Dura mater and medical devices

[Guest guest]

I am posting this from the CJD Voice Message Board since some people do not

have internet access. This is by Roussel whose son had a dura mater

transplant during brain surgery when he was 2 1/2 years old and died when he

was 19 years old.

Dura and Medical Devices

Mon Oct 12 16:01:22 1998

My opinion does not necessarily reflect those of CJDvoice.

Following my son’s death to CJD, I have researched the subject of cadaveric

dura mater transplants to great lengths as a vehicle to transmit CJD. The

product’s used is widespread and I was surprised to find out it was used a lot

in other kind of surgeries. Lyodura, which is a brand name, has the worst

track record for their production of cadaveric dura mater. The medical

community has found the product unsafe, have theoretically tied the product to

many CJD victims. The manufacturer, B. Braun Melsungen in Germany, claims it

has never been proven yet in a court of law, or by the medical community,

their Lyodura product carried the prion and has transmitted CJD. I think their

statement is accurate. Proving it without a doubt is no small feat and the

medical community has never taken the steps to do that. CJD is still a big

unknown. On the other hand, the company cannot prove their facilities and

products are free of prions therefore apart from the Lyodura itself, it also

raises other possibilities of IATROGENIC TRANSMISSION BY SURGICAL INSTRUMENTS.

One of the things that really bother me is they produced dura mater from 1969

to 1996. Up to 1987 they had a pooled manufacturing process. According to

their figures, they sold a million units worldwide. We all read about prions,

how you cannot destroy them through autoclaving, they withstand heat, they

withstand time, there are no chemicals found so far to destroy them. You have

this company which had all kinds of instruments and personnel come into

contact with prions, which also manufactures numerous other medical devices

most of them that comes in direct contact with the central nervous system.

They are the 14th largest suppliers to hospitals and clinics around the world,

a major portion of their sales are in North America. I am not a rocket

scientist but read the definition of IATROGENIC. If you ever worked in a

manufacturing facility, equipment, instruments, gets move around. I don’t know

if the FDA/Health Canada among others, has ever questioned this, sometimes the

obvious gets passed them. I know they have questioned themselves in FDA TSE

Committee Meetings. I don’t know if they ever asked this manufacturer, of

instruments they still import, to give some kind of statement to the effect

they never moved a single piece of equipment from the dura mater manufacturing

location of their facilities to another. Maybe they made a major discovery on

how to decontaminate instruments. Maybe it is time government agencies do

their jobs properly and protects their citizens. You be the judge of how safe

instruments are before they use them on you SEE LIST BELOW. In the future, I

for one will not count on government agencies to protect myself and will ask

the famous question, who manufactured these instruments you are going to use

on me or my family. I hope you will also take the necessary steps to protect

yourself.

To all of you which has lost somebody to CJD and it was classified under

SPORADIC, and are so afraid that it was familial, look at my example in the

paragraph above and maybe you have grounds to continue trying to come up with

answers. You rightly deserve answers to your questions by the organizations

that are there to protect us.

Here is a list of products they advertise on their web site: You can find more

information on these products at:

http://serv03.bbraun.com/BBRAUN/ENGLISH/INDEX.HTM

Abdominal Surgery, Administration Set, Anaesthesia, Regional, Anaesthetics,

Angiography, Arthroscopy, Arthroscopy, Aspiration, intraoperative and

postoperative, Bandage materials, Biopsies, Bioreactors, Bladder Drainage,

Blood administration Set, Blood Bank, Blood coagulation, Blood taking

equipment and laboratory supplies, Blood tubing systems, Cannulas.

cardiological peripheral urological, Cardiology, Cardiovascular Surgery,

Catheterization of the Vena Cava, Catheters, Catheters central venous, Central

Venous Catheterization, Central venous catheters, Chronic wound treatment

supplies, Clinical nutrition, Coagulation therapy, Connective tissue implants,

Continuous epidural and caudal Anaesthesia Sets, Continuous interpleural

Analgesia catheter Sets, Craniofacial Surgery, Customer-specific Sets,

Cystometrie, Dental, Dental Instruments, Dermatology, Diabetic care, Dialysis,

Dialysis concentrates, Dialysis technology, Dialysis units, Disinfectants,

Disinfection and hygiene, Drainage, Electrophysiology, Emergency systems,

Endoprosthesis, Endoscopy, Engineering and process technology for bioreactors,

ENT, Enteral feeding, Epidural Anaesthesia Sets, Extracorporeal blood

treatment, Fermentation and peripheral equipment, Fibrinolytic agents, Filter

products, Fine Dosage, Fine-Dosage Syringe, Flexible Organization and

Communication System for Infusion Therapy, General Surgery, Gynaecology,

Haemostasis, Haemostatic felt, Hand Surgery, Hemodynamics, Hemofiltration

solutions,

Heparin , HF Surgery, Hip- and knee-joint prostheses, Home care products,

Hygiene supplies, Hypodermic Needles, I.V. Administration Sets, I.V. Cannulae,

Incontinence care , Infusion pumps and equipment, Infusion solutions, Infusion

therapy, Infusion units and equipment, Initial Puncture, Injection

paraphernalia, Injection solutions and concentrates, Insulin Syringe,

Interpleural Analgesia, Irrigation solution, Irrigation Syringe, Laboratory

and blood-taking equipment, Laboratory equipment for microbiology and

chemistry, Laboratory supplies, LMW heparin, Local hemostyptic agents, Long-

term Infusion, Microsurgical sutures, Minimally-Invasive Surgery,

Miscellaneous, Monitoring Sets (CVP), Motor Systems, Multilumen Catheter,

Neddles for Epidural Anaesthesia, Neddles for Spinal Anaesthesia, Neddles,

hypodermic, Nerve Stimulator for Plexus Anaesthesia, Nerve Stimulators,

Neurosurgery, Nutrition (enteral/parenteral), Oncology, Opthalmology,

Orthopaedics, Osteosynthesis, Ostomy care, Outpatient infusion therapy, Oxygen

therapy, Pain therapy, Patient Controlled Analgesia (PCA), Percutaneous Liver

Biopsy, Percutaneous Liver Biopsy Set, Percutaneous Nephrostomy, Percutaneous

Nephrostomy Sets, Peritoneal dialysis

Peritoneal lavage, Plasmapheresis, Pleurocentesis and pleural drainage, Plexus

Anaesthesia Products, Port catheter systems, Portable Syringe Pumps, Practice

supplies and hygiene products, Pressure Monitoring, Process automation,

Retrograde or Antegrade Ureteric Stent Sets, Retrograde Urethrographie, Sets

for Combined Spinal / Epidural Anaesthesia, Skin closure, Special products for

outpatient surgery, Spinal column implants and instruments, Spine, Spine

Surgery, Sterilcontainer System, Sterile supply and disposal containers,

Stopcock Systems, Suprapubic Bladder Drainage Sets, Suprapubic Urine Drainage,

Surgical instruments, Surgical Instruments and Special Disciplines, Surgical

suture material, Syringes, Tissue glue, TIVA, Transfusion Therapy,Transfusion

Units and equipment, Transurethral Kidney Drainage, Traumatology, Ultrasonic

guided Fine Needle Biopsy Set, Ureteral Stent Sets, Ureteric Stenting, Urine

Drainage, Urology, Vascular grafts, Vascular prostheses, Venipuncture

Vessel replacement, Veterinary, Veterinary and equipment for vascular surgery,

Volume replacement therapy, Wound care, Wound closure , Wound drainage.

Please note I might have made a typo mistake on some of the products mentioned

above, the proper names are identified on their web site.

Regards

Roussel