title: Sterile reprocessing of surgical instruments in low- and middle-income countries: A multicenter pilot study.
abstract: BACKGROUND
  Surgical site infections increase the morbidity, mortality, and costs associated with surgical care. An estimated 96.2 million surgical procedures are performed in low- and middle-income countries (LMICs) each year. This pilot study assessed the steam sterilization aspect of the surgical instrument reprocessing practice in LMIC hospitals.
  
  
  METHODS
  Surgeons representing 26 hospitals in 9 different LMICs were consented to test the single most frequently used autoclave in their respective surgical departments. Participants conducted 10 chemical integrator tests and recorded the total cycle time, exposure temperature, and pressure on each test. Data were analyzed with descriptive statistics and reviewed by medical reprocessing experts.
  
  
  RESULTS
  Nine of the 26 (35%) study sites representing 7 countries returned their autoclave data and test strips (n = 90). Of the sites, 78% obtained acceptable readings on all 10 tests. When the data were compared against the recommended parameters for sterility, the results were less favorable. All 90 tests had at least 1 variable not within the target exposure time, temperature, or pressure.
  
  
  CONCLUSIONS
  This pilot study presents concerns in regard to the effectiveness of steam autoclaves used in LMIC hospitals and the subsequent risks this presents to surgical patients. We acknowledge the resource limitations in many LMIC hospitals. However, the international medical community must ensure that basic sterile practice guidelines are adhered to despite these constraints.
authors.affiliation: Department of Orthopaedics, University of British Columbia, Vancouver, BC, Canada. Electronic address: nathan.ohara@vch.ca.
authors.forename: Nathan N
authors.initials: NN
authors.lastname: O'Hara
authors.affiliation: Institute for Global Orthopaedic Trauma, San Francisco, CA.
authors.forename: Kushal R
authors.initials: KR
authors.lastname: Patel
authors.affiliation: Institute for Global Orthopaedic Trauma, San Francisco, CA.
authors.forename: Amber
authors.initials: A
authors.lastname: Caldwell
authors.affiliation: Medical Device Reprocessing Department, Vancouver General Hospital, Vancouver, BC, Canada.
authors.forename: Samantha
authors.initials: S
authors.lastname: Shone
authors.affiliation: Department of Pathology and Laboratory Medicine, University of British Columbia, Vancouver, BC, Canada.
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Bryce
mesh_terms: D003906:Developing Countries; D006302:Health Services Research; D006801:Humans; D010865:Pilot Projects; D013242:Sterilization / Q000379:methods*; D013525:Surgical Instruments
keywords: Autoclave; Low-income countries; Middle-income countries; Sterile reprocessing; Surgical instrument