Post on 18-Jul-2015
transcript
ISO 10993-7:2008 Biological Evaluation of Medical
Devices Part 7: Ethylene Oxide Sterilization Residuals
Joe Brinkman
Medical Research Manager
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ISO 10993-7 specifies allowable limits and
compliance methods for residual ethylene
oxide (EO) and ethylene chlorohydrin (ECH)
in individual EO-sterilized medical devices.
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Why test Ethylene Oxide (EO)?
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Why test Ethylene Oxide (EO)?
EO is known to exhibit a number of biological effects.
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Why test Ethylene Oxide (EO)?
EO is known to exhibit a number of biological effects.- Irritation
- Skin irritation, erythema, blisters and burns
- Eye irritation, cataracts after repeat exposure
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Why test Ethylene Oxide (EO)?
EO is known to exhibit a number of biological effects.- Irritation
- Skin irritation, erythema, blisters and burns
- Eye irritation, cataracts after repeat exposure
- Organ damage
- Lungs – bronchitis, pulmonary edema and
emphysema
- Central nervous system – nausea, vomiting,
headaches
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Why test Ethylene Oxide (EO)?
EO is known to exhibit a number of biological effects.- Irritation
- Skin irritation, erythema, blisters and burns
- Eye irritation, cataracts after repeat exposure
- Organ damage
- Lungs – bronchitis, pulmonary edema and
emphysema
- Central nervous system – nausea, vomiting,
headaches
- Mutagenicity
- Induces chromosomal aberrations
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Why test Ethylene Oxide (EO)?
- Cancer in animals and humans
- Lymphatic and other types of cancer
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Why test Ethylene Oxide (EO)?
- Cancer in animals and humans
- Lymphatic and other types of cancer
- Reproductive effects in animals
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Why test Ethylene Oxide (EO)?
- Cancer in animals and humans
- Lymphatic and other types of cancer
- Reproductive effects in animals
- Similar consideration was given to the harmful effects of
ECH and EG
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The Process
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The Process
Determine patient exposure
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The Process
Determine patient exposure
Select appropriate test method
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The Process
Determine patient exposure
Select appropriate test method
Prepare samples for testing
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The Process
Determine patient exposure
Select appropriate test method
Prepare samples for testing
Sterilize product
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The Process
Determine patient exposure
Select appropriate test method
Prepare samples for testing
Sterilize product
Perform test
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The Process
Determine patient exposure
Select appropriate test method
Prepare samples for testing
Sterilize product
Perform test
Interpret data
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Categorization of Devices
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Categorization of Devices
Non Patient Contacting – testing not required
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Categorization of Devices
Non Patient Contacting – testing not required
Limited Exposure – devices whose single or
cumulative repeated use or contact is up to 24 hours
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Categorization of Devices
Non Patient Contacting – testing not required
Limited Exposure – devices whose single or
cumulative repeated use or contact is up to 24 hours
Prolonged Exposure – devices whose single or
cumulative repeated use or contact is likely to exceed
24 hours but not 30 days
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Categorization of Devices
Non Patient Contacting – testing not required
Limited Exposure – devices whose single or
cumulative repeated use or contact is up to 24 hours
Prolonged Exposure – devices whose single or
cumulative repeated use or contact is likely to exceed
24 hours but not 30 days
Permanent Contact – devices whose single or
cumulative repeated use or contact exceeds 30 days
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Categorization of Devices
Direct Patient Contact
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Categorization of Devices
Direct Patient Contact
Indirect Patient Contact- Devices that serve as a conduit for entry into the patient
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Categorization of Devices
Direct Patient Contact
Indirect Patient Contact- Devices that serve as a conduit for entry into the patient
- Examples: Solution administration sets, extension
sets, transfer sets and blood administration sets
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Categorization of Devices
Grouping of Devices- Devices of similar design and materials but different sizes
may be grouped and the worst case selected for testing
as a representative of the group.
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Categorization of Devices
Grouping of Devices- Devices of similar design and materials but different sizes
may be grouped and the worst case selected for testing
as a representative of the group.
- Justification must be documented!
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Categorization of Devices
Grouping of Devices- Devices of similar design and materials but different sizes
may be grouped and the worst case selected for testing
as a representative of the group.
- Justification must be documented!
Device kits and trays- Initially determine residues for each EO and ECH
absorbing patients-contact device in the kit or tray, and
establish the worst-case device or devices. Additional
data can then be collected using just worst cases.
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Categorization of Devices
Grouping of Devices- Devices of similar design and materials but different sizes
may be grouped and the worst case selected for testing
as a representative of the group.
- Justification must be documented!
Device kits and trays- Initially determine residues for each EO and ECH
absorbing patients-contact device in the kit or tray, and
establish the worst-case device or devices. Additional
data can then be collected using just worst cases.
- Document the rationale!
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To view the complete presentation on ISO 10993-7- Check out NAMSA’s Seminars
- You can view the entire ISO 10993 Series here
For information about the services NAMSA can offer you regarding Ethylene Oxide- Visit our Materials Characterization and Analytical
Chemistry page, or
- Download our Materials Characterization and Analytical Chemistry brochure
For additional information - Contact us at clientcare@namsa.com