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Objective To compare the quality and safety of platelet-rich plasma (PRP) by blood bag and monopheresis. Methods A retrospective analysis was performed on 66 patients treated with autologous PRP therapy in the blood transfusion department of First Affiliated Hospital of Army Medical University from July 2019 to August 2021. According to preparation procedure, they were divided into blood bag group (n=30, with 47 times of preparation) and monopheresis group (n=36, with 36 times of preparation). The counts of erythrocytes, leukocytes and platelets and product multiples in the PRP products were detected and compared between the 2 groups. Adverse reactions were recorded and safety was evaluated. Results The preparation time, product volume, product concentration and product multiple were significantly better in the monopheresis group than the blood bag group (P < 0.01). The amount of mixed red blood cells was statistically less in the blood bag group than the apheresis group (P < 0.01). There was no notable difference in the amount of mixed white blood cells between the 2 groups. No adverse reactions were seen in both groups. Conclusion The monopheresis PRP products have higher platelets concentration than those by blood bag and need shorter time of procedure group. Therefore, monopheresis is recommended as first choice and blood bag as the alternative.

BACKGROUND: With blood component therapy becoming the standard of care in transfusion medicine globally, the quality control (QC) of these components has become a routine and mandatory program in all blood centers. Extensive utilization of blood components has been observed in our multidisciplinary tertiary care hospital. We use quadruple bag systems and automated component extraction facilities for collection and processing of whole blood (WB). In this study, we analyzed our data relating to QC of all blood components which we prepare and issue for transfusion. MATERIALS AND METHODS: The retrospective 5-year study comprised 47,430 WB collections which were separated into blood components using quadruple bags and automated component extraction machine. A total of 90 units of WB were processed into blood components for the machine calibration and validation. Routine use of the system was started once the calibration and validation results were acceptable. At least 1% of each component prepared was subjected to QC as per departmental standard operating procedures. Statistical analysis was done using the SPSS statistical package. RESULTS: The mean volume, hematocrit (Hct), platelet (PLT), and white blood cell (WBC) in 350 and 450 mL WB units were 394.63 mL, 39.43%, 0.93 × 1011, and 3.12 × 109 and 507.75 mL, 40.72%, 1.13 × 1011, and 3.45 × 109, respectively, with mean recovery of PLT and WBC in buffy coat being 95.54% and 68.63% and 97.87% and 74.51%, respectively. As high as 89.91% RBC recovery was noted in the packed red blood cell units which were subjected to QC. QC of random donor platelets was performed in 979 (2.36%) units with acceptable results. The mean fibrinogen and FVIII values were estimated to be 469.17 mg and 217.34 IU (1.07 IU/mL) and 600.21 mg and 273.39 IU (1.11 IU/mL) in fresh frozen plasma units prepared from 350 and 450 mL WB, respectively. A total of 578 (1.62%) units of cryoprecipitate were investigated for QC with favorable results. CONCLUSION: We conclude that QC data generated in this study will provide invaluable information about the performance of the latest blood collection systems. QC of all blood components under study complied with both national and international standards. We opine that all blood centers should establish a complete QC program and adhere to departmental protocols and manufacturer's instructions for its execution and effective outcome.

The presence of DEHP in PVC-based medical bags poses a significant health risk to patients undergoing blood transfusion. In order to fabricate safer medical fluid bag materials, the use of SEBS/PP polymer blend as a potential material was investigated. Polymeric blends with varying weight percentages of styrene-ethylene-butylene-styrene/polypropylene (SEBS/PP) were fabricated by melt mixing using an internal Haake mixer. The physical properties of the SEBS/PP polymer blends were investigated using differential scanning calorimetry (DSC), X-ray diffraction (XRD), and inductively coupled plasma–mass spectrometry (ICP-MS). In addition, measurements of the mechanical strength (tensile strength and Young's modulus) as per ASTM 638, polymer hardness was tested using a durometer and swelling was analysed through water absorption and compared with commercial PVC-based blood bags. The results indicate that the SEBS/PP 50/50 blend has approximately similar characteristics as PVC-based blood bags. The SEBS/PP polymer blend possesses approximate tensile strength and Young's modulus with values of 23.28 MPa and 14.42 MPa, respectively, to that of the conventional PVC blood bags. The results show that the SEBS/PP polymer blends have negligible zinc and aluminium migration with values of 1.6 and 2.1 mg/kg, respectively, and do not elute any harmful leachates, while the thermal studies indicate that the studied SEBS/PP materials are capable of withstanding steam sterilisation at 120 °C and cold storage below −40 °C. The investigated material can be utilized for medical fluid bags and contributes towards sustainable development goals, such as SDG 3 to ensure healthy lives and promote well-being, as well as SDG 12 to ensure sustainable consumption and production patterns. [ABSTRACT FROM AUTHOR]

BACKGROUND: With blood component therapy becoming the standard of care in transfusion medicine globally, the quality control (QC) of these components has become a routine and mandatory program in all blood centers. Extensive utilization of blood components has been observed in our multidisciplinary tertiary care hospital. We use quadruple bag systems and automated component extraction facilities for collection and processing of whole blood (WB). In this study, we analyzed our data relating to QC of all blood components which we prepare and issue for transfusion. MATERIALS AND METHODS: The retrospective 5-year study comprised 47,430 WB collections which were separated into blood components using quadruple bags and automated component extraction machine. A total of 90 units of WB were processed into blood components for the machine calibration and validation. Routine use of the system was started once the calibration and validation results were acceptable. At least 1% of each component prepared was subjected to QC as per departmental standard operating procedures. Statistical analysis was done using the SPSS statistical package. RESULTS: The mean volume, hematocrit (Hct), platelet (PLT), and white blood cell (WBC) in 350 and 450 mL WB units were 394.63 mL, 39.43%, 0.93 × 1011, and 3.12 × 109 and 507.75 mL, 40.72%, 1.13 × 1011, and 3.45 × 109, respectively, with mean recovery of PLT and WBC in buffy coat being 95.54% and 68.63% and 97.87% and 74.51%, respectively. As high as 89.91% RBC recovery was noted in the packed red blood cell units which were subjected to QC. QC of random donor platelets was performed in 979 (2.36%) units with acceptable results. The mean fibrinogen and FVIII values were estimated to be 469.17 mg and 217.34 IU (1.07 IU/mL) and 600.21 mg and 273.39 IU (1.11 IU/mL) in fresh frozen plasma units prepared from 350 and 450 mL WB, respectively. A total of 578 (1.62%) units of cryoprecipitate were investigated for QC with favorable results. CONCLUSION: We conclude that QC data generated in this study will provide invaluable information about the performance of the latest blood collection systems. QC of all blood components under study complied with both national and international standards. We opine that all blood centers should establish a complete QC program and adhere to departmental protocols and manufacturer's instructions for its execution and effective outcome. [ABSTRACT FROM AUTHOR]

A liquid chromatography with UV detection method has been developed and validated for the quantitation of di(2‐ethylhexyl)terephthalate, a blood bag plasticizer, and its monoester metabolite, mono(2‐ethylhexyl)terephthalate, in the four labile blood products: whole blood, red cells concentrate, plasma and platelet concentrate. Quantitation thresholds were compared with those obtained using the more conventional tandem mass spectrometry detection and revealed that UV performed better than mass spectrometry for the quantitation of di(2‐ethylhexyl)terephthalate. Liquid‐liquid extraction was selected for sample preparation. Recoveries ranged from 101 to 106 and from 80 to 83%, for di(2‐ethylhexyl)terephthalate and mono(2‐ethylhexyl)terephthalate, respectively, depending on the labile blood product. Repeatability and intermediate precision expressed as relative standard deviation were lower than 20% at the lower limit of quantitation and ranged from 1.9 to 11.2% for the other concentration levels. Regarding the trueness, bias ranged from ‐13.6 to 11.8%. The method was validated considering a total error of ± 20%. Lower limits of quantitation ranged from 500 to 680 nM for di(2‐ethylhexyl)terephthalate and were equal to 500 nM for mono(2‐ethylhexyl)terephthalate. Migration of di(2‐ethylhexyl)terephthalate from polyvinyl chloride blood bags was investigated and mono(2‐ethylhexyl)terephthalate concentrations were determined in each labile blood product. [ABSTRACT FROM AUTHOR]

The use of phthalates as a plasticizer in plasticized polyvinyl chloride (PVC) always poses the threat of migration of phthalates into the environment through medical equipment. Phthalates can be used with natural-based plasticizers, such as Epoxidized soybean oil (ESBO) known as phthalate’s scavenger and PVC stabilizers. PVC formulations were characterized by different combinations of di (2-ethylhexyl) phthalate (DEHP) 30-40% with 5% ESBO. PVC flexibility increased significantly in the presence of ESBO, without a change in strength (tensile test). The decrease of the Tg temperature by adding ESBO in Differential Scanning Calorimetry indicated that ESBO preserved DEHP in the polymer. Also, it was shown that the sterilization process with Ethylene Oxide, similar to ESBO, decreased the Tg of polymer. DEHP migration was evaluated at a maximum level to the environment using the Gas Chromatography test. Samples containing ESBO showed less hemolysis. ABSTRAK: Penggunaan phthalates sebagai plasticizer dalam plastik polyvinyl chloride (PVC) selalu menimbulkan ancaman penghijrahan phthalates ke alam sekitar melalui peralatan perubatan. Phthalates boleh digunakan dengan plasticizer berasaskan semula jadi, seperti minyak kacang soya Epoxidized (ESBO) yang dikenali sebagai pemulung phthalate dan penstabil PVC. Formulasi PVC dicirikan oleh kombinasi yang berbeza di (2-ethylhexyl) phthalate (DEHP) 30-40% dengan 5% ESBO. Fleksibiliti PVC meningkat dengan ketara di hadapan ESBO, tanpa perubahan kekuatan (ujian tegangan). Penurunan suhu Tg dengan menambahkan ESBO dalam Calorimetri Pengimbasan Berbeza menunjukkan bahawa ESBO mengekalkan DEHP dalam polimer. Juga, ditunjukkan bahawa proses pensterilan dengan Etilena Oksida, serupa dengan ESBO, menurunkan Tg polimer. Penghijrahan DEHP dinilai pada tahap maksimum ke lingkungan menggunakan uji Kromatografi Gas. Sampel yang mengandungi ESBO menunjukkan kurang hemolisis.

A novel inverter-based digital floating-gate MOSFET sensor design for commercial X-ray dosimetry is presented. The biomedical healthcare industry sterilizes blood products for storage purposes using Gamma and X-ray radiations. This requires an ultra-low-power dosimeter that ensures irradiation does not exceed the maximum allowable 50 Gy while providing the required minimum levels of 25 Gy. In this work, minimum-sized MOS transistor devices are employed in an inverter configuration, eliminating the continuous flow of current and reducing power consumption significantly. Maximum measured currents, which flow only during the transition period, are in the nA range, compared to continuous currents of conventional sensor designs in the μA range. Final measured results show the viability of the proposed design for radiation dosimetry applications. [ABSTRACT FROM AUTHOR]

The presence of DEHP in PVC-based medical bags poses a significant health risk to patients undergoing blood transfusion. In order to fabricate safer medical fluid bag materials, the use of SEBS/PP polymer blend as a potential material was investigated. Polymeric blends with varying weight percentages of styrene-ethylene-butylene-styrene/polypropylene (SEBS/PP) were fabricated by melt mixing using an internal Haake mixer. The physical properties of the SEBS/PP polymer blends were investigated using differential scanning calorimetry (DSC), X-ray diffraction (XRD), and inductively coupled plasma–mass spectrometry (ICP-MS). In addition, measurements of the mechanical strength (tensile strength and Young’s modulus) as per ASTM 638, polymer hardness was tested using a durometer and swelling was analysed through water absorption and compared with commercial PVC-based blood bags. The results indicate that the SEBS/PP 50/50 blend has approximately similar characteristics as PVC-based blood bags. The SEBS/PP polymer blend possesses approximate tensile strength and Young’s modulus with values of 23.28 MPa and 14.42 MPa, respectively, to that of the conventional PVC blood bags. The results show that the SEBS/PP polymer blends have negligible zinc and aluminium migration with values of 1.6 and 2.1 mg/kg, respectively, and do not elute any harmful leachates, while the thermal studies indicate that the studied SEBS/PP materials are capable of withstanding steam sterilisation at 120 °C and cold storage below −40 °C. The investigated material can be utilized for medical fluid bags and contributes towards sustainable development goals, such as SDG 3 to ensure healthy lives and promote well-being, as well as SDG 12 to ensure sustainable consumption and production patterns.

Free hemoglobin (FHB) concentration is considered a prospect quality indicator for erythrocyte suspensions (ES) under storage. Storage lesions alter the optical properties of ES and can be monitored by diffuse reflectance spectroscopy. Due to storage lesions, erythrocytes lyse and release hemoglobin into the extracellular medium. The purpose of the study is to model and assess the quality of ES units in a blood bank with diffuse reflectance measurements together with hematological variables reflecting absorption and scattering characteristics of ES. FHB concentrations were modeled based on the increased scattering in the extracellular medium. A semiempirical model was used for relating optical properties of ES to the diffuse reflectance measurements. The attenuation in the blood bag was computed and its influence was discarded via normalization, in accordance with Monte Carlo simulations. In the experiments, 40 ES units were measured multiple times during prolonged storage of 70 days. A generalized linear model was used for modeling the training set, and, in the validation, the highest correlation coefficient between predicted and actual FHB concentrations was 0.89. Predicting the actual value was accurate at a maximum level of R² = 0.80. The error rate of the model in diagnosing the true quality was about 10%. [ABSTRACT FROM AUTHOR]

The aim of RBC storage system in a blood bank is to counteract damage to the metabolic machinery and the membrane, to improve post-transfusion viability. In recent years, the need for strict control over the quality of blood has been emphasised. Such quality indicator includes extend of hemolysis and morphological changes of RBC during storage. This study was design to see extend of hemolysis and level of plasma lactate dehydrogenase (LDH) and plasma potassium, during processing and storage at different intervals under blood bank condition. Forty-six donors were selected and blood units were collected and stored under blood bank conditions. Mean plasma haemoglobin of stored blood was estimated by tetra methyl benzidine method (TMB) and percentage hemolysis was calculated on day 0, 1, 7, 21, 28, 35 and 42 days. Similarly plasma LDH and plasma potassium level was also assessed during storage. It was noted that free haemoglobin level and percentage hemolysis progressively increased with storage along with the level of LDH and potassium. However, extend of hemolysis did not exceed the permissible limit of 0.8% up to 42 days of storage. 15 blood bags which showed visual hemolysis on day 28 did not exceeded the threshold of 0.8% hemolysis, when interpreted by TMB method. It was concluded that TMB method is better than visual method for determination of hemolysis. The reduced hemolysis at this centre may be accounted for the use of additive solution SAGM (Saline, Adenine, Glucose, Mannitol) and DEHP (di-2-ethyl hexyl phthalate) as plasticizer in blood bags for storage. [ABSTRACT FROM AUTHOR]

NHS Blood and Transplant Tissue and Eye Services (TES) and Scottish National Blood Transfusion Services Tissues and Cells Directorate (TCD) currently bank whole, frozen femoral head bone from living donors who are undergoing primary hip replacement surgery. When required, the bone is issued to a surgeon still frozen on dry ice (- 79 °C). Consequently, the femoral head bone is not processed, is not sterilised and at the time of issue, it contains donor blood, bone marrow and associated cells. We have previously shown that, cut, shaped and washed bone from deceased donors can be processed to remove up to 99.9% of blood, bone marrow and associated cells (Eagle et al. 2015). However, cut and shaped bone is not suitable for some orthopaedic procedures and some orthopaedic surgeons do not wish to use irradiated bone; therefore in this report, a method has been developed in which whole femoral heads can be washed to remove donor blood and bone marrow components. Processing results in excess of 99% bone marrow component removal-soluble protein, haemoglobin and DNA; the procedure is performed inside a closed system, thereby eliminating the need for terminal sterilisation by irradiation. In addition, uniaxial testing demonstrated no difference in compressive strength between washed and unwashed bone. We suggest that this washed bone may be capable of improving incorporation after grafting without disturbing biomechanical properties of the graft. [ABSTRACT FROM AUTHOR]

Commercial infusion tubing and blood storage devices (tubing, blood and platelets bags) made of plasticized PVC were analyzed by spectroscopic, chromatographic and microscopic techniques in order to identify and quantify the additives added to the polymer (lubricants, thermal stabilizers, plasticizers) and to put into evidence their blooming onto the surface of the devices. For all the samples, deposits were observed on the surface but with different kinds of morphologies. Ethylene bis amide lubricant and metallic stearate stabilizers were implicated in the formation of these layers. In contact with aqueous media, these insoluble deposits were damaged, suggesting a possible particulate contamination of the infused solutions. [ABSTRACT FROM AUTHOR]

Current research analyzes the prevalence of ineptitude of blood donor candidates in a Hemotherapy Nucleus in Três Lagoas MS Brazil between 2007 and 2010. Prevalence in blood bag disposal was determined by positive serology and self-exclusion, coupled to the serumepidemiological characterization of disposals. During the period, some 12,303 people intended to donate blood but only 9,989 were successful, an ineptness prevalence between 15.6% and 22.3%. The main ineptitude causes were risk behavior for STDs (between 13.3% and 19.0%) in the case of male candidates; anemia (between 29.7% and 42.0%) and hypotension (between 17.7% and 43.6%) in female candidates. Within a total of 9.989 blood bags, disposal prevalence during the period ranged between 4.0% and 5.4%. In positive serology, disposal rate lay between 2.9% and 4.2%, whereas by self-exclusion it ranged between 0.9 and 1.3%. The main serological markers which caused disposals of blood bags comprised hepatitis B (anti-HBc - between 36.7% and 46.5%; HBsAg - between 3.8% and 17.8%); hepatitis C (between 7.9% and 26.9%), syphilis (between 5.4% and 22.8%), Chagas's disease (between 5.1% and 12.1%) and HIV (4.3% and 10.1%). Results show a high ineptitude rate for blood donation, even though disposal rates of blood bags tended towards a decrease which was probably due to campaigns in hemotherapy centers to increase the amount of repeated donors. [ABSTRACT FROM AUTHOR]

Three EBA specified blood bag configurations ('Eurobloodpack') are described which are capable of meeting >80% of its member's requirements. These include a 'top-and-top' and two 'bottom-and-top' packs enabling aseptic, pre-donation collection of up to 40 ml of samples, 427·5-522·5 ml of whole blood and the preparation of an extensive range of blood components. Features currently beyond the scope of ISO standardisation have been controlled including: anticoagulant and additive volumes; collection needle and sampling system; transfer tubing; cross-match line; base label; leucodepletion filter performance; compatibility of access ports and transfusion sets. Eurobloodpack has significant advantages for blood services and blood bag manufacturers. [ABSTRACT FROM AUTHOR]

Abstract: In the present research, the potential use of flexible disposable devices, specifically blood bags, for the fractionation of biological products using Aqueous Two-Phase Systems (ATPS) polymer–salt is studied and demonstrated. Purified human serum albumin (HSA) was used as model protein. Experiments were carried out on ATPS polyethylene glycol (PEG)–potassium phosphate constructed on rigid recipients (conical tubes) and flexible devices (blood bags). The device used for ATPS construction had no significant effect on HSA partition behavior. Protein partition towards the top phase was favored on systems constructed using PEG 1000g/mol and TLL 45% (w/w), achieving up to 85% recovery. On the other hand a recovery of 92% was achieved at the bottom phase when PEG 3350g/mol and TLL 25% (w/w) were used. Human serum was used as a complex sample on ATPS experiments. Selective fractionation of human serum proteins on ATPS constructed on flexible devices was achieved. ATPS constructed on blood bags required short equilibrium times (< 6min), meaning it is feasible to use this approach on mass scale. The potential use of flexible disposable devices, for the fractionation of biological products using ATPS polymer–salt was demonstrated. [Copyright &y& Elsevier]

Background and Objectives ISO standards for blood bags do not adequately define and control the dimensions of blood bag transfer tubing. This lack of standardization presents potential difficulties when making sterile connections between the wide range of tubing that has evolved in the absence of such standards. We aim to validate the suitability of the TSCD-II and provide a minimum standard for assessing the suitability of sterile connections (welds) between dissimilar tubing. Materials and Methods The Terumo TSCD-II was used in this study to connect by hermetic welding seven tubing types with a wide range of dimensions from five suppliers. Thirty sterile connections were made between each combination split between dry/dry, wet/wet and dry/wet connections. Welds were assessed for visual defects, by tensile stress test (TST) and pressure tests. Results All welds passed visual inspection and pressure tests. All welds had a minimum tensile strength of greater than 40 N and mean of greater than 45 N. Conclusion Successful connections have been made between dissimilar tube types and this work does not support the requirement for ‘tight’ tubing dimensional specifications. We have recommended to the ISO Technical Committee 76 Work Group 1 that ISO 3826-1 be revised and should include a minimum standard validation protocol for joining dissimilar tubing. [ABSTRACT FROM AUTHOR]

Abstract: Background: The US FDA and The Ministry of Health, Labor and Welfare of Japan have indicated that the risk assessment of di(2-ethylhexyl) phthalate (DEHP) released from polyvinyl chloride (PVC) medical devices requires immediate attention. In particular, the analysis of the exposure to DEHP from blood bags is very important for medical treatment. However, human exposure to DEHP via blood transfusion remains poorly understood. We evaluated DEHP and mono(2-ethylhexyl) phthalate (MEHP) levels, migration patterns, and metabolism in blood products for the detailed assessment of exposure to DEHP. Methods: A method that is based on column-switching liquid chromatography–electrospray mass spectrometry (LC–MS) coupled with on-line extraction was used for the direct analysis of DEHP and MEHP in the blood products. From the Japanese Red Cross Society, 78 blood products (red blood cell concentrate: n =18, irradiated red blood cell concentrate: n =18, whole blood: n =18, blood platelet: n =18, and frozen plasma: n =6) were sampled in January 2003 for use in this study. Results: The detection levels of DEHP and MEHP ranged from 1.8 to 83.2 μg/ml and from 0.1 to 9.7 μg/ml, respectively. The levels of MEHP and DEHP in the blood products were increased with increasing storage time. In addition, whole blood products in PVC bags had the highest DEHP levels compared to the other blood products. Our results indicate that the maximum level of human exposure to DEHP released from blood bags is 0.7 mg/kg weight/time. Conclusion: This first quantitative evidence may be useful for the risk assessment of DEHP released from blood bags. [Copyright &y& Elsevier]

ToF-SIMS with Ga+ ion as primary source is used to analyze plasticizers like bis(2-ethylhexyl) phthalate (DEHP) from the inner surface of the blood bags and their migration into the blood. Food packing materials were also analyzed for the presence of DEHP. The simplicity of using ToF-SIMS with high mass resolution as an aid in the identification and analysis are discussed. The ToF-SIMS results, the fragmentation pattern, and the ratio of ions were comparable to those obtained from traditional GC–MS analysis. This indicates that ToF-SIMS could be a promising technique for direct detection of DEHP (and phthalates in general) in blood bags and food packaging polymeric materials. [Copyright &y& Elsevier]