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The FDA has updated its safety recommendations regarding the use and reprocessing of flexible bronchoscopes, and in some cases it is recommended to use disposable bronchoscopes

Center Valley, Pennsylvania, July 12, 2021/PRNewswire/ - Olympus today announced that it supports the latest safety recommendations of the U.S. Food and Drug Administration (FDA), which include reprocessing and reprocessing of bronchoscopes. New recommendations for sexual use use bronchoscopy when appropriate.

In its June 25, 2021 safety newsletter "Updated Recommendations for Flexible Bronchoscopes and Reprocessing: FDA Safety Newsletter", the FDA stated that it "reminds healthcare institutions and staff responsible for reprocessing bronchoscopes and their accessories Pay attention to carefully follow the manufacturer’s reprocessing instructions.” iCommunication further advises healthcare providers to consider “in situations where the risk of transmission of infection increases (for example, multi-drug resistant microorganisms, patients with weakened immune functions, or patients with pre-existing diseases) Or when it is not supported to reprocess bronchoscopes immediately.” i Olympus recognizes the importance of FDA communication and stands ready to help healthcare providers make decisions about how to properly balance their bronchoscope portfolio. With the development of the market and the update of recommendations for use in many professional fields, Olympus will pursue the goal of becoming the preferred endoscope partner, develop a disposable device with good clinical significance, while continuing to provide its traditional reusable The product.

"We, like the FDA, recognize that under certain circumstances, it may be necessary to decide to use a sterile disposable bronchoscope for bronchoscopy," said Lynn Ray, global vice president and general manager of Olympus' Respiratory Business Unit. "We look forward to continuing to provide our industry-leading broad product portfolio of traditional bronchoscopes, as well as a growing series of disposable bronchoscopes, to meet the needs of our customers and provide each patient with a suitable endoscope."

Olympus provides a broad portfolio of traditional and disposable bronchoscopy products for the US market, allowing doctors to prioritize according to specific circumstances based on procedures and clinical needs. When disposable bronchoscopes are preferred, for example, as recommended by the FDA, Olympus provides Vathin H-Steriscope and Veran SPiN Vision disposable bronchoscopes, including seven different sizes of options, from ultra-thin bronchoscopes to more Large bronchoscopes have wide instrument channels specially designed for treatment procedures.

Regarding the FDA's specific recommendations for bronchoscope reprocessing, the Olympus flexible bronchoscope can be used safely and effectively in accordance with the Olympus Instructions for Use (IFU) included with each device. Health care institutions and staff responsible for reprocessing bronchoscopes and accessories should understand the importance of carefully following the manufacturer’s reprocessing instructions. Olympus recommendations for visual inspection and proper maintenance and repair of bronchoscopes and accessories should be followed. For additional information on the proper use of accessories, detergents and disinfectants, please refer to the information provided with the bronchoscope or contact the manufacturer directly.

The complete FDA safety recommendations are available online: https://www.fda.gov/medical-devices/safety-communications/flexible-bronchoscopes-and-updated-recommendations-reprocessing-fda-safety-communication.

Those interested in learning more about Olympus' commitment to help doctors choose the right bronchoscope for the right patient and the right case should contact their Olympus sales representative for more information or visit https:/ /medical.olympusamerica.com/procedure/Bronchoscopy and https://medical.olympusamerica.com/products/bronchoscope/h-steriscopes.

About Olympus Medical Systems Group Olympus is passionate about the solutions it creates for the medical, life sciences and industrial equipment industries.

Olympus' medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals provide diagnosis, treatment, and minimally invasive surgery to improve clinical outcomes, reduce overall costs, and improve the quality of life of patients. Olympus' medical product portfolio includes endoscopes, laparoscopes and video imaging systems, as well as surgical energy equipment, system integration solutions, medical services and various endotherapy instruments. For more information, please visit www.medical.olympusamerica.com.

i Flexible bronchoscopy and updated recommendations for reprocessing: FDA safety newsletter. FDA.gov. https://www.fda.gov/medical-devices/safety-communications/flexible-bronchoscopes-and-updated-recommendations-reprocessing-fda-safety-communication. Published on June 25, 2021. Visited June 26, 2021

SOURCE Olympus Medical System Group

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