DermaPure® Decellularized Dermal Allografts are produced from donated human tissue intended for transplant. All tissue is recovered, processed, stored and distributed for use in accordance with the standards of the American Association of Tissue Banks (AATB) and U.S Federal Regulations CFR 21 part 1270 and 1271.
DermaPure® Decellularized Dermal Allograft is intended to be used to provide reinforcement, repair, or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument.
Donors have been determined to be eligible for donation by CellRight Technologies at 1808 University City Blvd., Universal City, TX 78148. A Medical Director (licensed physician) evaluates donors for eligibility. Donor eligibility is based on the results of screening and testing. Screening includes a review of medical and social history, hospital records, infectious disease screening, autopsy report (if performed), and physical exam.
Infectious disease testing is performed by a laboratory registered with the U.S. Food and Drug Administration (FDA) and certified under CLIA standards or equivalent requirements. Test kits are FDA licenced or approved for donor testing. The following test criteria were met for this allograft:
|Blood Test||Acceptable Result|
|HIV I/II Antibody: Human Immunodeficiency Virus Type I/II||Negative/ Non-reactive|
|HBsAG: Hepatitis B Surface Antigen||Negative/ Non-reactive|
|HBcAB: Hepatitis B Total Core Antibody||Negative/ Non-reactive|
|HBV NAT: Hepatitis B Virus Nucleic Acid Test||Negative/ Non-reactive|
|HCV NAT: Hepatitis C Virus Nucleic Acid Test||Negative/ Non-reactive|
|HIV NAT: Human Immunodeficiency Virus Nucleic Acid Test||Negative/ Non-reactive|
|HCVAb: Hepatitis C Virus Antibody||Negative/ Non-reactive|
|RPR/STS for Syphilis||Negative/ Non-reactive|
*Additional tests, including but not limited to HTLV I/II, may have been performed and were found to be acceptable for transplantation.
Tissue is processed aseptically in a cleanroom environment using a validated method to remove the epidermis, cells, and cell remnants. Preparation exposes the skin to antibiotics-- gentamicin, nystatin, vancomycin, Primaxin IV, polymixin B —and processing reagents including sodium dodecyl sulphate, DNase, RNase, and glycerol. Tissue is treated to reduce residual content of reagents; however traces may remain.
NOTE: Follow instructions for allograft preparation prior to application.
Tissue labeled as sterile has been sterilized using gamma irradiation to Sterility Assurance Level (SAL) of 10-6.
It is the responsibility of the Tissue Dispensing Service, Tissue Distribution Intermediary, and/or End User Clinician to maintain tissue intended for transplantation in appropriate storage conditions prior to further distribution or transplant.
Remove the allograft from inner package and discard packaging mesh.
IMPORTANT: DO NOT implant packaging mesh.
DermaPure® has a distinct basement membrane (outer) and dermal surface (inner). When applied, the dermal surface should be placed in contact the vascular tissue, with the basement membrane side facing up.
The correct orientation for placement is shown below (fig 1.0), when the allograft tissue tab is positioned in the top right corner the dermal surface is on the underside of the allograft with the basement membrane outer-most
As with any allograft tissue, some risk of disease transmission exists. Adverse effects may include but are not limited to: infection, allergic reaction to residual processing reagents, immune response to allograft tissue, or loss of integrity/functionality of tissue. Caution should be used if the patient has a known sensitivity to any of the reagents/antibiotics listed in this insert.
Complete the enclosed Allograft Tracking Form and return to CellRight Technologies. Federal Regulations (21 CFR 1271.290(b)) and Joint Commission Standards (TS.03.02.01, EP 7) require proper tracking of this tissue. It is the responsibility of the end-user to provide this information, which enables CellRight Technologies to maintain records for tracing the tissue post-transplant.
Tissue tracking forms may be returned to CellRight Technologies via mail, fax at (210) 659-9556, or email to firstname.lastname@example.org.
Please contact Tissue Regenix Inc. at (855) 452‐0133 should you require additional information. CellRight Technologies makes no claims concerning the biological or biomechanical properties of the provided tissue. CellRight Technologies disclaims all liability and responsibility for any misuse of tissue provided for clinical application. CellRight Technologies is accredited by the American Association of Tissue Banks.
Read Instructions for Use
Single Patient Use Only
Store at Ambient Temperature
For use by licenced professional only
Gamma irradiated for sterility
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