Presentation on theme: "Blood Donor Written Statement of Understanding"— Presentation transcript:
1Blood Donor Written Statement of Understanding IntroductionOrieji Illoh, MDOffice of Blood Research and ReviewCBER/FDABlood Products Advisory CommitteeApril 29, 2011
2Outline Introduction Issues to be considered Donor consent: Current statusFDA requirements or recommendationsAABB standardsACBSA recommendations“Written statement of understanding” (WSU)Elements as outlined in the 2007 proposed rulePublic comments to the proposed ruleElements of the written statement of understandingEducational materialRisks and hazards of blood donationQuestions for the committeeSpeakers and topics
3IntroductionAbout 10 million allogeneic donors provided ~17 million donations of Whole Blood and Red Blood Cells in 2008.The blood donation process is highly safe but adverse reactions can occur.FDA has regulations for donor consent in Source plasma, plateletpheresis and plasmapheresis donors.The practice of donor consent for whole blood donors varies.3
4Blood donation process 1234RegistrationDonor provides identification and demographic informationDonor reads information about blood donation (Educational material)Donor consents to blood donationHealth history and limited physical examinationHealth history questions asked by blood center staffBlood pressure, pulse and hemoglobin levels are checkedDonationArm is cleansedBlood is drawn (6-10 minutes)Needle is removedRecoveryRest ~ 15minsSnacksAverage donation process takes just under one hour
5Issues for consideration Proposed “Written Statement of Understanding” for Whole Blood donorsContentHow to administerWhen to administerDoes not include informed consent for research studies.Including collection of repository samples.
7FDA requirements or recommendations Source Plasma21CFR“Guidance on Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs”Plateletpheresis and plasmapheresis21 CFR (c) and 21CFR (b)“Guidance for Industry and FDA Review Staff: Collection of Platelets by Automated Methods”Apheresis red blood cell donations“Guidance for Industry: Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods
8AABB Standard for Donor Consent Obtained on the day of donation and presented in understandable termsInformation provided regarding:Risks of the procedure.Tests performed to reduce the transmission of infectious diseases to the allogeneic recipient.An opportunity provided to ask questions and to give or refuse consent for donation.AABB. Standards for Blood Banks and Transfusion Services. 27th ed.
9Advisory Committee for Blood Safety and Availability: December 2008 Donor consent is generally adequate but lacks consistency.Include in consent formsThe effects of repeat donation on the donor population.The gender specific effects of iron deficiency on donors.The effects of collecting blood from anemic men using current donation thresholds.The disproportionate prevalence of adverse events in the youngest donors.ConsiderThe method and frequency of effective informed consent for repeat donations
10FDA Proposed Rule: Written Statement of Understanding
11“Written Statement of Understanding” - definition The term “Written Statement of Understanding” is used as a general term to differentiate it from informed consent for research as defined in 21CFR 50.25
122007 Proposed Rule: WSUThe 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.
132007 Proposed Rule: WSUIf 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.
142007 Proposed Rule: WSUBlood establishments would need to provide and ensure that the written statement to the donor:Is read and signed before each donation.Is written in clear terminology.Does not include language that would waive any of the donor's legal rights.FDA rulemaking is not intended to preempt state laws regarding donor consent for minors.
15Proposed Rule: WSU Representative comments from industry Agreement that donors should be adequately informed about the blood donation process and that there should be documentation that the donor has been so informed.Concern about how signature will be obtained.Consider electronic acknowledgement.Provide guidance that provides recommendations for compliance with this rule.
16Proposed Rule: Written Statement of Understanding: Selected elementsEducational materialsRisks and hazards of donation
17WSU: Educational materials AABB introduced educational materials in 1984.Current FDA recommendations for HIV education published in the 1992 memorandum.Incorporated into the AABB educational materials.AABB educational material version 1.3
18WSU: Educational materials Information about the behaviors that increase risks of relevant transfusion-transmitted infections.Signs and symptoms of such infections, and the consequent risk to the safety of the blood and blood component.Instructions for donors to self-defer if they determine that they have participated in an increased-risk behavior for, or show signs or symptoms of that relevant transfusion-transmitted infection.
19WSU: Educational materials This information may be provided in oral, written, or multimedia form in a manner designed to be understood by the donor.FDA may provide additional guidance in the future.
20WSU: Risks and hazards of Blood donation About 3 – 10% of blood donors will experience an adverse reactionEder A et al. Transfus Med Rev Jul;23(3):Severe adverse donor reaction rate in 2008 = 0.09% collection proceduresWhitaker BI et al. The 2009 National Blood Collection and Utilization Survey (presented at the 2010 AABB meeting)
21Risks and hazards of Whole Blood donation MinorMajorLong termDizzinessPresyncopeBruisesHematomasAllergicSyncope with loss of consciousness or injuryNerve damageArterial punctureIron deficiency with or without anemia
22Risks and hazards of blood donation Study: Post donation interview of 1000 Whole Blood donors% donor reaction rateAEs = Adverse effectsArm injuriesSystemic reactionsTotal AEsBruiseSore armHematomaSensory changesFatigueVasovagalNauseaand vomiting36.122.710.01.70.97.85.31.1Newman et al. Transfusion May;43(5):
23American Red Cross: 2006 hemovigilance data Rates of complications associated withallogeneic Whole Blood donation~ 6 million whole blood donations~ 349 complications/ 10,000 donationsMajor reaction rate (7.4/10,000)Most complications were minorHematomas (~75/10,000)Presyncopal (~258/10,000)Eder et al. Transfusion Sep;48(9):
24Blood donor fatalities FDA donor fatality reports: FY 2005 through FY 2009.In 2009,Whole blood fatalities2 cases - donation ruled out1 case - donation not ruled out but no causal relationshipAvailability/ReportaProblem/TransfusionDonationFatalities
25Questions for the committee Please comment on the seven proposed elements of the written statement of understanding as listed in FDA’s 2007 proposed donor eligibility rule.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?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.
26Questions for the committee Please comment: When should blood establishments administer the written statement of understanding?Before donor questions?Before physical examination?Before phlebotomy?Please comment: How often should blood establishments administer the written statement of understanding to Whole Blood donors?
27SpeakersChristine Grady, MSN, PhD : National Institutes of Health. Clinical CenterAn overview of informed consentBeth Shaz, M.D.: New York Blood CenterEvaluation of informed consent forms for adults and minors for whole blood donation used by United States blood centers.Ronald Domen, M.D.: Penn State Milton S. Hershey Medical CenterThe informed consent process in whole blood donation.