pH Value Proposition
BCSI’s pH BUSINESS’ RAISON d’ ÊTRE
BCSI asks, “If your loved one’s life depended on quality platelet therapy, would you prefer they receive a bag of platelets where the pH had been monitored through the supply chain and you were assured the levels never dropped below 6.2-6.4, or would you prefer a bag where pH had never been measured?”
Read on!
Platelet therapy is used to reduce the risk of bleeding in high risk patients such as those receiving chemotherapy, patients who have suffered severe trauma from incidences like car accidents and soldiers wounded in battle.
It is well known the FDA, the US military healthcare systems, regulatory agencies globally, and the blood bank industry worldwide, use pH monitoring as a marker for quality, viability and effectiveness of platelets. It is well documented that platelets whose pH levels fall below 6.2-6.4 loose most, if not all of their coagulation benefits (Ref deKorte et al, Dijkstra-Tiekstra et al, Dumont et al (BEST))
pH declines in a bag of platelets due to the normal processes of the platelets metabolizing the nutrients in the bag, pH declines as the environment becomes more acidic and effects platelet quality, viability and function. Time, donor, conditions during storage and transport can be a cause of the environment becoming more acidic. Additionally, there is emerging evidence in the literature which demonstrates when certain bacteria are present in platelet bags there is a measureable change in the pH levels of the platelets. It has been shown to cause pH to drop, sometimes below 6.2-6.4 within 36-48 hours after very low contamination. It is not unusual for the pH level to recover above 6.2-6.4 as the bacteria count increases over days 2 through 5 of storage. (Ref Montag et al 2007, Montag et al 2008, Barker et al)
pH monitoring is accepted as a quality control for platelets (See role of pH in platelet therapy below and related literature sources). In fact, the FDA mandates pH to be measured per their following directive:
Quality Control: As defined in 21 CFR 640.25 (b)(1-3), four collections per month prepared from different donors shall be tested at the end of the storage period for platelet count, pH, and actual plasma volume. FDA has interpreted that this requirement be applied across all possible production strata (machine type, site, product type). When this QC requirement is applied, it results in a large QC workload, and may also require that a substantial number of components be held for testing making them temporarily unavailable for distribution. At the same time, a small number of samples in each stratum limits the power of testing to detect process deviations.
Practically, this means the FDA requires that 1% (or 4 bags whichever is greater) of platelet bags collected have their pH measured after the platelets have expired. (After 5 days of storage).
In the U.S., there are two generally accepted ways to measure pH - pH Meters and Blood Gas Analyzers. There are blood banks who use these methods to monitor pH prior to transfusion and at different points along the supply chain. So, it is possible to receive platelets that have been quality controlled for pH changes through out the supply chain, in the U.S. and other markets not using the pH1000.
However, as noted in the above FDA Quality Control statement, current methods for doing these QC tests “results in a large QC workload…” The release of platelets for transfusion is therefore statistical and individual bags used for transfusion may not be 100% quality controlled. Once the pH1000 is approved, BCSI feels our benefits of being an easy to use, non invasive method for monitoring pH levels in platelet bags will create value above and beyond the currently approved US methods. (It will be easy to QC 100% of the bags in the system).
The pH1000 System is an easy to use, non-invasive method for measuring pH levels in platelet bags. The pH1000 System, where approved, allows the blood bank industry and clinicians to provide pH monitoring throughout the supply chain to ensure pH levels have stayed in the therapeutic range throughout the supply chain.
In markets where the pH1000 has yet to be approved, BCSI recommends measuring pH, using a pH meter, at least once daily until the bag is infused or discarded.
BCSI’s competitive advantages are ease of use and non invasive.
In the event the pH levels have dropped below the therapeutic range for whatever reason, the chances of the platelets being effective are significantly reduced.
The question is, “If your loved one’s life depended on quality platelet therapy, would you prefer they receive a bag of platelets where the pH had been monitored through the supply chain and you were assured the levels never dropped below 6.2-6.4, or would you prefer a bag where pH had never been measured?”
Read more about “Why is pH important”.
THE ROLE OF pH IN PLATELET THERAPY
