Novel Technology for Reprocessing Flexible Endoscopes

说明(申请人提供)：由于清洁不足是柔性内窥镜灭菌失败的主要原因，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)研究期间，Novaflux开发了基于其新型湍流两相流技术的高效、可靠的内窥镜内通道清洗工艺和设备。对有机土壤(OS)中的一系列生物体进行的模拟使用测试证实了该技术在执行有效循环方面的有效性，降低系数(Rf)和OS去除&gt；99.9%；因此，该技术可被认为等同于或优于人工预清洁。在第二阶段研究期间，建立了严格的物理化学流体动力学模型。这一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，用于产生对污染物清除及其从通道中传输至关重要的液滴。目前竞争的续展第二阶段应用旨在设计、建造和验证一种Beta原型AER，该AER具有经过验证的清洁协议，将确保99.9%的OS去除，生物抑制射频为&gt；5，杀菌保证为10-6。将两相流(TPF)过程与手动清洗进行比较，目的是表明与手动清洗相比，它实现了同等或更好的性能。开发的AER将提供样本端口和经过验证的协议，以允许用户监控最终漂洗水，以确保其不包含不可接受的生物杂质水平。这项研究的目标是完成这项技术的开发，并建造Beta NovaScope设备，以满足FDA对510K批准的要求。具体目标是：目标1：根据食品和药物管理局的流程，最后确定和确定NovaScope设备(硬件和软件)的设计要求(包括泄漏、堵塞和阻塞测试)、性能规格和标准；目标2：根据FDA对临床前和临床试验的GMP要求，验证、评估和改进(VAR)NovaScope的系统：机械、电气和化学；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/15883使用生物膜测试验证Beta NovaScope的性能和功能；目标5：验证使用反渗透水冲洗的Beta原型两相流系统的清洁效果；目标6：验证TPF-NovaScope AER的过程监控；目标7：准备、提交并获得临床评估所需的FDA-IDE和IRB的批准；目标8：展示在使用中的验证中的清洁和灭菌效果；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的批准过程进行最终审计；目标11：准备中期和最终报告和出版物；目标12：与FDA定期举行会议，讨论提交申请的要求和程序。

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.