Challenge: All reusable medical devices that are re-processed after use are subject to cleaning, disinfecting and/or sterilization according to well defined standards. Infection Prevention and Control Standard IC.02.02.01 in recent years has been updated, focusing on better updates to the high level disinfection of medical tools, particularly the endoscopes used in millions of varied procedures. Current technologies lack the specific options that can easily and repeatedly attain the high level disinfection of endoscopes. A disinfecting method must effectively kill all organisms, including spores, without damage to the article or goods being disinfected. Moreover, before sterilization can take place, the instrument must be cleaned to a validated standard of clean. Currently marketed re-processors lack one or more of these characteristics or features needed to meet the requirements of a robust cleaner and disinfector.
Proven Process Medical Devices was approached by a technology group that wanted to leverage the properties of bi-directional fluid flow mechanical agitation and incorporate them into a machine that would be easy to operate, would not require special connectors that may be lost or incorrectly attached, and would clean and disinfect endoscopic, laproscopic, and surgical tools with one press of a button.
Design Concept: Based on our customer’s patented concept, the engineering team had to create a fluidic push - pull parametric system that would generate enough force to flow liquids through the different sized lumens without the need for nozzles or connectors, and to direct the detergent and disinfecting agents completely through each of the lumens of a wide variety of instruments. Parametric vacuum and pressure processes were researched, and the exact fluid dynamics of the liquids were established for the highest efficiency.
Disinfecting solutions and the risks and benefits of varied processes, such as filtered and chemical disinfection, were researched. The risks and benefits of these processes were weighed, and the study led us to incorporate a liquid antimicrobial agent and an ozonation process to deliver purified water as a final rinse. Heating elements were added to increase the efficiencies of the liquid chemical cleaning solutions. Optimzation analysis of attaining disinfected, cleaned devices was researched, and the resulting algorithms were incorporated into proprietary software code that also included a simple user interface.
The Resulting Device: A single chamber processing unit has been designed, along with a holding tray to secure the lumened medical instruments and surgical tools to be readied for re-processing. The chamber is divided by a baffle that assists in generating the parametric fluid forces needed for reliable re-processing. A fully integrated water purification plant delivers the purified water for final rinse to remove the disinfecting chemicals from the device.
The Instrument Processor System is unique in that the technology eliminates the need for connectors, and is designed to process a variety of medical instruments including, but not limited to, endoscopes and surgical tools. It is the first and only Parametric Release liquid chemical Instrument Processor System that delivers the critical steps required to process a reusable medical instrument. Proven Process Medical Devices designed every aspect of the device, performed all product development activities, risk management, testing and documentation creation. PPMD also managed the 510(k) regulatory submittal process for this device with the FDA and we currently manufacture this device for our customer.