Pathogen reduction technology system for safer blood transfusions
Various safety measures are taken for blood products to prevent infections caused by bacteria, viruses, and other pathogens as well as side effects from transfused white blood cells. Currently, however, no method of testing or pathogen reduction can completely eliminate the risk of a transfusion-transmitted infection (TTI). In middle- and lowincome countries, blood donors have more infections than in high-income countries.*1 In fact, sub-Saharan Africa has the highest rate of HIV and malaria infection in the world, so reducing the risk of infection from blood transfusion is an important medical issue. In a survey conducted in the Republic of Ghana, TTIs from malaria are estimated to occur in up to 28% of blood donation recipients.*2
To improve this situation and others like it, the Terumo Group partnered with Japan International Cooperation Agency (JICA) and since 2017 has been conducting a program through public–private partnership for preventing disease transmission through blood transfusions in the Republic of Ghana.*3 Using the Mirasol Pathogen Reduction Technology (PRT) system developed by Terumo’s Blood Management Company (Terumo BCT), Terumo is working with the Ministry of Health and the National Blood Service, Ghana, to promote the routine use of the Mirasol PRT system for whole blood. A total of four Mirasol devices have been installed in the National Blood Service blood banks in both of Ghana’s main cities, Accra and Kumasi. After the pathogen reduction process, transfusions are given to the most vulnerable patients, including postpartum hemorrhage patients as well as child and adult oncology patients. A haemovigilance system to monitor safety of blood transfusions is also being implemented to accumulate data acquired throughout the entire process, from blood donation through preparation to the post-transfusion condition of the patient.*4 This will enable the analyses and assessments needed to keep adverse events from occurring.
Mirasol uses UV light and riboflavin (vitamin B2) to inactivate a broad range of pathogens, including bacteria, viruses such as HIV, parasites such as malaria, and white blood cells in blood products, reducing the risks of disease transmission and side effects from blood transfusions. It received the CE mark for platelets in 2007 and for plasma in 2008, and it is now sold in more than 20 countries, mainly in Europe, the Middle East, and Africa. Unlike in high-income nations, patients in middle- and low-income countries often receive transfusion of whole blood, rather than blood components. Therefore, Terumo sought the possibility of using Mirasol for whole blood. In 2014, the African Investigation of the Mirasol System (AIMS) clinical trial performed in Ghana was the first and only clinical trial to demonstrate that a pathogen reduction technology, specifically Mirasol, can effectively reduce the incidence of TTI of a bloodborne pathogen. The results of the AIMS trial were presented at the 2015 congress of the AABB (formally known as the American Association of Blood Banks) and were also featured in the medical journal The Lancet. That same year, Mirasol received the CE mark for whole blood treatment, marking the availability of the first and only PRT treatment for whole blood.
Training the local staff is essential for the smooth implementation of the PRT process and implementation of a haemovigilance program. In addition to the training performed in Ghana, Terumo also enlisted cooperation from the Japanese Red Cross Society to invite doctors and nurses from hospitals and the National Blood Service in Ghana to Japan. They were given training in haemovigilance as well as tours of blood collection and processing centers and hospitals. The visiting dignitaries were also given a tour of the Terumo comprehensive medical training facility, Terumo Medical Pranex. During this visit, there were opportunities to share, discuss, and exchange opinions on how Terumo may be able to further contribute to societal and healthcare development in Africa. These efforts are supported by the global collective strengths of Terumo, with associates from the Head Office, Terumo BCT, Inc., and Terumo Europe NV going beyond the boundaries of organizations and regions to cooperate and coordinate the ongoing activities.
This public–private partnership project with JICA will conclude in December 2018, but the Terumo Group will continue working to ensure the routine use of Mirasol in Ghana. Beyond this, Terumo also plans to use the experience and expertise gained from this project to help develop the infrastructure for an adequate, safe, and sustainable blood supply in Africa.
Source: Global Status Report on Blood Safety and Availability, World Health Organization, 2016
Source: Freimanis G, et al., “Investigating the Prevalence of Transfusion Transmission of Plasmodium within a Hyperendemic Blood Donation System,” Transfusion 2013; 53 (7): 1429–1441
Terumo applied and was selected for “Collaboration Program with the Private Sector for Disseminating Japanese Technology for the Social and Economic Development of Developing Countries” by JICA and has been conducting this program on an outsourced basis from JICA.
For haemovigilance, AABB Consulting Services, an affiliate of AABB (formerly the American Association of Blood Banks), is contracted to formulate and conduct facility assessment and implementation training programs as well as auditing and feedback.
Pathogen Reduction Process for Whole Blood Using Mirasol® PRT System
AIMS clinical trial being performed in Ghana
Mirasol® PRT system used in Ghana
Comment from Komfo Anokye Teaching Hospital
Dr. Shirley Owusu-Ofori
Head of Transfusion Medicine
Komfo Anokye Teaching Hospital
The Mirasol system would act as a major leap from our current status of blood safety with a high residual risk. It would afford a safer blood supply because it reduces bacteria, viruses, and parasites, and we do have quite a large number of these pathogens in our blood. Mirasol also inactivates white blood cells so it would afford the recipients less reactions in terms of transfusion adverse events.