India today is 9 percent short of its need for blood, amounting to 1.1 million units, albeit the shortage has reduced from 17 percent in 2013-14. There are 2708 blood banks, but 81 districts still lack one. There is no central collection agency, leaving the logistics of collecting blood to single blood banks and local governments. Rural areas find blood supplies harder to access.

India’s large and expanding population, as well as the growing demand for blood and blood components are expected to contribute to a greater demand in the blood banking and plasma products market. In addition, rising public demand for safer blood donation and transfusion services is likely to create a strong case for more automated blood collection devices, as well as leading to the increased use of leukocyte reduction filters.

Blood_BagsBlood_Bags

In 2016, the Indian blood collection equipment and devices market is estimated at Rs.177.58 crore. Blood bags contributed 63 percent to the market, with 11.53 million bags.  Multiple bags are more in demand, and have a 68.3 percent share in value terms, although in quantity terms the share is 40 percent. Triple bags are more popular than their counterparts, double and quadruple in the multiple bag segment. The discerning customer in the metros and large cities is opting for inline filter bags, sales of which in 2016 is estimated as 30,000 units. 

The market for blood collection monitors, blood donor couches, and tube sealers is estimated as 1000 units each in 2016. Tube strippers for blood bags and automatic blood component extractors are generally placed at the blood collection facilities by the vendors. 

The growth in the market is driven by a host of factors including technological advancements, introduction of innovative products, rise in blood transfusion procedures among the elderly and the chronically ill, and strong promotional campaigns undertaken by various collection agencies for encouraging blood donation. Epidemic rise in cancer and the ensuing spurt in cancer treatment procedures and rapid increase in complex surgical procedures such as open heart and orthopedic surgeries also provide the requisite impetus. Implementation of stringent regulations along with the increased focus of medical devices manufacturers on developing automated, improved solutions to collect, process and store blood and its components is fuelling growth in the market.

Global Market

The blood collection equipment market is expected to reach Rs.63,360 crore by 2021 at a CAGR of 5.3 percent from 2016 to 2021, propelled by the increasing number of surgical procedures requiring blood transfusions, growing number of accidental and trauma cases, and rising prevalence of diseases. 

Blood_BagsBlood_BagsBlood_Bags

The blood bags segment is estimated to be valued at Rs.1270 crore by 2016-end, and is expected to reach Rs.2620 crore by 2024-end. Global consumption of disposable plastic blood bags is expected to exceed 320 million units by 2024-end, increasing at a CAGR of 11.9 percent over the next 5 years. 

On the basis of sales channel, the blood bags market is segmented into tender sales and private sales. In 2015, tender sales segment was valued at Rs.722.56 crore. In terms of volume, tender sales channel segment is expected to expand at a CAGR of 9.9 percent. In 2015, blood banks end-user segment was pegged at 91 million units of disposable plastic blood bags. 

Stringent regulations along with the increased focus of medical device manufacturers on developing automated, improved solutions to collect, process, and store blood and its components will continue to fuel growth in the market.

Companies are focusing on developing automated collection devices that minimize the contamination risk associated with blood collection, reduce human intervention, and lower chances of pathogen development. These automated alternatives, which include autologous disposables and devices, have been gaining significant popularity in recent times. Other major technological advancements include development of blood bags with blood collection monitors, integrated filters, as well as tube sealers.

Major global players include AdvaCare Pharmaceuticals, Beckman Coulter, Inc., Becton, Dickinson and Company, Fenwal, Inc., Grifols International S.A., Haemonetics Corporation, Immucor, Inc., Kawasumi Laboratories, Inc., MacoPharma SA, Shanghai Transfusion Technology Co., Ltd., Stago, Terumo Corporation, and Terumo BCT, Inc.

Research Update

Blood_Bags

Most blood collection agencies require a 56-day minimum interval between donations of whole blood to allow hemoglobin levels to return to normal. However, recent studies suggest that the deferral should be lengthened to prevent iron deficiency. Researchers compared hemoglobin levels and iron parameters over 180 days in 24 new male donors and compared them to 25 regular male donors who had donated more than 10 times. Over the 180-day observation period, regular donors had lower levels of hemoglobin, ferritin, and hepcidin, while erythropoietin and soluble transferrin receptor were higher compared to new donors. 

Although hemoglobin indices returned to normal by day 57, both groups of donors had low levels of ferritin at day 57 compared to pre-donation levels. Only 25 percent of new and 32 percent of regular donors had returned to baseline levels. After 180 days, all regular donors and 82 percent of new donors had reached baseline ferritin levels. The study authors suggest ferritin levels may be used to determine personalized donation intervals, or the donation interval should be increased to 180 days to avoid iron deficiency in all donors. More research is needed to confirm these results and investigate trends in female donors.

Way Forward

Blood_Bags

While people are now alert to various infections, the industry is yet to overcome difficulties such as security and the accessibility to good-quality blood. This has led to very strict safety measurements being taken for both the donors as well as the blood banks, which have to be adhered to before any transfusion is carried out. The risk of spread of diseases through transfusions has decreased due to conduction of thorough testing and screening techniques and also with the assistance from latest technologies. 

Current conversion rates from plasma-derived to recombinant factor products are increasing the standard factor product cost. Collecting blood manually continues to be the most productive technique for collecting blood and the systems that are used in these procedures are extremely important to the blood banking industry.

Blood banks now readily await a safe technology that will combine with their processing systems and decrease the danger of transfusion-related infections to almost nil. The success of the market is ascertained by the capacity to provide cost-effective technologies with a wide kill range, strong safety profile, and effortlessness in the application. The provision to persuade the buyer decision-making processes combined with first-mover advantage will be significant in achieving a competitive edge. The market will observe a strong operation toward combining device production knowledge and biopharmaceutical technology, as companies work toward producing safer blood collection techniques and blood replacements.

Mannoj Panwar, Director-India & South Asia, Macopharma India
Industry Speak
A Real Need for High-End Blood Mixers in Indian Blood Banks

The Indian blood collection market has around 6000 blood collection monitors and most of them are basic blood collection mixers. These basic blood collection mixers can be considered good for in-house donations where blood bank has the UPS power point to take over in case of power failure. With low power backup of blood collection monitor, blood banks can only complete the running donation on battery of blood collection monitor. These basic blood collection monitors do not have sufficient battery back up to work in blood donation camps outside blood banks. All the blood bank those are allowed to hold the blood donation camps outside are uncomfortable using these basic blood collection monitors because of lack of UPS power point or poor battery backup of blood collection monitors. Mixing is a very critical phase in blood collection process, and if the anticoagulant is not properly mixed with the blood during the blood collection, it can cause clotting of blood and impact the quality of blood. The basic mixers are not coming with stand on which blood bank can keep the mixer to do the donation and blood banks are using a normal stand which is not very stable and convenient in day-to-day use. The basic blood collection monitors are also not having any good memory to save the donation data and do not have any means to transfer the collection data from mixer to blood bank officer’s laptop/computer. 

The Indian blood bank industry is really needing high-end blood collection monitor to improve the quality of the blood. The basic blood collection monitor does not have any bar code reader to avoid manual error. The Indian market should shift to advanced feature blood collection monitors. There are high-end international brands available in Indian market which give a good battery back up to handle blood donation camps without any UPS power points requirements. The Indian blood collection market is feeling the need of these high-end blood collection mixers. I am sure with these high-end blood collection monitors, Indian blood quality can easily improve and complete traceability can be achieved.

Mannoj Panwar
Director-India & South Asia,
Macopharma India

Anil Behal, CEO, Grabner International
Industry Speak
Why Should Infectious Hospital Air Spoil Good Work?

The best of operations and treatment fails if it is not supported by the hospital’s intention to excel. Be it material support or human support. 

Nasocomial infection is one of the prime culprits. The infectious hospital air is self-generating and hence cannot be eliminated altogether, though it can be controlled minute by minute. A sterile area gets contaminated as soon as the human presence is detected. Hospitals at best can control and take maximum care by adding a lot of technologies, which are available today to their protocol. Consumables should be avoided to the maximum to curtail cost and help the environment. 

Antibacterial dust-trapping mats, which have reusable adhesive base, should be kept at the entrance to capture foot-borne contamination.

Antibacterial concealed ultra-violet devices should be installed in the gangways. UV devices can also be added to the end points of the air conditioning ducts. 

Antibacterial nano paints are available which can help to keep the walls and floorings germ free. Best of paints are available which not only contain the bacterial growth but also decompose the assassinated bacteria even without light.

Air purifiers with washable filters can be kept at practical distance and air purifiers with HEPA and other consumable filters can be placed at sensitive places, depending on the traffic and size of the room. Ionizers can be installed to generate garden-fresh negative ions to keep the air fresh and dust free.

Corporates should be encouraged to participate in this exercise. Big size purifiers should be installed in the lobby and waiting areas which visibly promote brands on the walls of the air purifiers. 

Thus taking these measures you will incur a onetime expenditure over a couple of years. By inviting suppliers or corporates to install their brand-embedded air purifiers, one will provide them with an opportunity to advertise their products and also fulfill their social corporate responsibility, and fulfilling their own responsibility of providing non-contaminated surroundings to patients and staff. 

Timely action taken today will definitely help you achieve better results with a safe environment for the attendants, visitors, and faster recovery of patients. After all, why should the infectious hospital air spoil good work? 

Anil Behal
CEO,
Grabner International

Dr Rajesh Deshpande, Regional Manager-Medical Affairs, Medical Devices, Regional Business Centre, Asia, Fresenius Kabi
Industry Speak
Recent Trends in Blood Transfusion Medicine

Transfusion medicine has shown tremendous progress globally in recent times. Technological advancement has seen us progress from the conventional method of whole blood collection to automated techniques and separation of various blood components. In fact, this is the age of component therapy and automation. 

Automation has helped us redefine component preparation in the form of apheresis – wherein only the needed component is collected from a donor and the remaining components are returned back. 

Apheresis today supports not only component collection but also therapeutic procedures directly related to patient treatment modalities such as plasmapheresis and stem cell transplantation for treatment of cancer and other hematological disorders.

Increasing concern regarding transfusion safety has challenged the blood centers to provide safe and risk-free blood components.

Transfusion services are adopting new technologies and processes to minimize the risk of transfusion-associated adverse effects and infections.

The goal is minimal transfusion risk through safe blood practices. Today, new advancements are seen at various levels of the blood center. Some of the recent advancements related to collection and processing of blood and blood components are as follows: 

Blood packs with pre-donation sample pouch configuration. These have the provision to divert the initial blood sample of 20–30 mL blood into a sample pouch before the blood enters the collection container. This prevents any possible contamination of the collected blood from the bacterial flora present on the skin surface. 

Leukoreduction using integral filtration blood pack systems. Newer methods of providing leukoreduction of blood components are being introduced to remove white blood cells or leukocytes from the collected blood during processing. The harmful effects of leukocytes on transfusion to patients range from mild-febrile non-hemolytic transfusion reactions to fatal Graft vs. Host disease. Among various methods of leukoreduction, filtration is the most efficient method providing over 99.99 percent removal of white cells, making blood components safer. 

Integral filter packs provide a closed system pre-storage filtration with consistent and optimal removal of intact leukocytes through an attached leukoreduction filter. This technique ensures quality and safety. 

Automated blood component extractors. Use of automated component extractors ensures product quality with minimal human errors and variation. Consistent quantity and quality of blood components along with leukoreduction is assured. 

Presence of automated cannula breakers saves time, reduces the risk of hemolysis and minimizes the chances of stress injuries to the operators.

Dr Rajesh Deshpande
Regional Manager-Medical Affairs,
Medical Devices,
Regional Business Centre, Asia,
Fresenius Kabi

Himanshu Baid, Managing Director, Poly Medicure Ltd.
Industry Speak
Current Trends in Blood Banking

The current focus of blood transfusion centers in India is yet to achieve blood component usage rather than traditional whole blood usage. Today, we talk about advancements in terms of pathogen-free blood units amidst the growing threats of transfusion-related diseases like HIV and hepatitis. 

Even now, there are more than thousand blood banks out of total approximately 2800 in India which come under whole blood bank. And the demand is still for whole blood unit rather than its components. Mass awareness programs need to be undertaken for promoting usage of blood components. 

The trend of leuco-reduction in components is gaining pace and now there are more numbers of automatic component extractors being used all over the country. Blood bag manufacturers who used to make only single, double, triple bags have also started producing Top & Bottom (TAB) bags. Through buffy coat method, leuco-reduction can be achieved, due to which side effects of transfusion-related reactions like FNHTR, TRALI, platelet refractoriness, etc., can be avoided. The only equipment a blood bank requires is an automatic component extractor and TAB bags. In India, any blood bank can easily start preparing leuco-reduced components, except in few states like UP and West Bengal, where drug authorities have put a condition for getting a license for preparing leuco-reduced components. 

Today, business of apheresis is another growth driver of blood banking in India. There are approximately 1000 machines in India and over 

1 lakh kits being currently used per year. All these machines and kits are imported and therefore costly. The cost of one unit of platelets apheresis to the patient comes out to be between Rs.11,000 and Rs.15,000. 

The quality of blood/blood components is very important for the patient. Today, many local vendors have started manufacturing blood bank equipment, without having service backup. This equipment hardly works for six months, and thus the components lying in this troubled equipment start deteriorating. Ultimately, patients receiving such units suffer. So, a blood bank doctor must ensure to buy good-quality equipment with service backup rather than going for cheap equipment.

Himanshu Baid
Managing Director,
Poly Medicure Ltd.

Dr Suman Hegde, Consultant Pathologist, Mahalaxmi Memorial Hospital, and Blood Bank Officer, PG Hospital’s IMA Life Line Blood Bank, Karnataka
Second Opinion
Trenz in Saving Lives

With the start of New Year, the exciting question is what technology trends in blood bank will transform the lives in 2017 and beyond? Here is brief information about the emerging technology in the field of blood bank, sure to say in saving lives.

Solar power usage is the latest trend in technology to minimize the need of electrical energy. Solar-driven blood bank refrigerator is one such new equipment in the market that uses solar energy for cooling. For rural and low lying areas, where electricity does not reach, solar refrigerators come as a solution. The companies supply solar panels, batteries, charge controllers, AC/DC auto transfer switches, and AC/DC adapters as accessories. With the help of an AC/DC auto transfer switch, the refrigerator operates using AC power. This is useful when the battery is discharged due to cloudy and rainy days. When the battery is recharged, the refrigerator goes back to DC solar power. Some DC refrigerators work without solar panels, battery, or a charge controller.

Dry plasma/blood thawing bath, a unique device uses a sealed system for thawing, replacing the use of open water bath as in traditional cryobath, also has automatic leak detection sensors and thus fluid leakage from bags can easily be detected. They are very simple to operate, safe, provide gentle thawing conditions, easy to clean through wipe disinfection, and the thawing solution is changed once in a year. The benefits of dry thawing include reduced risk of product contamination through hairline cracks by water that can be encountered in traditional cryobath, less tissue destruction, no over-warming or under-thawing of products, faster temperature recovery of the equipment following each thaw when performing multiple thaws, elimination of the need to hand manipulate the products, and portable with no water to maintain.

Latest cryobaths and platelet agitators have 7-inch touch screens having multiple language display, integrated management system, facility to transfer data through pen drive to PC, and provision to connect to SCADA (supervisory control and data acquisition) that offers monitoring and controlling of sensors of devices placed at a distance from one central location.

Ever-evolving technology holds promise for better future blood bank services. 

Dr Suman Hegde
Consultant Pathologist,
Mahalaxmi Memorial Hospital, and Blood Bank Officer,
PG Hospital’s IMA Life Line Blood Bank,
Karnataka

Dr Amita Raoot, HOD Blood Bank, Lal Bahadur Shastri Hospital, Delhi
Second Opinion
Blood Cold Chain Maintenance – Backbone of Blood Banking

Ihave recently joined Lal Bahadur Shastri Hospital as incharge of Blood Bank. Ours is a 100-bedded hospital but caters to more patients (approximately equivalent to 200-bedded hospitals) because of its critical location in East Delhi. The blood bank in the hospital functions round the clock and blood transfusion is an imperative lifesaving service provided to the patients. 

After joining blood bank, I have realized in a short span of time that cold chain equipment is vital to smooth and effective functioning of the blood bank. Not only is the availability of adequate good-quality cold chain equipment essential for maintaining safe and convenient storage of whole blood and blood components, but also having a comprehensive equipment maintenance program in actual practice goes a long way in hassle-free smooth conduction of quality blood bank services. Maintenance of medical equipment is often restricted to mere procurement of easy-to-get to products within the proposed budget. However, this constricted perspective needs to be replaced with long-term policy of effective maintenance of the equipment. 

With this approach, I am trying to emphasize on a few basic maintenance issues. Most faults in refrigerators and freezers are the result of poor care and maintenance by the user. As per WHO, daily upkeep and preventive maintenance and rational use by staff prolongs the life of equipment, significantly decreasing safety risks and reducing replacement costs by 50 percent. The down time of cold chain equipment can be easily reduced by following the preventive maintenance procedures recommended by the manufacturer. Regular users must be trained in the safety elements of cold chain equipment and acquainted with some basic knowledge regarding the most important common and specific design features of blood refrigerators, plasma freezers, and platelet agitators.

After joining the department, the first thing I ensured was to develop SOP (standard operating procedure) for maintenance of blood cold chain equipment and adherence to them. Log books with updated information were made for each equipment. All maintenance and calibration details were recorded, together with any follow-up action taken, since this also forms a part of the quality assurance system. Weekly and monthly maintenance SOPs for equipment were made. Such meticulous documentation of the maintenance, servicing, and repair of all cold chain equipment can be useful in identifying whether or not the equipment has consistently performed to expectations, and selection of equipment in future. In addition, having CMC/AMC for the equipment made/renewed timely will help in suitable repair of the non-functional cold chain equipment. 

Most of these points may not be new to those working in blood banks; however, not much attention is given to the daily upkeep and preventive maintenance. As they say a stitch in time saves nine, importance of having a methodical program for maintaining good functional status of blood cold chain cannot be undermined to ensure smooth, uninterrupted, reliable, efficacious, and quality blood bank services.

Dr Amita Raoot
HOD Blood Bank,
Lal Bahadur Shastri Hospital,
Delhi


 

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