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Current Safeguards for Blood Products Recommended by FDA

Current Safeguards for Blood Products Recommended by FDA. TSE Advisory Committee October 14, 2004 Dorothy Scott, M.D. DH/OBRR/CBER/FDA. Donor Deferrals for [classical] CJD . Diagnosis of CJD Receipt of human pituitary growth hormone injections Dura mater transplant Family history of CJD

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Current Safeguards for Blood Products Recommended by FDA

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  1. Current Safeguards for Blood Products Recommended by FDA TSE Advisory Committee October 14, 2004 Dorothy Scott, M.D. DH/OBRR/CBER/FDA

  2. Donor Deferrals for [classical] CJD • Diagnosis of CJD • Receipt of human pituitary growth hormone injections • Dura mater transplant • Family history of CJD • Blood components withdrawn if post-donation finding that donor has CJD

  3. Donor Deferrals for vCJD Risk • Diagnosis of vCJD • BSE exposure risk: Products • Receipt of transfusion in the U.K. 1980-present • Injection bovine insulin (U.K. source) 1980-present • BSE exposure risk: Geographic • Travel/residence in certain countries with BSE • Exposure to British beef on military bases in Europe

  4. Geographic Donor Deferrals (Risk of BSE Exposure) • > 3 months residence in U.K. 1980 - 1996 • > 5 years France 1980 - present (vCJD cases; 5-10 % British beef consumption) • > 6 months on certain military bases 1980 – 1996 (up to 35% British beef consumption)

  5. Geographic Donor Deferrals (Risk of BSE Exposure) • 5 years residence/travel Europe, 1980 – present (blood components for transfusion only) • Model TSE agents partitioned/removed during plasma fractionation (published studies) • European risk of vCJD low (small BSE epidemic relative to U.K.) • Magnitude of risk reduction achieved by fractionation in general greater than that achievable by donor deferral • Effects on nationwide/worldwide plasma supplies uncertain, but potentially severe

  6. Implementation Geographic Donor Deferrals • Concerns about blood and plasma supply • addressed by: • Surveys/estimates of risk/benefit prior to • recommendations • - Phased implementation of donor deferrals • Blood supply monitoring (by blood suppliers, • HHS) • Recommendation to perform pilot studies if • more stringent deferrals undertaken

  7. Product Disposition: Post-Donation Discovery of Risk Factor or Disease • vCJD diagnosis – all products, including plasma derivatives, are withdrawn • CJD diagnosis – all components and unpooled plasma withdrawn • Risk factors for CJD, vCJD – all components and unpooled plasma withdrawn

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