Novel Technology for Reprocessing Flexible Endoscopes

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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.