It has been more than a year and a half since the Ebola outbreak began racing across western Africa. According to the U.S. Centers for Disease Control & Prevention (CDC), more than 28,000 people have been infected. Although the United States had very few Ebola patients, the Food and Drug Administration (FDA) recently released guidance for the collection of blood and blood components. These strategies aim to prevent infection of the blood supply during any future outbreak of the deadly virus.
The FDA’s new guidance includes the following recommendations for blood banks and related establishments:
When the CDC has made a determination that none of the countries surveyed have widespread transmission of the Ebola virus, it is appropriate to discontinue screening blood product donors for their risk of having the virus. The following recommendations only apply when the CDC has determined that at least one country has current widespread transmission.
- Donor History Questionnaire
When it has been determined that at least one country has widespread transmission, donor questionnaires should be updated to assess donor risk for the Ebola virus. The FDA recommends screening for the following:
- History of Ebola virus infection;
- History of residence in or travel in the past 8 weeks to a country with widespread transmission of the Ebola virus;
- History of close contact in the past 8 weeks with a person confirmed to have the Ebola virus or any person under investigation for infection; and
- History of notification by a public health authority that the prospective donor may have been exposed in the past 8 weeks to a person with the virus.
- Donor Deferral
When donor screening reveals possible exposure to the Ebola virus, the FDA recommends blood banks and related establishments take the following measures:
- For a donor with a history of Ebola infection, defer the donation indefinitely or until additional data regarding the persistence of the virus in survivors becomes available.
- For a donor who has resided in or visited a country with widespread transmission, defer the donation for 8 weeks from the date of departure.
- For a donor who has had close contact with any person under investigation for Ebola infection, or who has been confirmed infected, defer donation for 8 weeks after the last contact.
- For a donor who has been notified by a public health authority that he or she might have been exposed to the Ebola virus, defer the donation for 8 weeks following the possible exposure.
- Post-Donation Safeguards
When a blood bank or related establishment has collected blood or blood components from a donor who should have been deferred for risks related to residency, travel, or close contact, the establishment should quarantine and destroy all undistributed blood and blood components from the donor. The establishment should also notify consignees who received the supplies that they should do the same.
Upon learning a donor was later diagnosed as having the Ebola virus, the establishment should contact the FDA and appropriate state and local health authorities. If the affected blood products were transfused, consignees should also notify the physician of record for each recipient. All undistributed blood and blood components from the donor should be quarantined and destroyed.
For more information, blood establishments or health care professionals may read the FDA’s full guidance document here.
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