Implications of the US Food and Drug Administration draft guidance for mitigating septic reactions from platelet transfusions

Sachais, Bruce S.; Paradiso, Sarai; Strauss, D; Shaz, Beth H.

doi:10.1182/bloodadvances.2017008334

Cited by 10 publications

(7 citation statements)

References 26 publications

(24 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Further, a recent systematic review has suggested that transfusion of pathogen inactivated platelets increases transfusion requirements and the risk of developing platelet refractoriness , although there are also data to the contrary . Several multi‐centre studies (PREPAReS, EFFIPAP, MIPLATE) using the INTERCEPT and Mirasol systems are ongoing or recently completed, and it is anticipated that these data may assist in clarifying the efficacy of pathogen inactivated platelets . While the THERAFLEX system has not yet received regulatory approval for treatment of platelets, a phase I clinical trial of THERAFLEX‐treated platelets in healthy volunteers demonstrated that THERAFLEX‐treated platelets were cleared from circulation at a similar rate to untreated platelets, and did not cause any adverse reactions when transfused .…”

Section: Pathogen Inactivationmentioning

confidence: 99%

Refrigeration, cryopreservation and pathogen inactivation: an updated perspective on platelet storage conditions

et al. 2018

View full text Add to dashboard Cite

Conventional storage of platelet concentrates limits their shelf life to between 5 and 7 days due to the risk of bacterial proliferation and the development of the platelet storage lesion. Cold storage and cryopreservation of platelets may facilitate extension of the shelf life to weeks and years, and may also provide the benefit of being more haemostatically effective than conventionally stored platelets. Further, treatment of platelet concentrates with pathogen inactivation systems reduces bacterial contamination and provides a safeguard against the risk of emerging and re-emerging pathogens. While each of these alternative storage techniques is gaining traction individually, little work has been done to examine the effect of combining treatments in an effort to further improve product safety and minimize wastage. This review aims to discuss the benefits of alternative storage techniques and how they may be combined to alleviate the problems associated with conventional platelet storage.

show abstract

Section: Pathogen Inactivationmentioning

confidence: 99%

Refrigeration, cryopreservation and pathogen inactivation: an updated perspective on platelet storage conditions

et al. 2018

View full text Add to dashboard Cite

show abstract

“…As PRPs are available for distribution at 24 hours after collection, this may increase the platelet unitʼs overall shelf‐life and thus availability, thereby perhaps even decreasing the rate of outdate and wastage. Additional strategies that could improve the availability of PRPs include prompt availability of pre‐donation platelet counts and optimizing apheresis collections to meet platelet concentration and volume restrictions for PR treatment, also known as guard‐band limitations …”

Section: Resultsmentioning

confidence: 99%

“…Additional strategies that could improve the availability of PRPs include prompt availability of predonation platelet counts and optimizing apheresis collections to meet platelet concentration and volume restrictions for PR treatment, also known as guard-band limitations. 12 Concerns expressed regarding the use of PRPs include the potential need for maintaining a dual inventory of platelets due to supply limitations, decreased platelet count increments (PCIs), 13 risk of human leukocyte antigen (HLA) alloimmunization, 14 and the effect of psoralen on neonatal, pediatric, and obstetric patients. [15][16][17] Even with noninferior hemostatic function in hematology oncology patients, 18,19 decreased PCIs may result in increased platelet utilization and reduced platelet inventory.…”

Section: Pathogen Reduction (Pr)mentioning

confidence: 99%

How do you… decide which platelet bacterial risk mitigation strategy to select for your hospital‐based transfusion service?

Delaney

Flegel

et al. 2020

Transfusion

View full text Add to dashboard Cite

The United States Food and Drug Administration Final Guidance for Industry titled, “Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion” provides nine strategies for platelet bacterial risk mitigation. Even if it is assumed all strategies are comparable in terms of safety and efficacy, the decision of which to implement remains challenging. Some additional factors that warrant evaluation before selecting a strategy include the financial impact, process for implementation, logistics upon implementation, institutional acceptance by blood bank staff, administration and clinicians, and effect on platelet availability. To assist with this difficult choice, a panel of transfusion service physicians who have expertise on the topic and have already selected strategies for their transfusion services were recruited to provide varied perspectives. In addition, the use of a decision‐making tool that objectively evaluates defined criteria for assessment of the nine strategies is described.

show abstract

“…According to a US Food and Drug Administration (FDA) report, there are approximately 2·1 million PC transfusions annually, and 13 deaths due to bacterial contamination occurred from 2011 to 2015 . In 2016, the US FDA announced guidelines (draft) for mitigating of sepsis caused by platelet transfusions; they included methods for pathogen reduction and for point‐of‐care bacterial detection . In Japan, the shelf life of blood products is set shorter than in other countries .…”

Section: Discussionmentioning

confidence: 99%

Recipient sepsis caused by Lactococcus garvieae contamination of platelets from a donor with colon cancer

Nakamura¹,

Nakai²,

Sakata³

et al. 2018

Vox Sanguinis

View full text Add to dashboard Cite

Lactococcus garvieae is a well‐known fish pathogen that has low virulence in humans and is rarely isolated from the blood cultures of endocarditis patients. We describe herein the first reported case of transfusion‐transmitted L. garvieae sepsis caused by a contaminated platelet concentrate from a donor who consumed raw octopus before blood donation. Retrospective examination of the laboratory results of the index donor revealed that his haemoglobin levels had been steadily decreasing, which led to the detection of a latent colon cancer. The donors with colon lesions involving a latent cancer may relate an asymptomatic bacteremia.

show abstract

Implications of the US Food and Drug Administration draft guidance for mitigating septic reactions from platelet transfusions

Cited by 10 publications

References 26 publications

Refrigeration, cryopreservation and pathogen inactivation: an updated perspective on platelet storage conditions

Refrigeration, cryopreservation and pathogen inactivation: an updated perspective on platelet storage conditions

How do you… decide which platelet bacterial risk mitigation strategy to select for your hospital‐based transfusion service?

Recipient sepsis caused by Lactococcus garvieae contamination of platelets from a donor with colon cancer

Contact Info

Product

Resources

About