the safety of the blood supply richard j. davey, md director, division of blood applications, obrr,...
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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
0
5
10
15
20
25
30
% P
os
t-T
ran
sfu
sio
n
He
pa
titi
s
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
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
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