Vol.3, No.2, 93-98 (2011)
doi:10.4236/health.2011.32017
C opyright © 2011 SciRes. Openly accessible at http://www.scirp.org/journal/HEALTH/
Health
Assessment of the effectiveness of standardized
infusion devices for healthcare management
Shio Sugita1*, Hideko Aida2, A ya Okada3, Hiroyuki Kobayashi2
1Former Department of Nursing, Juntendo University Hospital, Tokyo, Japan; *Corresponding Author:
2Department of H o spital Administration, Juntendo University School o f Medici ne, Toky o, Japan
3Department of Nurs i n g , Junte ndo University Nerima Hospital, Tokyo, Japa n
Received 6 December 2010; revised 10 February 2011; accepted 15 February 2011.
ABSTRACT
Since standardization is an important safety
measure in healthcare systems, it is essential to
systematically assess the effects of introducing
new and increasingly complex medical equip-
ment, such as infusion dev ices. In this study, we
compared the effects of standardized polyvinyl
chloride (PVC)-free closed-system integrated
infusion devices with conventional infusion de-
vices. S pecifically, we assessed the s afe ty, work
efficiency, user-friendliness, and cost effec-
tiveness of these devices. Compared with con-
ventional infusion devices, integrated PVC-free
infusion devices were more expensive to pur-
chase and dispose, but were safer and more
user-friendly and efficient. Although it would be
preferable to use standardized infusion devices
in all hospital departments, their cost may limit
their application to departments that use
high-risk treatments, where they w ould be most
beneficial.
Keywords: Standardized Infusion Devices;
Efficiency Assessment; Healthcare Ma nagement;
Nursing Administration
1. INTRODUCTION
The use of infusion devices is complex and diverse,
due to not only differences in the pharmacological
agents that are infused but also the material of infusion
devices and their use with electronic medical equipment,
which can lead to medical accidents. According to the
Japan Council for Quality Health Care, 92 out of 1440
reports that were received from 204 medical institutions
during 2008 involved “management-related items” and
“the use of drains and tubes,” including extravasations of
intravenous infusions [1]. In addition, some previous
studies also have reported cases in which the combina-
tion of tubes and drugs caused dissolution and elution of
the highly toxic substance diethylhexyl phthalate (DEHP)
[2-4] and lipid-soluble drugs that caused cracks at the
connections of tubes, which caused leakage of the drug
[5-7]. After receiving reports of these cases, all medical
institutions in Japan have begun regulating the use of
infusion devices according to the composition of the
devices, such as polyvinyl chloride (PVC)-free, DEHP-
free, or conventional materials. However, this regulatory
process requires the medical staff to have extensive
knowledge about the selection and handling of infusion
devices, which depends on many factors, such as the
intended purpose of infusion, drug, drip rate, and the
patient’s condition.
In a previous study, we analyzed the risks that are as-
sociated with different pharmacological agents, infusion
routes, catheter-related infections, and electronic equip-
ment. Specifically, we selected PVC-free closed-system
integrated infusion devices (hereafter referred to as
standardized infusion devices) as the reference standard
in our hospital and introduced these devices into the
chemotherapy department, where strict control of the
safety of injections is required. Then, to determine the
effectiveness of these devices, we compared the time and
cost that was required to prepare these devices with
those of conventional devices, which consisted of a
combination of an infusion set, a T-shaped stopcock, and
an extension tube. The results showed that standardized
infusion devices improved work efficiency. However,
these devices were not as cost-effective as conventional
devices due to the cost of materials and the weight of
wastes [8].
In this study, we conducted a more comprehensive
study to assess the effectiveness of standardized infusion
devices, including their safety and user-friendliness.
2. SUBJECTS AND METHODS
This study was conducted in accordance with the
guidelines of our institutional review board.

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2.1. Comparison of the Incidence of
Adverse Events before and after the In-
troduction of Standardized Infusion
Devices
The safety of standardized infusion devices was as-
sessed by comparing the incidence of adverse events in
the medicine department and in the chemotherapy de-
partment. The study was conducted for 10 d before in-
troducing the standardized infusion devices and for 10 d
2 months afterwards. A check sheet was used to record
the number of patients who received an infusion every
day and the number of adverse events that occurred.
Then adverse events were checked: 1) “Leakage of drug
solution due to loosening (unfastening) of the connector
of the infusion device”, 2) “Leakage of drug solution due
to loosening of the joint between the intravenous needle
and the infusion device”, 3) “Attempts to disconnect the
joint manually were unsuccessful”, 4) “There was a
crack in the three-way stopcock”, 5) “The T-shaped
stopcock and the protective cap became dirty”, 6) “The
connector was no longer sterile after an infusion route
was established”, 7) “No infusion set was available for
the infusion pump that was used”, 8) “No infusion set
was available for the type of pharmacological agent that
was selected”. The incidence of adverse events was cal-
culated as the number of adverse events that occurred
per patient per day, and the number of adverse events
was calculated as the number of days in the survey pe-
riod divided by the number of patients. The incidence of
adverse events before and after the introduction of stan-
dardized infusion devices was compared by using
Fisher ’s exact test. The level of significance was defined
as 0.05.
2.2. Survey of User-Friendliness and Safety
Between February 21, 2008, and March 5, 2008, an
anonymous survey was conducted among 45 nurses who
worked in the medicine department and chemotherapy
department, where standardized infusion devices had
been used for more than 3 months. The survey asked
multiple-choice and yes/no questions about the user-
friendliness and usefulness of standardized infusion de-
vices, such as the ease of preparing the administration
route and precautions that were needed to ensure sterile
operation as well as free-response questions about the
perceived advantages and desired improvements in
standardized infusion devices. Specifically, the user-
friendliness of standardized infusion devices was com-
pared with conventional infusion devices by 5 categories:
“better”, “slightly better”, “same”, “slightly worse” and
“worse”. In addition, the usefulness of the all-in-one
nature, PVC-free components, and lock-type system of
standardized infusion devices and whether continued use
was desired was determined by “yes”, “no”, or “neither
yes nor no” responses.
For ethical reasons, we conducted this survey anony-
mously by allowing respondents to drop completed
questionnaires into a collection bag during a 2 week pe-
riod. Statistical analysis of the survey responses was
performed by using Mann-Whitney U tests with JMP 6
data analysis software. The level of significance was
defined as 0.05.
3. RESULTS
3.1. Comparison of the Incidence of
Adverse Events before and after the In-
troduction of Standardized Infusion
Devices
The incidence of adverse events before and after the
introduction of standardized infusion devices is summa-
rized in Table 1. One hundred forty-seven patients re-
ceived infusions during the survey period before stan-
dardization, while 389 patients received infusions after
standardization. The incidence of 4 different adverse
events decreased after the introduction of standardized
infusion devices. First, the incidence of the adverse
event “Leakage of drug solution due to loosening of the
joint between the intravenous needle and the infusion
device” decreased from 0.00204 events per patient per
day before the introduction to 0 afterwards. Second, the
incidence of the adverse event “Attempts to disconnect
the joint manually were unsuccessful” decreased from
0.00272 events per patient per day before the introduc-
tion to 0.00026 events per patient per day afterwards.
Third, the incidence of the adverse event “The T-shaped
stopcock and the protective cap became dirty” decreased
from 0.00272 events per patient per day before the in-
troduction to 0 afterwards. Fourth, the incidence of the
adverse event “Leakage of drug solution due to loosen-
ing (unfastening) of the connector of the infusion de-
vice” decreased from 0.00068 events per patient per day
before the introduction to 0.00026 events per patient per
day after wards. No other adve rse events o ccurred before
or after the introduction of standardized infusion de-
vices.
3.2. Survey of User-Friendliness and Safety
Forty-one out of 45 surveys were returned. Eleven out
of the 13 questions about the convenience of infusion
devices showed a statistically significant difference be-
tween the standardized and conventional infusion de-
vices, which indicated that the standardized infusion
devices were very user-friendly (Figure 1). In addition,

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Table 1. Comparison of the incidences of adverse events before and after the introduction of standardized infusion devices.
Adverse events Before After Before After
Number of patients who received infusio ns during the 10-day survey period 147 389 Number of occurrences/
patient/day
1) Leakage of drug solution due to loosening (unfastening) of the connector of the in fu-
sion device. 1 1 0.00068 0.00026
2) Leakage of drug solution due to loosening of the joint between the intravenous needle
and the infusion device. 3 0 0.00204 0.00000*
3) Attempts to disconnect the joint manually were unsuccessful (strong union). 4 1 0.00272 0.00026*
4) There was a crack in t h e t h ree-way stopcock. 0 0 0.00000 0.00000
5) The T-shaped stopcock and the protective cap became dirty. 4 0 0.00272 0.00000**
6) The connector was no longer sterile after an infusion route was established. 0 0 0.00000 0.00000
7) No infusion set was available for the infusion pump that was used . 0 0 0.00000 0.00000
8) No infusion set was available for the type of pha rmacological agent that was selected.0 0 0.00000 0.00000
Before: Before the introduction of the use of standardized infusion devices; After: After the introduction of the use of standardized infusion devices; * = p <
0.01 ** = p < 0.05.
Figure 1. Comparison of the user-friendliness of conventional and standardized infusion devices.
63.4% of respondents found the all-in-one nature of
standardized infusion devices to be useful, 95.1% stated
that their PVC-free properties were useful, 80.5% found
the lock-type system of the devices to be useful, and
70.7% indicated that they desired to continue using the
standardized infusion devices (Figure 2).
The following responses were listed as perceived ad-
vantages of standardized infusion devices: ease of pre-
paring the administration route; robust connection; no
need to select administration routes for every drug; ease
of tying the side tube without leakage of the drug solu-
tion; no need to select a compatible pump for the infu-
sion device; no risk of selecting the incorrect pump set-
ting; and no need for a protective cap for the T-shaped
stopcock. In addition, in the chemotherapy department,
the following benefits were repeatedly emphasized: no
leakage of the drug solution at the connection between
the intravenous needle and the infusion device; no risk
Openly accessible at

S. Sugita et al. / Health 3 (2011) 93-98
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96
Figure 2. Comparison of the usefulness of conventional and standardized infusion devices.
of selecting an inappropriate infusion device for each
drug; the ability to manually adjust the drip rate even
when infusion sets for pumps are used; and less time
needed to establish an intravenous route.
The following improvements were desired in stan-
dardized infusion devices: simpler evacuation of air
when connecting the side tube, miniaturization of the
structure that connects the intravenous needle to the in-
fusion device, improved description of the device on the
package, and a way to adjust the length of the infusion
device.
4. DISCUSSION
4.1. Safety Assessment
Our results showed that the incidence of adverse events
involving leakage of drug solutions decreased from an
incidence of 0.00204 per patient per day before the in-
troduction, to 0 after the introduction of standardized
infusion devices. Although the possibility of occurrence
of an incidence of drug solution leakage is very small,
the preparation of infusion routes is a routine method in
our hospital. Therefore, we consider this result to be
significant. Furthermore, this result is consistent with
our findings in a previous study [8]. Leakage of a drug
solution from an infusion device is a significant problem
in intravenous pharmacotherapy because the amount of
drug that enters the body will be less than desired and
cutaneous disorders may develop as a result of exposure
to the drug solution. Moreover, it is pointed out that the
additional medical costs are caused by incidents [9].
Previous studies have demonstrated that closed-system
devices, such as the standardized infusion devices in this
study, reduce the risk of infection [10]. Our results also
showed that the introduction of standardized infusion
devices reduced the incidence of adverse events involv-
ing manual operation and loss of sterility, which sug-
gested that these devices decrease the risk of infection
during their preparation and at the time of connection.
Collectively, these results demonstrated that standard-
ized infusion devices are safer than conventional infu-
sion devices. Furthermore, we think that an extensive
comparison of the incidence of adverse events by in-
creasing the number of samples is required in th e future.
4.2. Assessment of User-Friendliness
The results of the survey showed that standardized
infusion devices were more user-friendly than conven-
tional infusion devices in all aspects of their use, includ-
ing time, operation, cleaning, and risk of adverse events.
Moreover, the favorable responses to questions about
precautions that are needed for cleanliness of operation
and the ease of operation at the time of replacement
combined with the fact that standardized infusion de-
vices can be operated with precision suggested that any-
one can use these devices, even in emergencies. The
simple operation of standardized infusion devices is im-
portant because the most common causes of accidents
involving pharmacological agents during 2008 were
“lack of verification,” “insufficient knowledge,” and
“mistaken judgment,” while the most commo n causes of
tube-related accidents were “lack of verification” and
“mistaken judgment” [1]. To prevent adverse reactions
between the pharmacological agent and the materials
used in the infusion device and pump, it is necessary to
know how to select materials and instruments that are
appropriate for particular drugs. As a result, continuing

S. Sugita et al. / Health 3 (2011) 93-98
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9797
education about drugs and the properties of medical ma-
terials is necessary. However, since standardized infu-
sion devices are made with PVC-free components, it is
not necessary to use a specific infusion device for spe-
cific drugs. As a result, standardization not only simpli-
fies the practice but also the educational requirements of
infusion management.
These conclusions are supported by the finding that
most of the respondents in this study considered the
physical characteristics of standardized infusion devices
useful and desired to continue using them. Moreover,
their free responses indicated that standardized infusion
devices are safe, effective, and easy to use.
4.3. Assessment of Usability
In addition to safety and user-friendliness, we also as-
sessed the usefulness of standardized infusion devices in
terms of their work efficiency and cost-effectiveness. In
our previous study, we measured the work efficiency of
infusion devices by measuring the time that was needed
to prep are an in fusi on dev ice . We found th at th e pr epar a-
tion time for standardized infusion devices (55.8 (12.0) s)
(mean (SD) was shorter than that for conventional infu-
sion devices (96.1 (22.4) s) (Figure 3). In the chemo-
therapy department, the preparation time of conven tional
and standardized infusion devices was (97.0 (22.0)
mind-1) and (22.0 (3.0) mind-1), respectively. Thus, the
introduction of standardized infusion devices improved
the work efficiency of infusions by decreasing the time
that was required to select different products for each
drug [8].
In our previous study, we also determined the
cost-effectiveness of infusion devices by performing a
cost simulation of the purchase price of the devices, la-
bor costs for improving their work efficiency, and the
amount of medical waste they generated. We showed
that the cost of conventional infusion devices was
¥280,405 (Japanese Yen) for central venous routes and
¥1,003,019 for peripheral venous routes. In addition, we
predicted that the purchase price of standardized infu-
sion devices is higher than that for conventional devices,
despite the costs of medical waste disposal and labor
associated with improving work efficiency (Table 2) [8].
As a result, although standardized infusion devices are
more expensive than conventional infusion devices, the
standardized devices are safer and more user-friendly
and efficient. Ideally, standardized infusion devices
should be used in all hospital departments; however,
their higher cost may limit its introduction to depart-
ments that use high-risk treatments, such as the chemo-
therapy department, intensive care unit, and pediatric
ward, where they would be most beneficial.
Figure 3. Comparison of the time required to prepare a
fluid infusion route using conventional and standardized
infusion devices. (Sugita, S., et al. Evaluation of the cost
effectiveness and work efficiency of the use of standardized
infusion devices. Japanese Journal of Health Care Man-
agement, 9(4), 2009).
Table 2. Cost simulation.
Price
(Japanese
Yen/device)
Disposal
costs
(Japanese
Yen/100
devices)
Number
(devices/
month)
Price
(Japanese
Yen/month)
Disposal
costs
(Japanese
Yen/month)
Total costs
(Japanese
Yen/month)
Standardized-
Conventional
(Japanese
Yen/month)
Eliminated
personnel
costs
(Japanese
Yen/month)
Predicted costs after
the introduction of
the use of the
standardized type of
devices (Japanese
Yen/month)
Conventional 1,510 597 750 1,132,5004,475 1,136,975
Central
venous
infusion Standardized 1,900 663 750 1,425,0004,974 1,429,974+292,999 -12,594 +280,405
Conventional 480 454 9000 4,320,00040,856 4,360,856
Peripheral
venous
infusion Standardized 600 438 9000 5,400,00039,438 5,439,438+1,078,582-75,563 +1003,019
Sugita, S., et al . Evaluat ion of the cost effectiveness and work efficiency of the use of standar dized i nfusion devices . Japanese Jo urnal of Health Care Manage-
ent, 9(4), 2009. m

S. Sugita et al. / Health 3 (2011) 93-98
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98
Due to the increasing complexity of drug regimens
and drug-delivery devices, it is increasingly difficult to
perform cost-benefit analyses of all new medical equip-
ment. However, comprehensive assessments are impor-
tant to effectively implement and manage health safety
measures. In this study, we analyzed 4 different aspects
of infusion devices, which are considered to be compre-
hensive. Moreover, we consider that our future tasks are
to introduce this study results to another hospital and
then to be calculated based on the situation in that hos-
pital.
To enhance the safety of healthcare services, medical
devices should be stand ardized. In addition, standardiza-
tion should be applied at all medical institutions nation-
wide. Furthermore, pharmaceutical and medical equip-
ment companies should work with medical institutions
to improve the safety of drug delivery systems to help
develop safer and more effective medical care.
5. CONCLUDING REMARKS
To determine the overall effectiveness of using stan-
dardized infusion devices, we assessed their safety, work
efficiency, user-friendliness, and cost-effectiveness. Our
results showed that standardized infusion devices are
more expensive than conventional infusion devices;
however, standardized infusion devices are safer and
more user-friendly and efficient. Ideally, standardized
infusion devices should be used in all hospital depart-
ments, but their higher costs may limit their use to de-
partments that use high-risk treatments, where they
would be most beneficial. This study highlights the ad-
vantages of standardizing medical equipment, which is
important for improving healthcare management and
administration.
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