On 13 November 2014, a new study aiming at assessing the types and magnitudes of potential risks to neonates associated with medical-related exposures to di(2-ethylhexyl)phthalate (DEHP) was published in the Journal of Perinatology. There has since been some media coverage on the study, some of which includes a generalisation of all plastics, including PVC, which we would like to clarify.
PVC-based healthcare applications have a fundamental role in the quality of healthcare thanks to PVC’s technical properties including softness, sterilisability, clarity and transparency, durability and dependability, resistance to chemical stress cracking, flexibility and resilience, low cost, and many more. The properties of plasticised-PVC are essential for certain types of medical devices which, for example, need to be made extremely soft and flexible.
In order to make the PVC material soft and flexible, plasticisers are added. Several different plasticisers are available on the market today. PVCMed member companies support the supply chain as well as medical professionals in their willingness to use the appropriate plasticisers, while keeping all the key properties of PVC. Many different plasticisers have been developed such as adipate plasticisers, Butyryltrihexylcitrate (BTHC), Cyclohexane-1,2-dicarboxylic acid, diisononylester (Hexamoll® DINCH®), Di(2-ethylhexyl)terephthalate (Eastman™ 168), polymerics and trimellitic acid, 2-ethylhexylester (TOTM), which are increasingly being used in a wide array of medical applications allowing medical equipment purchasers to benefit from PVC’s unique properties. Concerns raised over DEHP should not impact the use of PVC as a material of choice for healthcare applications.
As part of its commitment to supporting all stakeholders involved in the manufacturing, buying and use of medical devices, the members of the PVCMed Alliance provided data to the Danish Environmental Protection Agency and the Danish Health and Medicines Authority for a recently published report that assessed existing potential alternatives to classified phthalates for medical devices.