June 26, 2014
Thanks to a recently approved FDA license, patients across the country in need of rare units of red blood cells may breathe a little sigh of relief. In late April, Gulf Coast Regional Blood Center became the first civilian organization licensed by the FDA to manufacture red blood cells using the Haemonetics ACP 215 Automated Cell Processor. This instrument is used to freeze and thaw rare units of red blood cells that aren’t commonly found in the general population.
For someone with rare blood traits that are only present in one in a million people, finding a matching unit can be a tricky waiting game - and sometimes patients can’t afford to wait. Red blood cell donations are good for 42 days when refrigerated and stored in a liquid state. Rare units, however, are frozen so they can be stored for 10 years and made quickly available when a rare patient need arises.
Usually an open system is used to freeze and thaw blood. When this method is used, the units expire 24 hours after being thawed, meaning there is very little time available to transfuse the units to the patient. The ACP 215, however, is a completely closed system. Units frozen and thawed on the ACP 215 are good for 14 days after being thawed.
“There have been times when a patient doesn’t get transfused within 24 hours, due to a variety of potential complications, so the unit has to be transfused to someone else or discarded,” Director of Technical Services Cheri Jennings said. “The ACP 215 allows us more time to use that special unit for someone who really needs it.”
The ACP 215 was originally developed for the U.S. Navy, which has been using it for years. Only a handful of civilian blood banks have one, and Gulf Coast Regional Blood Center is the first to apply for and receive a license from the FDA. The Blood Center has been using the ACP 215 since fall 2011 to provide units for patients in the Texas Gulf Coast region.
The FDA license opens up the door to send thawed units to blood centers across the American Rare Donor Program network, which uses a database to track and organize rare donor information. This means that if a rare unit from Houston was the only match for a patient in Seattle, the ACP 215 would allow time to thaw and ship the unit for patient use. While it is possible to ship frozen units, they are extremely fragile and can easily break before being thawed, leaving the patient stuck waiting for a one in a million unit to be found in their region.
Gulf Coast Regional Blood Center’s Consultation and Reference Laboratory processes approximately 1,400 units every month that vary in rarity from matching one in 1,000 people to one in a million. This spring, The Blood Center launched a new marketing campaign, One 2 One, designed to recruit rare donors in the Texas Gulf Coast region, with the goal of increasing the number of rare units donated and frozen for future patient use.
“We participate in the American Rare Donor Program, and people from across the country call us routinely for rare units. Because Houston is so diverse, we are fortunate to have a large supply of rare units,” Jennings said. “This will allow us to participate in that program more extensively and provide rare units to patients in need throughout the U.S.”