke.com.