Biomedical engineering

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Template:Globalize Image:Flu Vaccine.jpg Biomedical Engineering (also known as Bioengineering) is the application of engineering principles and techniques to the medical field. It combines the expertise of engineering with medical needs to improve healthcare. It is a less known discipline than other specialties such as electrical engineering or mechanical engineering. An increasing number of universities with an engineering faculty now have a biomedical engineering program or department from the undergraduate to the doctorate level. Traditionally, biomedical engineering has been an interdisciplinary field to specialize in after completing an undergraduate degree in a more traditional discipline of engineering or science. However, undergraduate programs are becoming more widespread.

Research and development is the most common line of work for biomedical engineers and covers a very wide array of fields: bioinformatics, medical imaging, image processing, physiological signal processing, biomechanics, biomaterials, systems analysis, 3-D modeling, etc. Examples of concrete applications of biomedical engineering are the development and manufacture of prostheses, medical devices, diagnostic devices and imaging equipement, laboratory equipment, drugs and other therapies as well as the application of engineering principles to biological science problems.

Clinical engineering is a branch of biomedical engineering for professionals responsible for the management of medical equipment in a hospital. The tasks of a clinical engineer are typically the acquisition and management of medical device inventory, supervising biomedical engineering technicians (BMETs), ensuring that safety and regulatory issues are taken into consideration and serving as a technological consultant for any issues in a hospital where medical devices are concerned. Clinical engineers work closely with the IT department and medical physicists.

Biomedical engineers usually require degrees from recognized universities, and sound knowledge of engineering and human anatomy and physiology. Their jobs often pay well (ranging from US $50,000 to $100,000 per year in 2005). Though the number of biomedical engineers is currently low (under 10,000), the number is expected to rise as modern medicine improves. Universities are now improving their biomedical engineering courses because interest in the field is increasing.

1 Medical Devices
2 Regulatory Issues
3 See also
4 References
5 Further reading
6 External links

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Medical Devices

A typical biomedical engineering department does the corrective and preventive maintenance on the medical devices used by the hospital, except for those covered by a warantee or maintenance agreement with an external company. All newly acquired equipement is also fully tested. That is, every line of software is executed, or every possible setting is exercised and verified. Most devices are intentionally simplified in some way to make the testing process less expensive, yet accurate. Many biomedical devices need to be sterilized. This creates a unique set of problems, since most sterilization techniques can cause damage to machinery and materials. Most medical devices are either inherently safe, or have added devices and systems so that they can sense their failure and shut down into an unusable, thus very safe state. A typical, basic requirement is that no single failure should cause the therapy to become unsafe at any point during its life-cycle. See safety engineering for a discussion of the procedures used to design safe systems.

Imaging technologies, such as MRIs, X-rays, CT scans, PET scans and PET-CT scans are typically the most complex equipement found in a hospital. Some of the modern devices that followed the invention of X-ray machines include pacemakers, infusion pumps, the heart-lung machine, dialysis machines, diagnostic equipment, artificial organs, implants, and advanced prosthetics.

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Regulatory Issues

Regulatory issues are never far from the mind of a biomedical engineer. To satisfy safety regulations, most biomedical systems must have documentation to show that they were managed, designed, built, tested, delivered and used using a planned, approved process. This is thought to increase the quality and safety of the therapy by reducing the likelihood that needed steps can be accidentally omitted.

In the United States, biomedical engineers may operate under two different regulatory frameworks. Clinical devices and technologies are generally governed by the Food and Drug Administration (FDA) in a similar fashion to pharmaceuticals. Biomedical engineers may also develop devices and technologies for consumer use, such as physical therapy devices, which may be governed by the Consumer Product Safety Commission. See US FDA 510(k) documentation process for the US government registry of biomedical devices.

Other countries typically have their own mechanisms for regulation. For example, in Europe the actual decision about whether a device is suitable is made by the prescribing doctor, and the regulations are to assure that the device operates as expected. Thus in Europe, the governments license certifying agencies, which are for-profit. Technical committees of leading engineers write recommendations which incorporate public comments and are adopted as regulations by the European Union. These recommendations vary by the type of device, and specify tests for safety and efficacy. Once a prototype has passed the tests at a certification lab, and that model is being constructed under the control of a certified quality system, the device is entitled to bear a "CE mark." The CE mark indicates that the device is believed to be safe and reliable when used as directed.

The different regulatory arrangements sometimes result in technologies being developed first for either the U.S. or in Europe depending on the more favorable form of regulation. Most safety-certification systems give equivalent results when applied diligently. Usually, once one such system is satisfied, satisfying the other requires only paperwork.

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