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Q: Is LifeCell Corporation the only source of AlloDerm?
A: Yes. LifeCell Corporation, of Branchburg, New Jersey, is the sole source of AlloDerm regenerative tissue matrix.
Q: When can I expect to receive my order?
A: Normal shipping of AlloDerm and Cymetra is via overnight delivery. We strive to process each order within 24 hours. We will also arrange delivery based on your specific directions. LifeCell does not ship on Fridays because AlloDerm and Cymetra require refrigeration upon arrival.
Q: What is the optimal temperature range in which to store AlloDerm?
A: Upon receipt, the AlloDerm tissue grafts must be stored under refrigeration at 1°C -10° C (34°-50° F) to preserve the product’s shelf life. The refrigerated shelf life of the AlloDerm tissue graft is 2 years following the date of processing. Although AlloDerm will ship out of refrigeration, this limited exposure will not affect product efficacy or shelf life.
Q: What happens if AlloDerm is left out of the refrigerator?
A:If AlloDerm has been left unrefrigerated, please contact LifeCell Customer Support at 800-367-5737.
Q: What is the shelf-life of AlloDerm?
A: AlloDerm has an expiration date that is noted on the package label.
Q:What is the shelf-life of Cymetra?
A: Cymetra has an expiration date that is noted on the package label.
Q: Once AlloDerm is rehydrated, how long can we keep it?
A: When fully hydrated, the AlloDerm matrix is ready to use. The matrix may be left in the second rehydration dish for up to 4 hours.
Q: What is the best way to determine the dermal side of the AlloDerm?
A: AlloDerm has two distinct sides: The basement membrane
and the dermal surface.
In an implant procedure, the dermal side should rest against the most vascular tissue to speed up the revascularization process.
How to Distinguish Sides
- Physical appearance
- Basement membrane side: Rough and dull.
- Dermal side: smooth and shiny.
- Distinguishing sides using the blood test
- Add a drop of blood to both sides and rinse with rehydration solution. Since blood readily infiltrates the vascular channels within the matrix, the dermal side will look bright red. The basement membrane side will look pink.
Q: What happens to AlloDerm after it is grafted or implanted into the body?
A: The ability of the AlloDerm matrix to support rapid revascularization and repopulation with the patient's cells allows the engrafted matrix to remodel into patient's own tissue and resist infection.
Q: What testing is performed on AlloDerm to ensure product safety?
A: AlloDerm is screened and tested according to FDA regulations, American Association of Tissue Banks Standards, and appropriate state regulations.
Q: Have there been any reports of latex reactions related to the use of AlloDerm?
A: AlloDerm is processed from cadaveric split thickness skin grafts. No latex products are added to the product or contained in any of the packaging material. Although some individuals contacting the tissue during the procurement of the skin or the processing of the grafts may have worn latex gloves, LifeCell is currently unaware of any reports of latex reactions, allergy or sensitivity related to the use of AlloDerm.
Q: Does AlloDerm contain antibiotics?
A: AlloDerm is contraindicated for use in any patient with a sensitivity to specific antibiotics listed on the package.
Q: Why are there no Material Safety Data Sheets associated with LifeCell products?
A: LifeCell has reviewed the requirements of the OSHA Hazard Communication Standard, 29 CFR 1910.1200, with regard to our products and services. It is our determination that our products are not Hazardous Chemicals as defined in the Standard and therefore do not require a Material Safety Data Sheet.
Q: How is AlloDerm procured and processed?
A: AlloDerm and Cymetra are composed of donated human dermal tissue. This donated tissue is recovered, processed, stored and distributed in conformance with the regulations of the Food and Drug Administration (FDA) and various State legislatures as well as the Standards of the American Association of Tissue Banks (AATB). These regulations and standards require extensive screening and testing of the tissue donor as well as the transplant grafts. Serological screening includes, but is not limited to, tests for evidence of hepatitis, AIDS and syphilis. Additionally, LifeCell tissue grafts undergo a patented process that cleans and removes the cellular components while preserving and stabilizing the biochemical and biomechanical properties of the grafts. |
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