Purpose: An ongoing investigation has uncovered significant violations of FDA regulations and determined that the Center for Reproductive Medicine does not have adequate protections in place against the risks of communicable disease transmission
The U.S. Food and Drug Administration’s (FDA) investigation of the Center for Reproductive Medicine in Lutz, Florida, a human cell, tissue and cellular and tissue-based product (HCT/P) establishment responsible for donor screening, donor testing, and the eligibility determination of anonymous and directed donors of reproductive HCT/Ps (oocytes and semen), as well as other activities such as storage, uncovered significant violations of FDA’s HCT/P regulations. FDA has identified significant deviations from requirements regarding donor eligibility screening and testing, and has determined that because the Center for Reproductive Medicine is in violation of 21 CFR Part 1271, the establishment does not provide adequate protections against the risks of communicable disease transmission through the use of the HCT/Ps (oocytes and semen) and has determined that there are reasonable grounds to believe that these violative HCT/Ps pose a danger to health.
As a result of the deviations from FDA regulations, on September 7, 2012, FDA issued an Order to Cease Manufacturing of HCT/Ps to Center for Reproductive Medicine and to its Owner, Dr. Stephen W. Welden. The Order requires the following actions with regard to HCT/Ps from anonymous and directed donors:
- the immediate cessation of all manufacturing of all HCT/Ps recovered on or after May 25, 2005 from directed or anonymous donors until compliance with the regulations in 21 CFR 1271 has been achieved and FDA provides written authorization to resume such operations; and
- continue to store all HCT/Ps recovered on or after May 25, 2005, which are in the establishment’s possession.
Additionally, the Order requests that the establishment immediately notify, by copy of the Order, all persons that were recipients of HCT/Ps subject to the Order, or have such HCT/Ps in storage. Note that HCT/Ps obtained from sexually intimate partners do not require donor screening and testing, and are not subject to the Order or notification request.
Specifically, FDA’s inspection and record review noted significant non-compliance with federal regulations pertaining to HCT/P donor eligibility requirements including, but not limited to:
- Failure to use appropriate FDA licensed, approved, or cleared screening tests to test a specimen from the donor of cells and tissues for evidence of infection due to relevant communicable disease agents.
- Failure to test a specimen from the donor of viable, leukocyte-rich cells or tissue to adequately and appropriately reduce the risk of transmission of relevant cell associated communicable diseases.
- Failure to test a specimen from the donor of reproductive cells or tissue to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents of the genitourinary tract.
- Failure to collect donor specimens for testing for relevant communicable diseases at the time of recovery of cells or tissue from the donors; or for oocyte donors, within 30 days prior to oocyte recovery or up to seven days after recovery; or for semen donors, up to seven days before or after recovery.
- Failure to screen an anonymous or directed donor of reproductive cells or tissue by reviewing the donor’s relevant medical records for risk factors for, and clinical evidence of, relevant communicable disease agents and diseases.
- Failure of a responsible person to determine and document the eligibility of a cell or tissue donor.
- Failure to establish and maintain procedures for all steps performed in testing, screening, and determining donor eligibility.
- Failure to establish and maintain a standard operating procedure governing the release of an HCT/P from a donor whose specimen tests reactive for cytomegalovirus (CMV).
- Failure to have a distinct identification code affixed to the HCT/P container that relates the HCT/P to the donor and to all records pertaining to the HCT/P.
Based on the inspectional findings, FDA believes that adequate steps have not been taken to prevent the introduction, transmission, or spread of communicable disease during the processing and storage of these HCT/Ps from anonymous and directed donors. With appropriate donor screening and testing, the overall risk of communicable disease transmission from donors of reproductive tissues to recipients through Assisted Reproductive Technology (ART) procedures is low. The actions of the Center for Reproductive Medicine regarding screening and testing of anonymous and directed donors increase the risk of communicable disease transmission, posing a danger to the health of the recipients.
- FDA recommends that recipients of tissue from anonymous and directed donations should discuss with their primary care provider what testing for communicable disease agents may be appropriate.
- Clients who, at the time of receipt of this Order, are currently undergoing hormonal stimulation for recovery or implantation of reproductive tissues should discuss their options regarding upcoming procedures with Dr. Welden.
- Review the Order to Cease Manufacturing issued to the Center for Reproductive Medicine and to its Owner, Dr. Stephen W. Welden for information on the nature of the establishment’s violations.
- Discuss with patients who received reproductive tissue from this establishment since March 25, 2005, what communicable disease testing may be appropriate.
- Order to Cease Manufacturing
- Tissue & Tissue Products
- FDA requirements for screening and testing of reproductive donors
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