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Biomedical Refrigerators and Freezers

Challenges Aplenty, While Opportunities Abound

India needs to transform to the necessary state-of-the-art blood storage facilities.

As the Indian population grows each year, the need for blood continues to escalate. And one of the most important priorities is to ensure that a safe, adequate supply of blood and blood products exists to meet increasing demand. Despite substantial development in the field of medicine, effective substitutes of blood and blood products have not been developed. Blood remains the mainstay of treatment for a wide range of medical conditions, and therefore a well-organized and effective blood transfusion service is vital for the healthcare delivery system. Access to safe blood and blood products and their judicious use remains a big challenge across the world.

Indian Market Dynamics
National Aids Control Organization (NACO) has been over the years releasing data over wasted blood. IT insists that over Rs. 28 lakh units of blood have been discarded by hospitals and blood banks in India during the last 5 years because of poor storage and management practices. In 2016-17 alone, over 6.57 lakh units of blood and its products were discarded. Maharashtra, Uttar Pradesh, Karnataka, and Tamil Nadu were among the worst offenders, discarding not just whole blood but even red blood cells and plasma as the life-saving components could not be used before their expiry date. Maharashtra, which is the only state to have crossed the one-million mark vis-a-vis collection of blood units, also accounted for the maximum wastage of whole blood, followed by West Bengal and Andhra Pradesh. Maharashtra, UP, and Karnataka were the top three offenders in the wastage of red blood cells. UP and Karnataka also wasted the maximum units of fresh frozen plasma.

One of the major reasons for blood wastage has been the absence of maintaining the required temperature of blood units during their 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 hospitals. Many of the blood units are destroyed by blood banks after their expiry date. This blood could have been given to the needy patients before its expiry. Thus high-performance refrigeration plays a large role in storage. There is a dire need to transform to the necessary state-of-the-art blood storage facilities.

National Blood Policy of India acknowledges this grave situation and has proposed an increase in blood storage facilities. The health ministry has also set guidelines to ensure appropriate storage of blood, according to which each district in the country must have at least one blood bank. However, a 2016 assessment of Indian blood banks shows that 87 districts have no blood banks. In addition, there are more than 6000 facilities such as district hospitals (DH), sub-divisional hospitals (SDH), community health centers (CHC) present across India excluding medical colleges, and more than 80 percent of these lack blood bank refrigerators/freezers to properly store blood.

Global Market Dynamics
The global blood bank refrigerators and freezers market was valuedat USD 972 million in 2016 and is expected to witness a robust 4.3 percent CAGR from 2016 to 2024, predicts Global Market Insights.

The steady rise in the number of blood banks in developing and developed regions, combined with government initiatives aimed at raising awareness about blood donation, will favor sustainable growth of the market over the years. And the rising government expenditure, growing number of surgical procedures, and increasing demand for blood are expected to boost the market further.

Integration is the key to advancement in technology in this market. Companies that offer the latest integrated technologies at an affordable cost are expected to thrive. The dominating technologies in the market along with the upcoming technologies are expected to revolutionize the market. Some of the global key players include Thermo Fisher Scientific Inc., Haier Biomedical, Eppendorf AG, Helmer Scientific, and VWR Corporation.

Need for Advanced Cooling Systems
Large-scale blood product storage presents unique refrigeration challenges that require a great deal of expertise in system design. Customized refrigeration solutions engineered specifically for blood storage applications are necessary in order to meet the application’s demands. For example, cooling equipment must achieve extremely low temperatures and maintain these temperatures steadily in order to comply with regulatory requirements and avoid contaminating this very high-value product. Additionally, blood storage refrigeration systems must use safe refrigerants, be designed for maximum reliability and redundancy, and be easy to maintain.

Plasma freezers. Centers for Disease Control (CDC) guidelines state that blood plasma, for example, can be stored for up to 3–7 years at a consistent –35 to –40F. These extremely low temperatures must be maintained constantly, even during maintenance. The systems, therefore, must be designed with components capable of operation in such extreme temperatures.

Refrigerants. Beyond temperature requirements, blood products are also very sensitive to chemical damage and contamination. As a result, refrigeration systems for these applications require the use of refrigerants that are unlikely to leak and cause damage. The refrigerant, therefore, must be deemed safe for use in medical cooling systems. The extremely low-temperature demands of blood plasma and other blood product storage must also be considered during refrigerant selection since many refrigerants cannot flow well at such low temperatures.

Reliability. In many other refrigeration applications, cooling systems are designed as a single, large, central unit. This is not a good choice for blood product storage as small maintenance issues can lead to large-scale product loss. Dividing the cooling among a number of smaller compressors is a far more suitable design for blood storage applications. In doing so, system designers significantly reduce the overall impact of a single compressor losing efficacy or failing entirely.

Redundancy. Full redundancy is ideal in blood plasma and other blood product storage applications. Fully redundant systems allow for maintenance to take place as necessary, without concerns over system failure. Systems with a number of smaller compressors are easier and less expensive to make fully redundant than large, single-unit systems. In addition, this reduces overall maintenance demands and makes it easier for end users to perform necessary maintenance. As a result, the system can be restored to functionality quickly in the event of most issues.

Customization. The demands for blood product storage are too great, and ultimately too application-specific, to support the use of off-the-shelf refrigeration technology. To guarantee success, blood product storage refrigeration systems should be custom-designed, with individual components custom-selected and sized to sustain the necessary low temperatures, avoid contamination and product loss, and simplify maintenance.

Road Ahead
Essential functions of a national blood system include framing the national policy, functional planning, setting standards, resource management, and cooperation between different national agencies to ensure safe blood and blood products and safe transfusion. In the past decade, a few credible steps have been taken to improve the quality of blood transfusion services like National Accreditation Board for Hospitals and Healthcare Providers accreditation program exclusively for blood banks (run by Quality Council of India), National Hemovigilance Program for continuous data collection and analysis of transfusion-related adverse reactions, etc. Such steps with the strengthening of existing blood banks and creation of new facilities keeping in mind equity and accessibility will help India to successfully achieve the intended goal.

The ever-increasing population and government initiatives in healthcare combined with growing blood donors will further increase the demand for blood bank refrigerators and freezers in coming years. This provides manufacturers with a large base for expansion and offers opportunity to launch technologically advanced products with superior quality.

Second Opinion

Trends in Biomedical Refrigerators and Freezers

Dr Amita Raoot
OD-Blood Bank,
Lal Bahadur Shastri Hospital, Delhi

Refrigeration is a vital element for a large number of clinical and biological research applications. The need for meticulous refrigeration and freezing has been highest in laboratories handling blood, blood products enzymes, DNA, tissue samples, and laboratories involved in human reproductive technology. According to a report by Global Market Insight, blood banks dominated the biomedical refrigerators and freezers market share with over 38 percent revenue for the year 2015. It is estimated to show further vigorous rise. The second-largest revenue-generating segment for biomedical refrigerators and freezers market has been the hospital sector, followed by pharmacies and diagnostic centers.

The presence of multiple large well-established and upcoming new small vendors as well as local and international manufacturers providing equipment both at high purchase costs and cheaper refurbished equipment makes the global biomedical refrigerators and freezers market quite uneven, and at the same time makes the industry highly competitive in terms of introducing innovative and technologically sophisticated equipment at more affordable rates. Some renowned names that have dominated the market by their global presence include Thermo Fisher Scientific, Helmer Scientific, Haier Biomedical, Terumo Corporation Aegis Scientific, Eppendorf, Philipp Kirsch, Leibherr Group, and Panasonic Healthcare. The increasing global competition makes it imperative for manufacturers to provide unique and advanced technological features in their products and ensure distinctive functionality and services.

In order to ensure preservation specific to the cellular type of any given tissue, the new emerging trends are novel ways to control the cooling curve to achieve what is known as controlled-rate cooling. Biomedical scientists and refrigeration engineers are collaborating to develop state-of-the-art refrigeration systems to meet critical need for precise temperature control as well as robust monitoring mechanisms. There is also a persistent need to update the alarm and monitoring systems to allow more accurate temperature management and controlling even minor temperature fluctuations that can adversely affect the preservation process. Computerized monitoring system that can control several refrigeration units at once allowing monitoring of temperature both on real-time and historic temperature and generating alarm as needed is emerging as the new technological trend.

Ever-increasing demand for blood transfusion, organ transplant, technological augmentation through greater focus on R&D, biopharmaceuticals, and cellular therapies along with increase in the number of blood banks and upgradation of research laboratories, hospitals, diagnostic centers, and educational institutes is bound to show pronounced influence both in terms of innovative technological advancement and increase in global market for biomedical refrigerators and freezers in the years to come.


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