The Pro-Close Neuroclosure System meets latest FDA requirements for pyrogen free individual packaged and sterile screws & plates.
- Each lot of cranial plates and screws is tested for endotoxins and ensured to meet the latest most rigorous FDA pyrogen-free requirements
- Each lot of cranial plates and screws are supplied sterile as opposed to non-sterile to meet FDA requirements which do not consider autoclaved devices as pyrogen-free unless the hospi-tal can verify that each autoclave run is pyrogen-free
- Detection of bacterial endotoxin contamination is essential to insure the safety of medical devices. Any product labeled pyrogen-free must be tested to verify that claim.
- According to the FDA guideline document for pyrogens1, the al-lowable amounts of endotoxin units (EU) for medical devices are:
"The new limit for medical devices is 0.5 EU/ml except for devices in contact with cerebrospinal fluid for which the limit Is 0.06 EU/ml."
- These are the limits in terms of the endotoxin test results. In terms of EU amounts per device, the limits are 20 EU for medical devices and 2.15 EU for devices in contact with cerebrospinal fluid. This guideline is issued under section 10.90(b) (21 CFR 10.90(b)) of the FDA regulations.
1 FDA Guideline on validation of the Limulus amebocyte lysate test as an end-product endotoxin test for human and animal parenteral drugs, biological products and medical devices (1987).
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