Migration of di(2-ethylhexyl) phthalate, diisononylcyclohexane-1,2-dicarboxylate and di(2-ethylhexyl) terephthalate from transfusion medical devices in labile blood products: A comparative study.

BACKGROUND AND OBJECTIVES: Polyvinyl chloride (PVC) plasticized with di(2-ethylhexyl) phthalate (DEHP) is a widely used material for medical transfusion devices. Not covalently bound to PVC, DEHP can migrate into blood products during storage. Recognized as an endocrine disruptor and raising concerns about its potential carcinogenicity and reprotoxicity, DEHP is gradually being withdrawn from the medical device market. Therefore, the use of alternative plasticizers, such as diisononylcyclohexane-1,2-dicarboxylate (DINCH) and di(2-ethylhexyl) terephthalate (DEHT), as potential candidates for the replacement of DEHP in medical transfusion devices has been investigated. The purpose of this study was to evaluate the quantity of PVC-plasticizers in the blood components according to their preparation, storage conditions and in function of the plasticizer. MATERIALS AND METHODS: Whole blood was collected, and labile blood products (LBPs) were prepared by the buffy-coat method with a PVC blood bag plasticized either with DEHP, DINCH or DEHT. DINCH and DEHT equivalent concentrations were quantified in LBPs by liquid chromatography-tandem mass spectrometry or coupled with UV and compared to DEHP equivalent concentrations. RESULTS: The plasticizer equivalent concentration to which a patient is exposed during a transfusion depends on the preparation of LBPs as well as their storage conditions, that is, temperature and storage time. At day 1, for all LBPs, the migration of DEHP is 5.0 and 8.5 times greater than DINCH and DEHT, respectively. At the end of the 49 days storage period, the DEHP equivalent concentration in red blood cells concentrate is statistically higher when compared to DINCH and DEHT, with maximal values of 1.85, 1.13 and 0.86 µg/dm2 /mL, respectively. CONCLUSION: In addition to lower toxicity, transfused patients using PVC-DEHT or PVC-DINCH blood bags are less exposed to plasticizers than using PVC-DEHP bags with a ranging exposure reduction from 38.9% to 87.3%, due to lower leachability into blood components.

Evaluation of BD Barricor™ and PST™ blood collection tubes compared to serum for testing 11 therapeutic drugs on a Roche Cobas® 8000 platform.

INTRODUCTION: The type of blood collection tube used when obtaining samples for therapeutic drug monitoring (TDM) has important implications on the accuracy of results. Serum tubes without a gel separator are currently considered best practice. We sought to evaluate the performance of Barricor™, a novel plasma tube that utilizes an inert mechanical separator, as well as a gel-based tube (PST™) for testing acetaminophen, digoxin, gentamicin, methotrexate, phenobarbital, phenytoin, salicylate, vancomycin, valproic acid, carbamazepine, and theophylline on a Roche Cobas® 8000 platform. METHODS: Paired patient samples were collected from individuals taking at least one of the medications evaluated. These were supplemented with spiked specimens to ensure a minimum of 40 paired samples per drug. All drugs were measured within two hours of collection on Roche e602 or c502 instruments. Deming regression was used to assess bias between Barricor™ vs serum and PST™ vs serum. Seven-day refrigerated stability was also assessed in Barricor™, PST™, and serum tubes in a subset of samples (n = 10) for each drug. RESULTS: Drug concentrations in Barricor™ were similar to serum for each drug assessed. In contrast, a negative bias was observed in PST™ compared to serum tubes for carbamazepine (-7.6%) and phenytoin (-6.8%) although this did not surpass our total allowable error goal of 10%. All drugs recovered within ±10% of baseline value when samples were stored refrigerated for 7 days except for carbamazepine, phenytoin, and phenobarbital where significant analyte loss was observed within the first day in PST™ tubes. CONCLUSION: Barricor™ tubes are a suitable alternative to serum for TDM on the Roche Cobas® 8000 platform.

Specification and Evaluation of Plasticizer Migration Simulants for Human Blood Products: A Delphi Study.

Potentially toxic plasticizers are commonly added to polyvinyl chloride medical devices for transfusion in order to improve their flexibility and workability. As the plasticizers are not chemically bonded to the PVC, they can be released into labile blood products (LBPs) during storage. Ideally, LBPs would be used in laboratory studies of plasticizer migration from the medical device. However, short supply (i.e., limited stocks of human blood in collection centres) has prompted the development of specific simulants for each type of LBP in the evaluation of new transfusion devices. We performed a Delphi study with a multidisciplinary panel of 24 experts. In the first (qualitative) phase, the panel developed consensus definitions of the specification criteria to be met by each migration simulant. Next, we reviewed the literature on techniques for simulating the migration of plasticizers into LBPs. A questionnaire was elaborated and sent out to the experts, and the replies were synthesized in order to obtain a consensus. The qualitative study established specifications for each biological matrix (whole blood, red blood cell concentrate, plasma, and platelet concentrate) and defined the criteria required for a suitable LBP simulant. Ten criteria were suggested: physical and chemical characteristics, opacity, form, stability, composition, ability to mimic a particular clinical situation, ease and safety of use, a simulant-plastic interaction correlated with blood, and compatibility with analytical methods. The questionnaire data revealed a consensus on the use of natural products (such as pig's blood) to mimic the four LBPs. Opinions diverged with regard to synthetic products. However, an isotonic solution and a rheological property modifier were considered to be of value in the design of synthetic simulants. Consensus reached by the Delphi group could be used as a database for the development of simulants used to assess the migration of plasticizers from PVC bags into LBPs.

Remodelling whole blood processing through automation and pathogen reduction technology at the Luxembourg Red Cross.

In 2014-2015, the Luxembourg Red Cross (LRC) implemented a fully automated system (FAS) able to process 4 whole blood units simultaneously, and a pathogen reduction technology (PRT) based on riboflavin and ultraviolet light to improve safety of platelet concentrates (PCs). In this observational study, the impact of both technologies to enable this centralised blood transfusion centre to provide safe and timely blood components supply for the whole country was analysed. Standard quality control parameters for blood components, productivity and safety were compared from data collected with the conventional semi- automated buffy coat method and with FAS/PRT. The FAS decreased processing time when compared with the buffy coat method and facilitated the daily routine at the LRC. Red blood cell concentrates, plasma units and PCs prepared with both methods were conform to the European Directorate for the Quality of Medicines & HealthCare specifications. PCs prepared by FAS showed high yields, with decreased variability when the device-related software (T-Pool Select) was used. PRT had minimal impact on platelet yields and product quality and induced no increase in transfusion reaction notifications. The FAS and PRT transformed the daily routine of blood component manufacture by allowing increased productivity and efficiency, notwithstanding resource containment and without impacting quality, yet promoting safety.

Effects of whole blood storage in a polyolefin blood bag on platelets for acute normovolemic hemodilution.

Acute normovolemic hemodilution (ANH) is a potential transfusion method for platelets, as well as for red blood cells. However, previous studies have shown that whole blood storage in ANH decreases platelet aggregability by 14.7-76.3% and that this decrease is not recovered by reinfusion. We investigated whether a new whole blood storage method for 6 h using a polyolefin bag, based on the platelet concentrates storage method, would maintain platelet function better than the conventional method using a polyvinyl chloride bag. We demonstrated that storage of whole blood in a polyolefin bag maintained ADP-induced aggregation rates at more than twofold higher than those in a polyvinyl chloride bag, and also significantly suppressed P-selectin expression, a platelet activation marker (ADP-induced aggregation rates: 24.6 ± 5.1% vs. 51.7 ± 11.5%, p = 0.002; P-selectin expression; 50.3 ± 8.4MFI vs. 31.6 ± 9.3MFI, p = 0.018). These results could be attributed to the high gas permeability of polyolefin, which lowered PCO2 and maintained a high pH with or without agitation. There were no significant changes in platelet count and red blood cell parameters due to the storage methods. Our results suggest that ANH using polyolefin bags is advantageous in improving hemostatic function compared to the conventional method.

Zwitterionic carboxybetaine polymers extend the shelf-life of human platelets.

The shelf-life of human platelets preserved in vitro for therapeutic transfusion is limited because of bacterial contamination and platelet storage lesion (PSL). The PSL is the predominant factor and limiting unfavorable interactions between the platelets and the non-biocompatible storage bag surfaces is the key to alleviate PSL. Here we describe a surface modification method for biocompatible platelet storage bags that dramatically extends platelet shelf-life beyond the current US Food and Drug Administration (FDA) standards of 5 days. The surface coating of the bags can be achieved through a simple yet effective dip-coating and light-irradiation method using a biocompatible polymer. The biocompatible polymers with tunable functional groups can be routinely fabricated at any scale and impart super-hydrophilicity and non-fouling capability on commercial hydrophobic platelet storage bags. As critical parameters reflecting the platelets quality, the activation level and binding affinity with von Willebrand factor (VWF) of the platelets stored in the biocompatible platelet bags at 8 days are comparable with those in the commercial bags at 5 days. This technique also demonstrates promise for a wide range of medical and engineering applications requiring biocompatible surfaces. STATEMENT OF SIGNIFICANCE: Current standard platelet preservation techniques agitate platelets at room temperature (20-24 °C) inside a hydrophobic (e.g., polyvinyl chloride (PVC)) storage bag, thereby allowing preservation of platelets only for 5 days. A key factor leading to quality loss is the unfavorable interaction between the platelets and the non-biocompatible storage bag surfaces. Here, a surface modification method for biocompatible platelet storage bags has been created to dramatically extend platelet shelf-life beyond the current FDA standards of 5 days. The surface coating of the bags can be achieved via a simple yet effective dip-coating and light-irradiation method using a carboxybetaine polymer. This technique is also applicable to many other applications requiring biocompatible surfaces.

Flow path system of ultraviolet C irradiation from xenon flash to reduce bacteria survival in platelet products containing a platelet additive solution.

BACKGROUND: Our previous study showed that ultraviolet C (UVC) from xenon (Xe) flash without any photoreactive compounds inactivated bacteria in platelet concentrates (PCs) with less damage to platelets (PLTs) as compared with Xe flash containing ultraviolet A, ultraviolet B, and visible light. Here, we report a UVC irradiation system for PCs under flow conditions consisting of a flow path-irradiation sheet, a peristaltic pump, and a collection bag. STUDY DESIGN AND METHODS: Platelet concentrates containing Ringer's solution (R-PCs) inoculated with bacteria were injected into a flow path sheet using a peristaltic pump, being irradiated with UVC from Xe flash. The quality of the irradiated PCs containing platelet additive solution (PAS-PCs) was assessed based on PC variables, PLT surface markers, and aggregation ability. RESULTS: Streptococcus dysgalactiae (12 tests) and Escherichia coli (11) were all negative on bacterial culture, while Staphylococcus aureus (12) and Klebsiella pneumoniae (14) grew in one and two R-PCs, respectively. Bacillus cereus spores were inactivated in 7 of 12 R-PCs. PC variables became significantly different between irradiated and nonirradiated PAS-PCs. P-selectin, first procaspase-activating compound (PAC-1) binding, and phosphatidylserine increased by irradiation. Aggregability stimulated by adenosine diphosphate, collagen, or thromboxane A2 increased in the irradiated PAS-PCs, while that by thrombin became smaller compared with nonirradiated controls. CONCLUSION: This newly developed system inactivated bacteria including spores in R-PCs. PAS-PCs irradiated by this system retained acceptable in vitro quality and aggregability. Usage of a peristaltic pump instead of agitator during irradiation may enable this system to be directly combined with an apheresis blood cell separator.

Simultaneous determination of di(2-ethylhexyl) phthalate and diisononylcyclohexane-1,2-dicarboxylate and their monoester metabolites in four labile blood products by liquid chromatography tandem mass spectrometry.

Di(2-ethylhexyl) phthalate (DEHP) is a common plasticizer that is largely used for PVC blood bags. The migration of DEHP from medical devices into labile blood products (LBP) is a well-known situation. While DEHP has beneficial effects on the storage of red blood cells, it can have toxicological impact due to its potential reprotoxic effects (classified group 1B). Since July 1st, 2015, the French law prohibits the use of tubing made in DEHP-plasticized PVC in paediatric, neonatal and maternity wards. This provision, which could extend in several years more widely to medical devices used for drugs infusion, dialysis, feeding and blood bags, has led manufacturers to replace DEHP to alternative plasticizers such as diisononylcyclohexane-1,2-dicarboxylate (DINCH). In this paper, a liquid chromatography-tandem mass spectrometry (LCMS/MS) method has been developed and validated for the determination of DEHP, DINCH and their corresponding monoester metabolites (MEHP and MINCH) in four labile blood products (LBP): whole blood (WB), red cells concentrate (RCC), plasma and platelet concentrate (PC). Due to strong contamination of blank LBP by DEHP because of its ubiquitous presence in working environment and despite the attention paid to avoid contamination of solvents and glassware, a trap chromatographic column was implemented between the solvent mixing chamber and the injector of the LC system. This set-up permitted to discriminate DEHP present in the sample to DEHP brought by the environmental contamination. In the optimized conditions, all compounds were separated in less than 10 min. The analytes were extracted from LBP samples using a liquid-liquid extraction. After optimization, recoveries were ranged from 47 to 96 %, depending on the analytes and the nature of LBP. Except for DEHP which exhibited RSD values of intermediate precision higher than 20 % at a concentration of 25 nM, all the precision results (repeatability and intermediate precision) were lower than 16 % and trueness values ranged from -16.2-19.8%. Using the validated method, the leachability of DEHP and DINCH from corresponding PVC-blood bags was investigated and the concentrations of their corresponding metabolites, MEHP and MINCH, were determined in whole blood, red cells concentrate, plasma and platelet concentrate.

Effect of phase-change material blood containers on the quality of red blood cells during transportation in environmentally-challenging conditions.

BACKGROUND: The effect of phase-change material blood containers on the quality of stored red blood cells (RBCs) transported in the Qinghai-Tibet Plateau remains to be studied. STUDY DESIGN AND METHODS: RBCs stored in a phase-change material blood container were transported from Chengdu to Tibet and then back to Chengdu. The detection time points were the 1st day of fresh-collected RBCs (group 1), the 14th day of resting refrigerated storage (group 2), and the 14th day of plateau transportation under refrigerated storage in the container (group 3). RBC counts, hemoglobin (HGB) content, free hemoglobin (FHb) content, blood biochemical indexes, hemorheologic indexes and 2,3-DPG content were detected. RESULTS: Compared with group 2, RBC counts and HGB were decreased, and the mean corpuscular volume (MCV), FHb and K+ content were increased in group 3. The glucose consumption and lactic acid production were significantly increased in groups 2 and 3. Compared with group 2, the 2,3-DPG content and whole blood viscosity were decreased in group 3. After resting refrigerated storage and plateau transportation, the RBC quality still met the national standard (GB18469-2012 whole blood and component blood quality requirements). CONCLUSION: The phase-change material blood container can be maintained at a constant temperature under plateau environmental conditions, ensuring that the quality of the stored RBCs is compliant with GB18469-2012 whole blood and component blood quality requirements.

Reduction of exposure to plasticizers in stored red blood cell units.

INTRODUCTION: Plastic can be toxic and hazardous to an organism's health, but it is being widely used in our daily lives. Di-2-ethylhexyl-phthalate is the most common plasticizer in medical devices made of polyvinylchloride and is commonly found in soft bags storing red blood cell units. Di-2-ethylhexyl-phthalate and its degradation product mono-2-ethylhexyl-phthalate can migrate into human body fluids, for example, blood and tissues. The aim of the study was to assess the concentration of plasticizers in red blood cell units according to storage time and after mechanical rinsing using a cell salvage device. METHODS: Levels of di-2-ethylhexyl-phthalate and mono-2-ethylhexyl-phthalate were analysed in 50 unwashed red blood cell units using liquid chromatography coupled with tandem mass spectrometry. In addition, phthalate concentrations were measured before and after mechanical rinsing in six more washed red blood cell units with storage times ranging between 36 and 56 days. A linear regression model was determined by the daily increase of di-2-ethylhexyl-phthalate and mono-2-ethylhexyl-phthalate in the stored red blood cell units subject to their storage time (range = 4-38 days), and the effect of mechanical rinsing on their phthalate concentration was calculated. RESULTS: A linear correlation was found between storage time of unwashed red blood cell units and the concentration of di-2-ethylhexyl-phthalate (p < 0.001) or mono-2-ethylhexyl-phthalate (p < 0.001). Stored red blood cell units older than 14 days had significantly higher concentrations of both contaminants than red blood cell units of shorter storage time (p < 0.001). Mechanical rinsing in washed red blood cell units attained a reduction in the di-2-ethylhexyl-phthalate and mono-2-ethylhexyl-phthalate concentration by a median of 53% (range = 18-68%; p = 0.031) and 87% (range = 68-96%; p = 0.031), respectively. CONCLUSION: Leaching of di-2-ethylhexyl-phthalate and mono-2-ethylhexyl-phthalate into red blood cell units depends on the duration of storage time. Plasticizers can be significantly reduced by mechanical rinsing using cell salvage devices, and thus, red blood cell units can be regenerated with respect to chemical contamination.

Whole blood preservation methods alter chemokine receptor detection in mass cytometry experiments.

A potential hurdle when applying mass cytometry to the field study setting is the streamlining of sample collection while at the same time protecting the integrity of important cell epitopes. Whole blood preservation kits applying fixation and/or permeabilization agents are increasingly used in clinical trials to preserve leukocytes needed for downstream analysis. We here present a structured overview of leukocyte surface marker detectability in samples processed with four commercially available whole blood preservation kits; 1) Proteomic Stabilizer, 2) Stable-Lyse V2 and Stable-Store V2, 3) Cytodelics and 4) Lyse/Fix Buffer, as well as in samples treated with buffers included in Mass-tag Cellular Barcoding kits. Isolated leukocytes were stained with a 28-marker panel (including 7 chemokine receptors) of metal-conjugated antibodies and analysed on a mass cytometer. Exploration of the data by manual gating and viSNE analysis showed that although many markers were similarly detected across all sample conditions, most of the chemokine receptors in our panel, particularly CXCR3, CCR4, CCR6 and CXCR5, were incorrectly detected in the preserved samples and thus incompatible with the fixation and permeabilization agents found in whole blood preservation kits and in buffers used prior to barcoding.

[Preparation of pooled granulocytes concentrates from whole blood buffy coats (PGC) as an alternative to apheresis]. / Le mélange de concentré de granulocytes de sang total (MCGST) comme alternative au concentré de granulocytes d'aphérèse (CGA).

BACKGROUND: The collection of granulocytes by apheresis requires volunteer donor stimulation by corticoids and the use of HES, a compound which is currently challenged by potential safety issues. Preparation of pooled granulocytes concentrates from whole blood buffy coats (PGC) represent an alternative to apheresis with a better benefit/risk for the donors. METHOD: Whole blood is collected in a bottom and top blood bag for buffy coat preparation. After centrifugation and separation, buffy coat are obtained. Twenty ABO matched buffy coats are selected for processing into one PGC. Four pools of five buffy coats were made, platelet additive solution is added to each pool, mixed gently and centrifuged. The red cell residue, supernatant and granulocyte rich layer are separated. Two granulocyte rich layers are pooled and added with 70mL of ABO matched plasma from the initial donations (=PGC10). The final PGC (=PGC20) is obtained by pooling two PGC10 into a platelet storage bag. Neutrophil content and in-vitro functionality are assessed at day of preparation (D1) and at expiry hour, 48 hours after collection (D2). RESULTS: On N=18, mean: Volume=408±4mL, 2.2*1010±0.24 neutrophils, Hematocrit=18%±3%, 4.7*1011platelets. Viability is well preserved: 95%±6% day of PGC preparation, 85%±7% after 24h of storage (D2). Functionality (ROS production measurement) is well preserved: 1.36±0.25 at D1 and 1.38±0.18 at D2. Expression and modulation of adhesion molecules after stimulation are normal at D1 and slightly decreased at D2 but still normal. CONCLUSIONS: PGC20 in vitro characteristics are in conformance with the EDQM guide (V19) and similar to apheresis for granulocytes content and hematocrit. The viability and two mean indicators which explore neutrophil function are well maintained during PGC preparation and after 24 hours of storage.

Ex vivo evaluation of the efficacy of canine fresh-frozen plasma thawed using a microwave plasma defroster.

BACKGROUND: Commercial microwave plasma defrosters (MPDs) are used globally in human medicine to safely thaw fresh-frozen plasma (FFP), but this technology has never been tested in a veterinary setting. This study was undertaken to assess the efficacy of a commercial MPD for the rapid thawing of canine FFP. STUDY DESIGN: Twenty-three units (twelve 120 mL and eleven 240 mL) of canine FFP were thawed using an MPD. Time-to-thaw and pre- and postthawing temperatures of the units were measured. Clotting factor activities (factors II, V, VII, VIII, IX, X, and von Willebrand factor), fibrinogen concentrations, prothrombin times, and activated partial thromboplastin times were measured. KEY FINDINGS: The evaluated MPD effectively thaws plasma quickly for both 120 mL units (2.7 ± 0.08 min) and 240 mL units (3.9 ± 0.15 min) while maintaining clinically relevant activities of clotting factors and fibrinogen concentration. While some measurements of factor VIII activity fell below the reference interval, none fell below 40%. One 240 mL unit had von Willebrand factor activity <70%. There was no evidence of excessively heated plasma to indicate a safety concern. SIGNIFICANCE: The MPD evaluated in this study provides a useful means to rapidly thaw canine FFP for correction of factor-deficient coagulopathy.

In vitro quality of apheresis platelets divided into paediatric-sized units and stored in PVC bags plasticised with TOTM, BTHC or DINCH.

BACKGROUND AND OBJECTIVES: Two of the predictive factors of the quality of small volumes of platelets suitable for paediatric use are bag size and material. This study evaluated the storage properties of paediatric platelet aliquots in TOTM-, BTHC- or DINCH-PVC bags. METHODS/MATERIALS: (i) Three apheresis platelet concentrates (PC) were pooled and split into three units. One was retained as an adult unit (control; polyolefin bag). The second and third units were split into four MacoPharma TOTM-PVC and BTHC-PVC paediatric bags, respectively. (ii) Two apheresis PC were pooled and split into two units. One PC was retained as an adult unit, and the other was split into four Fresenius DINCH-PVC paediatric bags. Testing was performed on storage for pH, blood gases, hypotonic shock response, soluble CD62P, LDH, glucose and lactate, ATP, CD62P, CD63, platelet-derived microparticles and annexin V. RESULTS: The volumes, platelet yields and pH of all paediatric units met local specifications. The TOTM-PVC bag showed no worse quality than the adult bag up to day 7 for all parameters studied, and it maintained pH higher than BTHC-PVC and DINCH-PVC over storage. The BTHC-PVC bag was shown to be the most gas permeable; however, it had the highest glucose consumption rates and the highest platelet activation. CONCLUSION: All bags showed an acceptable in vitro quality. Overall, the TOTM-PVC paediatric bag showed better platelet quality compared to the other storage bags, whereas storage in the BTHC-PVC bag resulted in poorer platelet quality.

Assessment of the permeability properties of cryopreservation outer bags used in NHSBT.

This study was carried out to investigate leakage/transport across the bag material of six outer cryopreservation bags in common use within NHS Blood and Transplant. In order to do this two different leak testing procedures; coloured dye and hydrogen tracer gas, were used. The data obtained show that a coloured dye cannot permeate through the materials both at room temperature and following storage at liquid nitrogen temperature (- 196 °C). In addition, when filled with the smallest elemental molecule, hydrogen, in the form of a tracer gas, all of the bags only allowed trace amounts of hydrogen to escape, either through the seal or the bag material. The data indicated that each of the bag materials tested would be capable of preventing bacterial or viral cross-contamination as long as the material remained intact.

Development of Antifouling and Bactericidal Coatings for Platelet Storage Bags Using Dopamine Chemistry.

Platelets have a limited shelf life, due to the risk of bacterial contamination and platelet quality loss. Most platelet storage bags are made of a mixture of polyvinyl chloride with a plasticizer, denoted as pPVC. To improve biocompatibility of pPVC with platelets and to inhibit bacterial biofilm formation, an antifouling polymer coating is developed using mussel-inspired chemistry. A copolymer of N,N-dimethylacrylamide and N-(3-aminopropyl)methacrylamide hydrochloride is synthesized and coupled with catechol groups, named DA51-cat. Under mild aqueous conditions, pPVC is first equilibrated with an anchoring polydopamine layer, followed by a DA51-cat layer. Measurements show this coating decreases fibrinogen adsorption to 5% of the control surfaces. One-step coating with DA51-cat does not coat pPVC efficiently although it is sufficient for coating silicon wafers and gold substrates. The dual layer coating on platelet bags resists bacterial biofilm formation and considerably decreases platelet adhesion. A cationic antimicrobial peptide, E6, is conjugated to DA51-cat then coated on silicon wafers and introduces bactericidal activity to these surfaces. Time-of-flight second ion-mass spectroscopy is successfully applied to characterize these surfaces. pPVC is widely used in medical devices; this method provides an approach to controlling biofouling and bacterial growth on it without elaborate surface modification procedures.

Centrifugation-free washing: A novel approach for removing immunoglobulin A from stored red blood cells.

Washed red blood cells (RBCs) are indicated for immunoglobulin A (IgA) deficient recipients. Centrifugation-based cell processors commonly used by hospital blood banks cannot consistently reduce IgA below the recommended levels, hence double washing is frequently required. Here, we describe a prototype of a simple, portable, disposable system capable of washing stored RBCs without centrifugation, while reducing IgA below 0.05 mg/dL in a single run. Samples from RBC units (n = 8, leukoreduced, 4-6 weeks storage duration) were diluted with normal saline to a hematocrit of 10%, and then washed using either the prototype washing system, or via conventional centrifugation. The efficiency of the two washing methods was quantified and compared by measuring several key in vitro quality metrics. The prototype of the washing system was able to process stored RBCs at a rate of 300 mL/hour, producing a suspension of washed RBCs with 43 ± 3% hematocrit and 86 ± 7% cell recovery. Overall, the two washing methods performed similarly for most measured parameters, lowering the concentration of free hemoglobin by >4-fold and total free protein by >10-fold. Importantly, the new washing system reduced the IgA level to 0.02 ± 0.01 mg/mL, a concentration 5-fold lower than that produced by conventional centrifugation. This proof-of-concept study showed that centrifugation may be unnecessary for washing stored RBCs. A simple, disposable, centrifugation-free washing system could be particularly useful in smaller medical facilities and resource limited settings that may lack access to centrifugation-based cell processors.

Investigation of the quality of stored red blood cells after simulated air drop in the maritime environment.

BACKGROUND: Maritime medical capability may be compromised by blood resupply. Air-dropped red blood cells (RBCs) is a possible mitigation factor. This study set out to evaluate RBC storage variables after a simulated parachute air drop into the sea, as limited data exist. STUDY DESIGN AND METHODS: The air load construction for the air drop of blood was subject to static drop assessment to simulate a worst-case parachute drop scenario. One control and two test Golden Hour shipping containers were each packaged with 10 RBC units. The control box was not dropped; Test Boxes 1 and 2 were further reinforced with waterproof boxes and underwent a simulated air drop on Day 7 or Day 8 postdonation, respectively. One day after the drop and once a week thereafter until Day 43 of storage, RBCs from each box were sampled and tested for full blood counts, hemolysis, adenosine triphosphate, 2,3-diphosphoglycerate, pH, extracellular potassium, glucose, lactate, deformability, and RBC microvesicles. RESULTS: The packaging configuration completed the air drop with no water ingress or physical damage. All units met UK specifications for volume, hemoglobin, and hemolysis. There were no significant differences for any of the variables studied between RBCs in the control box compared to RBCs in Test Boxes 1 and 2 combined over storage. CONCLUSION: The test proved that the packaging solution and the impact of a maritime air drop as performed in this study, on Day 7 or Day 8 postdonation, did not affect the in vitro quality of RBCs in SAGM over storage for 35 days.

Implementation of a new blood cooler insert and tracking technology with educational initiatives and its effect on reducing red blood cell wastage.

BACKGROUND: The objective was to report a successful implementation of a blood cooler insert and tracking technology with educational initiatives and its effect on reducing red blood cell (RBC) wastage. STUDY DESIGN AND METHODS: The blood bank database was used to quantify and categorize total RBC units issued in blood coolers from January 2010 to December 2015 with and without the new inserts throughout the hospital. Radiofrequency identification tags were used with special software to monitor blood cooler tracking. An educational policy on how to handle the coolers was initiated. Data were gathered from the software that provided a real-time location monitoring of the blood coolers with inserts throughout the institution. RESULTS: The implementation of the blood cooler with inserts and tracking device reduced mean yearly RBC wastage by fourfold from 0.64% to 0.17% between 2010 and 2015. The conserved RBCs corresponded to a total cost savings of $167,844 during the 3-year postimplementation period. CONCLUSIONS: The implementation of new blood cooler inserts, tracking system, and educational initiatives substantially reduced the mean annual total RBC wastage. The cost to implement this initiative may be small if there is an existing institutional infrastructure to monitor and track hospital equipment into which the blood bank intervention can be adapted when compared to the cost of blood wastage.