4/29/19: Advanced Sterilization Products Receives 510(k) Clearance for ASP AEROFLEX ™ Automatic Endoscope Reprocessor

Advanced Sterilization Products, AEROFLEX
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.

Advanced Sterilization Products announced today they 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 the fastest complete cycle time – just 22 minutes – of any AER currently sold in the United States.*

Flexible endoscopes are costly, complex and fragile instruments commonly used in minimally invasive procedures and are required to be high-level disinfected between every patient use. To effectively disinfect a flexible endoscope, it is essential that the active ingredient in the high-level disinfectant (HLD) be at or above the level required to kill microorganisms. 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.

Advanced Sterilization Products reports 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 is designed to ensure MRC testing compliance and increase productivity in the endoscopy suite,” said Amy Smith, Vice President of Advanced Sterilization Products. “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.”

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.

Note: *In countries where distributed. Includes wash, high-level disinfection, rinses, MRC testing and alcohol flush. For all qualified endoscopes except duodenoscopes which require additional time. Assuming nominal conditions for water pressure, flow rate and temperature.

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