03/05/2024
BioRinse
DermaPure® Decellularized Dermal Allograft Instructions For Use (IFU)
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.
Donor Screening / Testing
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:
Required Infectious Disease Tests and Acceptable Result
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.
Processing / Sterilization
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.
STORAGE
Storage Method:
Ambient
Special Instructions:
Do not Freeze
Protect from excessive heat
Must use once opened
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.
DermaPure® Tissue Preparation
Inspect for package integrity and expiration date prior to opening.
Peel outer package open and aseptically deliver inner package to the sterile field or sterile team member.
Partially fill a sterile basin with normal saline or isotonic solution of choice. (Minimum 400 mL). It is recommended that the temperature of the solution be not greater than 98.6°F or 37°C.
Remove the allograft from inner package and discard packaging mesh.
IMPORTANT: DO NOT implant packaging mesh.
Immerse the allograft in the sterile basin for 10 minutes, providing periodic gentle agitation.
DermaPure® should be used as soon as possible after opening. If the allograft is to be stored for longer than 2 hours after opening, it should be refrigerated at 34°F - 50°F (Immersed in normal saline or isotonic solution) in an aseptic container no longer than 24 hours.
DERMAPURE® APPLICATION
For use as a graft
Place the allograft onto the wound bed, with the basement membrane side outer-most. Utilising sterile scissors or scalpel, remove excess DermaPure®.
Secure the allograft with liquid skin adhesive, sterile adhesive strips, staples or sutures if needed.
Place a non-adherent contact layer over the allograft, followed by an appropriate bolster to mitigate movement of the allograft for 5 – 7 days.
Cover with a secondary dressing to maintain a moist environment.
Leave dressing in place for 5 – 7 days.
Subsequent dressing management should provide a moist environment, taking care not to pull off DermaPure® during the dressing change.
For use as an implant
DermaPure® Orientation
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
(Fig 1.0)
Warnings / Precautions
Intended for use in one patient, on a single occasion only.
Do not use if package integrity has been compromised.
Once the user breaks the package seal, the allograft must be transplanted or discarded.
Do not use past expiration date listed on the product label.
Do not sterilize or re-sterilize the allograft.
This allograft is intended for use by qualified healthcare specialists.
Although this allograft has been tested and screened for human pathogens and processed under aseptic conditions, human derived tissue may still transmit infectious agents.
