Personally, I think that this topic should be considered with the famous motto “If it ain’t broke, don’t fix it” . Obviously, these documents and the protocol to make all these devices safe and effective are necessary. However, if these legacy products have been used in hospitals, doctors offices, and over the counter for years already, and there hasn’t been a reason for retraction or recall, it’s not worth it to open up these cold cases. If it’s working, let it work. Precious time should not be wasted on things that don’t require the time. Especially with the healthcare system as out of whack as it is, paperwork time is precious because of the amount there is.

-John L.