Quality of methylene blue/light treated plasma using a DEHP-free bag system

Background

Di-ethyl-hexyl-phthalate (DEHP) is currently one of the major plasticizers used in blood bags. Due to its endocrine disrupting properties European regulators decided to ban its use in medical devices. Although, the final sunset date is not yet clear, DEHP-free blood bags will be essential in Europe within the next years. In the current study the quality of Methylene blue/light treated plasma using the DEHP-free version of the THERAFLEX MB-plasma system (Macopharma) was investigated.

Methods

Whole blood units (500 mL) were collected into 70 mL CPD anticoagulant solution in regular, DEHP-containing bags and kept at room temperature (22±2°C) overnight. After centrifugation plasma was separated and processed within 18 h after whole blood donation. Plasma units (n=8) were connected to the DEHP-free THERAFLEX MB-Plasma disposable (REF PROSDV1, Macopharma) and MB/light treatment was done according to the instructions of the manufacturer using the Macotronic B2 illumination device with a light dose of 120 J/cm². Plasma was then transferred through the Blueflex filter into the storage bag and frozen.

Results

Samples were taken before treatment (sample a), after Blueflex filtration (sample b) and after storage for 1 month (sample c) for the measurement of plasma factors showing a significant effect on the plasma factors (table 1). Coagulation times significantly increased (aPTT 7% and TT 13%) while the coagulation factors decreased significantly except for factors VII and protein S. Especially, fibrinogen (Clauss) (25%), factor V (10%), factor VIII (22%) and factor XI (18%) decreased. European guideline specifications however were hold for all plasma units. Factor VIII was >70% in untreated samples (82-170%) and >50% in MB/light treated samples (56-146%). The decrease of fibrinogen activity was <40% (17,1%-28,6%) after MB/Light treatment.

Conclusion

The plasma quality of MB/light-treated plasma using the THERAFLEX MB-Plasma disposable PROSDV1 without DEHP showed the expected increase/decrease of plasma factors. Data was comparable to published data obtained for the DEHP-containing disposables.

Offenlegung Interessenkonflikt:

Study was sponsored by Macopharma Productions (CS).