RE:RE:TSO3 south of the borderI don't think supply concerns enter into the FDA process, but they will certainly provide the industry and hospitals with considerable implimentation lead time, in the range of at least a couple of years, to adopt and have universal access to this new technology solution. However, on a medical-legal basis, should FDA state that they are establishing a new standard, the liabilities for any hospital or physician who has a patient injuried or exposed, or who dies, using an older unvalidated reprocessor remain very unclear. The lawyers will jump all over these cases. "Why did you not provide the new standard, knowing it is available, to your injured, or dead, patient?"
And, regarding the Steris 1, the FDA demanded its removal from the market with an installed base of 23,000 US units, because it had been extensively modified without FDA approval. Steris, however, very quickly made a new unit available, though its sales have cratered in the past couple of years and they closed their Ohio production facility last year. This new unit does not terminally sterilize, and the FDA is clear with Steris and users about this labelling, because the water used to rinse the peractetic acid from the instruments is not sterile, but is only filtered and treated with UV light to disinfect it. The addition of the UV light was a modifcation to improve the 1e over the 1, as the latter only filtered water. Instruments coming out of the 1e must be used immediately and cannot be stored, as well. This is still the best reprocessor on the market, IMHO, but it is in no way an equal to the VP4 sterilizer.