title: Multiple-test assessment of devices to protect healthcare workers when administering cytotoxic drugs to patients.
abstract: OBJECTIVE
  Evaluation of containment safety devices designed and introduced to protect preparers and administrators of hazardous drugs, through a multiple-test assessment.
  
  
  METHODS
  Six devices were compared: (1) Kis1 gravity-fed infusion set (Doran International, France), (2) Tevadaptor Spike Port Adapter (Teva Pharma AG, France), (3) Phaseal Infusion Adapter C100 (Carmel Pharma AB, France), (4) Codan Connect Z (Codan, France), (5) Pchimx with or without a cap (Doran International, France), and (6) Clave extension set 011-H1225 with or without Spiros (Hospira, France). Assessment of exposure to hazardous drugs was performed using quinine as fluorescent marker. Mechanical tests included tightness, tension tests, and estimation of the force required to connect the infusion device to the bag. Ergonomic tests were performed by six pharmaceutical technicians. Microbiological contamination was tested with media-fill, on connected bag.
  
  
  RESULTS
  No cytotoxic contamination was detected when using Phaseal, Tevadaptor or the Clave extension set with Spiros, Pchimx with a cap or Connect Z devices. For mechanical tests, all devices complied with the norm. Microbiological growth was observed neither in bags nor in tubings. The ergonomic study revealed differences between the devices for potential cytotoxic contamination risk only, but not for handling.
  
  
  CONCLUSIONS
  The use of containment safety devices offers improved handling conditions of hazardous compounds. As this study takes various selection criteria into account, its results offer assistance in choosing the most suitable device.
authors.affiliation: Biopharmacy, Galenic and Hospital Pharmacy Department, UFR Pharmacie, Université Lille Nord de France, Lille, France.
authors.forename: Thomas
authors.initials: T
authors.lastname: Queruau Lamerie
authors.forename: Laurent
authors.initials: L
authors.lastname: Carrez
authors.forename: Bertrand
authors.initials: B
authors.lastname: Décaudin
authors.forename: Lucie
authors.initials: L
authors.lastname: Bouchoud
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Goossens
authors.forename: Christine
authors.initials: C
authors.lastname: Barthélémy
authors.forename: Pascal
authors.initials: P
authors.lastname: Bonnabry
authors.forename: Pascal
authors.initials: P
authors.lastname: Odou
mesh_terms: D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects; D002626:Chemistry, Pharmaceutical / Q000295:instrumentation* / Q000592:standards*; D003603:Cytotoxins / Q000008:administration & dosage* / Q000009:adverse effects; D006282:Health Personnel / Q000592:standards*; D006801:Humans; D011482:Protective Devices / Q000592:standards*
chemical_list: D000970:Antineoplastic Agents; D003603:Cytotoxins