NOVAFLUX Technologies -- Our Technology

Current reprocessing methods do not provide adequate cleaning of endoscope internal channels primarily because of fundamental limitations in fluid dynamics. These methods employ liquids at a low flow velocities not sufficient to generate the turbulence and shear stresses required to remove patient soils from the narrow channels. The complex arrangement of internal channels, components, and connections of flexible endoscopes further hampers the cleaning of the internal channel surfaces in their entirety. Therefore, a different means to deliver flow to the internal surfaces of the endoscope is necessary. The two-phase cleaning method developed by Novaflux overcomes these limitations by generating turbulence and high shear stresses in the narrow channels. The Novaflux cleaning process achieves effective and complete cleaning of endoscope internal channels. A new dimension of reprocessing medical devices with narrow lumens is now being developed by Novaflux Technologies. The new flow has finally arrived to solve this major source of cross infection in the medical and dental fields.

A photograph of the endoscope reprocessing device developed by Novaflux. The system includes a two-phase flow generator and a distribution system, a control unit that would allow us to program and study different cleaning and disinfecting cycles and a spray system to achieve the cleaning of the exterior surfaces of endoscopes. This device will be used to finalize the prototype needed for clinical studies and for the 510(k) applications to the FDA.

The aim of Phase I was to test and validate an integrated cleaning and disinfecting device and protocol for flexible endoscopes. Both the exterior surface and internal channels of flexible endoscope were cleaned with the device and system developed in the Phase I study. The experimentation was done in a laboratory setting, using Bacillus spores in standard soils as the fouling agent. A further objective was to test and validate this same process in a clinical setting at Thomas Jefferson University Medical School in Philadelphia. A fully automated and programmable endoscope reprocessing device was designed, constructed and tested in Phase I. The major task included the development of an integrated system that could “simultaneously” perform the cleaning and disinfection of internal channels and exterior surfaces of an endoscope. The device enables the turbulent two-phase flow cleaning method to be applied to all internal channels and performs the cleaning and disinfection of external endoscope surfaces using a modified dishwashing-like system. The device is fully automated using a programmable logic controller (PLC), which controls fluid delivery, cycle time, and sequence. These features were necessary to perform the studies needed to satisfy the specific aims of Phase I.

The device consists of four major parts. The Two-Phase Flow and Liquid Delivery Module (TFLD), which has two main functions: i) generating and delivering two-phase flow for internal channel reprocessing, ii) dispensing cleaning and disinfecting liquids for internal and external reprocessing. The Electrical and Control Module (EC), allows for fully automated control of all internal and external cleaning steps. The Fluid Distribution Manifold (FDM) serves as an interface between the washer and the TFLD. And finally, the Washer, which is a modified dishwasher that cleans the external surfaces of the endoscope with top and bottom mounted spray arms.

The device described above was then rigorously tested to determine the proper chemistry and the optimal protocol for cleaning. The results matched or exceeded expectations in all cases, up to 8 logs of organisms could be removed from air-water narrow channels of flexible endoscopes.

A picture of surrogate endoscope (no sheath) specially designed to validate the cleaning of internal channels with the two-phase flow technology. This instrument should allow us to visually observe and quantify the cleaning of each internal channel and complex connections in flexible endoscope internal fluid circuits.

In Phase I, an automated device to clean the internal surfaces of endoscopes with two-phase flow was designed, constructed, and tested. The tests showed that when two-phase flow was delivered according to a specific protocol, Bacillus subtilis spores more than 6 log reduction was achieved. The effective fluid dynamics parameters as well as the cleaning and disinfecting compositions were defined in the Phase I study. Preliminary assessment of the two-phase cleaning method using radionuclide imaging technique confirmed the efficiency of the process in cleaning gastrointestinal (GI) endoscopes, thus supporting the effectiveness of cleaning according to standard microbiology methods. The central hypothesis of the Phase II program is that because turbulent two-phase flow is effective in cleaning narrow lumens of flexible endoscopes with high reliability, the optimized device and protocol should reduce the need for manual cleaning, shorten the reprocessing time cycle, reduce the exposure of endoscopes to corrosive sterilants, and ultimately reduce the risk of patient infection. The goals are to systematically study and validate the two-phase cleaning method, develop an optimal device and protocols (both in-vitro and in a clinical setting) to achieve effective reprocessing of flexible endoscope.

Please contact novaflux@novaflux.com for more information.

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