Former FDA Commissioner and QA Advisory Board Member David Acheson gives a perspective on the E.coli outbreak in Europe.
The on-going devastation in Europe linked to E. coli O104 serves as a strong reminder to those of us in the United States that we are always one step away from a major food safety crisis. The most recent numbers would indicate over 1,500 individuals have been diagnosed with infection and over 470 have developed hemolytic uremic syndrome (HUS) and 18 have died. HUS is one of the most devastating complications of foodborne illness that I know of. HUS is a combination of kidney failure, anemia and loss of ability to form blood clots due to low platelets and results in a dire situation with, as we have seen so far in this on-going outbreak, a significant mortality rate. In the almost 25 years that I have been dealing with Shiga toxin producing E. coli like the O104 strain and the infamous O157:H7 strain, I have never seen HUS rates even close to this outbreak.
As we look on from the outside at the outbreak in the European Union, it is natural to wonder if this could happen in the United States. I have very little doubt that it could, and so we should not lose this opportunity to learn more lessons about food safety. Unfortunately, we can never offer a 100% guarantee of prevention even with the most stringent regulatory requirements. That said, the most important lesson is to focus on building systems that prevent such a situation occurring here in the U.S. Yes, it would be appropriate for Federal regulators to recognize that many serotypes of E. coli other than O157:H7 are capable of causing disease – but I doubt that declaring another half dozen E. coli as adulterants would have any impact on the likelihood of an O104 outbreak in the U.S.
The solution does not lie in narrowly focused approaches, but rather should be aimed at broad mitigation strategies that are focused on reducing the risks in general for all pathogenic E. coli and not just a few serotypes.
Read the full article at Leavitt Partners.