Elevating the standard of endoscope processing: Terminal sterilization of duodenoscopes using a hydrogen peroxide–ozone sterilizer - 28/02/19
, Karine Martel a, Bradley J. Catalone, PhD, MBA bHighlights |
• | Terminal sterilization of duodenoscopes can be achieved by a hydrogen peroxide-ozone sterilizer. |
• | Sterility of duodenoscopes was achieved under laboratory worst-case conditions. |
• | Sterility of patient-soiled duodenoscopes was achieved under clinical conditions. |
• | A sterility assurance level of 10−6 was demonstrated. |
Résumé |
Background |
The health care community is increasingly aware of the processing challenges and infection risks associated with duodenoscopes owing to published reports of outbreaks and regulatory recalls. Studies have demonstrated that the current practices are inadequate for consistently producing patient-ready endoscopes. Alternatively, terminal sterilization would offer a greater margin of safety and potentially reduce the risk of patient infection. The purpose of this study was to evaluate the efficacy of a hydrogen peroxide–ozone sterilizer with regulatory clearance for terminal sterilization of duodenoscopes.
Methods and Results |
Validation studies were performed under laboratory simulated-use and clinical in-use conditions. The overkill method study demonstrated a reduction of at least 6-log of Geobacillus stearothermophilus spores at half-cycle, providing a sterility assurance level of 10−6. In addition, the sterilizer achieved a 6-log reduction of G stearothermophilus in the presence of inorganic and organic soils in a simulated-use study. The clinical in-use study confirmed that the sterilizer achieved sterilization of patient-soiled duodenoscopes under actual use conditions.
Conclusions |
Simulated-use and clinical in-use studies demonstrated the efficacy of a hydrogen peroxide–ozone sterilizer for terminal sterilization of duodenoscopes. This offers health care facilities a viable alternative for duodenoscope processing to enhance patient safety as part of a comprehensive infection control strategy.
Le texte complet de cet article est disponible en PDF.Key Words : Endoscope, Low Temperature Sterilization, Carbapenem-Resistant Enterobacteriaceae, Cholangiopancreatography, Endoscopic Retrograde, Gastrointestinal Endoscopy, Sterility Assurance Level
Plan
| Funding/support: This study was funded by TSO3. Use and cleaning of the duodenoscopes for the clinical study was performed by hospital personnel in accordance with their established practices, without direction by the study sponsor. Sampling of the duodenoscopes was conducted by qualified personnel of the company. This work was executed and monitored in accordance with an ISO 13485:2016 quality system. All of the work presented here was subject to review by the US Food and Drug Administration and led to regulatory clearance of the sterilizer studied for terminal sterilization of duodenoscopes. |
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| Conflicts of interest: None to report. |
Vol 47 - N° 3
P. 243-250 - mars 2019 Retour au numéro
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