Phased implementation of pathogen‐reduced platelets in a health system facilitates increased manufacturing at the blood center

Abstract

BACKGROUND: Pathogen reduction treatment (PRT) reduces the risk of transfusion-transmitted infections from established and emerging organisms. Manufacturing, however, is complex. In our university health system, we phased in pathogen-reduced platelets (PR PLTs) by patient population. We then assessed the implementation strategy and investigated factors in the supply chain that prevented us from meeting the goal of providing greater than 90% PR PLTs within 6 months. ABBREVIATIONS: BMT = bone marrow transplant; CMV = cytomegalovirus; FDA = US Food and Drug Administration; LIS = laboratory information system; PR PLTs = pathogen-reduced platelets; PRT = Pathogen reduction treatment; SOPs = standard operating procedures; UCSD = University of California San Diego. From the

Pathogen‐reduced platelets in pediatric and neonatal patients: Demographics, transfusion rates, and transfusion reactions

“…Currently, PR PLT are being transfused in variable and increasing proportions across the United States; 33, 34 however, the majority of the published studies are on adult hematology‐oncology patients. There remain limited data available on the experience of PR PLT transfusions in pediatric and neonatal patients 28 .…”

Inactivation of a broad spectrum of viruses and parasites by photochemical treatment of plasma and platelets using amotosalen and ultraviolet A light

“…It has been in routine use for more than 15 years, with blood centers in more than 30 countries producing more than 6,900,000 treated products worldwide. It is currently the only PRT for platelets approved by the US Food and Drug Administration (FDA) and several European regulatory agencies . Evaluated through numerous in vitro studies and extensive clinical trials, as well as through postmarketing surveillance, the system was shown to preserve the hemostatic properties of plasma and PC while inactivating high levels of a variety of pathogens .…”

Introducing new transfusion technology: the ethics of tiered transfusion safety

“…In this issue of TRANSFUSION , Allen et al describe a closely related ethical issue: two tiers of safety that developed in a university health care system during the phased introduction of pathogen‐reduced (PR) platelets. The process, from blood center to bedside, proved to be lengthy and complex, involving not only mastering the manufacturing technology, but modifying information systems, creating standard operating procedures, and educating staff and clinicians; it is worth reading about their experience for this reason alone.…”

“…Allen et al have outlined a reasonable process of allocation, which they describe as practical and ethical. They began a year before implementing PR platelets by obtaining approval (and funding) from the hospital quality council.…”

“…Blood centers and transfusion services have additional public health responsibilities beyond the individual patient, including the ethical challenge of providing equitable access to, and fair allocation of, limited national resources, often of varying safety profiles. The report of Allen et al serves to remind us that the introduction of new technology may be complicated by real or perceived tiered levels of safety and that these need to be addressed openly and honestly. There will be differing strategies for negotiating the ethical issues, and none is likely to be perfect.…”