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      Bacterial Contamination of Single- and Multiple-Dose Vials after Multiple Use and Intravenous Admixtures in Three Different Hospitals in Iran

      Iranian Journal of Pharmaceutical Research : IJPR
      Shahid Beheshti University of Medical Sciences
      microbial contamination, mdvs, adxs, hospitals

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          Abstract

          There is possibility of microbial contamination of any single-dose vials (SDVs), multiple-dose vials (MDVs) and admixtures (ADXs) during the preparation and injection to the patients that could be resulted in bloodstream infection. The goal of this study was to investigate the microbial contamination of MDVs and SDVs after multiple use and ADXs prepared by nursing staff in the treatment room versus those prepared by the hospital pharmacist in the clean room. The sterility of 43 opened MDVs and SDVs, 92 prepared ADXs in treatment room and 17 prepared ADXs in clean room were studied by membrane filtration method. Only one of 92 ADXs prepared in treatment room was contaminated with Bacillus subtilis (%1.1) and none of the ADXs prepared in clean room, MDVs and SDVs had microbial contamination. Although good sanitization practices and training of nurses could reduce the risk of microbial contamination in traditional units, using clean room for preparation of parenteral products could be the best strategy.

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          An outbreak of Serratia marcescens associated with the anesthetic agent propofol.

          In October 1999, 7 patients with postoperative infections caused by Serratia marcescens were identified at a community hospital in Ontario, Canada. We describe the investigation of this outbreak.
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            I.V. admixture contamination rates: traditional practice site versus a class 1000 cleanroom.

            The contamination rates associated with the preparation of medium-risk i.v. admixtures in a traditional practice site and in a class 1000 cleanroom were compared. Simulated product media fills served as the samples. Each investigator, a pharmacist and a pharmacy technician, prepared 500 vials and 500 small-volume parenteral (SVP) bags in five separate runs at a traditional practice site and in a cleanroom. United States Pharmacopeia chapter 797 medium-risk compounding procedures were followed, and strict adherence to aseptic technique was employed. Single-strength tryptic soy broth was substituted for the drug and diluent in the admixtures. Positive and negative controls were also prepared and stored for the duration of the study. The pharmacist and technician prepared a total of 4057 samples: 2027 samples (1014 vials and 1013 SVP bags) were prepared in a class 1000 cleanroom, and 2030 (1014 vials and 1016 SVP bags) were prepared at a traditional practice site. Contamination rates did not significantly differ between the traditional practice site (0.296%) and the cleanroom environment (0.344%) (p = 1.0). A significant difference in the number of contaminated samples was found between the two investigators (2 of 2057 were contaminated by the pharmacist and 11 of 2000 were contaminated by the technician) (p = 0.012). Contamination rates by the pharmacist (p = 1.0) and technician (p = 1.0) did not significantly differ between sites. The most important variable affecting microbial contamination of admixtures was the aseptic technique of personnel, not the environment in which the drugs were compounded.
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              Enterobacter cloacae and Pseudomonas aeruginosa polymicrobial bloodstream infections traced to extrinsic contamination of a dextrose multidose vial.

              To identify risk factors for polymicrobial bloodstream infections (BSIs) in neonatal intensive care unit (NICU) patients during an outbreak of BSIs. During an outbreak of BSIs, we conducted a retrospective cohort study, assessed NICU infection control practices and patient exposure to NICU healthcare workers (HCWs), and obtained cultures of the environment and HCW hands. During the period May 3 to 7, 1996, 5 infants contracted BSIs caused by both Enterobacter cloacae and Pseudomonas aeruginosa, and one infant contracted a BSI caused by E cloacae only. For each pathogen, all isolates were identical on DNA typing. Infants exposed to the following were more likely than nonexposed infants to have BSI: umbilical venous catheters (6/14 vs 0/7, P = .05), total parenteral nutrition given simultaneously with a dextrose/electrolyte solution (6/12 vs 0/9, P = .02), or one HCW (5/7 vs 1/13, P = .007). Neither environmental nor HCW hand cultures yielded the outbreak pathogens. Quality control cultures of intravenous solution bags were negative. We speculate that a dextrose multidose vial became contaminated during manipulation or needle puncture and that successive use of this contaminated vial for multiple patients may have been responsible for BSIs. Aseptic techniques must be employed when multidose vial medications are used. Single-dose vials should be used for parenteral additives whenever possible to reduce the risk of extrinsic contamination and subsequent transmission of nosocomial pathogens.
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                http://creativecommons.org/licenses/by/3.0/

                microbial contamination,mdvs,adxs,hospitals
                microbial contamination, mdvs, adxs, hospitals

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