MDR Driving Non-PVC and Alternative PVC Solutions
The European Union’s (EU) new Medical Devices Regulation (MDR) and initiatives such as Health Care Without Harm (HCWH) are bringing a wave of change to the global medical device industry, and has design and development teams rolling their sleeves up to find non-PVC (polyvinylchloride) material solutions, as well as alternative PVC formulations for current and new medical device products.
Jacqueline Anim, Principal Material Engineer and Subject Matter Expert at Ethicon, a Johnson & Johnson company recently said in a Plastics Today article, “To meet today’s complex medical device design requirements, such as the EU’s MDR, most OEMs are moving toward the selection of specific materials that enhance the biological safety of devices.”
Alternative Material Options
Resin manufacturers and film producers are investing considerable time and resources to bring alternative medical grade plastics to market, both alternative formulations of PVC and non-PVC options.
Additionally, medical device companies across the globe have innovative products in the development pipeline. With a worldwide push for the replacement of plasticizer-filled plastic products, teams are scrambling to evaluate alternative materials and pinpoint best fit scenarios to meet regulations, sustainability efforts, device characterization and performance requirements.
MDR and CMR Substances
MDR, which is set for enforcement beginning mid-2020, has raised concerns about phthalates and other hazardous chemicals within PVC-based medical devices, and calls out a limit on carcinogenic, mutagenic, reprotoxic chemical substances (CMR) within invasive and direct contact with the body medical devices.
One restricted substance within MDR is DEHP. For over a decade, worldwide government agencies and expert panels have noted concerns in regards to PVC-based products containing DEHP due to the potential risk to individuals’ health. It has been classified as a reproductive toxicant within many countries. As a widely used plasticizer rendering PVC soft and malleable, it has been highly desirable for medical devices such as blood bags, tubing and pre-sterilized single use health care products.
In the United States the FDA has noted adverse effects in experimental animals exposed to DEHP and issued a Public Health Notification to the medical community, identifying medical procedures that could result in exposure to relatively high levels of DEHP in sensitive patients. Both the U.S. and EU are recommending that some medical devices be made of alternative DEHP-free materials.
Current Medical Devices Often Made of Malleable PVC-Based Materials:
- IV Bags and Tubing
- Dialysis Devices and Tubing
- Nasogastric Feeding Tubes
- Umbilical Artery Catheters
- Blood Bags
- Respiratory Devices and Tubing
- Infusion Devices
- Bypass Devices and Tubing
- In Vitro Diagnostic Devices
- Nutrition Feeding Bags
- And More
Have a Medical Device Material Challenge?
As an industry leader in the radio frequency welding and heat sealing of thermoplastic medical devices, and through our long-standing relationships with thin film material providers of PVC, polyurethane (PU), thermoplastic elastomers (TPE), thermoplastic olefin (TPO) and other non-PVC alternatives, the Genesis Plastics Welding engineering staff continues to work with global clients to identify and test best material options, all while promoting cost savings and overall business goals.
Our extensive database of raw material options bridges the gap for product development teams. Don’t be stumped by a material challenge. Our team is here to help support medtech innovation and development.