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Introduction

No. 037. A randomised single-blind comparison of the effectiveness of the high-level disinfectants Tristel Fuse (chlorine dioxide) and Cidex OPA ( ortho -phthaldehyde) for use with flexible cystoscopes.

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Introduction

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  1. No. 037 A randomised single-blind comparison of the effectiveness of the high-level disinfectants Tristel Fuse (chlorine dioxide) and Cidex OPA (ortho-phthaldehyde) for use with flexible cystoscopes Mark R Fraundorfer ,Peter J Gilling, Michael Addidle, Rana Reuther, Michelle Lockhart, Christopher Frampton. Tauranga New Zealand Introduction Tristel Fuse is a high level chlorine dioxde based disinfectant used in an automated tray (Stella) with a five minute soak time. Cidex OPA (orrtho-Phthalaldehyde) is a common FDA approved high level disinfectant used in an automated reprocessor (Medivator) Results 1. 181 patients evaluated, Tristel n=94 Cidex n=97 Mean age 72.1 yrs 83% males 57% bladder tumour surveillance 2. UTI rate: Tristel Fuse 3.2% Cidex OPA 4.6% NS 3. Leucocyturia: Tristel Fusel 29% Cidex OPA 20% NS 4. No significant difference between Tristel Fuse and Cidex OPA for all clinical efficacy parameters ( AUA-7, QoL, UDI6, and UDI2) 5. Positive culture rates: Nil in all cystoscope washings and brushings. One positive culture each from Stella tray rim and Cidex OPA rinse water 6. Total cycle time (mean mins) Tristel 7.5 Cidex OPA 26.8 7. Cost per cycle (NZD) Tristel Fuse $14.43 Cidex OPA $26.77 8. Capital cost (NZD) Tristel Stella $5,875 Cidex OPA $74,250 Tristel StellaTM Aim The objectives of this study were to compare the effectiveness of Tristel Fuse with Cidex OPA in terms of clinical efficacy, safety, cost-effectiveness and ease-of-use. Methods 465 patients undergoing flexible cystoscopy were screened with 184 consenting and then randomised to either the Fuse or Cidex OPA arms. The primary endpoint was the rate of urinary tract infection as determined by a MSU 3-7 days post intervention. The secondary endpoints for the comparison include clinical, microbiological, cost-effectiveness, ease-of-use and safety endpoints. Clinical endpoints were; the Short Form Urogenital Distress Inventory (UDI-6) + 2 questions from the long form addressing the symptoms of Nocturia and Urgency, the American Urological Association Symptom Index (AUA-7) and a single Question Quality of Life Score (QoL). These were assessed on the day of the procedure and 3-7 days afterwards Microbiological cultures were grown from equipment samples collected after the first and last disinfection on each Study clinic (as per SNZ HB 8149:2001 Microbiological Surveillance of Flexible Hollow Endoscopes). These samples included sterile washings (10 ml Normal Saline) and sterile brushings of the working channel of the flexible cystoscopes, which were inoculated onto Blood Agar and MacConkey Agar and incubated aerobically. Further samples were taken from the Medivator AER (lid, rinsing solution and entry and exit ports), Stella inner tray and exit port. Conclusions This study confirms that the two high-level disinfectants studied provide microbiological sterilization of flexible cystoscopes when employed following the manufacturers recommendations. The costs both fixed and per-procedure favoured Tristel Fuse suggesting that this product maybe more cost-effective in this setting. Surgeon and nurse data on safety, acceptability and ease-of-use were comparable Poster presentation sponsor

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