La preparazione delle sacche di nutrizione parenterale in una Farmacia Ospedaliera: studio delle relazioni fra contaminazione particellare ambientale ed infezioni nosocomiali

[Autom. eng. transl.] The risk of parenteral administration of substances prepared in Pharmacy Hospitals, well known in the literature, is minimized in Italy also realizing the bags for Parenteral Nutrition (NP) in controlled contamination environments. To confirm this, the study aims to compare the data deriving from environmental particle monitoring with correlatable nosocomial infections (INC) to the administration of NP bags coming from the same environments. Within the routine quarterly monitoring of 2008 in a Hospital Clean Room, the 10μ and 25μ diameter particles (capable of conveying the micro-organisms) were evaluated under operational conditions, ie during normal staff activity. The list of recipient subjects of NP was then compared with the database of nosocomial infections of the same hospital, defining "related" pneumonia, meningitis and blood infections (sepsis / bacteremia), which arose within 72 hours from the administration of the bag itself. . The results were correlated by the Spearman test (p = 0.05). The particle count has shown a maintenance of quality standards according to ISO 14644 and GMPs in the area specifically intended for the manipulation of drugs. However, it also showed a significant increase in the concentration of airborne particles in the second quarter, compared to I and III, for both dimensions taken into consideration. Even the INCs seem to grow from the first (1 infection) to the second four-month period (9), with a progressive decrease in the last quarter of 2008 (4). The Spearman test, carried out between 25μ particles and INC; between 10μ and INC particles and finally between the 25μ and 10μ particles shows a correlation of 1, 0.50 and 0.50 respectively. The study showed a possible correlation between the number of 10μ and 25μ sampled particles and INC developed in NP patients. However, the small number of recorded infections and the absence of a microbiological control of the bags involved, as well as the known presence in the literature of other risk factors for nosocomial infection in the patients considered (urinary catheter, invasive maneuvers), make it unlikely l association between the two events. This study, the first to relate the results of environmental monitoring to patient outcomes, therefore presents itself as proof of further accuracy in surveillance and control systems, aimed at the careful care and protection of patient safety.