Rethinking Needles For Simple, Safe, And Painless Blood Collection

Rethinking Needles For Simple, Safe, And Painless Blood Collection

The manufacturers of new blood collection devices are rethinking needles and venipuncture and opening an exciting frontier of product design that includes automated robotic devices and needle-free technology.

Clinical diagnostics is integral to many fields of medicine, and blood continues to be the preferred sample medium for testing. The collection of blood is considered a remedy for certain conditions for centuries. Yet, for many years, blood sample collection technology did not keep pace with the advances in diagnostic assays and instrumentation that have allowed rapid measurements to be performed on small volumes of blood outside of the traditional clinical laboratory setting. Blood samples for diagnostic testing in our country are still being routinely obtained by venipuncture or by lancing the finger (fingerstick), both of which have certain disadvantages. Problems still exist at the moment when human skin is pricked and blood is drawn or absorbed. Venipuncture remains painful, and results generated from dried blood spot (DBS) cards still suffer from certain drawbacks. It is problematic for many patients and participants, and it is costly and cumbersome for many labs. On the basis of these limitations, advancement of point-of-care (PoC) diagnostics, and the decentralization of healthcare have created the need for simple, safe, standardized, and painless devices for blood collection, both within and outside traditional healthcare settings.

The manufacturers of new blood collection devices are rethinking needles and venipuncture and opening an exciting frontier of product design. New devices use capillary action to draw blood through tiny channels. These disposable devices can replace traditional venipunctures at medical laboratories in the years to come as they can collect 150 microliters of blood, enough to test for cholesterol, blood sugar, cancer cells, infections, and other ailments. Buyers and manufacturers of blood collection devices have emphasized prevention of injury and reduction of blood-borne pathogen exposure, so manufacturers are now also making substantial improvements toward safer blood collection products. For instance, the vacuum tube blood-collection systems are making blood draws safer and easier, and their results more accurate. These devices prevent needle stick injury by eliminating needles from human contact and avoid the chances of the spray of fluid getting into the air when the needle is retracted and also avoids the potential aerosoling.

Patient-centered care represents a paradigm shift in how patients and providers think about the processes of treatment and healing. More researchers and technicians, and the clinicians who rely upon them, are adopting and adapting patient-centric technologies to improve the quality of patient care and thus support enhanced clinical outcomes. Included in this proliferation, the remote patient monitoring makes many aspects of healthcare less invasive and intrusive for patients. This approach is proving so beneficial for both patients and healthcare professionals, that it has touched off a new wave of innovation—that of remote blood collection using microsampling technology. The microsampling technology, which can be easily used by patients themselves, is less invasive than traditional blood collection, is well-suited for children, and an option for individuals who experience needle anxiety. From the perspective of those collecting and analyzing samples, this technology provides a reliable and economical collection, shipping and storage solution, as well as new opportunities to gather stable samples in low-resource regions.

Indian Market

In 2018, the Indian blood bags market is estimated at Rs 150.53 crore, and 12 million bags by units. The single bags dominate in volume terms and the multiple bags in value terms. Inline filter bags are the fastest growing category in this segment.

In 2018, 6 million single bags, valued at Rs 33 crore were sold. The multiple bags amounted to 5.45 million bags, valued at Rs 79.03 crore. In the multiple bags category, the triple bags dominated with a 50 percent market share by value, and 52 percent by volume.

Terumo Penpol dominates this segment  and is a leader by far. It is working to increase its manufacture of blood bags from 40 million per annum by 2020. This is 10 million higher than its current 30 million that is being manufactured at its advanced facility in Thiruvananthapuram. Its parent company in Colorado, USA, is part of a larger Japanese firm. In December 2018, the Union Government signed an agreement with Terumo for Japan-India Institute of Manufacturing (JIM) in upskilling Indian medical device sector in Japanese shop-floor practices. JIM is a joint training initiative between the governments of India and Japan. The training is intended to create a pool of 30,000 skilled engineering manpower for Indian manufacturing industry.

J. Mitra is also aggressive and has seen steady growth in this segment over the last couple of years. HLL Lifecare is an active player in this segment. Fresenius, Maco, and Polymed are the other players. Fresenius and Maco are the importers, while the other vendors have manufacturing facilities in India. Innvol Medical India Limited, Chennai, with The Tamil Nadu Industrial Development Corporation Ltd. (TIDCO), having equity participation in the company and BL Lifesciences are regional players.   JMS is planning an entry into India, and is exploring setting up a facility, perhaps in collaboration with Innvol. A manufacturing facility is in the offing for Maco too; the company may tie up with BL Lifesciences. There are some other regional players also.

Global market

According to the market research report offered by Transparency Market Research, the global market for blood collection stood at USD 8.06 billion in 2018 and is projected to achieve a value of USD 9.8 billion by the end of 2022, registering a promising 4.70 percent CAGR. The increasing demand for blood donations is fueling the demand of blood collection devices. According to the American National Red Cross, around 7000 units of platelets and 10,000 units of plasma are required daily in the US and nearly 21 million blood components are transfused each year in the US. Increasing prevalence of certain disease conditions such as cancer, HIV/AIDS, diabetes, coronary heart disease, and anemia are the driving factor for the growth of the blood collection devices. In addition, increasing numbers of surgeries and high demand for blood transfusion and casualty cases are further driving the growth of the devices.

On the other hand, the lack of skilled professionals and the high cost of automated blood collection devices are predicted to hamper the growth of the market in the next few years. Nonetheless, the rising focus of the key players on innovations and technological developments in the blood collection products and procedures are projected to offer growth opportunities, which will further support the growth of the overall market. Also, the rising awareness programs that are being conducted by governments to enlighten people concerning the healthy and safe ways to collect blood are predicted to ensure the market growth in the coming years.

Among the key products, the blood collection needles and syringes segment is expected to hold a huge share of the global blood collection market and is anticipated to exhibit a healthy growth rate. Geographically, North America is likely to attain the top position in the market in terms of market share and is further expected to remain in the similar position by registering a 4.90 percent CAGR. Furthermore, Asia-Pacific is anticipated to experience a rapid growth in the coming years, thanks to the development of the healthcare infrastructure in developing economies.

The global market is highly competitive in nature, owing to the large number of players operating in it. With the entry of several new players, the competition among the prominent players in the market is projected to get intense. The rise in the number of collaborations and mergers is predicted to create substantial opportunities for the players, which will further support the market growth in the coming few years. In addition, advancements and innovations in this field are estimated to accelerate the growth of the market over the next few years. The USFDA approved blood collection devices with their increased acceptability helps to favor the further growth of the market. The leading players engaged in the market across the globe include Sarstedt, Nipro Corpration, Qiagen, Tasso, Becton, Dickinson and Company, Terumo Corporation, DBS System, Medtronic, Greiner Holding, F.L. Medical SRL, Seventh Sense Biosystems, Abbott Laboratories, Bio-Rad Laboratories, Fresenius SE & Co. KGaA, Velano Vascular, and Haemonetics Corporation.

Tasso, Inc., engaged in the manufacture of HemoLink, a simplified blood collection device used in the various diagnostic applications in September 2017 received USD 3 million funding from Defenses Advanced Research Projects Agency (DARPA) to advance their HemoLink technology by collaborating with GenTegra LLC, a company engaged in the manufacture of product used in biopreservation, biobanking, and IVD.

DBS System granted the USPTO patent for HemaXis Microfluidic blood collection platform in November 2017. HemaXis DB is microfluidic blood collection system, which uses the microfluidic chip with a standard filter card and protective case to provide the practical solution for blood collection procedure.

Seventh Sense Biosystems, Inc. in February 2017 received USFDA clearance for its new blood collection device named Touch Activated Phlebotomy (TAP), a novel blood collection device used for convenient and painless blood testing. Moreover in October 2017, Ionis Pharmaceuticals- a company engaged in the RNA-targeted drug discovery and development to develop drug for severe and orphan disease has collaborated with Seventh Sense Biosystems to support the development of improved blood collection and diagnostic devices. The collaboration enables the further product development of TAP device for blood testing.

Velano Vascular, Inc., manufactures the needle-free, vascular device for blood collection, received the USFDA approval for its updated version of a needle-free blood draw device. The Velano device is designed to reduce blood draw related anxiety and discomfort in hospital patients allowing safer work environment for healthcare professionals.

BD announced the commercial availability of the CE-IVD marked PAXgene Blood ccfDNA tube in February 2018. The plastic blood collection tube, which includes a proprietary sample stabilization additive and BD Vacutainer Hemogard technology to help protect healthcare worker safety, was designed to ensure accurate and reproducible results in molecular diagnostic testing applications. The product was developed by PreAnalytiX GmbH, a joint venture between BD and Qiagen.

Technological advances

In the recent years, as technology has increased in availability and complexity, the experts in the laboratories are receiving wide range of opportunities and challenges. In case of opportunity, automated method of collection enables technologists to perform a greater variety of tests on smaller sample quantities with greater accuracy of outcomes than the manual blood collection process. Therefore, there is an increasing number of laboratories taking their pace in the market of automated platforms.

Automated robotic device for faster blood testing. Many people have had chance encounters with medical professionals who are not yet adept at drawing blood. After just one of these unpleasant experiences, one will understand the appeal of the new venipuncture robot created by the Rutgers University, New Jersey. Not only can this robot find a vein on the first try, but it can also process the blood and perform basic analysis on it. This automated blood drawing and testing device provides rapid results, potentially improving the workflow in hospitals and other health-related institutions to allow healthcare practitioners to spend more time treating patients. Integrating miniaturized robotic and microfluidic (lab-on-a-chip) systems, this technology combines the breadth and accuracy of traditional blood drawing and laboratory testing with the speed and convenience of PoC testing.

The robot has not yet been given permission to stab into the unyielding flesh of a human volunteer. But, when and if the venipuncture robot becomes a reality, the patient will start by placing his or her arm on the platform under the robot’s arm. The robot uses a camera to scan the arm and identify veins. Unlike a human, the robot can address common issues with lining up a vein with the needle. Once the system has infiltrated a vein, it can begin drawing blood directly into a testing apparatus. So, while the idea of a robot drawing your blood might not be any less distressing than having a person on the other end of the needle, patients can take comfort in knowing this blood-testing robot could give the doctor easier access to the health information flowing through patient’s veins. The device could provide rapid test results at bedsides or in ambulances, emergency rooms, clinics, and doctors’ offices.

Needle-free technology to improve safety and patient experience. The dreaded needlestick in the healthcare environment is a source of nightmares for many people, ranging from young children getting their first inoculations to adults with high cholesterol going in for periodic blood tests. People have dreamed about getting rid of needles for years, not only to help patients relax when getting their blood drawn, but also to keep healthcare workers safe. Worker safety watchdogs have been lobbying for safer ways to give injections and draw blood, but until recently, the thought of doing away with the needlestick completely was only a pipe dream. But now, some forwarding thinking organizations are trying to make that dream a reality by using needle-free technology. The needle-free device eliminates the pain and anxiety associated with blood collection while advancing high standards and practices.

Innovative vein visualization devices make drawing blood effortless. Going to a doctor’s office or a hospital is not usually a fun outing. These visits can be particularly stressful if one needs to give blood or engage in a procedure that requires a needlestick. This process can cause anxiety, especially if a nurse or another practitioner cannot find a vein to begin the blood draw or IV. Touching an arm to feel for the vein is not a tried-and-true method for locating a vein. However, technological advances provide great solutions to these problems, and vein visualization technology may be the answer to this dilemma. The technology uses infrared light to illuminate the area where a venipuncture is going to occur so that the practitioner can find a vein to use in the procedure

Wearable blood collection device is under development. Verily, the life sciences arm of Google parent company Alphabet, is reportedly developing a wearable blood collection device with retractable microneedles and magnetic components to make blood samples more efficient and less painful. The blood collection device has already been tested in the form of a watch to make it more convenient for patients requiring frequent monitoring to get blood drawn. This could be the latest example of a growing trend toward needle reduction in healthcare. A number of potential uses for the blood collection device are currently being explored by the Verily team. The most likely use, which has been discussed internally, would be to use it to track key blood markers for people that are enrolled in clinical trials. Another more speculative use would be to replace blood draws in some medical settings.

Automated electronic blood collection monitor for good quality blood collection. A blood collection monitor (BCM) is developed to monitor collection of blood in a blood bag during blood donation and are so designed that they protect against over or under collection of blood. Apart from displaying weight and volume of blood, these monitors have an automated clamping system which clamps the tube once the required blood is collected from the donor. Thus, there is no risk of excess blood collection since the BCM has audio-visual alarms to monitor the collection process. The device provides smooth, gentle, and uniform mixing of whole blood with anticoagulant without damaging blood cells and platelets during collection of blood which helps in increasing red cells, platelets, and plasma yield. BCMs are also available with battery backup feature, making them ideal for use not only in blood banks but also in outdoor camps. By using them, a phlebotomist can handle more than one donor at a time.

Outlook

Diagnostic blood testing is the most commonly performed clinical procedure in the world, and it influences most of the medical decisions made in hospitals and laboratories. Blood is like the cliff notes to one’s health: it can tell a doctor everything from how well the organs are working to whether one needs to add more iron in diet. Though it is common, the act of drawing and analyzing blood is not easy; manufacturers will continue to improve on a variety of safer products for blood collection. Many needlesticks and other cuts can be prevented by using medical devices designed with safety features and by the proper disposal of sharps. Because a variety of safety features, new technologies, and automation will be available in blood collection products, healthcare workers are encouraged to assess the needs of their organizations, i.e., the setting, type of patient population serviced, budget, and emphasis on safety within the institution when selecting a device.

What ties together all the new threads in blood collection product design is a desire to minimize pain and discomfort for participants along with prevention of transmission of infectious diseases. The device manufacturer can assist this aim, but the healthcare facility is ultimately responsible for validating products and writing procedures for use. They have been doing the same thing for decades. Although new innovations are not expected to change the world overnight, the new devices’ applications could include wellness testing, chronic disease management, and reproductive health, among others. And with the growing awareness toward health and increasing efforts of various government and nongovernment organization for blood donation, the blood collection business is certainly ripe for change.

Second Opinion
A Key Step In Good Patient Experience

Phlebotomy, which dates back to the age of ancient Greece, has gained importance through the evolution of medicine by becoming a fundamental diagnostic procedure and forms the cornerstone of modern healthcare delivery. Nowadays it is also considered as an important quality indicator for patient experience. Hence, making the blood draws more efficient seem to be increasingly important to practitioners. It is further supported by a growing trend toward innovations in blood collection.

Today’s blood collection system is composed of a multi-sample vacuum collection needle or butterfly needle sets, a disposable tube holder, vacutainers, latex free gloves, and tourniquet. A recent addition has been the needle safety device, which is directly attached to the needle. Post phlebotomy procedure, the safety device can be activated with the thumb (single-handedly), thereby preventing needlestick injury. Another important blood collection device is vacutainer blood transfer devices used to protect the phlebotomist from an accidental needlestick when transferring blood from a syringe to the vacutainers. The syringe is attached to the top of the device, the tubes are then inserted into the holder until the stopper is punctured by the needle inside the holder. These transfer devices are especially helpful during blood collection, through indwelling central or IV catheters, which otherwise are prone for sample hemolysis.

Further innovative technologies are under research to achieve robotic phlebotomy and needle-free microsampling for evaluation of the drug levels and the biochemistry parameters of blood. These devices would ensure accurate and precise collection of a fixed volume of blood, would require minimal training, and are user-friendly. They would enable blood collection to be less painful and accessible at remote locations.

Through the years, technology has provided useful devices to aid the phlebotomists in their craft, increasing the quality of collected specimens and safety of the patients. Moreover, the evidence based medicine paradigm has codified precise references and guidance. However, there is no formula that can tell which is the right vein, right needle, right angle, and right force which would yield a perfect blood draw. The only certainty is that all the efforts made should be toward patient safety and quality of phlebotomy services.

Dr Rajesh Bendre
Chief Pathologist and Head laboratory, Medicine and Blood Bank Services,
Jaslok Hospital and Research Centre

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