Specification and Evaluation of Plasticizer Migration Simulants for Human Blood Products: A Delphi Study.

ABSTRACT: Potentially toxic plasticizers are commonly added to polyvinyl chloride medical devices for transfusion in order to improve their flexibility and workability. As the plasticizers are not chemically bonded to the PVC, they can be released into labile blood products (LBPs) during storage. Ideally, LBPs would be used in laboratory studies of plasticizer migration from the medical device. However, short supply (i.e., limited stocks of human blood in collection centres) has prompted the development of specific simulants for each type of LBP in the evaluation of new transfusion devices. We performed a Delphi study with a multidisciplinary panel of 24 experts. In the first (qualitative) phase, the panel developed consensus definitions of the specification criteria to be met by each migration simu

SUBMITTER: Thelliez A 

PROVIDER: S-EPMC8392596 | biostudies-literature | 2021 Jul

REPOSITORIES: biostudies-literature