Particulate and Microbial Contamination in In-Use Admixed Parenteral Nutrition Solutions

Abstract

Particulate matters such as glass particles that enter the body, being contained in infusion solutions not only cause infusion-related phlebitis but also have been suggested to damage various organs such as the lungs, brain, kidneys, liver, and spleen. [1][2][3][4] However, in Asian countries such as Japan, adequate attention is not paid to particulate contamination of parenteral solutions. For example, many drugs in glass ampoules are added to parenteral nutrition solutions, and preuse filtration is rarely performed in the preparation of parenteral nutrition solutions in the dispensary or ward. In addition, many medical institutions do not use in-line filters at the time of administration of admixed parenteral nutrition solutions. One of the reasons for the lack of adequate attention to particulate contamination of parenteral solutions may be poor recognition of this contamination because of only a few previous studies on in-use admixed parenteral nutrition solutions.5-7) Therefore, we evaluated particulate contamination of in-use admixed parenteral nutrition solutions and also microbial contamination of these solutions. MATERIALS AND METHODSWe collected residual solutions in bags of in-use parenteral nutrition solutions in 10 hospitals (215-756 beds) in Yamaguchi Prefecture, Japan, and evaluated particulate and microbial contamination in these residual solutions (total, 199 samples). Seven of the 199 samples were used as controls because they had not been mixed with ampoules or vials (unadmixed parenteral nutrition solutions).The size and number of particles were measured using a light blockage particle counter KL-04 (Rion K.K., Tokyo, Japan). In addition, the volume of the residual solution in the bag was measured. Of the 192 samples, one (50 ml residual solution) [termed admixed solution A: composition; one bag of 1700 ml sugar/electrolytes/amino acid, one vial of a vitamin complex preparation (Maltamin ® ), two glass ampoules of 1 ml/A panthol (Pantol ® ), two glass ampoules of 20 ml/A sodium chloride (Conclyte-Na ® ), two glass ampoules of 2 ml/A metoclopramide (Primperan ® ), and two glass ampoules of 10 ml/A potassium L-aspartate (Aspara K ® )] was passed through 0.22 mm membrane filters, 5 cm in diameter (Nippon Becton Dickinson Co., Tokyo, Japan), and the particles on this filter were observed and identified using a scanning electron microscope JSM-5600LV coupled to an energy dispersion spectroscope JEO-2200 (JMS, Tokyo, Japan).Microorganisms were quantified by the filter filtration method. The residual solution (5 ml) in the bag was passed through 0.22 mm membrane filters (5 cm in diameter), and 100 ml sterile physiological solution was passed through the filters to eliminate carry-overs such as sugar and amino acid on the filter. The filters were placed on Trypticase soy agar II with 5% sheep blood (Nippon Becton Dickinson Co., Tokyo, Japan) and incubated for 1-7 d at 30°C.The number of particles in residual solutions was compared according to the particle size (Ն1.3 mm, Ն5 mm, Ն10 mm, Ն50 mm) betwe...

Particulate and Microbial Contamination in In-Use Admixed Intravenous Infusions

“…These results were consistent with the presence of a large amount of glass fragments in hyperalimentation fluids admixed with glass ampoule drugs observed in our previous study. 9) Therefore, for the prevention of mixture of particles such as glass fragments, pre-filled syringe drugs may be useful.…”

A Systematic Review and Meta-Analysis of the Risk of Microbial Contamination of Aseptically Prepared Doses in Different Environments

“…It is noteworthy that in one of the three controlled studies that examined this hypothesis using individual doses (and another excluded study (34)), no infections were noted as a result of additions (N = 150 (16) and N = 192 (34)). However, it seems that these studies are underpowered and their overall quality considered to be poor according to the GRADE criteria (44,45).…”

Avoid Drug Incompatibilities: Clinical Context in Neonatal Intensive Care Unit (NICU)

“…These particles can come directly from the preparation (glass or rubber fragments) or be linked to the existence of drug incompatibilities in the context of a multi-infusion [20]. The administration of these particles can have serious consequences for the patient, as endothelial lesions and thrombosis [21,22], and the use of inline filters has been shown to reduce the number of general complications and Systemic Inflammatory Response Syndrome (SIRS) [23].…”