Contamination of platelet storage bags by phthalate esters

Abstract

Phthalate esters are the most extensively used plasticizers in the manufacture of Polyvinylchloride (PVC) plastic. Many medical devices used in the collection and storage of blood components are made of PVC plastic containing di(2‐ethylhexyl) phthalate (DEHP). DEHP leaches at a rate of 100 μglml · d into platelet concentrate (PC) supernatant when PCs are stored in PVC containers. It is only possible to store PCs for 72 h in this DEHP plastic, after which time the platelet function has deteriorated and they cannot be used for transfusion therapy. Since it was desirable to find a container that permitted longer storage times and because of the concern for the toxicity of DEHP, new bags, manufactured with different plastic formulations without this ptasticizer, were tested for PC storage. Using these new containers, such as the PL732 [polyolefin (PO) plastic], and the CLX300 and PL1240 [tri(2‐ethylhexyl) trimelli‐tate (TEHTM) PVC plastic], it was possible to store PCs for 5 d while preserving platelet function.

In spite of these new plastic bags being manufactured without DEHP, we found DEHP and its metabolite mono(2‐ethylhexyl) phthalate (MEHP) as contaminants of the supernatant of the PCs stored in these containers. After analyzing the plastic material of each of these containers, we were able to identify the source of the contamination as coming from the plastic materials that were used in the manufacture of the bags. The sterilization process of the PL732 bag was investigated, since it was found that when the plastic of the PL732 bag was analyzed prior to sterilization, no contamination by DEHP was detected; however, whether the PL732 bag was sterilized together with the primary PVC bag or separately, using ethylene oxide, contamination by DEHP was found, suggesting contamination of the sterilization unit by DEHP.