Autor: |
Dufresne, Sylvie, Richards, Thomas, Molloy-Simard, Vanessa |
Předmět: |
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Zdroj: |
Canadian Journal of Infection Control / Revue Canadienne de Prévention des Infections; Fall2017, Vol. 32 Issue 3, p165-171, 7p |
Abstrakt: |
Background: Flexible gastrointestinal (GI) endoscopes have been associated with patient-to-patient transfer of multidrug-resistant bacteria that are not inactivated by high-level disinfection. This has resulted in calls to reprocess GI endoscopes by sterilization. However, traditional low-temperature sterilization methods are not cleared by the United States FDA to terminally sterilize complex multichannel endoscopes. Aim: Demonstrate that the STERIZONE® VP4 Sterilizer (VP4 Sterilizer) can sterilize a multichannel colonoscope using a new gravity-based inoculation method. Methods: In accordance with US, EU and Canadian requirements, a direct-inoculation method was developed to demonstrate that the VP4 Sterilizer can sterilize a multichannel colonoscope under both half-cycle and simulated-use conditions. Findings: Half-cycle and simulated-use testing demonstrated that the VP4 Sterilizer can sterilize a multichannel colonoscope with a sterility assurance level of SAL-6. Validation of the inoculation method using surrogate lumens, confirmed that the center of each lumen contained >106 test organisms. Furthermore, both high and low-level recovery was achieved for each lumen within a multichannel colonoscope. Conclusion: Flexible colonoscopes can be terminally sterilized using the VP4 Sterilizer. It is the first vapor-based sterilization technology that is FDA cleared to sterilize a four-channel flexible colonoscope. [ABSTRACT FROM AUTHOR] |
Databáze: |
Complementary Index |
Externí odkaz: |
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