Yarmouk University

Hijjawi Faculty for Engineering Technology

Department of Biomedical Systems and

Informatics Engineering

Training Report
Name Ruba Faisal Mustafa Al-Zyout

Student Number 2013977092

Training Supervisor Eng. Sami Al-Mashaqbeh

Dr. Asem Al-Zoubi

Training Period 20/6/2019 to 20/12/2019

Company Prince Rashid Ben Al-Hassan

Military Hospital

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 Acknowledgement
The opportunity to train is one of the most important experiences I have had
during my university career. I have learned a lot of medical information, as well
as getting to know many distinguished people in the field of medical engineering.
Really it was a special period for me.

At first, I thank Allah for honoring me with health, knowledge, a desire to reach
and helped me to complete my training period.

I also would like to thank the most precious persons in my life; my father and
my mother who have always been by my side and support me financially and
morally. As my brothers and my little sister because they trusted me that I could
achieve what I want.

Also for my supervisors from Yarmouk University (YU); Eng. Sami Al-
Mashaqbeh and Dr. Asem Al-Zoubi. I thank them for their advice, guidance,
cooperation and the support through this training.

Special thanks to all staff of the biomedical engineering and technicians

department in Prince Rashid Ben AL-Hassan Military Hospital for their
encouragement, learning, advising and sharing their experience with us.

I would like to also thank all faculty members in department of biomedical

engineering who has taught me important information and encourage me along
my studying period in the university.

Finally, my thanks to my relatives especially my cousin Jafar Bassam and all my

friends. May Allah bless you all and make you always proud of me.

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 Abstract
The training period is one of the graduation policies of Hijjawi Faculty for
Engineering and Technology, where the student takes a period of 6 months in
training, whether in one place or more in order to obtain the practical side
extensively for all that was theoretically studied in the college. I choose to
practice in "Prince Rashid Ben Al-Hassan Military Hospital" for 6 months from
20/6/2019 to 20/12/2019.

During these six months of training I learned about large number of medical
instruments available in the hospital, consists of many departments such as
Intensive Care Unit, Sterilization Department, Kidney Department, Laboratory
Department, Radiation and other departments.

The field of medical engineering is a humanitarian field in the first place.

Therefore, we must work very accurately, adhere to all safety rules, be always
ready to work under pressure and give the best result whether it is individual or
group work.

My report includes this period in details, safety in hospital, some medical devices
with their work principle and troubleshooting, some forms for medical devices
data, lessons learned and skills that I have get.

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 Table of Contents
Acknowledgement ..................................................................................... ii
Abstract ..................................................................................................... iii
Table of Contents ...................................................................................... iv
List of Figures ........................................................................................... vi
List of Tables ........................................................................................... vii
Chapter 1 Introduction ................................................................................1
1.1 Training life (My personal experience) .............................................1
1.2 Company Profile ................................................................................2
1.2.1 The achievements of training ......................................................3
1.2.2 Hospital Departments ..................................................................3
1.2.3 Hospital Contact ..........................................................................4
1.3 Training Program ...............................................................................4
1.3.1 Training Schedule ........................................................................4
1.3.2 The Work Team ...........................................................................5
1.4 Medical Equipment Classifications ...................................................5
1.5 Maintenance .......................................................................................7
Chapter 2 Safety In Hospital .......................................................................8
2.1 Patient Safety .....................................................................................8
2.2 Safety During Maintenance ...............................................................9
2.3 Environmental Safety ......................................................................10
Chapter 3 ICU and CCU Unit ..................................................................11
3.1 Patient Monitor and Central Station ................................................12
3.1.1 Purpose ......................................................................................12
3.1.2 Principles of Operation .............................................................12
3.1.3 Troubleshooting .........................................................................13
3.2 Syringe Pump...................................................................................13
3.2.1 Purpose ......................................................................................13
3.2.2 Principles of Operation .............................................................14
3.2.3 Troubleshooting .........................................................................14
3.3 Infusion Pump ..................................................................................15
3.3.1 Purpose ......................................................................................15

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 3.3.2 Principles of operations ............................................................15
3.3.3 Troubleshooting .........................................................................16
Chapter 4 Laboratory Department ...........................................................17
4.1 CBC (Counter Blood Cell) Device ..................................................17
4.1.1 Purpose ......................................................................................17
4.1.2 Principles of operation ..............................................................18
4.1.3 Troubleshooting .........................................................................19
4.2 Clinical Chemistry Analyzer ...........................................................19
4.2.1 Purpose ......................................................................................19
4.2.2 Principles of operation ..............................................................20
4.2.3 Choosing a Clinical Chemistry Analyzer ..................................20
4.2.4 Troubleshooting .........................................................................21
Chapter 5 Sterilization Department ..........................................................22
5.1 Steam Sterilization ...........................................................................25
5.1.1 Purpose ......................................................................................25
5.1.2 Principles of operation ..............................................................26
5.1.3 Advantages and Disadvantages of Steam Sterilization:............28
5.1.4 Troubleshooting .........................................................................28
5.2 Gas Sterilization...............................................................................28
5.2.1 Purpose ......................................................................................28
5.2.2 Principles of operation ...............................................................29
5.2.3 Advantages and Disadvantages of Gas Sterilization ................31
5.2.4 Troubleshooting .........................................................................32
Chapter 6 Forms of Medical Devices Maintenance .................................33
6.1 Local Purchase Form .......................................................................33
6.2 Maintenance Request Form .............................................................34
Chapter 7 Conclusion................................................................................35
7.1 Lessons Learned ..............................................................................35
7.2 Recommendations for new trainees.................................................36
References .................................................................................................37

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 List of Figure
Figure 1.1: Prince Rashid Ben Al-Hassan Military Hospital………………………….2
Figure 3.1: ICU Room………………………………………………………………..11
Figure 3.2: Patient Monitor…………………………………………………………..12
Figure 3.3: Patient Monitoring System……………………………………………....13
Figure 3.4: Syringe Pump…………………………………………………………….13
Figure 3.5: Syringe Pump Design……………………………………………………14
Figure 3.6: Infusion Pump……………………………………………………………15
Figure 4.1: Count Blood Cell Device………………………………………………...17
Figure 4.2: CBC Principle……………………………………………………………18
Figure 4.3: Clinical Chemistry Analyzer…………………………………………….19
Figure 4.4: Methods of sample loading and flexibility of assay choice……………...20
Figure 5.1: Sterilization Department…………………………………………………22
Figure 5.2: Sterilization Department Layout…………………………………………23
Figure 5.3: Washer Machine…………………………………………………………24
Figure 5.4: Packaging Area…………………………………………………………..24
Figure 5.5: Table of Spaulding Classification System……………………………….25
Figure 5.5: Steam Sterilizer…………………………………………………………..26
Figure 5.6: Control Screen for the Steam Sterilizer…………………………………27
Figure 5.7: Steam Sterilization Cycles……………………………………………….27
Figure 5.8: Gas Sterilizer……………………………………………………………..29
Figure 5.9: Control Screen for the Gas Sterilizer…………………………………….30
Figure 5.10: Gas Sterilization Cycle…………………………………………………31
Figure 6.1: Local Purchase Form…………………………………………………….33
Figure 6.2: Maintenance Request Form……………………………………………...34

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 List of Table
Table 1.1: Team Members……………………………………………………………..5
Table 5.1: The Relation between Temperatures with Gas Exposure………………...30

vii
List of Figures

vi
List of Tables

vii
 Chapter
1 Introduction

1.1 Training life (My personal experience)

Training is an opportunity for student to examine the relationship between the
theoretical part and the practical part to see most of medical devices and their
components and to define the troubleshooting and errors that occur and how to
solve them. It can improve the trainee communication skills and teamwork.

Now that this period is over, I see that I have achieved many of the goals I
wanted. During my theoretical period, things were unclear about medical devices
and their components as they are now. I learned how to deal with medical devices
from the moment there is a malfunction in it until the solution to that malfunction
and to apply all safety matters, whether it is on me, the patient, the doctor and
the environment around.

Really, I express myself as a lucky person because of studying this field and
thank God for that.

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1.2 Company Profile
Prince Rashid Ben Al-Hassan Military Hospital

Figure 1.1: Prince Rashid Ben Al-Hassan Military Hospital

Prince Rashid Ben-Al-Hassan Military hospital Founded in 1966 and it is the

main referral hospital in the North of Jordan. It’s belonging to Jordanian Royal
Medical Services (JRMS).

JRMS contains all major medical and surgical specialties, and a plenty of sub
specialties that are capable to deal with almost all cases, and able to provide the
most recent and professional interventions and operations with very high
standers that made it one of the most important centers in Middle East and the
whole world.

The hospital contains many engineers belonging to JRMS, who hold high
scientific degrees and are able to deal with medical devices and malfunctions
that occur in them accurately, following all safety methods as well as being able
to give information to all their trainees in the field of biomedical engineering.

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1.2.1 The achievements of training
There are many goals to be achieved during the training period, the most
important of which are:

1. The ability to link between the theoretical sides that was studied in the college,
with the practical side through seeing medical devices and their components,
knowing the principles of their work, the most important faults that occur in them
and how to solve them.
2. Learn the steps followed from the moment there is a malfunction in the medical
device until the malfunction is solved.
3. Follow all safety rules carefully when dealing with medical devices.
4. Improve the communication skills of the trainee, and how he/she deals with
doctors, engineers and patients in work environment.
5. Learn to fill out medical maintenance forms in case of malfunctions.
6. How to submit an application to purchase a medical device, taking into account
the most important specifications required for the device and the cost.

1.2.2 Hospital Departments

 Emergency: Containing beds and rooms equipped operations and ambulances
modern addition to the airstrip for helicopters cases of air evacuation.

 Operations: It includes (6) Operations rooms equipped to deal with all inputs
and surgical endoscope surgery.

 Intensive Care Unit: It contains (8) dynasty equipped with modern devices
connected to a central control unit.

 Radiology Department: Provides all services such as x-ray, CT scans and

magnetic resonance imaging.

 Department of Artificial Kidney Unit: A new building for this section was
opened a few months ago.

 Laboratory Department.

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  Unit Gastrointestinal Endoscopy.

 Sterilization Department: It contains just two methods of sterilization; steam

sterilization and gas sterilization.

 Unit Disease and Dialysis.

 Kids and Prematurity.

 Dental Section.

1.2.3 Hospital Contact

 Tel.: +96227100047
 Email: prmh@jrms.gov.jo
 Address: Irbid/Jordan. "Audion"

1.3 Training Program

1.3.1 Training Schedule

In the hospital, there are many medical departments, but there is only one
maintenance workshop. My training was completely practical depending on the
maintenance request that comes from any department; so there was not any
schedule followed during the training period. We go to department and take the
simple equipment like DMM, screw drivers and soldering device, so that we can
detect the fault and its location then to solve it. If we must have more equipment
to reach out the solution, we ask the nursing staff to send the device to the
workshop to fix the problem.

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1.3.2 The Work Team
The manager was Eng. Mahmoud Al-Okour and the other team members are
divided according to this table:

Table 1.1: Team Members

The Subject of Training Technician/Engineer Name

Sterilization Eng. Audai Ibrahim

Hemodialysis Eng. Yones

Radiation Eng. Hamzah

Ventilation Eng. Aktham Malkawi

Laboratory Eng. Rakan Al-Deasi

Dental Unit/ICU Eng. Jafar Athamneh

Children Eng. Mustafa Al-Dohny

1.4 Medical Equipment Classifications

There are many classifications for medical devices; here I will classify all
the devices I have seen in the hospital into 3 groups:

1) Diagnostic devices: Devices are not treated the patient end does not
interfere with his treatment.
2) Therapeutic Devices: Devices are interfaces in giving the patient
treatment.
3) Life support devices: Devices are needed to complete the patient's life
in some pathological cases.

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 Table 1.2: Classifications of Medical Devices

Diagnostic Devices Therapeutic Devices Life Support Devices

CT scan Syringe Pump Hemodialysis

Thermometer Infusion Pump DC Chock

Gastroscopy Phototherapy Ventilator

Ophthalmoscope Electric Bed Baby Incubator

MRI Anesthesia

Ultrasound

ECG

X-ray Diagnostic System

Centrifuge

Microscope

Audiometer

Pulse Oximeter

Patient Monitor

Blood Cell Counter

Medical Devices Malfunctions

There are many types of medical devices malfunctions and they are:

 Mechanical malfunctions.
 Electrical malfunctions.
 Software malfunctions.

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1.5 Maintenance
Maintenance includes the procedures and requirements for preserving the
performance of the devices.

Types of Maintenance:

1) Preventive Maintenance: Schedule planned actions performed as

recommended by the manufacturer to increase life of equipment, reduce failures
and breakdowns and reduce cost of replacement. Examples of this type of
maintenance: Oil Changing, Greasing, General Visual Inspections and Changing
Filters.
2) Predictive Maintenance: Techniques that help determine the condition of in-
service equipment to predict when maintenance should be performed. Oil
Analysis is an example on it.
3) Breakdown Maintenance: Maintenance performed on equipment that has
been broken down and became unusable.

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 Chapter
2 Safety in Hospital

The golden rule of “Safety in hospital” is simply everyone’s responsibility. It can

not be performed by one person or one group or one department.

Medical errors may occur in different health care settings, and those that happen
in hospital can have serious consequences because it is a place where biological
agents, infections samples, toxic and corrosive chemicals, radioactive materials
are handled. One of the most effective ways to reduce work place hazards and
injuries is through a comprehensive, protective safety and health care
management system. It is a proactive, collaborative process to find and fix
workplace hazards before employees are injured or became ill.[1]

The benefits of implementing safety and health management systems include

protecting workers, saving money, and making all your hazards specific
programs more effective.[1]

There are many types of safety in the hospital, but here I will mention the most
important of them.

2.1 Patient Safety

Patient Safety is a health care discipline that emerged with the evolving
complexity in health care systems and resulting rise of patient harm in health
care facilities. It aims to prevent and reduce risks, errors and harm that occur to
patients during provision of health care. A cornerstone of the discipline is
continuous improvement based on learning from errors and adverse events.[2]

And among the most important things to follow to maintain the patient's safety:

1) Educate patients about using blood thinners safely.

8
 2) Prevent central line associated blood stream infections.
3) Limit shift durations for medical residents and other hospital staff if possible.
4) Have a periodic checks of ground wire continuity of all instruments and devices.
5) No other apparatus should be put where the patient monitoring is connected.
6) Use good hospital design principles.

2.2 Safety During Maintenance

Maintenance is a high risk activity because it often requires working alongside
a running process and in close contact with the device. Its operations typically
include both disassembly and reassembly, often involving complicated
machinery. This can be associated with a greater risk of human error, increasing
the accident risk. [3]

Working under time pressure is also typical for maintenance operations,

especially when shutdowns or high-priority repairs are involved.

In order to reduce these risks, there are rules that must be followed while
performing maintenance of any device:

1) Planning.
2) Making the workplace safe.
3) Use of appropriate equipment.
4) Safe work procedures have to be communicated and understood by
workers and supervisors, and applied correctly.
5) The maintenance process needs to end with checks to make sure that the
task has been completed, that the machine under maintenance is in a safe
condition, and that all waste material that has been generated during the
maintenance process has been cleaned away.

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2.3 Environmental Safety
The environment within the hospital is critical for life support, so
there are some rules for its safety:
1) Keep floor surfaces clean and dry. Clean up all spills promptly, and
use “wet floor” signs as appropriate.
2) Use night lights or supplemental lighting to help patients move safely in low-

light areas and situations.

3) Regularly assess the environment, including patient rooms and common areas,

for potential fall hazards (e.g., clutter, cords, poorly designed furniture, sharp
edges, carpeting hazards, etc.).
4) Ensure that appropriate signage is used in the facility and that the wording is

clear and readable.

5) Keep hospital bed brakes locked unless the bed is being moved, and make sure

wheelchair wheels are locked when patients are transferring in or out of chairs
or the chairs are stationary.

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 Chapter
3 ICU and CCU Unit

An intensive care unit (ICU) provides the critical care and life support for acutely
ill and injured patients. Unless you are an emergency admission, you will need a
referral from your doctor or specialist to be admitted to ICU.

How do I choose ICU Site?

These departments should be located near to laboratory department, radiology
department and operation room in case of ICU and near to catheter operation
room, in case of CCU. In these rooms there are no external ventilation, internal
and moderate light; there are good sterilization and earthing system.

Devices in section
Electrical bed, Patient monitor, Ventilator, Defibrillator (dc shock), Heating
cooling machine, Infusion pump, Syringe pump, Suction, Incubator,
Hemodialysis machine, Portable x-ray, Blood gas analyzer and Pulse Oximeter.

Figure 3.1: ICU Room [4]

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3.1 Patient Monitor and Central Station

3.1.1 Purpose
Patient monitors measure, record, distribute and display combinations of
biometric values such as heart rate, SPO2, blood pressure, temperature and more.
High-capability, multi-function monitors are typically used in hospitals and
clinics to ensure a high-level of quality patient care. Portable patient monitors
are designed to be compact and power-efficient. This allows them to be used in
remote areas or by paramedics to aid diagnosis in the field, enable monitoring
and transmitting data to health care providers in other locations.[5]

Figure 3.2: Patient Monitor [6]

3.1.2 Principles of Operation

Physiologic monitors can be configured, modular, or both. Configured monitors
have all their capabilities already built-in. Modular systems feature individual
modules for each monitoring parameter or group of parameters; these modules
can be used in any combination with each bedside monitor or be interchanged
from monitor to monitor. Some physiologic monitoring systems have the
capabilities of both modular and configured systems. With these monitors,
frequently used parameters (e.g., ECG) are configured to the monitor, but
modules As monitoring data is collected, some central stations are beginning to
send the information to the patient’s electronic medical record.[5]

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 Figure 3.3: Patient Monitoring System[7]

3.1.3 Troubleshooting
1) The heart rate is inaccurate, the action taken change the lead or electrode
position.
2) The respiration waveform is not displayed on the screen, possible cause the
electrode is dry, the action taken apply gel to the patient body or replace the
electrode with new one.
3) Cannot measure CO2, possible cause the filter line is clogged, the action taken
to replace the filter with new one.
3.2 Syringe Pump
3.2.1 Purpose
A syringe pump is a pump used to deliver accurate and accurate amounts of fluid
in high-impact research environments ranging in fields from chemistry to
neuroscience.

Figure 3.4: Syringe Pump[8]

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3.2.2 Principles of Operation
Syringe pump generally consist of a drum that is attached to a piston. The piston
is operated by a motor through a drive screw or worm gear which helps in
pushing the plunger of syringe in or out resulting in a smooth flow. The syringe
is engaged on a clamp on the frame and the plunger of the syringe is displaced
by movement of drum.

Most of the syringe pump can work with different syringes of different
diameters, but the diameter has to be entered in beginning to make sure correct
volume is dispensed. These guidelines should be read from manufacturer
guidelines, and made sure whether syringes with different diameter can be used.
The user can set the parameters such as flow rate, dispense volume and syringe
diameter.

Figure 3.5: Syringe Pump Design[9]

3.2.3 Troubleshooting
1- Battery failure, solved by replacing it.
2- Malfunction the stepper motor, solved by replacing it.
3- Broken Fuse on the entrance of AC power, replace it.

14
3.3 Infusion Pump

3.3.1 Purpose
An infusion pump is a medical device that delivers fluids, such as nutrients and
medications, into a patient’s body in controlled amounts. They are in widespread
use in clinical settings such as hospitals, nursing homes, and in the home.[10]
In general, an infusion pump is operated by a trained user, who programs the
rate and duration of fluid delivery through a built-in software interface..

Figure 3.6: Infusion Pump[11]

3.3.2 Principles of operations

Infusion pumps can administer fluids in ways that would be impractically
expensive or unreliable if performed manually by nursing staff. For example,
they can administer as little as 0.1 mL per hour injections (too small for a drip),
injections every minute, injections with repeated boluses requested by the
patient, up to maximum number per hour (e.g. in patient-controlled analgesia),
or fluids whose volumes vary by the time of day.[12]

Because they can also produce quite high but controlled pressures, they can inject
controlled amounts of fluids subcutaneously (beneath the skin), or epidurals (just
within the surface of the central nervous system - a very popular local spinal
anesthesia for childbirth).

15
3.3.3 Troubleshooting
1- When there is a power supply failure, in this case we should check the power
cable then check the source of central electricity and then the power supply
circuit.
2- A problem in air bubble detector, it solved by cleaning or replacing it.
3- Malfunction in Pump or the motor, solved by replacing it.
4- Battery destruction: batteries should be replaced between 18 and 24 months.

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 Chapter
4 Laboratory Department

4.1 CBC (Counter Blood Cell) Device

4.1.1 Purpose
This device, used to measure the number of red blood cells, white blood cells,
and platelets in the blood. The amount of hemoglobin (substance in the blood
that carries oxygen) and the hematocrit (the amount of whole blood that is made
up of red blood cells) are also measured. A Counter Blood Cell is used to help
diagnose and monitor many conditions.

Figure 4.1: Count Blood Cell Device

17
4.1.2 Principles of operation
Typically, analysis begins when a well mixed whole blood sample is placed on
a rack in the analyzer. The instrument utilizes flow cells, photometers and
apertures in order to analyze different elements in the blood. The cell counting
component counts the numbers and types of different cells within the blood. A
special photometer called a hemoglobin meter measures the amount of
hemoglobin. This is done by adding a diluent that lyses the red blood cells which
is then pumped into a spectra-photometric measuring cuvette. The change in
color of the lysate equates to the hemoglobin content of the blood. This
information can be very helpful to a physician who, for example, is trying to
identify the cause of a patient's anemia. The results are printed out or sent to a
computer for review.[13]

Figure 4.2: CBC Principle[14]

Blood cell counting occurs by flow cytometry when a very small amount of the
specimen is aspirated, diluted and passes through an aperture and a laser flow
cell. Sensors count and identify the number of cells passing through the aperture.
The two main types sensors used are laser light detectors and electrical
impedance. The instrument determines the type of blood cell by analyzing data
about the size and aspects of light as they pass through the cells. Some

18
 instruments measuring different characteristics of the cells in order to categorize
them.[13]

4.1.3 Troubleshooting
1- If the readings are zeroes or there are incorrect readings.

- clean the needles then clean the chambers after that swipe air sample the readings
should be nearby zeros, if we still have the same problem then replace the filters
and swipe air sample then swipe a sample for 3 times to make sure that the
readings are correct.

2-When there is a power supply failure, in this case we should check the power
cable then check the source of central electricity and then the power supply
circuit.

4.2 Clinical Chemistry Analyzer

4.2.1 Purpose
It is a medical laboratory device used to calculate the concentration of certain
substances within samples of serum, plasma, urine and/or other body fluids.
Substances analyzed through these instruments include certain metabolites,
electrolytes, proteins, and/or drugs

Figure 4.3: Clinical Chemistry Analyzer[15]

19
4.2.2 Principles of operation
Analyzers are highly automated to maximize throughput, to improve user safety
from biohazards, and to diminish the risk of cross-contamination. Samples are
loaded into the machine and tests are programmed by the user. A probe measures
an aliquot of sample and places it into a reaction vessel. Reagents are added from
an on-board refrigerated supply. Incubation time is allowed, if required; then
photometric or ion-selective electrode (ISE) testing determines the concentration
of analyze. Results are displayed on screen or sent to a printer or computer.
4.2.3 Choosing a Clinical Chemistry Analyzer
Your choice of chemical analyzer will depend on the types of test you wish to
run and the throughput you require. Other factors include sample handling,
degree of automation, data management, operating costs, footprint, and whether
the machine can handle micro volume samples.
The most common test method is Photometry. The sample is mixed with the
appropriate reagent to produce a reaction that results in a color. The
concentration of the analyte determines the strength of color produced. The
photometer shines light of the appropriate wavelength at the sample and
measures the amount of light absorbed, which is directly correlated to the
concentration of the analyte in the sample.
The other major analytical method is the use of Ion Selective Electrodes to
measure ions such as Na+, K+, Cl–, and Li+. An ISE is a sensor that determines
the concentration of ions in a solution by measuring the current flow through an
ion selective membrane.

Figure 4.4: Methods of sample loading and flexibility of assay choice[16]

20
4.2.4 Troubleshooting
1. If a results card becomes jammed in the printer, you can open the analyzer front
panel and remove the card.
2. Reinitializing the analyzer may become necessary if the software becomes
corrupted. A Code 28 error message is a warning that the software has become
corrupted and must be reinitialized.
3. If the ambient temperature is outside the analyzer operating range (15-32°C; 59-
90°F). Press EXIT to acknowledge the message. Adjust the room temperature,
or power down the analyzer and move it to a warmer or cooler environment.

21
 Chapter
5 Sterilization Department

Sterilization describes a process that destroys or eliminates all forms of microbial

life and is carried out in health-care facilities by physical or chemical methods.
Steam under pressure, dry heat, ETO gas, hydrogen peroxide gas plasma, and
liquid chemicals are the principal sterilizing agents used in health-care facilities.
It is done under controlled conditions with adequate managerial and technical
supervision at the optimum cost and contributes to improve patient’ safety
programs through the reduction in hospital infection rat

Figure 5.1: Sterilization Department

How do I choose Sterilization Department Site?

1. The department should be designed so that it is physically separated from all

other work areas.

22
2. The department should be designed to facilitate a unidirectional flow from the
‘dirty’ area to the ‘clean’ area.
3. There should be a changing area for workers includes, toilet facilities and lockers
in proximity to the decontamination area.
4. Access to the wash room and to the clean room should be through dedicated
gowning rooms provided with hand hygiene facilities.
5. The wash room, clean room and sterilizer unloading area should be free from
‘opening’ windows, and unclean areas.
6. All rooms in the department should be mechanically ventilated and controlled to
provide a comfortable working environment, (typically temperatures should be
controlled between 18-22ºCelsius and relative humidity should be controlled
within the range 35-60%).
7. Staff movement between dirty and clean areas should not be possible without
passing through a clothing change and wash-up area.
8. Storage facilities for bulk items should be provided external to the clean room
and the wash room 9-Number of Washers, ultrasonic, sterilizers & other
equipments according to floor dimension, Staff total number & work load.

Figure 5.2: Sterilization Department Layout[15]

23
 Figure 5.3: Washer Machine

Sterile items should be stored and handled in a manner that maintains the
integrity of packs and prevents contamination from any source.

Figure 5.4: Packaging Area

24
Classification of the Risk from Medical Equipment

The classification system developed by Spaulding1 divides medical

equipment/devices into three categories based on the potential risk of infection
involved in their use:

Figure 5.5: Table of Spaulding Classification System [17]

5.1 Steam Sterilization

5.1.1 Purpose
Steam sterilization is the most common and most preferred method employed
for sterilization of all items that penetrate the skin and mucosa if they are heat
stable.

Autoclaves use steam as a carrier of thermal energy or heat. Steam is a much

more efficient carrier of heat than air. The steam softens the outer layer of
microorganisms, which permits the thermal energy or heat to enter the organism
and come in contact with the proteins in the organisms. The proteins are then
denatured thus become unable to do their normal function in the cell leading to
cell death.

25
 Figure 5.5: Steam Sterilizer

5.1.2 Principles of operation

Six factors are particularly critical to a sure successful steam sterilization:

1. Time
2. Temperature
3. Moisture
4. Direct steam contact
5. Air removal
6. Drying

26
 Figure 5.6: Control Screen for The Steam Sterilizer

Steam Sterilization Basic Cycles:

1) Pre-Conditioning: during this phase, air is removed from the chamber and the
load is humidified by means of alternating vacuum and pressure pulses.
2) Exposure: during this phase, the chamber temperature is raised to and held at the
programmed sterilizing temperature for the programmed exposure time (both are
user selectable). The exposure also may be controlled by accumulated F for
liquids if a load probe and appropriate sterilizer controls are used.
3) Post-Conditioning: during this phase, dry goods loads are cooled and dried or a
liquids load is cooled. The chamber pressure is brought to atmospheric.

Figure 5.7: Steam Sterilization Cycles[18]

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5.1.3 Advantages and Disadvantages of Steam Sterilization Advantages:
- Highly effective.

- Rapid heating and rapid penetration of instruments.

- Nontoxic.

- Inexpensive.

- Can be used to sterilize liquids.

Disadvantages:

- Items must be heat and moisture resistant.

- Will not sterilize powders, ointments or oils.

- Needs good maintenance.

5.1.4 Troubleshooting
1. If debris in door seal, clean it and the door frame.
2. If the Improper Bowie-Dick packs positioning in chamber, ensure that the
Bowie-Dick test pack is the only item in the chamber and is positioned on the
lowest shelf near the drain, and rerun the cycle.
3. If the printer will not print or its print is illegible, check or replace printer ribbon.

5.2 Gas Sterilization

5.2.1 Purpose
The active agent of the gas sterilization process can be ethylene oxide or another
highly volatile substance. The highly flammable and potentially explosive nature
of such agents is a disadvantage unless they are mixed with suitable inert gases
to reduce their highly toxic properties and the possibility of toxic residues
remaining in treated materials. The whole process is difficult to control and
should only be considered if no other sterilization procedure can be used. It must
only be carried out under the supervision of highly skilled staff.

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 Figure 5.8: Gas Sterilizer

5.2.2 Principles of operation

The sterilizing efficiency of ethylene oxide depends on the concentration of the
gas, the humidity, the time of exposure, the temperature, and the nature of the
load. In particular, it is necessary to ensure that the nature of the packaging is
such that the gas exchange can take place.

Ethylene oxide gas is toxic, carcinogenic explosive and can cause strictly
controlled environment. It is used to sterilize the heat sensitive items. The
process is long in comparison to other processes, typically taking four to six
hours, but is less aggressive in terms of products compatibility. Aeration time
must be carefully validated to ensure residual EO products fall below
internationally agreed level.

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 Table 5.1: The Relation between Temperatures with Gas Exposure

Temperature Gas Exposure Only Total Cycle

55 C Time 1 hour 3 hours and 45 minutes

37 C Time 3 hours 5 hours and 30 minutes

Figure 5.9: Control Screen for the Gas Sterilizer

Gas Sterilization Basic Cycles:

1) Pre-Conditioning Phase:
a- Pre-Heat: The chamber walls are heated to the selected temp.
b- Air Removal: Deep vacuum is created within the chamber to remove the air and
to improve the penetration and humidification of the load.
c- Humidification: Injection of low temp, steam to humidify the load and
improving the ETO penetration.
2) Gas Exposure Phase:
a- Cartridge Puncture: The difference in pressure between the vacuum in the
chamber and the pressure outside the chamber provides the force used to
puncture the cartridge.

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 b- Gas Exposure: Throughout the gas exposure, the sterilizer maintains negative
pressure to ensure gas will not escape the chamber.
c- Gas Removal: Deep vacuum is created to remove most of the ETO gas followed
by fresh air purge but the material of the load will continue release the gas
therefore the need for aeration.
3) Aeration: From two to four hours.

Figure 5.10: Gas Sterilization Cycle

5.2.3 Advantages and Disadvantages of Gas Sterilization Advantages:

- Easy to use.

- High efficiency

- Low temperature

- Two programs exists

Disadvantages:

- ETO is a toxic gas

- Long period of time is needed for its cycle

- Very expensive

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5.2.4 Troubleshooting
1. If there is no vacuum, check the air compressor cause it may be switched off or
the vacuum line is broken.
2. If the water tank is empty, there will be low humidity.
3. If there is no gas, then there is a leak from the chamber or the gas bottle is empty.
4. If the door does not open, the aeration valve is blocked or there is a fault in the
venture system.

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 Chapter
Forms of Medical Devices
6
Maintenance

In the field of maintenance for medical devices, there are a set of official forms
for this. In my training, I have seen two types of them which they are:
1. Local Purchase Form.

2. Maintenance Request Form.

6.1 Local Purchase Form

It is a written request use when wanting to buy a device from a local company.

Figure 6.1: Local Purchase Form

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6.2 Maintenance Request Form
It is a written request when the device has a certain malfunction and need
maintenance.

Figure 6.2: Maintenance Request Form

34
 Chapter
7 Conclusion

The training period was very important to me. I learned a lot of things that I did
not know, and I also saw many medical devices that I studied at university. I
learned how to maintain a set of devices and what are the most important steps
to do so.

Technicians and engineers at the hospital have learned me how to distinguish

between the service manual and the operating manual. Also how to submit a
tender request for a specific device and the steps taken to fill out any
maintenance form.

I learned how to be more patient person, and not to judge anything quickly.

Diligence at work, love of learning and strong determination are among the most
important reasons for development in any field and that health is the most
important thing that a person possesses.

7.1 Lessons Learned

The most important lessons I learned during my training period:

1. The ability to link between the theoretical side and the practical side in the field of medical
devices.

2. Know the difference between the service manual and the operation manual.

3. The necessary steps when performing maintenance for any medical device.

4. The importance of teamwork to find the best solution.

5. The necessity of discipline in time and all the rules within any organization.

35
 6. Not monopolizing information that would help others.

7. Accurately adhere to safety rules.

8. Development of personal and communication skills.

7.2 Recommendations for new trainees

The most necessary tips I want to give to new trainees:
1. Make sure to gain knowledge from every department you train in.
2. Link between the theories you studied and practical work you do, review
theoretical information whenever you need to.
3. Read the service manuals of the devices, and follow its instructions.
4. Follow all the listed safety precautions when dealing with the devices.
5. Always ask for advice when in doubt.
6. Commitment to scheduled days and hours.
7. Writing down everything related to medical devices that you see in the hospital
on a regular basis.

36
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