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AN INTERNATIONAL FLAVOR. TRANSFUSION SAFETY. Motor cycling 1:50 20 Cigarettes/d 1:200 Hit by car 1:20,000 BC pills 1:50,000 Earthquake 1:600,000 (IRS audit 1:100) (Lottery 1:4 million). HBV 1:63,000 HCV 1:103,000 HTLV 1:250,000
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AN INTERNATIONAL FLAVOR TRANSFUSION SAFETY
Motor cycling 1:50 20 Cigarettes/d 1:200 Hit by car 1:20,000 BC pills 1:50,000 Earthquake 1:600,000 (IRS audit 1:100) (Lottery 1:4 million) HBV 1:63,000 HCV 1:103,000 HTLV 1:250,000 Sepsis 1:500,00 HIV 1:676,000 RISK DATA – U.S. Deaths/person yr Infection / tx unit * * 1996 data
Risks of Transfusions Immediate or Delayed • Acute hemolysis • Allergic reactions • Fluid overload • Air embolus • Acute infections Immediate
Risks of Transfusions Delayed • Late hemolytic transfusion reactions • Infections: bacterial, hepatitis, HIV, malaria • Serum sickness • Post-tx purpura • GVHD • Immunologic impairment NK, abnormal T4:T8
GLOBAL BLOOD SAFETY DATABASE • 80% of world’s population lacks reliable and safe blood • There is urgent need to ensure transfusion safety
GLOBAL BLOOD SAFETY DATABASE • 43% of blood used in developing countries is NOT tested for tx transmissible infections (HIV, HCV, HBV, Syphilis, Chagas) • Globally, 5-10% of HIV infections are caused by unsafe blood and blood products.
GLOBAL BLOOD SAFETY DATABASE • Bld tx may account for up to 15% of HIV transmission in developing countries • Only 66% of developing and 46% of the least developed countries screen for HIV (testing can double the cost of a unit) • The private sector is driven by commercial interests, and both public and private programs rely on high-risk paid donors given a shortage of voluntary donors
WHO Strategies to reduce the risk of tx transmission of HIV (1989) • Promote voluntary, unpaid, low risk blood donors • Develop national HIV screening policies with simple, rapid, reliable tests and proper QA • National advisory committees
WHO Strategies to reduce the risk of tx transmission of HIV (1989) • Enlist political, religious, and cultural leaders for public support • Limit clinical use of blood • Define a simple blood-banking package of equipment, consumables, data-handling capacity, and human skills needed for blood banks in major hospital centers
Other Measures • Voluntary donation - a public responsibility • MDs have responsibility for safe tx • Adapt guidelines to local needs • Use more autologous tx and blood salvage • Do cost-benefit analyses • Monitor implementation of blood safety legislation • Use an independent authority for monitoring
National Strategy for a safe blood supply • Screen all collections for tx-transmissible infections, using effective assays • Training- screening, processing • Maintain QA and good SOP • Compatibility test always even if post tx • Use a central system for supply, distribution of reagents • Use a COLD chain for storage, transport
Testing Techniques • ELISA vs RPHA (reverse passive hemagglutination) • Hepatitis B core Ab* vs HBsAg • Nucleic Acid Amplification (NAT)* The Indian Drugs and Cosmetics (1st amendment) Rules, 1992(3)act: Each unit must be tested for HBV, HIV, syphilis and malaria by ELISA or RPHA *Reduce “window”
SOURCE OF BLOOD Singh Jpn J Infect Dis 2004 (New Delhi)
Seropositivity rates Pd=paid; V=volunteer; T=totalSingh Jpn J Infect Dis 2004
Markers of Transfusion transmissible diseases 1996 to 2002 in India • Volunteers increased from 47% to 56% • HIV seropositivity increased from 0.16% to 0.3% • HBsAg decreased from 1.55% to 0.99% • VDRL – no trend (0.11-0.66%) • HCV testing from June 2001-Dec 2002, prevalence of 0.4% • All markers significantly lower in volunteers, lowest in students Sharma :Natl Med J India 2004, PGI Chandigarh
Indian Survey Results, 1996 • 78 of 604 (13%) blood banks returned surveys • 58% of units were from paid donors • 95% of blood banks tested for HIV • 87% for Hepatitis B(13% used ELISA) • 67% for malaria • 6% for HCV Kapoor, Indian J Gastroenterol, 2000
Change from paid to volunteer donors Decreased transfusion associated hepatitis from 51% to 16% in Japan
Appropriateness of Tx • Blood Centers from Delhi, Nasik, Bangalore, Imphal surveyed • N=1062 transfusions • 87% were adult recipients • At ages 25-34, 73% were female • Indications: anemia 60%, surgery 42%, acute bleed 26%, pregnancy 16% • IDA, volume replacement – misuse ? Bray: transf med 2003