Amit Chopra, MD and VP/GM, India and Middle East, Thermo Fisher Scientific

Blood remains the mainstay of treatment for a wide range of medical conditions, which is why a well-organized and effective blood transfusion service is vital for the healthcare delivery system. From rising incidences of hematological disorders, increases in dengue epidemic, a rise of thalassemic children to additional reasons including fighting cancer and treating chronic disease and replacing blood lost in traumatic accidents; the blood stocks are barely adequate resulting in huge demand supply gaps. Various clinical initiatives, such as the development of less-invasive surgical technologies in operating theaters, and improved research and development of stem cells coming from cord blood, bone marrow or blood, also contribute to the upsurge for both the need and usage of blood and its components.

The blood banking scenario

India collects approximately 11 million blood units every year. A recently concluded assessment of licensed blood banks in India revealed that the average blood donation rate in India is 0.8, which is lower than many high-income countries leading to a shortfall in quantum and access to safe blood. Rational use of blood also needs to be ensured to enhance utilization, as one unit of blood can benefit more than one beneficiary through separation into its components and proper storage. Nowadays, most blood banks split the whole blood into its components to prevent transfusion associated circulatory overload (TACO) contributed by transfusion of extra plasma. This restriction makes the usage of whole blood transfusion less common among doctors who are insisting on transfusing blood components for treatment of diseases. This increasing preference toward usage of blood components has improved the demand for advanced blood component separating technologies. In developed markets like North America and Western Europe, there is sustained focus on the replacement of older blood bank equipment, driving the need to maintain proper storage conditions per regulatory and/or advisory committees. Conversely, in developing regions, blood banking operations are still focused on adopting good manufacturing processes to meet technical standards for equipment types and quality, such as increased traceability, data connection with equipment, validation and qualification, and cGMP compliance. Fortunately, procedures for blood processing and banking have improved substantially over the years, through centrifugation and cold storage innovations that enhance preservation of this precious resource, maximizing availability of quality blood and it components.

The blood banking process

Blood banking process includes the collection of blood, its separation into different cellular and plasma components, and storage of the resulting blood products under conditions that preserve function for its various applications. It also includes typing for transfusion (ABO group and Rh antigen) and testing for red blood cell antibodies and several infectious diseases, to reduce the risk of transfusion-related adverse events. This highly complex process is performed under specific standards to ensure transfusion efficacy of the resulting products. Most blood is collected as venous blood with an added preservative, or whole blood (WB), and is then separated by centrifugation into red blood cells, cryoprecipitated antihaemophilic factor (AHF), platelets and plasma, which can later be transfused to multiple patients with different needs. Whole blood and packed red blood cells require storage at 1°C-6°C, for a maximum period of 42 days. Blood plasma is processed into a variety of products that must be stored frozen at -18°C or lower.  One of the key blood banking challenges lies in the processing and storage of the donated blood, hence choice of suitable centrifugation and storage system for blood and components is of great importance.

Choice of centrifuges

Centrifugation is at the core of blood bank operations, with most laboratories needing to invest in more than one type of centrifuge. There are different considerations important to determine the type of centrifuges that best meet the needs of a laboratory. In 2016, the centrifugation-based separation accounted for the largest share of the global market primarily due to its wide usage among end users. The blood banks are dependent on consistent and accurate centrifuge operation to separate serum/plasma from cellular components. Plasma separation from raw whole blood is usually required for blood-based clinical diagnostics. Centrifuges, working on the principle of sedimentation, are being used widely for the separation of blood cells based on size and density into more manageable cell populations. Increasing government initiatives for R&D and increasing advancement in clinical and medical fields to develop access to better healthcare are playing a key role in the development of new-generation centrifuges. Large capacity centrifuges maximize the built-in features that simplify use, thus accommodating high demand and multiple users for increased productivity. This includes rotor management features that allow regulation of run parameters, enhancing consistent performance. Specialized rotors are available for high-throughput processing, or blood bag variations. The speed and dependency that modern centrifuges bring to the blood banks is an invaluable technology to integrate automation. Thermo Scientific Heraeus Cryofuge centrifuge series, have first of its kind centrifuges with processing capacity of 16 blood bags at a time, having user friendly designs, improved ergonomics with full GMP/GLP traceability and compliance. In addition to centrifugation, the company provides reliable blood bank solutions for sample preparation, blood testing, whole blood and component storage and research.

Cold storage

The viability of blood products requires storage within a specific temperature range at all times throughout their shelf life, and therefore accurate, stable and reliable cold storage equipment is paramount. Blood bank refrigerators and plasma freezers must adhere to cGMP, and exhibit specialized technical features for temperature stability, control and monitoring.

Conclusion

While the health sector in India has made outstanding accomplishments in the past few decades, it has not reciprocated sufficiently to fulfill the country's objective on blood-transfusion facilities. Although National Blood Policy of India acknowledges this grave situation and has proposed an increase in its blood storage facility, its translation into reality is still a distant dream. There is the need to transform the present state-of-affairs to the necessary state-of-the-art in terms of blood storage facilities. For more than 30 years, Thermo Fisher Scientific has supplied its range of centrifuges for blood component separation to leading independent, government and charitable blood banks, private and government hospitals, and government and private medical institutions across India, and more recently in Sri Lanka, Bangladesh, Nepal, Bhutan and the Maldives. The company has also been involved with India’s AIDS Control program and has collaborated with the National AIDS Control Organization to upgrade the nation’s blood processing and testing facilities with updated centrifuges to help provide safe blood components for transfusion to patients across the country.

Despite the current advances in healthcare delivery, access to safe blood and blood products and their judicious use remains a challenge. Considering the deleterious effect of poor quality practices on patient care, it is imperative that specific programs and strategies to improve quality systems are developed and implemented across the country. There exists tremendous scope in India to cater to healthcare needs of its ever-growing population, improve the quality of life for its citizens, and fight against various seasonal outbreaks of dengue to ensure availability of safe blood component in the near future.

 


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