Ensuring the Highest Standards of Safety and Quality
At Pinnacle Egg Bank, we prioritize our donors’ and recipients’ safety and well-being. Adhering strictly to FDA regulations, we ensure that every step of our egg donation and storage process meets the highest safety and quality standards.
FDA Requirements for Egg Donors
- Donor Physical Examination: Every donor undergoes a comprehensive physical examination to ensure their suitability for egg donation.
- Donor Questionnaire: Donors complete an in-depth questionnaire to assess their eligibility.
- Infectious Laboratory Tests: We conduct laboratory tests for infectious diseases at an FDA-approved facility. These tests are performed 30 days before, or up to 7 days after, the egg acquisition process.
- Eligibility for Use of Tissue (Anonymous Donors): Non-identified (anonymous) donors must be eligible to use tissue as per FDA standards.
- Directed (Known) Donors: In cases of directed (known) donations, even if the tissue is deemed ineligible, it may still be used but with appropriate labeling and informed consent.
We adhere to all FDA requirements as part of our commitment to maintaining the highest safety and compliance standards in our egg donation process. For further details on our adherence to FDA requirements, you can refer to the FDA’s guidelines here.
Rigorous Donor Screening and Testing
Our comprehensive donor screening process includes thorough medical, genetic, and psychological evaluations. We adhere to FDA guidelines for infectious disease testing, ensuring all donors are screened for HIV, hepatitis, and other transmissible diseases to safeguard the health of recipients. All Pinnacle Egg donors are screened and tested in compliance with the FDA Code of Federal Regulations, Title 21, Subpart 1271.
FDA Female Donor Testing Includes:
- CT/NG NAT – Chlamydia/Gonorrhea Nucleic Acid Test
- HBcAb, Total – Total Hepatitis B Core Antibody Test
- HBsAg – Hepatitis B Surface Antigen Test
- HCV Ab – Hepatitis C Antibody Test
- HIV-1/HCV/HBV Ultrio NAT – HIV/Hepatitis C/Hepatitis B Nucleic Acid Test
- HIV-1/2 Plus O EIA – HIV-1/2 Plus O Enzyme Immunoassay
- T. pallidum, IgG (Syphilis) – Syphilis IgG Antibody Test
- West Nile Virus, RNA – West Nile Virus RNA Test
Transparent and Detailed Record Keeping
We maintain meticulous records of donor information, handling and storage conditions, and recipient details. Our state-of-the-art record-keeping system ensures traceability and compliance with FDA regulations.
Advanced Tissue Handling and Storage
Our facility utilizes the latest technology in egg collection, processing, preservation, and storage. We strictly adhere to FDA standards to maintain the viability and safety of our reproductive tissues.
Quality Control and Assurance
We have implemented comprehensive quality control and assurance measures, including regular audits, staff training, and equipment validation, to meet and exceed FDA requirements consistently.
Adherence to Labeling Mandates
We follow FDA mandates on labeling reproductive tissues. Our labels provide essential information, including donor identification and test results, ensuring accuracy and reducing the risk of errors. As required by 21 CFR 1271.55 (a)(3) of the regulations, Pinnacle Egg Bank includes a Summary of Records that documents the tests performed on the donor and an interpretation of the results with each shipment.
Responsible Reporting Practices
In the rare event of an adverse reaction, we promptly report to the FDA. This commitment to transparency helps maintain the integrity and safety of reproductive tissue use nationwide.
Registration and Certification
Our clinic facilities are registered with the FDA and adhere to the highest standards set by professional accrediting organizations in tissue banking.