iso 10993-6: biological evaluation of medical devices - tests for local effects after implantation
TRANSCRIPT
ISO 10993-6
Biological Evaluation of Medical Devices
Tests for local effects after implantation
Presenters: Kelli Young, DVM
Lyn M. Wancket, DVM, PhD, DACVP
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ISO 10993-6 offers general guidelines for
evaluating local tissue responses to implants
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What is the purpose of conducting implant
studies?
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What is the purpose of conducting implant
studies?
Regulatory – address safety/biocompatibility
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What is the purpose of conducting implant
studies?
Regulatory – address safety/biocompatibility
Screening tool for Research & Development
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What is the purpose of conducting implant
studies?
Regulatory – address safety/biocompatibility
Screening tool for Research & Development- Example:
- Developing specific implant characteristics
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What is the purpose of conducting implant
studies?
Regulatory – address safety/biocompatibility
Screening tool for Research & Development- Example:
- Developing specific implant characteristics
- Porous surface to promote ingrowth
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What is the purpose of conducting implant
studies?
Regulatory – address safety/biocompatibility
Screening tool for Research & Development- Example:
- Developing specific implant characteristics
- Porous surface to promote ingrowth
- Coatings to prevent cell attachments
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What is the purpose of conducting implant
studies?
Regulatory – address safety/biocompatibility
Screening tool for Research & Development- Example:
- Developing specific implant characteristics
- Porous surface to promote ingrowth
- Coatings to prevent cell attachments
- Anti-microbial coatings
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What is the purpose of conducting implant
studies?
Regulatory – address safety/biocompatibility
Screening tool for Research & Development- Example:
- Developing specific implant characteristics
- Porous surface to promote ingrowth
- Coatings to prevent cell attachments
- Anti-microbial coatings
- Stimulation of specific cells – osteoinduction
- Etc.
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Tests for local effects after implantation
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Tests for local effects after implantation
Evaluates a material’s potential effects on
surrounding living tissue
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Tests for local effects after implantation
Evaluates a material’s potential effects on
surrounding living tissue
Use of device can determine location of implant
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Tests for local effects after implantation
Evaluates a material’s potential effects on
surrounding living tissue
Use of device can determine location of implant
Can be conducted in a variety of test models
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Tests for local effects after implantation
Evaluates a material’s potential effects on
surrounding living tissue
Use of device can determine location of implant
Can be conducted in a variety of test models
Size of the implant may determine test model
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Tests for local effects after implantation
Evaluates a material’s potential effects on
surrounding living tissue
Use of device can determine location of implant
Can be conducted in a variety of test models
Size of the implant may determine test model
Need multiple evaluation intervals- Short term, 2 up to 12 weeks
- Long term, > 12 weeks
- Degradable materials will have multiple intervals
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Degradable materials
These materials will result in a response that is
different to non-absorbable materials (negative
control)
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Degradable materials
These materials will result in a response that is
different to non-absorbable materials (negative
control)
Consider the use of a similar comparative control
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Degradable materials
These materials will result in a response that is
different to non-absorbable materials (negative
control)
Consider the use of a similar comparative control
Intervals need to be based on absorption profile- Pilot study or utilize other means to determine
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Degradable materials
These materials will result in a response that is
different to non-absorbable materials (negative
control)
Consider the use of a similar comparative control
Intervals need to be based on absorption profile- Pilot study or utilize other means to determine
Location markers
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Implant sites
Location varies depending on use of device
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Implant sites
Location varies depending on use of device
Test and control sites- Negative control- HDPE
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Implant sites
Location varies depending on use of device
Test and control sites- Negative control- HDPE
- Sponsor provided controls
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Implant sites
Location varies depending on use of device
Test and control sites- Negative control- HDPE
- Sponsor provided controls
- Test and control(s) implanted in each test model
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Implant sites
Location varies depending on use of device
Test and control sites- Negative control- HDPE
- Sponsor provided controls
- Test and control(s) implanted in each test model
- Total of at least 10 tests and 10 control sites at termination
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Evaluation
Macroscopic observations of implant sites
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Evaluation
Macroscopic observations of implant sites
Microscopic evaluation – primary basis of evaluation- Compared to the negative control and scored
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Evaluation
Macroscopic observations of implant sites
Microscopic evaluation – primary basis of evaluation- Compared to the negative control and scored
Looking for point at which test article reaches steady
state- Multiple intervals allow for this to be evaluated
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Evaluation
Macroscopic observations of implant sites
Microscopic evaluation – primary basis of evaluation- Compared to the negative control and scored
Looking for point at which test article reaches steady
state- Multiple intervals allow for this to be evaluated
Sponsor supplied control article help define the
reaction- Absorbable materials will “normally” stimulate an influx of
phagocytic cells to remove the material. Comparisons to a
non-absorbable, inert material will give a misleading
impression
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To view the complete presentation on ISO
10993-6
- Check out NAMSA’s Seminars
- You can view the entire ISO 10993 Series here
For information about the services NAMSA
can offer you regarding implantation
- Visit our Biocompatibility page, or
- Download our Biocompatibility brochure
For additional information
- Contact us at [email protected]