Why don't we get 7-day pathogen reduced platelets?

[Mabel Adams]

Latest issue of AABB News mentions that both LVDS and PR platelets have seven-day shelf-lives but ours from ARC are still 5.  Can someone explain how we can get 7-day PR platelets?  Is this an ARC problem? 

We really don't want to start using Verax on LVDS platelets because we hope that more improvements are coming to platelet dating soon.  Cold stored can be used only for bleeding patients so we couldn't always use them up, they must be on standing order only, and we are 4 hours' drive from our supplier for getting more RT plts.

[REN_NH]

 

Found this conclusion statement online from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11016247/

Chemical and Microbiological Changes of Expired Platelet Concentrate

Chemical and Microbiological Changes of Expired Platelet Concentrate

Nora Y Hakami, ¹ Abdulrahman M Al-Ahdal, ^{1 , 2} Afnan J Al-Sulami, ³ Httan M Alabbadi, ³ Mamdouh M Sindi, ⁴ Kholoud A Gholam, ³ Maiman M Bayuomi, ³ and Talal Qadah ¹

Author information Article notes Copyright and License information PMC Disclaimer

"Platelet concentrate, among other blood components, is considered an inventory management challenge due to its short shelf life. This study showed that extending platelet concentrate storage is possible for up to seven days without any chemical or microbial changes. Extending storage time for platelet concentrate will save money, increase availability, and save more patients. Further studies are required to evaluate platelet function during expiry time and to assess the stability of platelet morphology and function.

It is recommended that platelet concentrate storage time be extended to day seven after obtaining approval from the medical director in case of shortages or high demands. However, further studies must confirm these findings and determine the most effective strategies for improving platelet concentrate quality. Additionally, it would be ideal to investigate the clinical implications of these findings."

 

[jshepherd]

The 5 or 7 day shelf life of PR or LVDS platelets depends on the timing and method of how the bacterial sampling is being done. There were several options laid out by the FDA when the whole LVDS thing was implemented, and ARC chose to go with the 36 hour LVDS process, which did not allow for a 7 day platelet expiration, but only a 5 day. Other blood suppliers chose to perform LVDS at 48 hours, which will give you a 7 day expiration. It is an ARC problem. 

Verax is not FDA approved for PR platelets, so you can't use it to extend the expiration. We were doing Verax on our normal PAS platelets before the LVDS rule went into effect, and had to stop once ARC switched over to all PR. 

We recently brought in cold stored platelets from ARC. FDA says these are best for bleeding patients, but won't allow transfusion services to maintain a dual inventory and preferentially select CSPs over RT platelets based on the patient need. They say if all you have is CSPs, then they can be given to anyone who needs platelets. ARC supplies us from Omaha and St. Paul, and I am in Denver, so getting RT platelets here is feasible, and has been fine, but it's not practical as we have to get a shipment daily to maintain our inventory and keep platelets in house for trauma (Level 1 adult, level 2 peds center). We decreased our standing order of RT platelets to get CSPs in house, and we use the CSPs only when we are out of RT platelets - as the FDA has said is approved, but also to reduce the amount of platelets we are tossing due to short expiration.  

[Mabel Adams]

3 hours ago, jshepherd said:

We recently brought in cold stored platelets from ARC. FDA says these are best for bleeding patients, but won't allow transfusion services to maintain a dual inventory and preferentially select CSPs over RT platelets based on the patient need. They say if all you have is CSPs, then they can be given to anyone who needs platelets. ARC supplies us from Omaha and St. Paul, and I am in Denver, so getting RT platelets here is feasible, and has been fine, but it's not practical as we have to get a shipment daily to maintain our inventory and keep platelets in house for trauma (Level 1 adult, level 2 peds center). We decreased our standing order of RT platelets to get CSPs in house, and we use the CSPs only when we are out of RT platelets - as the FDA has said is approved, but also to reduce the amount of platelets we are tossing due to short expiration.  

We are considering CSPs but we are 4 hours from our supplier and can't predict whether use that day will be prophylactic or bleeding patients. Also, our ARC won't make CSP platelets for the near future so they will have to come Fed Ex with 10 days left on them. We are trying to gather data on our usage pattern for types of patients, but it is extremely variable week to week.  If anyone has a reasonable way to model this, please share!  ARC requires a standing order so we couldn't get more CSP if we used them until the next shipment.  

[Mabel Adams]

On 5/8/2024 at 10:27 AM, Mabel Adams said:

Latest issue of AABB News mentions that both LVDS and PR platelets have seven-day shelf-lives but ours from ARC are still 5.  Can someone explain how we can get 7-day PR platelets?  Is this an ARC problem? 

AABB Director of Regulatory Affairs answered my post on the AABB page saying that PR platelets in the US can't be 7 days and they will review the article.