By Aparna Ahuja, MD
Many life-changing inventions are the result of scientific breakthroughs. Others are triggered by unfortunate circumstances. Jan Zysko, an engineer at the National Aeronautics and Space Administration (NASA), was inspired to design a cabin pressure monitor system following the death of golf champion Payne Stewart in a plane crash, which was facilitated by incapacitation of the pilots and passengers by hypoxia after a sudden loss in cabin pressure.1
For Joseph Kleiner, a personal event served as motivation to design a product that would revolutionize blood collection. After observing his gravely ill wife endure multiple needlesticks to draw a sufficient amount of blood for the tests ordered by her doctors, Kleiner resolved to find a way to improve the process, which at the time was often arduous and imprecise. Back then, spillage of the blood was possible during transfer of blood from a syringe to a test tube, and patients often required separate venipunctures for each blood test ordered (e.g., chemistry, hematology, coagulation).
This resolution sparked his idea for the “Evacutainer” blood collection system. His system incorporated an evacuated test tube sealed with a rubber stopper, a 3-inch-long double-pointed needle and a holder for fitting the two together. The tube served as both a syringe for drawing blood and a sealed container for transporting the sample.2 The vacuum inside of the tube facilitated tube filling with the appropriate volume of blood and the Evacutainer enabled drawing of multiple tubes with one needlestick. The tubes were packaged and shipped in vacuum tins similar to coffee cans in contrast to the use of clamps to prevent dislodging of the stoppers during autoclaving.
The tube was patented in 1949 by Becton, Dickinson and Company and become known as the BD Vacutainer® Tube. This year marks the 70th anniversary of the tube’s patent.
Technological Advances in Blood Sample Collection
While the 1970s are often remembered for the popularity of the floppy disk and the dawn of video games, it brought about technological advances in blood collection as well. The BD Vacutainer® Tube was also refined to meet the evolving needs of the laboratory professional.
Previously, laboratory professionals had to prepare the solutions for the additive tubes and dispense them directly into the tubes. Lines also had to be etched in the tube in order to identify the proper draw volume. BD Vacutainer® Tubes became available with pre-filled additives to ensure a correct blood to additive ratio and to stabilize and preserve the specimen prior to analytical testing. Depending upon the applicable test, the additive promoted faster clotting or prevented clotting, and designated by color-coded tube closures (e.g., green for sodium heparin, gray for sodium fluoride). Prefilled additive tubes can save time for laboratory professionals who may now perform other tasks.
Gel Separation: Gel separation technology was developed (for serum in 1976 and for plasma in 1987),3,4 whichprovided a physical and chemical barrier between the serum or plasma and the cells. This separation enabled sampling, transport and storage of the specimen in the primary tube and eliminated the need for aliquoting.
Smaller Volumes: Obtaining large volumes of blood may be detrimental for infants, pediatric patients and critically ill patients. Not only it is often difficult to draw blood from these patients, but the potential for anemia exists as well. The BD Microtainer® brand tube provides an alternative for patients for which smaller volumes of blood are advantageous (e.g., elderly patients with fragile veins, infants, small children and other patients with compromised veins)[e.g., oncology or dialysis patients].
The early years of the AIDS epidemic highlighted the potential for disease transmission via blood, an occupational concern for the healthcare worker. In addition to the human immunodeficiency virus (HIV), the Hepatitis C Virus and Hepatitis B Virus are common bloodborne pathogens that put healthcare workers at risk.5 The Hemogard™ closure of BD Vacutainer® Tubes was designed with an integrated shield that may prevent contact with blood on the stopper or tube rim and minimizes splatter during closure removal.
Further safety measures were added to the portfolio, which included the conversion of glass tubes to plastic. Plastic tubes, which are shatter resistant, reduce the risk of healthcare worker exposure to potentially infectious organisms as a result of dropping of the tubes or tubes breaking in the centrifuge. Additionally, the implementation of safety-engineered blood collection needles and wingsets have decreased the number of incidents of needlestick injuries in accordance with the Needlestick Safety and Prevention Act.6
Challenges in Urine Specimen Collection
After blood, urine is the most common specimen used in diagnostic testing. However, challenges in urinalysis may arise when testing cannot be performed as per CLSI guidelines (i.e., within two hours of collection).7 Without a preservative, bacteria in the urine will continue to metabolize and reproduce, changing urine chemistry components, which can lead to false results. In 2002, the BD Vacutainer® Urinalysis Preservative Tube was introduced, which helps to inhibit the metabolism of the bacteria and ensures specimen stability until testing.
Today, laboratory testing continues to play a major role in medical decisions, with millions of specimens collected daily in hospitals, clinics and physicians’ offices worldwide.8 While product innovations have been developed to enhance the collection process, it is important to note that proper management of the preanalytical process is vital for quality test results. Training on the process as well as adherence to the product’s instructions for use (e.g., adequate mixing, clot time) can help laboratory professionals in this effort.
Innovations can stem from many sources, whether from a NASA engineer’s inspiration that led to safeguards in aviation or Kleiner’s simple blood collection device, which has helped to shape the future of laboratory medicine and the way that diagnostic testing impacts global healthcare. Today, BD produces more than six billion BD Vacutainer® Tubes. 9
- Cabin pressure monitors notify pilots to save lives. Available at https://spinoff.nasa.gov/Spinoff2015/t_4.html
- Bush V, Cohen R. The evolution of evacuated blood collection tubes. Lab Med 2003;34:304-310.
- Laessig RH, Westgard JO, Carey RN, Hassemer DJ, Schwartz TH, Feldbruegge DH. Assessment of a serum separator device for obtaining serum specimens suitable for clinical analyses. Clin Chem 1976;22:235-239.
- Calam RR. Specimen processing separator gels: An update. J Clin Immunol 1988;11:86-90.
- Jagger J, Perry J, Gomaa A, Kornblatt Phillips E. The impact of U.S. policies to protect healthcare workers from bloodborne pathogens: The critical role of safety-engineered devices. J Infect Public Health 2008;1:62-71.
- Hoffmann C, Buchholz L, Schnitzler P. Reduction of needlestick injuries in healthcare personnel at a university hospital using safety devices. J Occup Med Toxicol 2013;8:20-25.
- CLSI. Urinalysis; Approved Guideline—Third Edition. CLSI document GP16-A3. Wayne, PA: Clinical and Laboratory Standards Institute; 2009.
- Archibong E, Konnaiyan KR, Kaplan H, Pyayt A. A mobile phone-based approach to detection of hemolysis. Biosens Bioelectr 2017;88:204-209.
- BD internal data for 2018.
Dr. Aparna Ahuja is the Worldwide Vice President, Medical Affairs, Preanalytical Systems (PAS) for BD. She has experience in pathology laboratories and provides medical, technical and laboratory customer-focused leadership. She chairs PAS Global Clinical Council since 2015 and is the Medical Affairs Representative member of the Global Inclusion Council.