Use of quantitative microbiological analyses to trace origin of contamination of parenteral nutrition solutions

Abstract

In the summer of 2010, parenteral nutrition (PN) admixtures were administered to neonates in the Pediatric Department of the University Medical Center Mainz that provoked severe clinical sequelae. Contamination of a dummy infusion with Enterobacter cloacae and Escherichia hermannii was detected on the day of the incident, and the same isolates were subsequently grown from all PN admixtures as well as from the parent amino acid solution from which the admixtures had been prepared. Quantitative microbiological analyses paired with the determination of endotoxin concentrations enabled the conclusion to be reached that the amino acid solution had represented the primary source of contamination, which must have occurred in the distant past and may have derived from passage of the bacteria through a crack in the glass container. The findings have large implications, and the approaches employed should become of value when similar incidents occur again in the future.

In-use physicochemical and microbiological stability of biological parenteral products

“…If a microorganism with a higher growth rate than the ones tested happened to contaminate the compounded product, holding times solely derived from the microbial challenge study would be misleading. 59,64,65 In addition, it is not feasible to distinguish different risk levels of contamination during aseptic preparation of various products at the same working session. Therefore, all products must be handled with the same diligence, and this preparation practice should be based on the products most sensitive to contamination.…”

“…Although specific i.v. filters, such as 0.2-mm positively charged nylon filters, have been shown to bind endotoxin 59 and have been sometimes used (e.g., for administration of total parenteral nutrition compounded from various components for pediatric use in hospital pharmacies), it is imperative to ensure the absence of contamination.…”

Prävention von Gefäßkatheter-assoziierten Infektionen bei Früh- und Neugeborenen

“…Bei einer Zubereitung in der Apotheke kommt es im Vergleich zur Zubereitung auf der Station signifikant seltener zu einer bakteriellen Kontamination [207,208]. Es sind auch Ausbrüche aufgrund der Kontamination von industriell hergestellten Parenteralia bekannt [216,217]. In 13,8 % der von Vonberg und Gastmeier referierten Ausbrüche [215] [209,212].…”

Enhancing Patient Safety through the Use of a Pharmaceutical Glass Designed To Prevent Cracked Containers

“…i) And in 2010, three of 11 infected neonates died when their parenteral nutrition was prepared from a bottle that contained a crack (5,17).…”

“…), permitting rapid and complete introduction of microbial contamination into a patient's circulation. Accordingly, these breaches in container closure can lead to bacteremia, fungemia, sepsis, or death (3)(4)(5).…”