Advanced Sterilization Products Receives 510(k) Clearance for ASP AEROFLEX ™ Automatic Endoscope Reprocessor

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.

Medical Device News Magazine
Medical Device News Magazine provides our readership with breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

The ArthroFree system is the first FDA-cleared wireless camera for arthroscopy and general endoscopy, both areas of minimally invasive surgery. The system is designed to help surgeons work with aximum dexterity and focus.
The project, which was led by the University of Southern California, included large increases in representation among men of African, Hispanic and Asian ancestries, that were contributed in part by an ongoing collaboration between the U.S. Department of Veterans Affairs and DOE reports Argonne.
This innovative software turns smartphones into medical-grade stethoscopes, allowing people to capture, analyze, and share critical heart health data with medical personnel from the comfort of any location notes Sparrow BioAcoustics.
"Taewoong Medical becoming an Olympus group company is also a major milestone in our global growth strategy," said Henry Shin, CEO of STARmed. "We look forward to our products being made available to more patients through Olympus' global distribution network."
The company reports they have successfully met the six-month primary endpoint for the first-ever female patient implanted with the UroActive™ System, the first smart automated artificial urinary sphincter (AUS) to treat SUI.

By using this website you agree to accept Medical Device News Magazine Privacy Policy