Randomized Comparison of 3 High-Level Disinfection and Sterilization Procedures for Duodenoscopes

Snyder, Graham M; Wright, Sharon B.; Smithey, Anne; Mizrahi, Meir; Sheppard, Michelle; Hirsch, Elizabeth B.; Chuttani, Ram; Heroux, Riley; Yassa, David S.; Ólafsdóttir, Linda Björk; Davis, Roger B.; Anastasiou, Jiannis; Bapat, Vijay; Bidari, Kiran; Pleskow, Douglas K.; Leffler, Daniel A.; Lane, Benjamin C.; Chen, Alice; Gold, Howard S.; Bartley, Anthony; King, Aleah D.; Sawhney, Mandeep S.

doi:10.1053/j.gastro.2017.06.052

Cited by 85 publications

(78 citation statements)

References 21 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Biofilms may contribute to the recovery of viable microorganisms post processing even when current guidelines are followed. 31,60 The bulk of the literature about the processing of duodenoscopes relates to the currently recommended guidelines of performing HLD. Recent studies show positive bacterial contamination of duodenoscopes after HLD 58,60-62 and double-HLD processing.…”

Section: Sampled Sitementioning

confidence: 99%

“…31,35 A study by Snyder et al showed no significant difference between duodenoscopes processed by HDL, double HLD, or HLD combined with EO sterilization, with positive bacterial growth being detected following all three processing methods. 31 Terminal sterilization of duodenoscopes has been identified as a leading solution for improving duodenoscope processing outcomes since it offers a significantly greater margin of safety than HLD. [36][37][38] According to the Spaulding classification scheme, flexible gastrointestinal endoscopes are classified as semi-critical devices, in which case sterilization is recommended, or if this is not possible, processing using HLD at a minimum.…”

Section: Introductionmentioning

confidence: 99%

“…[25][26][27][28][29] Repeated HLD has not been shown to consistently provide a patient-ready endoscope. 13,[30][31][32][33][34] The use of HLD combined with EO sterilization, which is time-consuming, 6 also does not guarantee that the duodenoscope is microorganism free. 31,35 A study by Snyder et al showed no significant difference between duodenoscopes processed by HDL, double HLD, or HLD combined with EO sterilization, with positive bacterial growth being detected following all three processing methods.…”

Section: Introductionmentioning

confidence: 99%

“…13,[30][31][32][33][34] The use of HLD combined with EO sterilization, which is time-consuming, 6 also does not guarantee that the duodenoscope is microorganism free. 31,35 A study by Snyder et al showed no significant difference between duodenoscopes processed by HDL, double HLD, or HLD combined with EO sterilization, with positive bacterial growth being detected following all three processing methods. 31 Terminal sterilization of duodenoscopes has been identified as a leading solution for improving duodenoscope processing outcomes since it offers a significantly greater margin of safety than HLD.…”

Section: Introductionmentioning

confidence: 99%

“…6 EO sterilization turnaround times are typically 17 to 48 hours, which require a costly increase in duodenoscope inventory. 6,31,34 For these reasons, EO sterilization is not considered a long-term solution, 36,46 highlighting the need for new low-temperature sterilization technologies specifically validated for duodenoscopes. 27,36,37,46 Recently, multiple hospitals in the United States and Canada implemented hydrogen peroxide−ozone terminal sterilization instead of HLD as an alternate solution to prevent or eradicate patient infections linked to inadequately processed duodenoscopes.…”

Section: Introductionmentioning

confidence: 99%

See 4 more Smart Citations

Elevating the standard of endoscope processing: Terminal sterilization of duodenoscopes using a hydrogen peroxide–ozone sterilizer

Molloy-Simard¹,

Lemyre²,

Martel³

et al. 2019

American Journal of Infection Control

View full text Add to dashboard Cite

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.

show abstract

Section: Sampled Sitementioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Elevating the standard of endoscope processing: Terminal sterilization of duodenoscopes using a hydrogen peroxide–ozone sterilizer

Molloy-Simard¹,

Lemyre²,

Martel³

et al. 2019

American Journal of Infection Control

View full text Add to dashboard Cite

show abstract

A Systematic Review of Disposable Sheath Use During Flexible Endoscopy

Ofstead¹,

Hopkins²,

Quick³

et al. 2019

AORN Journal

View full text Add to dashboard Cite

Flexible endoscopes are exposed to blood, mucus, and other secretions during procedures. Single-use sheaths are designed to prevent contact between contaminants and reusable endoscope components. This systematic review examined findings from 22 studies that assessed endoscopic sheath use during urologic, gastrointestinal, or respiratory procedures. The evidence showed that sheaths were durable and yielded faster endoscope turnover times because their reusable components did not require high-level disinfection or sterilization. After a brief learning period, health care providers successfully assembled and maneuvered sheathed endoscopes. Patients generally did not experience greater discomfort during procedures in which sheaths were used. Microbial cultures of sheathed endoscopes were negative or similar to unsheathed endoscopes. More research is needed to evaluate the potential effect of disposable sheaths on infection risks. The evidence suggests that sheaths are a viable option for reliably providing a barrier between endoscopes and patients without affecting the quality of endoscopic procedures.

show abstract