Hi -
Help Please as the Boss and I differ on the term "reprocess".
Can anyone help me out and help me to understand if / when a device is considered to be a reprocessed device.
The UDI compliance date for "reprocessed Class II" devices is September 2015. For non-reprocessed Class II devices, the date is September 2016. The device is a prescription device used in hospitals.
I am interested to learn if (880.6740) Vacuum-powered body fluid suction apparatus (vacuum regulator) is considered to be a "reprocessed" device. The instructions for use and hospital protocol is to clean the outside of the device and disinfect and/or sterilized with ETO if the device becomes contaminated. Also, there is mention not to return contaminated devices to the manufacturer for repair (user is instructed to disinfect/sterilize before returning).
I may be totally off-base however, my brain keeps telling me the device is considered "reprocessed" and I believe the due date to be Sept. 2015.
Any thoughts, comments and advice would be greatly appreciated

Help Please as the Boss and I differ on the term "reprocess".Can anyone help me out and help me to understand if / when a device is considered to be a reprocessed device.
The UDI compliance date for "reprocessed Class II" devices is September 2015. For non-reprocessed Class II devices, the date is September 2016. The device is a prescription device used in hospitals.
I am interested to learn if (880.6740) Vacuum-powered body fluid suction apparatus (vacuum regulator) is considered to be a "reprocessed" device. The instructions for use and hospital protocol is to clean the outside of the device and disinfect and/or sterilized with ETO if the device becomes contaminated. Also, there is mention not to return contaminated devices to the manufacturer for repair (user is instructed to disinfect/sterilize before returning).
I may be totally off-base however, my brain keeps telling me the device is considered "reprocessed" and I believe the due date to be Sept. 2015.
Any thoughts, comments and advice would be greatly appreciated

