Olympus Supports New FDA Guidance on Bronchoscope Reprocessing
FDA Updates Safety Recommendations on Flexible Bronchoscope Use and Reprocessing, Recommending Single-Use Bronchoscopes in Certain Cases
CENTER VALLEY, Pa., July 12, 2021 /PRNewswire/ -- Olympus announced today that it supports the updated safety recommendations from the U.S. Food and Drug Administration (FDA), which include new recommendations regarding bronchoscope reprocessing and the use of single-use bronchoscopes when appropriate.
In its June 25, 2021 Safety Communication, "Flexible Bronchoscopes and Updated Recommendations for Reprocessing: FDA Safety Communication," the FDA states that it is "reminding health care facilities and staff responsible for reprocessing bronchoscopes and their accessories about the importance of carefully following the manufacturer's reprocessing instructions."i The Communication further recommends healthcare providers consider "a single-use bronchoscope in situations where there is increased risk of spreading infection (for example, multidrug resistant microorganisms, immunocompromised patients, or patients with prior disease) or when there is no support for immediate reprocessing of the bronchoscope."i Olympus recognizes the importance of the FDA's communication and stands prepared to aid healthcare providers in navigating decisions around how to appropriately balance their bronchoscopy portfolio. As markets evolve and recommendations for use are updated across many specialty areas, Olympus will pursue its goal of being the endoscopy partner of choice, developing single-use devices where they make good clinical sense while continuing to provide its traditional re-usable offerings.
"We recognize, like the FDA, that specific situations may warrant the decision to perform a bronchoscopy with a sterile single-use bronchoscope, said Lynn Ray, Global VP and General Manager for the Olympus Respiratory Business Unit. "We look forward to continuing to provide a broad portfolio of our industry-leading traditional bronchoscopes, as well as an ever-growing line of single-use bronchoscopes to meet the needs of our customers and to provide the right endoscope for every patient."
Olympus offers a broad portfolio of traditional and single-use bronchoscopes for the U.S. market, allowing physicians to prioritize on a case-by-case basis depending on procedural and clinical needs. When a single-use bronchoscope is preferred, such as in situations recommended by the FDA, Olympus offers the Vathin H-Steriscope and the Veran SPiN Vision single-use bronchoscopes, which include seven different size options, ranging from ultra-slim to larger bronchoscopes with wide instrument channels designed for therapeutic procedures.
Regarding recommendations from the FDA specific to bronchoscope reprocessing, Olympus flexible bronchoscopes can be safely and effectively used following the Olympus Instructions for Use (IFU) provided with each device. Health care facilities and the staff members responsible for reprocessing bronchoscopes and their accessories should understand the importance of carefully following the manufacturer's reprocessing instructions. The Olympus recommendations for visual inspection and proper maintenance and repair of bronchoscopes and accessories should be observed. For additional information including the appropriate use of accessories, detergents, and disinfectants, refer to the information provided with your bronchoscope or contact the manufacturer directly.
The full FDA safety recommendation is 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 the Olympus commitment to helping physicians select the right bronchoscope, for the right patient, for the right case, should contact their Olympus sales representatives 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 deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce overall costs, and enhance the quality of life for patients. Olympus' Medical portfolio includes endoscopes, laparoscopes, and video imaging systems, as well as surgical energy devices, system integration solutions, medical services, and a wide range of endotherapy instruments. For more information, visit www.medical.olympusamerica.com.
i Flexible Bronchoscopes and Updated Recommendations for Reprocessing: FDA Safety Communication. FDA.gov. https://www.fda.gov/medical-devices/safety-communications/flexible-bronchoscopes-and-updated-recommendations-reprocessing-fda-safety-communication. Published June 25, 2021. Accessed June 26, 2021
SOURCE Olympus Medical Systems Group
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