Evaluation of microbial contamination associated with different preparation methods for neonatal intravenous fat emulsion infusion

Crill, Catherine M.; Hak, Emily B.; Robinson, Lawrence A.; Helms, Richard A.

doi:10.2146/ajhp090199

Cited by 25 publications

(35 citation statements)

References 22 publications

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“…188 Likewise, no growth has been seen after 24-hour infusion of IVFE direct from the manufacturer's container to pediatric patients. 179 Similarly, a single in vitro study has documented no contamination with drawn-down IVFE units when infused over 24 hours to pediatric patients. 179 In comparison, a 3.3% contamination rate has been reported for IVFE repackaged in syringes and infused over 12 hours, 179 while rates of 2.3%-6.6% have been reported for repackaged syringes infused over 19 hours or more.…”

Section: Question 11 What Methods Of Repackaging Ivfe Intomentioning

confidence: 99%

“…IVFE supports the growth of bacteria and fungi, [169][170][171][172][173][174][175] and microorganisms have been identified in IVFE after completion of infusion to patients. [176][177][178][179] Systemic infection in neonates has been linked to multiple bedside caregivers repeatedly withdrawing IVFE doses from a single IVFE unit. [180][181][182] In addition, administration errors with IVFE including overdose have been documented in neonates.…”

Section: Question 11 What Methods Of Repackaging Ivfe Intomentioning

confidence: 99%

“…[177][178][179]188 The methodologies for IVFE delivery that have been evaluated include separate infusion direct from the manufacturer's container, repackaged into a syringe, a drawn-down IVFE unit (ie, original manufacturer container with some of the volume purged aseptically), and repackaged bags with the use of an automated compounding device (ACD).…”

Section: Question 11 What Methods Of Repackaging Ivfe Intomentioning

confidence: 99%

“…IVFE is particularly susceptible to contamination or instability because of these unique formulation characteristics. 60,68,[176][177][178][179][188][189][190][191][192][193][194][195][196] Several factors contribute to risk of negative clinical outcomes due to compromised IVFE sterility or stability including effect of the container material, length of infusion, length of time between infusion set change, effect of infusion from source container such as infusion from the original container, infusion as an IVFE admixture, and infusion of IVFE transferred to a secondary container. 60,68,[176][177][178][179]188,[194][195][196] The BUD for unspiked IVFE in original packaging is dictated by the manufacturer's expiration date (Table 19).…”

Section: Recommendationmentioning

confidence: 99%

“…60,68,[176][177][178][179]188,[194][195][196] In addition, the Centers for Disease Control and Prevention provides no guidance on infectious risk for BUD of IVFE transferred to a secondary container. Instead, the most recent statement recommends IV tubing replacement every 24 hours for both IVFE infused separately or when given as part of a TNA.…”

Section: Table 20 (Continued)mentioning

confidence: 99%

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A.S.P.E.N. Clinical Guidelines

Boullata

Gilbert

Sacks

et al. 2014

J Parenter Enteral Nutr

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253

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Background: Parenteral nutrition (PN) is a high-alert medication available for patient care within a complex clinical process. Beyond application of best practice recommendations to guide safe use and optimize clinical outcome, several issues are better addressed through evidence-based policies, procedures, and practices. This document provides evidence-based guidance for clinical practices involving PN prescribing, order review, and preparation. Method: A systematic review of the best available evidence was used by an expert work group to answer a series of questions about PN prescribing, order review, compounding, labeling, and dispensing. Concepts from the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) format were applied as appropriate. The specific clinical guideline recommendations were developed using consensus prior to review and approval by the American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) Board of Directors. The following questions were addressed: (1) Does education of prescribers improve PN ordering? (2) What is the maximum safe osmolarity of PN admixtures intended for peripheral vein administration? (3) What are the appropriate calcium intake and calciumphosphate ratios in PN for optimal neonatal bone mineralization? (4) What are the clinical advantages or disadvantages of commercially available premade ("premixed") multichambered PN formulations compared with traditional/customized PN formulations? (5) What are the clinical (infection, catheter occlusion) advantages or disadvantages of 2-in-1 compared with 3-in-1 PN admixtures? (6) What macronutrient dosing limits are expected to provide for the most stable 3-in-1 admixtures? (7) What are the most appropriate recommendations for optimizing calcium (gluconate) and (Na-or K-) phosphate compatibility in PN admixtures? (8) What micronutrient contamination is present in parenteral stock solutions currently used to compound PN admixtures? (9) Is it safe to use the PN admixture as a vehicle for non-nutrient medication delivery? (10) Should heparin be included in the PN admixture to reduce the risk of central vein thrombosis? (11) What methods of repackaging intravenous fat emulsion (IVFE) into smaller patient-specific volumes are safe? (12) What beyond-use date should be used for (a) IVFE dispensed for separate infusion in the original container and (b) repackaged IVFE? (JPEN J Parenter Enteral Nutr. 2014;38:334-377)

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Section: Question 11 What Methods Of Repackaging Ivfe Intomentioning

confidence: 99%

Section: Question 11 What Methods Of Repackaging Ivfe Intomentioning

confidence: 99%

Section: Question 11 What Methods Of Repackaging Ivfe Intomentioning

confidence: 99%

Section: Recommendationmentioning

confidence: 99%

Section: Table 20 (Continued)mentioning

confidence: 99%

See 3 more Smart Citations

A.S.P.E.N. Clinical Guidelines

Boullata

Gilbert

Sacks

et al. 2014

J Parenter Enteral Nutr

Self Cite

253

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Microbiological and Endotoxin Contamination

Bohrer

2012

Sources of Contamination in Medicinal Products and Medical Devices

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Use of Intravenous Lipid Emulsions With Parenteral Nutrition: Practical Handling Aspects

Boullata

Berlana

Piętka³

et al. 2020

J Parenter Enteral Nutr

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A number of topics important to the handling of intravenous lipid emulsions (ILEs) were discussed at the international summit. ILE handling includes the preparation and the administration steps in the typical use of parenteral nutrition (PN). The discussion and consensus statements addressed several issues, including standardization of the PN process, use of commercially available multi‐chamber PN or compounded PN bags, the supervision by a pharmacist with expertise, limiting ILE repackaging, and infusion duration.

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Evaluation of microbial contamination associated with different preparation methods for neonatal intravenous fat emulsion infusion

Abstract: Repackaging IVFE into sterile syringes resulted in bacterial contamination and should be avoided in clinical practice. IVFE samples obtained using the drawdown procedure under sterile conditions for infusion over 24 hours revealed no microbial contamination.

Cited by 25 publications

References 22 publications

A.S.P.E.N. Clinical Guidelines

A.S.P.E.N. Clinical Guidelines

Microbiological and Endotoxin Contamination

Use of Intravenous Lipid Emulsions With Parenteral Nutrition: Practical Handling Aspects

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