FDA doesn' t even know of all the reprocessors that exist. According to the GAO report, FDA suspects there are third-party reprocessors that have never even registered with them. FDA clearly has the authority to enforce safety and effectiveness standards, yet it has looked the other way, allowing this practice to go on with very little oversight. Yet, to date FDA has chosen not to enforce these standards. Today, there is nothing on the books that prevents hospitals from using a reprocessed device on a patient without their knowledge or consent.
Nothing is required to prove that the device is safe and effective.
And nothing prevents a hospital from charging the patient and the Federal government through Medicare for a new device when a secondhand one is used. When we buy a part for our car, the mechanic is required to tell us if the part is new or rebuilt and we are charged accordingly. Until recently, FDA's primary reason for not enforcing these standards was the increased regulatory burden. I find this an irresponsible and fully unacceptable failure on the part of FDA to ensure patient safety. I understand that FDA has a lot on its plate.