The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) has released a new guidance document aimed at adopting a new and more flexible recommendation for the donation of tissue, blood and plasma products.
Plasma Donation: FDA Lays Groundwork for New Plasma Donation Questionnaires
The guidance, Implementation of an Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Source Plasma, references FDA's requirements that donation centers subject donors to a questionnaire that is intended to screen out those with certain risk factors that are unable to be reliably tested for and could result in contaminated specimens.
In recent years, FDA said it has become increasing aware that full-length questionnaires are time-consuming and lengthy, and likely pose an inconvenience-if not a barrier-to frequent plasma donation.
To alleviate some of those challenges, FDA said it will now recognize an abbreviated donor history questionnaire that may be used by frequent Source Plasma donors.
That standard, the Plasma Protein Therapeutics Association (PPTA) Source Plasma donor history questionnaires and accompanying materials (SPDHQ documents), "will provide blood establishments that collect Source Plasma with a specific process for administering questions to Source Plasma donors to determine their eligibility to donate," FDA explained.
The SPDHQ (version 1.2) documents include full- and abbreviated-length donor history questions, directions for use, medication deferral lists, risk posters to educate donors and travel posters to indicate which geographic regions preclude donation.
FDA said the PPTA documents, in addition to meeting FDA's standards, also exceed them in several others. For example, they contain questions regarding a patient's history of cancer, transplants, skin grafts and pregnancy.
FDA wrote that while it recognizes the documents, it is "not requiring or recommending that donors be screened or deferred for these issues."
Establishments will thus be allowed to modify the questionnaire if they wish to do so. "If you choose to implement the acceptable SPDHQ documents and omit these questions, you would still be in compliance with FDA requirements."
Other FDA-approved documents may also be used instead of PPTA-approved documents, FDA added.
Other Standards on the Horizon?
FDA said the PPTA standard could become just one of several to be adopted by the agency.
"In the future, we, FDA, may recognize other Source Plasma donor history questionnaires and accompanying materials as acceptable," it said. Those materials would be made available on FDA's website as they are approved for use, and include a "specific process for administering questions to determine their eligibility to donate."
Those standard questionnaires found to be acceptable will be ones allowing a blood establishment to determine if a donor is eligible per the requirements of 21 CFR 640.63 on the day of requirement, FDA wrote.
However, if multiple standards are used, establishments should take care to administer the same documents to the same patients.
Explained FDA: "For example, if you choose to implement the Abbreviated PPTA Donor History Questionnaire, you should also implement the Full-Length PPTA Donor History Questionnaire as described in the Directions for Use."