Advanced Sterilization Products (ASP) has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its 22-minute Aeroflex automatic endoscope reprocessor (AER).
Aeroflex AER is the high-level disinfection system, which will help clean and disinfect flexible endoscopes from a range of manufacturers.
According to the company, Aeroflex system provides the fastest complete cycle time of 22 minutes compared to any AER currently sold in the US.
Flexible endoscopes are costly, complex and fragile instruments generally used in minimally invasive procedures. They are required to be high-level disinfected between every patient use.
The active ingredient in the high-level disinfectant (HLD) must be at or above the level required to kill microorganisms to effectively disinfect a flexible endoscope.
As per the professional society standards and HLD instructions for use, the critical measurement called minimum recommended concentration (MRC), should be taken every time when an endoscope is reprocessed.
The current method needs dipping a test strip into the HLD and subjectively evaluating the color change of the test strip against a visual scale. Testing may be missed or done incorrectly, based on the manual nature of the process.
Aeroflex is claimed to be the only AER with Autosure MRC Monitor, an integrated system to automatically test HLD MRC levels every cycle. It will help avoid the use of manual test strips.
Aeroflex with Autosure will be installed with a touchscreen user interface and an electronic records management system to enhance efficiency, accuracy and compliance with record keeping requirements compared to manual systems.
ASP global marketing vice president Amy Smith said: “AEROFLEX with AUTOSURE is designed to ensure MRC testing compliance† and increase productivity in the endoscopy suite.
“Additionally, this is an integrated system with intuitive functionality that’s intended to be quick and easy to learn and operate. ASP remains committed to continually improving delicate instrument reprocessing with innovations that make a real difference in every day practice.”
ASP is involved in the designing and delivering of advanced infection prevention solutions for the customers in the health sector.