New surgical technology: do we know what we are doing?
How can we best protect patients while making progress?
The pace of development in new surgical procedures and technologies continues to accelerate, driven in part by manufacturers, surgeons and community expectations. Despite regulatory bodies such as the Therapeutic Goods Administration (TGA), new devices can enter the market with little or no evidence of their effectiveness, and even their safety can be poorly evaluated. The withdrawal of the DePuy Orthopaedics articular surface replacement hip prosthesis illustrates the difficulty in anticipating the unintended problems with a joint prosthesis that superficially appeared to be little different from hundreds of others already available on the market.1
Innovation is not well regulated
While the TGA attempts to assess devices, the evidence base necessary for determining their durability in human use is rarely available or is inadequate. The introduction of new procedures is even less regulated. If a completely new procedure is developed and a Medicare item number is sought, then the Medical Services Advisory Committee2 would usually assess its merits; however, this is not required in the public health system.
Of greater concern is the ability to use existing Medicare descriptors to cover new procedures. This occurred with the introduction of laparoscopic cholecystectomy in 1991 and enabled…