Benjamin Kung
College of Physicians & Surgeons of Alberta, Canada
Title: Medical device reprocessing (MDR) in Alberta Medical Clinics – Patient safety risk warrants regulatory oversight
Biography
Biography: Benjamin Kung
Abstract
Historically in Alberta, responsibility for monitoring infection prevention & control (IPAC) in non-governmental, unaccredited medical clinics had fallen on the business owner and/or physicians. In 2007, a sentinel event triggered a government directed review of IPAC in these settings. A program was created under the direction of a 10-member Advisory Committee: infectious disease specialists, medical officers of health, senior infection control practitioners, and community physicians and surgeons. CPSA has since actively monitored IPAC with a priority on standards for MDR (cleaning, disinfection, and sterilization of medical devices).
Alberta has approximately 1700 medical facilities in the “non-governmental, unaccredited” category. Over 600 (> 35%) perform some type of MDR and these were assessed for adherence to standards between 2008-15. In 2013, a provincial policy for reporting the most critical deficiencies was formalized. From 2013-15, 131 assessments identified 17 (13.0%) with risks exceeding the reporting threshold to Public Health. Deficiencies contributing to the likelihood of reporting included, but were not limited to: inadequate device cleaning, lack of monitoring sterilization cycles for physical (time, temperature), chemical, and/or biological parameters, use of unlicensed sterilizers, and inadequate level of reprocessing given device risk classification (Spaulding’s). Post-exposure risk assessment deemed four (3.0%, n=131) a sufficient threat to initiate lookbacks for bloodborne pathogen exposure (HIV, HBV, HCV).
Formal reporting and post-exposure risk assessment confirmed initial observations suggesting clinics performing MDR are at elevated risk of breaching IPAC principles that may jeopardize patient safety. The logistics and value of providing clinic support via robust regulatory controls is worth exploring.