SAFETY STANDARDS


 
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HRT® is committed to the highest quality and safety standards. Our biologic allografts undergo strict processes and procedures to ensure the utmost in tissue quality and patient safety.

 

100% Natural Human Tissue Allografts

HRT® amniotic allografts are minimally manipulated allografts, derived from 100% natural human tissue. No additional cells, tissues or synthetic materials are added during processing.

Quality Source

HRT® amniotic tissue allografts are derived from amniotic and placental components donated by live, healthy, U.S.-based female donors, after scheduled, successful Cesarean section deliveries. This method allows for collection in a sterile O.R. environment, and better preserves the natural state and integrity of the tissues as they do not undergo the excess stress or pressure of a natural delivery process.

Screening

HRT® only processes tissues that have passed a stringent screening process. Prior to collection, all donors are screened for medical history, and serologic testing and culture swabs are performed before the tissues are accepted.

Only once the tissue is cleared is it allowed to complete the processing stage. During processing, the tissues undergo multiple cleansing and purification cycles to remove any potential contaminants. Processed tissue must pass a thorough inspection process and meet strict requirements before being approved for final packaging.

All donors have been screened for the following communicable disease markers:

Human Immunodeficiency Virus (HIV): HIV-1/2 Antibodies, Nucleic Acid Test for HIV-1 RNA

Hepatitis B Virus (HBV): HBV Surface Antigen, HBV Core Antibody (Total), Nucleic Acid Test for HBV NAT RNA

Hepatitis C Virus (HCV): HCV Antibody, Nucleic Acid Test for HCV RN

Human T Cell Lymphotrophic Virus I/II: HTLV-I/II Antibod

Syphilis: Rapid Plasma Reagin Screen*, or Treponemal Specific Tes

Cytomegalovirus: CMV Antibody (Total)

Strict Processing

HRT® processes all tissues in an ISO Class 6 Clean Room environment, in accordance with Current Good Tissue Practices (CGTP) set forth by the FDA.