|
Return to Newsletter DEHP AND PATIENT SAFETY Medical manufacturers strive to provide safe alternatives to plasticizers Medical tubing and bags have strict performance requirements for patient safety and ease of use. Among these are: flexibility, cleanliness, no extractables and sterilizability. For many years, PVC (polyvinyl chloride) was the most common plastic used for medical-grade tubing and fluid containers. Recently, manufacturers have shifted their focus to alternative plastics, as safer alternatives. PVC is an inherently rigid plastic, and has required the addition of plasticizers or softeners to give it the properties necessary for IV tubing and bags. A common additive is DEHP or di-ethyl hexyl phthalate. Over many years of use, providers and researchers determined that DEHP presented patient and environmental risks as an additive. DEHP-containing medical devices present a health risk because they contribute to dioxin formation during manufacture and incineration. In use, the devices can leach phthalate, which is a known reproductive toxicant linked to birth defects. A 2002 FDA warning to healthcare providers indicated that some patients may be at risk from DEHP leaching from PVC medical devices and recommended switching to alternative products. Major medical device manufacturers are working to eliminate phthalate from their IV products to ensure a clean and safe fluid path. Several medical-grade plastics are available that do not require plasticizers and there are non-DEHP versions of PVC as well. More than 100 healthcare organizations have taken steps to reduce or eliminate the use of DEHP-containing plastics in their facilities. Check your tubing and bag products to determine if they contain DEHP or visit www.noharm.org for more information. |
||