title: Residual total protein and total organic carbon levels on reprocessed gastrointestinal (GI) biopsy forceps.
abstract: Many single-use (disposable) devices are reprocessed between patient uses. In the past, a visual determination was considered the endpoint of "clean" for cleaned reusable devices. In this report, we measured quantitative endpoints by measuring residual total protein and residual total organic carbon before and after cleaning with commercially available cleaners for medical devices on 15 single-use gastrointestinal biopsy forceps inoculated with a three-protein test soil before and after cleaning. Each device was extracted separately and tested using Bradford's reagent for total protein and a direct digestion method for total organic carbon. Data for pre- and post-cleaned devices were generated for all five cleaning cycles. The highest amounts of residual total protein and total organic carbon found on precleaned devices were 61.8 microg/cm(2) and 39.1 microg/cm(2), respectively, on the outer surfaces. The highest amounts of residual total protein and total organic carbon on postcleaned device extracts were 4.0 microg/cm(2) and 2.2 microg/cm(2), respectively, on the outer surfaces. All postcleaned devices were visually clean. Our results provide quantitative total protein and total organic carbon levels for cleaned single-use biopsy forceps.
authors.affiliation: Center for Devices and Radiological Health, Food and Drug Administration, Rockville, Maryland 20850, USA.
authors.forename: Sharon K
authors.initials: SK
authors.lastname: Lappalainen
authors.forename: Shanti V
authors.initials: SV
authors.lastname: Gomatam
authors.forename: Victoria M
authors.initials: VM
authors.lastname: Hitchins
mesh_terms: D001706:Biopsy / Q000295:instrumentation; D002244:Carbon / Q000032:analysis*; D004209:Disposable Equipment; D004866:Equipment Contamination; D017743:Equipment Reuse; D041981:Gastrointestinal Tract / Q000737:chemistry / Q000601:surgery; D006801:Humans; D011506:Proteins / Q000032:analysis*; D013242:Sterilization / Q000379:methods; D013525:Surgical Instruments / Q000706:statistics & numerical data*
chemical_list: D011506:Proteins; D002244:Carbon