Clinical Engineering

Presented by:DR.Esraa Mamdouh

Email:esraa.shebib@must.edu.eg
 1. Quality means getting
whatyou pay for.
WHAT IS QUALITY?

2.
Exceeding customer expectation.
 1. ✓ Doing the right things
(what)
2. ✓ To the right people (to whom)
WHAT IS QUALITY in
healthcare?
3. ✓ At the right time (when)

4. ✓ And doing things right

first time
Quality is free..

• If you do a quality
job it will not cost you,
what costs you is non
quality.
Healthcare goal.
• The healthcare goal of system is health development i.e. a
process of continuous and progress improvement of health
status of a population.
• To achieve this goal health care service are usually
organized at three levels.
 Healthcare levels

• Primary healthcare.
• Secondary healthcare.
• Tertiary healthcare.
 1. Availability &
Appropriateness
2. Access & Affordability
3. Equity & Equality
Dimensions/Components 4. Technical Competence & Skills
quality in healthcare 5. Timeliness & Continuity
6. Safety & Reliability
7.
& Caring
Respect
(Interpersonal
relations)
8. Efficien
cy
10.
9. Effectiv
Amenities
 Availability & Appropriateness
•The availability of a needed test, procedure,
treatment or service to the patient in his needs.
•The degree to which the care / intervention
provided is relevant and appropriate to the patient’s
clinical needs, given according to the current state
of knowledge.(relevant)
-Doing the right things in accordance with the
purpose.
 Access &
Affordability
• Everyone should have access to quality
health care. Access refers to the ability of the
individuals, to obtain health services.
Some of the factors that can affect access are:
• a) Distance: e.g. If the access to quality
health care may becomes a problem due
to far distance.
• b) Financial: e.g. where cannot
people afford the services.
• c) Culture, beliefs and values.
 Technical competence & Skills

•Technical competence as an indicator of quality

assurance implies that we should have adequate
knowledge and skills to carry out our functions
in order to provide quality services.
•With respect to what we cannot do, we are
expected to refer them to other centers or
personnel who are more competent to handle it.
•Our practice should also be followed by-
Standard Treatment Guideline.
 Safety & Reliability

• Safety means that when providing health

services, we reduce to the barest minimum
injuries, infections, harmful adverse effects and
other dangers to clients and to staff.

• Reliability: measures how consistent the

quality and safety of health care systems or
processes perform over a required period of
time.
 Effectiveness and
Efficacy(organization)
•The degree to which the care/intervention is provided in the
correct manner, given the current state of knowledge, in order
to achieve the desired outcomes.
•Type of care that produces positive change in the patient's
health or his/her quality of life.
 Efficiency(managers)
•The efficiency with which services are
provided. The relationship between the
outcomes (results of care) and the resources
used to deliver patient care.
•Efficiency is the provision of high-quality
care at the lowest possible cost.
 Amenities
•These are indirect features
that can be provided by our
health facilities to make life
comfortable and pleasant for
clients.

For example, cleanliness,

comfortable seats & beds,
television sets, media,
educational materials &
videos, indication signs, best
possible general facilities and
physical environment etc. in
the healthcare entity.
It has four main
components(juran):
-
• Quality planning,
• Quality assurance,
• Quality control ,
• Quality improvement.

Quality management is focused not

only on product and service quality, but
also
on the means to achieve it.
 Quality planning(QP)
•QP is to design a process that will be able to
meet established goals under operating conditions.
Quality Planning Steps:
• Identify customers, both external and internal.
• Determine customer needs.
•Develop service/product features that respond to
customer needs.
• Establish quality goals that meet the needs of customers.
• Develop a process that can produce the needed service/product
features.
 Quality
• Assurance(QA)
A quality assurance (QA) approach
involves eliminating defects.
• In an assembly line, defects refer to those
performers who carry out a task or service
poorly.

It is a way of preventing mistakes and defects

in manufactured products and avoiding
problems when delivering products or
services to customers.
• QA is very important in the medical field because it
helps to identify the standards of medical equipment
and services.
• Hospitals and laboratories make use of external agencies
in order to ensure standards for equipment such as X-
ray machines, Diagnostic Radiology.
Quality control (QC)
• QC is a process by which entities
review the quality of all factors
involved in production.
• It begins with sample collection and
ends with the reporting of data.
• QC is essential for the medical
industry as the equipment produced is
meant for medicinal purposes.
 Continuous Quality
Improvement
Quality Improvement Tools:
1. Brainstorming.
2. Multi-voting.
3.Data Collection Tools (Check
sheets Surveys)
4. Flow Charting (NO YES END PATIENT )
5.Cause-Effect Diagram (Car Lost
Control Slippery Road Flat Tire Driver).
6. Histogram.
 • Clinical Management System.
Healthcare • Hospital
Enterprise
(ERP)
Management Systems
Resource Planning

Management • EHR electronic health record /EMR

• Pharmacy Management System
Solutions • Laboratory Management System
Categories • PACS
• Research Systems
• Medical Transcription Systems.
• EHR/ EMR. The EHR incorporates
all provider records of encounters
where the patient has received
medical care.

• EMR becomes an EHR when

Reports and histories (labs,
pharmacy, radiology, consults, etc)
are electronically added items in
the record are electronically
exchanged with other providers.
 PAC
S
Picture Digital diagnostic image
(radiological) Archiving Electronic
storage retrieval (no lost films!)
Communication Computer network
(multiple access) System Control of
the processes (integrated technology)
• HL7
• DICOM (Digital Imaging and Communication)
• Security Standards (IEEE Compliant Standards)
Role of CE in Quality assurance?

Clinical engineers employed in industry work

to assure that new products will meet the needs
of tomorrow's medical practice.
They are involved in aspects of the
development all process, medical
design and development,
from through device
product
sales and support.
Role of CE in Quality management?

Clinical Engineering Department (CED) provide

comprehensive equipment maintenance, repairs
and management services with high customer
satisfaction and to expend service on medical
equipment.
Types of Maintenance

1.Preventive Maintenance (PM)

2. Corrective Maintenance (CM)
3. Computerized Management
Maintenance System
(CMMS)
1.Preventive Maintenance (PM)

“Schedule of planned maintenance actions aimed

at the prevention of breakdowns and
failures” Primary goal-Preserve and enhance
equipment reliability.
Why do we need a PM program?
The PM will include but not limited to the
following benefits:
•Increases life of equipment
•Reduces failures and breakdowns
•Reduces costly downtime
•Decreases cost of replacement
•Allows for money to be budgeted for repairs
•Lowers need for extensive parts inventory
Why do we need a PM program?
The PM will include but not limited to the
following benefits:
•Increases life of equipment.
•Reduces failures and breakdowns.
•Reduces costly downtime.
•Decreases cost of replacement.
•Allows for money to be budgeted for repairs.
•Lowers need for extensive parts inventory.
-It would be better if you can upload the PM procedure in to your
Computerized Maintenance
Management System (CMMS) and be available for all your technical staff. For an example of
PM procedure
2. Corrective Maintenance (CM)

In this type, actions such as repair, replacement, or

restore will be carried out after the occurrence of a
failure in order to eliminate the source of this failure
or reduce the frequency of its occurrence.
The difference between corrective maintenance and
preventive maintenance is that for the corrective
maintenance, the failure should occur before any
corrective action is taken.
How can we achieve a best practice of maintenance?

This is achieved through a mix of in-house

maintenance and services purchased from supplying
companies and/or third-party services.
3. Computerized Maintenance Management System
(CMMS)
Evaluation of indicators requires the collection, storage, and
analysis of data from which the indicators can be derived.
The CED must consistently gather and enter data into the
database. The database becomes the practical definition
of the services and work performed by the department.
This standardized database allows rapid, retrospective
analysis of the data to determine specific indicators
identifying problems and assist in developing solutions for
implementation.
A minimum database should allow the gathering
and storage of the following data:
• Vendor Labor.
• Spare Parts.
• Time.
• Problem Identification.
• Equipment Identification.
• Service Requester.
Example:
Ray Cox, a 33 year old oil-field worker underwent radiation therapy
because of cancer in his right shoulder. He had undergone a number
of treatments before so it had more or less turned into a routine. This
treatment occasion on the 21 of March 1986 started just as the others.
Ray laid face down at the treatment table, the nurse Mary Beth
positioned the THERAC-25 radiotherapy machine and went into the
control room. The radiation unit was maneuvered by a VT 100
terminal that was connected to a PDP-11 computer. The video and
audio between the patient room and the control room was out of
work at this occasion.
Example:
The radiation unit had two modes: a high-power x-ray dose to radiate tumors
and a low-power electron beam for subsequent treatment.

1. High power x-ray dose = 25,000 rads. At this state a metal plate is
automatically inserted between the radiation unit and the patient in order to
create the emission of x-rays when electrons hit the metal plate. The
intensity of the radiation is also dampened. This state was chosen by giving
the command “X” as in x-ray.

2. Low power x-ray dose = 200 rads. No metal plate is used but a low power
level beam is directed towards a specific area. This was the treatment Ray
should have. This state was chosen by giving the command ”E” meaning low
power electronic beam.
Example:
The nurse entered the command ”X” and realized immediately that it
was wrong. She corrected it with the “arrow-up” key to enter the
“edit” function and changed the command from “X” to “E” This was
also confirmed at the screen whereupon the nurse pressed the “return”
key.
The correction was quick – less than 8 seconds. The nurse got the
next message from the system “E -Beam ready”.
Mary Beth pressed the key to start the treatment and received the
message “Malfunction 54” from the machine. Of course she was
surprised and tested again.
 Example:
In the treatment room Ray lay at the table and waited. Used to the earlier treatments he
was calm and relaxed. Suddenly he experienced an excruciating stabbing pain in his left
shoulder He lost his breath and didn’t manage to move enough until the pain hit him
again, this time into his neck. He then screamed to Mary Beth but as the connection
between the treatment room and the control room was broken, she could not see him or
hear him screaming. Before Ray managed to leave the treatment table a third dose went
through his neck and shoulder. Ray rushed out into the corridor shouting that there is
something wrong with the machine, he got electric current from it. Neither Mary Beth or
anybody else understood what had happened. When they examined the machine it
reported that Ray had received the prescribed dose of 200 rads but in fact he had received
75,000 rads.

Ray started to vomit blood and for the next week needed morphine. By June, most of
his body was paralysed. He lapsed into a coma and died in September in a Dallas
hospital.
What happened?

Reports now started to stream in regarding resembling incidents with the same
equipment. Eventually a thorough investigation of the radiation unit was carried
out. It was then found out that when an error was corrected – changing from ”X”
till ”E” too quickly, the program that controlled the function in the radiation unit
went astray. It then executed a compromise between the two states – the high
power level remained but the metal plate was removed. Consequently, what had
happened to Ray and some other patients was that they had received high power
level radiation directed towards an unprotected body without the metal plate in
between.

The engineers who had designed the machine had not believed it possible to
correct an error as quickly as some of the operators had done. They had not tested
and investigated how quickly such action could be performed.