All clinical laboratories require refrigerators and freezers in addition to analyzers and equipment in order to operate and meet regulatory requirements. As the sophistication of refrigeration devices has grown significantly in the past 15 years, most clinical labs and hospital facilities use medical-grade refrigeration in order to ensure the integrity of sensitive controls and reagents, as well as vaccines, blood and blood products, and other patient specimens.

In order to produce accurate test results, all reagents, controls, and samples must be stored within the manufacturers' recommended temperature ranges. Likewise, the storage of blood products requires sensitive and reliable temperature control mechanisms that not only control and maintain uniform temperature, but also have visual indicators and data recorders to document that proper storage conditions are being maintained over time.

Whether the refrigeration devices used in the lab and throughout the facility have built-in temperature monitoring and remote notification, or the lab or facility utilizes a third-party system for this activity, it is important to incorporate a system that provides alarming notifications if the devices go out of temperature range. The performance of refrigeration units cannot be physically monitored at all times, so in order to ensure these devices continue to function properly in perpetuity, a continuous monitoring system should be in place. Accreditation and regulatory bodies require such documentation as well.

The type or size of the refrigerator selected (e.g., full size or under-counter; single or double-door) and physical placement within the lab will be unique to the needs and layout of each lab, but consideration should be given to efficient user access and proper segregation of products and specimens.

As with any technology acquisition, it is important to find the best refrigeration type and configuration unique to the individual lab. With this in mind, the lab should determine its core needs and then incorporate and arrange the devices accordingly. For a small lab with limited space, having a greater number of smaller, under-counter units may be preferable to fewer upright units. For larger labs with more space flexibility, the opposite may be true. Regardless, all clinical labs that utilize refrigerated products should seek to acquire medical-grade devices in order to ensure product and specimen integrity.

Global Market

The global market for biomedical refrigerators and freezers was valued at USD 2.91 billion in 2015. The market is expected to expand at a 4.21 percent CAGR over the period between 2016 and 2024, and rise to a valuation of USD 4.28 billion by 2024.

The global market has a handful of regional players and only a few international companies, reports Transparency Market Research. Though regional players command power in their respective countries, giving stiff competition to global ventures with their economical offerings, the market witnessed the dominance of three international companies in 2015 - Thermo-Fisher Scientific, Inc., Panasonic Healthcare Co. Ltd., and Eppendorf AG. Collectively, these international giants accounted for nearly 60 percent of the global market. Other aggressive brands include Haier Biomedical, Helmer Scientific, VWR Corporation, ARCTIKO A/S, Biomedical Solutions Inc., EVERmed S.R.L., and Philipp Kirsch GmbH.

Samples having biomedical origin require specific conditions for effective storage. Therefore, governments across the world recommend use of biomedical refrigerators and freezers for storage of biological samples/units. Biomedical refrigerators and freezers are widely used in blood banks, hospitals, pharmacy stores, research laboratories, and diagnostic centers.

Increasing demand for blood transfusions, personalized medicine, cellular therapies, organ transplant, and vaccines is the primary factor fueling the demand for biomedical refrigerators and freezers across the world. Additionally, rising research and development activities in the field of life science and biotechnology are propelling the uptake of biomedical refrigerators and freezers in research institutes. On the other hand, presence of a large number of local players, offering products cheaper than branded products coupled with rising trend of using refurbished equipment, is restraining the growth of the global biomedical refrigerators and freezers market.

In 2015, the blood bank refrigerators segment accounted for the largest share of the global biomedical refrigerators and freezers market. The blood bank refrigerators segment is majorly driven by a steady rise in the number of blood banks in developing and developed regions. According to the Central Drugs Standard Control Organization (India), there were approximately 2545 registered blood banks in India and the number is expected to reach more than 3000 in the next five to ten years. Thus, rising number of blood banks would contribute to market growth. The laboratory/pharmacy/medical freezers segment is anticipated to expand at the fastest growth rate over the next six years. The rising number of medical facilities and diagnostic centers due to growing prevalence of chronic diseases is anticipated to push the demand for laboratory/pharmacy/medical freezers.

The blood banks segment was valued as the largest market in terms of revenue in 2015. Factors such as rising demand for blood transfusions, whole blood, and blood components led to an increase in the number of blood banks globally, which in turn boosted the growth of the segment in 2015. The blood banks segment is expected to maintain its leadership position during 2016-2022 in terms of revenue. Installation of premium-priced equipment, such as shock freezers, plasma freezers, and blood bank refrigerators in blood banks, is expected to propel the growth of the segment. Moreover, rising research and development activities in biopharmaceutical and life science field is anticipated to fuel demand for biomedical refrigerators and freezers in research laboratories and institutions. Therefore, the research laboratories segment is projected to expand at the fastest CAGR during 2016-2022.

North America accounts for the largest share of the global biomedical refrigerators and freezers market and is expected to dominate the market during 2016-2022. Factors contributing to the growth of market in North America are presence of large number of healthcare facilities and the rising demand for this equipment.

However, the global biomedical refrigerators and freezers market will amass a prominent share in overall revenues from emerging markets in the next few years. To appeal to clients and exploit the vast growth opportunities in these regions, leading vendors are being compelled to offer low-priced products and enter into collaborations with promising regional players. Increasing medical tourism in emerging countries further promotes healthcare spending for biomedical refrigerators and freezers.

Challenges

Many factors contribute to the poor storage and transportation of biological samples in developing countries. Limited resources and lack of access to appropriate technology are two major challenges that threaten biological samples safety.

Limited resources discourage some countries from purchasing purpose-designed biomedical freezers. In countries with restricted economies, domestic refrigerators and freezers are often used for the storage of blood and blood components. Although generally affordable, they are not suitable for blood storage because they are not designed for this purpose. The insulation in domestic equipment is poor and, in the event of power failure, they will not hold temperatures well. Furthermore, domestic refrigerators do not have temperature monitoring devices, such as audiovisual alarms for temperatures outside the set limits for the products being refrigerated. Even basic blood time temperature indicators are not yet in common use.

In India, especially in remote rural areas, hospitals are often dependent on fuel-driven generators for their electricity supplies which may be inadequate to meet their power needs, particularly the special requirements of blood bank refrigerators and freezers that must function continuously. Frequent power cuts - sometimes of long duration - occur in hospitals located in remote areas. In such situations, safe storage may not be possible and blood components often have to be discarded. In addition, sensitive blood bank refrigerators, in common use in developed countries, often get damaged because of power surges in the developing world where replacements are not easily obtained.

A high ambient temperature and humidity in the laboratory as well as in the environment where blood is collected and transported adversely affect the performance of blood storage equipment. Such adverse environmental situations place stress on the equipment, and their ability to maintain temperatures within acceptable ranges is reduced.

Green Technology to Act as Transformational Trend

Emission of harmful greenhouse gases is a major concern with conventional refrigerators and freezing equipment. As the concerns and awareness regarding the harmful effects of these emissions to the health of the planet rise globally, the demand for greener equipment is gathering strength.

In the next few years, most of the new product designs entering the global biomedical refrigerators and freezers will be greener. The switchover will be expedited by strict government regulations regarding emission control and initiatives from product manufacturers toward innovation.

Dr Anju Verma, Chief Medical Officer, Rotary Blood Bank, New Delhi
Second Opinion
Essential to Maintain Quality and Cold Chain of Blood Components

Blood Donation by voluntary donors and the ability to use donated blood and plasma is integral to the healthcare system. After collection of blood, it is processed into various components and tested for HIV, Hepatitis B, Hepatitis C, VDRL, and Malaria by all the blood centers.

Quality of processes, products, and people is the cornerstone of any good blood bank. Blood banks cater to the requirement of patients who require blood and various components.

Fresh frozen plasma (FFP) is plasma that has been separated from a unit of whole blood within 6 to 8 hours of collection, and has been rapidly frozen and maintained at all times at a temperature of −20°C or lower. There is no lower temperature limit for the storage of FFP, although it is stored in the freezers for one year below −25°C. The stability of clotting factors on storage is dependent on the storage temperature available.

Blood bank freezers used in blood banks adhere to the norms laid down by FDA. They provide constant temperature as low as −40ºC

Design features common to refrigerators and freezers are:

  • Audiovisual alarms: Temperature out of range, door ajar, and power failure (warning) with battery backup
  • Temperature display unit
  • Continuous temperature recorder: Seven-day chart with battery backup or installation of data logger
  • Roll-out type of drawers or trays
  • Interface for remote temperature monitoring
  • Casters for easy movement of equipment
  • Cabinet of the refrigerator or freezer which stores blood packs or plasma packs, respectively

Key factors in the design of the cabinet are: A. Structure, B. Insulation, C. Interior lining, D. Doors and lighting, E. Shelving.

Critical equipment like freezers is essential and is procured as per the number of components prepared by the center. Their regular maintenance is equally important.

Improving the quality and performance requires a systematic, planned, and continuous, ongoing program which is the responsibility of every individual in the organization. Efficiency, effectiveness, timeliness, and availability are important dimensions of quality care, performance, and management of services rendered by the blood bank.

Dr Anju Verma
Chief Medical Officer,
Rotary Blood Bank, New Delhi


10 Diagnostic Imaging Trends for 2018

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