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Medical equipment management is an important issue for safety and cost in modern hospital operation. In addition, the use of an efficient information system effectively promotes the managing performance. In this study, we designed a framework of medical equipment management system used for in-house clinical engineering department. The system was web-based, and it integrated clinical engineering and hospital information system components. Through related information application, it efficiently improved the operation management of medical devices immediately and continuously. This system has run in the National Taiwan University Hospital. The results showed only few examples in the error analysis of medical equipment by the maintenance sub-system. The information can be used to improve work quality, to reduce the maintenance cost, and to promote the safety of medical device used in patients and clinical staffs.
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Abstract—Medical equipment management is an important
issue for safety and cost in modern hospital operation. In
addition, the use of an efficient information system effectively
promotes the managing performance. In this study, we
designed a framework of medical equipment management
system used for in-house clinical engineering department. The
system was web-based, and it integrated clinical engineering
and hospital information system components. Through related
information application, it efficiently improved the operation
management of medical devices immediately and continuously.
This system has run in the National Taiwan University Hospital.
The results showed only few examples in the error analysis of
medical equipment by the maintenance sub-system. The
information can be used to improve work quality, to reduce the
maintenance cost, and to promote the safety of medical device
used in patients and clinical staffs.
I. INTRODUCTION
ODAY's medical environment is highly dependent on
various types of medical equipment to complete the
diagnosis and treatment for patients with care. These medical
devices must be kept in good condition to prevent from
injuries occurred in patients as well as in users. Moreover, to
face the tough competition environment and complex health
care system, the hospital should take the appropriate cost
controls in response to that situation. The clinical engineering
department (CED) in the hospital is responsible for the
patient and clinical staff safety in using medical devices.
Besides, the cost control in related operational activities of
medical devices (such as purchase, contract, repair, and
maintenance) is another important job for this department
[1]-[3]. For these goals, CED is responsible for purchase
assessment, safety installation, warranty assurance,
correcting repair, contrast monitoring, preventive
maintenance, and identifying discard to provide safe,
effective, and economical services and equipment that are
necessary for patient care research and community service.
To promote the operating performance, it is needed with a
Manuscript received April 22, 2010; revised June 22, 2010.
*C. H. Chien is with the Graduate Institute of Electrical Engineering,
National Taiwan University, Taipei, Taiwan 100, ROC and also with the
Department of Biomedical Engineering, National Taiwan University
Hospital, Taipei, Taiwan 100, ROC (886-2-2356-2092; fax:
886-2-2383-2677; e-mail: d91921022@ ntu.edu.tw).
Y. Y. Huang is with the Institute of Biomedical Engineering, National
Taiwan University, Taipei, Taiwan 100, ROC (e-mail: yyhuang@
ntu.edu.tw).
F. C. Chong. is with the the Graduate Institute of Electrical Engineering,
National Taiwan University, Taipei, Taiwan 100, ROC (e-mail:
fcchong@cc.ee.ntu.edu.tw).
systematic managing strategy [4]-[6].
The Medical Equipment Management System (MEMS) is
used for data collection and management. It incorporates the
equipment inventory, a work order system, the preventive
maintenance schedules/procedures, outsourcing contract
management and all service history records. Besides, it is also
an administrative tool to track equipment, to initiate work
orders, to obtain performance indicators, to determine
equipment failure trends, to identify training needs, and to
produce management reports.
This paper presents an information framework to build and
to enhance CED on the medical equipment management
capabilities. With this method, we will show a framework of
MEMS from system network architecture to the relationships
between each sub-system model. Few examples on
operational management analysis by the MEMS (such as
failure trends, specific device malfunction analysis) will be
shown in results. These operating data were derived from the
operating results in National Taiwan University Hospital
(NTUH) in 2009. NTUH is a medical center with 2300 beds
and owns more than 30,000 pieces of medical equipment. We
will discuss how to use the information to improve the
operation quality and to control the potential risk in medical
equipment.
II. METHOD
The appropriate and efficient use of this integrated system
is inevitably related to proper functionality differentiation of
each specific module and network architecture.
A framework of medical equipment management system for in-house
clinical engineering department
Chia-Hung Chien*, Yi-You Huang, and Fok-Ching Chong
T
Fig. 1. The systems network architecture of medical equipment
mana
g
ement s
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stem formed b
y
the intranet and internet construction.
32nd Annual International Conference of the IEEE EMBS
Buenos Aires, Argentina, August 31 - September 4, 2010
978-1-4244-4124-2/10/$25.00 ©2010 IEEE 6054
A. The system network architecture
The system network architecture (Fig. 1) was designed
under the consideration of data safety and work performance.
This was divided into three parts. First, the intranet in hospital
connects the overall operating computers of hospital and the
hospital information system (HIS). HIS sends some basic
information of medical equipment (such as budget, purchase,
and property information) to the MEMS. The inner users can
also access MEMS through the intranet. Second, the MEMS
was set up in the intranet of CED and connected to the
intranet of the hospital through a router. The architecture will
increase the work performance for the inner users of CED in
input or query data to MEMS and system maintenance. In
addition to MEMS, the local network also includes a Web
server of CED and a database. Third, the Web server of CED
connects to the internet through a firewall and provides a
service for supporting outside branch member to access the
database of CED, which shares related information like the
procurement, maintenance, and contract related.
B. The medical equipment management system architecture
The MEMS, the main elements is shown in Fig. 2, which
contains ten sub-systems, i.e. the basic information,
procurement, acceptance, discard, maintenance, installation
verification, warranty inspection, prevent maintenance, and
contract management. These systems were designed
according to the operational activity of CED. On the basis of
different operating attribution, they can be classified into four
groups.
The first group is the basic information, which primarily
provides fixed information to other sub-systems such as
inventory information, staff data, equipment maintenance
vendors, user department and their cost center code. These
data comes from HIS and automatically updates. When a user
operates other sub-system and inputs a key word, this related
basic information will be loaded to an appropriate field. The
mechanic will reduce the user operating time and increase the
data correctness.
The second group contains the procurement, acceptance,
and discard practices. These practices focus on document
assessment. Therefore, the timing record is crucial to the
daily work activities of engineer in CED. Biomedical
managers must be able to correctly assign staffs for the right
job and to monitor the rate of progress. The administrative
staff needs to record the right date and time at different
conditions such as receipting, dispatching, inspecting, and
closing in service case. Besides, the date and time data will be
automatically reloaded by the system when a user inputs the
case number. Moreover, the engineer needs to key in the
assessing results to the system. The history information of
related equipment could also be queried by these sub-systems.
The maintenance function is used for amending the error data
and provides managing authorization for a specific user.
The third group is mainly aimed at medical equipment
maintenance and the repair work of CED, which is the busiest
in MEMS for daily work. In NTUH, the repair cases were
around eighty thousand per year. Its users include clinical
staffs of the hospital and administrators and biomedical
engineers (BME) in CED. To clinical staffs, its function is
like an order work system when the equipment has a
breakdown. Besides, it also provides user tracing the progress
and content of maintenance or repair. For administrators in
CED, their major works focus on inputting the time to the
system when the repair case is in the key point such as receipt,
dispatch, user retrieve, and close moment. For engineers in
CED, they input the repair content, delay reasons, and the
finished time of ending repair. Besides, the biomedical
mangers can query related statistics from the sub-system to
obtain performance indicators, to determine equipment
failure trends, to identify training needs, and to produce
management reports.
The final group includes warranty, maintenance, and
contract management systems. The attribution of the group
belongs to managing activities which have the property of
period plan in advance. So, the system can send a notice to an
engineer according to the important time point of
predetermined schedule such as warranty expired, executing
prevent maintenance, or carrying out the contract service.
This information can be triggered by BME to print a work
order. Besides, the BME can also set and manage related
equipment list and time schedule. The query function shows a
list of requesting work orders in the certain period. All the
content of performance in the group will be integrated with
the general maintenance of data. To query by inventory
number, the user can easily get related information with
different maintenance stratagems for certain equipment.
Finally, the maintenance statistic function provides
biomedical managers the information about the performance
of BME and outsourcing.
C. Developing tools
The developing tools are used for web page design and
database building. First, the web pages of MEMS were
designed by the Visual studio C# and the web server of CED
by the FrontPage and Dreamweaver, because the software is
easy to get and easy to use. The C# was adopted by the IT
Fig. 2. Relationship between the modules of the medical equipment
management system.
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department of NTUH and used for the HIS programming,
because the web page designed by C# is more efficient than
FrontPage in processing the complex operating environment.
About the database tools, the Microsoft SQL server was
adopted for local database of CED, and Oracle Database was
used for HIS. The factors of selecting different databases
were considered with the using volume, cost, performance
and efficiency. Sometimes, the Microsoft ACCESS was also
used for preliminary verification for the programming test of
dynamic web page.
It seems that Microsoft software products were used for
deployment because they are standby for us. Developers can
choose familiar tools to construct their system. In
consideration of the developing cost, they may use
open-source solutions such as Linux.
III. RESULT
The user interface of MEMS is shown in Fig.3. The left
side of the graph shows the working menu and the right is the
executing result. It was designed by Visual studio C# and
users operate the function on their computer browser.
Different roles (such as clinical staffs, administrator,
biomedical engineer etc.) have different authorities to open
different functions.
In the maintenance data, we not only look into a general
cause of the malfunction but also analyze the causes by
specific types of equipment or user behavior. Fig. 4 shows the
twelve types of error code and the statistic graph for the
failure items of medical equipment repair cases. The statistic
data was explored from the MEMS in NTUH around 6000
pieces.
Among them the number 8 (outdated parts) has the biggest
amount. It means that it had a lot of repair cases due to the
outdated equipment. Moreover, the specific types of
equipment failure analysis can be exploried from repair
records.
Fig. 5 shows the statistic graph with regard to the failure
analysis of portable physiological monitors that are
commonly used in nursing department. The data was
collected from the repair records of this type instrument
around three years with total of 2538 cases. The common
failures include sensor, probe, null function, replacement cuff,
power supply, battery, fittings, manufacturers, panel module,
replacing bag, corrector, scrapped, and other issues. The
sensor, probe, and cuff account for most of these failure items.
These three parts are usually connected to patients, which are
easy to damage due to pulling or tension. By contrast, the
panel module and battery are two frequently encountered
problems that are related to the machine.
If we want to know what the error behavior for certain
brand and model, we can set specific field on the query
function of MEMS to get related information. The
information can be used to prevent maintenance schedule or
Fig. 4. The statistic graphic for the failure items of medical equipment
repair cases come from National Taiwan University Hospital in 2009
Fig. 3. The user interface of medical equipment management system
Fig. 6. The failure analysis for a specific type of patient monitor
Fig. 5. The failure analysis of portable physiological monitors
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purchase assessment. Fig.6 shows a failure analysis for a
specific type of patient monitor. The failure item of power
supply occurred more frequently than that on the portable
monitor (14% vs. 7%). Whether the problem comes from the
original design or is due to improper operation of users awaits
further exploration.
IV. DISCUSSION
Our results demonstrated the ability of data analysis for
maintenance history records with MEMS. It just uses the
partial function of the MEMS in all operating activities of
CDE. Fig. 4 shows an error analysis of one-year maintenance
records in 2009. It revealed a major problem that the
equipment was too old to be maintained and repaired in the
hospital. To reduce the idle time during equipment shutdown,
a stock plan is needed for some parts in general use. Once the
maintenance frequency of the equipments increases or the
related parts are not available, a proposal for a new budget
plan is needed.
Fig. 5 and Fig. 6 reveal an error analysis for specific type
device. These results provide useful information for
managing strategies to medical equipment. For example,
sensors and probes were the major problems happened in the
cases of malfunction devices. To prevent the problems, a
safety stock of these consumables should be kept to reduce
the breakdown time during repair. Besides, education for
users is needed to reduce the malfunction factor of human
errors, such as no charging battery, plugging error site for
power cord, and breaking probe wire etc. Moreover, when
users purchase the same type device, the information can
assist users to define a proper specification and brand.
In many cases the CED is managed according to three
approaches: totally internal, totally external and a
combination between internal and external resources. In the
initial design for developing the management system, it is
necessary to consider the real operation mode of CED. In our
system, which is designed for a combination type, the
function of contract management is a sub-system for
managing the outsourcing service especially for high value
equipment, such as CT and MRI. In the sub-system, the
service response time and the maintenance quality are the two
important monitoring items.
In this study, the MEMS covers all activities in CED on
medical equipment management. Through systematic data
collection in each stage (such as purchase, contract, repair,
and maintenance), it provides useful information to advance
the management ability in CED more effectively and
efficiently. With regard to how to run data into useful
information, however, the data format and operating interface
are very important. They will influence the information
whether is accurate and comprehensive. Data quality
initiatives can help to insure the accuracy of
clinical/biomedical engineering data. Some important key
fields in designing database may be considered. The basic
information of medical equipment should include:
nomenclature, manufacturer, nameplate model, serial number,
acquisition cost, condition code, and maintenance assessment.
To record key date in working condition includes: accepting,
assigning, ending, and retrieving case. To record related
person in these operating activities includes: user, engineer,
manager, department chief, contact phone number, and
related cost center code. The cost data is also important for
modern enterprise, so the related cost value like purchase,
installation, training, consumables, operating, maintenance,
contract, and disposal needs to be involved. Other useful data
could include: warranty, location, other contractor agencies,
scheduled maintenance due dates, and intervals.
V. CONCLUSION
Medical equipment has become an important component of
modern health services. But the related management or
maintenance is particularly weak in the districts. The growth
in capabilities to manage or maintain medical equipment has
lagged far behind the rate of deployment of equipment. In
addition to the traditional operation management, the patient
safety, operation performance in cost/efficient analysis, and
risk evaluation and control are the important issues for using
medical equipment in hospital [7][8]. A framework of
medical equipment management system has been proposed in
the paper for assisting in-house CE department early to
confront the potential risk.
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The appropriate deployment of technology contributes to the improvement in the quality of healthcare delivered, the containment of cost, and to increased access to services offered by the healthcare system. Over the past one-hundred years, the dependence of the healthcare system on medical technology for the delivery of its services has continuously grown. In this system, the technology facilitates the delivery of the "human touch." Medical technology enables practitioners to collaboratively intervene together with other caregivers to treat patients in a cost-effective and efficient manner. Technology also enables integration and systems management in a way that contributes to improvements in the level of health indicators. Hospital and clinical administrators are faced with the expectation for return on investment that meets accounting guidelines and financial pressures. This article describes the emerging process for managing medical technology in the hospital and the role that clinical engineers are fulfilling.
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This manuscript describes the different phases of developing, implementing, and evaluating a unique fully automated clinical engineering system at the Ministry of Health in Jordan. This covers automating all related technical issues in 29 hospitals, 685 health centers, 332 dental clinics, 348 pediatrics and mother care clinics, and 23 blood banks. Every piece of medical equipment was assigned an identity code that can be recognized through a bar code scanning system, and similarly, all other involved parameters, such as hospitals, personnel, spare parts, workshops, and others, are also coded comprehensively. The system presents a powerful software package designed based on Oracle and implemented using a network covering different locations of the Directorate of Biomedical Engineering (DBE) at the Ministry of Health all over Jordan through Web-based interactive connection. The complete automation system proves to be invaluable tool to manage, control, and report all different parameters concerning the considered clinical engineering system including all medical equipment at minimum cost and time as compared with international systems. It is also the first comprehensive system that can read and report in both Arabic and English languages. The system was evaluated and found to be reliable, effective, and unique compared with internationally available systems. The DBE with this automated clinical engineering system has the ISO 9000/2000 certification.
Article
Over 8000 new medical devices are marketed in the United States each year. Before marketing, manufacturers of high-risk, or class III, devices provide the Food and Drug Administration (FDA) with scientific clinical evidence that the devices are “safe and effective”; 50 to 80 of these devices receive FDA approval annually. Some 3500 medium-risk (class II) products are approved for marketing by the FDA after the manufacturer has submitted a 510(k) notification. The device must be “substantially equivalent” to an existing marketed device, as demonstrated by product-specific performance requirements or “special controls.” Only 8 percent of 510(k) notifications have special controls . . .
How to Organize a System of Healthcare Technology Management
  • Andreas Lenel
  • Caroline Temple-Bird
  • Willi Kawohl
  • Manjit Kaur
Andreas Lenel,Caroline Temple-Bird,Willi Kawohl,Manjit Kaur, "How to Organize a System of Healthcare Technology Management", World Health Organization,2009
Total Product Life Cycle, Center for Devices and Radiological Health
  • David W Feigal
David W. Feigal, M.D., M.P.H., "Total Product Life Cycle, Center for Devices and Radiological Health", FDA Available: www.fda.gov.
Management and Assessment of Medical Technology, Clinical Engineering (Principles and Applications in Engineering)
  • Y David
  • Thomas M Judd
  • Y David
  • Thomas M Judd
Y David and Thomas M. Judd, "Management and Assessment of Medical Technology, Clinical Engineering (Principles and Applications in Engineering)", CRC, New York, 2003.
Medical Equipment Planning Guidance article
Medical Equipment Planning Guidance article, Health Devices, vol. 26, no. 1, pp. 4-12, 1997