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Particulate Contamination in Pediatrics & Neonatology

What is Particulate Contamination

Particulate contamination is the unintended presence of extraneous, mobile, and undissolved particles in parenteral solutions.3, 4 

Causes of particulate contamination are primarily drugs that are present in various containers (e.g., vials, ampoules, pre-filled containers, and premixed solutions). Many types of particulate contamination derive from glass, plastic, rubber and/or undissolved solids. These particles can vary in size and may cause serious damage to neonatal and pediatric patients. 

 

Did you know that is estimated that 1 Mio. particles per day are infused in an ICU setting?1,2

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References

1. Mehrkens HH, Klaus E, Schmitz JE. Possibilities of material contamination due to additional injections. Klin Anasthesiol Intensivther. 1977;14:106-13.

2. Walpot H, Franke RP, Burchard WG, Agternkamp C, Müller FG, Mittermayer C, Kalff G. Particulate contamination of infusion solutions and drug additives within the scope of long-term intensive therapy. 1. Energy dispersion electron images in the scanning electron microscope-REM/EDC. Anasthesist. 1989;38(10):544-8.

3. Werner BP, Winter G. (2015) Particle contamination of parenteralia and in-line filtration of proteinaceous drugs. Int J Pharm;496(2):250-67

4. Doessegger L, Mahler HC, Szczesny P, Rockstroh H, Kallmeyer G, Langenkamp A, Herrmann J, Famulare J. (2012) The potential clinical relevance of visible particles in parenteral drugs. J Pharm Sci; 101(8): 2635-44

5. Jack T. Micro Particles Contamination. Innocent Bystander or Real Threat? 2012 (Presentation: „_Micro Particles Contamination_Jack_MHH_2012“).

6. Boehne M, Jack T, Köditz H, Seidemann K, Schmidt F, Abura M, Bertram H, Sasse M. In-line filtration minimizes organ dysfunction: new aspects from a prospective, randomized, controlled trial. BMC Pediatr. 2013;13:21.

7. Puntis JW, Wilkins KM, Ball PA, Rushton DI, Booth IW. Hazards of parenteral treatment: do particles count? Arch Dis Child 1992 Dec;67(12):1475–7.

8. Breaux CW, 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 Sep;22(9):829–32.

9. Bradley JS, Wassel RT, Lee L, Nambiar S. Intravenous ceftriaxone and calcium in the neonate: assessing the risk for cardiopulmonary adverse events. Pediatrics 2009 Apr;123(4):e609–13.

10. Monte SV, Prescott WA, Johnson KK, Kuhman L, Paladino JA. Safety of ceftriaxone sodium at extremes of age. Expert Opin Drug Saf 2008 Sep;7(5):515–23.

11. Perez M, Maiguy-Foinard A, Barthélémy C, Décaudin B, Odou P. Particulate Matter in Injectable Drugs: Evaluation of Risks to Patients. Pharmaceutical Technology in Hospital Pharmacy 2016;1(2):91-103.

12. Van Lingen RA, Baerts W, Marquering ACM, Rujis GJHM. The use of in-line filtration in sick newborn infants. Acta paediatrica 2004; 93:1-5.

13. Heyman S. Toxicity and safety factors associated with lung perfusion studies with radiolabeled particles. J Nucl Med Off Publ Soc Nucl Med 1979 Oct;20(10):1098–9.

14. Lofthus RM, Srebnik HH. The physical dimensions of the human neonatal cardiovascular system. J Biomech Eng 1987 Nov;109(4):336–9.

15. Bethune K Allwood M, Grainger C, Wormleighton C; British Pharmaceutical Nutrition Group Working Party. (2001) 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;17(5):403-8.

16. Virlouvet AL, Pansiot J, Toumazi A et al. In-line filtration in very preterm neonates: a randomized controlled trial. Sci Rep 2020; 10(5003).

17. Jack T, Boehne M, Brent BE, Hoy L, Köditz H, Wessel A, Sasse M. In-line filtration reduces severe complications and length of stay on pediatric intensive care unit: a prospective, randomized, controlled trial. Intensive Care Med. 2012; 38:1008–1016.