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FDA Publishes New Guidance Document on Mitigating Bacterial Contamination in Platelet Components

30/10/2019

The FDA’s final guidance document on mitigating bacterial contamination in platelet components, released on September 30, 2019, formally recognises the risk of transfusion-transmitted bacterial infections and the need for additional safety measures to protect patients.

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The FDA guidance document describes several strategies which can be used to mitigate the sepsis risk associated with platelet transfusions, including pathogen inactivation (PI); Large Volume Delayed Sampling (LVDS); and various primary with secondary testing strategies, almost all of which require aerobic and anaerobic bottles1.

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What does the new standard mean for blood centres?

For blood centres currently using pathogen inactivation, no changes are required to meet the new FDA guideline. With PI, the procedures and products are already in compliance with the new standard. For blood centres using bacterial detection, compliance depends on the processes. The FDA guidance includes several bacterial detection options which, if implemented
according to the guidance, meet the minimum standard.

For blood centres where processes do not yet align with the FDA guidance, these are some aspects to consider in determining how to revise procedures and implement the required steps to meet the standard:

4-fold

The addition of anaerobic cultures may increase the rate of false positives as much as 4-fold, which may lead to increased wastage, increased reagent
consumption, and potentially more product re-calls

-16 ml

The 16 ml sampling of the final product may lead to a reduced platelet count in the product, which may need to be compensated by modifying donation specifications or component processing specifications

5-day

The sampling after 36 hours with a 12-hour hold to obtain a 5-day shelf life for the platelets leads to much older platelets being issued, contrary to the main objective of issuing fresh latelets as much as possible

+1 step

Secondary testing either via culture or secondary rapid testing can be operationally challenging and entail new processes, SOPs, etc.

INTERCEPT pathogen inactivation for platelets

With pathogen inactivation, these potential obstacles are eliminated. In addition, pathogen inactivation offers efficiency and quality improvements to blood centres, including:

  • Safer blood products. Approximately 2.3 million PCs
    have been manufactured worldwide (Cerus Corporation;
    unpublished data) without a reported septic fatality.2
  • Faster blood products. Depending on the
    availability of NAT results, pathogen-inactivated
    platelets may be available as soon as Day 1.
  • More differentiated blood products. With pathogen
    inactivation, blood centres are able to offer blood products
    that are free of bacteria, viruses, and pathogens.
  • More efficient blood products. By eliminating multistep
    tests and complex inventory management, blood
    centres can streamline operations and costs

FDA approved

Cerus’ INTERCEPTTM Blood System is currently the only FDA-approved pathogen-reduction technology to treat platelet components, and has been deployed at blood centres and major academic hospitals around the world,
including the American Red Cross. In fact, in an open letter3 to the healthcare community, published October 2019, Chris Hrouda, President of Biomedical Services at the American Red Cross, said: “Pathogen reduction is the preferred approach of the American Red Cross for enhancing the safety and availability of platelets for transfusion.”

The global leader in blood safety

When it comes to safeguarding the world’s blood supply, Cerus is leading the way with expertise and solutions that are changing the industry. To find out more about the INTERCEPTTM Blood System and the benefits of pathogen inactivation for your blood centre, contact our customers services by phone at +31 33 496 0600 or by email customer_services@cerus.com.

 

Reference:
1
“Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance

the Safety and Availability of Platelets for Transfusion ǀ Guidance for Industry,” U.S. Department of Health and
Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, September 2019
2 Benjamin et al, “Hemovigilance monitoring of platelet septic reactions with effective bacterial protection systems,”

Transfusion 2017 Dec;57(12):2946-2957, doi: 10.1111/trf.14284
3 Chris Hrouda, “Securing the future of the U.S, blood supply: an open letter to the health care community,” Oct. 2019, retrieved from https://www.redcrossblood.org/biomedical-services/hospitalcustomers/open-letter-to-the-u-s--health-care-community.html