Past ACC President Ralph Brindis, MACC, et al., was published in BMJ recently on the need for international collaboration in device clinical standards. Brindis and the other authors discuss differences in the stringency of the approval process between Europe and other parts of the world and stress that patients around the world should be protected by similar requirements for device safety. The authors discuss the recommendations of the Global Harmonization Task Force, which includes representatives of regulatory agencies in Europe, North American, Japan and Australia, to promote common principles for evaluating devices. The authors write:

"…it would be inappropriate for higher levels of evidence to be required in Europe and North American than in parts of Africa and Asia. There should be no ‘region of least resistance’ where devices could be approved more rapidly and on the basis of less evidence. Rather, efforts should be concentrated on developing a global approach. For each type of high risk device, this should include a specific determination of how safe is ‘safe enough’ relative to its therapeutic benefit."

Their recommendations make sense, although I think it might be difficult to implement in reality. Additionally, I would argue that the U.S. process is too burdensome, and we could stand to learn something from Europe. However, any loosening in pre-market requirements must be made up by post-market surveillance, which we do poorly now. We can use the ACC’s NCDR and other registries to uplevel post-market surveillance, accelerate speed of products to market, and improve the safety profile of such products. This is promoting innovation -- it’s heading offshore unless we get more proactive here.