Assessment of the effectiveness of standardized infusion devices for healthcare management

doi:10.4236/health.2011.32017

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Vol.3, No.2, 93-98 (2011)

doi:10.4236/health.2011.32017

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: [email protected]

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.

S. Sugita et al. / Health 3 (2011) 93-98

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,

S. Sugita et al. / Health 3 (2011) 93-98

9595

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

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

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

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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