Medical Equipment Engineering: Design, manufacture and applications

The evolution of medical equipment engineering is progressing rapidly, with advances in digital healthcare technologies such as artificial intelligence, virtual/augmented reality, 3D-printing, robotics and nanotechnologies developing at pace. Medical equipment engineering can assist in surveying workplace inefficiencies, and develop efficient optimisation processes, through data research and intelligent learning automation. This edited book covers the benefits of the integration of lean manufacturing, smart sensors, 5G technology, IoTs, virtual reality, 3D printing, robotics and automation.
Medical Equipment Engineering: Design, manufacture and applications discusses the technological requirements that bring robots closer to humans in smart equipment manufacturing environments where computer-integrated equipment manufacturing, high levels of adaptability and rapid equipment design changes are successfully integrated with digital information technology, while ensuring that these new processes still protect worker safety.
A holistic view of medical equipment engineering will affect many areas, most notably: equipment services and engineering business models, equipment reliability and continuous productivity, machine safety, standards and maintenance, IT security and equipment product lifecycles. Topics such as industry value chain, industry demonstration and technicians and workers' education and skills will also be explored.
This book is essential reading for all engineers and designers working in medical equipment manufacturing, and related fields such as AI, virtual reality, smart sensors, 3D printing, robotics and automation.
- Book DOI: 10.1049/PBHE054E
- Chapter DOI: 10.1049/PBHE054E
- ISBN: 9781839537066
- e-ISBN: 9781839537073
- Page count: 378
- Format: PDF
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Front Matter
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1 Medical equipment engineering revolution
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The application of engineering principles, technology, and design principles to medicine and biology for healthcare reasons is known as medical equipment engineering (BEE) or biomedical system engineering (BSE) (e.g., diagnostic or therapeutic). BEE is a traditional logical science used to promote therapy, monitoring, and diagnosis in the field of medicine (Figure 1.1). The management of modern medical equipment in hospitals and the healthcare sector while complying with pertinent industry standards falls under the purview of a biomedical engineer. This is a job that also goes by the name of clinical engineering or biomedical equipment technician (BMET), and it entails purchasing, routine testing, preventive maintenance, and providing equipment recommendations.
In contrast to many other engineering disciplines, medical equipment engineering has just lately been a separate field of study. A new subject frequently undergoes this transformation as it transitions from being an interdisciplinary specialty among already-established topics to being regarded as a field in and of itself. Research and development are a large portion of the job in medical equipment engineering and biomedical engineering, which encompasses a wide range of subfields (bioinformatics, biomechanics, biomaterials, tissue engineering, genetic engineering, pharmaceutical technology, medical imaging, implants technology, hospital, and medical devices) (Figure 1.2). Development of biocompatible prostheses, different diagnostic and therapeutic medical devices ranging from clinical equipment to microimplants, common imaging equipment such as magnetic resonance imaging (MRI) and EKG/ECG, regenerative tissue growth, pharmaceutical drugs, and therapeutic biologicals are a few notable applications of biomedical engineering.
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2 Medical device manufacturing
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The fourth industrial revolution, often known as Industry 4.0, is the source of Quality 4.0. The first revolution began with the development of machine manufacture, steam power and the emigration of farmers to urban areas before the fourth revolution. Production was mechanised during the second industrial revolution, and the cost of consumer and industrial goods was reduced through mass production. The third industrial revolution includes the introduction of electronics and control systems, which helped reduce prices while increasing product complexity and lowering expenses. New quality paradigms, methods and technologies are being driven by the fourth industrial revolution of today (Figure 2.1).
There are many obstacles to designing and manufacturing safer products, particularly in the medical device manufacturing industry. Regulatory requirements are only one factor; if device companies want to stay competitive and use cutting-edge technologies, including the Internet of Things (IoT), artificial intelligence (AI), machine learning, augmented reality and even robotics, they must step up their game and incorporate emerging and constantly evolving technologies (Figure 2.2). These modern manufacturing technologies have come together to form Quality 4.0.
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3 Challenges and impact of medical equipment engineering
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The COVID-19 pandemic has shown how vulnerabilities in global healthcare systems can have profound implications for physical and mental health, economic recovery, confidence and trust in government, and social cohesion. Organisation for Economic Co-operation and Development (OECD) reported that since 2020, COVID-19 cases had totaled around 500 million across the world, with over 6 million deaths registered. These numbers are underrated as many COVID-19 cases were not reported, especially in lower- and middle-income countries. This public health crisis has also led to cascading health and economic crises from which most countries are only now beginning to emerge (Figure 3.1).
It is of utmost importance to strengthen health system preparedness and broader resilience to manage and contain emerging infectious pathogens or other potential shocks. Resilient health systems are required to build stronger and fast recovering economies further contributing to greater health and social and economic productivity.
The World Health Organization (WHO) plays a central role in facilitating the sharing of knowledge across countries on health policies and practices, as well as providing a broad range of global public goods (GPGs). GPGs in this context denote protecting and promoting global public health. Three categories of GPGs were highlighted to strengthen the global health systems: research and assessment, normative functions, and managing externalities. Figure 3.2 illustrates the relationship between spending on resilience and pandemic preparedness, at the national and international levels where the research and assessment portfolio is subcategorized into health technology research and development, marketing approval, health technology assessment, product quality assessment, treatment guidelines, delivery, and health systems research; normative functions portfolio is subcategorized into standard setting, regulations, and policies; and managing externalities is subcategorized into infectious disease surveillance, strategic stockpiles of drugs and vaccines, and early warning systems.
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4 Physiotherapy on e-health platforms
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In recent years, e-health, or the use of technology to deliver healthcare services, has grown in popularity. Physiotherapy is a branch of healthcare that deals with the treatment of physical conditions and injuries through various therapeutic techniques such as exercise, manual therapy, and education. With the rise of technology, physiotherapy has evolved, and now e-health platforms have emerged as a new way of delivering physiotherapy services.
Physiotherapy is one industry where e-health has had a substantial impact. Physical therapy, usually referred to as physiotherapy, is a discipline of medicine that focuses on the rehabilitate the problems from musculoskeletal, neurological, cardiopulmonary, sports, and various specialties. Exercise prescriptions, electrical modalities, manual therapy, and other hands-on therapy methods are used to assist patients in healing from dysfunctions or problems and enhancing their general physical function.
E-health platforms are online platforms that allow patients to access physiotherapy services from the comfort of their homes. These platforms provide a range of services such as teleconsultation, online appointment booking, and access to physiotherapy exercise programs.
This chapter will explore the application of e-health platforms in physiotherapy. The advantages and challenges of using these platforms will be discussed, along with the numerous e-health tools and technologies that are currently accessible for physiotherapy globally.
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5 Adoption of Building Information Modelling in Malaysia medical facilities building construction
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The Malaysia government acknowledged the importance of BIM technology for the medical facilities building, and the first pilot project that adopted BIM in Malaysia was the medical facilities building known as the National Cancer Institute (NCI) in the 2010. Building Information Modelling (BIM) is a new innovative technology for the construction industry stakeholders. BIM is a modelling technology and processes to communicate, produce and utilise the digital data information for the integration of the construction data and information throughout the project life cycle, with the purpose to enhance the efficiency, increase the productivity as well as enhance the collaboration among the project stakeholders. The government of Malaysia acknowledges the paramount importance of BIM technology for the transformation toward a more sustainable construction environment particularly in the construction of the medical facilities building construction. This study focused on the adoption of BIM technology in the construction of medical facilities building in Malaysia. The benefits of BIM for facilities management and the benefits of the implementation of NCI as the pilot medical facilities building are discussed.
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6 Medical equipment engineering standards for design and risk management of immersive virtual reality for in-clinic and home used
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Virtual reality (VR) refers to a computer-generated three-dimensional environment that can create a virtual world, tricking the human brain through visual, auditory, and tactile stimuli. It provides users with a sense of mental and physical immersion by responding to their movements and interactions in the real world. In recent years, the use of immersive VR technology in medical rehabilitation has become increasingly prevalent. Consequently, it is crucial to examine the ergonomic design of VR systems tailored for different target populations, whether for in-clinic or home use. Additionally, conducting risk analyses and implementing effective management strategies are vital to ensure the safe and reliable use of VR as a medical device.
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7 Medical equipment engineering in industrial revolution
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Technological advancements alter the way humans generate goods. The industrial revolution refers to the transition from primitive to advanced manufacturing technologies. The First Industrial Revolution is regarded as a major breakthrough in human history since it affected nearly every area of everyday living throughout the world. Societies all across the world were barely surviving prior to the First Industrial Revolution. The disease was pervasive, famines were widespread, poverty was ubiquitous, and trade was restricted to adjacent geographic regions. The First Industrial Revolution brought about significant social transformation. One significant development was the transition from handwork done at home in cottage industries to work done in factories.
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8 Medical equipment engineering in industrial revolution
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Human beings have seen three industrial revolutions and currently living in a rapid changing world that is undergoing fourth industrial revolution. Started in 1760, the first industrial revolution begun with the invention of steam engine where the society's lifestyle changed from agriculture (farming based) to the manufacturing process. People's lives were based on the feudal system in which landholders provide land to tenants in exchange for their loyalty and service. The revolution period was from 1760 to 1900 and the transition period was from 1860 to 1900. Coal was used mainly as energy resource during this time period as the main transport means was train. Textile as well steel industries started to bloom during this era of the first industrial revolution.
The second industrial revolution period begun in the early of 1900 and went on till 1960 where the transition period was from 1940 to 1960 with the internal combustion engine which was the major achievement of mankind during this era. Mass production occurred during this era of rapid industrialization by using oil and electricity. Cars begun to appear on roads with Benz and BMW pioneering the automation world. This was followed by third industrial revolution from 1960 till the end of millennium 2000. Natural gas and nuclear energy paved the way during the transition period of 1980-2000.
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9 Ethics, guidelines, and policy for technology in healthcare
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This chapter will explore the current body of evidence on the challenges and concerns that various technology has created in healthcare. It will describe the ethical challenges stakeholders face with the commonly embraced technology in healthcare delivery, education, and research. It will examine how the various actors assess and understand the impact of technology on the delivery of care and their outcomes while ensuring the protection of the patients and the community. It will explore how the stakeholders balance technology's universal benefits and risks in healthcare outcomes, value creation, and access. It will describe how frameworks have been developed to guide the ethical and moral use of technology in healthcare and on strategies for regulators to implement. This will ensure the just and ethical use and incorporation of technology in healthcare in advanced and less advanced communities.
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10 Medical equipment engineering and manufacturing standard and policies
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The manufacture of medical devices has included the design of the hardware and software which is required to comply with the standards that have been set by the international authorities such as FDA or IEC standards. This is to ensure that the final product that is manufactured by the medical equipment manufacturer, in making a safe and effective use of the devices to the end user. Throughout the manufacturing process, the risk assessment is one of the important keys to the success of launching medical products. This is because those related assessments or testing that have been done during the manufacturing process will act as a valid proof to verify the performance of the device so that it is safe to be used by fulfilling safety requirements such as the electrical safety test, electromagnetic compatibility (EMC) or GUI testing.
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11 Reimagining medical equipment engineering education: does industry 4.0 need education 4.0?
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In this particular chapter that there has been a discussion on the medical equipment Engineering education and its effect on the industry 4.0 has been spoken. Further there has been the shedding of the light on the concept and current scenario of industry 4.0 and education 4.0 has been viewed. In the research methods, the effective tools have been discussed along with the inclusion and exclusion criteria and Boolean search strategy. The data types and database have also been included in this section. In this research paper, it is discussed how education 4.0 in industry 4.0 enabled personalized learning in engineering education. It also helps in the development of the medical equipment that provides technical solution to the education. It also helps in the discussion on these points that help to understand the condition of the industry 4.0.
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12 Wireless communication technologies for medical equipment engineering
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A fast, stable, and reliable network security of the wireless networking infrastructure is important for communications, medical data transmission, patient monitoring, and inventory management in a healthcare setting. Therefore, improving fault-tolerance and maximizing energy-efficiency of the system lifetime, protection of data as well as strong network security are the key elements to be considered with the increasing number of patients. Meanwhile, medical devices and equipment should be able to provide accurate and secure data protection with precision and speed. Lastly, cost-effectiveness and sustainability approaches need to be thought of in order to prolong the network lifetime to bring forward wireless technologies in the healthcare industry to the next level.
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13 Human-robot interaction in medical equipment manufacturing
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The market for medical devices includes implants, tools, and equipment used for treatment, observation, and diagnosis. Implantable cardiac and diabetes monitoring are among them, as well as reconstructive equipment like hip and knee replacements.
Typically, the use of robots has moved fast from industrial to social reasons. Because of this, robots can now communicate with humans in a natural way. With the on-demand adjustable manufacture of complicated geometries, additive manufacturing (AM) techniques have been significantly reshaping the medical sectors, particularly medical equipment manufacturing, tissue engineering and implantable medical devices. Robots not only make AM easier but they also take care of 3D printers, which are also robots, automate post-processing for AM, and let architects come up with creative, adaptive ways to build the environment around us. To closely monitor the process before, during, and after the construction, active head control and dynamic deposition measurement are utilised.
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14 Trends in medical equipment engineering for additive manufacturing in the Industry 4.0 era
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Medical field is creating a pathway for the holistic life as well as meeting the demands for well-being of the society. The sustainability of medical field becomes possible with the development of new and advanced medical devices and components. The technology upgradation is true with proper knowledge and awareness within medical equipment engineering. The medical field is witnessing tremendous growth in the year after year, it always becomes possible with inheritance of latest technologies every time. The present era is for Industry 4.0, it leads the world into perfect digitalization. Every single component of the system inside the digitization process is used to be interconnected and enabled the space for virtual representation.
The process makes many things very simple and even more flexible. The software-controlled system can help us to overcome any common errors made in the traditional manual system. Here the automation process enjoys the advancements in the information technology and communication process to transform the normal devices into the smart device. This Industry 4.0 setting up the smart technologies to make the paradigm shift towards advancements in the medical equipment engineering. The process of additive manufacturing which is also refereed as rapid prototyping or 3D printing comes under the part of Industry 4.0, it helps to achieve higher the level of precision and flexible to produce more intricated shapes of medical devices. The present chapter is intended to discuss more about the additive manufacturing concepts and their impact in the recent developments in the medical equipment engineering.
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15 Application of e-platforms in physiotherapy education
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Overall, online classes can provide physiotherapy students with a flexible and convenient way to learn and practice their skills, while also allowing them to complete their education during times when in-person classes are not possible.
Online education in physiotherapy offers numerous benefits and drawbacks. On the positive side, it provides greater flexibility and convenience for learners as they can attend classes from anywhere and at any time. It also offers a wider range of course options and can be more cost-effective. Additionally, the use of technology allows for interactive learning experiences and the ability to access a wealth of information easily. On the negative side, online education can lack the hands-on experiences and personal interaction found in traditional classroom settings. It also requires a high level of self-motivation and discipline as students are responsible for their own learning. Overall, online education in physiotherapy offers a viable alternative for those seek further their education, but it is important to weigh the advantages and disadvantages to determine if it is the right fit.
In conclusion, e-platforms have revolutionized physiotherapy education, making it more accessible, interactive, and engaging. With the continued evolution of e-platforms, physiotherapy students can expect to benefit from even more innovative and effective learning tools in the future.
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16 Challenges and considerations in e-health platforms
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E-health platforms face a number of challenges and considerations, including technical, privacy and security, accessibility, and user experience. To be successful, e-health platforms must be designed and implemented with these challenges in mind and must provide tangible benefits for patients and healthcare providers.
Regulating the challenges and considerations in e-health platforms requires a multi-faceted approach, involving legislative frameworks, privacy and security regulations, interoperability standards, certification programs, ethical guidelines, and international collaboration. By implementing robust regulatory measures, governments and regulatory bodies can foster the safe, secure, and efficient use of e-health platforms, ultimately benefiting healthcare providers, patients, and the healthcare system as a whole.
E-health platforms need to be integrated with existing healthcare systems to ensure that patients receive a seamless and coordinated care experience. However, integrating with existing systems can be challenging, particularly in cases where different systems are used across multiple healthcare providers and institutions.
Overall, addressing these challenges is critical to the successful implementation and adoption of e-health platforms and the delivery of quality, accessible healthcare services.
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17 Telerehabilitation in physiotherapy
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Telerehabilitation, or the use of technology to provide rehabilitation services remotely, has been shown to be effective in a variety of settings. It has the potential to improve access to rehabilitation services for individuals living in rural or remote areas, reduce barriers to care such as transportation and childcare, and increase patient satisfaction. However, there are also potential drawbacks to telerehabilitation, such as the need for reliable internet access and privacy concerns. Overall, telerehabilitation can be a useful addition to traditional rehabilitation services, but further research is needed to fully understand its effectiveness and optimal implementation.
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18 Artificial intelligence in sports
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AI has the potential to greatly enhance the way we train, compete, and watch sports. The use of AI in sports is still in its infancy but its application in computer vision, performance analysis, decision-making, and training and rehabilitation can revolutionize the industry. However, we must also consider the ethical implications of using AI in sports, such as data privacy and fairness in competition. As technology continues to advance, we can expect to see even more innovative uses of AI in the sports industry.
In conclusion, AI has the potential to revolutionize the sports industry by enhancing training, analysis, decision-making, and the viewing experience for fans. However, as with any technology, there are also challenges and ethical considerations that must be taken into account. With the continued advancement of AI, it will be important for sports organizations, coaches, and fans to stay informed and stay engaged in the ongoing conversation about the impact of AI in sports.
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19 Case study 1: image processing for medical application of preventing the spread of COVID-19
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This study presented security system equipped with an ability to detect body temperature to reduce the spread of COVID-19. Generally, temperature screening was done using a thermometer gun. However, its usage was limited and cannot be used together as a security system. Thus, this study developed a smart lock door system with a contactless temperature screening based on Internet of Things (IoT). The built system consists of an ESP32, microcontroller, the MLX90640 sensor as temperature screening, solenoid door lock, the Haar cascade algorithm for face detection, the local binary pattern histogram algorithm for face recognition. The system may send temperature data to the database website, sending an alert if the object has a temperature above 38°C. The results of this study showed that the average temperature difference between thermos gun and the MLX90640 was 0.1°C and 0.09°C at a distance of 10 cm and 12 cm, respectively. Those distances were considered as the effective distance. The proposed face recognition succeeded in recognizing the object with an accuracy of 80% in dark condition and 100% in bright condition. Face recognition and temperature screening were successfully sent to the database with a time difference of sending data was 0.3 s. An alert can be sent to the Telegram in real-time manner when the temperature and face were recognized as a suspect of COVID-19. The security system cannot be opened when the recognized face was not in the database.
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20 Nanotechnology in biomedical application: pH-responsive starch nanoparticles
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This chapter was devoted to prove the capability of starch nanoparticles as a potential nanocarrier in biomedical applications especially for the drug delivery system. Numerous authors had been introduced starch nanoparticles through physically or chemically modifications and their experiments were designed to investigate the morphological study, pH responsiveness studies, in vitro drug release, and kinetic release study of starch nanoparticles with a modeled drug. Further analysis was carried out on the drug releases starch nanoparticles which provided a general statement that percentage of drug released with time from starch nanoparticles was influenced by the pH of physiological media. The obtained data from the release of drug from starch nanoparticles were fitted with different kinetic release equations to determine whether the drug release mechanism was a swelling, diffusion, or surface-erosion controlled system. The drug could release from starch nanoparticles through swelling, surface erosion, or diffusion of the nanoparticles. Thus, the starch nanoparticles were practically a viable solution as a nanocarrier in biomedical applications, with the in vitro release data showing the combination of impressive drug release behavior and sensitivity to the pH of the surrounding medium.
This work provides results that suggest the potential of starch nanoparticles as controlled release nanocarriers for drug delivery systems in biomedical applications. The data from the previous experiments can be used as a foundation for future research. More detailed work needs to be carried out to find accurate information on physical and chemical behavior can be obtained to improve the material performance. Future recommended research can involve the in vivo drug release from starch nanoparticles and clinical trials. This is crucial because such data could be used as a future guideline to produced starch nanocarrier with better clinical response, tolerability, and lower side effects towards human. Other future extension can be the study of synthesis conditions of starch nanoparticles, the biocompatibility of the material with a different type of drug and other relevant parameters.
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21 E-Health on ankle rehabilitation
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Technology applications in health care provide extensive support for patient management, such as managing patients remotely via telerehabilitation, wearable devices, and mobile health applications. The reality of e-health in physiotherapy practice in a clinical setting is that it is steadily improving people's quality of life by enabling them to have healthier and more satisfying lives. Furthermore, e-health applications will aid in the monitoring of patients' progress by tracking their records in real time and motivating individuals during their rehabilitation. Lateral ankle sprains are a common condition reported in clinical settings among the elderly and sporting population that affect the mobility of an individual. Implementing e-health in ankle rehabilitation would provide patients with better support while they were undergoing rehabilitation.
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22 Medical equipment for back pain
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Back pain has become a major problem in most of the community, though those symptoms sometimes resolve on their own over time. In some people, the back pain normally resolves as soon as they rest their body by lying down or simply sitting on their favorite chair. Some of them even attend massage centers or physiotherapy to ease their pain that is not resolved with simple sitting and lying down. The pain should be more concerning when none of these methods ease the pain away and make it even worse. In many severe cases, a phenomenon known as sciatica occurs, where the back pain usually radiates to your legs, causing muscle strain and making it harder for you to even walk or sit. On the bright side, some medical equipment has been and is being built in order to help those people with unresolved back pain. Back pain is one of the most prevalent pain disorders, with significant individual and social implications. Back pain or lower back pain, commonly known as LBP, is defined based on the length of the pain symptoms, with acute pain lasting less than 4 weeks, subacute pain lasting between 4 and 12 weeks, and chronic back pain lasting more than 12 weeks. Despite the fact that many patients heal completely with no residual abnormalities, 15-20% of patients continue to experience pain symptoms after 12 weeks. Surgery to repair any damage to the spine is rarely the first option unless the damage or injury is pervasive that it is beyond repair. Despite the fact that each major or minor spine injury may be treated surgically, there are several restrictions to spinal surgery. According to Bajwa and Haldar, the subject of pain is always brought up when considering back surgery. Most surgeries are performed in the belief that the discomfort would go away. In many circumstances, surgery does not relieve pain, particularly in the long run. Often, the freedom to move and the suffering worsen. Whenever a person's motion is restricted, the regions adjacent to it must make up for the shortfall and work harder. Because of the added tension, the surrounding regions become weary much faster. Moreover, when motion is restricted post-spinal surgery, the patient will have to sit or lie down for a very long period as part of the recovery. When this happens, the patients are at high risk for developing deep vein thrombosis as there will be a blood clot formation in the leg area which will lead to unbearable pain and swelling of the posterior thigh of the leg. The clots will eventually block the blood vessels supplying the leg and prevent them from being properly perfused with blood. In extreme cases, the clots might break into tiny pieces and travel throughout the blood vessels and may eventually end up in the lungs or brain leading to pulmonary embolism, risk of stroke, or even death. Besides surgical repair, many medical equipment that are solely meant for the spine can be widely used to correct and facilitate some minor and non-invasive injuries to the spine.
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Back Matter
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