Heh. Did you note the title of the book? I hardly think anyone is going to be trying to
eat any of our products.
I have conclusive circumstantial evidence that EtO sterilization of
medical devices is not prohibited in Japan. We sell on a bulk private label basis to a number of multinational medical companies that then resell our products around the world, including in Japan in several instances. All of our sterile product, as sold worldwide, is clearly and prominently labeled "Sterile EO", the international symbol/text for EtO sterilization. In all cases, it's sold as we package and label it...no re-packaging or re-labeling is done. (We have multiple business and regulatory ways of knowing this, and verifying it.) Sterile application technique requires that the product be in its unopened pouch all the way to the point of application, and the personnel doing the application are most often quite highly educated and trained medical personnel...different ones at every hospital or other procedural site, of course.
It seems implausible that we could have been shipping product for many years, that has been used by thousands of such individuals in Japan, and yet no one had ever read the label and discovered that they were working with a device that was sterilized in a (supposedly) prohibited manner.
I am looking for help on this matter, but it
does need to be medical-device-knowledgable help.
