Blood bank refrigerators going strong

The number of units of blood collected has increased from 11.9 million in 2016-17 to 11.45 million in 2017-18. This trend, along with the focus on prevention of blood wastage, will certainly lead to increased demand for blood refrigeration units for proper storage.

As the world’s population grows each year, the need for blood components continues to escalate. Every two seconds, someone across the world needs blood. And one of the society’s most important priorities is to ensure that a safe, adequate supply of blood and blood products exists to meet this demand. There is no alternative product that can replace human blood, and the supply depends entirely on voluntary donations, which never fully meets demand. This supply constraint, coupled with the limited shelf-life of blood components, often make it difficult for blood centers across the world to establish stockpiles and maintain more than a few days’ supply to meet routine transfusion demands.

As per national data, India needs 8.5 million odd units annually as against some 5 to 5.5 million units that are collected. However, out of this, about 71 percent of whole blood (WB) and 10 percent of blood components are wasted annually due to various reasons cited as: over-collection and under-collection of blood from donors; RBC contamination of plasma and platelets; blood bag leakages; presence of hemolysis, clots, lipemic appearance, greenish and yellowish (icterus) discoloration; expiry date; and sero-reactivity for infectious diseases.

One of the major reasons for blood wastage has been the absence of maintaining the temperature of blood units during its shifting from the blood bank to the recipient department or on receiving it back at the blood bank owing to its non-utilization. There seems to be a lack of proper storage and handling facilities and qualified technicians at the hospital, and many of such units are destroyed by the blood bank because of reaching expiry date, which could have been given to those in need of blood.

Thus, high performance refrigeration plays a large role in storage. Units of WB and packed red blood cells (pRBC) must be stored at 2–6°C, for a maximum permitted period of 35 and 42 days, respectively. Maintaining this tight temperature band at all times is a critical requirement of blood bank cold chain. Below 2°C, the blood hemolysis and transfusing hemolyzed blood can cause renal failure and fatal bleeding problems and above 6°C blood is at the risk of bacterial contamination. Also, this precise cooling is required to maintain blood’s oxygen-carrying ability and to prevent red cell membrane rupture. Various blood-storage equipment are available in the market but these regular/conventional refrigerators and freezers are not equipped to store blood and its components.

Indian scenario
India has been undertaking transformational work to achieve Sustainable Development Goals (SDG) targets, including those under SDG 3 to ensure Good Health and Well-being for all. The National Health Policy 2017, too, takes into account universality, equity, and affordability as key principles for meeting India’s health targets. While the recently launched Ayushman Bharat aims to offer universal access to healthcare services, measures are still needed to standardize the nature and quality of health services across geographies and types of healthcare centers.

Like in any other reformative process, the foundation must be fortified first. Blood transfusions are a key life-saving intervention as per the World Health Organization (WHO), being an integral part of most medical procedures. While the National AIDS Control Organization (NACO) and National Blood Transfusion Council (NBTC) have made substantial strides in achieving the objectives of the National Blood Policy, 2002, there are still gaps to be addressed to improve transfusion services in the country.

Challenges of adequacy, availability, and delivery. Access to affordable, adequate, and safe blood and blood products becomes more important in Indian context as our blood requirement has heightened owing to a large burden of trauma, communicable and vector-borne diseases, and pregnancy-related complications.

The WHO estimates that blood donation by 1 percent of the population is generally the minimum needed to meet a country’s most basic blood requirements. Recently, India’s blood collection fell nearly 15 percent, or 1.9 million units short of this 1 percent benchmark. The WHO norm, however, is based on global averages and does not take into account India-specific factors and disease burden. Moreover, it is based on population need, assuming universal access to health services, while in reality the actual clinical demand of blood in healthcare facilities is lower.

Ideally, all blood need should be converted into clinical demand by ensuring access, enhancing infrastructure, and improving health-seeking behavior of the population. Even though India has adequate number of blood banks to cater to its population, these are unevenly spread across geographies. The gap between need and actual demand should instead be met by focusing on efficient functioning and service delivery as well as infrastructure development of existing facilities.
To improve access and availability without additional resource commitments, there is a scope for institutionalizing the partially centralized hub-and-spoke model, where a fully equipped centralized blood center can cater to multiple satellite blood banks or storage centers performing limited functions. Blood delivery within this model can further be strengthened through innovative technologies, and already some start-ups are exploring drone delivery.

It is imperative for national estimates to be updated periodically to accurately estimate need and demand, and compare these against blood utilization. NACO’s first Blood Requirement Estimation conducted in 2017 was a step in this direction; it pegged blood demand at 26.5 million units. To meet this demand, a ready pool of healthy low-risk donors needs to be maintained through promotion of voluntary non-remunerated blood donations. There is immense scope for mobilizing the private sector to encourage blood donation in fulfillment of their social responsibility.

Another means of ensuring adequate blood supply using the existing donor pool is by reducing dependence on whole blood. The WHO recommends a 90:10 ratio for use of blood components and whole blood (only limited clinical interventions require whole blood). Collection of blood components through apheresis or component separation after whole blood collections are means of inching closer to this ratio.

Ensuring blood safety through operational and technological initiatives. Major improvements will have to be made at blood-bank level, as many blood banks do not have proper standard operating procedures (SOPs), even though these are regulatory requirements. Recently, the NITI Aayog conducted a blood bank assessment in Sonbhadra, an aspirational district in Uttar Pradesh, and preliminary results show that focusing on rigid processes and commensurate training of staff can go a long way in improving blood safety.

Model donor selection and donor referral processes are also prescribed by the NBTC to reduce risk of transfusion-transmitted infections (TTIs), which endanger patient safety – between 2014 and 2017, 1.58 percent of the blood collected was discarded due to reactivity for TTIs. Logistical factors like expiry of components, or deterioration during storage, also contribute to wastage. The risk of infection and quantum of blood wastage can be reduced through maintenance of process integrity, and adoption of advanced, economically pragmatic technologies. NITI Aayog’s experience with disruptive technologies across sectors has been positive, and even in the blood space, promoting advanced screening like NAT and ELISA along with pathogen-reduction technologies can reduce the burden of TTIs.

In 2016, the ministry of health and family welfare launched e-Rakt Kosh, an ICT-enabled Blood Bank Management Information System that interconnects all blood banks in a state into a single network, and there is a scope to scale up its usage. For blood banks, it is a tool to standardize and streamline SOPs and workflow. Its citizen interface assists potential donors and patients, giving real-time information about nearest blood banks, donation camps, and blood availability including of a particular blood group.

India is on the right track to strengthen its existing blood transfusion system, but uniform implementation of policy guidelines, adoption of innovative technology, and collaboration between public and private sector are imperative in ensuring translation of policy objectives into action.

Global market
The global blood bank refrigerator market is expected to grow at a CAGR of 5.64 percent during 2018 to 2025, estimates Technavio. A key factor driving the growth of the market is the rise in number of road accidents and sports injuries. Road accidents and injuries sustained by individuals while playing sports are two of the major factors contributing to the rising number of surgeries that require the use of donor blood to replace the blood loss of patients. A steep rise in road accident injuries was witnesses in 2018, which clearly indicated the requirement of huge blood transfusions due to injuries sustained in accidents. This, in turn, will lead to the demand for blood bank refrigerators from hospitals, clinics, and blood banks to store blood and blood components.

Vendors in the market are striving hard to garner large shares by offering additional software and hardware products to end users. For instance, B Medical System offers Data Monitoring Network (DMN), which is a software for the collection, long-term data, and visualization of temperature data. It offers an integrated event and activity history of all appliance components as well as graphical visualization of all temperature curves.

The presence of software and hardware components makes it possible to cater to specific customer requirements and ensure the complete and safe documentation of temperature data, thus leading to increased adoption of blood bank refrigerators.

Vendors update
In August 2019, Helmer Scientific launched the Pro Line platelet incubators and agitators that offer optimized platelet storage and support blood bank compliance. They combine innovations in performance, reliability and efficiency to keep platelet supplies safe and ready to use.

In July 2019, LEC Medical launched the Control Plus – a new range of medical refrigeration that measures both the core temperature of the fridge, as well as the vaccine itself. Featuring an improved controller, larger internal capacities and a flat door to save valuable space in a busy medical environment, the Control Plus range is designed for a variety of locations, from pharmacies and hospitals, through to laboratories and general practice.

In January 2019, Follett LLC has chosen TechTrans to serve as its single-source partner to provide authorized installation services for the company’s high-performance refrigerators and freezers designed for the healthcare market. Under the agreement, TechTrans will provide nationwide transportation, delivery and installation services for Follett’s healthcare refrigeration products to hospitals, pharmacies, ER centers, family clinics, and other medical facilities.

Technological advances
Standards for blood banking have evolved with medical and technological advances. Blood banks, crucial in bringing life-saving benefits of transfusion to patients in need, are of key importance in medical logistics, ensuring the availability of safe and effective blood components in a timely manner. The easiest way to accomplish this is to have an appropriate inventory of products of optimal quality on the shelf at all times, and highly specialized refrigeration equipment is critical to achieve this. Because the required storage temperatures of blood products need to be maintained 24×7 and can be subjected to different variables (frequency of door openings, product load density, power outages, and changes in room temperature), the accuracy of the temperature control systems used in blood bank refrigerators and plasma freezers is crucial.

Microprocessor-based control is the most advanced, precise, and reliable technology for controlling and maintaining temperatures. The onboard monitor makes provisions for alarm conditions through both audio and visual indicators, tracking events such as open doors, temperature deviations, and power failures. Battery backup capabilities are also essential to ensure full alarm functionality in the event of a power failure. The recent integration of dual-cooling technology differs significantly from conventional cascade refrigeration technology in fundamental design and operation. In dual-cooling systems, the two independent refrigeration systems provide a reliable and exceptionally stable ultra-low temperature environment. In case of an unexpected failure of one cooling circuit, the other circuit will maintain the freezer in the preferred range, protecting samples until service can be arranged. This level of ultra-low temperature back-up cannot be achieved by conventional cascade systems.

As technology has evolved, so has the way users can monitor and interact with their precious cargo. High-performance blood bank refrigerators and plasma freezers are now compatible with external, wireless monitoring solutions. New systems are designed to monitor critical parameters, including temperature, relative humidity, CO2 concentration, and differential pressure. In the event of a power or mechanical failure, the wireless monitoring device instantaneously notifies users through audio/visual alarms, email, text message, telephone, and fax. All of the data that is being monitored is continuously recorded to meet various regulatory requirements.

New units are also available with embedded motherboards. Once integrated into a blood inventory and storage unit, the embedded motherboard performs the job of controlling, monitoring, comparing trends, and reporting temperatures to ensure smooth and reliable operation. These embedded motherboards can process large amounts of data, both rapidly and accurately. They can wirelessly transmit key data via their Wi-Fi or Ethernet features to provide control centers with crucial operational information, that is, real-time temperature monitoring, detailed supply of blood, alerts for any issues that may arise, reordering timing, and additional requirements. Some of these blood bank refrigeration units include user-friendly graphical displays, icons, and alarms to visually and audibly communicate the system’s status. For example, a green thermometer icon communicates that conditions are normal whereas a red flashing one would indicate that the temperature is too high. Audible and remote alarms are also available, enabling blood bank workers to promptly respond when a warning is triggered.

Outlook
Going forward, greater transparency and stronger regulations are needed for improved functioning of the blood banks. With the growth in blood donation in the country, the currently available blood bank refrigerators are conceptualized and designed to meet the challenging requirement of modern-day blood to efficiently conserve whole blood and its derivatives. NACO in collaboration with Government of India has been promoting voluntary blood donation. The number of units of blood collected has increased from 11.9 million in 2016-17 to 11.45 million in 2017-18. This trend, along with the focus on prevention of blood wastage, will certainly lead to increased demand for blood refrigeration units for proper storage.