The Safety of the Blood Supply

Richard J. Davey, MDRichard J. Davey, MDDirector, Division of Director, Division of Blood Applications, Blood Applications, OBRR, CBER, FDAOBRR, CBER, FDA

Blood Donation in the United Blood Donation in the United StatesStates

Eight million plus volunteers Eight million plus volunteers First-time donors 15-25% First-time donors 15-25% Average 1.6 donations per yearAverage 1.6 donations per year 15 M units of whole blood 15 M units of whole blood

collectedcollected 4% autologous4% autologous 2% directed2% directed

14 M units of RBCs transfused14 M units of RBCs transfused % who can donate. 40 - 45%% who can donate. 40 - 45% % who % who actuallyactually donate. 2.5 - donate. 2.5 -

4.5%4.5% Periodic shortages and appeals. Periodic shortages and appeals.

Postponement of surgery.Postponement of surgery.

Blood Organization in the Blood Organization in the USAUSA

AABBAABB. 2400 . 2400 institutions. 9000 institutions. 9000 members. members. Transfusion.Transfusion. Standards. Annual Standards. Annual meeting.meeting.

American Red CrossAmerican Red Cross. . 45% of blood supply. 45% of blood supply. 35 blood centers. One 35 blood centers. One FDA license.FDA license.

America’s Blood America’s Blood CentersCenters. 45% of blood . 45% of blood supply. 70 blood supply. 70 blood centers. Separate FDA centers. Separate FDA licenses.licenses.

Hospital blood banksHospital blood banks. . 10% of blood supply. 10% of blood supply. FDA registered.FDA registered.

Regulation of the US Blood SupplyRegulation of the US Blood Supply

FDA insures the “safety, purity and potency” of FDA insures the “safety, purity and potency” of blood products. Blood is subject to both blood products. Blood is subject to both “biologics“biologics” and ” and “drug”“drug” regulatory oversight. regulatory oversight. cGMP: “Current Good Manufacturing Practices”cGMP: “Current Good Manufacturing Practices”

Code of Federal Regulations (CFR)Code of Federal Regulations (CFR) FDA GuidancesFDA Guidances FDA Registration. Local collection and testing FDA Registration. Local collection and testing

of blood, or transfusing blood only (hospitals)of blood, or transfusing blood only (hospitals) FDA License: Collection, testing and shipping FDA License: Collection, testing and shipping

across state lines. (blood centers)across state lines. (blood centers) FDA enforcement options: “483” observations, FDA enforcement options: “483” observations,

warning letters, suspension, revocation. warning letters, suspension, revocation.

State regulations, OSHA, CDC, AABB and CAPState regulations, OSHA, CDC, AABB and CAP

Five Layers of SafetyFive Layers of Safety

1.1. Selection of suitable donorsSelection of suitable donors Donor history questionnaireDonor history questionnaire Limited physical examinationLimited physical examination

2.2. Donor deferral registriesDonor deferral registries3.3. Testing for infectious agentsTesting for infectious agents4.4. Quarantining of blood while Quarantining of blood while

verifying suitabilityverifying suitability5.5. Taking corrective actions to Taking corrective actions to

address errorsaddress errors

Blood Donor QualificationBlood Donor Qualification Regulations and guidancesRegulations and guidances Hemoglobin levelsHemoglobin levels Risk behavior questionsRisk behavior questions TravelTravel

MalariaMalaria vCJD (“mad cow disease”)vCJD (“mad cow disease”)

TestingTesting HIV, HCV, HBV, othersHIV, HCV, HBV, others

Chagas diseaseChagas disease Dengue ?Dengue ? XMRV ?XMRV ?

Transfusion Transmitted DiseaseTransfusion Transmitted DiseasePost –Transfusion Hepatitis Risk: 1969-Post –Transfusion Hepatitis Risk: 1969-

20052005

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10

15

20

25

30

% P

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Year of Introduction of Test

Volunteer DonorsHBsAg

ALT

CUE

HIV-1

Anti-HBc

HCV 1.0

HIV-1/2HCV 2.0

HTLV 1.0

HCV 3.0p24 Ag

HTLV 2.0

HTLV-I/II

HCV/HIVNAT

WNV NATHBsAg 3

Chagas?Babesiosis?vCJD?

After H. Alter

Hospital Transfusion Issues: Events Hospital Transfusion Issues: Events Reported by the SHOT Program in Reported by the SHOT Program in

England, 1996-2001.England, 1996-2001.

Incorrect blood transfused

Acute reaction

Delayed reaction

PTP

TRALI Infections

GVHD

Transfusion Safety OptionsTransfusion Safety Options

Hand-held bar code scannersHand-held bar code scanners Radio frequency “smart-tags” Radio frequency “smart-tags”

and readers (RFID)and readers (RFID) Wi-Fi technologyWi-Fi technology Blood bag “dispenser” Blood bag “dispenser”

systemssystems

Dedicated phlebotomists Dedicated phlebotomists Two separate blood samples Two separate blood samples

on all new patientson all new patients Transfusion Safety OfficerTransfusion Safety Officer

Transfusion Safety OfficerTransfusion Safety Officer

Most serious hazards of Most serious hazards of transfusion occur transfusion occur outside of the laboratory

The principal role of the TSO is to work outside of the laboratory to improve patient safety during transfusions

Most TSOs are RNs or PAs Most TSOs are RNs or PAs with >3 yrs experience, with >3 yrs experience, preferably in med-surg preferably in med-surg in-patient settingsin-patient settings

Blood Safety InnovationsBlood Safety Innovations

Research: Is “Old” Blood Research: Is “Old” Blood OK?OK?

Future Directions in Transfusion Future Directions in Transfusion ScienceScience

Understand blood storage lesionUnderstand blood storage lesion Better storage containers and Better storage containers and

conditionsconditions Blood management Blood management

Appropriate use of blood to minimize its Appropriate use of blood to minimize its use use

Pathogen reduction technologiesPathogen reduction technologies Minimize infectious hazardsMinimize infectious hazards

Artificial oxygen carriersArtificial oxygen carriers Minimize reactions, storage lesion and Minimize reactions, storage lesion and

infectious hazardsinfectious hazards

The Primary Focus of Blood The Primary Focus of Blood Safety: The PatientSafety: The Patient

The Patient

Research

Safe Donors

FDA

Hospitals

Industry

Blood Centers

Questions about today's Questions about today's webinar?webinar?

Toll-free 1-888-INFO-Toll-free 1-888-INFO-FDA (888-463-6332)FDA (888-463-6332)

One the web One the web www.fda.govwww.fda.gov

E-mail E-mail ocod@fda.hhs.govocod@fda.hhs.gov