Nurse inspecting blood bag with platelets

How to Comply with FDA Guidance on Bacterial Risk Controls for Platelets

Nurse holding a blood bag with platelets

According to the FDA, October 2021 is the deadline to introduce bacterial risk control strategy to increase platelet safety and availability*.

Are you equipped to deal with this shift?  

Cerus’ INTERCEPT® blood systems are the front-runners in pathogen-reduced platelet storage. Proper conduct for shipping INTERCEPT platelet bags is the following**:

  • “Inspect the final storage containers for any scrapes or leaks. If a leak is detected, follow instructions in General Product Handling.
  • Routinely disinfect shipping containers per institutional procedure and schedule.
  • Remove clamps from containers prior to packing.
  • If using an overwrap, ensure the size is adequate for the amount of containers shipped. Overwrap should be single use only.
  • Pack containers to avoid friction or pressure points.
    • Place tie tags flat against the container and near the end flap.
    • Flat placement within the shipping container is preferred with ports alternating with the stack.
    • If the bag must be folded to fit within the shipping container, fold at the bottom not at the ports.
  • Avoid excessive compression on contents. when packing the shipping container.
  • Consider acquiring shipping containers that best fit the size of the INTERCEPT® final storage containers.”

These instructions would normally be easy to follow, but INTERCEPT® bags are longer than the standard apheresis bags. This leads to a breach of their recommended conduct because you may have to fold bags to make them fit in your old shipping containers, resulting in increased pressure on the bag heat seals at the folds and a potential rupture.

MaxPlus Platelet Shipper Closed Front Exterior View with 4 Provided Coolant BottlesMaxQ Research has developed a shipper specifically for these bags. The MaxPlus Platelet Shipper is purposefully designed to meet Cerus’s recommended storage guidelines. Developed with direct input from Cerus, the container is sized to ensure the bags lay flat without folding. The shipper is made from polypropylene corrugated plastic, which allows for a fast and easy cleaning process. Cerus recommends the MaxPlus Platelet Shipper as the primary option for shipping their bags. In addition, the shipper can also hold standard platelet apheresis bags, providing your centers with the much needed operational flexibility to support distribution of mixed platelet inventory.

The MaxPlus Platelet shipper can store up to 12 INTERCEPT® bags (depending on the draw amount per bag) compared to the industry standard eight. This extra space comes at no additional weight or storage space, as our shippers are actually smaller and lighter than the industry standard E38 shippers. The optimal dimensional weight lowers shipping and packaging costs per unit of platelet shipped. Our Platelet shipper is just one solution of our many made to help address the challenges of the blood supply chain.

References:

*Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion: Guidance for Industry. US FDA; Dec 2020.

**INTERCEPT® Blood System for Platelets: Blood Center Handling Recommendations