Regulatory & Compliance


Regulatory Standards

LevaGRAFTM (human Amniotic Membrane Allograft) and LevaSOLTM (human Amniotic Fluid Allograft) are classified and qualify as a human tissue allograft (HCT/P) as outlined in 21CFR 1271 under Section 361 of the Public Health Service Act. Both LevaGRAF and LevaSOL meet the requirements for “Homologous Use”.

Notice

LevaGRAFTM  and LevaSOLTM are classified by the FDA as minimally manipulated HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps). Only clinicians with proper medical credentials can purchase and administer these products as required by Federal Law. The HCT/P is intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer’s objective and intent. Following use, dispose of any unused product and packaging, in accordance with medical practices and procedures and all relevant local, state and federal law and regulations.

HCT/P Tracking

Hospitals, authorized user clinicians and physicians are required by The Joint Commission and FDA to properly record, store and maintain patient records as it pertains to all allograft materials. It is the user clinician’s responsibility to complete the TRANSPLANT UTILIZATION RECORD in detail and return as indicated in the Package Insert.

Disclaimer

The contents and information provided within this site are informational in purpose and nature. Our intention is to educate and inform, not to suggest or provide medical advice. The statements are representations regarding our products have not been evaluated by the FDA. Our products and the information provided by Levana Biologic Solutions, LLC are not intended to diagnose, treat, cure or prevent any condition or disease. We make no representations or warranties about the use or efficacy of our products, expressed or implied. If you have a specific health concern, consult a physician or health care provider.


Donor Eligibility and Requirements

Donor Selection Process

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and 42 CFR part 493, all contracted laboratories performing human specimen tests are certified and meet the requirements and guidelines as determined by the Centers for Medicare and Medicaid Services (CMS).

Donor Pre-Screening Criteria

For donor consideration for the Levana Biologics postnatal tissue and amniotic fluid donation program; preliminary eligibility requirements include: (1) C-Section Delivery (2) Over 18 years of age (3) Uncomplicated Pregnancy (4) Singleton (5) Medical and comprehensive social history questionnaire (6) Blood samples and lab work- pre-screened lab results must be free from risk factors, active infections, communicable disease agents and diseases as required by the FDA.

Pre-Screening lab test results must be found non-reactive and/or negative for the following communicable diseases and other agents:

HIV I/II AB

HIV/HCV/HBV NAT

HBC AB

HBS AG

RPR or FTA-ABS

HCV AB

Donor Eligibility

Once a donor is approved for eligibility, the donor mother is permitted to participate in the donated birth tissues program. The day of the scheduled Cesarean Section delivery, the donor is asked to sign an informed voluntary consent form permitting and acknowledging the donation of their birth tissues. A secondary assessment is performed preceding delivery that includes (1) Updating donor mother’s medical and social history questionnaire to identify any changes in relevant risk factors since the initial pre-screening date. (2) Blood samples are obtained to test for infectious diseases (see above list). Additional tests may be performed for other communicable diseases, such as West Nile Virus, T. Cruzi, Cytomegalovirus and Epstein – Barr virus.

In compliance with the U.S. Public Health Service guidelines, the results of these recoveries adhere to the regulations requisite to HCT/P recovery and pre-screening and testing of the donor tissues as verified through the tests performed and outlined above. All results are evaluated by the Medical Director and have been found acceptable according to regulations, standards and SOPs. Donor screening tests are performed by laboratories which are CLIA certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), and use FDA-licensed tests when available, including LABS, Inc., ARUP, Clongen, or VRL Laboratories.


General Product Information

LevaGRAFTM

LevaGRAFTM is aseptically processed and gamma-irradiated for maximum patient safety and is one of the safest human Amniotic Membrane Allografts on the market. LevaGRAFTM is a chorion-free placental collagen covering, that has been processed utilizing a proprietary approach to both prolong and sustain the beneficial nutrients and growth factors following transplantation. LevaGRAFTM is offered in a variety of sizes to reduce waste and is available in a hydrated and dehydrated format.

Specifications

LevaGRAFTM is prepared from donated Amnion Membrane tissue that is procured during Cesarean Section delivery from a volunteer donor. The tissue is processed within 72 hours of a C-section recovery. The allografts are processed in various sizes appropriate for surgical implantation, using glutaraldehyde 1.0%, gentamicin in 0.9% NaCI and terminally sterilized using gamma (25 kGy) irradiation.

LevaGRAFTM is a Human Cellular and Tissue Based Product (HCT/P) as defined by the US Food and Drug Administration (21CFR Part 1271). The donor from whom this allograft was derived has been tested and found negative for hepatitis B, hepatitis C, human immunodeficiency virus type 1 & 2, and syphilis using FDA-licensed test kits by a CLIA certified lab.

Indications and Uses

LevaGRAFTM may be used in covering wounds and surgical sites.  Clinicians using LevaGRAFTM should possess the training and skills necessary for use.

Contraindications

LevaGRAFTM should not be used if the expiration date has been surpassed, container in which the product is stored is damaged, container is not labeled, or the product has not been stored at the recommended temperature.  Product should not be used on areas with active or latent infection present.  No other absolute contraindications are known to exist.

Storage

LevaGRAFTM is stored at room (ambient) temperature. The grafts are stored for up to 2 years from the date of irradiation, as long as the package has not been breached.

Dosage and Application

  1. The amount or size of LevaGRAFTM needed is based on the condition and size of the defect.
  2. Preparation of the host bed is important and it should be devoid of debris.
  3. The allograft should be applied in a manner to prevent displacement.
  4. Following application to the patient, record the following information in the hospital tissue storage service record and the patient’s medical record: allograft description, lot number or unique graft identification number, date and time of implantation, and other relevant information.
  5. This allograft is intended for single patient use only and may not be re-sterilized.

Handling Instructions for LevaGRAFTM

Dehydrated LevaGRAFTM  Instructions for Use

  1. Thoroughly inspect outer most package prior to opening to ensure that integrity has not been compromised.
  2. Opening the outer peel package is accomplished by grasping both sides (wings) of the peel pouch, slowly pulling apart, and aseptically passing the inner package containing the graft to the scrub nurse or surgical assistant.

NOTE: Dry amniotic membrane is packaged with a fold on one of its corners to orient the user to the baby side of the membrane. The corner fold is towards or over the baby side, which is the side that is applied to the patient’s affected area.

  1. When opening the inner peel pouch, be sure to identify the baby-side and maintain that orientation until the membrane is applied to the targeted site.
  2. The scrub nurse or surgical assistant opens the inner pouch by grasping both sides (wings) of the peel pouch, slowly pulling apart the two sides of the pouch.
  3. Remove the dry Amniotic allograft tissue from the inner pouch. Handle the allograft with care, as it is very fragile and may tear.
  4. Once the allograft inner pouch is opened, the allograft must be used within 24hr.
  5. Cut the dry allograft to appropriate size and place in the desired area.
  6. The patient’s body fluids will naturally hydrate the allograft. However, once in place, the dry allograft may be rehydrated with drops of normal saline being careful not to displace the allograft.

Hydrated LevaGRAFTM Instructions for Use

  1. To ensure that package integrity has not been compromised, thoroughly inspect outer most package prior to opening
  2. Opening the outer peel package is accomplished by grasping both sides (wings) of the peel pouch, slowly pulling apart, and aseptically passing the inner package containing the graft to the scrub nurse or surgical assistant.
  3. The scrub nurse or surgical assistant opens the inner pouch by grasping both sides (wings) of the peel pouch, slowly pulling apart the two sides of the pouch.

NOTE: Wet amniotic membrane is packaged with a cut on one of its corners to orient the user to the baby side of the membrane. When the cut corner is oriented on the top left of the membrane the baby side is positioned on the underside of the membrane and is the side that is applied to the patient’s affected area.

  1. LevaGRAFTM is oriented between 2 telfa gauze sheets with a cut corner. Orient the cut corner to the top left. Peel the back telfa gauze sheet from the front telfa. The allograft will stick to the front telfa gauze and the baby side will be the exposed side of the allograft. The allograft may be cut to the appropriate size while still adhered to the front telfa gauze.
  2. Apply the allograft to the patient’s affected area with the front telfa gauze still attached to the allograft. (The baby side of the amnion is considered to contain the richest source of nutrients).
  1. Peel the front telfa gauze away from the allograft.
  2. Once the allograft inner pouch is opened, the allograft must be used within 24 hours.

LevaSOLTM

LevaSOLTM is a minimally manipulated, 100% pure amniotic fluid allograft that has been bioengineered utilizing a cutting-edge sterile filtration technology that delicately extracts dead tissue and debris from the fluid. LevaSOLTM is free of cryoprotectants and additives, making it safe for patients who may suffer from allergies and/or immunocompromised individuals. LevaSOLTM has been cryopreserved to ensure maximum patient safety while preserving high concentrations of beneficial proteins, extracellular matrix components and hyaluronic acid. Components of LevaSOLTM interact with Multiple Tissue Types to enhance the body’s own healing process and stimulate normal regeneration to provide strength in healing.

Specifications

LevaSOLTM is an injectable allograft sterile filtered and tested under USP <71> guidelines. Sterile-filtered LevaSOLTM has no live cells, cell debris, hair, vernix or other debris. Sterile- filtered LevaSOL contains human proteins, hyaluronic acid, cytokines and chemokines which are known to promote healing and protect human cells and tissues.

Amniotic Fluid Allograft is prepared from birth tissues donated after Cesarean Section delivery from a volunteer donor.  The Amniotic Fluid is retrieved and processed within 72 hours from time of C-section. The surgical site is prepped according to AORN standards for incision disinfection.  Prior to the delivery of the baby, amniotic fluid is aseptically aspirated into a sterile container.  LevaSOLTM is a Human Cellular and Tissue Based Product (HCT/P) as defined by the US Food and Drug Administration (21CFR Part 1271). The donors from whom allografts are derived  test negative for hepatitis B, hepatitis C, human immunodeficiency virus type 1 & 2, and syphilis using FDA-licensed test kits by a CLIA certified lab.

Disclaimer: LevaSOLTM contains a high quantity and multi-dimensional array of proteins, growth factors and regenerative properties.  LevaSOLTM is depleted of live stem cells, dead tissue, or debris. The product is intended to support the body’s natural ability to repair itself by stimulating the body’s own cells to heal, repair and regenerate.

Indications and Uses

LevaSOLTM is aseptically packaged in a vial or eye dropper format. Injections can be administered subcutaneously (“SC”), intramuscularly (“IM”), or into a joint.

Contraindications

LevaSOLTM should not be used if the expiration date has been surpassed, container in which the product is stored is damaged, container is not labeled, or the product has not been stored at the recommended temperature.  Product should not be used on areas with an active or latent infection. This product is not safe for intravenous injection (IV), and should not be injected into the spinal canal, or in vital organs (including the heart and other areas of the central nervous system), nor the circulatory system. No other absolute contraindications are known to exist.

Storage

LevaSOLTM must be stored at -20oC or colder temperatures.  The allograft may be stored for up to 2 years from the date of packaging, as long as the package has not been breached, and proper temperature has been maintained. Once LevaSOLTM has been thawed, it must be used immediately or discarded.

Dosage and Application

  1. The amount or volume of LevaSOLTM needed is based on the condition and size of the defect.
  2. Preparation of the host bed is important and it should be devoid of debris.
  3. The allograft should be applied in a manner appropriate for covering.
  4. Following application to the patient, record the following information in the hospital tissue storage service record and the patient’s medical record: allograft description, lot number or unique graft identification number, date and time of implantation, and other relevant information.
  5. This allograft is intended for single patient use only and may not be re-sterilized.

Handling Instructions for LevaSOLTM

The amniotic fluid is retrieved and processed aseptically, packaged, labeled with the Lot or Identification Number (LOT/ID), volume, and expiration date.  The amniotic fluid is processed using a proprietary sterile filtration method.

Preparation of Peel Packaged LevaSOLTM

  1. To ensure that integrity has not been compromised, thoroughly inspect outer most package prior to opening
  2. Opening the outer peel package is accomplished by grasping both sides (wings) of the peel pouch, slowly pulling apart. Open the inner package containing the allograft vial in a similar manner.

NOTE: Only the fluid inside of the vial is sterile.  The polypropylene packages and the outside of the vial are NOT STERILE.

  1. Prior to use, thaw the frozen vial (while in the plastic peel packaging) in a hand or a warm water bath until the entire volume is completely thawed, approximately 5 min per mL of frozen fluid. It is recommended that before removing or aspirating from the vial, either centrifuge or wrist-snap vial to move all fluid product out of cap down into the vial. (NOTE: Internal threading of vial cap may retain a minimal volume of fluid. Handle aseptically.)
  2. Open the vial by unscrewing the lid counter clockwise removing the lid. Once the vial is opened, use within 24hr.
  3. Aseptically, using a sterile needle and syringe, aspirate the amniotic fluid from the vial.
  4. Either spray the fluid on the wound bed or inject into the applicable tissues as required.
  5. LevaSOLTM can be injected using a 27g or 29g needle.

References

  1. Standards for Tissue Banking; Arlington, VA: American Association of Tissue Banks AATB), Latest Edition.
  2. Technical Manual for Tissue Banking; Arlington, VA: American Association of Tissue Banks (AATB), 1993.
  3. United States Public Health Service.
  4. Federal Food and Drug Administration (FDA): Federal Register (Vol. 58, No. 238, pp. 65514-65521), CFR 1271
  5. United States Pharmacopoeia (USP) 71
  6. Code of Federal Regulations (CFR) 610.12