Ultimately, approval of the tissue for use is made by the Medical Director following an intensive and complete medical review and pre-natal evaluation prior to delivery.
We examine:
- Tissue harvest and release criteria
- Identification of the donor
- Medical record or hospital chart
- Treating physician interview
- Family interview
- Serologic testing
- Physical assessment of the donor
- Tissue evaluation
- Donor history evaluation
- Medical director oversight
Screening Exclusions:
+ Creutzfeldt-Jakob disease (CJD)
+ Family history of blood relative with CJD
+ Recipients of human pit-hGH from 1963-1985
+ Recipients of non-synthetic dura matter grafts
+ Progressive encephalopathy
+ Encephalitis: active vim1 or of unknown origin
+ Neurologic disease of unestablished diagnosis
+ Progressive multifocal leukoencephalopathy
+ Subacute sclerosing panencephalitis
+ Reyes syndrome
+ Rabies
+ Recreational Drug use
+ Prescription medication use
+ Age below 18 and over 35 years of age
Once the placental tissue and fluid are harvested it is sent for serological testing, this same testing is repeated 2 additional times before the product can be released for implantation serological testing includes:
All tissue is held in quarantine until microbiological and blood tests are completed. These tests are required by the AATB and the U.S. Food & Drug Administration (FDA) and include analysis of infectious diseases including HIV, hepatitis B and C, and syphilis.
Processing and packaging are performed using sterile techniques in clean room conditions to maintain biological integrity. On occasion, low dose radiation is used to aid in sterilization. Final processed tissues are tested for microbiological contamination in accordance with United States Pharmacopeia (USP) guidelines to ensure compliance with regulatory requirements. Although there is some theoretical risk for disease transmission, the use of allografts that have undergone rigorous donor screening, serological testing, and formal processing has significantly reduced this risk.