FDA Issues Ebola Disease Considerations for HCT/P Establishments

The Food and Drug Administration’s Office of Therapeutic Products (OTP) issued a safety and availability notice July 10 that includes considerations for voluntary implementation of human cells, tissues, and cellular and tissue-based product (HCT/P) donor screening related to the current Ebola disease outbreak.

The communication was not issued as guidance to industry with specific donor screening recommendations.

FDA outlined additional considerations for establishments wishing to voluntarily determine whether, within 21 days before HCT/P recovery, a donor was diagnosed with, or suspected of having, Ebola disease, had close contact with an infected individual, traveled to or resided in an area with widespread transmission or was notified by a public health authority of a potential exposure.

The agency also noted that “robust, routine screening measures... are already in place for evaluating risk factors and conditions as well as clinical evidence and physical evidence of infection in HCT/P donors.” These existing safeguards “may identify individuals screened for potential donation who are diagnosed with Ebola disease or who are currently at greatest risk for infection with Ebola disease.”

FDA will continue to monitor the outbreak and communicate new information as it becomes available.

AABB Resources for HCT/P Facilities

AABB and the Hematopoietic Progenitor Cell Task Force have developed example donor history questionnaire (DHQ) questions and flowcharts to assist HCT/P establishments that choose to incorporate FDA’s voluntary considerations when evaluating an individual’s eligibility to donate. Use of these examples is optional and not driven by FDA guidance or recommendations. When used, they should be added to the end of the DHQ in the “Area for Additional Questions.” OTP has reviewed the examples and concurs that they align with the intent of the safety and availability communication.

Importantly, OTP’s considerations for HCT/P establishments are distinct from FDA’s Office of Blood Research and Review recommendations for blood establishments. The information provided by OTP for HCT/P establishments is intended to inform establishment decision-making and is not accompanied by formal recommendations.

In contrast, blood establishments are expected to implement the recommendations in Sections III.A.2 and III.B of the updated Ebola guidance within four weeks, as directed in FDA’s June 29 safety and availability notice.

Additional information for blood collection facilities related to Ebola disease risk is available on the AABB website.