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Risk of particulate contamination

TIME:2016-12-26 15:39:45

What is the particulate contamination?

Particulate contamination describes the unintended presence of extraneous, mobile and undissolved particles in a parenteral solution. These particles can be of various size,defining them as detectable by visual inspection (in general ≥ 50 μm) or as sub-visible with a range of 2-50 μm in size in general. Especially the sub-visible sized particles demand specific analytical tests for their detection (BSP 2009; USP 2009).

 

The causes of particulate contamination

Several causes of particulate contaminations of IV fluids are known. This is because drugs are available in various containers (like vials, ampoules, pre-filled containers and premixed solutions) and their usage and manipulations are highly diversified.

Consequently, many types of particle contamination can occur:

uGlass

uPlastic

uRubber

uUndissolved particles/drugs

 

Glass ampoules especially pose a high risk of particulate contamination, as glass fragments may enter the ampoule when it is opened [Douglas et al. 2001]. If a needle (for example 18G) is used for removing a glass ampoule’s content, small glass particles can pass through the needle into the syringe and easily be injected into patients. This risk remains if drugs are routinely administered via the injection port of the intravenous cannula, which is a safety measure designed to decrease sharps injuries to the medical staff [Lye 2003].

 

Plastic contamination occurs frequently due to particles from the infusion container’s raw material itself and from the injection port due to its usage with sharp items [Walpot et al. 1989]. The insertion of a needle through the stopper of a medication vial or infusion container can shear off a small piece of the stopper. This particle may float in the medication or IV solution. If the particle is small or masked (e.g. by the label, a matching background or a colored vial), the contamination may be unnoticed. The particle may then be aspirated into a syringe and injected into a patient [Roth 2007]. 

 

Undissolved solids in drugs or parenteral solutions can also be an origin of particulate contamination [Durgan et al. 2004]. A further frequent cause of particles occurs as a consequence of incompatibilities. This is an undesirable reaction between an admixtured drug and the carrier solution, the container or further drugs added to the IV solution itself. Incompatibilities can also be present when various solutions are mixed in infusion lines and catheters for parenteral administration. As one consequence of an incompatibility, precipitations can occur leading to the particulate contamination [Josephson 2006, RCN 2005, Douglas et al. 2001].

 

The occurrence of contamination was shown by Preston et al.[2004], who identified glass particles bigger than 130 μm in 57 % of the controlled injectable solutions. Additionally, Lye [2003] found in a number of more than 500 glass ampoules an average of 0.22 glass particles per unit. The injection of such particles into the body of the patient is therefore a prominent risk.

 

Prominent risks of particulate contamination

The particles from plastic, glass or rubber can have unfavorable effects, especially in patients who are already ill. Particles as small as 1.5 μm can cause blockages in patients, whereas particles of 6 μm can cause blockages in healthy subjects

[Lehr et al. 2002; Anonymous 2004]. Damage to various organs, such as the lungs, kidneys, liver and spleen are described in general [Yorioka et al. 2006, Lye 2003, Puntis et al. 1992, Walpot et al. 1989, Turco et al. 1971], but particularly affected are severely ill patients [Jack et al. 2009, Oie et al. 2005, DeLuca et al. 1975, Schroeder et al. 1976, Turco et al. 1971]. Patients with prior organ damage are especially sensitive, as particles can exacerbate their impaired blood micro-circulation [Anonymous 2004, Lehr et al. 2002]. A further clinical sign that can be caused by glass particles from glass ampoules is phlebitis [Yorioka et al. 2006, DeLuca et al. 1975, Schroeder et al. 1976]. Phlebitis is evident as local warmth, with pain, swelling and reddening at the affected site of parenteral administration [Grunewald et al. 2004]. 

 

The infusion of glass particles can lead to pulmonary silicotic changes and nodular fibrosis of the liver, spleen and small intestines as a result of foreign body reaction [Lye 2003, Sabon et al. 1989]. Also, glass fragments in drugs have been shown to induce an adult respiratory distress syndrome and pulmonary artery granuloma in immature infants [Yorioka et al. 2006, Puntis et al. 1992, Walpot et al. 1989]. Contamination with silicone particles can lead to granulomatous lung disease [Bowen et al. 1981]. Other complications recorded in association with plastic migration include lung disease [Rodriguez et al. 1989], myocarditis [Kossovsky et al. 1990], and skin rash [Ellenbogen et al. 1975]. These contaminations have been

reported after migration of large volumes of plastic. Little is known about the effect of silicone in humans over a long period. Animal studies demonstrated minimal reactions in the brain [Dewan et al.1995a] and lungs [Dewan et al. 1995b; publications ex Dewan et al.2002]. Rubber complications range from clinically occult pulmonary granulomas to local tissue infarction and pulmonary infarction. [Roth 2007, Lehr et al. 2002].

 

Particles from plastic, glass or rubber can cause phlebitis and also damage the lungs, kidneys, liver and spleen. Apart from harming patients, this may lead to additional treatment costs as well as extended duration of hospital stays.

 

 

Literature

Anonymous. Risks due to particles in infusion therapy-experts promote use of infusion filters (Transl.: Gefahren durch Partikel in der Infusions therapie–Experten fordern Einsatz von Infusionsfiltern). Krankenpfl J 2004; 42(3-4): 97

 

Bowen JH, Woodard BH, Barton TK, Ingram P and Shelburne JD. Infantile pulmonary hypertension associated with foreign body vasculitis. Am J Clin Pathol 1981; 75(4): 609-14

 

BSP: British Pharmacopoeia, 2009

 

DeLuca PP, Rapp RP, Bivins B, McKean HE and Griffen WO. Filtration and infusion phlebitis: a double-blind prospective clinical study. Am J Hosp Pharm 1975; 32(10): 1001-7

 

Dewan PA, Ehall H, Edwards GA, Middleton DJ, Terlet J. Plastic particle migration during intravenous infusion assisted by a peristaltic finger pump in an animal model. Pediatr Surg Int 2002; 18(5-6):310-4

 

Douglas JB, Hedrick C. Pharmacology. In: Perucca R. Infusion therapy equipment: types of infusion therapy equipment. In: Infusion therapy in clinical practise. Philadelphia: Saunders 2001; 176-208

 

Durgin JM, Hanan ZI. Thomson Delmar Learning's Pharmacy Practice for Technicians 2004; 227

 

Ellenbogen R, Rubin L. Injectable fluid silicone therapy. Human morbidity and mortality. JAMA 1975; 234(3): 308-9

 

Grunewald M, Kobbert E, Terodde H. Pflege von Patienten mit Erkrankungen des Herz-Kreislauf- und Gefassystems. In: Kellnhauser E, Schewior-Popp, et al. Thiemes Pflege. Stuttgart, New York: Thieme 2004; 316-317

 

 

Jack T, Boehne M, et al. In-line filtration reduces the incidence of SIRS in critically ill children. Poster presentation, ISICEM 2009

 

Josephson DL. Risks, complications, and adverse reactions associated with intravenous infusion therapy. In: Josephson DL. Intravenous infusion therapy for medical assistants. The American association of Medical Assistants. Clifton Park: Thomson Delmar Learning 2006; 56-82

 

Kossovsky N, Cole P, Zackson DA. Giant cell myocarditis associated with silicone. An unusual case of biomaterials pathology discovered at autopsy using X-ray energy spectroscopic techniques. Am J Clin Pathol 1990; 93(1): 148-52

 

Lehr HA, Brunner J, Rangoonwala R and 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): 514-20

 

Lye ST, Hwang NC. Glass particle contamination: is it here to stay? Anaesthesia 2003; 58(1): 93-4

 

Oie S, Kamiya A. Particulate and microbial contamination in in-use admixed parenteral nutrition solutions. Biol Pharm Bull 2005; 28(12): 2268-70

 

Rodriguez MA, Martinez MC, Lopez-Artiguez M, Lusia M, Bernier F. and Repetton M. Lung embolism with liquid silicone. J Forensic Sci 1989; 34(2): 504-10

 

Preston ST, Hegadoren K. Glass contamination in parenterally administered medication. J Adv Nurs 2004; 48(3): 266-70

 

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

 

RCN. Royal College of Nursing. Standards for infusion therapy. 2005

 

Roth JV. How to enter a medication vial without coring. Anesth Analg 2007; 104(6): 1615

 

Sabon RL Jr, Cheng EY, Stommel KA and Hennen C. Glass particle contamination: infl uence of aspiration methods and ampule types. Anesthesiology 1989; 70(5): 859-62

 

Schroeder HG, DeLuca PP. Particulate matter assessment of aclinical investigation on fi ltration and infusion phlebitis. Am J Hosp Pharm 1976; 33(6): 543-6

 

Turco SJ, Davis NM. Detrimental effects of particulate matter on the pulmonary circulation. JAMA 1971; 217(1): 81-2

 

USP: United States Pharmacopeia, 2009

 

Walpot H, Franke RP, Burchard WG, Agternkamp C, Muller FG, Mittermayer C, Kalff G. The filter effectiveness of common 15-micron filters (DIN 58362). II: Scanning electron microscopy and roentgen analysis. Infusions therapie 1989; 16(3): 133-9

 

Yorioka K, Oie S, Oomaki M, Imamura A and Kamiya A. Particulate and microbial contamination in in-use admixed intravenous infusions. Biol Pharm Bull 2006; 29(11): 2321-3


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