title: Multiple withdrawals from single-use vials: a study on sterility.
abstract: BACKGROUND
  Reutilization of single-use vials containing medical drugs is still under discussion. This practice has been adopted as a standard to avoid drug wastage, particularly in developing countries and in the aftermath of disasters. Some studies have assessed sterility of medications stored in single-use vials after utilization as multiple doses; however, most of these were limited to one single drug, included a low number of samples and did not consider an intermediate transfer step from the vial to a disposable syringe. The purpose of this study was to assess microbial contamination of samples withdrawn over three days from disposable syringes prepared from single-use vials.
  
  
  METHODS
  A prospective sterility study was conducted. A total of 600 initial samples were prepared from six-hundred 10 mL single-use vials of physiological solution into six-hundred 20 mL disposable syringes. Samples were prepared in three different standard operating rooms, on six different days and by the same operator, using basic sterile technique. All syringes were capped, placed together in a non-sterile steel container, covered with a clean drape and stored in the refrigerator at 4°C under non-sterile conditions. Using basic sterile technique, four samples were withdrawn daily and cultured from each syringe over the next 3 days. Microbial growth was examined on Sabouraud agar and chocolate agar culture media.
  
  
  RESULTS
  A total of 7200 samples were collected and 14,400 cultures were performed. No evidence of microbial growth in any of the culture media plates was found.
  
  
  CONCLUSIONS
  This study demonstrated that contents initially stored in single-use vials and subsequently transferred into disposable syringes in an operating room using sterile technique, maintain sterility after 4 withdrawals per day for a total of 3 days.
authors.affiliation: CRIMEDIM - Research Center in Emergency and Disaster Medicine, University of Piemonte Orientale A. Avogadro, Novara, Italy. Electronic address: ripoll@med.unipmn.it.
authors.forename: Alba
authors.initials: A
authors.lastname: Ripoll Gallardo
authors.affiliation: CRIMEDIM - Research Center in Emergency and Disaster Medicine, University of Piemonte Orientale A. Avogadro, Novara, Italy. Electronic address: meneghettigrazia@gmail.com.
authors.forename: Grazia
authors.initials: G
authors.lastname: Meneghetti
authors.affiliation: CRIMEDIM - Research Center in Emergency and Disaster Medicine, University of Piemonte Orientale A. Avogadro, Novara, Italy. Electronic address: luca.ragazzoni@med.unipmn.it.
authors.forename: Luca
authors.initials: L
authors.lastname: Ragazzoni
authors.affiliation: Department of Virology and Microbiology, Ospedale Maggiore della Carità, Novara, Italy. Electronic address: vesselina.kroumova@maggioreosp.novara.it.
authors.forename: Vesselina
authors.initials: V
authors.lastname: Kroumova
authors.affiliation: CPO-Piemonte and Unit of Medical Statistics and Epidemiology, Department of Translational Medicine, University of Piemonte Orientale, Novara, Italy. Electronic address: daniela.ferrante@med.unipmn.it.
authors.forename: Daniela
authors.initials: D
authors.lastname: Ferrante
authors.affiliation: CRIMEDIM - Research Center in Emergency and Disaster Medicine, University of Piemonte Orientale A. Avogadro, Novara, Italy. Electronic address: pierluigi.ingrassia@med.unipmn.it.
authors.forename: Pier Luigi
authors.initials: PL
authors.lastname: Ingrassia
authors.affiliation: Department of Virology and Microbiology, Ospedale Maggiore della Carità, Novara, Italy. Electronic address: p.tagliani@libero.it.
authors.forename: Paola
authors.initials: P
authors.lastname: Ruzza
authors.affiliation: Department of Virology and Microbiology, Ospedale Maggiore della Carità, Novara, Italy. Electronic address: angeladellera58@yahoo.it.
authors.forename: Angela
authors.initials: A
authors.lastname: Dell'Era
authors.affiliation: CRIMEDIM - Research Center in Emergency and Disaster Medicine, University of Piemonte Orientale A. Avogadro, Novara, Italy. Electronic address: ester1086@libero.it.
authors.forename: Esther
authors.initials: E
authors.lastname: Boniolo
authors.affiliation: CRIMEDIM - Research Center in Emergency and Disaster Medicine, University of Piemonte Orientale A. Avogadro, Novara, Italy. Electronic address: gjergji33@yahoo.it.
authors.forename: Gjergji
authors.initials: G
authors.lastname: Koraqe
authors.affiliation: Department of Translational Medicine, Università del Piemonte Orientale Amedeo Avogadro, Novara, Italy. Electronic address: fabrizio.faggiano@med.unipmn.it.
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Faggiano
authors.affiliation: CRIMEDIM - Research Center in Emergency and Disaster Medicine, University of Piemonte Orientale A. Avogadro, Novara, Italy. Electronic address: dellacorte.f@gmail.com.
authors.forename: Francesco
authors.initials: F
authors.lastname: Della Corte
mesh_terms: D001419:Bacteria / Q000302:isolation & purification*; D002626:Chemistry, Pharmaceutical; D003080:Cold Temperature; D004209:Disposable Equipment / Q000382:microbiology*; D004340:Drug Contamination / Q000517:prevention & control*; D004349:Drug Packaging; D004356:Drug Storage; D017743:Equipment Reuse; D011446:Prospective Studies; D013594:Syringes / Q000382:microbiology*; D013997:Time Factors
keywords: Disposable equipment; Drug contamination; Drug packaging; Drug storage; Single-use vial; Syringes/microbiology