PB's perinatal products are recovered at a scheduled, full-term cesarean delivery, after the donor has been screened through a medical and social history review and serology testing for communicable disease.
After recovery, tissue is processed within a defined window, carries a unique lot identifier, and is held in quarantine until sterility testing from a third-party laboratory and internal release criteria are met. Whether a specific intended use of the finished product is regulated solely under section 361 of the PHS Act depends on minimal manipulation, homologous use and absence of a systemic effect, a determination the clinic and its counsel make for that use.
Buyers should request the donor eligibility summary, lot-specific certificate of analysis and sterility testing results for any perinatal allograft before purchase, and should maintain lot-level traceability on the patient record once the product is used.
Every perinatal allograft traces back to a specific donor and lot, so clinics should keep lot-level documentation on file and linked to the patient record for traceability.