Tag Archives: U.S. Food and Drug Administration

New instruction for Medical Device Reusage by FDA

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The U.S. Food and Drug Administration announced steps to help reduce the risk of exposure to improperly reprocessed devices that can lead to the transmission of disease.

Medical devices intended for repeated use are commonplace in health care settings. They are typically made of durable substances that can withstand reprocessing, a multistep process which includes cleaning, disinfecting, or sterilization to remove debris and biologic materials that may transmit infection between patients. While successful reprocessing of reusable devices occurs routinely in health care settings, there are some devices which present particular challenges to reprocessing.