Polyvinyl Chloride Blood Bags Research Articles

High‐performance liquid chromatography–ultraviolet detection method to evaluate the migration of di(2‐ethylhexyl) terephthalate and its metabolite from polyvinyl chloride bag in four labile blood products

AbstractA 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.

In vitro evaluation of di(2-ethylhexyl)terephthalate-plasticized polyvinyl chloride blood bags for red blood cell storage in AS-1 and PAGGSM additive solutions.

Di(2-ethylhexyl)phthalate (DEHP) makes polyvinyl chloride flexible for use in blood bags and stabilizes the red blood cell (RBC) membrane preventing excessive hemolysis. DEHP migrates into the blood product and rodent studies have suggested that DEHP exposure may be associated with adverse health effects albeit at high dosages. Although structurally and functionally similar to DEHP, di(2-ethylhexyl)terephthalate (DEHT; or Eastman 168 SG [Eastman Chemical Company]) is metabolically distinct with a comprehensive and benign toxicology profile. This study evaluated RBC stability in DEHT-plasticized bags with AS-1 and PAGGSM compared to conventional DEHP-plasticized bags with AS-1. Thirty-six whole blood units were collected into CPD solution, leukoreduced, centrifuged, and divided into RBCs and plasma. To limit donor-related variability, three ABO-identical RBCs were mixed together and then divided equally and stored among the three different plasticizer and additive solution combinations. RBCs from 12 trios were analyzed for a standard panel of in vitro variables on Day 0 and after storage. No individual bag on Day 42 exceeded the US 1.0% hemolysis criteria. While hemolysis during storage was higher in the DEHT bags, the PAGGSM RBCs were close to the control RBCs (0.38% vs. 0.32%, respectively). ATP retention was higher than 70% and potassium levels were similar regardless of plasticizer. Additional RBC variables exhibited some significant differences but were not viewed as clinically important. DEHT/PAGGSM provides similar hemolysis protection to that of DEHP/AS-1. Although hemolysis values with DEHT and AS-1 are higher than that of DEHP, DEHT is a potential DEHP alternative.

Pilot study on novel blood containers with alternative plasticizers for red cell concentrate storage.

Di (2-ethylhexyl) phthalate (DEHP), a typical plasticizer used for polyvinyl chloride (PVC) blood containers, is eluted from the blood containers and exerts protective effects on red blood cells. However, a concern for detrimental effects of DEHP on human health has led to the development of potential DEHP substitutes. Here, we compared the red blood cell preservation ability of two types of non-DEHP blood containers with safe alternative plasticizers to that of DEHP blood containers. Red cell concentrates in mannitol-adenine-phosphate solution (MAP/RCC) were stored for 6 weeks in PVC blood bags containing DEHP, di-isononyl-cyclohexane-1,2-dicarboxylate (DINCH) and di (2-ethylhexyl) 4-cyclohexene-1,2-dicarboxylate (DOTH), or 4-cyclohexene-1,2-dicarboxylic acid dinonyl ester (DL9TH) and DOTH. There was no significant difference in the total amount of plasticizer eluted into MAP/RCC (till 3 weeks from the beginning of the experiment), hemolysis of MAP/RCC, and osmotic fragility of MAP/RCC between the non-DEHP blood containers and DEHP blood containers. Hematological and blood chemical indices of MAP/RCC in all containers were nearly the same. Thus, DOTH/DINCH and DOTH/DL9TH blood containers demonstrate the same quality of MAP/RCC storing as the DEHP blood containers. Since DOTH, DINCH, and DL9TH were reported to be safe, DOTH/DINCH and DOTH/DL9TH blood containers are promising candidate substitutes for DEHP blood containers.

TREATMENT OF DISCARDED BLOOD UNITS: DISINFECTION WITH HYPOCHLORITE / FORMALIN VERSUS STEAM STERILIZATION

Blood bank regulations and bio medical waste rules of India advocate disinfection of contaminated blood units. Incineration is not recommended due to poly-vinyl chloride (PVC) content of blood bags. This study was designed to evaluate the efficacy of chemical disinfection of blood units deliberately contaminated with Staphylococcus aureus and E. coli with 1 and 6 % hypochlorite, 10% formalin and 33% formaldehyde and autoclaving of blood units contaminated with the above mentioned vegetative forms and B. stearothermophilus spores. Only 33 % formaldehyde could bring about 5 log reduction of bacteria but it is highly irritating and toxic. Autoclaving at 15 lbs pressure for 2 hours uniformly inactivated the vegetative forms and B. stearothermophilus spores. Thus, autoclaving of PVC blood bags is a safer and reliable method compared to chemical disinfection.

Increased Lipid Peroxidation of Erythrocytes in Blood Stored in Polyvinyl Chloride Blood Storage Bags Plasticized with Di‐[2‐Ethyl Hexyl] Phthalate and Effect of Antioxidants

Abstract Background and Objectives: Previous work in this laboratory has shown significant decrease in vitamin E in erythrocytes in blood stored in polyvinyl chloride (PVC) bags plasticized with di‐[2‐ethyl hexyl] phthalate (DEHP), and in erythrocytes incubated in vitro with DEHP. Since vitamin E is a major antioxidant, a study was carried out to find out whether this decrease observed in vitamin E has an effect on lipid peroxidation in blood stored in DEHP‐plasticized PVC blood bags. Materials and Methods: Blood was collected in Penpol blood storage bags (which is a DEHP‐plasticized PVC bag) and parameters of lipid peroxidation, i.e. activity of superoxide dismutase (SOD), catalase, glutathione peroxidase, glutathione reductase, concentration of malondialdehyde (MDA), conjugated dienes, hydroperoxides, glutathione and vitamin E studied in erythrocytes after various periods of storage as compared to glass bottles. Erythrocytes were also incubated in vitro with DEHP with and without vitamin E, and changes in lipid peroxidation studied. Results:Blood stored in Penpol bags showed increased lipid peroxidation in erythrocytes as compared to that stored in glass bottles, as is evident from a greater increase in MDA and a greater decrease in glutathione and a significant decrease in vitamin E. The addition of vitamin E decreased the formation of MDA and conjugated dienes and prevented the decrease in vitamin E. However in spite of increased lipid peroxidation in the presence of DEHP, the release of K+ and hemoglobin from erythrocytes was lower. When there was an increase in DEHP taken up by erythrocytes, there was a corresponding decrease in vitamin E. More important, whenever there was an increase in vitamin E in erythrocytes (when RBCs in the presence of DEHP were incubated with vitamin E), there was a progressive decrease in DEHP. Conclusion: DEHP caused increased lipid peroxidation in erythrocytes. At the same time, it decreased the release of K+ and hemoglobin from erythrocytes. It is possible that the stabilizing effect of DEHP on the erythrocyte membrane may offset the detrimental effects of the increased lipid peroxidation it causes.

Increased Lipid Peroxidation of Erythrocytes in Blood Stored in Polyvinyl Chloride Blood Storage Bags Plasticized with Di-[2-Ethyl Hexyl] Phthalate and Effect of Antioxidants

Background and Objectives: Previous work in this laboratory has shown significant decrease in vitamin E in erythrocytes in blood stored in polyvinyl chloride (PVC) bags plasticized with di-[2-ethyl hexyl] phthalate (DEHP), and in erythrocytes incubated in vitro with DEHP. Since vitamin E is a major antioxidant, a study was carried out to find out whether this decrease observed in vitamin E has an effect on lipid peroxidation in blood stored in DEHP-plasticized PVC blood bags. Materials and Methods: Blood was collected in Penpol blood storage bags (which is a DEHP-plasticized PVC bag) and parameters of lipid peroxidation, i.e. activity of superoxide dismutase (SOD), catalase, glutathione peroxidase, glutathione reductase, concentration of malondialdehyde (MDA), conjugated dienes, hydroperoxides, glutathione and vitamin E studied in erythrocytes after various periods of storage as compared to glass bottles. Erythrocytes were also incubated in vitro with DEHP with and without vitamin E, and changes in lipid peroxidation studied. Results: Blood stored in Penpol bags showed increased lipid peroxidation in erythrocytes as compared to that stored in glass bottles, as is evident from a greater increase in MDA and a greater decrease in glutathione and a significant decrease in vitamin E. The addition of vitamin E decreased the formation of MDA and conjugated dienes and prevented the decrease in vitamin E. However in spite of increased lipid peroxidation in the presence of DEHP, the release of K⁺ and hemoglobin from erythrocytes was lower. When there was an increase in DEHP taken up by erythrocytes, there was a corresponding decrease in vitamin E. More important, whenever there was an increase in vitamin E in erythrocytes (when RBCs in the presence of DEHP were incubated with vitamin E), there was a progressive decrease in DEHP. Conclusion: DEHP caused increased lipid peroxidation in erythrocytes. At the same time, it decreased the release of K⁺ and hemoglobin from erythrocytes. It is possible that the stabilizing effect of DEHP on the erythrocyte membrane may offset the detrimental effects of the increased lipid peroxidation it causes.

Migration of a phthalate ester plasticizer from polyvinyl chloride blood bags into stored human blood and its localization in human tissues

Abstract A plasticizer, di-2-ethylexyl phthalates, was found to be extracted from polyvinyl chloride plastic blood bags by both human and dog blood at 4°C at a rate of 0.25±0.03 mg per 100 ml per day. Plasticizer was found in both the lipid-containing and lipid-free fractions of plasma whereas red cells contained only minor amounts. Seven of 12 lung-tissue samples taken at autopsy from patients who had received transfusions of stored blood contained detectable amounts of plasticizer. One patients, after open-heart surgery, excreted a urinary metabolite of the plasticizer in excess of the amount calculated to have been received in the transfused blood. The additional metabolite possibly came from plasticizer extracted from the polyvinyl chloride tubing of the cardiopulmonary unit. Although the toxicology implications of these observations are not currently known, it is suggested that tractable materials to blood or its fractions be developed.

Migration of a phthalate ester plasticizer from polyvinyl chloride blood bags into stored human blood and its localization in human tissues

Migration of a phthalate ester plasticizer from polyvinyl chloride blood bags into stored human blood and its localization in human tissues

The effect of different agitation modes on platelet metabolism, thromboxane formation, and alpha‐granular release during platelet storage

Platelet concentrates (PCs), prepared by plateletpheresis, were stored in aliquots in polyvinylchloride blood bags for 5 days at 22 degrees C under rapid, slow, or no agitation. Nonagitated PCs were also stored in a 98-percent oxygen atmosphere. In nonagitated PCs, pO2, lactate production, and platelet factor 4 (PF 4) concentration increased, whereas the ATP level and pH dropped rapidly. These changes were somewhat minimized in nonagitated PCs stored in oxygen. There was no significant difference between the two agitated groups. The increase in PF 4 correlated inversely to the decrease in ATP: r = -0.91, p less than 0.001, n = 24. The formation of thromboxane B2 (TxB2) after stimulation with arachidonic acid or collagen was significantly higher in slowly agitated PCs on Day 5 than on Day 0 (p less than 0.01). Nonagitated PCs produced lower levels of TxB2 (collagen stimulation) on Day 5 (p less than 0.05). In unstimulated PCs, the levels of TxB2 and ATP were inversely correlated on Day 5 (r = -0.70, p less than 0.001, n = 20). In vivo survival was performed after 72 hours of storage; mean survival (+/- SD) was 6.5 (+/- 0.3) days for nonagitated oxygenated PCs and 6.8 (+/- 0.7) days for agitated PCs. In nonagitated PCs, anaerobic metabolism increased, although oxygen diffusion through the container wall was sufficient. Agitation seems to facilitate the diffusion of oxygen through the storage medium. Nonagitated PCs were stored safely for 24 hours; this period can be extended to at least 72 hours when aerobic metabolism is maintained.

Storage of platelets on flatbed agitators in polyvinyl chloride blood bags plasticized with tri(2-ethylhexyl) trimellitate.

Data are presented showing that platelets in polyvinyl chloride blood bags plasticized with tri(2-ethylhexyl) trimellitate can be stored on flatbed agitators (shakers) without the pH falling below 6.0. The lowest pH seen after 7 days of storage in 46 units with platelet yields ranging from 3.6 to 13.3 X 10(10) per unit was 6.43. These bags have a O2 transmission rate of 13.3 mumol per hour per bag. Platelet bags with a O2 transmission rate of 7.9 mumol per hour per bag experience a pH fall after 5 days of storage on the shaker in units whose platelet yield on average exceeds 10 X 10(10). Platelets can be stored on first-generation shakers (70 cycles/min, stroke = 1 inch) without an attempt at manual resuspension of the platelet button. The count after 30 minutes on the shaker averaged 89 +/- 15 percent of the expected count, indicating that resuspension was nearly complete after a relatively short period. Red cells, but not platelets, settled out during storage on the shaker.

Phthalate ester toxicity in human cell cultures

Di-2-ethylhexyl phthalate and butyl glycolyl butyl phthalate, plasticizers which can be leached into blood from polyvinyl chloride-containing medical devices, cause significant growth inhibition in cultures of the human diploid cell strain WI-38. The ID50 (dose which causes 50% growth inhibition in tissue culture) values for di-2-ethylhexyl phthalate and butyl glycolyl butyl phthalate were 70 μ m and 12 μ m, respectively, for WI-38 cells. Toxic effects were greater in a replicating cell population than in a nonreplicating, confluent cell layer. WI-38 cells which were grown in 160 μ m di-2-ethylhexyl phthalate for 3 days, and subsequently subcultured into control medium, showed only 60% of control growth after 5 days in control medium. Cells treated with 14 μ m butyl glycolyl butyl phthalate for 3 or 5 days exhibited growth equivalent to the controls when subcultured into control medium. Toxic levels for di-2-ethylhexyl phthalate were within the range of concentrations found in blood which has been stored in polyvinyl chloride blood bags for up to 21 days at 4°C. ID50 values were reported for several other phthalate esters and for two nonphthalide compounds which are leachable from certain polyvinyl chloride plastic medical devices.

2584. Transfused phthalate from PVC blood bags: Jaeger, R. J. & Rubin, R. J. (1972). Migration of a phthalate ester plasticizer from polyvinyl chloride blood bags into stored human blood and its localization in human tissues. New Engl. J. Med.287, 1114

2584. Transfused phthalate from PVC blood bags: Jaeger, R. J. & Rubin, R. J. (1972). Migration of a phthalate ester plasticizer from polyvinyl chloride blood bags into stored human blood and its localization in human tissues. New Engl. J. Med.287, 1114

2584. Transfused phthalate from PVC blood bags: Jaeger, R. J. & Rubin, R. J. (1972). Migration of a phthalate ester plasticizer from polyvinyl chloride blood bags into stored human blood and its localization in human tissues. New Engl. J. Med.287, 1114

2584. Transfused phthalate from PVC blood bags: Jaeger, R. J. & Rubin, R. J. (1972). Migration of a phthalate ester plasticizer from polyvinyl chloride blood bags into stored human blood and its localization in human tissues. New Engl. J. Med.287, 1114

Migration of a phthalate ester plasticizer from polyvinyl chloride blood bags into stored human blood and its localization in human tissues.

A plasticizer, di-2-ethylhexyl phthalate, was found to be extracted from polyvinyl chloride plastic blood bags by both human and dog blood stored at 4°C at a rate of 0.25 ± 0.03 mg per 100 ml per day. Plasticizer was found in both the lipid-containing and lipid-free fractions of plasma whereas red cells contained only minor amounts. Seven of 12 lung-tissue samples taken at autopsy from patients who had received transfusions of stored blood contained detectable amounts of plasticizer. One patient, after open-heart surgery, excreted a urinary metabolite of the plasticizer in excess of the amount calculated to have been received in the transfused blood. The additional metabolite possibly came from plasticizer extracted from the polyvinyl chloride tubing of the cardiopulmonary unit. Although the toxicologic implications of these observations are not currently known, it is suggested that plastic formulations that do not contribute any extractable materials to blood or its fractions be developed.