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This is the second part of the
Computerized Medical Equipment Management System or CMEMS. In this part
we'll have a practical example to demonstrate what is a Computerized
Medical Equipment Management System, and the example will be about HEMS system,
which is developed by the EQ2. And, we will cover these points. Then, we'll talk
about the planning for a new Computerized Medical Equipment
Management Systems, and the points, which we should consider during the
planning of such system, and how to implement this system. Now, I'll start
with this practical example. These systems have evolved over time. After the
IBM PC introduction in mid-1980, systems based on PC-databases started to appear. An example of Computerized Medical Equipment
Management System, which was developed by the University of Vermont.
This system is called "Hospital Engineering Management System or HEMS.
It was founded in 1985. We can see here, a screenshot for the main page, which had
been used from 1985 till 2010. In this slide, we see the new software for the
HEMS in 2017. This is a screenshot for the main page. As we can see, we have
different modules. We have work orders, generate schedule, assign work orders,
equipment inventory, equipment types, equipment models, schedules, procedures,
parts, reports, and so on. The HEMS system consists of data on
the medical equipment inventory on work information, or what's also known as work orders, can be separated into scheduled
and unscheduled. And, also, we have other information. All combined to create a complete history for each medical device. As we'll see in the next slide. So, firstly we have two types of maintenance.
We have in-house maintenance or clinical engineering services / hospital clinical
engineering services inside the hospital. And, we have out house services or vendor
services. The work orders are for the in-house services will be generated. We
have two types of the work orders. We have unscheduled work orders due to unscheduled work requests. And, we have pending scheduled
work orders generated by the PM scheduler of the computerized medical
equipment management systems. So, we have different inputs, as we can see here, for
the work order control. We have from the pending scheduled work orders, and
unscheduled work requests. We have input also from parts, and equipment inventory.
The output of the work order control will be for medical
equipment history. Also, the medical equipment history have different inputs.
One of them is a work order control, which is generated by the in-house staff.
Whereas, we also have work orders or vendor service information, which is considered as out-house services. We have the equipment inventory. So, the medical equipment history will be
the second step. And based on this medical equipment history, reports will
be generated, which is the essential point behind this computerized medical
equipment management system, which has helped us to reduce cost, to improve the quality
of the care, to perform a lot of tasks, which we'll talk about in the next slides. Now, we will watch a short video about the
HEMS system. HEMS is an acronym for Hospital Engineering Management System.
We have different staff, who helps to generate (create) such computerized medical
equipment management system. And, also, the report generated by such system
will be useful for different types of the staff, as we can see here, starting
with the vice-president and ending with the clinicians. So, one of the features
is being secured and real-time. So, we can update data in a real-time. Also, we will see important features of the HEMS system, which include:
first integrations with the HIS (Hospital Information System) system. This is very important and essential the integration or interoperability with medical
devices based on IHE, which is the International Healthcare Enterprise.
Also, another feature of the HEMS system is the RTLS, which is
an acronym for the real-time location system. The network information, the
electronic patient health information (ePHI) checks, also the connection directly to the the electronic medical
record (EMR) of a patient or a electronic patient record. Also, one of
the feature of the HEMS system is the ability to connect with electrical
safety analyzer or biomedical equipment testing. And, also another
feature, which is very important concerning HEMS system and we will see
this later, it can work either as offline or online. As we said before, usually most
of the commercial computerized medical equipment management either can be
offline or online. The HEMS has the capability of being installed as offline
and online, so cloud or hospital server. So, this is a short brief about the HEMS
system. Now, we'll talk about the different parts of this HEMS system. We
will talk firstly about the medical equipment import inventory. Then, we will
talk about the maintenance information. Then, we will talk about reports
generated by such computerized system. So, now, we will start with the medical equipment
inventory. There are different types of data, which are related to the medical
equipment inventory. This can be classified as either essential data,
additional data or network connectivity. Essential data: can be unique
identification number, device type, manufacturer, model, serial number,
and so on. Additional data could be a photo, which is taken for this device,
the life expectancy, the service contract data, software version, the
MAC address and IP address, purchase order number and PDF, and so on. The
network connectivity becomes now essential due to the connectivity needed with the medical devices, and with hospital
information system (HIS). So, such information or data will include the IP and the MAC
address, the host, the gateway, the mask, antivirus, duplex and other information.
As we can see, this is an example of the type of data. This is a screenshot, which
has been taken for of the inventory information. It includes some of the
essential data, and as well as some of the other data. We can see here an
example of the connectivity data. As we said before, the IP address,
the MAC address, the DHCP server, the port number, and so on. Also,
important point concerning the medical equipment inventory is to have a
standardized format. Concerning the standardized format, we
should talk about the FDA initiative, and nomenclature, which has been used
based on the requirement of the FDA initiative. It's essential that the data
fields to be input in a standardized format using a systemic approach according to the
nomenclature. Why this is important, because in case we have a recall device,
and we should search for it in our medical equipment inventory, this will be
even missed or very difficult, in case we don't have a standardized format. So, in
2013, the FDA put forth the final rule related requirement for a unique device
identifier (UDI) for medical devices, which also known as UDI.
The identifier contains unique device and production data. This rule mandates
companies to use the UDI system in stages. The first stage started in
September 24, 2014. And, this will be ended in September 24, 2020. This is an example of
the UDI, which is proposed by the FDA, or which has been initiated by the
FDA. Now, we'll talk about the second part of the HEMS system. So,
the first step will be the medical equipment inventory, the establishment of
such medical equipment inventory. The next step will be the maintenance
information generated related to this medical equipment inventory. This
information can be separated into two parts: scheduled maintenance and
unscheduled maintenance information. The scheduled one will be separated into
routine inspections, or known as IPM inspection and preventive maintenance
procedures, and a special inspection procedures. The scheduled maintenance is
at the core of the computerized medical equipment
management system usage due to the cost and resource factors. A key part of the
maintenance is to automate this. To automate the preventive maintenance and
inspection program due to the large number or the quantity of medical
devices and the differing requirements for intervals and tasks.
As an example in the case of a hospital or even a medical center with a large
number of medical devices in its medical inventory, this task will be very
difficult to make a preventive maintenance schedule, and to assign this
task to a staff in our clinical engineering department. So, having a
computerized medical equipment management system will automate this
process, and will make easier for the staff, and will save a lot of time and
cost. So, as we said, this maintenance information will be separated into
scheduled and unscheduled one. The schedule and also will be separated into
routine and specialized. The information or the element, which we are
needed in addition to the to the procedure schedule and the equipment,
will be the parts required, the spare parts required in the IPM or the
inspection and preventive maintenance, the biomedical testing equipment or
testing equipment in general, also staff skilled required, and finally the
results. The tasks included in routine inspection of procedures will be a
general physical check up, an electrical safety, also check up based on standards such as IEC 60601-1. Also, the tasks such as filter cleaning, visual inspection, and so on.
This is an example of the routine tasks, which are performed in routine scheduled maintenance procedures. In addition to the routine,
we have the special inspection procedure, which some devices may have: custom self-tests to be administrated, uncommon measurement procedures, or even a
specialized parts replacement. In this case, this is considered as specialized
or special inspection procedure. and this is a part of the scheduled
maintenance information. Now, we'll talk about the second part of the maintenance
information, which will be the "unscheduled maintenance". The unscheduled
maintenance work includes: repairs, incoming inspection in case of a new
equipment has been delivered for the hospital, recalls, updates for the equipment, and a modification of some
equipment, installations and other work that is not scheduled. So, the unscheduled
work will include repairs, incoming inspections of new equipment, recalls,
updates, modifications, and installations and other work that is not
scheduled. Repairs will be the majority of typical medical device life cycle
maintenance cost. So, the repairs will represent the most of the cost
concerning a typical medical device life cycle maintenance
cost. For this, we should consider this cost concerning the labor parts and
shipping. Another point is the failure rate associated with the repairs. It is also
important reliability measure. So, the problem type and resolution
need to be documented, typically with a code for searching and test description
to show the specification related to this problem. Why is this important?
This will be important in the generating of the reports, and the analysis of
reports in order to take actions. Here is an example of some maintenance code,example
for common problems, such as random failures. This is a code in case if we have a
random failures maintenance related and battery replacement may be also used.
This is an example of unscheduled work order in the
HEMS system. In addition to the information related to scheduled and
unscheduled maintenance information, we have non maintenance information. Such
information will include: the asset data on purchase cost, depreciation, and
parts; risk management data on the user errors, incidents and recalls; data
to support the purchasing function, such as the parts data for ordering
inventories to assess future purchases; and finally functional information for
example major medical equipment items for state agencies. So, we have started
with the establishment of the medical equipment inventory. Then, we talked about
the maintenance information related to during the life cycle of these medical devices, which is the maintenance information. Now,
we will talk about the last point, which will be related to the
maintenance information as well as the medical equipment inventory. It will
be the analysis, and the reports which is the idea behind the computerized medical
equipment management system. We have different types of reports, which will be
used in by different type of staff or healthcare staff. For example, we have
reports generated by the computerized maintenance management system will be
related to the administration. We have other type of reports will be related to
the clinical staff / risk management, facilities management, regulatory
compliance officers. For example in the case of the administration, we have
reports related to the medical equipment replacement, the downtime, the cost of
labor, and charges to the department's for
hospitals that use a chargeback system, and so on. For the
clinical staff and risk management, we have reports related to the user use
errors, or no problem found and incidents, damage / abuse, and so on. In the case of
the facilities management, we have reports related to the maintenance
schedules and procedures interactions with support departments related to the
work reliability and finally device histories. Concerning the reports for
regulatory compliance officers, we have the results related to the accreditation
requirements. Such requirement are needed by regulatory
compliance and Joint Commission. Now, we will see some examples of these
generated reports. The first type of the reports, the first example will be about
the medical equipment downtime results. Downtime can be related or has an
impact on the patient care. For example, in the case of a physiological monitor
or defibrillator, so it will compromise the patient care. Other results
or impact of the equipment downtime or the medical equipment
downtime will be the cost that are lost or the income lost. The lost
income, this cost can be varied based on the equipment. We have the essential
equipment of the hospital, which are found in the laboratory and imaging. As
well as, we have the complex system such as a robotic surgical system. The down
time for such the system will mean that the loss of big income, and this
has impact on the balance sheet for the hospital. For example, in the case of the laboratory equipment exams are low in
cost, but high numbers will make the cost higher. For example, the test will
be around ten dollars or seven dollars, but we have large number
of tests will be performed in the laboratory equipment. If we take the
example of the imaging exams or tests are higher individual cost ranging from
the hundred to thousand dollars. And, the cost will be even much higher in the
expensive system or medical device systems such as robotic surgical system,
this will be cost of 10 of thousands of the dollars. So, this is an example of the
cost of the test in the laboratory services, in the radiology, in MRI, CT
scan, PET scan. As we can see, this is the cost and this is a cost for the
charge of the hospital. This will be the charge for the
professional physicians (radiologists and laboratory physicians or doctors), and
this will be the total charge loss in case of we have medical
equipment downtime. So, downtime, as we said before, means money. This exam chart data has been taken from the University of North Carolina
hospitals. So, the second type of our reports, which is generated by computerized medical equipment
management system will be the workload balancing. So, another advantage of the CMEMS is the analytics included to perform tasks, such as distributing the
workload associated with PM inspection program. As we said before, it's very
difficult to make a preventive maintenance schedule for a hospital or a
Medical Center with a large number of medical devices. And, what will be more
even difficult, it will be the assigning of these tasks generated by this PM
schedule with staff available in the clinical engineering department. For
the thousand of devices with differing schedules and requirements, the resources
must be balanced between the staff and between even the available testing
equipment, PM schedules, and so on. These resources include the medical
equipment safety and performance testing equipment, as we said, and, most
importantly the staff work time. So, we have three elements. We have the medical
devices in the PM schedule. We have the medical testing equipment, which are also
limited. We have also the limited number of staff, who should make this matching.
Trying to make this matching manually, this will take a lot of time, and
this will cost a lot of loss, or will be expensive concerning the cost for the
clinical engineering department. Having a computerized medical equipment
management system, all these tasks will be done more fast, more efficient, and
will save a lot of money. Another type of generated reports by
computerized medical equipment management system is the safety committee quality groups. Now, we'll see two types of the
report generated to the Safety Committee or quality groups. The first one will be
general concerning the work order generated, the reason behind it, and
analysis during four-month period. Then, we'll have another report, which
generates the number of the work orders generated based on specific
devices, which will be more useful. This one will have will help the clinical engineering department to take general actions. Whereas, the
second type of the report, which we will see in the next slides, will
help us to take actions on concerning specific devices on the hospital or a
medical center. So, as we can see, these are the numbers of the work orders
generated in a four-month period. The reason behind these work orders can
be either maintenance, use error, damage, or no problem found. As we can see
here, in this chart that the higher number of work orders was the result of
"no problem found". So, we should take actions based on the reason behind these
work orders. This is another type of reports generated
for the Safety Committee. This is based on the work orders generated
based on a specific device, and what is percent percentage available. So, user
error and no problem found work orders by device type. As we can see
different types, we see ventilators, fetal monitors, patient's lift, anesthesia
machine, and so on. As we can see, it's recommended that the percentage of the
work order based on the user error or no problem
found shouldn't exceed 10%. As we can see in these work orders chart
based on a specific devices, most of the devices are below this percentage, which
means the performance for this department is good. So, this data is more
specific than the previous trend graph, which shows the work orders in four
month period because it focuses on device types, as we see on a
fetal monitor, or a ventilator, or anesthesia machine, and so on.
The criterion, as we said, shouldn't exceed ten percent. As we have
seen that, all the devices have have not exceeded this percentage. If the devices
types were over this limit, which will be the ten percent, than either
staff training, reviewing techniques, or human factors aspects of the device
should be considered. So, after we have a practical example for computerized
medical equipment management system, which was the HEMS, now, we will talk
about the planning and the implementing a computerized medical equipment system
for a new department, or for new users, or new clinical engineering users. If you have a clinical engineer, who has never had a
computerized medical equipment management system to help run their
clinical engineering department or having using the basic tools, such as the
spreadsheet like Excel sheets, then this person should learn about the
system to be able to plan the acquisition of the computerized
medical equipment mentioned management system, and to implement it effectively.
Also, we should analyze the the current practices of of this engineer, and engineering department, and see if they fit
with computerized medical equipment management system. What are the factors,
which we should consider when we are planning for the acquisition of a
computerized medical equipment management systems? Some of the factors
include: the ease of use especially speed and accuracy of data entry. Another points
will be the functions and the features, the number of facilities and departments
that can be supported, support of for the system, update history, web-based
capabilities, interface capabilities with the hospital information system, as we
said before the data format the SQL output. This is important especially, if
we have a limitation in the type of the reports generated by this
computerized medical equipment management system. Then the reporting the
handheld netbook capabilities for the mobile leads in case we have different
sides or multi-site case of hospital or from medical center, test devices
interfaces. All these points, we have talked about and with the HEMS, we should
have. As we have seen before, that HEMS has the capabilities for the
connection with the HIS system, with medical devices, with the testing medical
equipment, with the ePHI or the electronic patient health information,
and so on. So, these points should be considered when we are talking about the
planning for the acquisition of a new computerized medical equipment
management system. Also, in the third part, I will talk about the computerized
medical equipment management system and my proposal concerning the application
of Big Data and artificial intelligence (AI) for the computerized medical equipment
management system, and how this will help to enhance the healthcare technology
industry. Finally, we'll talk now about the implementation advices for
this computerized medical equipment system. In general, the hardware should
not only be the limitation for such system, we should consider, as we said, software,
workflow, processes procedures, and reporting also should be considered when
we are talking about the acquisition or the planning for a new CMEMS system.
Also, great expectations are not achieved if the system is not planned for
or implemented correctly. Finally, the implementation phase can be
daunting in case we have a large number of the medical devices for starting up
system in a new hospital or a medical system. We have for example data
conversion, training to of staff, hardware needs, interfacing, and so on. This will be
very very very difficult and daunting for a large Hospital starting up system.
Finally, thank you.