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Changes in Equipment for Processing Blood Donor Samples Issued

Changes in Equipment for Processing Blood Donor Samples Issued 2025

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The document outlines the FDA's policy changes regarding the use of automated equipment for processing blood donor samples, specifically ABO/Rh grouping and antibody screening tests. It states that licensed blood establishments can implement approved automated systems without prior specific approval from CBER, provided they follow manufacturer's directions and maintain proper documentation. The memo emphasizes the importance of on-site instrument qualification, parallel testing, and adherence to standard operating procedures to ensure blood safety and compliance during routine inspections.

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What is the new blood product?

New Blood Product Combining RBCs, Plasma Associated With Improved Survival After Trauma. A new blood product that combines red blood cells and plasma in one bag is associated with better survival from a penetrating major trauma injury compared to RBCs alone, new research suggests.

What is the new technology to draw blood samples?

Aletta, the worlds first Autonomous Robotic Phlebotomy Device (ARPD), is transforming blood collection with fully automated, AI-driven robotic precision. Using state-of-the-art Doppler ultrasound-guided imaging combined with robotic needle insertion, Aletta optimizes accuracy and safety for all patients.

What are the steps in collection and processing of blood after blood donation?

Each blood donation is broken down into its separate component parts using a centrifuge. Red blood cells, plasma, or platelets are extracted using specialised machines. All the different components are sent to their specific holding areas where they will be quarantined until all the required testing is completed.

How long must records of donor blood testing be legally retained?

Many blood bank records, such as donor history forms, must now be kept indefinitely due to the need to review the records in cases of possible transfusion-transmitted diseases.

What is the Blockchain for blood donation?

Blockchain can make data from that path visible, while protecting the security of private information. With this new system, when a donation occurs, the unit is scanned and all the related blood data is put on the blockchain (supported by the EY OpsChain platform).

What are the side effects of apheresis blood donation?

As with regular blood donations, apheresis is generally painless. Still, there may be some side effects, such as discomfort in the arm where the needle is inserted, lightheadedness, sweating, or a drop in blood pressure.

During which blood manufacturing process can constituents of the blood be returned to the donor?

RBC components can also be prepared by automated apheresis methods, which are continuous collection systems that remove blood from a donor, collect RBCs and return the remaining blood and plasma to the donor.

What is the new technology in blood donation?

The objective of using BlockChain Technology (BCT) in blood bank system is to ensure that the patient gets safe blood. This can be achieved by the different entities in the chain; verifying the quality / expiry of blood from the blockchain that provides the trust factor that is required.

Changes in Equipment for Processing Blood Donor Samples Issued 2025

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What is the new blood product?

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What are the steps in collection and processing of blood after blood donation?

How long must records of donor blood testing be legally retained?

What is the Blockchain for blood donation?

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People also ask

What are the side effects of apheresis blood donation?

During which blood manufacturing process can constituents of the blood be returned to the donor?

What is the new technology in blood donation?

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Changes in Equipment for Processing Blood Donor Samples Issued 2025

Here's how it works

The easiest way to modify Changes in Equipment for Processing Blood Donor Samples Issued in PDF format online

Complete this form in 5 minutes or less

Got questions?

What is the new blood product?

What is the new technology to draw blood samples?

What are the steps in collection and processing of blood after blood donation?

How long must records of donor blood testing be legally retained?

What is the Blockchain for blood donation?

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People also ask

What are the side effects of apheresis blood donation?

During which blood manufacturing process can constituents of the blood be returned to the donor?

What is the new technology in blood donation?

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