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Sterilization for Medical Devices | FDA
- https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/sterilization-medical-devices
- Medical devices are sterilized in various ways, including ethylene oxide and radiation. Read more on the FDA’s actions to advance medical device sterilization.
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 …
Ensuring Safe, Effective Medical Device Sterilization in …
- https://www.fda.gov/news-events/fda-voices/preventing-medical-device-shortages-ensuring-safe-and-effective-sterilization-manufacturing
- Earlier this year, the FDA was made aware of the closure of a large device sterilization facility—which sterilized 594 types of medical devices—because of concerns about the …
FDA Continues Efforts to Support Innovation in Medical …
- https://www.fda.gov/news-events/press-announcements/fda-continues-efforts-support-innovation-medical-device-sterilization
- The sterilization of medical devices is a vital process for helping to prevent serious infections. The U.S. Food and Drug Administration continually works to …
Gamma Sterilization of Medical Devices - Food and …
- https://www.fda.gov/media/132374/download
- Medical Devices FDA MEDICAL DEVICE ADVISORY MEETING NOVEMBER 6, 2019 . Typical gamma sterilization applications . ... ISO 11137-1 is the Standard for Radiation …
Sterilization | Disinfection & Sterilization Guidelines
- https://www.cdc.gov/infectioncontrol/guidelines/disinfection/sterilization/index.html
- Most medical and surgical devices used in healthcare facilities are made of materials that are heat stable and therefore undergo heat, primarily steam, sterilization. However, …
FDA Innovation Challenge 1: Identify New Sterilization …
- https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/fda-innovation-challenge-1-identify-new-sterilization-methods-and-technologies
- In response to the February 2019 closure of a large device sterilization facility, the FDA is taking steps to ensure that hospitals, health care providers, and patients have access to …
Sterilants and Disinfectants for Processing Reusable …
- https://www.fda.gov/medical-devices/reprocessing-reusable-medical-devices-information-manufacturers/fda-cleared-sterilants-and-high-level-disinfectants-general-claims-processing-reusable-medical-and
- Sep 25, 2019
CFR - Code of Federal Regulations Title 21 - Food and …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=880.2800
- The information on this page is current as of Jan 17, 2023. For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). …
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