Last week the Food and Drug Administration (FDA) released a final guidance document aimed at helping manufacturers improve the safety of reusable medical devices. Following the recent news coverage of the Superbug Outbreaks in the U.S. we are all aware of how complex device designs can inhibit effective reprocessing of endoscopes; the same is true for other reusable medical devices.
The FDA's guidance document, titled "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labelling" includes six criteria that medical device manufacturers should take into consideration when designing a reusable medical device and when creating the instructions for use. Essentially, these criteria recommend that manufacturers validate the reprocessing methods for their devices to ensure that a technician can effectively disinfect or sterilize the devices by following the manufacturer's instructions for use. The FDA believes that when manufacturers adhere to this guidance document, the risk of device contamination and infection transmission will be significantly reduced.
This guidance document also provides more detailed information on when issues must be reported to the FDA. After the superbug outbreak, numerous cases of unreported infections came to the surface; it was found that many were not reported due to unclear reporting guidelines.
For more information, you can download a copy of the guidance document here...
The FDA's guidance document, titled "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labelling" includes six criteria that medical device manufacturers should take into consideration when designing a reusable medical device and when creating the instructions for use. Essentially, these criteria recommend that manufacturers validate the reprocessing methods for their devices to ensure that a technician can effectively disinfect or sterilize the devices by following the manufacturer's instructions for use. The FDA believes that when manufacturers adhere to this guidance document, the risk of device contamination and infection transmission will be significantly reduced.
This guidance document also provides more detailed information on when issues must be reported to the FDA. After the superbug outbreak, numerous cases of unreported infections came to the surface; it was found that many were not reported due to unclear reporting guidelines.
For more information, you can download a copy of the guidance document here...
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