Advanced Sterilization Products (ASP) has announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the ASP AEROFLEX Automatic Endoscope Reprocessor (AER). The high-level disinfection system, which is designed to be used to clean and disinfect flexible endoscopes from a wide range of manufacturers, offers fast complete cycle time - just 22 minutes.
According to professional society standards and HLD instructions for use, this critical measurement, known as the minimum recommended concentration (MRC), should be taken every time an endoscope is reprocessed. The current method requires dipping a test strip into the HLD and subjectively assessing the color change of the test strip against a visual scale.
Given the manual nature of this process, testing may be missed or done incorrectly. AEROFLEX is the only AER with AUTOSURE MRC Monitor, an integrated system to automatically test HLD MRC levels every cycle, eliminating the need for manual test strips.
It is estimated that 32 million gastrointestinal (GI) endoscopy procedures using a flexible endoscope are performed each year in the United States. To keep pace with procedure demands, endoscopy managers are looking for ways to decrease the time and effort required to confidently reprocess endoscopes.
AEROFLEX with AUTOSURE will be equipped with a touchscreen user interface and an electronic records management system designed to improve efficiency, accuracy and compliance with record keeping requirements compared to manual systems.
For more information, please visit www.ASP.com.
