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Ambu® aScope™ Gastro and Ambu® aBox™ 2

February 23, 2022 by Gustavo Romero-Velez and David Miller Pechman

Ambu® aScope™ is a sterile single-use gastroscope which was released in conjunction with Ambu® aBox™ 2, a next-generation display with advanced processing technology offering high quality images during endoscopic procedures. In 2005, the American College of Chest Physicians published a consensus statement on the Prevention of Flexible Bronchoscopy-Associated Infection.1 Since then, there has been a great concern by the FDA on the prevention of these types of nosocomial infections leading to post-market surveillance of endoscopic devices.2 Bacterial biofilm-related infection rates have been reported to be as high as 10%, which has led to the development and approval of single-use duodenoscopes with adequate results.3,4 Disposable endoscopes will help prevent endoscopy-associated infections.5

The FDA has determined that the Ambu® aScope™ Gastro and Ambu® aBox™ 2 is substantially equivalent a predicate device, the Olympus TJF-Q180V.

The device is approved by the FDA to examine or perform procedures within the stomach. It is approved as a single-use device. It is intended for use on one patient during a single procedure.

The use of this device is contraindicated if there is an absolute contraindication for endoscopy. It is not intended to be reprocessed (cleaned, disinfected/sterilized) and used on another patient.

References

  1. Mehta AC, Prakash UBS, Garland R, et al. American College of Chest Physicians and American Association for Bronchology [corrected] consensus statement: prevention of flexible bronchoscopy-associated infection. Chest. 2005;128(3):1742-1755. doi:10.1378/chest.128.3.1742
  2. Saleem N, Ismail MK, Tombazzi CR, Soin S, Dhruva SS. Endoscopic transmission of carbapenem-resistant Enterobacteriaceae: implications for U.S. Food and Drug Administration approval and postmarket surveillance of endoscopic devices. Gastrointestinal Endoscopy. 2021;93(1):231-238. doi:10.1016/j.gie.2020.07.061
  3. Ryu K, Jang S. Single Use (disposable) Duodenoscope: Recent Development and Future. Clin Endosc. Published online June 22, 2021. doi:10.5946/ce.2021.075
  4. Tran VN, Park S, Khan F, et al. Collective bacterial disinfection by opto-chemical treatment on mature biofilm in clinical endoscope. Journal of Photochemistry and Photobiology B: Biology. 2022;226:112367. doi:10.1016/j.jphotobiol.2021.112367
  5. The Lancet Gastroenterology & Hepatology. Scoping the problem: endoscopy-associated infections. The Lancet Gastroenterology & Hepatology. 2018;3(7):445. doi:10.1016/S2468-1253(18)30168-7