title: Lumen claims of the STERRAD 100NX sterilizer: testing performance limits when processing equipment containing long, narrow lumens.
abstract: BACKGROUND
  According to manufacturers information, the STERRAD 100NX sterilizer-a low temperature H(2)O(2) gas plasma sterilizer-can adequately process single channel stainless steel lumens with an inside diameter of 0.7 mm or larger and a maximum length of 500 mm using standard cycle sterilizing conditions. The aim of this study was to qualify the performance of this H(2)O(2) gas plasma sterilizer under different experimental settings representing worst case conditions.
  
  
  METHODS
  Inoculated carriers were placed at the midpoint position of specified lumens and then submitted to flex scope sterilizing conditions. To simulate insufficient cleaning or crystalline residues, we added organic and inorganic challenges to our inoculated carriers.
  
  
  RESULTS
  For experiments done with unchallenged carriers, quantitative analysis reached a log(10) reduction rate of ≥5.71, whereas qualitative results showed no growth in 24 out of 30 biologic indicators tested using flex scope half cycle conditions. Any additional kind of challenge significantly impaired the sterilization outcome.
  
  
  CONCLUSIONS
  The findings of our current study emphasize the importance of a thorough validated cleaning of medical devices as well as timing for cleaning and decontamination before being exposed to the H(2)O(2) sterilization process and, furthermore, the need for strict adherence to manufacturer's recommendations.
authors.affiliation: Clinical Institute of Hospital Hygiene, Vienna General Hospital, Medical University of Vienna, Austria. magda.diab-elschahawi@meduniwien.ac.at
authors.forename: Magda
authors.initials: M
authors.lastname: Diab-Elschahawi
authors.forename: Alexander
authors.initials: A
authors.lastname: Blacky
authors.forename: Nicole
authors.initials: N
authors.lastname: Bachhofner
authors.forename: Walter
authors.initials: W
authors.lastname: Koller
mesh_terms: D015169:Colony Count, Microbial; D004864:Equipment and Supplies / Q000382:microbiology*; D001411:Geobacillus stearothermophilus / Q000187:drug effects* / Q000528:radiation effects*; D006861:Hydrogen Peroxide / Q000494:pharmacology; D050296:Microbial Viability / Q000187:drug effects / Q000528:radiation effects; D058626:Plasma Gases / Q000494:pharmacology; D013242:Sterilization / Q000379:methods*
chemical_list: D058626:Plasma Gases; D006861:Hydrogen Peroxide