DermaPure® IFU

DermaPure®

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

  1. Inspect for package integrity and expiration date prior to opening.
  2. Peel outer package open and aseptically deliver inner package to the sterile field or sterile team member.
  3. 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.

  4. Remove the allograft from inner package and discard packaging mesh.

    IMPORTANT: DO NOT implant packaging mesh.

  5. Immerse the allograft in the sterile basin for 10 minutes, providing periodic gentle agitation.
  6. 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

  1. Place the allograft onto the wound bed, with the basement membrane side outer-most. Utilising sterile scissors or scalpel, remove excess DermaPure®.
  2. Secure the allograft with liquid skin adhesive, sterile adhesive strips, staples or sutures if needed.
  3. Place a non-adherent contact layer over the allograft, followed by an appropriate bolster to mitigate movement of the allograft for 5 – 7 days.
  4. Cover with a secondary dressing to maintain a moist environment.
  5. Leave dressing in place for 5 – 7 days.
  6. Subsequent dressing management should provide a moist environment, taking care not to pull off DermaPure® during the dressing change.

For use as an implant

  1. Place the allograft into the area needing integumental tissue with the dermal side against the most vascular tissue. Utilising sterile scissors or scalpel, remove excess DermaPure®.
  2. Secure the allograft with sutures if needed.

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.
  • Adverse events potentially attributable to this allograft must be reported promptly to CellRight Technologies at (210) 659-9353 or by email to: customercare@cellrighttechnologies.com

Adverse Effect

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.

Tissue Tracking

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 customercare@cellrighttechnologies.com.

Customer Service

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.

Definition of symbols

Read Instructions for Use

Single Patient Use Only

Store at Ambient Temperature

For use by licenced professional only

Gamma irradiated for sterility

Manufacturer

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