1. TRANSFUSION SAFETY AN INTERNATIONAL FLAVOR

2. RISK DATA – U.S. 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 Deaths/person yr Infection / tx unit * * 1996 data

3. Risks of Transfusions Acute hemolysis Allergic reactions Fluid overload Air embolus Acute infections Immediate or Delayed Immediate

4. Risks of Transfusions Late hemolytic transfusion reactions Infections: bacterial, hepatitis, HIV, malaria Serum sickness Post-tx purpura GVHD Immunologic impairment NK, abnormal T4:T8 Delayed

5. GLOBAL BLOOD SAFETY DATABASE 80% of world’s population lacks reliable and safe blood There is urgent need to ensure transfusion safety

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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 National Strategy for a safe blood supply

12. Testing Techniques ELISA vs RPHA (reverse passive hemagglutination) Hepatitis B core Ab* vs HBsAg Nucleic Acid Amplification (NAT)* *Reduce “window” The Indian Drugs and Cosmetics (1 st amendment) Rules, 1992(3)act: Each unit must be tested for HBV, HIV, syphilis and malaria by ELISA or RPHA

13. SOURCE OF BLOOD YearPaid %Volunteer %Total 199788.411.612,126 199883.516.519,165 199985.314.721,209 200084.115.923,238 200181.418.627,428 200282.117.925,423 Singh Jpn J Infect Dis 2004 (New Delhi)

14. Seropositivity rates Year HBsAg(%) Pd V T HCV Ab(%) Pd V T 19972.21.21.7n/a 19981.81.11.7n/a 19991.81.31.7n/a 20001.91.21.80.30.20.25 20011.81.01.71.10.30.9 20021.91.41.80.50.10.4 Pd=paid; V=volunteer; T=total Singh Jpn J Infect Dis 2004

15. 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

16. 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

17. Change from paid to volunteer donors Decreased transfusion associated hepatitis from 51% to 16% in Japan

18. 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