Donor Hemovigilance during Preparatory Plasmapheresis

Abstract

Background: Reports on unexpected donor events (UEs) during preparatory plasmapheresis (PPP) are scarce, and rarely consider technical UEs. Methods: Defined local and systemic UEs were graded by severity; technical UEs were not graded. On January 1, 2008, E.B.P.S.-Logistics (EBPS) installed the UE module for plasma management software (PMS). Donor room physicians entered UEs daily into the PMS. Medical directors reviewed entries quarterly. EBPS compiled data on donors, donations and UEs from January 1, 2008 to June 30, 2011. Results: 66,822 UEs were observed during 1,107,846 PPPs for a corrected incidence of 6.55% (1.4% local, 0.55% systemic, 4.6% technical UEs). 3.36% of PPPs were accompanied by 1 UE and 1.18% by >1 UE (2-5). 13.7% of donors undergoing PPP for the first time, 9.7% of those having a second PPP and 4.0% of those having a third or more PPPs were associated with UEs. Most common UEs were repeated venipuncture, and broken-off collection due to venous access problems and small hematomas. Severe systemic UEs occurred at a rate of 36 per 100,000 PPPs. Conclusions: Technical UEs were common with PPP. UEs accompanied first and second donations significantly more frequently than for subsequent donations.

Donor Hemovigilance with Blood Donation

“…Our catalogue of local and systemic UEs corresponds to that established in the literature for BDs [5,21,24]. Applying EMA criteria for frequency of adverse drug reactions [25] to donor hemovigilance, overall local, systemic and technical UEs as defined here were commonly associated with BD (2.4%).…”

“…Of course, one may look upon repeated venipunctures and failing to establish or maintain sufficient blood flow as part of local UEs. However, technical UEs have substantial economic implications as they contribute substantially to cost in terms of personnel time, supplies, and lost donors [24]. These aspects are simply not covered by the designating such UEs as ‘hematoma', and they are not primarily of concern to the donor.…”

Donor Safety in Haemapheresis: Development of an Internet-Based Registry for Comprehensive Assessment of Adverse Events from Healthy Donors

“…As shown in table 1, the number of AEs reported in the context of haemapheresis varies by two log steps from 0.025% [9] to 5.77% and 6.55% [10,11]. One explanation for this wide range is that some authors included mild, clinically insignificant donor reactions (e.g., small haematomas, short vasovagal reactions without faint, mild paresthesia [11][12][13][14]), whereas other reports referred to moderate and severe adverse events (SAEs) [14][15][16] or to SAEs only [9,17]. But even within the donor reaction grading 'SAE', the results may vary by 10-fold between 0.025% [9] and 0.24% [13].…”

Comments on the Judgement of the Court of Justice of the European Union of April 29, 2015: Is the Permanent Exclusion of MSM from Giving Blood Compatible with the Directive 2004/33/EC? What Are the Consequences for Blood Donations in Germany?

“…There is still a medical risk for the donor [20,21,22]. It is also unethical to discard the donation or to use it for quality control issues.…”