Last fall, I said that a Food and Drug Administration Guidance on detection of bacteria in platelets was expected, and we got a draft in December. ABC’s Scientific, Medical, and Technical (SMT) group has spent the interval assembling comments on the guidance to submit to FDA. There is a strong sense that FDA’s approach in the draft is complex enough that the incentive of possibly extending platelet dating is inadequate to promote the critical intervention for sepsis mitigation, i.e. voluntary secondary bacterial testing with rapid assays or culture-based methods. ABC is asking that FDA reconsider and mandate the use of secondary testing in the transfusion service. Moreover, we propose simpler alternative strategies that would improve patient safety and allow extended platelet dating. For example, delaying primary culture until later in storage combined with the use of larger inocula in our culture systems will reduce the risk of bacterial contamination, while extending platelet storage to seven days without secondary testing. Such approaches are not perfect, but represent progress and would balance operational burdens and consumption of resources with a more flexible inventory. Going forward, we would be responsible for conducting surveillance to assess their impact and amending our approaches, when appropriate, based on the data.
A week after issuing the draft guidance, the agency approved the first pathogen reduction (PR) system for platelets. Good news: it will make primary and secondary bacterial testing unnecessary – hemovigilance data emerging from the European Union suggests that PR approaches 100 percent effectiveness in preventing bacterial sepsis from platelets. Less good news: I estimate its cost at$50-75 per platelet dose, there are no resources committed for its use, and a mandate for platelet PR has only minority support among the ABC members. Accordingly, we have asked the agency to clarify issues that will affect decisions about its implementation. Can FDA estimate the relative impact on platelet sepsis of the measures in the guidance vs. the use of PR? Is the agency willing and able to support risk and healthcare economic evaluations of the alternatives available to reduce platelet-associated sepsis – particularly in the more global context of competing patient safety priorities – both in and outside of transfusion medicine? Does FDA have an approach to relax or discontinue existing donor infectious disease screening measures that may become unnecessary with the use of PR (which would partially offset the costs of the process)?
ABC submitted comments on March 9, but FDA will still accept yours. The agency’s response will provide an interesting look at how the feds respond to calls for value-based healthcare.
Louis Katz, MD, Chief Medical Officer, lkatz@americasblood.org