1 / 8

Blood Donor Written Statement of Understanding Questions for the Committee

Blood Donor Written Statement of Understanding Questions for the Committee. Blood Products Advisory Committee April 29, 2011. Question 1. Please comment on the seven proposed elements of the written statement of understanding as listed in FDA’s 2007 proposed donor eligibility rule.

toby
Download Presentation

Blood Donor Written Statement of Understanding Questions for the Committee

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Blood Donor Written Statement of UnderstandingQuestions for the Committee Blood Products Advisory Committee April 29, 2011

  2. Question 1 Please comment on the seven proposed elements of the written statement of understanding as listed in FDA’s 2007 proposed donor eligibility rule.

  3. 2007 Proposed Rule: WSU • The donor has received and reviewed the educational material. • The donor agrees not to donate if the donation could result in a potential risk to the safety, purity, or potency of the blood supply. • A sample of the donor’s blood will be tested for specified relevant transfusion-transmitted infections and for syphilis.

  4. 2007 Proposed Rule: WSU • If any of the tests is reactive, the sample of blood will be tested further. • If the donation is determined to be not suitable or if the donor is deferred from donation, the donor’s record must identify the donor as ineligible to donate and the donor must be notified. • The hazards and risks of the donation procedure are explained. • The donor has the opportunity to ask questions and withdraw consent at any time.

  5. Question 2 Does the Committee agree that the data support a need for minimum standards for the explanation of the risks and hazards of Whole Blood donation to the donor?

  6. Question 3 Please comment on what methods are acceptable for presenting the written statement of understanding to the donor, and how the donor should acknowledge receipt of this statement.

  7. Question 4 • Please comment: When should blood establishments administer the written statement of understanding? a) Before donor questions? b) Before physical examination? c) Before phlebotomy?

  8. Question 5 Please comment: How often should blood establishments administer the written statement of understanding to Whole Blood donors?

More Related