Novel Technology for Reprocessing Flexible Endoscopes

描述（由申请人提供）：由于清洁不充分是柔性内窥镜消毒失败的主要原因，迫切需要对现有的清洁方法进行根本性的修改。在第一阶段（Grant # 1R43DK58622-01）和第二阶段（Grant # 2R44DK58622-02）研究中，Novaflux开发了基于其新型湍流两相流技术的工艺和设备，用于高效可靠地清洁内内镜内部通道。在有机土壤（OS）中对一系列生物进行模拟使用测试，证实了该技术在执行一个经过验证的循环时的有效性，减少系数（RF）为bbb50， OS去除率>为99.9%；因此，该技术可被认为相当于或优于人工预清洗。在第二阶段的研究中，建立了一个严格的物理化学流体动力学模型。该模型为狭窄通道的清洁和冲洗提供了严格的基础，并导致发现了一种新的方法来产生对污染物去除和从通道中运输至关重要的液滴。目前的竞争延续II期申请旨在设计、构建和验证beta原型AER，该AER具有经过验证的清洁方案，可确保99.9%的OS去除，生物负荷RF为bb50，灭菌保证为10-6。将两相流（TPF）工艺与人工清洗进行比较，目的是表明与人工清洗相比，它实现了同等或更好的性能。开发的AER将提供采样端口和经过验证的协议，允许用户监测最终冲洗水，以确保其不含不可接受的生物负荷水平。该研究的目标是完成该技术的开发，并构建Beta NovaScope设备，以满足FDA对510K批准的要求。目标1：根据FDA流程确定和定义NovaScope设备的设计要求（包括泄漏、堵塞和阻塞测试）、性能规范和标准（硬件和软件）；目标2：根据FDA对临床前和临床试验的要求，按照GMP流程验证、评估和改进NovaScope的机械、电气和化学系统（VAR）；目标3：根据prEN 15883国际标准，使用放射性核素成像测试验证Beta NovaScope的性能和功能；目标4：根据新的国际标准EN/ISO 15883，使用生物膜测试验证Beta NovaScope的性能和功能；目的5：验证Beta原型两相流系统使用反渗透水冲洗的清洗效果；目标6：验证TPF-NovaScope AER的过程监控；目标7：准备、提交和接收临床评价所需的FDA-IDE和IRB批准；目标8：证明使用中的清洁和灭菌效果-临床使用验证；目标9：进行临床后最终验证和评估，并改进NovaScope设备；目标10：对FDA批准过程进行最终审核；目标11：编写临时和最后报告和出版物；目标12：与FDA定期召开会议，讨论提交申请的要求和流程。

DESCRIPTION (provided by applicant): Since inadequate cleaning is the main cause of failure in sterilizing flexible endoscopes, cardinal modification of existing cleaning methods is urgently needed. During the Phase I (Grant # 1R43DK58622-01) and Phase II (Grant # 2R44DK58622-02) studies, Novaflux developed processes and devices based on its novel turbulent two-phase flow technology for cleaning endoscope internal channels with high efficiency and reliability. Simulated-use testing with a range of organisms in organic soils (OS) have confirmed the effectiveness of the technology in performing a validated cycle with reduction factor (RF) > 5 and OS removal > 99.9%; thus, the technology can be considered equivalent to or better than manual pre-cleaning. A rigorous physicochemical hydrodynamic model was developed during the Phase II study. This model provides a rigorous basis for the cleaning and rinsing of narrow channels and led to the discovery of a new means for generating the droplets critical to contaminant removal and their transport from channels. The current Competing Continuation Phase II application is aimed at designing, building and validating a Beta-prototype AER that has a validated cleaning protocol that will ensure 99.9% OS removal, a bioburden RF of > 5 and a sterilization assurance of 10-6. The two-phase flow (TPF) process will be compared to manual cleaning with the objective of showing that it achieves equivalent or better performance compared to manual cleaning. The AER developed will provide sample ports and validated protocols to allow users to monitor the final rinse water to ensure it does not contain unacceptable bioburden levels. The objectives of the study are to complete the development of the technology and to build the Beta NovaScope device to satisfy FDA requirements for 510K approval. The Specific Aims are to: Aim 1: Finalize and define design requirements (including leak, blockage and obstruction testing), performance specifications and standards of the NovaScope device (hardware and software) according to the FDA process; Aim 2: Validate, assess and refine (VAR) the NovaScope's systems: mechanical, electrical, and chemical, following the GMP process according to FDA requirements for preclinical and clinical trials; Aim 3: Validate the performance and functionality of the Beta NovaScope using radionuclide imaging testing according to the prEN 15883 International Standard; Aim 4: Validate the performance and functionality of the Beta NovaScope using biofilm testing in accordance with the new International Standard EN/ISO 15883; Aim 5: Validate cleaning efficacy of Beta prototype two-phase flow system using RO water rinse; Aim 6: Validate process monitoring for TPF-NovaScope AER; Aim 7: Prepare, submit and receive approval for FDA-IDE and IRB needed for the clinical evaluation; Aim 8: Demonstrate cleaning and sterilization efficacy in-use - clinical in-use validation; Aim 9: Conduct post-clinical final validation and assessment, and refine the NovaScope device; Aim 10: Perform final audit for FDA approval process; Aim 11: Prepare interim and final reports and publications; Aim 12: Hold periodic meetings with the FDA regarding requirements and process for submitting an application.