Biomedical engineering

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Biomedical engineering (BME) is the application of engineering principles and techniques to the medical field. It combines the design and problem solving expertise of engineering with the medical expertise of physicians to help improve patient health care and the quality of life of healthy individuals. As a relatively new discipline, much of the work in biomedical engineering consists of research and development, covering an array of fields: bioinformatics, medical imaging, image processing, physiological signal processing, biomechanics, biomaterials and bioengineering, systems analysis, 3-D modeling, etc. Examples of concrete applications of biomedical engineering are the development and manufacture of biocompatible prostheses, medical devices, diagnostic devices and imaging equipment such as MRIs and EEGs, and pharmaceutical drugs.

Biomedical engineers usually require degrees from recognized universities, and sound knowledge of engineering and biological science. Their jobs often pay well (ranging from US $50,000 to $125,000 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. Currently, according to U.S. News & World Report, the program at Johns Hopkins University is ranked first in the nation in the category of bioengineering/biomedical engineering. At the undergraduate level, an increasing number of programs are also becoming recognized by ABET as accredited bioengineering/biomedical engineering programs in the United States. Duke University, ranked second in the U.S. by U.S. News, was the first program accredited by the Engineering Council for Profession Development (now ABET) in September of 1972.

1 Medical Devices
2 Tissue Engineering
3 Regulatory issues
4 Biomedical engineering training
5 Clinical engineering
6 Founding figures
7 See also
8 Notes
9 References
10 Further reading
11 Biomedical Engineering Books
12 External links

[edit] Medical Devices

An AbioCor artificial heart, an example of an artificial organ

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 equipment 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 equipment 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.

[edit] Tissue Engineering

Main article: Tissue engineering

One of the goals of tissue engineering is to create artificial organs for patients that need organ transplants. Biomedical engineers are currently researching methods of creating such organs. In one case bladders have been grown in lab and transplanted successfully into patients^[1]. Bioartificial organs, which utilize both synthetic and biological components, are also a focus area in research, such as with hepatic assist devices that utilize liver cells within an artificial bioreactor construct^[2].

[edit] 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 according to a planned, approved process. This is thought to increase the quality and safety of diagnostics and therapies by reducing the likelihood that needed steps can be accidentally omitted again.

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. In Europe, for example, 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, indicating 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. Frequently, once one such system is satisfied, satisfying the other requires only paperwork.

[edit] Biomedical engineering training

An increasing number of universities with an engineering faculty now have a biomedical engineering program or department from the undergraduate to the doctoral 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, the reason for this being the requirement for biomedical engineers to be equally knowledgable in engineering and the biological sciences. However, undergraduate programs of study combining these two fields of knowledge are becoming more widespread. As such, many students also pursue an undergraduate degree in biomedical engineering as a foundation for a continuing education in medical school.

ABET accredited undergraduate programs

[edit] Clinical engineering

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.

[edit] Founding figures

Robert Langer - Institute Professor at MIT, runs the largest BME laboratory in the world, pioneer in drug delivery and tissue engineering
Otto Schmitt (deceased) - biophysicist with significant contributions to BME, working with biomimetics
Ascher Shapiro (deceased) - Institute Professor at MIT, contributed to the development of the BME field, medical devices (e.g. intra-aortic balloons)
John G. Webster - a pioneer in the field of instrumentation amplifiers for the recording of electrophysiological signals
U. A. Whitaker (deceased) - provider of The Whitaker Foundation, which supported research and education in BME by providing over $700 million to various universities, helping to create 30 BME programs and helping finance the construction of 13 buildings

[edit] See also

[edit] Notes

^ Doctors grow organs from patients' own cells, CNN, April 3, 2006
^ Trial begins for first artificial liver device using human cells, University of Chicago, February 25, 1999

[edit] References

[edit] Further reading

Bronzino, Joseph D. (2000). The Biomedical Engineering Handbook - Second Edition. CRC Press.
- Volume 1. ISBN 0-8493-0461-X.
- Volume 2. ISBN 0-8493-0462-8.