This video will certainly have to do with the 2nd component
of the health care innovation life-cycle, the management component. The healthcare
modern technology life-cycle will be divided right into two almosts all: the planning component
as well as the management part. The bridge between them will be the release
phase. As well as, the results will certainly be utilized as a comments for the preparation component from the
administration part. The monitoring part will certainly be divided into 4 phases: education and learning,
compliance, upkeep, and safety and security. I will certainly begin now with the speak about the
deployment stage, which is the bridge in between the planning part and also the
monitoring part. There are numerous implementation tasks, consisting of the
plans for the invoice of the item, the installation, the approval screening,
check-up for preventive maintenance inclusion or exemption, and also other
deployment tasks. It'' s vital to include the secret participants early in
the deployment process.This includes
: the building and construction, facilities engineering,
electrical experts, architects, tool individuals, and so on. The one more crucial factor is the
centers considerations. The facilities factors to consider ought to include the
physical room need, structural demand, shielding need, the
electric power need, home heating and air conditioning requirement, and also ultimately the
pipes need. For huge things, such as the imaging systems, lab
analyzers, as well as the sterilizers, the facility should be prepared well for the
release of such innovation in the medical facility. I will extract from our previous
functional instance “” the installment for a brand-new MRI device – 1.5 Tesla MRI maker””.
The necessary area will be around the 25 meter square,
as well as the weight of the magnetic will certainly be around 4 heaps. This will be the sensible instance for the release phase, and part of
activities and the deployment stage. We can see in this slide: the practical
diagram for an MRI collection. The functional representation will certainly divide the MRI suite into
4 areas or security zones: the security zone 1, which would be the outpatient
entry, the safety and security area 2, the safety area 3, and the safety zone 4. Likewise,
we will certainly should need to speak regarding the space need. This will certainly be shown
in the MRI collection crucial strategy. We have the main MRI scanning room. We have the
control area, as well as various other areas. For the lack of time, I will just chat
about MRI scanning room, and also not in depth. Just a quick speak about it. We
can see below different drawings for the MRI scanning room.We can see the
flooring
preparing illustration, the shown ceiling illustration. Additionally, we can see a.
cross sectional sight for the MRI scanning space. And, another drawing for.
the MRI scanning space. It'' s important in every area to consider the center.
requirements. As I said before, I will only concentrate regarding MRI scanning area. So, we.
have different facilities demand: architectural, illumination, power,.
communication and also unique systems, home heating, ventilation, and air condition, or.
what'' s also referred to as cooling and heating, as well as ultimately plumbing as well as medical gases.
These. demands will be based on standard as well as standards. As an example, in.
USA they use the F.G.I., which is.
the center standards Institute. So, the facilities needs will be necessary. We should consider the exact same needs for every room in a medical facility. Here, also,.
the necessary devices list in MRI Scanning Room. We have a list of.
devices. We have a details code for every thing (ID). We have a nomenclature. It reveals a specific name, which can be made use of in any area in.
a healthcare facility, also with a summary, the required quantities for this.So,.
this is an instance for the implementation, the setup demand in the.
deployment phase. As we claimed in the past, there are lots of various other activities, like the approval testing, the check-up for the PM (preventive maintenance) inclusion or PM exemption. This will certainly be applied likewise for the MRI machine, or.
any type of other machine. Below is an instance for the preventative maintenance addition or.
exclusion. As we can see, for every gadget we need to have a danger number. As well as, based.
on this number, we will certainly make a decision if this gadget will certainly be included or omitted from.
the precautionary upkeep timetable, and the necessary period (PM period). If it'' s the annual,. biannual, or other period. Likewise, another factor
, we ought to take into consideration when we make. examination for the PM inclusion or exemption is needed time for each. gadget. As well as, we multiply this by the number of gadgets or
the quantities. As well as,. we can identify the total time needed for.
these medical tools. And also, lastly, we can determine the complete time, which is.
called for to be included in the jobs in the PM timetable. So, this one more point, which.
additionally ought to be considered during the deployment phase.Here, just how we
can.
calculate this risk number. As shown right here, from the previous practical example,.
I will certainly consider only the extensive treatment device. We have the person monitor, the.
central terminal, and the adult ventilator. As we said, we need 8.
patient screens with a central station, and also 8 grown-up ventilators. The total.
score for a patient monitor will certainly be 10, which indicates that we require to have.
a yearly maintenance for the client screen, and the main station. Whereas,.
the danger number for the grown-up ventilator will be around 17, which implies that we.
should have 2 PMs, 2 preventive maintenance every year. So, it'' s a. semi-annual. The necessary time for a client screen for an examination as well as preventive maintenance (I.P.M.) for a client.
screen will certainly be around 50 mins, for the Central Station will be around 35.
mins, and also for the adult ventilator will certainly be likewise 50 minutes. So, the total.
time to examine up or to make the I.P.M.For 8 client monitors will be around 400. mins, for the Central Terminal will certainly be 35 mins, and for the adult ventilators. will certainly be around 800 minutes.
So, if we include these numbers with each other, we ' ll. have how much time required for the I.P.M., the inspection as well as preventive. maintenance for the brand-new devices in the critical care unit( ICU). Similarly, we make the same calculation for the other equipments. For example, for. the CT scanner, we should have either a semiannual or every three months. The.
duration will certainly be 180 minutes, which suggests 3.
hours. In case we have 2 PMs (preventive maintenance). That'' s indicate we
should. have a 6 hrs for the yearly precautionary upkeep of the CT. scanner. Here, how we can determine the above threat number.Here is an instance
for. a patient screen
, for a Central Station, additionally and for adult ventilator. After the release phase, the first phase in the monitoring component will be the education. The education, as we claimed.
previously, must be done for 2 kinds or 2 categories. The initial type or team will.
be for the users. The 2nd component will be for the clinical design personnel. For.
user training, the training ought to be occur prior to the.
first use in the patient. This is since of the security to ensure that the use of.
this tool will be secure after ideal training have actually been given for.
the users.We have what we
call the incredibly individuals. Typically, in each division, we have. employees with special skills and experience. We call them the extremely individuals. Typically, we educate the super individual, and also. then the extremely individual will train the rest of the staff. Also, some divisions. having staff dedicated to the
training, such as a registered nurse instructor. It ' s more suitable that. the very first training to be done by the specialist instructors from the. producer. Another factor, which also need to be thought about during the training. After the passing of the very first year (from training), we make what we call the competency test. The competency examination is to ensure that the customer still have. enough info regarding exactly how to utilize this equipment
or gadget. The second phase. in the administration part will certainly be the conformity.
Conformity will be with the. policies, standards, and certification company. And this will. be necessary as well as critical.
Right here is an example what the guidelines or requirements. Here, we can see the criteria for I.E.C. for the clinical devices. Right here, likewise. another instance regarding the certification organization. One of one of the most crucial. of them is a Joint Compensation global, or what ' s known as J.C.I.'In Lebanon, we have
what we call the HAS. The 3rd stage in the monitoring component will be the maintenance. As we stated before, a.
check up for the preventative upkeep incorporation or exemption will certainly be carried out in.
the deployment phase based upon a danger number. We ought to make what we quality.
assurance inspections as well as maintenance. And also, this is needed for many medical.
devices as well as system. Arranged preventative maintenance, and safety and security and.
efficiency screening are required in order to maintain scientific modern technology.
running effectively and also secure for the patients.In case of failures incident,. repair work are applied
. Additionally, the retraining of team is crucial, if this failing is. the outcome of an individual mistake
. So, upkeep is an extremely important part. It'' s important to mention that we have various kinds of upkeep. We have.
preventative maintenance, which is carried out in a regular method. As an example, annually.
or every six months, this depends, as we stated previously, on the threat of this device. Yet.
presently we are relocating to an additional kind of upkeep,.
which is called the anticipating upkeep. So, upkeep has.
gone through history in three stages. We have actually begun with the.
restorative upkeep, then we have passed to the preventive maintenance.And, presently.
we are utilizing the predictive maintenance. So, what is the difference between the. preventative upkeep and predictive maintenance? This also has been covered. in the previous videos, which is I.P.M. For example, for a ventilator, this is. based on the Fluke Biomedical examination and preventative maintenance (I.P.M.). The. assessment and also preventative maintenance for a ventilator will certainly be be divided. right into 4 parts. The first part will be a physical check-up for the ventilator. The 2nd component will certainly be an examination for the electric safety and security, as well as the 3rd part. will be a preventive upkeep done based on the manufacturer ' s. recommendation.And, the tail end will certainly'be
about the efficiency
testing for this. tool. And, this will certainly be based on the I.E.C. needs, or one more needs. relying on each country. For instance, if it '
s IEC this will be the IEC 60601-2-12 (2009). Additionally, in a similar way the electrical safety and security needs to be done based upon the. electric as well as the IEC 60601-1-1. So, as we said before, we currently move from. the preventive maintenance to the predictive upkeep.
So, what is the. difference in between them? Normally, in the preventative upkeep,. it must be performed in a details duration, usually every 3 months or 6. months or twelve month or as needed.
Nonetheless, in the predictive upkeep, we gather information from each gadget daily, and we make an evaluation. for every part or each part of this device. As well as, based on this analysis, the. period will certainly be readjusted.
This will cause have a much better assistance for the device. I will offer a basic example. In situation of a ventilator, generally.
an annual or every year, we change the oxygen cell (sensing unit).
Whereas, the replacement of.
the oxygen cell will not be any type of more relying on the duration. It will certainly be a lot more based.
on the condition of this oxygen cell. So, a daily check-up of the problem of.
this (oxygen sensor). For instance in situation of the O2 cell (oxygen cell) we inspect the milli-volt (mV) value of this cell,.
if it'' s close or near to the 5 milli-volt at 21% oxygen focus, which remains in a medical.
air. This implies that we need to change this O2 cell. For this, we make a day-to-day.
exam for this element, as well as based on just we advise when.
this component should be replaced.So, the anticipating maintenance is a much better.
choice. It'' s extra affordable, and also extra dependable than the usage of the preventive.
maintenance, which is just based on a period without taking right into account the.
conditions of the components in each gadget. Also another factor, which I should.
mention, the predictive maintenance now ends up being offered for several reasons. Among.
them is automation. One more reason for this action or the.
transfer into an anticipating upkeep is the assimilation of the medical.
gadgets with the HIS (Hospital Info System) system and also the integration.
in between the C.M.M.S system, which is an electronic maintenance administration.
system, with the HIS system.The HIS system is
the hospital info. system.
So, it ends up being extra less complicated currently to perform the anticipating.
maintenance comparative to the limitation in previous years, where we.
had actually isolated medical devices or systems, which are.
entirely isolated from the HIS system or the C.M.M.S. system. So, now predictive.
upkeep has actually ended up being a better choice, and also is currently is currently much more adapted.
in even more healthcare facilities worldwide. So, we have actually started with a talk regarding the implementation. And, we relocated to discuss the education and learning, Then, we'' ve spoke about the compliance,.
the maintenance, as well as currently we'' ll speak about the security. The security is an aspect of crucial value in evaluating the risk of the gadget, as well as the ramifications for.
the individual safety and security. Among the main reasons for for the start or the.
start of the our scientific design domain is the client safety and security, and also the.
danger regulated specifically by the application of electrical security. This has resulted in the a develop.
the need for the scientific design division in each hospital.So, safety and security.
still is an important point for us, and also we ought to think about in order to make sure.
that tools are risk-free to use with clients. And, another factor to make sure.
that functional mistakes and also safety problems are taken care of prior to have a threat on.
an individual or also an operator or a customer of this clinical devices. In the event.
of having an error or security problem, an activity will be taken to.
solve this issue. Finally, the disposal of the clinical.
gadget. All technologies get to an end of life, and also must be disposed and also taken.
out of the solution. This can be for numerous reasons. Among them when it damages,.
or when this tool or system because of a costly maintenance prices. Another factor will be the safety issues, as we claimed before, in instance we have safety and security.
problems considering using a special gadget or devices. In this situation, we require.
to remove it from service, as well as dispose it.Another reason is a governing.
production, or obsolescence or when a tool becomes outdated, a.
notification will certainly be received from the supplier or distributor concerning this.
device is obsolete. And also there'' s a restricted time before be.
gotten rid of from solution. And, various other reasons as we said, regulatory prohibition. Restriction will be for instance in Lebanon a formaldehyde gas,.
which is a cold sanitation, has actually been forbidden in Lebanon. So, simply another.
reason to dispose this device, as well as eliminate it from service, to take it out of the.
solution. Also, age by itself, it'' s not a reason to
change, however. occasionally age on its own is another factor. As an example, in instance of a new.
modern technology is emerged, so we need to change old modern technology. But we should.
focus about crucial point in the disposal, which is the proper disposal of.
equipment. We ought to take into account the environmental.
requirements. An additional point, which is essential in the.
healthcare technology life-cycle will certainly be the data collection as well as analysis, as well as the.
outcomes,. Information collection and also evaluation is very important as we said previously.
in the preparation part, and also in the administration part.The end results also is. crucial to have a responses from the management to the preparation part. So, data.
collection and evaluation. An essential element of the medical care technology.
administration is the collection of information, information and actions, which has.
been shown in the previous graph as a grey circles. In the planning component, information collection will be the continuous monitoring of:.
innovations, the market, what we indicate by the industry the offered.
brand names, and so on, the security concerns, in case we have a threat recalls and also alerts,.
insurance coverage, and also medical end results. We ought to always make a collection of.
data and evaluation in the planning component. Worrying innovations, for instance in some cases as we.
stated, we have the new emerging technologies or trends new medical.
equipment trend.This is essential to collect information regarding it in instance we.
require to make choice for the purchase of a new device or the.
substitute of our old technology.Also, information collection
as well as evaluation is necessary and essential in the monitoring part. This. information would certainly include dependability
, support costs, recalls,. and customer mistakes.
As we stated, the recalls or risk recalls. is extremely crucial to
be thought about in order to guarantee that our medical devices are secure to use. Additionally,.
one more essential point, which we can gather details about is the individual errors. In case we have a.
a great deal of errors, we should have taken an action, which is the.
training (retraining) of personnel in the correct use this medical device, or.
might be some modification, or the eliminate of the device itself in instance we can not.
improve the circumstance. Right here'' s an example of the reporting, which are gathered from.
the management part. This is a work order trends information extracted from the computerized.
upkeep administration system (C.M.M.S.). It shows the reason behind the work.
order. As we can see, the huge number of the job orders because of “” no trouble located”” factor. Not a problem found this means that what we must boost our make a.
modification for the policies and the procedure pertaining to the job demand.
issued from the various departments.Also, we can see other factors for the. work orders.
So, we should collect this information, make evaluation of this information and also.
based upon this analysis we will make our referrals, and take activities. Lastly, the results, as we said in the past, the experience in the monitoring part.
will be gathered, and bridge back to the planning component to improve.
decision-making in the planning cycle. Lastly, thank you. In instance you have any inquiry, feel totally free to ask.
