How do we implement Day 6 and Day 7 platelets at a hospital-based transfusion service?

Area of Science:

• Blood banking and transfusion medicine
• Regulatory affairs in healthcare
• Microbiology and infectious diseases

Background:

• Current regulations focus on blood component safety, purity, and potency.
• Evolving regulations address risks like bacterial contamination in platelets (PLTs).
• Recent updates mandate bacterial control and donor notification for PLTs.

Purpose of the Study:

• To describe the implementation of extended platelet (PLT) dating up to 7 days.
• To detail the process changes required for adopting new FDA guidance and technologies.
• To share experiences as early adopters of this practice change in a hospital transfusion service.

Main Methods:

• Updating Food and Drug Administration (FDA) registration.
• Modifying supplier agreements.
• Implementing changes in laboratory information systems and transfusion processes.
• Utilizing FDA-cleared storage containers and bacterial detection devices.

Main Results:

• Successful implementation of a process to support Day 6 and Day 7 PLTs.
• Demonstration of a feasible approach for hospital transfusion services to extend PLT shelf life.
• Ensured compliance with updated regulatory requirements for bacterial contamination control.

Conclusions:

• Extended PLT dating to 7 days is achievable with new technologies and regulatory compliance.
• This practice enhances the safety and availability of platelet products.
• The described implementation process serves as a model for other transfusion services.