overview [phlebotomy | coagulation and hematology]

The Evolution of Evacuated Blood

Collection Tubes ©2003 BD
Valerie Bush, PhD, FACB, MT (ASCP),1 Richmond Cohen, PhD2
1BD Vacutainer Systems, Preanalytical Solutions, Franklin Lakes, NJ, 2First Quality Products, Inc., McElhattan, PA
DOI: 10.1309/JCQE33NBYGE0FFQR

왘 The introduction of evacuated tubes electrolyte measurements, they added Prior to the issuance of the patent,

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greatly enhanced the precision and mineral oil to the tubes to prevent loss of Kleiner approached BD with the Evacu-
accuracy of test results by reducing CO2. For serum specimens, the technolo- tainer. BD subsequently hired Kleiner as
errors in collection, (eg, blood-to- gist would use wooden applicator sticks a consultant for the product and changed
additive ratios or contamination). to loosen the clot from the tube walls. the name of his tube to Vacutainer™.
왘 This article reviews the history of Before drawing blood from the next Shortly thereafter, it became one of the
evacuated tubes, the regulations and patient, the laboratory would wash the sy- company’s largest selling items.
manufacturing of evacuated tubes, ringes and tubes. This required many rinse BD Vacutainer™ tubes were pack-
the additives used in evacuated cycles to remove all of the soap residue. aged and shipped in vacuum tins similar
tubes, and some environmental Needles were resterilized and occasionally to coffee cans [I2]. This was a
factors influencing product resharpened using a grinding wheel. breakthrough at the time because previ-
performance. The shortcomings of these ously, a heavy clamp was used to prevent
techniques are numerous. First, the pa- the stoppers from popping off during au-
“A laboratory test is no better than tient is subjected to the pain of multiple- toclaving. Initially, BD made only 1 kind
the specimen, and the specimen no better needle entries to the vein. Secondly, the of Vacutainer™ tube, but now it makes
than the manner in which it was possibilities for errors to occur during the hundreds of styles and sizes. The current
collected.” So stated the advertising lan- collection and transfer process and the evacuated tube system utilizes color-
guage of BD (Becton Dickinson) to pro- safety risks are apparent. Also, time is coded stoppered tubes containing the vac-
mote the first evacuated blood collection consumed with the multiple punctures uum and a holder that supports a
tubes, back in the late 1940s and early and transfers. double-ended needle. The color-coded
1950s.1 This technology for blood collec- closures differentiate tube types.
tion, patented in 1949, is substantially History of Evacuated Tubes BD was the only evacuated tube
similar to the technology pervasive in The introduction of evacuated blood manufacturer in the United States until
clinical practice today. collection systems provided greater the early 1970s when other manufacturers
Consider what it was like to draw safety, while offering ease-of-use, speed, entered the market. F2 illustrates a histor-
blood without an evacuated tube system. and accuracy in blood-to-additive ratios. ical time line for FDA clearance of evac-
Even before collecting blood, the labora- Many advancements in blood collection uated tubes. Contact information for
tory had to prepare solutions for the addi- techniques and devices have been made tubes currently sold in the United States
tive tubes (eg, EDTA, citrate) and in recent years.2 However, the technique is shown in T1.
dispense them into test tubes for blood of blood collection with the first evacu- Today, there are regulatory agencies
anticoagulation. Then, to identify the ated tubes was not quite the same as the and guidelines that ensure the consistency
proper draw volume, the laboratory had process used today. During blood collec- in the design and manufacture of blood
to etch lines in the borosilicate glass tion with evacuated tubes, as one end of collection systems [eg, Food and Drug
tubes. The phlebotomist collected blood the needle enters the patient’s vein, the Administration (FDA); International
specimens with needles and glass other end can penetrate through the rub- Standardization Organization (ISO); and
syringes. For patients who required many ber stopper as the tube is pushed into the National Committee for Clinical Labora-
tests, the phlebotomist might have to open end of the holder. The vacuum en- tory Standards (NCCLS)].4-6 Major regu-
304 stick the patient multiple times, at least ables the tube to fill with the appropriate latory developments in the evolution of
once for chemistry, once for hematology, volume of blood. Additional tubes may evacuated tubes are also depicted in F2.
and once for coagulation. be inserted into the holders after comple- Federal requirements governing investi-
After collection, the phlebotomist tion of the previous draw, when multiple gations involving medical devices were
would transfer the blood into a series of specimens are required. enacted as part of the Medical Device
test tubes. They sealed the tubes with The first evacuated tube patent, Eva- Amendment (1976) and the Safe Medical
black rubber stoppers for transportation cutainer, was invented by Joseph Kleiner Devices Act (1990).7 These amendments
of the specimens to the laboratory. For and assigned to BD in 1949 [F1 and I1].3 to the Federal Food, Drug and Cosmetic

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305

[F1] Copy of the original patent for the BD Vacutainer™ Blood Collection System.3 (Reprinted with permission.)

© laboratorymedicine> april 2003> number 4> volume 34

 mark. Furthermore, all class I and II med-
ical devices sold in the United States
must receive clearance from the FDA and
Center for Device and Radiologic Health
(CDRH) prior to sale. Included in the
FDA’s review of the 510k (premarket no-
tification) are the physical description of
the product and contents, as well as prod-
uct performance for safety and effective-
ness. General manufacturing practices are
described below.

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Glass evacuated blood collection
tubes can be made from glass canes cut
to predetermined lengths and fired at 1
end to close the bottom. Plastic blood
collection tubes may be manufactured by
an injection-molding process.11 A mold is
made to the specific size of tube desired.
Typically, in the molding process, a hot,
molten material is injected into a cold
mold for the tube. After the tube material
cools and solidifies, the mold is opened,
and the tube is ejected.
Once the tube is formed, additives
may be topically applied and dispersed
along the inner wall of the tube.12
[I1] Original Evacutainer® tubes and packaging. Most of these additives are considered
to be “dry.” Tubes are spray coated
on the market prior to 1976 were grand- with additive formulations onto the
fathered from the premarket notification inner wall using a series of nozzles.
(to the FDA) requirement. The Needle Dispensing is achieved by either pres-
Stick Safety and Prevention Act revises sure activation or volume displace-
and builds upon the Bloodborne Pathogen ment. The coating is dried by forced
Directive promulgated by the federal Oc- air or vacuum. Alternatively, additives
cupational Safety and Health Administra- that are dispensed into the tube as a
tion (OSHA).10 Provisions of the new law fluid and remain as a liquid are con-
require changes to an institution’s current sidered “wet.” A gel barrier may also
exposure control plan to include ‘safety- be dispensed into the formed tube for
engineered’ products for blood collection. gel separator tubes.
The definition of safety-engineered med- After any additive or gel is inserted,
ical devices includes plastic evacuated the tubes are then evacuated and
tubes with shielded caps. stoppered. An evacuating-closure device
evacuates the interior of the tube and ap-
Manufacturing Evacuated plies a stopper to the opening of the
[I2] Packaging of Vacutainer™ tubes in Tubes tube.12 The tubes are subsequently labeled
vacuum cans. At least 2 standards organizations, appropriately. In the early days, evacuated
NCCLS and ISO, have promulgated stan- tubes were hand assembled and not steril-
306 dards for the manufacturer of evacuated ized, but now manufacturers in the United
Act define the regulatory framework for tubes.5,6 These standards define the tube States run automated machine lines and
medical device development, testing, ap- dimensions for compatibility with cen- sterilize their tubes. Sterilization is typi-
proval, and marketing. Additionally, the trifuges and automated instruments, draw cally accomplished by irradiation after
Federal Quality System Regulation and fill accuracy, types of additives and evacuation and is now only rarely
(QSR) and ISO define quality system additive tolerances, sterility, and labeling achieved through autoclaving.13 After
requirements for the manufacture of med- criteria. Manufacturers are encouraged to sterilization the tubes are wrapped and
ical devices.8,9 Any class I or II products follow these guidelines to obtain CE boxed for shipping.

laboratorymedicine> april 2003> number 4> volume 34 ©

Materials in Evacuated Tubes

Tubes
Today, evacuated tubes are available
in glass or plastic, although a trend to-
ward plastic is occurring due to recent
safety legislation.10 Most often, the plas-
tic material is polyethylene terephthalate
(PET). Glass and PET are viable materi-
als for the tubes because they are clear,
they can hold a vacuum for an extended

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period, and they have the toughness to
withstand centrifugation.14
There are benefits to using tubes
made from either material. The plastic
tubes are less likely to break and with the
growing concerns about the spread of
bloodborne pathogens, this is an impor-
tant safety feature. Furthermore, the plas-
tic tubes weigh less than glass tubes,
reducing costs associated with transport
and disposal. However, glass tubes pro-
vide a greater barrier to air and water
vapor transfer than PET. In later sections,
we discuss how this difference in barrier
properties affects tube expiration dates,
shelf-life properties, and preanalytical
variables.

Additives
Although there are evacuated glass
blood collection tubes without additives
used to yield serum, all other evacuated
tubes contain at least some type of addi-
tive. Many of these additives are the same
as those used in transfer tubes before
evacuated tubes were introduced. The
additives range from those that promote
faster clotting of the blood, to those that
enable anticoagulation, and to those that
preserve or stabilize certain analytes or
cells. The inclusion of additives at the
proper concentration in evacuated tubes
greatly enhances the accuracy and consis-
tency of test results and facilitates faster
turnaround times in the laboratory.
Additives may exist as either dry or
liquid (“wet”) in evacuated tubes depend- 307
ing on whether the tube is glass or PET,
and depending on the stability of the so-
lution. The NCCLS and ISO define the
concentrations of these additives
dispensed into tubes per milliliter of
blood. Although the additives themselves
may be stable in plastic evacuated tubes, [F2] Historical time line of evacuated tubes21

© laboratorymedicine> april 2003> number 4> volume 34

 International Council for Standards in shelf life of the product can limit the sta-
Web Sites for Major
Evacuated Tube
Manufacturers in the US T1 Hematology.15 EDTA is an efficient anti-
coagulant which does not affect cell
bility of biochemical additives. As a re-
sult, some of these additives are often
counts and minimally affects cell size. only available in glass tubes. When bio-
Name Brand Names EDTA prevents clotting by chelating cal- chemical additives are placed in plastic
cium, an important cofactor in coagula- tubes, they may require special packaging
Becton Dickinson & Co. BD Vacutainer™ tion reactions. The amount of EDTA per to maintain stability.
Franklin Lakes, NJ milliliter of blood is essentially the same Heparinized plasma is commonly
800-631-0174
www.bd.com/vacutainer for all 3 forms of EDTA (1.5-2.2 used in chemistry in STAT or routine
mg/mL).6 However, slight differences in analyses. Heparin is a mucopolysaccharide
Greiner Meditech VACUETTE®
hemoglobin may be observed between combined with a cation (Na+, Li+, NH4+)

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Baltimore, MD
888-286-3883 K2EDTA and K3EDTA due to dilutional to enhance its solubility. It anticoagulates
www.greiner-lab.com effects from K3EDTA.15 blood by inhibiting thrombin and Factor
Sherwood Davis & Geck MONOJECT® For coagulation testing, only liquid Xa. Evacuated heparin tubes contain 10
St.Louis, MO additives are currently available. This is to 30 USP units/mL blood.6
800-527-1973
www.kendallhq.com to preserve the 9:1 ratio (blood:citrate) A special additive mixture that is
recommended for coagulation testing.16 found only in glass evacuated tubes for
Sarstedt, Inc.* Monovette®
Newton, NC To maintain this ratio, coagulation tubes coagulation testing is called CTAD (citric
800-257-5101 are typically available in glass (to reduce acid, theophylline, adenosine, and dipyri-
www.sarstedt.com water loss). Evacuated plastic coagulation damole). The CTAD cocktail minimizes
*Sarstedt does not manufacture evacuated tubes, although tubes consisting solely of PET have spe- platelet activation after blood collection.18
these products can be used in aspiration mode to simulate cial packaging to prevent water vapor This additive is sensitive to light and is
evacuation.
from escaping over the shelf life of the currently only available in glass evacu-
tube. Also available are plastic evacuated ated tubes.
the water in which they are dissolved can tubes containing liquid additives with a Thrombin tubes are often used for
diffuse out of a plastic tube over time. If polypropylene insert tube within the PET STAT serum testing due to the short clot-
water vapor escapes from the tube, the outer tube. In such configurations, the ting time. Thrombin is an enzyme that
dilution provided by the remaining water inner polypropylene tube prevents the converts fibrinogen to fibrin. Thrombin
in the tube is reduced, potentially affect- loss of water vapor, while the outer PET tubes are available in either glass or plas-
ing results. Using the products within the tube preserves the vacuum. tic. Plastic thrombin tubes require special
manufacturer’s stated shelf life ensures Trisodium citrate (Na3C6H5O7·2H20), packaging to protect against moisture.
minimal water loss and the correct blood- buffered or unbuffered, is the current Thrombin is dispensed into tubes to 2
to-additive ratio. standard anticoagulant for coagulation NIH units/tube.6
testing. Some manufacturers buffer with
Inorganic Additives citric acid to maintain the pH and mini- Gel
There are several different types of mize damage to the glass tube wall. Corning Medical’s, now Sherwood
inorganic additives in blood collection Some manufacturers may also coat the Medical, Corvac® tube was the first gel
tubes. These include those that are com- glass tube wall. Before coagulation test- tube marketed. BD gel tubes were intro-
pletely inorganic in composition, (eg, sil- ing became automated, several citrate duced in 1975, and BD re-introduced
ica and sodium fluoride), and those that concentrations in evacuated tubes were with a different gel material in 1976.
are alkaline metal salts of organic acids, available. Today, it is available as either a Terumo followed BD with the
[(eg, disodium ethylenediaminetetraacetic 3.2% or 3.8% concentration. Different AUTOSEP® tube in the early 1980s. The
acid (Na2EDTA), K3 or K2EDTA, citrate concentrations can have significant function of the gel is to provide a physi-
trisodium citrate, and potassium oxalate]. effects on aPTT and PT results so inter- cal and chemical barrier between the
Most dry additives tend to not be a limit- changing these within a laboratory is not serum or plasma and the cells. The usage
ing factor in determining the shelf life of recommended.16 The different citrate of gel barriers has provided a large bene-
the evacuated tube. concentrations affect different patient fit in collecting, processing, and storage
308 For hematology applications, EDTA populations and reagent responsiveness.17 of the specimen in the primary tube.
is available in 3 forms, including dry ad- Separator gels are capable of provid-
ditives (K2EDTA or Na2EDTA) and a Biochemical Additives ing barrier properties because of the way
liquid additive (K3EDTA). EDTA is com- Biochemical additives or enzymes they respond to applied forces. After
bined with a metal cation to enhance its (ie, heparin or thrombin) are susceptible blood is drawn into the evacuated gel
solubility and maintain pH. K2EDTA is to instability and/or degradation. Expo- tube, and once centrifugation begins, the
slightly more soluble than Na2EDTA and sure to irradiation during sterilization of g-force applied to the gel causes its vis-
is the anticoagulant recommended by the tubes and to moisture or light during the cosity to decrease, enabling it to move or

laboratorymedicine> april 2003> number 4> volume 34 ©

flow. Materials with these flow character- stability of the additive, as well as vacuum
istics are often called thixotropic. Once retention. The NCCLS and ISO state that
centrifugation ceases, the gel becomes an the draw volume of an evacuated tube
immobile barrier between the supernatant must be within ±10% of the label draw
and the cells. The nature of the movement throughout the shelf life.4,5 This limit is
of gels in evacuated blood collection set to minimize significant changes in
tubes is described elsewhere.19 blood-to-additive ratios. If the environ-
When first introduced, separator mental conditions under which evacuated
tubes contained a silicone gel, but these tubes are stored are not consistent with
were unstable after sterilization. Gels are those recommended by the manufacturer,
generally comprised of more than 1 com- it is possible that the draw volume of the

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ponent. They may consist of a primary tubes may be affected. In the next section,
organic phase, referred to as a resin, an we will discuss the potential impact of
inorganic powder, and a network stabi- such environmental factors on the draw
lizer.20 The inorganic phase is needed to volume of evacuated tubes.
adjust the density of the gel so that it is
between the density of the serum or Environmental Factors
plasma and the cells. To render the Affecting Evacuated Tubes
organic and inorganic phases compatible, It is important to understand that
a chemical stabilizer must be added as evacuated blood collection tubes are not
another component to the gel. Due to the completely evacuated. In fact, there is a
composite nature of gels, the shelf life of small amount of gas (air) still residing in
gel tubes is finite. the tube, at low pressure. The higher the
pressure of the gas inside the tube on the
Expiration Dates of Evacuated date of manufacture, the lower the
Tubes intended draw volume will be for a tube
The expiration dates of glass tubes are of a given size. The draw volume speci-
generally limited by the shelf life of the fied for a given tube is achieved by man-
additives because vacuum and water-vapor ufacturing the tube at a designated
losses are minimal over time. As reviewed evacuation pressure.
in the earlier sections, gels and additives The dynamics of blood collection in-
sensitive to irradiation and the environment side the tube are based on the ideal gas law:
are often the limiting factors in determining PV=nRT
expiration dates for glass tubes. In the equation, P is the pressure
The expiration dates of evacuated inside the tube, V is the volume that the
plastic tubes are often also limited by the gas occupies, n is the number of moles
same factors that were noted for glass of gas inside the tube, R is the universal
tubes. In addition, evacuated plastic tubes gas constant, and T is the temperature
do sustain a measurable loss of vacuum inside the tube.
over time, and some evacuated plastic According to the equation, if the
blood collection tubes may have their ex- moles of gas and the temperature do not
piration dates determined by their ability change, the product of pressure and vol-
to assure a known draw volume. Because ume is a constant. Consider now the role
of the lower water-vapor barrier proper- of the residual gas during the blood col-
ties of PET that have already been dis- lection process in an evacuated tube.
cussed, the expiration dates of wet When blood starts filling the tube, the
additive plastic evacuated tubes are deter- residual gas inside is confined into a de-
mined by the barrier provided either by creasing volume, causing the pressure of 309
the insert tube or by the special packag- the gas to increase. When the pressure of
ing. Most evacuated tubes on the market this gas reaches ambient pressure, the col-
have at least a 12-month shelf life. lection process is completed for that tube.
Expiration dates are determined Note that because there is gas inside
through shelf-life testing performed under the tube on the date of manufacture, envi-
known environmental conditions. Shelf ronmental conditions could alter the pres-
life of an evacuated tube is defined by the sure of this gas inside the tube during

© laboratorymedicine> april 2003> number 4> volume 34

 storage and impact the resulting draw vol- evacuated to lower pressures for 3. Kleiner J. “Blood collecting apparatus”, U.S.
ume. Therefore, it is important that tubes customers drawing blood at high altitude. Patent No. 2,460,641, August 1945.

be stored under recommended conditions. 4. Code of Federal Regulations. Food, Drug and
Cosmetic Act. Pub. L. No. 75-717, 52 Stat. 1040
Humidity (1038), as amended 21 U.S.C. §§ 301 et seq.
Temperature The impact of storage under different 1976.
To understand the impact of tempera- humidity conditions could potentially im- 5. International Standards Organization (ISO):
Single-use containers for venous blood specimen
ture on draw volume, the ideal gas law is pact only plastic evacuated tubes, due to collection. 6710, 1996.
again applied. According to the equation, the greater permeability of these materials 6. National Committee for Clinical Laboratory
if tubes are stored at low temperature, the to water vapor relative to glass. Condi- Standards (NCCLS): Evacuated tubes and
additives for blood specimen collection. H1-A4,
pressure of the gas inside the tube will tions of very high humidity could lead to December 1996;16(13).
decrease. This would lead to an increase the migration of water vapor inside a tube

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7. United States Code Public Law. - Safe Medical
in draw volume for the evacuated tube. that contains a moisture-sensitive mate- Devices Act. Standards for New Medical Devices
Conversely, higher temperatures could rial, such as a lyophilized additive. Condi- 101-629, 104 Stat. 4511 (1990).
cause reductions in draw volume. tions of very low humidity could hasten 8. Federal Register. US Food and Drug
Administration Reference 21 CFR 820. Medical
These reductions in draw volume the escape of water vapor from a tube Devices; Current good manufacturing practice
could be exacerbated at higher tempera- containing a wet additive. It is possible final rule; Quality system regulation.
1996;61(195).
tures in plastic evacuated tubes. This oc- that such storage conditions could com-
9. International Standards Organization (ISO):
curs because the permeability of the promise the accuracy of clinical results. Quality Systems - Medical devices – Particular
plastic to gas increases with increasing requirements for the application of EN ISO 9001,
temperature. Thus, more moles of gas mi- Light EN ISO 13485, 2001.

grate inside the tube resulting in greater As previously mentioned, the CTAD 10. Federal Register - Occupational Exposure to
Bloodborne Pathogens; Needlestick and Other
rates of draw loss over time. Additionally, additive is photosensitive. Normally, this Sharps Injuries; Final Rule. 66:5317-5325.
PET is less resistant to high temperatures additive has a slightly yellow appearance 11. Kasai M, Yamazaki S, Miyake S. “Blood
than glass. When plastic tubes are that becomes clear when no longer viable. collecting tube”, U.S. Patent No. 4,985,026,
January 1991.
exposed to very high temperatures These tubes are generally packaged in small
12. Hatakeyama T. “Vacuum blood collecting
(≥60°C), the plastic softens, and under quantities to minimize exposure to light. production appts. – has tubular container storage
worst-case conditions, may deform. feeder, pinhole checker, blood coagulant sprayer
dryer, and separating agent injector”. U.S. Patent
For plastic tubes that contain a liquid Summary No. 5,129,213, July 1992.
additive, the water-vapor permeability of Blood collection and analysis are useful 13. Antignani A, Cheng E, Evans J, Grippi, et al.
the tube will increase with temperature. diagnostic tools in the practice of laboratory “Method of using additive formulation and
This enables water to escape at a faster medicine. The advent of evacuated blood method for making tube with an additive
formulation”, U.S. Patent No. 6,187,553, February
rate, potentially altering the blood-to- collection tubes significantly improved accu- 2001.
additive ratio. racy and precision, safety, ease-of-use, 14. Wayman DJ. Plastic blood tubes improve safety.
Also, it should be noted that the sta- and speed of the diagnostic process. We Plastics News, 1994;June 6:52.
bility of certain other tube additives, for have shown the progression of technology 15. International Council for Standards in
Hematology. Recommendations of the ICSH for
example, biochemicals or even gel, could and regulatory events that have brought EDTA anticoagulation of blood for blood cell
be negatively impacted by increased tem- evacuated tubes to their current status. counting and sizing. Am J Pathol. 1993;100:371-
perature in evacuated tubes. As discussed We have discussed factors that influ- 372.
16. National Committee for Clinical Laboratory
above, gel is a heterogeneous compound ence evacuated tube performance. Tube Standards (NCCLS): Collection, Transport, and
that could possibly sustain some degrada- material, additive stability, and environ- Processing of Blood Specimens for Coagulation
tion when exposed to high temperatures. mental conditions impact the expiration Testing and General Performance of Coagulation
Assays. H21-A3, December 1998.
dates of certain tubes. It is important to
17. Adcock, DM, Kressin DC, Marlar RA. Effect of
Altitude store evacuated blood collection tubes 3.2% vs 3.8% sodium citrate concentration on
In situations where blood is drawn at under the conditions recommended by routine coagulation testing. Am J Clin Path.
1997;107:105-110.
high altitudes (≥5,000 feet), the draw vol- the manufacturer to assure an accurate
18. Narayanen S. Inhibition of in vitro platelet
ume again may potentially be affected. draw volume and clinical results over the aggregation and release and fibrinolysis. Ann Clin
Because the ambient pressure at high alti- shelf life of the product. Lab Sci. 1989;19:260-265.
310 tude is lower than at sea level, the pres- 19. Lin F-C, Cohen R, Losada R, et al. Cellular
sure of the residual gas inside the tube sedimentation and barrier formation under
1. Becton Dickinson and Company. Joseph Kleiner centrifugal force in blood collection tubes. Lab
will reach this reduced ambient pressure and the origins of the Vacutainer™. The Echo. Med. 2001;32:588-594.
during filling earlier than if the tube were Becton Dickinson and Company, Franklin Lakes, 20. Pradhan S, Narayanan S, Lin FC. “Blood
drawn at sea level. Hence, the draw vol- NJ: 1991 (Spring);11:3-5, 1991(September);11:5- partitioning composition”. U.S. Patent No.
7; 1996(December);16:1 4,994,393, February 1991.
ume will be correspondingly lower. Some
2. Bush VJ, Leonard L and Szamosi DI. 21. FDA Web Site. Available at: http://www.accessdata.
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laboratorymedicine> april 2003> number 4> volume 34 ©