At the recently completed GHX Healthcare Supply Chain Summit, I had the opportunity to ask former Senate Majority Leaders Tom Daschle and Bill First if Congress gives much consideration to the global implications of healthcare reform. The Senators agreed, probably not enough. Fortunately, as I mentioned in an earlier blog post (April 10), the FDA has, as it has worked with other regulatory bodies to achieve some consistency in how countries around the global plan to implement regulations to require the unique identification of medical devices.
If successful, a more globally harmonized approach to unique device identification (UDI) can yield both operational savings, as well as data that can help improve the quality of patient care. Not only can global manufacturers reduce the costs associated with regulatory compliance, but we can also use UDI to link data in product registries being developed by both public and private entities around the globe. After all, if we are all calling the same product the same thing, we can better relate the data captured in product registries in Switzerland or Germany, as an example, with ones developed by the US government or a private enterprise like Kaiser Permanente.