FDA publishes draft guidelines for handling platelets
Proposed new guidelines from the Food and Drug Administration have the potential to alter the way blood centers handle platelets destined for patients.
The draft guidance, “Bacterial Risk Control Strategies for Blood Collections Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion,” would replace a draft guidance issued in March 2016.
The updated guidelines are designed to control the risk of bacterial contamination of room temperature platelets, said Dr. Samantha Gomez Ngamsuntikul, associate medical director at BioBridge Global. Platelets donations that are four or five days old are associated with a higher risk of negative reactions in patients.
“The new guidance would require more testing of platelets,” Dr. Ngamsuntikul said. “We currently do a primary culture at 24 hours. If the new guidance is implemented, we would be required to rapid test to release on day 4 and day 5. It will be a lot more testing.”
One way to avoid additional testing would be implementing a process called pathogen reduction, she added. Pathogen reduction involves treating the platelet donations to inactivate infectious microbes.
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