FDA’s Validated IFU Requirements For “High Risk” Devices (Part II)
In Part I of this blog (Novo blog number 115, 12/13/19) we pointed out that “The #1 responsibility of everyone involved in reusable medical device processing is to minimize the risk of patient harm caused by a device that remains contaminated with organic debris after processing.” The responsibility to minimize...
FDA’s Validated IFU Requirements For “High Risk” Devices (Part I)
The #1 responsibility of everyone involved in reusable medical device processing is to minimize the risk of patient harm caused by a device that remains contaminated with organic debris after processing. This responsibility begins with pre-cleaning the device at point of use and it continues through all of the processing...
