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Situation: Lady works for this medical device manufacturer company. The area where the workers create the medical devices is considered a clean area. Even with that bacteria from outside still come on to the floor from the shoes of the workers.
These places are regulated by the FDA. I am not sure whether the FDA has such rules for product accidentally going on the floor. They always instructed us(workers) to trash any product that has touched the floor when being audited but when we aren't we are told and practiced to wipe the product off with alcohol and push the product through the normal process.
The medical devices are used inside of people to help with the heart and other important body parts inside the body. Bacteria isn't a good thing. If the product is to be trashed when beingaudited, why not practice the same when not being audit. The lady isn't sure about all dept in the company but this is done in her dept where she works. Even the instructor of the line has no problem with this. I am sure the government money is being used for some of these products being pushed out. If the patient has medicare or medicaid and go to the hospital to get treated and treatment requires the use of this product than the cost of the product will be transfer into the bill billed to the government. Should this person speak to a lawyer who handles Qui Tam?