Updated FDA guidelines and recommendations for controlling risk of bacterial contamination require shipping and distribution innovations
Ever since the FDA issued new guidelines and recommendations for “controlling the risk of bacterial contamination of room temperature stored platelets intended for transfusion” (Docket Number: FDA-2014-D-1814); shipping and distribution of platelets has become a major area of compliance for blood collection establishments and transfusion services blood distribution. A direct approach to comply with the FDA guidelines is the application of Pathogen Reduced Platelets (PRP), or Pathogen Reduction Technology (PRT), such as you would with the Cerus INTERCEPT® Blood System. However, the Cerus INTERCEPT® Blood System bags are larger than standard apheresis bags, propagating a change in the post-production and packaging process for PRP/PRT systems.
In a recent clinical study published in Transfusion journal (2020), Fadeyi et. al. reported a fatal septic reaction in a patient transfused with Pathogen-Reduced Platelets*. The study findings highlight a potential physical pressure-induced leak in the platelet bag which could have resulted in the post-processing environmental contamination.
One of the less commonly addressed contamination risks in blood center operation is in packaging. For instance, the commonly used platelet distribution boxes, such as Sonoco Thermosafe® E38 foam boxes, have a smaller inner dimension which leads to folding of the PRP/PRT Platelet bags, during packing. This may increase pressure near the fold or near the tubing causing potentially weaker points for rupture. Furthermore, standard cardboard shippers cannot be cleaned effectively, due to their porous surface retaining moisture, which quickly becomes a breeding ground for all types of bacterial growth**. Reusing these non-sterilizable, poor fitting, shipping boxes can significantly increase the risk of contamination during shipment***.
MaxQ worked with CERUS to develop and qualify an exclusive solution for the storage and distribution of PR Platelets produced using the Cerus INTERCEPT® Blood System. The MaxPlus Platelet Shipper is the new standard in ensuring platelet safety. These highly reusable systems come equipped with specialized phase change materials (PCM), high quality vacuum insulation, resulting in a turn-key solution that is 40% smaller than the current Sonoco Thermosafe® E38 foam boxes. All-season qualification of up to 30 hours, in safely transporting of 1-12 Cerus INTERCEPT® Blood System bags, make these the most cost-effective solution. The MaxPlus Platelet Shipper provides a 15-18% reduction in shipping costs. The MaxQ shipper is also qualified to ship other standard Platelet apheresis bags like Amicus, Trima, etc.
The MaxPlus Platelet Shipper is a sustainable solution for the FDA PR Platelet compliance requirement. Using the MaxPlus Platelet Shipper, Cerus INTERCEPT® Blood System bags can be shipped/stored flat, thereby eliminating potential pressure buildup inside the bag. Chemical and weather resistant plastic outer and inner liners are easy to clean and replace without the worry about moisture building up inside a porous surface.
This versatile system bolsters protection of platelets in post-production and handling environments, ensuring safe transport of platelets from donors to recipients. In addition, the MaxPlus Platelet shipper can naturally last for hundreds of courier and dozens of airline shipments, due to its impact resistant design, when compared to the standard cardboard shippers. The MaxPlus Platelet shippers arrive flat to help save storage space. Customer and operation specific branding (logos) can be added and pack-out instructions are included.
Streamline your blood center operations and save costs with the MaxPlus Platelet Shipper. View more information here, or reach out to us at sales@packmaxq.com. Our expert team is standing by to support you in any way possible.
References:
*Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion. United States, FDA, Center for Biologics Evaluation and Research. (2020, December). Retrieved February 24, 2021
**FDA Guidance for Bacterial Mitigation in Platelets. (n.d.). Retrieved February 24, 2021.
***Fatal sepsis associated with a storage container leak permitting platelet contamination with environmental bacteria after pathogen reduction. Transfusion. Fadeyi, Emmanuel A., et al. (2020).
