My son wears a custom made shiley tracheostomy (7.7 id 5.0 od 57mm long).Covidien is the company that makes them.They use a chemical called dehp.They have put 2 pamphlets in the boxes.One says you can clean the trach and the other says for single use only, do not clean, and do not use over 29 days due to the dehp.We have no idea what we are to do and there are no healthcare professionals that are willing to make the decision.My son is allergic to many things.We have had problems with his eyes swelling up since we started using the shiley custom trach.We used the portex for 30 years without any problems, but they no longer make that particular trach.My biggest concern is why the fda allows a company to use such a horrible chemical, dehp, in a product that is being put into people's bodies that are already so medically evolved? no other company uses this in making trachs but again we cannot switch because no one will make a custom trach out of pvc.The only other custom trachs in the us are made from silicone, bivona, which we tried but my son literally died.He is highly allergic to silicone we found out.I would like to have you take a look at the company, covidien, and tell me why you give them permission to use dehp.I would also like you to consider making the company stop using this chemical.There is no reason why one company has to use something that can cause so many more problems for these patients.I also realize we are exposed somewhat to this chemical in many products, but we do not wear the products 24/7.The products we are exposed to are not put in our bodies 24/7.Another huge problem is that the insurance companies will not allow the patient to have more than one trach per month.That already puts it over the 29 days.The trach needs to be changed weekly at least.We then cannot clean the trach, custom, again.So how do we reuse the product under these conditions? thank you very much.(b)(6).Trilogy 100 ventilator, ventilator circuits, compressor, plastic tubing for everything, trach masks (we have to put tape on them due to his skin will breakdown if the plastic sits on him).Fda safety report id # (b)(4).
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