Ahlam Al-Qadasi

Medical Device Technology, 21 September

Clinical engineering
Dr. Mohmood Aldobali

X-ray devices form a fundamental pillar in the modern healthcare

system, being widely used in diagnostic and therapeutic fields,
ranging from detecting simple fractures to complex medical
procedures such as cardiac catheterization. These devices are
characterized by their superior diagnostic capabilities and their
ability to provide precise images of the internal tissues of the body,
which helps doctors in making appropriate diagnoses and devising
effective treatment plans. However, with the rapid development of
medical imaging technologies and the notable increase in the number
of devices used in hospitals and medical centers, the need for effective
and accurate management of the lifecycle of these devices has
emerged, starting from the planning phase for purchase, through
maintenance and operation, to the safe disposal at the end of their
.productive life

Managing the lifecycle of X-ray devices represents a multifaceted

challenge; it requires a deep understanding of the technologies used,
economic considerations, and health and environmental dimensions.
On one hand, the high costs of purchasing and maintaining these
devices pose a significant financial burden on healthcare institutions,
necessitating careful planning for resource management and
reducing unnecessary expenses. On the other hand, there are
significant health and environmental risks; while X-ray radiation
provides diagnostic and therapeutic benefits, it poses a risk to the
health of medical staff and patients, and improper disposal of
.radioactive waste threatens the environment

Therefore, precise planning and management of the lifecycle of X-ray

devices is crucial to ensure the optimal use of this sensitive
technology, reduce costs, and maintain health and environmental
safety. This research aims to review best practices in this field,
analyze the challenges and issues associated with it, and propose
solutions and recommendations for improving the management of
the lifecycle of X-ray devices through a comprehensive study
.covering all its phases, from planning for purchase to safe disposal
 :This study aims to achieve the following objectives

A comprehensive review of the literature on the management of ** .

the lifecycle of medical devices, focusing on X-ray devices:** This
includes analyzing current practices and identifying strengths and
.weaknesses in existing systems

Identifying factors affecting the efficiency of managing the** .

lifecycle of X-ray devices:** Economic, technical, health, and
environmental factors that influence the effectiveness of lifecycle
.management will be identified

Proposing an improved model for managing the lifecycle of X- ** .

ray devices:** A model will be developed that considers all
influencing factors and aims to enhance efficiency, reduce costs, and
.mitigate risks

Evaluating the economic and environmental impacts of the** .

practical application of the proposed lifecycle management model:**
The effectiveness of the model in reducing costs and negative
.environmental impacts will be measured

Providing practical recommendations for healthcare institutions ** .

and policymakers to improve the management of the lifecycle of X-
ray devices:** Specific recommendations will be formulated to assist
.in adopting best practices
Identifying future research gaps in the field of managing the ** .
lifecycle of X-ray devices:** Areas requiring further research and
.development will be identified

How can the management of the lifecycle of X-ray devices improved

in light of current technological, economic, and environmental
changes to ensure optimal resource use, reduce costs, and maintain
?public safety and health as well as environmental protection

The management of medical device lifecycles, especially X-ray

devices, is an emerging research field attributed to the high costs of
these devices, their significant impact on the quality of healthcare,
and the environmental risks associated with them. Lifecycle
 management involves multiple stages, starting from planning for
purchase, through installation, maintenance, use, and finally, the safe
.disposal of the device at the end of its productive life

Theories:** Best practices in managing the lifecycle of medical **

:devices are based on several theories, including

Lifecycle Management:** This theory focuses on managing all ** -

stages of the product lifecycle, from planning to disposal, to ensure
maximum value and minimize costs. This theory is applied to X-ray
devices through careful planning for purchasing devices that meet
the institution's needs, planning for preventive maintenance, and
.managing radioactive waste

Total Quality Management:** This theory contributes to** -

ensuring the quality and reliability of X-ray devices by controlling
.quality at all stages of the lifecycle, from design to disposal

Circular Economy:** This theory emphasizes reusing and ** -

recycling components of X-ray devices to reduce waste and negative
.environmental impacts

Practice:** Current practices for managing the lifecycle of X-ray **

:devices vary across healthcare institutions, but generally include

Planning for device purchases:** This involves assessing the ** -

institution's needs, comparing the technical specifications of different
.devices, and determining the budget

Preventive maintenance:** Preventive maintenance helps extend ** -

.the life of devices and reduce emergency repair costs

Managing radioactive waste:** Safe disposal of radioactive ** -

.waste is crucial for maintaining health and environmental safety

Training medical and technical staff:** Training contributes to ** -

.the optimal use of devices and reduces the risk of errors
 X-rays are a type of electromagnetic radiation with a wavelength
ranging from 10 to 0.01 nanometers, meaning their energy ranges
between 120 electron volts (eV) and 120,000 electron volts (keV).
They were discovered by German scientist Wilhelm Röntgen in 1896
at the University of Würzburg, for which he received the Nobel Prize
.in Physics in 1901

Production of X-rays ###

X-rays were discovered in 1895 by the German scientist

Wilhelm Roentgen. Roentgen directed a high-energy
electron beam through a vacuum tube accelerated by a high
voltage of up to 30,000 volts. When the accelerated electrons
struck the glass of the vacuum tube, Roentgen observed a
noticeable glow on a fluorescent screen placed a short
distance away. This glow persisted even when a wooden
 board was placed between the vacuum tube and the
fluorescent screen. Roentgen concluded that there were
strong rays emitted from this tube and named them "X-
rays" since he was not yet aware of their properties. In
".Germany, they are referred to as "Röntgen rays

:X-rays are produced in two ways

By accelerating charged particles, typically electrons, -

which create a continuous spectrum (a mixture of short and
.very short electromagnetic waves)
Or during electron transitions within an atom or molecule -
.from a very high energy level to a lower energy level

X-rays are generated when electrons suddenly lose energy

upon colliding with other atoms. The device that produces
X-rays accelerates electrons emitted from a filament to high
speeds so they collide with a metal known as the target.
When the accelerated electrons transfer part of their energy
to the atoms of the metal to excite them, the remaining
energy is emitted in the form of electromagnetic radiation
.(X-rays)

Both methods are utilized in an X-ray tube, where electrons

are generated at the cathode (a glowing filament similar to a
light bulb) and accelerated before colliding with the
positively charged anode, resulting in a strong deceleration.
This process produces X-rays and heat. About 99% of the
electrical energy used is converted into heat, which is not
useful, while only 1% is transformed into X-rays. When
electrons collide with the electrons of the target metal atoms,
they knock them out of the atom. Since the atom cannot
remain electron-free for long, an electron from outside the
atom fills the vacant space, emitting an X-ray during this
.transition with a specific wavelength
 Today, ceramics are used as the anode material, with the
area of electron impact covered by molybdenum, copper, or
.tungsten

The diagram below illustrates the X-ray tube: (K: the

cathode, the source of electrons; A: the anode, which
.produces X-rays; C: the cooling system)

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X-ray Analysis and Applications ###

After studying and analyzing the spectrum of X-rays, it

was found that they have a shorter wavelength than
ultraviolet rays, which means they possess higher energy.
For this reason, X-rays can penetrate the human body, but
they do not penetrate bone. This property is utilized in
bone imaging; by placing an X-ray-sensitive film behind a
person's leg and directing X-rays for a short time from the
other side, the shadow of the X-rays can be captured on
.the film, revealing a clear image of the bone structure
If we assume that our eyes could see within the frequency
range of X-rays, the image we would perceive would be
!similar to those taken in a hospital

Uses of X-rays ###

Medical Radiography:** X-rays are used to detect ** -

dental and bone fractures, locate solid objects like
.shrapnel or bullets within the body, and identify tumors
Cancer Treatment:** X-rays can kill and eliminate ** -
cancerous cells. Healthy body cells can regain their vitality
.after a recovery period and return to normal
Industrial Applications:** X-rays are employed to ** -
detect defects and cracks in metal molds and wood used
in boat construction. Additionally, studying the absorption
spectrum of these rays allows for the identification of
elements in various materials and their analysis, as X-rays
.can distinguish each chemical element
Security:** X-rays are utilized in monitoring ** -
passengers' luggage at airports to search for weapons or
.explosives
Solid-State Physics:** X-ray diffraction has revealed ** -
specific symmetries in certain solids (crystals), marking a
significant breakthrough in studying solid properties,
.crystal structure, and atomic composition
Art Analysis:** X-rays are used to identify painters' ** -
techniques and distinguish between authentic and
counterfeit paintings, as the colors in old paintings contain
many metallic compounds that absorb X-rays, while
modern paints consist of organic compounds that absorb
.X-rays to a lesser extent

Dangers of X-rays ###

X-rays are classified as ionizing radiation, which means

they can ionize the medium they pass through by
displacing electrons from atoms and molecules. This can
cause changes in living cells, potentially leading to cancer.
Therefore, governments establish guidelines and laws
 regarding the use of X-rays in medicine and industry,
monitoring compliance and penalizing violations according
.to established regulations

However, X-rays are also used in combating cancer by

focusing X-rays on cancerous cells. DNA in living
organisms is very sensitive to X-rays, with damage
increasing as absorption of X-rays rises. This means that
exposure to even a small dose of X-rays carries the
potential risk of converting a healthy cell into a cancerous
one. Consequently, this risk is considered when using X-
.rays for diagnosis or treatment

In general, pregnant women should not be exposed to X-

rays, and caution is advised when using them on children,
as they may cause infertility in both men and women if
.the reproductive organs are exposed

?What Can We See with X-rays ###

Many components of the universe, such as the sun, stars,

galaxies, black holes, and pulsating stars, emit X-rays. For
this reason, satellites equipped with sensitive X-ray
observatories have been launched to capture images
based on the X-rays emitted from these celestial bodies.
.The following table includes some of these images

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‫التقطت هذه الصورة في مارس‬

‫ للكرة األرضية بواسطة قمر‬1996
،NASA ‫صناعي تابع لوكالة الفضاء‬
‫وتوضح الصورة في المنطقة الحمراء‬
‫أشعة اكس تكونت من اصطدام‬
‫جسيمات مشحونة بالطبقات العليا‬
‫للغالف الجوي وهي غير خطيرة ألنها‬
.‫ال تنفذ إلى سطح األرض‬
 ‫الشمس أيضا تطلق أشعة اكس‬
‫والصورة المقابلة أخذت للشمس في‬
‫‪ 27‬ابريل ‪ 2000‬بواسطة قمر‬
‫صناعي ‪Yokoh‬‬

‫صورة توضح ثقب اسود تصل درجة‬

‫حرارته إلى مليون درجة مئوية يبعث‬
‫أشعة اكس‪.‬‬

‫صورة بأشعة اكس لبقايا مجرة‬

‫تعرضت إلى انفجار عظيم توضح‬
‫المناطق الزرقاء مكان تركيز أشعة‬
‫اكس بينما المناطق الخضراء هي‬
‫أشعة مرئية والمناطق الحمراء ألشعة‬
‫الراديو المنبعثة‪ ،‬وهذا يعتمد على‬
‫توزيع درجة الحرارة للمجرة‪.‬‬

‫‪---‬‬

‫‪:Results and Discussion ##‬‬

‫** )‪**:Quantitative Results (Hypothetical Example‬‬

‫‪Variable‬‬ ‫‪| Mean‬‬ ‫| ‪| Standard Deviation | p-‬‬

‫‪| value‬‬
----------------|----------------------|-----------------------------------------|
|----------|----
Preventive Maintenance Cost (in thousands) | 15 |5 |
| | 0.01
Emergency Maintenance Cost (in thousands) | 25 |8 |
| | 0.001
Failure Rate (number of failures annually) | 2 |1 |
| | 0.05
User Satisfaction (on a scale from 1 to 5, 5 = highest satisfaction) | 3.8 |
| -| | 0.7

**:Interpretation of Quantitative Results**

The results showed a statistically significant difference between

preventive maintenance costs and emergency maintenance costs
(p<0.001). The average emergency maintenance cost was approximately
double that of preventive maintenance. Additionally, there was an inverse
relationship between the implementation of preventive maintenance and
the failure rate (p<0.05), suggesting that investing in preventive
maintenance reduces emergency maintenance costs and improves device
performance. Regarding user satisfaction, the average rating was
relatively high (3.8 out of 5), indicating an acceptable level of user
satisfaction with the devices and maintenance services. However, further
analysis is needed to identify reasons for not achieving a higher
.satisfaction level

**:Qualitative Results (Hypothetical Example) **

:Through interview analysis, three main themes emerged

Importance of Training:** Participants emphasized the importance ** *

of training medical and technical staff on the correct use of devices to
.reduce failure rates and extend device lifespan
Challenges in Waste Management:** Participants noted difficulties ** *
in managing radioactive waste due to high costs and strict regulatory
.requirements
Funding Shortages:** Participants expressed concerns about** *
insufficient funding allocated for device maintenance and upgrades,
.negatively impacting the quality of healthcare services

**:Discussion of Results**
 The quantitative results demonstrate the importance of investing in
preventive maintenance to reduce long-term costs and extend device
lifespan. These results align with numerous previous studies that have
shown the effectiveness of preventive maintenance in reducing
maintenance costs and failure rates. The qualitative results highlight the
significance of human factors (training) and logistical factors (waste
management and funding) in managing the lifecycle of X-ray devices. A
gap is observed between best practices (indicated by quantitative results)
and the reality on the ground (shown by qualitative results). Insufficient
funding and inadequate training hinder the ideal implementation of
.recommended practices

**:Recommendations**

.Increase investment in preventive maintenance *

.Develop effective training programs for medical and technical staff *
.Establish effective strategies for managing radioactive waste *
Allocate sufficient budgets for maintaining and upgrading X-ray *
.devices
Conduct future studies to identify factors affecting user satisfaction *
.more accurately

In conclusion, this hypothetical study highlighted the importance of

investing in preventive maintenance for X-ray devices to reduce long-
term costs and improve device efficiency. The study also underscored the
role of human and logistical factors in the successful management of the
lifecycle of these devices, emphasizing the need for proper training for
medical and technical staff, effective waste management solutions, and
adequate funding. Despite the limitations of this hypothetical study, it
points to the necessity for more comprehensive field research to deepen
the understanding of these factors and develop more effective
management strategies. Future studies are recommended to involve larger
and more geographically diverse samples, focusing on measuring user
satisfaction indicators more accurately and evaluating the impact of
various interventions on extending device lifespan and reducing
maintenance costs. Investment in infrastructure and qualified human
resources is essential to maximize the benefits of X-ray devices and
.ensure the quality of healthcare services

References ###

Ali, Zaid. (2023). *Management of the Lifecycle of Medical Devices: .1

A Case Study in Hospitals in the Kingdom*. Journal of Health
 Administration, Volume 15, Issue 2, 120-145. DOI:
.10.1234/jsh.2023.15.2.120 (Hypothetical DOI)

Mohamed, Ahmed. (2022). *Preventive Maintenance in the .2

Healthcare Sector: A Practical Guide*. Scientific Publishing House,
.Cairo

World Health Organization. (2021). *Global Guidelines for Medical .3

.Device Management*. Geneva, Switzerland

American Association of Physicists in Medicine. (2020). *Safety .4

.Standards for the Use of X-ray Devices*. Washington, USA

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