Effectiveness of in-Line Filters to Completely Remove Particulate Contamination During a Pediatric Multidrug Infusion Protocol

Abstract

The large number of drugs administered simultaneously to neonates and children in hospital results in the formation of particles that are potentially infused. We have investigated the ability of IV in-line filters to eliminate particulate matter from multidrug infusion lines and so prevent contamination. The impact on particle occurrence of the internal volume of the IV line below the in-line filter was then evaluated. The multidrug therapy given to children was reproduced with and without in-line filtration. Three combinations with a filter were tested to vary the internal volume (V) between the filter and the catheter egress. The catheter was then connected to a dynamic particle count to evaluate the particulate matter potentially administered to children during infusion. The introduction of in-line filters led to a significant reduction in overall particulate matter, from 416,974 [208,479–880,229] to 7,551 [1,985–11,287] particles (p < 0.001). Larger particles of ≥10 and 25 µm were also significantly reduced. Adding an extension set to the egress of the in-line filter (V = 1.7 mL) caused a significant increase in particulate contamination for both. This study showed that in-line filtration is an effective tool in preventing particle administration to patients. Their position in the infusion in-line is therefore important because of its impact on internal volume and drug particle formation.

<p>Pharmaceutical Quality of Selected Metronidazole and Ciprofloxacin Infusions Marketed in South Eastern Nigeria</p>

“…The particulate contaminants can be detectable particles that are visible on visual inspection with sizes ≥50 µm or sub-visible particles that are not detectable on visual inspection with sizes varying between 2 and 50 µm 36 . Both visible and sub-visible particulate contaminations in parenteral fluids or solutions are dangerous [36][37][38][39][40] as these fluids are meant to pass through the blood vessels. The present study showed that the drug products are free from both visible and sub-visible particulate contaminations and their use cannot lead to the deleterious effects of particulate contamination.…”

Optimising an Infusion Protocol Containing Cefepime to Limit Particulate Load to Newborns in a Neonatal Intensive Care Unit

“…Currently, no standard recommendations have been issued by the three main Pharmacopoeias (European, American and Japanese) for dynamic particle counting. This work has been carried out in our laboratory using a new technique for the dynamic counting of non-visible particles (<50 µm) which indicates the potential particulate load to which patients are exposed [ 16 , 17 , 22 , 32 , 33 , 34 ]. With the use of this appliance, different assembly lines used for infusion protocols in intensive care units (adult, paediatric and neonatal) can be reproduced and studied in vitro.…”

“…With the use of this appliance, different assembly lines used for infusion protocols in intensive care units (adult, paediatric and neonatal) can be reproduced and studied in vitro. The results obtained make it possible to compare the particulate load of two infusion lines and thus highlight the reduced exposure to particles through the use of filters [ 16 , 17 , 22 , 33 ].…”

“…However, Bradley et al have reported that the use of a multi-lumen device does not prevent the formation of precipitate at the end of intravenous tubing [ 5 ]. Another solution is an in-line filtration to limit the administration of particles, particularly in neonatal and paediatric units [ 20 , 21 , 22 ], reducing associated respiratory, haematological and renal complications [ 7 ]. Whereas in some studies, the use of in-line filters in PICUs and NICUs has led to a significant decrease in the occurrence of systemic inflammatory response syndrome (SIRS), thrombosis and sepsis [ 6 , 21 ], other studies point to an absence of data supporting the significance of filters in reducing sepsis [ 23 ], phlebitis [ 24 ] or in preventing mortality or morbidity in newborns [ 25 , 26 ].…”

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

“…Variation exists in the lower range of particle sizes evaluated in these studies, which may reduce the ability to accurately determine the total number of particles in a given solution. However, estimates of the number of particles infused in critically ill neonates and children suggest that exposure to particles could approach or exceed 1 million particles measuring ≥2 microns each day 9,46,61,68 . Several investigators have advocated more widespread use of filters, especially for the critically ill 15 .…”