FDA Considerations for Tissue Establishments Regarding Monkeypox Virus
On Monday, August 29, the FDA reported working closely with the CDC and other federal and international agencies to monitor reports of monkeypox and populations at greatest risk of infection. FDA has now released information and considerations for human cell, tissue, and cellular and tissue-based product (HCT/P) establishments regarding monkeypox virus (MPXV) and HCT/P donation.
“Due to the robustness of existing donor screening recommendations, the FDA does not recommend using laboratory diagnostic tests to screen HCT/P donors for monkeypox virus. The HCT/P establishment’s responsible person (21 CFR 1271.3(t)) must determine and document the eligibility of a cell or tissue donor (21 CFR 1271.50). Based on information available at this time, establishments may wish to consider, whether, in the 21 days prior to HCT/P recovery, the donor:
- was diagnosed with or was suspected of having a monkeypox infection;
- had close contact with a person or an animal diagnosed with or suspected of having monkeypox infection regardless of the donor’s vaccination status; or
- developed a rash or other symptoms suggestive of monkeypox infection."
On August 15, the AATB Physicians Council provided information on the monkeypox virus, stating that the tissue establishment’s medical director is responsible for evaluating donors for the possibility of
communicable disease transmission via HCT/Ps and that a thorough medical and social history is crucial. AATB will continue to monitor the MPXV outbreak and global guidance as it becomes available.