Recommendations for in vitro evaluation of blood components collected, prepared and stored in non-DEHP medical devices.

Background And Objectives: DEHP, di(2-ethylhexyl) phthalate, is the most common member of the class of ortho-phthalates, which are used as plasticizers. The Medical Device Regulation has restricted the use of phthalates in medical devices. Also DEHP has been added to the Annex XIV of REACH, "Registration, Evaluation, Authorisation and Restriction of Chemicals" due to its endocrine disrupting properties to the environment.

Assessment of the soluble proteins HMGB1, CD40L and CD62P during various platelet preparation processes and the storage of platelet concentrates: The BEST collaborative study.

Background: Structural and biochemical changes in stored platelets are influenced by collection and processing methods. This international study investigates the effects of platelet (PLT) processing and storage conditions on HMGB1, sCD40L, and sCD62P protein levels in platelet concentrate supernatants (PCs).

Study Design/methods: PC supernatants (n = 3748) were collected by each international centre using identical centrifugation methods (n = 9) and tested centrally using the ELISA/Luminex platform.

Survey of blood centre readiness regarding removal of DEHP from blood bag sets: The BEST Collaborative Study.

Background And Objectives: Di(2-ethylhexyl) phthalate (DEHP) must be removed from blood bag sets in Europe by 27 May 2025. DEHP is known to interact with the red blood cell (RBC) membrane, resulting in reduced haemolysis and thus prolonging shelf-life. Current non-DEHP alternatives result in increased haemolysis requiring reconsideration of the RBC shelf-life.

Not all red cell concentrate units are equivalent: international survey of processing and in vitro quality data.

Introduction: In vitro qualitative differences exist in red cell concentrates (RCCs) units processed from whole blood (WB) depending on the method of processing. Minimal literature exists on differences in processing and variability in quality data. Therefore, we collected information from blood manufacturers worldwide regarding (1) details of WB collection and processing used to produce RCCs and (2) quality parameters and testing as part of routine quality programmes.