Donor screening
Screening begins before donation. Donor medical and social history is reviewed for risk factors for relevant communicable diseases, following criteria set out in the regulation. A donor found ineligible is excluded.
For birth tissue, donation follows scheduled caesarean delivery with informed consent. The tissue would otherwise be discarded, and collection poses no risk to mother or infant.
Testing
Donor testing covers relevant communicable disease agents including HIV, hepatitis B and C, syphilis and others specified in the regulation, using FDA-licensed screening tests where available, performed in appropriately certified laboratories.
Processing and controls
Processing occurs under current good tissue practice — controls on facilities, environment, equipment, personnel, procedures and records, designed to prevent contamination and cross-contamination.
Terminal sterilisation is not universal across tissue products, since some processes would damage the tissue. Whether and how a specific product is sterilised or aseptically processed is a legitimate question to ask.
Tracking
Establishments must be able to trace each product from donor to recipient and back. This exists so that if a problem is identified, affected products and recipients can be located.
It is reasonable to ask a clinic for the processor's name, the product identifier, and confirmation that the establishment is FDA-registered — all of which can be checked independently.
This article covers general science and published research. Whether any approach is appropriate for you is a clinical question, answered by a licensed provider through a good-faith exam.
Movera Wellness Institute. Medical services are provided by licensed California practitioners. Supervising physician: Dr. Arnold S. Kremer, DO (CA license #20A4242).