Background and importance Sterility of parenteral nutrition mixtures is verified by anaerobic and aerobic seeding of preparations incubated for 5 days (BACTEC). In May 2019, an aerobic sample was positive for BGN Pseudomonas putida on a bag for adult parenteral nutrition (PN). The product batch involved patients followed at home.
Aim and objectives The objective was to present the acute management of this incident, the investigations carried out to identify the origin of the contamination and the corrective actions implemented.
Material and methods Acute incident management: (i) patient identification, patient and physician information; (ii) substitution to ready to use PN; (iii) analyse samples of the day’s production; (iv) inform the health services, department heads, the regional health agency and the establishment’s management; and (v) quarantine the laboratory and suspend sterile preparation activities during investigations.
Investigations conducted in multidisciplinary collaboration (pharmacists, biologists, hygienists, quality division, hospital direction): (i) visit to the laboratory by the hospital hygiene service; (ii) surface sampling, analysis of microbiological and particulate monitoring over the last 30 days; and (iii) chronology of the production day: analysis of the batch file and survey of the unit’s agents.
Results Twenty-two bags of adult NP were contaminated by two environmental germs: Pseudomonas putida and microbacterium species. Three bags were partially administered over a period of 17 hours: patients were asymptomatic. No paediatric NP bags were contaminated.
The chronology of the incident and bacteriological investigations made it possible to identify a single source of contamination: the single channel automated compounding device allowing the addition of lipids to the bags. However, it was not possible to distinguish whether the origin came from a sterile medical device or from a batch of contaminated lipids.
Conclusion and relevance This episode attests to the effectiveness of bacteriological controls carried out on NP preparations (BACTEC). A 24 hour release period for NP bags between production and dispensing of PN bags and a pharmaceutical operational on-call to manage this type of alert have been set up. To satisfy the nutritional needs of newborns, we are studying the development of an ultrafast sterility test of the PN samples in order to release the preparations within 8 hours.
References and/or acknowledgements No conflict of interest.
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