Our founder was interviewed by the Minneapolis Star Tribune concerning an article the Tribune assembled on how Ethylene Oxide (EO) cancer risk can affect medical device manufacturers in the Twin Cities area.
What we found notable about this experience was that, with no lawsuits or many EO facilities in Minneapolis, the echoes of past EO lawsuits are still reverberating in the press years after the original concerns over EO cancer and subsequent major litigation.
We are not dogmatically anti-EO at NextBeam (it is a very high-performance sterilant), but we continue to believe that the litigious environment surrounding the EO industry coupled with the new EPA regulations promulgated earlier this year makes EO a fraught choice for any medical device that could be sterilized in another mature modality.
I Want to See if I Can Shift my Device From EO to E-Beam. How Do I Get Started?
A specific product’s engineering team is best positioned to understand its material performance characteristics, its specific performance requirements, and how to test/validate these in a new sterilization modality.
From an E-Beam sterilization validation standpoint, we recommend dose mapping and performing a max dose study as early as possible: these are fairly inexpensive and fast ways to eliminate risk.
At NextBeam, we typically recommend a consultation with our technical team and the device’s design team as a first, simple step before any testing is performed. There is no charge for this consultation. Contact us today to get started.
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