by David S. Enterline MD
Examining prefilled syringes versus bottle-filled cartridges for contrast-enhanced CT examinations.
A decade ago, the introduction of the first spiral CT scanners
began a revolution in CT technology that continues to this day. The
increased speed of the new slip-ring scanners gradually increased
the capabilities, resolution, and clinical efficacy of CT. The new
capabilities provided by faster CT scanners led to the development
of new studies, such as multiphase examinations and CT angiography.
These developments have caused the clinical utilization of CT to
skyrocket. Indications for CT continue to grow, and there is an
increasing reliance on the modality for diagnosis and
intervention.
Among the changes brought about by spiral CT technology is a
re-examination of contrast-media dosing protocols. By taking
advantage of the increased speed afforded by spiral CT scanners,
many patient examinations can be performed quickly using a reduced
dose of contrast agent. The use of a power injector for contrast
media is now standard in part because it helps users take full
advantage of shorter examination times to increase patient
throughput. The combination of increased speed and potentially
reduced contrast dose makes this technology very attractive. At the
same time, increased financial pressures have resulted in staffing
reductions and tighter controls on capital budgets. These factors
contribute to increased workloads, and have necessitated
improvements in efficiency.
In 1998, the introduction of multidetector CT (MDCT) scanners
further increased examination speed. In fact, 16-detector scanners
are now up to 100 times faster than first-generation spiral CT
scanners.1 The increased capabilities of MDCT scanners are used to
shorten examination time, increase the data collected in the same
amount of time, or some combination of the two. The busy CT
department, however, needs more than a fast CT scanner. As scan
times decrease, the time needed for CT-suite setup and cleanup and
for patient preparation becomes a critical factor in departmental
efficiency. For the CT technologist, multitasking is the norm; the
technologist must keep the patient safe and comfortable, obtain
important patient information, perform equipment checks, administer
contrast, and lead the patient through the examination
effectively.
Supplies used for manual filling of contrast media syringes: empty syringe cartridge, transfer tubing, transfer straw, contrast bottle, and hand-control syringe. Figure reprinted with permission from Applied Radiology. Enterline DS. Prefilled syringes: applications in CT imaging. Applied Radiology. 2001;30(suppl):1-14.
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Approximately half of all CT examinations are performed using
contrast agents. While brain CT and some pediatric studies may
still be performed using a hand-injected bolus, the use of a power
injector is now standard for almost all contrast-enhanced
examinations. The technologist loads and operates the injector.
Poor technique can lead to technologist injury or to contamination,
misadministration, or the accidental injection of air.
Prefilled contrast media syringes simplify the tasks associated
with contrast injection. Prefilled syringes have a set volume and
concentration of contrast agent in a power injectorcompatible
syringe. They are considerably easier to use than bottle-filled
cartridges and reduce the possibility of contamination or
misadministration. According to a recent survey commissioned by the
American Society of Radiologic Technologists (ASRT), most CT
technologists prefer prefilled syringes to bottle-filled
cartridges, believing them to be safer and more efficient (12). Until now, however, the potential of prefilled syringes to
improve efficiency has not been evaluated scientifically. For this
reason, a multicenter time-and-motion analysis of the efficiency of
using prefilled syringes was undertaken in 2002.
METHODS
Independent observers from a company specializing in
time-and-motion evaluations monitored and recorded the time
necessary to perform the steps of contrast-enhanced CT
examinations. The four participating sites were Duke University
Medical Center, Durham, NC; Massachusetts General HospitalWest
Imaging, Waltham, Mass; MD Anderson Cancer Center, Houston; and
Charleston Area Medical CenterGeneral Division, Charleston, W Va.
None of these institutions had been using prefilled syringes prior
to the study.
The contrast-enhanced CT examinations of 401 patients were
studied. Of these 401 examinations, 206 were performed using
prefilled syringes and 194 were performed using bottle-filled
cartridges. In one instance, the contrast loading method was not
recorded. The bottle-filled cartridge method involves tearing the
seal off of a vial of contrast medium, drawing the contrast into a
syringe compatible with a power injector, labeling the syringe
according to departmental guidelines, and disposing of the used
supplies. When using a prefilled syringe, the technologist selects
the syringe, removes the rubber safety cap, and installs the
syringe in the injector head. With both methods, care must be taken
to expel any air before administering contrast to the patient.
In this study, time data points were recorded for total patient
time in the room, scan setup time, total scan time, contrast
loading time, contrast cleanup time, and room cleanup time.
Scan setup time was defined as the interval between the
patient's entry of the room and the initiation of the CT scan.
Activities typically performed during this time are patient
positioning, establishment of intravenous (IV) access, and console
setup. Scan time was measured from the initiation of the CT scan
until the end of scanning. This phase included entering data,
obtaining all preliminary and standard images, and reviewing the
images. Contrast loading time was defined as the time needed to
complete all elements of loading the power injector (getting
contrast, loading the contrast into the injector, and purging air
from the extension tubing). Contrast cleanup time was also
monitored; this consisted of the time needed to remove the contrast
cartridge and connection tubing and discard it, as well as to wipe
the power injector when necessary. Room cleanup time was defined as
the time used to escort the patient from the room, clean the room
(including the table and scanner), and change the linens for the
next patient.
The project was approved by the institutional review boards of
each of the four participating centers. Since the study did not
affect the care provided to patients, no patient consent process
was deemed necessary. Participating technologists completed a form
indicating their consent to be monitored, as well as a short
opinion survey on prefilled syringes. Time-and-motion
data were recorded only by objective, trained monitors using
stopwatches. The monitors observed the actions of the technologists
from a distance, in an unobtrusive manner. Data were recorded for
each of the activities described. Type of examination;
patient-location category (inpatient, outpatient, or emergency
department); contrast medium concentration; contrast volume; and
injection rate were also recorded.
This study was designed to have a 95% confidence interval.
Time-and-motion data from individual observations were entered into
a database, tabulated, and summarized. Mean time intervals were
calculated for each of the periods described. Differences in the
mean time intervals recorded using the two contrast methods were
compared using an independent two-tailed unpaired t test, with
statistical significance determined as P<.05.
Efficiency gains for various study components were expressed as
a percentage of the mean time recorded using bottle-filled
cartridges. For example, the prefilled syringe contrast loading
time efficiency was derived as the result of bottle-filled
cartridge contrast loading time minus prefilled syringe contrast
loading time divided by bottle-filled cartridge contrast loading
time.
RESULTS
Distribution of contrast methods by site is found in Table 1. At
MD Anderson Cancer Center, most examinations were performed using
prefilled syringes; at Duke University Medical Center,
approximately two thirds of examinations were conducted using
bottle-filled cartridges. The distribution of examination types is
found in Table 2. Most examinations monitored were performed in
outpatient settings. Of all examinations monitored, 89% were
outpatient, 8% were for inpatient, and 3% were performed in the
emergency department.
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The most frequently monitored examination was CT of the abdomen
and pelvis or abdomen, which accounted for 38% of examinations
monitored, followed by CT of the chest, abdomen, and pelvis (23%)
and CT of the chest (18%). The type and concentration of contrast
used was recorded in 400 of 401 examinations. The contrast agent
most often used in the study was iopamidol, used in 289 procedures,
followed by iohexol (63 procedures), ioversol (41 procedures), and
iopromide (8 procedures). Most studies (73%) were performed using a
contrast-medium concentration of 300 mg I/ml; the remaining
examinations were performed using concentrations of 320, 350, or
370 mg I/ml. The prefilled syringes used in this study contained
iopamidol in all cases but one. The mean volume of contrast
administered in this evaluation was 130 ml (range: 30 to 200 ml).
Contrast media were administrated at a mean rate of 2.5 ml per
second (range: 0.5 to 5 ml per second). Differences between the two
methods in terms of mean contrast volume (129 ml for prefilled
syringes and 132 ml for bottle-filled cartridges) or mean injection
rate (2.43 ml per second for prefilled syringes and 2.57 ml per
second for bottle-filled cartridges) were not statistically
significant.
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In 14 cases, data were excluded from the final analysis of time
efficiency. Five of these cases represent a single missing data
point. In eight cases, excessive time (defined as a value of
greater than twice the mean value) passed while the patient waited
in the room for an IV to be restarted or for patient transport. In
these cases, the time value was considered an outlier, and the
entire examination was excluded from the efficiency analyses. In
one case, an intervention was performed (after initial scanning)
that took substantially more than twice the mean scan time. Of the
remaining 387 examinations, 202 were performed with prefilled
syringes and 185 with bottle-filled cartridges.
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The mean times measured for the various parts of the CT
examination are shown in Table 3. Statistically
significant improvements in mean times were noted when
technologists used prefilled syringes for the following study
components: contrast loading time, room setup, disposal of
supplies/injector cleanup, and overall patient time in the
room.
As expected, prefilled syringes showed the greatest time savings
over bottle-filled cartridges for those activities most closely
dependent on the contrast method used, such as contrast loading
time and disposal of supplies/injector cleanup. Overall, recorded
examination times in the prefilled syringe group were approximately
9% shorter than those in the bottle-filled cartridge group, but how
much of this improvement is attributable to the contrast method is
unclear. One explanation for the improved overall examination time
in the prefilled syringe group is the slightly increased proportion
of inpatient examinations performed using bottle-filled
cartridges.
(1) (Load time BFC - Load time PFS)/Load time BFC (2) (Injector clean time BFC - Injector clean time PFS)/Injector clean time BFC (3) (Setup time BFC - Setup time PFS)/Setup time BFC (4) (Load time BFC - Load time PFS) + (Injector clean time BFC - Injector clean time PFS)/Patient time in room BFC
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The calculated efficiency improvements for prefilled syringes
for contrast loading, setup time, and overall patient time in the
room (expressed as a percentage of bottle-filled cartridge time)
are shown in Table 4. As expected, the greatest gain in
efficiency came from the contrast loading time. Overall setup time
and overall patient time, which are measures progressively less
sensitive to factors related to contrast administration, show
smaller efficiency gains overall. Taken together, contrast-related
activities account for 8.8% of total patient time in the room.
Therefore, the theoretical maximum increase possible in overall
study efficiency was less than 9%. In this study, we demonstrated a
3% increase in overall efficiency due to the use of prefilled
syringes, a finding consistent with a 33% decrease in injector
loading time.
*One week = 5 full days and one half day of CT operation **One year = 5 full days and one half day of CT operation for 52 weeks (#)Days here = 9-hour scanning days (@)Days here = 14-hour scanning days
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The total mean time savings in the prefilled syringe group
attributable to the contrast method selected was 39 seconds. The
potential effect of a time savings of 39 seconds per study is
modeled in Table 5 for a variety of clinical settings. It is
assumed that 50% of all examinations are contrast enhanced. It is
further assumed that a noncontrast examination requires
approximately 60% as much time as a contrast examination, since
noncontrast examinations do not require IV access or contrast
preparation time and tend to have shorter scan durations.
DISCUSSION
Radiologic technologists are in short supply. There is a 15.3%
hospital job-vacancy rate for imaging technologists, surpassing the
rate for the more publicized nursing shortage, as reported in a
study by the American Hospital Association.2 A shortage of
technologists is reported in 71% of hospitals, resulting in a
market where the most experienced technologists often go to the
highest bidders. Therefore, improving salaries, benefits, and work
conditions has become essential to staff retention. This means that
CT departments must place a higher value on job satisfaction and
favorable work conditions for technologists.
The recent introduction of prefilled contrast-media syringes
compatible with a specific power injector potentially allows for
more rapid loading and cleanup of the injector. In addition,
prefilled syringes minimize the risk of contrast spilling on the
technologist, contamination of the contrast through lapses in
sterile technique during filling, and misadministration of contrast
due to mislabeling. Significant air bubbles can be generated by
rapid aspiration of contrast from a bottle, so prefilled syringes
minimize the risk of air-bubble injection. There is also a
decreased potential risk of breakage, since prefilled syringes are
plastic, but bottles of contrast are glass. Prefilled syringes are
also more compliant with new medication standards proposed by the
Joint Commission on Accreditation of Healthcare Organizations3
stating that, to ensure safe and accurate dispensing of
medications, all medications must be appropriately and safely
labeled using a standardized method. The standards further state
that medications are to be dispensed in the most
ready-to-administer form possible to minimize opportunities for
error.3 Prefilled syringes fulfill these criteria much better than
hand-filled syringes. Frequently, bottle-filled cartridges or
syringes filled with contrast are not fully labeled. The potential
advantages of prefilled syringes have been discussed at
length.4
The impressive gain in efficiency shown by this study may
actually underestimate the efficiency gains possible through use of
prefilled syringes. The participating centers were not using
prefilled syringes prior to the study, and only 2 of 29
technologists monitored for the study had extensive experience
using prefilled syringes; in effect, the participating centers were
at the bottom of the learning curve. It is likely that greater
efficiency could be realized at centers that have already
incorporated prefilled syringes into their departmental
routines.
This study has some limitations. The overall time-and-motion
data are very sensitive to issues not related to contrast
administration. In fact, only 8.8% of total examination time was at
all related to contrast preparation, injection, or cleanup. A
further limitation was that the patient populations from the
participating centers were not balanced in terms of patient source
(inpatient, outpatient, or emergency department) or contrast method
used. Since the data collected in this study are heavily skewed
toward outpatient examinations, the study findings are most
relevant for the outpatient setting. Contrast examinations,
however, are more common in this group of patients. However,
contrast examinations are more common in this group of
patients.
CONCLUSION
In this study, contrast loading times decreased 33% when
prefilled syringes were used. In addition, room setup efficiency
increased 10% and overall examination efficiency increased 3%.
These findings suggest that the use of prefilled syringes can
potentially increase CT department throughput while improving
technologists' satisfaction levels. As actual scanning times
continue to decrease, the time spent administering contrast will
become an increasingly large part of overall examination time,
making efficiency differences between prefilled syringes and
bottle-filled cartridges even more pronounced. Modeling the data
obtained in this study shows that a facility could save from 4 to 8
days per year per scanner by converting to prefilled-syringe use,
depending on workloads and scheduling efficiency. If the time saved
by using prefilled syringes is used to perform additional
examinations, the revenue generated might offset or exceed the
incremental cost of converting to prefilled contrast-media
syringes.
JCAHO Proposed Revisions to Medication Use Standards
In the interest of ensuring the safe and accurate dispensing of medications, the Joint Commission on Accreditation of Healthcare Organizations has proposed regulations ensuring that all medications must be appropriately and safely labeled using a standardized method. The relevant sections, TX.3.9 and TX.3.10 are printed below in their entirety.
STANDARD
TX.3.9. All medications are appropriately labeled.
INTENT OF TX.3.9
All medications dispensed to, or otherwise prepared for use, in patients are appropriately and safely labeled using a standardized method according to applicable law and regulation, accepted standards of practice, and organizational policy. At a minimum, all medication labels should include: drug name, strength, amount (if not apparent by the container - e.g. gradations on a syringe), and expiration date. If dispensed for administration by another individual then any applicable cautionary statements must be included on the medication label or attached as an accessory label (eg, requires refrigeration, for IM use only, etc.). In addition, all compounded intravenous admixtures and TPN solutions must be labeled with the scheduled date, time and rate of administration, when appropriate. All labels for infusions products (including plain IV's) must have the label on the container, which is being hung for a patient (i.e., not the overwrap).
The only medications that do not need to be labeled are those drawn-up for immediate administration to the patient, or those already appropriately labeled. Anytime one or more medications are drawn-up or prepared for later use, the container (e.g. syringe, bottle) must be appropriately labeled. In addition, every drug must be labeled during any intermediate step of the preparation process, if the medication could possibly be confused or mistaken for another. When a commercial label is on the medication container, the organization label should not cover it. Information on the commercial label does not need to be duplicated on the organization's label.
When the organization provides pharmacy services, and medications are prepared, dispensed, or distributed by departments other than the pharmacy, including physician offices, the organization must assure that the labeling requirements and information on the label are equivalent throughout the organization.
STANDARD
TX.3.10 When pharmacy services are provided by the organization, a safe and effective patient medication dose distribution system is implemented.
INTENT OF TX.3.10
When pharmacy services are provided, the pharmacy is responsible for the control and distribution of all medications used in the organization. When departments other than the pharmacy distribute medications, the pharmacy must design, monitor and assure that the medication distribution system and controls used meet applicable law and regulation, accepted standards of practice and organizational policies and procedures.
To ensure safe and accurate dispensing of medications, medications are dispensed in the most ready-to-administer form possible to minimize opportunities for error.
Unit dose or unit-of use packaging is used for any drug where accuracy in dosing is required and the medication is available from the manufacturer in such packaging, or repackaging into unit-dose is feasible to do.
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The study reported here was funded, in part, by an educational
grant from Bracco Diagnostics Inc. Data collection for the time and
motion study was managed by Dale Ewalt, VP, Collaborative Group,
Hunt Valley, Md.
David S. Enterline, MD, is assistant professor of radiology, Duke University Medical Center, Durham, NC.
References:
- Rubin GD. Techniques for performing multidetector-row computed tomography angiography. Techniques in Vascular and Interventional Radiology. 2001;4:2-14.
- AHA Commission on Workforce for Hospitals and Health Systems. In Our Hands: How Hospital Leaders Can Build a Thriving Workforce. Chicago: American Hospital Association; 2002.
- Joint Commission on Accreditation of Healthcare Organizations. Compre-hensive accreditation manual for hospitals: proposed revisions to medication use standards. Sections TX.3.9 and TX.3.10. Available at: http://www.jcaho.org. Accessed January 17, 2003.
- Enterline DS. Prefilled syringes: applications in CT imaging. Applied Radiology. 2001;30(suppl):1-14.