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Background: Bronchoscopy is generally a safe and efficient procedure. However, the risk of cross-contamination with reusable flexible bronchoscopes (RFB) has been detected in several outbreaks worldwide. Aim: To estimate the average cross-contamination rate of patient-ready RFBs based on available published data. Methods: We performed a systematic literature review in PubMed and Embase to investigate the cross-contamination rate of RFB. Included studies identified indicator organisms or colony forming units (CFU) levels, and total number of samples >10. The Contamination threshold was defined according to the European Society of Gastrointestinal Endoscopy and European Society of Gastrointestinal Endoscopy Nurse and Associates (ESGE-ESGENA) guidelines. To calculate the total contamination rate, a random effects model was applied. Heterogeneity was analysed via a Q-test and illustrated in a forest plot. Publication bias was analysed via the Egger's regression test and illustrated in a funnel plot. Results: Eight studies fulfilled our inclusion criteria. The random effects model included 2169 samples and 149 events (positive tests). The total RFB cross-contamination rate was 8.69% ± 1.86 (standard division [SD]) (95% confidence interval [CI]: 5.06-12.33%). The result showed significant heterogeneity of 90% and publication bias. Discussion: Significant heterogeneity and publication bias is likely associated with varying methodology and aversion towards publishing negative findings, respectively. Based on the cross-contamination rate an infection control paradigm shift is needed to ensure patient safety. We recommend to follow the Spaulding classification and classify RFBs as critical items. Accordingly, infection control measures such as obligatory surveillance, and implementing single-use alternatives must be considered where feasible.
RESUMO
BACKGROUND AND OBJECTIVE: Until 2009, only reusable bronchoscopes were marketed, but the introduction and widespread adoption of single-use flexible bronchoscopes (SFBs) as an emerging technology has since accelerated. Several studies have described the costs of reusable flexible bronchoscopes (RFBs) and SFBs. This meta-analysis aimed to compile the current published evidence to analyse the cost of different scenarios using RFBs and SFBs. METHODS: All published literature describing the cost of RFBs or SFBs was identified by searching PubMed, Embase and Google Scholar, limited to those between 1 January, 2009 and 6 November, 2020. Included studies should report the total cost of RFBs. Continuous data were extracted for relevant outcomes and analysed using RStudio® 4.0.3 as the standardised mean difference and standard error of the mean in a mixed-effects model. Risk of bias was assessed based on the reporting quality. RESULTS: In the systematic literature review, 342 studies were initially identified, and 11 were included in the final analysis. The mean RFB procedure cost was $266 (standard error of the mean: 34), including capital investments, repairs and reprocessing costs of $91, $92 and $83, respectively. The mean SFB procedure cost was $289 (standard error of the mean: 10). The incremental cost was $23 (standard error of the mean: 33) and was not significant (p = 0.46). Because of the economy of scale, RFB is more likely to be cost minimising compared with SFB when performing 306 or 39 procedures per site or RFB, respectively. CONCLUSIONS: In this study, we found no significant difference in the cost of use between RFBs and SFBs and a high risk of bias.
RESUMO
BACKGROUND: Multiple infection outbreaks have been linked to contaminated duodenoscopes worldwide. However, the contamination rate of patient-ready duodenoscopes varies highly amongst published studies testing this subject. We aimed to estimate the contamination rate of reprocessed patient-ready duodenoscopes for endoscopic retrograde cholangio-pancreatography (ERCP) based on currently available data. METHODS: We searched the PubMed and Embase databases from January 1, 2010 until March 10, 2020, for citations investigating contamination rates of reprocessed patient-ready duodenoscopes. Studies not assessing other types of endoscopes than duodenoscopes were excluded from the analysis. Study eligibility and data extraction was evaluated by three reviewers independently. A random-effects model (REM) based on the proportion distribution was used to calculate the pooled total contamination rate of reprocessed patient-ready duodenoscopes. Subgroup analyses were carried out to assess contamination rates when using different reprocessing methods by comparing single high-level disinfection (HLD) with double HLD and ethylene oxide (EtO) gas sterilization. Additionally, we investigated the contamination rate between studies conducted following an outbreak compared to non-outbreak-initiated studies. FINDINGS: We identified 15 studies that fulfilled the inclusion, which included 925 contaminated duodenoscopes from 13,112 samples. The calculated total weighted contamination rate was 15.25% ± 0.018 (95% confidence interval [Cl]: 11.74% - 18.75%). The contamination rate after only using HLD was 16.14% ± 0.019 (95% Cl: 12.43% - 19.85%) and after using either dHLD or EtO the contamination rate decreased to 9.20% ± 0.025 (95% Cl: 4.30% - 14.10%). Studies conducted following an outbreak (n=4) showed a 5.72% ± 0.034 (95% Cl: 0.00% - 12.43%) contamination rate, and non-outbreak-initiated studies (n=11) revealed a contamination rate of 21.50% ± 0.031 (95% Cl: 15.35% - 27.64%). INTERPRETATION: This is the first meta-analysis to estimate the contamination rate of patient-ready duodenoscopes used for ERCP. Based on the available literature, our analysis demonstrates that there is a 15.25% contamination rate of reprocessed patient-ready duodenoscopes. Additionally, the analysis indicates that dHLD and EtO reprocessing methods are superior to single HLD but still not efficient in regards to cleaning the duodenoscopes properly. Furthermore, studies conducted following an outbreak did not entail a higher contamination rate compared to non-outbreak-initiated studies. FUNDING: The authors received no financial support for the research, authorship, and/or publication of this article.
