Manual Reprocessing Medical Devices

Reprocessing of Reusable Medical Devices | FDA

https://www.fda.gov/medical-devices/products-and-medical-procedures/reprocessing-reusable-medical-devices

Adequate reprocessing of reusable medical devices is vital to protecting patient safety. Inadequate cleaning between patient uses can result in the retention of …

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/reprocessing-reusable-medical-devices-information-manufacturers

Reusable medical devices are devices that health care providers can reprocess and reuse on multiple patients. In March 2015, the Agency published Final Guidance for Industry …

How are Reusable Medical Devices Reprocessed? | FDA

https://www.fda.gov/medical-devices/reprocessing-reusable-medical-devices/how-are-reusable-medical-devices-reprocessed

Stand-alone reprocessing service facilities. In general, reprocessing reusable medical devices involves three steps: At the point of use, such as in the operating room, devices …

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

Center for Devices and Radiological Health. This guidance provides recommendations for the formulation and scientific validation of reprocessing instructions for reusable …