Sick of it
Joined: 11 Feb 2003
Posts: 46
Posted: Fri Feb 28, 2003 6:04 am Post subject: Reuse - Getting the FDA to answer 1st Try
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THE FOLLOWING IS AN E-MAIL SENT TO THE FDA DR. CHIU S. LIN: WHO IS OVER THE FDA DEPARTMENT RESPONSIBLE FOR DIALYZERS AND STERILANT. <
><
>I will be letting you know over the next three weeks his response. If none then I would like to enlist your help and will give you the e-mail address and fax number to assist me in attaining a response. The following letter was crafted by a Chemical Engineer with 20 years in medical device Manufacturing and has at one point manufactured Hemodialyzers.<
> <
>Lets get the answers. Thank you - SICK OF IT<
><
>Dear Dr. Chiu S. Lin : Can you please provide a reference to the validation requirements for sterilants and germicides used in the reprossessing of hemodialyzers? What are the manufacturer's and dialysis clinic's responsibilities to validating the use of the sterilants/germicides and what clinical data may be available on the safety of these chemicals? Are there any studies on the toxicology or long term exposure to such chemicals through hemology or blood analysis of patients?<
><
>Are dialysis clinics required to do any residual analysis for cleaning agents or sterilants prior to each reuse of a filter?<
><
>Can a dialysis clinic justifiably reuse a filter beyond 15 times, the in-vitro test terminal cycle under hemodialyzer reuse guidelines?<
><
>We in the dialysis community appreciate the efforts of the agency to provide safer medical devices.<
>Thank You, <
><
><
><
>
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patient
Joined: 29 Oct 2002
Posts: 137
Posted: Fri Feb 28, 2003 10:52 am Post subject: letter
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Great Letter! You're speaking for a lot of patients.
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ExUser
Joined: 14 Feb 2003
Posts: 4
Posted: Sun Mar 02, 2003 5:33 am Post subject: Good Letter
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Thanks for speaking out and searching for answers. I will fax or e-mail when you need it. The more of us that ask the hard questions then the more thay have to watch what they do to patients.
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SS aka Spouse Support
Joined: 05 Mar 2003
Posts: 1
Posted: Wed Mar 05, 2003 12:48 pm Post subject: FDA response on reuse- not forthcoming
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Since contacting the FDA and DR. CHIU S. LIN there has been no response.......anyone surprised?<
>The issues raised are the same issues that any medical device company selling a product would have to demonstrate; that is sound clinical and unequivocal safety and efficacy data to the FDA should the agency visit the company, (and they do visit at least once every year or so for routine audits, as well as in acute recall incidents). If the FDA conducted an audit specifically dealing with the reuse of hemodialyzers, and the company had weak or little evidence that the devices could be safely sterilized in multiple reuse scenarios through exhaustive testing to ensure chemical sterilants are not left in the filter and that filter performance and blood/clot evacuation is safe through such methods, the agency would likely cite and find the company in violation of the Good Manufacturing Practices promulgated under CFR 820 of the Food and Drug Cosmetic Act, and potentially force the company to remove products from the market, pay fines and potentially prosecute officials of the company! All of this is being done on other medical devices to ensure that products perform according to the "intended use"; which in the case of hemodialyzers (filters) that are known to be reused, compels THE MANUFACTURER to certify (validate) reuse under conditions equivalent to those in the clinics and under all sterilization scenarios and patient demographics. The Agency is very specific in it's statutes that the maker of a device design must anticipate proper and improper use of the medical device, and must certainly address and prove the performance, safety and efficacy of the device design when the company KNOWS HOW THE DEVICE WILL BE USED, WHICH IN OUR CASE MEANS--EVERYONE KNOWS IT WILL BE REUSED UP TO XX NUMBER OF TIMES.....<
>BUT THIS IS NOT THE APPROACH BEING TAKEN either with hemodialyzer device makers OR THE REPROCESSORS--WHICH IN THIS CASE IS THE CLINIC! I assume this approach is not being taken....because such studies cannot be found that link all performance values of filters in 1st use, 2nd, 3rd.....30th, with various reported sterilization processes, chemicals, water quality, etc included as factors and the result on patient blood chemistry evaluations...across many, many patients if you really want clinical data......this my friends is an almost impossible study to conduct ! Think about all the factors.....! Nobody in the industry wants to conduct such a study...it could take years and probably wind up inconclusive, or worse yet for the company's, demonstrate degradation of patient outcomes through reuse!<
>We will continue to seek answers from FDA on why manufacturers and reprocessors of medical devices are all held to standards protecting the public health except for the hemodialysis industry and clinics.....until then... be well [SS]
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Conference
Joined: 06 Mar 2003
Posts: 1
Posted: Thu Mar 06, 2003 7:46 am Post subject: Here are the numbers and addresses
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Well, I had a conference call with Dr Kang,with the new administration the top Doc. He was so concerned almost 2 years ago that nothing was done.<
><
>His number is (or whomever is new) 410-786-6841/410-786-3162<
>address is:<
>7500 Security Blvd.<
>S-3-02-01<
>Baltmore, Maryland 21244-1850<
><
>Then we have Mr. Hash whose name is most likely different....but this is the number when we conferenced called.<
>Mr.Hash 202-690-5727.<
> They both stated that FDA and HCFA Powerless need to call the number below.<
>Top Scientist:<
>Dr. Mary Reed 301-594-3660<
>She actually
agged about a dializer used well over a hundred times.<
>FDA can take this off their shelves today if they chose to. The fact that it hasnt been done shows that they could care less. They know what it is and will have a hard time explaining their actions as is HCFA for ignoring the problem,even after being given the documents. <
>The day is soon that those in positions of trust have been negligent to those they were intrusted to help.<
>It is going to get interesting sooon....!
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patient
Joined: 29 Oct 2002
Posts: 137
Posted: Mon Mar 24, 2003 7:11 am Post subject: FDA
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have they responded to your letter yet. I would like and answer on this.
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Sick of it
Joined: 11 Feb 2003
Posts: 46
Posted: Mon Mar 24, 2003 7:14 am Post subject: responding
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They have not even acknowledged the e-mail we are sending for a thrid time and will be posting the ne letter on this site.
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Curious
Joined: 02 Feb 2003
Posts: 39
Posted: Tue Mar 25, 2003 5:52 am Post subject: Email the string
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Everyone email the string and each put down our concerns.
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patient
Joined: 29 Oct 2002
Posts: 137
Posted: Tue Mar 25, 2003 7:13 am Post subject: Dialysis vs. War and Terrorism deaths.
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I am another person with the same
name , "patient"<
><
><
>At my university, many students use <
>www.ratemyprofessor.com<
><
>It can give you an idea of how such ratings could be done.
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Reusing non reuse item
Joined: 14 Apr 2003
Posts: 1
Posted: Mon Apr 14, 2003 11:46 am Post subject: reuse
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<
> MAUDE Database<
><
> BRAND NAME<
> PSN DIALYZER (PSN 170)<
> TYPE OF DEVICE <
> HOLLOW FIBER DIALYZER<
> BASELINE BRAND NAME<
> PSN DIALYZER (PSN 170)<
> BASELINE GENERIC NAME<
> HOLLOW FIBER DIALYZER<
> BASELINE CATALOGUE NUMBER<
> R5M4235<
> BASELINE MODEL NUMBER<
> PSN 170<
> BASELINE DEVICE FAMILY<
> POLYSYNTHANE HEMODIALYZER<
> BASELINE DEVICE 510(K) NUMBER<
> K980656<
> BASELINE SHELF LIFE INFORMATION<
> NO <
> IS BASELINE PMA NUMBER PROVIDED? <
> NO <
> BASELINE PREAMENDMENT?<
> NO <
> TRANSITIONAL?<
> NO <
> 510(K) EXEMPT?<
> NO <
> SHELF LIFE(Months)<
> NA<
> DATE FIRST MARKETED<
> 09/16/1998<
> MANUFACTURER (Section F) <
> BAXTER HEALTHCARE CORP.<
> 1900 HIGHWAY, 201 NORTH<
> MOUNTAIN HOME AR 72653 2497 <
><
> MANUFACTURER (Section D) <
> BAXTER HEALTHCARE CORP.<
> 1900 HIGHWAY, 201 NORTH<
> MOUNTAIN HOME AR 72653 2497<
><
> MANUFACTURER CONTACT<
> CHRISTIANA BIELINSKI <
> ROUTE 120 & WILSON ROAD<
> ROUND LAKES , IL 60073<
> (847) 270 -6756 <
><
> DEVICE EVENT KEY<
> 409661<
> MDR REPORT KEY<
> 420609<
> EVENT KEY<
> 397802<
> REPORT NUMBER<
> 1423500-2002-01256<
> DEVICE SEQUENCE NUMBER<
> 1<
> PRODUCT CODE<
> FJI<
> REPORT SOURCE<
> MANUFACTURER <
> SOURCE TYPE<
> USER FACILITY <
> EVENT TYPE<
> MALFUNCTION <
> TYPE OF REPORT<
> INITIAL<
> REPORT DATE<
> 08/30/2002<
> 1 DEVICE WAS INVOLVED IN THE EVENT<
> 1 PATIENT WAS INVOLVED IN THE EVENT<
> DATE FDA RECEIVED<
> 09/27/2002<
> IS THIS AN ADVERSE EVENT REPORT?<
> NO <
> IS THIS A PRODUCT PROBLEM REPORT?<
> YES <
> DEVICE OPERATOR<
> HEALTH PROFESSIONAL<
> DEVICE MODEL NUMBER<
> PSN 170<
> DEVICE CATALOGUE NUMBER<
> 5M1817<
> DEVICE LOT NUMBER<
> NA01<
> WAS DEVICE AVAILABLE FOR EVALUATION?<
> NO <
> IS THE REPORTER A HEALTH PROFESSIONAL?<
> YES <
> WAS THE REPORT SENT TO FDA?<
> NO <
> DATE MANUFACTURER RECEIVED<
> 08/30/2002<
> WAS DEVICE EVALUATED BY MANUFACTURER?<
> DEVICE NOT RETURNED TO MANUFACTURER <
> IS THE DEVICE SINGLE USE?<
> YES <
> TYPE OF DEVICE USAGE<
> UNKNOWN <
><
>ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION <
>REPORT DATE: 08/30/2002 MDR TEXT KEY: 1460127 Patient Sequence Number: 1<
>CUSTOMER REPORTS MULTIPLE INCIDENTS OF DIFFICULTY RINSING RENALIN FROM THE PSN 170<
>DIALYZER. IT WAS REPORTED THAT IT TAKES AN INCREASED AMOUNT OF TIME AND AN EXTRA LITER<
>OF SALINE TO RINSE RENALIN FROM THE DIALYZER. IT WAS NOTED THAT THE UNITS IN QUESTION<
>WERE NOT USED ON ANY PT. NO PT INJURY OR MEDICAL INTERVENTION WAS REPORTED PER<
>CUSTOMER.<
> <
>ADDITIONAL MANUFACTURER NARRATIVE <
>REPORT DATE: 08/30/2002 MDR TEXT KEY: 1460130 <
>PLEASE NOTE THAT THE PSN DIALYZER IS LABELED FOR SINGLE USE ONLY. MANUFACTURER ADVISED<
>THE CUSTOMER OF THIS INFO AND COMMUNICATED THAT PRE-PROCESSING AND RE-PROCESSING<
>PROCEDURES HAVE NOT BEEN VALIDATED BY THE MANUFACURER FOR THE PSN DIALYZER.<
>MANUFACTURER DISCUSSED THE PRODUCT'S RECOMMENDED USAGE ASD DESCRIBED IN THE<
>PRODUCT'S DIRECTIONAL INSERT PROVIDED WITH EACH CARTON OF PRODUCT.
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Incident
Joined: 28 Apr 2003
Posts: 1
Posted: Mon Apr 28, 2003 4:05 am Post subject: reuse,...just say NO
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w Search<
> Back To Search Results<
><
> MAUDE Database<
><
> BRAND NAME<
> RENALIN<
> TYPE OF DEVICE <
> COLD STERILANT<
> MANUFACTURER (Section F) <
> MINNTECH CORP.<
> 14605 28TH AVE. NORTH<
> MINNEAPOLIS MN 55447 <
><
> MANUFACTURER (Section D) <
> MINNTECH CORP.<
> 14605 28TH AVE. NORTH<
> MINNEAPOLIS MN 55447 <
><
> MANUFACTURER CONTACT<
> 14605 28TH AVENUE, NORTH<
> MINNEAPOLIS , MN 55447<
> (763) 553 -3300 <
><
> DEVICE EVENT KEY<
> 439424<
> MDR REPORT KEY<
> 450431<
> EVENT KEY<
> 426554<
> REPORT NUMBER<
> 2150060-2003-00005<
> DEVICE SEQUENCE NUMBER<
> 1<
> PRODUCT CODE<
> LIF<
> REPORT SOURCE<
> MANUFACTURER <
> SOURCE TYPE<
> HEALTH PROFESSIONAL,USER FACILITY <
> EVENT TYPE<
> OTHER <
> TYPE OF REPORT<
> INITIAL<
> REPORT DATE<
> 03/20/2003<
> 1 DEVICE WAS INVOLVED IN THE EVENT<
> 1 PATIENT WAS INVOLVED IN THE EVENT<
> DATE FDA RECEIVED<
> 03/21/2003<
> IS THIS AN ADVERSE EVENT REPORT?<
> YES <
> IS THIS A PRODUCT PROBLEM REPORT?<
> NO <
> DEVICE OPERATOR<
> HEALTH PROFESSIONAL<
> WAS DEVICE AVAILABLE FOR EVALUATION?<
> NO <
> IS THE REPORTER A HEALTH PROFESSIONAL?<
> YES <
> WAS THE REPORT SENT TO FDA?<
> NO <
> DISTRIBUTOR FACILITY AWARE DATE<
> 02/21/2003<
> DEVICE AGE<
> UNKNOWN<
> EVENT LOCATION<
> OUTPATIENT TREATMENT FACILITY<
> DATE REPORT TO MANUFACTURER<
> 02/24/2003<
> DATE MANUFACTURER RECEIVED<
> 02/24/2003<
> WAS DEVICE EVALUATED BY MANUFACTURER?<
> DEVICE NOT RETURNED TO MANUFACTURER <
> IS THE DEVICE SINGLE USE?<
> YES <
> TYPE OF DEVICE USAGE<
> INITIAL <
> PATIENT OUTCOME<
> OTHER REQUIRED INTERVENTION <
><
> ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION <
> REPORT DATE: 03/20/2003 MDR TEXT KEY: 1563014 Patient Sequence Number: 1<
> 2 MINUTES INTO TREATMENT, PT REPORTED HAVING A TINGLING SENSATION AND NUMBNESS IN THE MOUTH AND FELT VERY "STRANGE". TREATMENT WAS STOPPED AND THE SET UP WAS CHANGED OUT. TREATMENT WAS REINITIATED ON A "DRY PACK" DIALYZER AND PT COMPLETED TREATMENT WITHOUT ANY COMPLICATIONS. NO HOSITALIZATION WAS REQUIRED. PT DOING FINE WITH NO FURTHER PROBLEMS REPORTED.<
> <
> ADDITIONAL MANUFACTURER NARRATIVE <
> REPORT DATE: 03/20/2003 MDR TEXT KEY: 1563017 <
> H11 - NURSE STATED ALL HOSES WERE ATTACHED AND THE DIALYSATE FLOW ESTABLISHED DURING RI
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Another
Joined: 25 Apr 2003
Posts: 3
Posted: Mon Apr 28, 2003 4:07 am Post subject: Report
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<
><
> MAUDE Database<
><
> BRAND NAME<
> MEDISYSTEMS HEMODIALYSIS BLOOD TUBING SET<
> TYPE OF DEVICE <
> HEMODIALYSIS BLOOD TUBING SET<
> BASELINE BRAND NAME<
> MEDISYSTEMS HEMODIALYSIS BLOOD TUBING SET<
> BASELINE GENERIC NAME<
> HEMODIALYSIS BLOOD TUBING SET<
> BASELINE CATALOGUE NUMBER<
> K3-9605/9750<
> BASELINE DEVICE FAMILY<
> BLOOD TUBING SET<
> BASELINE DEVICE 510(K) NUMBER<
> K811839<
> BASELINE SHELF LIFE INFORMATION<
> YES <
> IS BASELINE PMA NUMBER PROVIDED? NO <
> BASELINE PREAMENDMENT?<
> NO <
> TRANSITIONAL?<
> NO <
> 510(K) EXEMPT?<
> NO <
/>> SHELF LIFE(Months)<
> 36<
> DATE FIRST MARKETED<
> 09/08/1982<
> MANUFACTURER (Section F) <
> MEDISYSTEMS CORP.<
> 701 PIKE STREET<
> SUITE 1600<
> SEATTLE WA 98101 3016 <
><
> MANUFACTURER (Section D) <
> MEDISYSTEMS CORP.<
> 701 PIKE STREET<
> SUITE 1600<
> SEATTLE WA 98101 3016<
><
> MANUFACTURER CONTACT<
> LAURA PLATH <
> 701 PIKE STREET<
> SUITE 1600<
> SEATTLE , WA 98101-3016<
> (206) 834 -1200 <
><
> DEVICE EVENT KEY<
> 432631<
> MDR REPORT KEY<
> 443654<
> EVENT KEY<
> 419982<
> REPORT NUMBER<
> 2919260-2003-00001<
> DEVICE SEQUENCE NUMBER<
> 1<
> PRODUCT CODE<
> FJK<
> REPORT SOURCE<
> MANUFACTURER <
> SOURCE TYPE<
> HEALTH PROFESSIONAL,DISTRIBUTOR <
> REMEDIAL ACTION<
> OTHER <
> EVENT TYPE<
> INJURY <
> TYPE OF REPORT<
> INITIAL<
> REPORT DATE<
> 01/16/2003<
> 1 DEVICE WAS INVOLVED IN THE EVENT<
> 1 PATIENT WAS INVOLVED IN THE EVENT<
> DATE FDA RECEIVED<
> 02/14/2003<
> IS THIS AN ADVERSE EVENT REPORT?<
> YES <
> IS THIS A PRODUCT PROBLEM REPORT?<
> NO <
> DEVICE OPERATOR<
> HEALTH PROFESSIONAL<
> DEVICE CATALOGUE NUMBER<
> K3-9605/9750<
> WAS DEVICE AVAILABLE FOR EVALUATION?<
> NO <
> IS THE REPORTER A HEALTH PROFESSIONAL?<
> YES <
> WAS THE REPORT SENT TO FDA?<
> NO <
> DISTRIBUTOR FACILITY AWARE DATE<
> 01/14/2003<
> EVENT LOCATION<
> OUTPATIENT TREATMENT FACILITY<
> DATE REPORT TO MANUFACTURER<
> 01/16/2003<
> DATE MANUFACTURER RECEIVED<
> 01/16/2003<
> WAS DEVICE EVALUATED BY MANUFACTURER?<
> DEVICE NOT RETURNED TO MANUFACTURER <
> IS THE DEVICE SINGLE USE?<
> YES <
> TYPE OF DEVICE USAGE<
> INITIAL <
> PATIENT OUTCOME<
> OTHER <
><
> ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION <
> REPORT DATE: 01/16/2003 MDR TEXT KEY: 1539194 Patient Sequence Number: 1<
> USER FACILITY CONTACTED BAXTER IN 2003 TO REPORT ONE INCIDENT OF AN ANAPHYLACTIC REACTION TO THE CA-HP 210 DIALYZER IN USE. BAXTER FORWARDED THIS COMPLAINT TO MEDISYSTEMS AS MANUFACTURER OF THE BLOOD LINE THAT WAS A CONCOMITANT PRODUCT DURING TREATMENT. THE PT EXPERIENCED AN ANAPHYLACTIC REACTION THREE MINUTES INTO HEMODIALYSIS TREATMENT. SYMPTOMS INCLUDE DIZZINESS, VOMITING, DIFFICULTY BREATHING, FAINTING, AND HIVES. PT WAS ADMINISTERED OXYGEN AND BENADRYL 25MG IVP. SYMPTOMS RESOLVED AND PT WAS ADMITTED TO ICU. FACILITY MEDICAL DIRECTOR BELIEVES THIS<
> INCIDENT WAS A REACTION TO RENALIN IN THE RE-USE DIALYZER. PT'S SYMPTOMS ARE CONSISTENT WITH RENALIN REACTION BUT THIS COULD NOT BE CONFIRMED AS THE SYSTEM TESTED NEGATIVE PRIOR TO PT PUT-ON AND NO ALARM STATES WERE PRESENT ON THE MACHINE. THE PT IS NOW USING SINGLE USE DIALYZERS AND NO FURTHER REACTIONS ARE REPORTED. THIS MDR IS FILED ONLY FOR THE MEDISYSTEMS BLOOD TUBING SET AS A CONCOMITANT PRODUCT DURING TREATMENT. THERE IS NO EVIDENCE THAT THE BLOODLINE IN USE CAUSED OR CONTRIBUTED IN ANY WAY TO THIS EVENT.<
> <
> ADDITIONAL MANUFACTURER NARRATIVE <
> REPORT DATE: 01/16/2003 MDR TEXT KEY: 1539197 <
> NA<
> <
><
> PATIENT TREATMENT DATA<
> Date Received: 02/14/2003 Patient Sequence Number: 1<
> #<
> Treatment<
> Treatment Date<
> 1,BAXTER CA-HP 210 DIALYZER, RE-USE, RENATRON,<
> 2,DIALYZER RE-USE SYSTEM, FRESENIUS 2008H.,
