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Reprocessing of Reusable Medical Devices | FDA
- https://www.fda.gov/medical-devices/products-and-medical-procedures/reprocessing-reusable-medical-devices
- When the labeling instructions for reprocessing are completely and correctly followed after each use of the device, reprocessing results in a medical device that can be safely used more...
Reprocessing of Reusable Medical Devices: Information …
- https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/reprocessing-reusable-medical-devices-information-manufacturers
- Reprocessing of Reusable Medical Devices: Information for Manufacturers Reusable medical devices are devices that health care providers can reprocess and reuse on …
How are Reusable Medical Devices Reprocessed? | FDA
- https://www.fda.gov/medical-devices/reprocessing-reusable-medical-devices/how-are-reusable-medical-devices-reprocessed
- Adequate reprocessing of reusable medical devices is a critically important step in protecting patient safety. Reprocessing is intended to remove blood, tissue, and other …
Reprocessing Medical Devices in Health Care Settings: …
- https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reprocessing-medical-devices-health-care-settings-validation-methods-and-labeling
- Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff March 2015 Download the …
Reprocessing of Reusable Medical Devices: Information …
- https://www.fda.gov/medical-devices/reprocessing-reusable-medical-devices/reprocessing-reusable-medical-devices-information-patients
- You may be aware of incidents where inadequately reprocessed reusable medical devices were used on patients. It's important to know that the risk of infection from inadequate …
Reprocessing Medical Devices in Health Care …
- https://www.fda.gov/media/80265/download
- Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff Document issued on: …
Info for Health Care Facilities: Reprocessing of Reusable …
- https://www.fda.gov/medical-devices/reprocessing-reusable-medical-devices/information-health-care-facilities-reprocessing-reusable-medical-devices
- FUJIFILM Medical Systems, U.S.A., Inc. Validates Reprocessing Instructions for Model ED-530XT Duodenoscopes: FDA Safety Communication. …
FAQ: Reprocessing and Reuse of Single-Use Devices, …
- https://www.fda.gov/regulatory-information/search-fda-guidance-documents/frequently-asked-questions-about-reprocessing-and-reuse-single-use-devices-third-party-and-hospital-0
- Third-party and hospital reprocessors of single- use devices (SUDs) are subject to all the regulatory requirements currently applicable to original equipment manufacturers, …
FDA’s Approach to Medical Device Servicing
- https://www.fdanews.com/ext/resources/files/Conference2/MDQC19Presentations/Josephson-Servicing-Remanufacturing.pdf
- Medical device manufacturers are required to comply with FDA’s Quality System Regulation (QSR), which specifies manufacturing conditions and standards that …
Federal Register :: Refurbishing, Reconditioning, …
- https://www.federalregister.gov/documents/2016/03/04/2016-04700/refurbishing-reconditioning-rebuilding-remarketing-remanufacturing-and-servicing-of-medical-devices
- Repair: Return the device or component to original specifications including replacing non-working components or parts outside of routine or periodic upkeep for the …
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