DEHP-Free Products, Including Barrier Film, for Medical Devices
Vancive Medical Technologies™, formerly Avery Dennison Medical Solutions, is offering DEHP-free products, including InteliShield™ Barrier Film, to manufacturers of temporary adherent medical devices who are concerned about potential DEHP requirements.
“With the introduction of DEHP-free Vancive Medical Technologies™ InteliShield barrier film for ostomy applications, we are anticipating a growing demand for plasticizer-free medical devices,” said Kevin Jones, global segment market manager, Vancive Medical Technologies. “That need gained even greater urgency when fresh concerns arose in the European Union over use of the plasticizer DEHP in medical products.”
DEHP [Di(2-ethylhexyl) phthalate] is a general purpose plasticiser which is used mainly for making PVC soft and pliable. Following a study asserting that blood bags containing DEHP posed a significant health risk, the European Commission recently requested an updated opinion from its Scientific Committee on New and Emerging Health Risks. The Committee was asked to review and reevaluate safety concerns related to the use of DEHP in PVC plasticized medical devices. It was also asked to identify possible alternatives to DEHP that could reduce potential risks. The review is expected to be completed by March 2013.
“In light of the European Commission’s action, medical device manufacturers are well advised to conduct an internal review of their product offerings,” Jones added. “Manufacturers will want to make sure they are ahead of the curve and prepared for any eventuality. They should have options on hand that will allow them to adapt to new regulatory requirements that could be forthcoming.”
Vancive Medical Technologies