Insights: A Cerus Leadership Blog

Are You Ready to Meet the FDA’s Platelet Safety Guidance Deadline?

(October 2020) Likely not since World War II have the topics of blood and blood components had greater awareness in our public discourse. Lately, our news feeds are saturated with hematology-centric headlines reminding the general public that the safety and availability of blood are essential. This is, of course, a world that our community lives and breathes every day. Despite the background noise, there is little awareness of one of the most relevant blood safety directives in years: the FDA’s bacterial contamination guidance for platelets.

With five months before the Guidance for Industry on Bacterial Risk Control Strategies for Platelets takes effect, our team is struck by the overwhelming support from the industry on the treat vs. test paradigm. Innovation that realizes a new foundational strategy for blood safety seems to be a unanimous theme in our conversations.

Fortunately, pathogen reduction (PR) offers just such a transformational approach to blood safety. Today, PR is the only FDA guidance option that reduces transfusion-transmission infection risk beyond bacteria, with the ability to inactivate viruses, protozoans, and white blood cells. PR can also serve as an alternative to certain tests and donor deferrals, thereby helping to expand the donor pool. This last point is especially relevant in light of the current and future pandemic-related challenges to securing sufficient blood donors. It also underscores the nationwide need for supply chain security.

The Road to Compliance

Recognizing the long-term value of PR for the stability of the blood supply, many of the major blood centers in the U.S. are moving ahead with the broad roll-out of the INTERCEPT Blood System. This includes the American Red Cross (ARC), which is well advanced in its changeover plan to a complete PR platelet inventory. The largest provider of platelets in the U.S., the ARC has spoken publicly about their desire to ensure a consistent, readily available inventory at scale. In preparation for guidance, the ARC is directing all customers to begin updating their IT systems now to accommodate INTERCEPT-treated platelets.

Operational Efficiencies Realized

We continue to offer our support to all U.S. blood centers and hospitals in their decision making around their future platelet supply strategy in light of the final FDA bacterial contamination guidance. Over the last year, our commercial team has partnered with hundreds of blood centers and hospital transfusion services on the implementation of INTERCEPT. As a result, we have seen improved operational efficiencies from customers who can now offer a simple, streamlined, ready-to-transfuse solution while realizing cost offsets and reduced logistical complexity. The benefits of improved product shelf-life and reduced product expiry have generated real savings as a result of PR implementation for platelets. We encourage you to connect with us if you have questions or concerns around the distinct needs your site may face.

Preparing for the Next Pandemic

While the SARS-Cov-2 virus does not appear to be transfusion-transmitted, the theoretical risk of transfusion-transmission cannot be excluded, as highlighted in the June 2020 editorial in TRANSFUSION. (Katz, 2020; 60; 1111-1114). This pandemic brings to light the susceptibility of our blood supply, demonstrating the need to have a proactive safety measure in place to address future threats.

Fortunately, some of the most strategic minds in our industry are already tackling this topic and the known gaps in the current testing based paradigm. For example, Dr. Susan Stramer, vice president of scientific research at the ARC, recently offered insights into the fragility of the U.S. blood supply because of emerging pathogens. She also highlighted the tools needed by blood centers and hospitals to mitigate risk now and going forward, which includes pathogen reduction. You can hear the full podcast discussion here.

Risk Reduction Beyond Bacteria

As our community works together over the coming months to meet the guidance, we remain committed to ensuring hospitals and blood centers understand the full spectrum of benefits related to the implementation of our INTERCEPT Blood System. If you have not familiarized yourself with our technology or our implementation process, here are a few pieces that offer insights: 

• Brochure: “Was it the Platelets?”
• White Paper: “Why Pathogen Reduction – Use of Pathogen Reduced Platelets for Patient Safety and Sustainability?”
• Yale-New Haven Hospital Case Study: “Logistical Management of Incorporating Pathogen Reduced Platelets into Inventory”

Our team is here to help, so please reach out to GuidanceQuestions@cerus.com if we can provide you more information on pathogen reduction, the INTERCEPT Blood System, and how we might help you to implement guidance at your hospital or blood center.

About Vivek Jayaraman
Vivek is a member of the Executive Leadership Team. As Chief Operating Officer, he oversees commercial operations, supply chain, customer service, and manufacturing operations at Cerus. Previously, he served as the company’s chief commercial officer from August 2016 to March 2020.