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Biomedical Refrigerators and Freezers

Adoption of New Technologies

Technological advances in blood bank refrigerators and freezers have led to the introduction of new products with improved monitoring, tracking, and safety features.

Despite the current advances in technology in healthcare delivery, access to safe blood and blood products, and their judicious use remains a big challenge. According to the World Health Organization (WHO) around 50,000 hospitals provide blood transfusion serving a population of around 4 billion (based on 130 countries). There is a stark difference between developed and developing nations as less than half of hospitals in developing nations provide blood transfusion services. Around 93 million blood units are donated annually, and 50 percent of them are collected in developed countries which are home to only 16 percent of world’s population.

While the health sector in India has made outstanding accomplishments in the past few decades, it has not reciprocated sufficiently to fulfil the country’s objective on blood transfusion facilities. The Indian blood transfusion network is plagued by inadequacy of blood storage centers, dominance of private sector over public sectors, lack of proper facilities, storage, and quality of services etc. Grave situation of blood collection, storage, and utilization in India can be judged from a basic indicator of maternal health, wherein one-third of maternal deaths occur due to shortage of blood transfusion. Although National Blood Policy of India acknowledges this grave situation and has proposed an increase in blood storage facility, its translation into reality is still a distant dream.

On a daily basis, blood banks witness a huge inflow of blood units from blood donation and outflow to hospitals and research centers, thereby necessitating the need for proper preservation and trackable storage solutions. Blood banks and facilities that work with blood products need to use specialized refrigeration units to remain compliant with the law and maintain high storage standards for patient safety. One of the major concerns with storing blood products is the narrow range of acceptable storage temperatures necessary. If blood gets too warm or too cold, it may be spoiled, or there could be concerns about its integrity that would make it inadvisable to transfuse. Blood bank refrigerators thus have to have very carefully control temperatures, and use tight vacuum seals and fans to maintain the temperature within a narrow range.

Technological advances in blood bank refrigerators and freezers have led to the introduction of new products that will improve the monitoring and tracking of blood products, thereby reducing medical errors. Even small and medium-scale vendors have enhanced their product offerings in terms of technology to meet standards set by governing bodies and the fast-changing requirements of end-users. Current systems in the market include monitoring equipment to regularly check and report temperatures. They may also have security measures like locking doors to protect the integrity of the contents. Locks may open with keys or number pads, depending on design and the level of access control needed.

Refrigeration units come in a range of sizes for different applications and can be custom built if necessary. In addition, they may include rapid recovery systems to equalize the temperature when the door is opened and closed. For safety, some blood bank refrigerator equipments sound an alarm or send a signal to a monitoring room when the temperature exceeds the safe range. Logs can be stored in digital format to generate a record showing that the facility’s fridges have been maintained in the proper range. Sliding shelves and trays are also rounded so as to not puncture bags of blood products, and may include grips with antibacterial plastic coatings to keep the interior clean. Blood bank freezers are also available for plasma, which can be frozen for storage and thawed when it is needed. The best option can depend on the type and volume of blood products handled in a facility.

The Indian Market
Although there is an increasing trend regarding the number of blood banks in India over the years, the point of concern is the pace of increment. Another concern is the blood banks in the public sector. Whatever increase in a number of blood storage facilities India has witnessed, it was mostly because of private sectors. Growth in the government sector is too slow paced. The Union health ministry is now coming up with 79 new blood banks in different states, Uttar Pradesh, J&K, Chhattisgarh, and Andhra Pradesh, to address the shortfall. Over the past two years, the ministry has proposed 1135 government blood banks in the country and planned to operationalize 780 blood banks, out of which 300 blood banks could be made fully operational.

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, as of July 2017, there are a total of 2903 blood banks in the country indicating less than three blood banks for every 10 lakh people. There are 81 districts in the country, spread across 14 states/UTs, which do not have a single blood bank. 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.

Wastage of the collected blood has been consistently more than 10 percent in the country. While there seem to be no global markers for such wastage, India has a fairly high rate of wastage especially when the collection is less than the requirement. According to National Aids Control Organization (NACO), more than one million units of collected blood have been discarded each year since past five years because of poor storage and management practices. 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. 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 nonutilization.

Lack of linkage between peripheral health facilities with central level blood banks is also one of the reasons for blood wastage. 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 through linking of district blood banks with peripheral health institutions. Keeping this in mind, the health ministry has launched the e-RaktKosh initiative, an integrated Blood Bank Management Information System (MIS). This web-based mechanism interconnects all the blood banks of the state into a single network. It is also able to assemble heterogeneous data into legible reports to support decision making from effective donor screening to optimal blood dissemination in the field. The Integrated Blood Bank MIS refers to the acquisition, validation, storage, and circulation of various live data and information electronically regarding blood donation and transfusion service.

Global Market Dynamics
The global blood bank refrigerators market is expected to reach USD 990 million by 2019 growing at a CAGR of over 5 percent over the next three years. 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 have favored the sustainable growth of the global blood refrigerator and freezer market in the past few years. With the evolution of modern healthcare systems, increase in life expectancy, and a higher incidence of diseases, the need for whole blood and blood derivatives is growing. Also, the evolution of medical practices and increased sophistication of surgical and medical procedures have intensified the need for the availability of blood on standby. This has increased the demand for blood transfusions and blood products. This increase in demand, will, in turn, propel growth in the global blood refrigerator and freezer market over the next few years.

In the years to come, stringent emission regulation norms and rising awareness about the harms of greenhouse gases emitted from refrigeration systems to the environment will compel product manufacturers to design greener products. Companies are surely coming to terms with the several changes aimed at fortifying this switchover, such as worldwide bans on refrigerants like hydrofluorocarbons (HFCs). As a result, more green refrigerators and freezers will enter the industry in the next few years.

The global market consists of different international, regional, and local vendors. The market competition is foreseen to increase with the rise in technological innovation and M&A activities in the future. Moreover, many local and regional vendors are offering specific application products for varied end-users. The new vendor entrants in the market are finding it hard to compete with the international vendors based on quality, reliability, and innovations in technology. Key vendors in the global market include Helmer Scientific, HaierMedical, Eppendorf AG, Panasonic Healthcare, Thermo Fisher, Panasonic Biomedical, Lorne Laboratories Limited, VWR Corporation, Arctiko A/S, and Sanyo.

Technology Trends
As technology has evolved, so has the way users can monitor and interact with their precious cargo. Because the required storage temperatures of blood products need to be maintained 247 and can be subjected to different variables, the accuracy of the temperature control systems used in blood bank refrigerators and plasma freezers is crucial. High-performance refrigerators and freezers are compatible with external, wireless monitoring solutions and are energy efficient. Nowadays, blood bank refrigerators and freezers have evolved to become more than just safe cold storage devices.

RFID. The refrigeration units are now equipped with RFID (radio frequency identification) technology. RFID blood refrigerators and freezers are used to read blood donor labels and their contents, track on-hand inventory, and track when items have been removed or added. These RFID systems can transmit their data wirelessly to control stations for review and analysis. A network of blood banks can now track which of their locations can provide enough blood quickly during an emergency.

Wireless monitoring. The current available refrigeration 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.

Temperature monitoring and alarm safety. As blood storage efficiency is subject to a range of variables such as power failure, the frequency of inventory load, door openings, and changes in room temperature. This has created an opportunity for services like real-time information, data management, and remote access to data through mobile and other devices. Recent introduction of externalmonitoring helps monitor temperature, humidity, and differential pressure in real-time.

Microprocessor-based control is the most advanced, precise, and reliable technology for controlling and maintaining temperatures. Multi air-flow plenum system ensures outstanding temperature uniformity in larger capacity models. Defrost cycles can now run automatically during low use periods by programming the actual time desired in the systems.

Environment friendly. Clinicians working across blood banking and transfusion applications can now reduce the environmental footprint of their operations by selecting certified energy-efficient refrigerators that have received the US Environmental Protection Agency (EPA) Energy Star standards. The EPA recently finalized the first Energy Star specifications for laboratory refrigerators to help facilities identify products that can reduce energy utilization and lifetime costs related to this critical category of equipment.

The high-performance blood bank refrigerators are powered by technologies designed to provide temperature uniformity to continually detect and adapt to user patterns, offering significant energy savings without compromising performance.

Road Ahead
Every drop of blood is a precious resource. The challenges to overcome hindrances and wastage may be through unification of blood transfusion services to maintain the standard or duplication of services, focus on quality of service provided, adoption of newer technologies, strengthening of reporting and information system to maintain the inventory, emphasis on equitable distribution blood and blood products, and many more. Choosing high performance products, like the technology currently available in cold storage equipment, is a critical step in maintaining the blood supply. New refrigeration technology incorporating features like precise temperature performance, continuous monitoring solutions, and data logging capabilities are critical for blood banks to deliver blood products in their most potent form to patients in need.

Going forward, greater transparency and stronger regulation are needed for improved functioning of the blood banks. The e-RaktKosh portal envisaged to provide real-time information of blood availability is a step in the right direction. The portal has to be expanded to ensure real-time and accurate availability of information. The rules governing the operation of the blood banks were also modified recently to allow transfer of blood between registered blood banks to avoid wastage. Detailed guidelines have also been issued in this regard.

With the growth in blood donation in the country, the currently available blood bank refrigerator 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 9.94 million in 2013–2014 to 10.9 million in 2015–2016. This growth trend will further lead to increased demand for blood refrigeration units for proper storage.

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