Leakage of isopropanol from port protectors used in neonatal care—Results from an in vitro study

Abstract

Background To decrease contamination of needleless catheter hubs, caps or port protectors impregnated with isopropanol (IPA) have been developed and shown to be superior to other disinfection methods. The safety of the caps has been questioned, as they can be associated with alcohol leakage across the hub membrane. Objectives We evaluated the use of IPA caps and the scrub-the-hub method from the safety standpoint of possible alcohol leakage across the hub membrane. Methods Circuits imitating an intravenous line were constructed. Circuits with an IPA cap were flushed with sodium chloride after the hub had been exposed to the cap for 1 hour, 24 hours, and 7 days. At the end of each period the fluid was collected and amounts of IPA in it were measured, using gas chromatography. Scrub circuits without IPA caps were also tested and ethanol from these was measured using the same method. Results In this in vitro study, IPA was detected in all samples from cap circuits, and ethanol was detected from all scrub circuits. Leakage increased over time in IPA circuits. After 24 hours and 7 days of exposure, the first injection resulted in higher amounts of IPA; thereafter, the levels decreased. The amounts of ethanol measured from the scrub circuits were low. Conclusions IPA caps can cause leakage of alcohol across the hub membrane. Leakage increased over time, and a 30 sec drying time was not sufficient to solve the problem. Scrub-the-hub seems safe to use with regard to alcohol leakage.

In vitro assessment of isopropanol leakage from antiseptic barrier caps into commonly used needleless connectors

“…The combination Safeflow and Swabcap showed a maximum isopropanol leakage of 1.755 mg after 24 hours, compared to 2.066 mg in our study. Due to the different methodologies used in the literature (which aimed to mimic the real-world conditions 19,20 ) and in our study (which aimed to determine how much isopropanol passes from the ABC to downstream of the NC), the comparison of the results is difficult. However, the results in the literature and in our study are of the same order of magnitude: Safeflow leaks more isopropanol than Bionector 19 and Smartsite leaks more isopropanol than Caresite.…”

“…Due to the different methodologies used in the literature (which aimed to mimic the real-world conditions 19,20 ) and in our study (which aimed to determine how much isopropanol passes from the ABC to downstream of the NC), the comparison of the results is difficult. However, the results in the literature and in our study are of the same order of magnitude: Safeflow leaks more isopropanol than Bionector 19 and Smartsite leaks more isopropanol than Caresite. 20 Interestingly, the leakage hypotheses are also supported by the findings of Rickard et al, 22 who reported that 2 NCs (Smartsite or MaxPlus, unspecified) became opaque during their study of ABCs, suggesting that isopropanol appears to have seeped between the inner rubber and outer plastic, denaturing the plastic.…”

“…19,20 Hjalmarsson et al 19 reported isopropanol leakage ranging from 0.154 to 0.405 mg after 24 hours depending on the NC–ABC combination used (ie, Swan-lock or Bionector coupled to SwabCap or Curos). 19 Particularly, the combination of Bionector and SwabCap showed a maximum isopropanol leakage of 0.372 mg after 24 hours, compared to 1.220 mg in our study. The combination Safeflow and Swabcap showed a maximum isopropanol leakage of 1.755 mg after 24 hours, compared to 2.066 mg in our study.…”

“…However, in 2 recent studies, isopropanol contained in the ABCs leaked into the NC, raising safety questions about potential isopropanol exposure to patients during routine care, particularly in a pediatric and neonatal intensive care settings. 19,20 To date, no publication has compared a wide range of NCs with respect to the parameters influencing the leakage of isopropanol from ABC to the NC.…”

SHEA Neonatal Intensive Care Unit (NICU) White Paper Series: Practical approaches for the prevention of central-line–associated bloodstream infections

“…Disinfectant caps containing 70% isopropyl alcohol placed over intravenous needleless connectors act as antiseptic barriers by passive disinfection, decreasing hub colonization. 31 Two in vitro studies found leakage of alcohol through the hub membrane, 32,33 but the potential clinical significance of this leakage is unknown. Adverse effects resulting from alcohol leakage in a clinical setting have not been identified.…”