Update on the Use of Filters for Parenteral Nutrition: An ASPEN Position Paper

Patricia Worthington, Kathleen M Gura, Michael D Kraft, Reid Nishikawa, Peggi Guenter, Gordon S Sacks, ASPEN PN Safety Committee, Patricia Worthington, Kathleen M Gura, Michael D Kraft, Reid Nishikawa, Peggi Guenter, Gordon S Sacks, ASPEN PN Safety Committee

Abstract

Intravenous in-line filters play a critical role in promoting patient safety during parenteral nutrition (PN) administration. Guidelines for using filters for PN have been issued by a number of professional organizations and manufacturers of PN components. Yet despite this guidance, filter use remains controversial. Recent changes in recommendations for filtering lipid injectable emulsions have added to confusion and created considerable variation in practice. This Position Paper aims to review past guidance regarding the filtration of PN, examine the clinical consequences of infusing particulate matter, discuss the challenges and issues related to filtration, and clarify the American Society for Parenteral and Enteral Nutrition (ASPEN) recommendations for the use of filters for PN administration. This paper was approved by the ASPEN Board of Directors.

Keywords: filters; intravenous fat emulsions; lipid injectable emulsion; parenteral nutrition; patient safety.

© 2020 American Society for Parenteral and Enteral Nutrition.

References

    1. Sacks GS, Rough S, Kudsk KA. Frequency and severity of harm of medication errors related to the parenteral nutrition process in a large university teaching hospital. Pharmacotherapy. 2009;29(8):966-974.
    1. Ayers P, Adams S, Boullata J, et al. American Society for Parenteral and Enteral Nutrition. A.S.P.E.N. Parenteral nutrition safety consensus recommendations. JPEN J Parenter Enteral Nutr. 2014;38:296-333.
    1. Boullata JI, Gilbert K, Sacks GS, et al. A.S.P.E.N. clinical guidelines: parenteral nutrition ordering, order review, compounding, labeling, and dispensing. JPEN J Parenter Enteral Nutr. 2014;38(3):334-377.
    1. Food and Drug Administration safety alert: Hazards of precipitation associated with parenteral nutrition. Am J Hosp Pharm. 1994;51(11):1427-1428.
    1. American Society for Parenteral and Enteral Nutrition (ASPEN). Parenteral Nutrition-New Recommendations for In-line Filters. Accessed September 2, 2020.
    1. Infusion Nurses Society. Infusion therapy standards of practice. J Infus Nurs. 2016;2016(1S):S11-S159.
    1. Cohen MR, Smetzer JL. ISMP medication error report analysis. Selected medication safety risks to manage in 2016-Part I intravenous fat emulsion needs a filter. Hosp Pharm. 2016;51(5):353-357.
    1. ISMP Medication Safety Alert. ISMP Quarterly Action Agenda. Accessed September 2, 2020.
    1. Bethune K, Allwood M, Grainger C, Wormleighton C. Use of filters during the preparation and administration of parenteral nutrition: Position paper and guidelines prepared by a British pharmaceutical nutrition group working party. Nutrition. 2001;17(5):403-408.
    1. Puntis J, Hojsak I, Ksiazyk J; ESPGHAN/ESPEN/ESPR/CSPEN working group on pediatric parenteral nutrition. ESPGHAN/ESPEN/ESPR/CSPEN guidelines on pediatric parenteral nutrition: organizational aspects. Clin Nutr. 2018;37(6 Pt B):2392-2400.
    1. Martindale RG, Berlana D, Boullata JI, et al. Summary of proceedings and expert consensus statements from the international summit “Lipids in Parenteral Nutrition”. JPEN J Parenter Enteral Nutr. 2020;44 Suppl 1:S7-S20.
    1. Christensen ML, Ayers P, Boullata JI, et al. Lipid injectable emulsion survey with gap analysis. Nutr Clin Pract. 2017;32(5):694-702.
    1. Ball P. Intravenous in-line filters: filtering the evidence. Currt Opin Clin Nutr. 2003;6(3):319-325.
    1. Puntis JWL, Wilkins KM, Ball PA, Rushton DI, Booth IW. Hazards of parenteral treatment: do particles count? Arch Dis Child. 1992;67(12):1475-147
    1. Benlabed M, Perez M, Gaudy R, et al. Clinical implications of intravenous drug incompatibilities in critically ill patients. Anesth Crit Care Pain Med. 2019;38(2):173-180.
    1. Filtration Devices for Infusion Therapy & Drug Delivery. Pall Corporation. Published2020. Accessed September 2, 2020.
    1. Boehne M, Jack T, Köditz H, et al. In-line filtration minimizes organ dysfunction: new aspects from a prospective, randomized, controlled trial. BMC Pediatr. 2013;13:21.
    1. McKinnon BT. FDA safety alert: hazards of precipitation associated with parenteral nutrition. Nutr Clin Pract. 1996;11(2):59-65.
    1. Driscoll DF, Bacon MN, Bistrian B. Effects of in-line filtration on particle size in total nutrient admixtures. JPEN J Parenter Enteral Nutr. 1996;20(4):296-301.
    1. Matlow AG, Kitai I, Kirpalani H, et al. A randomized trial of 72- versus 24-hour intravenous tubing set changes in newborns receiving lipid therapy. Infect Control Hosp Epidemiol. 1999;20:487-493.
    1. Davis NN, Turco S, Sivelly E. Particulate matter in I.V. infusion fluids. Bull Parenter Drug Assoc. 1970;24(6):257-270.
    1. Davis NM, Turco S, Sivelly E. A study of particulate matter in I.V. infusion fluids. Am J Hosp Pharm. 1970;27(10):822-826.
    1. Davis NM, Turco S. A study of particulate matter in I.V. Infusion fluids-Phase 2. Am J Hosp Pharm. 1971;28(8):620-623.
    1. Turco SJ, Davis NM. Particulate matter in intravenous infusion fluids-Phase 3. Am J Hosp Pharm. 1973;30(7):611-613.
    1. Hill SE, Heldman LS, Goo ED, Whippo PE, Perkinson JC. Fatal microvascular pulmonary emboli from precipitation of a total nutrient admixture solution. JPEN J Parenter Enteral Nutr. 1996;20(1):81-87.
    1. Knowles, JB, et al, Pulmonary deposition of calcium phosphate crystals as a complication of home total parenteral nutrition. JPEN J Parenter Enteral Nutr. 1989; 13(2):209-213.
    1. Robinson LA, Wright BT. Central venous catheter occlusion caused by body-heat-mediated calcium phosphate precipitation. Am J Hosp Pharm. 1982;39(1):120-121.
    1. Breaux CW Jr, Duke D, Georgeson KE, Mestre JR. Calcium phosphate crystal occlusion of central venous catheters used for total parenteral nutrition in infants and children: prevention and treatment. J Pediatr Surg. 1987;22(9):829-832.
    1. Maki DG, Goldman Dam Rhame FS. Infection control in intravenous therapy. Ann Intern Med. 1973;79(6):867-887.
    1. Wilmore DW, Dudrick SJ. An in-line filter for venous solutions. Arch Surg. 1969;99(4):462-463.
    1. Jornitz MW, Akers, JE, Agalloco JP, Madsen RE, Meltzer TH. Considerations in sterile filtration. Part II: the sterilizing filter and its organism challenge: a critique of regulatory standards. PDA J Pharm Sci Technol. 2003;57(2):88-96.
    1. O'Grady NP, Dellinger EP, Gerberding JL, et al. Guidelines for the prevention of intravascular-catheter related infections. Morb Mortal Wkly Rep (MMWR). 2002;51(RR-10):1-29.
    1. Oie S, Kamiya A. Particulate and microbial contamination in in-use admixed parenteral nutrition solutions. Biol Pharm Bull. 2005;28(12):2268-2270.
    1. O'Grady NP, Alexander M, Burns LA, et al. Guidelines for the prevention of intravascular catheter-related infection. Clin Infect Dis. 2011;52(9):e162-e193.
    1. United States Pharmacopeia. Pharmaceutical compounding-sterile preparations (Chapter 797). In: The United States Pharmacopeia, 36th rev, and the National Formulary. Rockville, MD: The United States Pharmacopeial Convention; 2008.
    1. Mirtallo J, Canada T, Johnson D, et al. Safe practices for parenteral nutrition. JPEN J Parenter Enteral Nutr. 2004;28(6):S39-S69.
    1. Hirsch A. In line filters and injectable lipid emulsions. GASPEN Newsletter. 2019;(5):6-9.
    1. Intralipid 20%. Package insert. Fresenius Kabi; 2015.
    1. Nutrilipid. Package insert. B. Braun Medical Inc; 2017.
    1. Clinolipid. Package insert. Baxter Healthcare Corporation; 2016.
    1. SMOFlipid. Package insert. Fresenius Kabi; 2015.
    1. Omegaven. Package insert. Fresenius Kabi; 2018.
    1. VA Comprehensive Pharmacovigilance Center. Intralipid IV fat emulsion products in Biofine containers: particulate matter observed. Medication Safety Seconds. 2016;6(1):3.
    1. United States Pharmacopeia. Chapter <788>Particulate Matter in Injections. USP 35. In: The United States Pharmacopeia, 36th rev, and the National Formulary. Rockville, MD: US Pharmacopeial Convention; 2013.
    1. Tran T, Kupiec TC, Trissel LA. Particulate matter in injections: what is it and what are the concerns. Int J Pharm Compounding. 2006;10(3):202-204
    1. Langille SE. Particulate matter in injectable drug products. PDA J Pharm Sci Tech. 2013;67(3):186-200.
    1. Perez M, Maiguy-Foinard A, Barthelemy C, Decaudin B, Odou P. Particulate matter in injectable drugs: evaluation to risks to patients. Pharm Technol Hosp Pharm. 2016;1(2):91-103.
    1. Gordon S. Sacks, filtration of parenteral nutrition admixtures: friend or foe. Nutrition. 1997;13(10):936-937.
    1. Newton DW, Driscoll DF. Calcium and phosphate compatibility: revisited again. Am J Health Syst Pharm. 2008;65(1):73-80.
    1. Trissel LA, Gilbert DL, Martinez JF, Baker MB, Walter WV, Mirtallo JM. Compatibility of medications with 3-in-1 parenteral nutrition admixtures. JPEN J Parenter Enteral Nutr. 1999;23(2):67-74.
    1. Lehr H-A, Brunner J, Rangoonwala R, Kirkpatrick CJ. Particulate matter contamination of intravenous antibiotics aggravates loss of functional capillary density in postischemic striated muscle. Am J Respir Crit Care Med. 2002;165(4):514-520.
    1. Perez M, Decaudin B, Maiguy-Foinard A, et al. Dynamic image analysis to evaluate subvisible particles during continuous drug infusion in a neonatal intensive care unit. Sci Rep. 2017;7(1):9404.
    1. Townsley MI. Structure and composition of pulmonary arteries, capillaries and veins. Compr Physiol. 2013;2(1):675-709.
    1. Krishna A, Rice M, Kester T, Waters M, Wilson T. Particulate study on NeoProfen, a neonatal injectable product. PDA J Pharm Sci Technol. 2016;70(1):76-92.
    1. Shay DK, Fann LM, Jarvis WR. Respiratory distress and sudden death associated with receipt of a peripheral parenteral nutrition admixture, Infect Control Hosp Epidemiol. 1997;18(12):814-817.
    1. McNearney T, Bajaj C, Boyars M, Cottingham J, Haque A. Total parenteral nutrition associated crystalline precipitates resulting in pulmonary artery occlusions and alveolar granulomas. Dig Dis Sci. 2003;48(7):1352-1354.
    1. Reedy JS, Kuhlman JE, Voytovich M. Microvascular pulmonary emboli secondary to precipitated crystals in a patient receiving total parenteral nutrition: a case report and description of the high- resolution CT findings. Chest. 1999;115(3):892-895.
    1. Melchore JA. Sound practices for consistent human visual inspection. AAPS Pharm Sci Tech. 2011;12(1):215-221.
    1. Das T, Nema S. Protein particulate issues in biologics development. Am Pharm Rev. 2008;11(3):52-57.
    1. Corvari V, Narhi LO, Spitznagel TM, et al. Subvisible (2-100 μm) particle analysis during biotherapeutic drug product development: Part 2, experience with the application of subvisible particle analysis. Biologicals. 2015;43(6):457-473.
    1. Jack T, Brent BE, Muller M, et al. Analysis of particulate contamination of infusion solutions in pediatric intensive care unit. Intensive Care Med. 2010;36(4):707-711.
    1. Ball PA, Bethune K, Fox J, et al. Particulate contamination in parenteral nutrition solutions: still a cause for concern. Nutrition. 2001;17:926-929.
    1. Hardy G, Puzovic M. Formulation, stability, and administration of parenteral nutrition with new lipid emulsions. Nutr Clin Pract. 2009;24(5):616-25.
    1. United States Pharmacopeia. Chapter <729>. Globule Size Distribution in Lipid Emulsions. In: The United States Pharmacopeia, 36th rev, and the National Formulary. Rockville, MD: United States Pharmacopeia; 2019.
    1. FDA Intralipid Alerts. . Accessed December 16, 2019.
    1. Food and Drug Administration. Intralipid 20 Percent IV Fat Emulsion by Baxter: Recall - One Shipment of Product Exposed to Subfreezing Temperatures. Published October 5, 2017. Accessed September 2, 2020.
    1. Perez M, Decaudin B, Abou Chala W, et al. In vitro analysis of overall particulate matter contamination exposure during multidrug IV therapy: Impact of infusion sets. Pediatr Blood Cancer. 2015;62(6):1042-1047.
    1. Perez M, Decaudin B, Chahla WA, et al. Effectiveness of in-line filters to completely remove particulate contamination during a pediatric multidrug infusion protocol. Sci Rep. 2018;8(1):1-8.
    1. Jack T, Boehne M, Brent BE, et al. In-line filtration reduces severe complications and length of stay on pediatric intensive care unit: A prospective, randomized, controlled trial. Intensive Care Med. 2012;38(6):1008-1016.
    1. Benlabed M, Martin Mena A, Gaudy R,et al. Analysis of particulate exposure during continuous drug infusion in critically ill adult patients: a preliminary proof-of-concept in vitro study. Intensive Care Med Exp. 2018;6(1):38.
    1. Foster JP, Richards R, Showell MG, Jones LJ. Intravenous in-line filters for preventing morbidity and mortality in neonates. Cochrane Database Syst Rev. 2015;(8):CD005248.
    1. Schmitt E, Meybohm P, Herrmann E, et al. In-line filtration of intravenous infusion may reduce organ dysfunction of adult critical patients. Crit Care. 2019;23:373.
    1. Gill M. Filtering out the Facts: Recommendations to Optimize Performance of In-Line Filters for Parenteral Nutrition and Intravenous Fat Emulsion Infusions. BD. Published August 2019. Accessed January 27, 2020.
    1. Chau D, Gish B, Tzanetos D, Zhang C. A dangerous side of in-line filter when used for vasoactive infusions in infants. APSF newsletter. 2013;28(2):43
    1. IV in-line Filter FAQs. CareFusion 2010. Published 2010. Accessed October 5, 2020.
    1. Newton DW. Y-site compatibility of intravenous drugs with parenteral nutrition. JPEN J Parenter Enteral Nutr. 2013;37(3):297-299.
    1. Canadian Vascular Access Association. Occlusion management guideline for central vascular access devices (CVADs). J Can Vascular Access Assoc. 2013;7(Suppl. 1):3-31.

Source: PubMed

3
Se inscrever