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FDA Draft Guidance: Bacteria Risk Control Strategies for Blood Collection Establishments and Transfusion Services

This article reviews the significant elements of the FDA Draft Guidance on bacteria risk control strategies for blood collection establishments and transfusion services to enhance the safety and availability of platelets for transfusion. It discusses the challenges for implementing suggested process changes and how the Final Guidance may appear after public comments have been submitted.

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FDA Draft Guidance: Bacteria Risk Control Strategies for Blood Collection Establishments and Transfusion Services

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  1. Catherine A. Mazzei, MD Medical Director American Red Cross 6230 Claremont Ave. Oakland, CA  94618 (510) 594-5265 catherine.mazzei@redcross.org

  2. I have no relevant financialrelationships to disclose

  3. FDA Draft Guidance: Bacteria Risk Control Strategies For Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion

  4. Objectives Review the significant elements of the Draft Guidance Identify the challenges for implementing suggested process changes Discuss how the Final Guidance may appear after public comments have been submitted

  5. Current Risk Rates • Acute hemolytic transfusion reactions: 1: 40,000 (reaction) to 1: 600,000 (death) • TRALI: 1: 12,000 transfusions • Bacterial Contamination: 1: 2,000 to 1: 3,000 platelets 1: 38,565 RBCs • Sepsis, Apheresis Platelets: 1:100,000 • Allergic: 13-33% of all reactions • Anaphylaxis: 1500,000 transfusions

  6. Transfusion Fatalities Reported to the FDA, 2010-2014 US DHS Annual Report, 2014

  7. Evolution of Bacterial Risk Control Strategies Visual inspection Surrogate tests Culture based tests

  8. Strategies in 2003 Avoidance  Reduction  Inhibition *  Inactivation *  Detection * Not available then

  9. Strategies Now Avoidance  Reduction  Inhibition *  Inactivation  Detection * Not available

  10. Section 1 Subsection

  11. FDA Draft Guidance • “Considering the increased rates of transfusion-related septic reactions and fatalities associated with transfusion of day 4 and day 5 stored platelets, and after considering the outcome of performing a rapid bacterial detection test on the day of transfusion, the FDA Blood Products Advisory Committee (BPAC or Committee) recommended in September 2012 testing of day 4 and day 5 stored platelets with a rapid test prior to transfusion even when a primary culture-based test performed on day 1 was negative.”

  12. After 24 hours, 8mL of platelet component is tested for bacteria >95% recovery in 24 h. >98% within 72 h. Test continues for entire life of platelet (4 more days) Red Cross Current Process(Bacterial Detection)

  13. Potential Impact of Revised FDA Guidance on Bacterial Detection (Draft guidance document issued March 14, 2016) BloodCenter Hospital 1 2 3 4 5 6 Day 0 7 CURRENT PRACTICE TODAY – bacterial screening at blood center; possible point-of-release testing to extend to 7 days HOSPITAL InitialCulture Draw BLOOD CENTER 12 hr hold Sample @ ~24 hr Initial culture at the blood center only

  14. FDA Recommendations to Transfusion Services A. Apheresis platelets that have been treated by pathogen reduction at the blood collection center require no further measures. B. Apheresis Platelets and Pre-Storage Pooled Platelets Previously Tested Using a Culture-Based Test We recommend implementing secondary testing of previously cultured apheresis platelets and pre-storage pooled platelets to enhance platelet safety through day 5 of storage as described below: 1. On the day of transfusion, perform rapid testing on day 4 or day 5 platelets using a device cleared by FDA. Consistent with the instructions for use of the FDA-cleared rapid bacterial detection device, rapid testing of apheresis platelets is conducted within 24 hours prior to transfusion; or, 2. Culture on day 4, using a device cleared by FDA, and release as follows: a. If the instructions for use of the bacterial detection device specify a minimal incubation period, release the platelet product consistent with the incubation period specified in the instructions for use of the bacterial detection device. b. If the instructions for use of the bacterial detection device do not specify a minimal incubation period, release the platelet product at least 12 hours after sampling if the establishment has in place measures to promptly alert the receiving establishments receiving in the event that a distributed platelet product is subsequently identified as positive for bacterial contamination. c. If you wish to release the platelet product during the incubation period of the culture, we recommend performing a test using an FDA-cleared rapid bacterial detection device prior to release, and within 24 hours prior to transfusion.

  15. FDA Recommendations to Transfusion Services Transfusion Services using plateletspreviously tested using a culture-based test: • Test on Day 4 or Day 5 with an FDA approved rapid test or Culture on Day 4 • Testing with a method designated as a “safety measure” by FDA that allows extension of dating for 24 hours • Includes extending shelf-life to 7 days • Verax Platelet PGD test is the only approved “safety measure”

  16. Release Testing of Platelets • Verax Biomedical Platelet PGD • Bacterial contamination rate after testing (culture): 1 in 2,302 • Bacterial contamination rate after release testing: 1 in 9,206

  17. Potential Impact of Revised FDA Guidance on Bacterial Detection (Draft guidance document issued March 14, 2016) BloodCenter Hospital 1 2 3 4 5 6 Day 0 7 CURRENT PRACTICE TODAY – bacterial screening at blood center; possible point-of-release testing to extend to 7 days HOSPITAL DRAFT FDA GUIDANCE – bacterial screening for platelets both early and late in storage InitialCulture InitialCulture Draw Draw BLOOD CENTER 12 hr hold Sample @ ~24 hr Sample @ ≥24 hr 12 hr hold Initial culture at the blood center only Initial culture at the blood center... ...secondary testing, probably at hospital, starting on day 4. PATHOGEN REDUCTION – comments submitted on draft guidance urge replacement of bacterial screening Draw Treat@ ≤24 hr PRT apheresis platelets “…require no further measures” up to day 5. Future: seek new claim for extended storage Treat on Day 0

  18. Pathogen Reduction Technologies for Platelets • Amotosalen plus UVA • Intercept by Cerus • Riboflavin plus UV • Mirasol by Terumo • UVC • Theraflex by Macopharma

  19. Amotosalen

  20. Pathogen Inactivation

  21. INTERCEPT’s Broad Spectrum of Pathogen Inactivation Routinely tested agents ENVELOPED VIRUSES SPIROCHETESTreponema pallidumBorrelia burgdorferi Bifidobacterium adolescentis* Propionibacterium acnes* Clostridium perfringens (vegetative)* Lactobacillus species* GRAM-NEGATIVE BACTERIA HIV-1HIV-2*DHBV (HBV model virus)BVDV (VCV model virus)HTVL-IHTLV-II Klebsiella pneumoniae Escherichia coli* Serratia marcescens* Pseudomonas aeruginosa* Salmonella choleriaesuis* Enterobacter cloacae*Yersinia enterocolitica*Anaplasma phagocytophilum^ ENVELOPED VIRUSES HIV-1HIV-2HBVHCVHTVL-IHTLV-II PROTOZOAN PARASITES Trypanosoma cruziPlasmodium falciparumBabesia microti Leishmania mexicana* WNV CMV*Chikungunya Dengue*Influenza A LEUKOCYTEST-cells GRAM-POSITIVE BACTERIA Staphylococcus epidermidis Staphylococcus aereus* Listeria monocytogenes* Corynebacterium minutissimum* Streptococcus pyogenes* Bacillus cereus vegetative)* Bacillus cereus (spore forming)* NON-ENVELOPED VIRUSES SPIROCHETES Bluetongue virus Calicivirus*Parvovirus B19^Adenovirus Treponema pallidum * Platelets package insert only ^ Plasma package insert only

  22. INTERCEPT Blood System, Platelets, Package Insert, March 2016. • Aubry M. et al. Transfusion. 2016 Jan;56(1):33-40. (Zika in Plasma)

  23. Objectives • Review the significant elements of the Draft Guidance • Identify the challenges for implementing suggested process changes • Discuss how the Final Guidance may appear after public comments have been submitted

  24. Thank You! Catherine A. Mazzei, MD (510) 594-5265 (p) catherine.mazzei@redcross.org

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