Safety Info Center

Indications for Use

ActiGraft® System (RD2 System) is intended to be used at point-of-care for the safe and rapid preparation of Whole Blood Clot (WBC) gel from a small sample of a patient’s own peripheral blood. Under the supervision of a healthcare professional, the WBC gel produced by ActiGraft is topically applied for the management of exuding cutaneous wounds, such as leg ulcers, pressure ulcers, diabetic ulcers, and mechanically or surgically-debrided wounds.

Important Safety Information

ActiGraft was not verified to be compatible with other wound care products. Assure the patient monthly blood draw is below 250ml per month. Throughout the processing and application of ActiGraft System, use universal precautions as defined by the facility policy and procedure manual. All parts of the procedure shall be performed in such a manner as to minimize splashing, spattering, and generation of potential droplets of blood. The ActiGraft System includes blood-contacting components that have been sterilized by Ethylene Oxide, which may cause serious allergic reactions in patients that are sensitized. Failure to follow instructions may lead to suboptimal outcomes or product failure. Outcomes may vary.

Use of the System

The ActiGraft should be used in conjunction with standard of care procedures for comprehensive wound management such as:

  • Removal of necrotic or infected tissue
  • Off-loading
  • Compression therapy for venous stasis ulcers
  • Establishment of adequate blood circulation
  • Management of wound infection
  • Wound cleansing
  • Nutritional support, blood glucose control for subjects with diabetic ulcers
  • Bowel/bladder care for subjects with pressure ulcers at risk for contamination
  • Management of underlying disease

Contraindications

The ActiGraft is contraindicated in patients with the following types of wounds:

  • Wounds due to malignancy
  • Wounds with active clinically diagnosed infection

Precautions

  • Some blood-contacting components of the ActiGraft have been sterilized by Ethylene Oxide, which can cause serious allergic reactions in some sensitized individuals.
  • Throughout the processing and application of ActiGraft, use universal precautions as defined by the facility policy and procedure manual. All parts of the procedure shall be performed in such a manner as to minimize splashing, spattering, and generation of potential droplets.
  • Calcium gluconate should only be used with ActiGraft system.
  • Calcium gluconate (Preservative Free): Use only if solution is clear and seal intact.
  • Calcium Gluconate Note: Supersaturated solutions are prone to precipitation. The precipitate, if present, may be dissolved by warming the vial to 60C to 80C, with occasional agitation, until the solution becomes clear. Shake vigorously. Allow to cool to room temperature before dispensing. Use Calcium Gluconate only if clear immediately prior to use.
  • If a patient complaint on increase in pain in the days following ActiGraft application, even if the clot is complete and intact, consider to remove the clot to expose the wound and explore for possible infection in the wound or in the near area.

Important Safety Information

This information is derived from the Instructions for Use (IFU) for Legacy Medical Consultants amniotic allograft products. Please refer to the full IFU included with your product for complete information. For questions, contact Legacy Medical Consultants at (817) 961-1288.

Restricted Use

These products are donated human tissue (HCT/P), regulated under 21 CFR Part 1271. They are restricted to use by, or on the order of, a licensed healthcare professional (physician, dentist, podiatrist, optometrist, nurse practitioner, or physician assistant). For single patient use, on a single occasion only.

Intended Use

These allografts are intended to serve as a protective barrier and provide wound coverage for partial- and full-thickness acute and chronic wounds, including wounds with or without muscle, tendon, or bone exposure when a protective barrier is medically necessary. Products may be applied for the duration of the wound, weekly, or at the discretion of the treating clinician.

Contraindications

These allografts should not be used on:

  • Areas with active or latent infection
  • Patients with a disorder that would create an unacceptable risk to their health while using this product

These allografts have not been tested in combination with other products.

Warnings

Sterility and Handling

  • Do not freeze by any method.
  • Do not re-sterilize by any method. Exposure to irradiation, steam, ethylene oxide, or other chemical sterilants may render the allograft unfit for use.
  • Once the allograft seal has been compromised, the allograft must be transplanted or discarded.
  • Do not use if pouch integrity has been compromised.
  • The outermost pouch is not sterile and must not be placed on an operative field.

Do Not Use Under the Following Conditions:

  • Mishandling has caused damage or contamination
  • The allograft is past its expiration date
  • Any packaging elements, labels, or barcodes are missing, damaged, illegible, or defaced
  • The product has not been stored according to specifications

Notify Legacy Medical Consultants immediately at (817) 961-1288 if any of these conditions exist or are suspected.

Precautions

Although all efforts have been made to ensure the safety of these allografts, there is no assurance that any allograft is free from all infectious diseases or microbial contamination. Current technologies cannot preclude the transmission of certain diseases, known or unknown.
Healthcare professionals should discuss possible complications with the patient prior to use.

Adverse Events

General risks and complications from allograft use may include, but are not limited to:

  • Infection, bleeding, swelling, and redness
  • Potential injury to nerves and other soft tissue
  • Transmission of disease of unknown etiology
  • Transmission of infectious agents including, but not limited to, HIV, hepatitis, syphilis, or microbial contaminants
  • Immune response, including graft-versus-host reaction or other allergic reactions
  • Alloantibody development in patients who may be future recipients of allograft tissue or cells

Adverse outcomes potentially attributable to any of these products must be reported promptly to Legacy Medical Consultants at (817) 961-1288.

Storage

Store at ambient temperature: 15°C to 30°C (59°F to 86°F). Do not freeze. Products may be stored up to 5 years from the date of manufacture. It is the responsibility of the Tissue Dispensing Service, Tissue Distribution Intermediary, and/or end-user clinician to maintain appropriate storage conditions and monitor expiration dates.

Donor Screening

All donors are screened and tested for communicable disease risks in compliance with FDA regulations (21 CFR Part 1271) and the standards of the American Association of Tissue Banks (AATB). Testing is conducted by an FDA-registered laboratory certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Donors have been found nonreactive or negative for HIV, Hepatitis B, Hepatitis C, HTLV-I/II, Syphilis, and West Nile Virus, among others.

For complete donor screening details, sterility information, and instructions for use, please refer to the IFU included with your product, or contact Legacy Medical Consultants at (817) 961-1288.