title: Reprocessing and sterilization of single-use electrophysiological catheters: removal of organic carbon and protein surface residues.
abstract: Although evidence to date indicates that reprocessing electrophysiological (EP) catheters results in clean, sterile devices, some concerns persist with regard to the risk of residual contamination. We examined the ability of a defined reprocessing procedure coupled with a validated sterilization protocol to remove organic carbon and protein residues from worst-case soiled EP catheters resulting in clean, sterile devices. Total organic carbon (TOC) determinations indicated that detergent residues on reprocessed used catheters were nominal and significantly lower than organic carbon levels present on new catheters. Determination of the mean residual organic carbon and protein contaminants on soiled and reprocessed EP catheters further indicated that TOC and protein were reduced (> or =99% of residue removed) below previously reported levels and current accepted standards. Moreover, reprocessed end-of-life catheters (six clinical uses, plus five reprocessings) were examined for residual microorganisms and found to be sterile. End-of-life catheters that had been inoculated with >10(6) CFU Bacillus atrophaeus spores and subjected to a half-cycle ethylene oxide exposure were also found to be sterile. Our data indicate that EP catheter cleaning and reprocessing using defined protocols effectively removes detergent residues and biological contamination, and provides sterile devices.
authors.affiliation: SterilMed, Inc., R&D Division, 11400 73rd Ave North, Maple Grove, MN 55369, USA. blester@sterilmed.com
authors.forename: Bruce R
authors.initials: BR
authors.lastname: Lester
authors.forename: Nicole P
authors.initials: NP
authors.lastname: Boser
authors.forename: Keith
authors.initials: K
authors.lastname: Miller
authors.forename: Mark
authors.initials: M
authors.lastname: Schnapf
authors.forename: Beth A
authors.initials: BA
authors.lastname: Jacques
authors.forename: Brian F
authors.initials: BF
authors.lastname: Sullivan
authors.forename: George L
authors.initials: GL
authors.lastname: Marchin
mesh_terms: D001419:Bacteria / Q000737:chemistry / Q000254:growth & development; D002241:Carbohydrates / Q000032:analysis; D002244:Carbon / Q000032:analysis*; D002404:Catheterization; D003902:Detergents / Q000032:analysis; D004594:Electrophysiology / Q000295:instrumentation*; D004731:Endotoxins / Q000032:analysis; D017743:Equipment Reuse; D009930:Organic Chemicals / Q000032:analysis*; D011506:Proteins / Q000032:analysis*; D013242:Sterilization / Q000379:methods*
chemical_list: D002241:Carbohydrates; D003902:Detergents; D004731:Endotoxins; D009930:Organic Chemicals; D011506:Proteins; D002244:Carbon