Human platelet lysate (hPL) is a supplement for cell culture media that can be derived from platelet concentrates. As not-for-profit blood establishments, we endorse the evolution of maximally exploiting the potential of donated blood and its derived components, including platelets. The decision to use platelet concentrates to supply hPL as a cell culture supplement should align with the principles and values that blood establishments hold towards the use of donated blood components in transfusion. As a consequence, questions on ethics, practical standardization of hPL production and logistics as well as on assuring hPL quality and safety need careful consideration. We therefore propose an opinion on some of these matters based on available literature and on discussions within the proceedings of the Working Group on Innovation and New Products of the European Blood Alliance. In addition, we propose collaboration among European blood establishments to streamline efforts of hPL supply to maximize the potential of hPL and its application in the wider field of medicine.

Towards standardized human platelet lysate production in Europe: An initiative of the European Blood Alliance.

Transfusion of bacterially contaminated platelets, although rare, is still a major cause of mortality and morbidity despite the introduction of many methods to limit this over the past 20 years. The methods used include improved donor skin disinfection, diversion of the first part of donations, use of apheresis platelet units rather than whole-blood derived pools, primary and secondary testing by culture or rapid test, and use of pathogen reduction. Primary culture has been in use the US since 2004, using culture 24 h after collection of volumes of 4–8 mL from apheresis collections and whole-blood derived pools inoculated into aerobic culture bottles, with limited use of secondary testing by culture or rapid test to extend shelf-life from 5 to 7 days. Primary culture was introduced in the UK in 2011 using a “large-volume, delayed sampling” (LVDS) protocol requiring culture 36–48 h after collection of volumes of 16 mL from split apheresis units and whole-blood derived pools, inoculated into aerobic and anaerobic culture bottles (8 mL each), with a shelf-life of 7 days. Pathogen reduction using amotosalen has been in use in Europe since 2002, and was approved for use in the US in 2014. In the US, recent FDA guidance, effective October 2021, recommended several strategies to limit bacterial contamination of platelet products, including pathogen reduction, variants of the UK LVDS method and several two-step strategies, with shelf-life ranging from 3 to 7 days. The issues associated with bacterial contamination and these strategies are discussed in this review.

Bacterial Contamination of Platelet Products

Although refrigerated storage slows the metabolism of volunteer donor RBCs, cellular aging still occurs throughout this 

Proteostasis and metabolic dysfunction in a distinct subset of storage-induced senescent erythrocytes targeted for clearance

Abstract Di-2-ethylhexyl phthalate (DEHP) is commonly used in the manufacturing of plastic materials, including intravenous bags, blood storage bags, and medical-grade tubing. DEHP can leach from plastic medical products, which can result in inadvertent patient exposure. DEHP concentrations were measured in red blood cell units stored between 7 and 42 days (17–119 μg/ml). Using these concentrations as a guide, Langendorff-perfused rat heart preparations were acutely exposed to DEHP. Sinus activity remained stable with lower doses of DEHP (25–50 μg/ml), but sinus rate declined by 43% and sinus node recovery time (SNRT) prolonged by 56.5% following 30-min exposure to 100 μg/ml DEHP. DEHP exposure also exerted a negative dromotropic response, as indicated by a 69.4% longer PR interval, 108.5% longer Wenckebach cycle length (WBCL), and increased incidence of atrioventricular (AV) uncoupling (60-min exposure). Pretreatment with doxycycline partially rescued the effects of DEHP on sinus activity, but did not ameliorate the effects on AV conduction. DEHP exposure also prolonged the ventricular action potential and effective refractory period, but had no measurable effect on intracellular calcium transient duration. Follow-up studies using human-induced pluripotent stem cell-derived cardiomyocytes confirmed that DEHP slows electrical conduction in a time (15 min–3 h) and dose-dependent manner (10–100 μg/ml). Previous studies have suggested that phthalate toxicity is specifically attributed to metabolites of DEHP, including mono-2-ethylhexylphthalate. This study demonstrates that DEHP exposure also contributes to cardiac dysfunction in a dose- and time-dependent manner. Future work is warranted to investigate the impact of DEHP (and its metabolites) on human health, with special consideration for clinical procedures that employ plastic materials. 

Evidence for the cardiodepressive effects of the plasticizer di-2-ethylhexyl phthalate

Clinical evaluation of novel blood collection and storage bags containing alternative plasticizers to <scp>DEHP</scp> : Recommendations from the <scp>BEST</scp> collaborative

Current transfusion practice and need for new blood products to ensure blood supply for patients with major hemorrhage in Europe

BACKGROUND AND OBJECTIVES
Early balanced transfusion is recommended for resuscitation of patients with severe bleeding. Whole blood (WB) is reintroduced as a feasible alternative to blood components, as it includes red blood cells, plasma and platelets in a physiological ratio.


MATERIALS AND METHODS
In this review, we aim to provide practical guidance and a framework for blood providers aiming to implement a WB programme. The review summarizes recommendations and practical implications identified from published literature, regulatory requirements and current programmes.


RESULTS
WB donors are selected based on national donor selection criteria. When the patients' ABO-type is unknown, low titre anti-A and anti-B group-O WB (LTOWB) are recommended. ABO-group type-specific blood can be used in patients with known ABO type. Anticoagulants include CPD and CPDA-1. Leukoreduction can be performed with a platelet-sparing filter. WB is stored at +2 to -6°C for up to 35 days. Rotation of the stock and re-manufacturing to red cell concentrates minimizes outdating. The EDQM Guide to the preparation, use and quality assurance of blood components provides the minimum requirements. Post-implementation follow-up includes haemovigilance and quality surveillance. End users should be involved in the development of the programme and training of personnel. Emergency collection of WB can enable transfusion to patients in remote areas, during disasters and during war.


CONCLUSION
We conclude that implementation of a WB programme for routine and emergency management of patients with severe bleeding can be performed in a structured, safe and sustainable way.

Implementation of a whole blood programme within a blood service: Practical guidance for blood providers.

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. As such, the sunset date for commercialisation of DEHP‐containing blood bags is May 27th 2025. There are major concerns in meeting this deadline as these systems have not yet been fully validated and/or CE‐marked. Also, since DEHP is known to affect red cell quality during storage, it is imperative to transit to non‐DEHP without affecting blood product quality. Here, EBA members aim to establish common grounds on the evaluation and assessment of blood components collected, prepared and stored in non‐DEHP devices.

/pdf/recommendations-for-in-vitro-evaluation-of-blood-components-20pmqs85.pdf

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

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Current transfusion practice and need for new blood products to ensure blood supply for patients with major hemorrhage in Europe

Implementation of a whole blood programme within a blood service: Practical guidance for blood providers.

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