Letters to FDA
Joined: 28 Apr 2003
Posts: 1
Posted: Mon Apr 28, 2003 5:02 am Post subject: Sent letters and Faxed Letters
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I faxed letters to the following:Also certified mail<
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>Dr. Sean Tunis<
>Director of Clinical Standards and Quality<
>Chief Officer of Services CMS<
>His Address is the following:<
>7500 Security Blvd <
>53002-01<
>Baltimore, Maryland 21244<
>His office number:410-786-6841<
>Fax Number: 410-786-6857<
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>Dr. Chin Lin<
>FDA Charge of Infection Control<
>Device Branch Office of Device Evaluation<
>CDRH_480<
>9200 Corporate Blvd<
>Rockville,Maryland<
>20850<
>Fax Number is 1-301-480-3002<
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>I would suggest that it is mailed or faxed. This way they are in receipt of it. Also leave your name and address to have a response. This is a way of making them accountable and to see if you are ignored.Their job is to protect the public.<
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>My letters where on my concern of the chemical and that personally many workers have come to this organization with Pulmonary problems,nosebleeds,passing out,difficulty in
eathing, cancers and asthma after working with these chemicals. We want to make sure that these are not done by these chemicals. We feel that more needs to be done and not allow the companies to not research the possibility of it causing cancers,only research can tell us this.<
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>We also realize that this chemical can be taken off the market if they chose tomorrow until these issues are investigated. Reuse was to be a choice and it is only a profit motive,with patients not told of side effects. Patients not told of what happens if it is not rinsed out and the fact that this chemical is not FDA approved,only cleared as a device and there needs to be more done to protect the patients and workers from this chemical.This chemical we feel has not had the research to state it safe and asked Minntech to once again give us a statement stating it is as they put it, as safe as salad dressing and it is only vinegar. I challenge them to eat a salad. They are the ones who do their own research as all we can see,and the reluctance to share the information is disturbing to me. If its safe then put it in writing.<
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>We are going on the record as why it is necessary as each patient can do no reuse as an option. The patients are denied Informed consent on this chemical as to where an educated choice can be made.<
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>Also I wrote to Minntech Corporation on my concerns and the fact that we will notify each CEO on the major corporations on our reservations on using this chemical on their patients and the healthcare workers exposed. I personally feel this is a dangerous chemical and our history as a nation, finds out many times after the fact that it has harmed. The reporting system doesnt happen. The ones that are reported, the dializer is never found for further study.<
>Minntech also was given the opportunity to have a letter enclosed with ours that the chemical is safe We will see if they will take up the offer.<
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>Minntechs address is the following:<
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>Mr. Roy Malkin CEO/<
>Dr. RC "Kip Kippenhan Vice pres<
>R+D Sterilants/Disenfectants/Cleaners<
>Minntech Corporation <
>14605 28th Ave North<
>Minneapolis, Minnesota 55447<
>Fax 786-553-3387<
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>We are keeping a paper trail and asking for phone conferences with our journalist. I dont know the other companies address that does paracitic acid, so if some Nancy Drew or Hardy Boy will find this for us.<
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>I personally feel that this chemical is dangerous and why use it if a patient doesnt have to.<
>Arlene<
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> Edited by: realdialysisethics at: 4/28/03 9:10:40 am<
