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. 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. MATERIALS AND METHODS: Based on data as well as the input of relevant stakeholders a rationale for the validation of each component was composed. RESULTS: The red cell components will require the most extensive validation as their quality is directly affected by the absence of DEHP, as opposed to platelet and plasma components. CONCLUSION: Studies in the scope of evaluating the quality of blood products obtained with non-DEHP devices, under the condition that they are carried out according to these recommendations, could be used by all members of the EBA to serve as scientific support in the authorization process specific to their jurisdiction or for their internal validation use.

Cost-effectiveness of questionnaires in preventing transfusion-transmitted infections.

BACKGROUND: The cost-effectiveness of the donor health questionnaire (DHQ) as a tool to assess donor eligibility has not been quantified. This study focused on cost-effectiveness of the DHQ in preventing transfusion-transmitted infections (TTIs). STUDY DESIGN AND METHODS: Data on whole blood donor eligibility assessments in the Netherlands in 2008 to 2010 were analyzed. Based on test results and epidemiologic data on TTIs, the number of donor visits in their window phase was calculated. Subsequently, the incremental cost-effectiveness ratio (ICER) of the DHQ was calculated. RESULTS: The overall annual deferral rate in the study period was 9.6% (9.3%-10.0%). The annual deferral rate for TTI risk was 0.86% (0.82%-0.89%). Taking into account the number of self-deferrals, deferral rate for TTI risk in all donors was 1.90% (1.81%-2.02%). The calculated annual numbers of prevented cases of TTI were hepatitis B, 0.142; hepatitis C, 0.010; human immunodeficiency virus, 0.016; and syphilis, 0.135. The annual costs for TTI risk-related eligibility assessments, deferrals, and substitutions were €84,807 (€55,193-€123,811) for the blood establishment (BE) and €90,501 (€46,965-€159,571) for deferred donors. Annual savings were €991 (€276-€2325), while annual quality-adjusted life-years (QALYs) gained were 0.120 (0.059-0.226). Hence, the ICER for the DHQ on preventing TTIs was €696,744 (€315,422-€1,611,681) for BE costs only and €1,449,055 (€669,439-€3,145,961) including costs for deferred donors. CONCLUSION: The DHQ enhances self-selection and should not be abandoned. However, the DHQ is not a cost-effective tool for further reducing TTIs. The high costs per case prevented and the small number of QALYs gained argue against maintaining deferral policy through the DHQ at the current level.

Potential human transmission of amyloid ß pathology: surveillance and risks.

Studies in experimental animals show transmissibility of amyloidogenic proteins associated with prion diseases, Alzheimer's disease, Parkinson's disease, and other neurodegenerative diseases. Although these data raise potential concerns for public health, convincing evidence for human iatrogenic transmission only exists for prions and amyloid ß after systemic injections of contaminated growth hormone extracts or dura mater grafts derived from cadavers. Even though these procedures are now obsolete, some reports raise the possibility of iatrogenic transmission of amyloid ß through putatively contaminated neurosurgical equipment. Iatrogenic transmission of amyloid ß might lead to amyloid deposition in the brain parenchyma and blood vessel walls, potentially resulting in cerebral amyloid angiopathy after several decades. Cerebral amyloid angiopathy can cause life-threatening brain haemorrhages; yet, there is no proof that the transmission of amyloid ß can also lead to Alzheimer's dementia. Large, long-term epidemiological studies and sensitive, cost-efficient tools to detect amyloid are needed to better understand any potential routes of amyloid ß transmission and to clarify whether other similar proteopathic seeds, such as tau or α-synuclein, can also be transferred iatrogenically.