Tissues of Animal Origins

B

BKyleB

#1
The European Directive on medical devices utilizing animal tissues. This Directive covers devices incorporating animal tissues into the finished device but also has requirements concerning animal tissues (or derivatives) used during the manufacture of devices.

The ISO 13485/2003 auditor that we have in now is asking us how we intend to address the use of animal tissues as process aids, e.g. bovine stearates in polymers.

I am looking for any ideas of how others have addresses this and how they have handled it with their suppliers. Just getting into this, so not too sure on the direction to go. Has anyone else experienced this, and have their ISO auditors brought this up? I understand this is starting to become more and more of a hot topic.

Any help would greatly be appreciated.
:thanks:
 
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A

Aaron Lupo

#2
BKyleB said:
The European Directive on medical devices utilizing animal tissues. This Directive covers devices incorporating animal tissues into the finished device but also has requirements concerning animal tissues (or derivatives) used during the manufacture of devices.

The ISO 13485/2003 auditor that we have in now is asking us how we intend to address the use of animal tissues as process aids, e.g. bovine stearates in polymers.

I am looking for any ideas of how others have addresses this and how they have handled it with their suppliers. Just getting into this, so not too sure on the direction to go. Has anyone else experienced this, and have their ISO auditors brought this up? I understand this is starting to become more and more of a hot topic.

Any help would greatly be appreciated.
:thanks:
I read your post over a couple times and I am not sure what you are asking/seeking?
 
B

BKyleB

#3
Let me try to clarify. Our ISO auditor wants to know how we are meeting the requirements laid down in the Council Directive 93/42/EEC with respect to medical devices manufactured using tissues of animal origin. The concern is that medical devices can have a danager of transmitting forms of animal spongiform encephalopathy through the medical devices if the plastic etc is generated from Animal tissue. For example some stearates are derived from bovine tallow. Zinc stearate is used in the manufacturing process for polymer extrusion, injection and blow molding. It is used as a lubricant for the process and can be applied to the polymer or used as a constituent in a mold release agent e.g. spray. Therefore, all polymeric materials in a single-use medical device could have potentially come into contact with bovine derived stearates. Please note that some zinc stearates can be vegetable oil based, but the majority are from bovine tallow.Devices that utilise animal tissues derived from tallow from the affected species during manufacture may not need the type testing certification route provided that the manufacturer is able to demonstrate that the material used meets certain criteria which include:
Demonstrate that the Tallow used as the starting material for the manufacture of tallow derivatives is sourced from animals deemed fit for human consumption.

I am wondering how others are getting their suppliers to show they are a.) not using tallows derived from animals, b.) If they are, how they are treating them etc.
Does this help? :confused:
 
P

Pataha

#4
I understand the use zinc stearate as a stabilizer for plastics that are going to be subject to irradiaton sterilization. Thereby, using your sterility validation y verication protocols and evidence - irradiation is suppose to destroy all living material - if you chose to use a bovine based substance. The problem with virus is that they are not complete DNA to begin with. So even with irradiation, how would you ensure total destruction of the virus?
Would it not be better to spec a plastic that does not need this type of stablilizer.

But as a release agent, why aren't you using a soy lecithin or some other plant based edible compound?

Plus, your supplier, how do you accept them as being an approved supplier? If you are worried about them providing you the correct substance, shouldn't you consider a different supplier?

Is you plastic Medical Grade? If it is a poosible carrier, how is it medical grade?
 
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B

BKyleB

#5
We do not terminally sterilize any of our products. Actually all of our products are products that come in contact with intact skin. This is where I get a little confused on these questions we are being asked. Our products are mainly for respiratory care and are not implatable or anything like that. The most contact they come in to is with the lips / mouth. Our mouth pieces are of course medical grade, but it appears the auditor wants to know about the other plastics we use for housings etc as to the animal tissue origin.
 
D

Dan Armstrong

#6
Sterilization would probably be ineffective anyway. BSE is thought to be caused by prions, or mis-folded proteins.
 
P

Pataha

#7
I ama little unclear, what are you using the zinc stearate for?

The chart on the website from our supplier for release agents does not recommend the use of zinc stearate.

Are you molding this product yourself or having it contracted?

How were your suppliers selected for providing these products?

Coming into contact with lips and mouth, lends one to:
How do you protect the patient from cross contamination from sores and lesions?
 
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