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Saturday, September 18, 2021

Neurosurgery

From Wikipedia, the free encyclopedia
 
Parkinson surgery.jpg
Stereotactic guided insertion of DBS electrodes in neurosurgery
Occupation
Activity sectors
Surgery
Description
Education required

or

or

Fields of
employment
Hospitals, Clinics

Neurosurgery or neurological surgery, known in common parlance as brain surgery, is the medical specialty concerned with the prevention, diagnosis, surgical treatment, and rehabilitation of disorders which affect any portion of the nervous system including the brain, spinal cord, central and peripheral nervous system, and cerebrovascular system.

Education and context

In different countries, there are different requirements for an individual to legally practice neurosurgery, and there are varying methods through which they must be educated. In most countries, neurosurgeon training requires a minimum period of seven years after graduating from medical school.

United States

In the United States, a neurosurgeon must generally complete four years of undergraduate education, four years of medical school, and seven years of residency (PGY-1-7). Most, but not all, residency programs have some component of basic science or clinical research. Neurosurgeons may pursue additional training in the form of a fellowship after residency, or, in some cases, as a senior resident in the form of an enfolded fellowship. These fellowships include pediatric neurosurgery, trauma/neurocritical care, functional and stereotactic surgery, surgical neuro-oncology, radiosurgery, neurovascular surgery, skull-base surgery, peripheral nerve and complex spinal surgery. Fellowships typically span one to two years. In the U.S., neurosurgery "is a small specialty, constituting only 0.5 percent of all physicians."

United Kingdom

In the United Kingdom, students must gain entry into medical school. MBBS qualification (Bachelor of Medicine, Bachelor of Surgery) takes four to six years depending on the student's route. The newly qualified physician must then complete foundation training lasting two years; this is a paid training program in a hospital or clinical setting covering a range of medical specialties including surgery. Junior doctors then apply to enter the neurosurgical pathway. Unlike most other surgical specialties, it currently has its own independent training pathway which takes around eight years (ST1-8); before being able to sit for consultant exams with sufficient amounts of experience and practice behind them. Neurosurgery remains consistently amongst the most competitive medical specialties in which to obtain entry.

History

Neurosurgery, or the premeditated incision into the head for pain relief, has been around for thousands of years, but notable advancements in neurosurgery have only come within the last hundred years.

Edinburgh Skull, trepanning showing hole in back of skull Wellcome M0009393.jpg

Ancient

The Incas appear to have practiced a procedure known as trepanation since before European colonization. During the Middle Ages in Al-Andalus from 936 to 1013 AD, Al-Zahrawi performed surgical treatments of head injuries, skull fractures, spinal injuries, hydrocephalus, subdural effusions and headache. In China, Hua Tuo created the first general anaesthesia called mafeisan, which he used on surgical procedures on the brain.

Modern

HochbergFig1.jpg

There was not much advancement in neurosurgery until late 19th early 20th century, when electrodes were placed on the brain and superficial tumors were removed.

History of electrodes in the brain: In 1878 Richard Caton discovered that electrical signals transmitted through an animal's brain. In 1950 Dr. Jose Delgado invented the first electrode that was implanted in an animal's brain, using it to make it run and change direction. In 1972 the cochlear implant, a neurological prosthetic that allowed deaf people to hear was marketed for commercial use. In 1998 researcher Philip Kennedy implanted the first Brain Computer Interface (BCI) into a human subject.

History of tumor removal: In 1879 after locating it via neurological signs alone, Scottish surgeon William Macewen (1848-1924) performed the first successful brain tumor removal. On November 25, 1884 after English physician Alexander Hughes Bennett (1848-1901) used Macewen's technique to locate it, English surgeon Rickman Godlee (1849-1925) performed the first primary brain tumor removal, which differs from Macewen's operation in that Bennett operated on the exposed brain, whereas Macewen operated outside of the "brain proper" via trepanation. On March 16, 1907 Austrian surgeon Hermann Schloffer became the first to successfully remove a pituitary tumor.

Modern surgical instruments

The main advancements in neurosurgery came about as a result of highly crafted tools. Modern neurosurgical tools, or instruments, include chisels, curettes, dissectors, distractors, elevators, forceps, hooks, impactors, probes, suction tubes, power tools, and robots. Most of these modern tools, like chisels, elevators, forceps, hooks, impactors, and probes, have been in medical practice for a relatively long time. The main difference of these tools, pre and post advancement in neurosurgery, were the precision in which they were crafted. These tools are crafted with edges that are within a millimeter of desired accuracy. Other tools such as hand held power saws and robots have only recently been commonly used inside of a neurological operating room. As an example, the University of Utah developed a device for computer-aided design / computer-aided manufacturing (CAD-CAM) which uses an image-guided system to define a cutting tool path for a robotic cranial drill.

Organised neurosurgery

World Academy of Neurological Surgery's conference

The World Federation of Neurosurgical Societies (WFNS), founded in 1955, in Switzerland, as a professional, scientific, non governmental organization, is composed of 130 member societies: consisting of 5 Continental Associations (AANS, AASNS, CAANS, EANS and FLANC), 6 Affiliate Societies, and 119 National Neurosurgical Societies, representing some 50,000 neurosurgeons worldwide. It has a consultative status in the United Nations. The official Journal of the Organization is World Neurosurgery. The other global organisations being the World Academy of Neurological Surgery (WANS) and the World Federation of Skull Base Societies (WFSBS).

Main divisions

General neurosurgery involves most neurosurgical conditions including neuro-trauma and other neuro-emergencies such as intracranial hemorrhage. Most level 1 hospitals have this kind of practice.

Specialized branches have developed to cater to special and difficult conditions. These specialized branches co-exist with general neurosurgery in more sophisticated hospitals. To practice advanced specialization within neurosurgery, additional higher fellowship training of one to two years is expected from the neurosurgeon. Some of these divisions of neurosurgery are:

  1. Vascular neurosurgery includes clipping of aneurysms and performing carotid endarterectomy (CEA).
  2. Stereotactic neurosurgery, functional neurosurgery, and epilepsy surgery (the latter includes partial or total corpus callosotomy – severing part or all of the corpus callosum to stop or lessen seizure spread and activity, and the surgical removal of functional, physiological and/or anatomical pieces or divisions of the brain, called epileptic foci, that are operable and that are causing seizures, and also the more radical and very, very rare partial or total lobectomy, or even hemispherectomy – the removal of part or all of one of the lobes, or one of the cerebral hemispheres of the brain; those two procedures, when possible, are also very, very rarely used in oncological neurosurgery or to treat very severe neurological trauma, such as stab or gunshot wounds to the brain)
  3. Oncological neurosurgery also called neurosurgical oncology; includes pediatric oncological neurosurgery; treatment of benign and malignant central and peripheral nervous system cancers and pre-cancerous lesions in adults and children (including, among others, glioblastoma multiforme and other gliomas, brain stem cancer, astrocytoma, pontine glioma, medulloblastoma, spinal cancer, tumors of the meninges and intracranial spaces, secondary metastases to the brain, spine, and nerves, and peripheral nervous system tumors)
  4. Skull base surgery
  5. Spinal neurosurgery
  6. Peripheral nerve surgery
  7. Pediatric neurosurgery (for cancer, seizures, bleeding, stroke, cognitive disorders or congenital neurological disorders)

Neuropathology

Neuropathology case V 03.jpg

Neuropathology is a specialty within the study of pathology focused on the disease of the brain, spinal cord, and neural tissue. This includes the central nervous system and the peripheral nervous system. Tissue analysis comes from either surgical biopsies or post mortem autopsies. Common tissue samples include muscle fibers and nervous tissue. Common applications of neuropathology include studying samples of tissue in patients who have Parkinson's disease, Alzheimer's disease, dementia, Huntington's disease, amyotrophic lateral sclerosis, mitochondria disease, and any disorder that has neural deterioration in the brain or spinal cord.

History

While pathology has been studied for millennia only within the last few hundred years has medicine focused on a tissue- and organ-based approach to tissue disease. In 1810, Thomas Hodgkin started to look at the damaged tissue for the cause. This was conjoined with the emergence of microscopy and started the current understanding of how the tissue of the human body is studied.

Neuroanesthesia

Neuroanesthesia is a field of anesthesiology which focuses on neurosurgery. Anesthesia is not used during the middle of an "awake" brain surgery. Awake brain surgery is where the patient is conscious for the middle of the procedure and sedated for the beginning and end. This procedure is used when the tumor does not have clear boundaries and the surgeon wants to know if they are invading on critical regions of the brain which involve functions like talking, cognition, vision, and hearing. It will also be conducted for procedures which the surgeon is trying to combat epileptic seizures.

History

Trepanning, an early form of neuroanesthesia, appears to have been practised by the Incas in South America. In these procedures coca leaves and datura plants were used to manage pain as the person had dull primitive tools cut open their skull. In 400 BC the physician Hippocrates made accounts of using different wines to sedate patients while trepanning. In 60 AD Dioscorides, a physician, pharmacologist, and botanist, detailed how mandrake, henbane, opium, and alcohol were used to put patients to sleep during trepanning. In 972 AD two brother surgeons in Paramara, now India, used "samohine" to sedate a patient while removing a small tumor and awoke the patient by pouring onion and vinegar in the patient's mouth. Since then, multiple cocktails have been derived in order to sedate a patient during a brain surgery. The most recent form of neuroanesthesia is the combination of carbon dioxide, hydrogen, and nitrogen. This was discovered in the 18th century by Humphry Davy and brought into the operating room by Astley Cooper.

Neurosurgery methods

Neurosurgery
ICD-10-PCS00-01
ICD-9-CM0105
MeSHD019635
OPS-301 code5-01...5-05

Neuroradiology methods are used in modern neurosurgery diagnosis and treatment. They include computer assisted imaging computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), magnetoencephalography (MEG), and stereotactic radiosurgery. Some neurosurgery procedures involve the use of intra-operative MRI and functional MRI.

In conventional open surgery the neurosurgeon opens the skull, creating a large opening to access the brain. Techniques involving smaller openings with the aid of microscopes and endoscopes are now being used as well. Methods that utilize small craniotomies in conjunction with high-clarity microscopic visualization of neural tissue offer excellent results. However, the open methods are still traditionally used in trauma or emergency situations.

Microsurgery is utilized in many aspects of neurological surgery. Microvascular techniques are used in EC-IC bypass surgery and in restoration carotid endarterectomy. The clipping of an aneurysm is performed under microscopic vision. Minimally-invasive spine surgery utilizes microscopes or endoscopes. Procedures such as microdiscectomy, laminectomy, and artificial disc replacement rely on microsurgery.

Using stereotaxy neurosurgeons can approach a minute target in the brain through a minimal opening. This is used in functional neurosurgery where electrodes are implanted or gene therapy is instituted with high level of accuracy as in the case of Parkinson's disease or Alzheimer's disease. Using the combination method of open and stereotactic surgery, intraventricular hemorrhages can potentially be evacuated successfully. Conventional surgery using image guidance technologies is also becoming common and is referred to as surgical navigation, computer-assisted surgery, navigated surgery, stereotactic navigation. Similar to a car or mobile Global Positioning System (GPS), image-guided surgery systems, like Curve Image Guided Surgery and StealthStation, use cameras or electromagnetic fields to capture and relay the patient’s anatomy and the surgeon’s precise movements in relation to the patient, to computer monitors in the operating room. These sophisticated computerized systems are used before and during surgery to help orient the surgeon with three-dimensional images of the patient’s anatomy including the tumor. Real-time functional brain mapping has been employed to identify specific functional regions using electrocorticography (ECoG)

Minimally invasive endoscopic surgery is commonly utilized by neurosurgeons when appropriate. Techniques such as endoscopic endonasal surgery are used in pituitary tumors, craniopharyngiomas, chordomas, and the repair of cerebrospinal fluid leaks. Ventricular endoscopy is used in the treatment of intraventricular bleeds, hydrocephalus, colloid cyst and neurocysticercosis. Endonasal endoscopy is at times carried out with neurosurgeons and ENT surgeons working together as a team.

Repair of craniofacial disorders and disturbance of cerebrospinal fluid circulation is done by neurosurgeons who also occasionally team up with maxillofacial and plastic surgeons. Cranioplasty for craniosynostosis is performed by pediatric neurosurgeons with or without plastic surgeons.

Neurosurgeons are involved in stereotactic radiosurgery along with radiation oncologists in tumor and AVM treatment. Radiosurgical methods such as Gamma knife, Cyberknife and Novalis Radiosurgery are used as well.

Endovascular surgical neuroradiology utilize endovascular image guided procedures for the treatment of aneurysms, AVMs, carotid stenosis, strokes, and spinal malformations, and vasospasms. Techniques such as angioplasty, stenting, clot retrieval, embolization, and diagnostic angiography are endovascular procedures.

A common procedure performed in neurosurgery is the placement of ventriculo-peritoneal shunt (VP shunt). In pediatric practice this is often implemented in cases of congenital hydrocephalus. The most common indication for this procedure in adults is normal pressure hydrocephalus (NPH).

Neurosurgery of the spine covers the cervical, thoracic and lumbar spine. Some indications for spine surgery include spinal cord compression resulting from trauma, arthritis of the spinal discs, or spondylosis. In cervical cord compression, patients may have difficulty with gait, balance issues, and/or numbness and tingling in the hands or feet. Spondylosis is the condition of spinal disc degeneration and arthritis that may compress the spinal canal. This condition can often result in bone-spurring and disc herniation. Power drills and special instruments are often used to correct any compression problems of the spinal canal. Disc herniations of spinal vertebral discs are removed with special rongeurs. This procedure is known as a discectomy. Generally once a disc is removed it is replaced by an implant which will create a bony fusion between vertebral bodies above and below. Instead, a mobile disc could be implanted into the disc space to maintain mobility. This is commonly used in cervical disc surgery. At times instead of disc removal a Laser discectomy could be used to decompress a nerve root. This method is mainly used for lumbar discs. Laminectomy is the removal of the lamina of the vertebrae of the spine in order to make room for the compressed nerve tissue.

Surgery for chronic pain is a sub-branch of functional neurosurgery. Some of the techniques include implantation of deep brain stimulators, spinal cord stimulators, peripheral stimulators and pain pumps.

Surgery of the peripheral nervous system is also possible, and includes the very common procedures of carpal tunnel decompression and peripheral nerve transposition. Numerous other types of nerve entrapment conditions and other problems with the peripheral nervous system are treated as well.

Conditions

Conditions treated by neurosurgeons include, but are not limited to:

Recovery

Post operative pain

Pain following brain surgery can be significant and may lengthen recovery, increase the amount of time a person stays in the hospital following surgery, and increase the risk of complications following surgery. Severe acute pain following brain surgery may also increase the risk of a person developing a chronic post-craniotomy headache. Approaches to treating pain in adults include treatment with nonsteroidal anti‐inflammatory drugs (NSAIDs), which have been shown to reduce pain for up to 24 hours following surgery. Low quality evidence supports the use of the medications dexmedetomidine, pregabalin or gabapentin to reduce post-operative pain. Low quality evidence also supports scalp blocks and scalp infiltration to reduce postoperative pain. Gabapentin or pregabalin may also decrease vomiting and nausea following surgery (very low quality medical evidence).

Notable neurosurgeons

See also

Stereotactic surgery

From Wikipedia, the free encyclopedia

Stereotactic surgery
Brain biopsy under stereotaxy.jpg
Brain biopsy using a needle mounted on a stereotactic instrument
Other namesStereotaxy
Specialtyneurosurgery

Stereotactic surgery is a minimally invasive form of surgical intervention that makes use of a three-dimensional coordinate system to locate small targets inside the body and to perform on them some action such as ablation, biopsy, lesion, injection, stimulation, implantation, radiosurgery (SRS), etc.

In theory, any organ system inside the body can be subjected to stereotactic surgery. However, difficulties in setting up a reliable frame of reference (such as bone landmarks, which bear a constant spatial relation to soft tissues) mean that its applications have been, traditionally and until recently, limited to brain surgery. Besides the brain, biopsy and surgery of the breast are done routinely to locate, sample (biopsy), and remove tissue. Plain X-ray images (radiographic mammography), computed tomography, and magnetic resonance imaging can be used to guide the procedure.

Another accepted form of "stereotactic" is "stereotaxic". The word roots are stereo-, a prefix derived from the Greek word στερεός (stereos, "solid"), and -taxis (a suffix of New Latin and ISV, derived from Greek taxis, "arrangement", "order", from tassein, "to arrange").

Procedure

Stereotactic surgery works on the basis of three main components:

  • A stereotactic planning system, including atlas, multimodality image matching tools, coordinates calculator, etc.
  • A stereotactic device or apparatus
  • A stereotactic localization and placement procedure

Modern stereotactic planning systems are computer based. The stereotactic atlas is a series of cross sections of anatomical structure (for example, a human brain), depicted in reference to a two-coordinate frame. Thus, each brain structure can be easily assigned a range of three coordinate numbers, which will be used for positioning the stereotactic device. In most atlases, the three dimensions are: latero-lateral (x), dorso-ventral (y) and rostro-caudal (z).

The stereotactic apparatus uses a set of three coordinates (x, y and z) in an orthogonal frame of reference (cartesian coordinates), or, alternatively, a cylindrical coordinates system, also with three coordinates: angle, depth and antero-posterior (or axial) location. The mechanical device has head-holding clamps and bars which puts the head in a fixed position in reference to the coordinate system (the so-called zero or origin). In small laboratory animals, these are usually bone landmarks which are known to bear a constant spatial relation to soft tissue. For example, brain atlases often use the external auditory meatus, the inferior orbital ridges, the median point of the maxilla between the incisive teeth. or the bregma (confluence of sutures of frontal and parietal bones), as such landmarks. In humans, the reference points, as described above, are intracerebral structures which are clearly discernible in a radiograph or tomograph. In newborn human babies, the "soft spot" where the coronal and sagittal sutures meet (known as the fontanelle) becomes the bregma when this gap closes.

Guide bars in the x, y and z directions (or alternatively, in the polar coordinate holder), fitted with high precision vernier scales allow the neurosurgeon to position the point of a probe (an electrode, a cannula, etc.) inside the brain, at the calculated coordinates for the desired structure, through a small trephined hole in the skull.

Currently, a number of manufacturers produce stereotactic devices fitted for neurosurgery in humans, for both brain and spine procedures, as well as for animal experimentation.

Types frame systems

  1. Simple Orthogonal System: The probe is directed perpendicular to a square base unit fixed to the skull. These provide three degrees of freedom by means of a carriage that moved orthogonally along the base plate or along a bar attached parallel to the base plate of the instrument. Attached to the carriage was a second track that extended across the head frame perpendicularly.
  2. Burr Hole Mounted System: This provides a limited range of possible intracranial target points with a fixed entry point. They provided two angular degrees of freedom and a depth adjustment. The surgeon could place the burr hole over nonessential brain tissue and utilize the instrument to direct the probe to the target point from the fixed entry point at the burr hole.
  3. Arc-Quadrant Systems: Probes are directed perpendicular to the tangent of an arc (which rotates about the vertical axis) and a quadrant (which rotates about the horizontal axis). The probe, directed to a depth equal to the radius of the sphere defined by the arc-quadrant, will always arrive at the center or focal point of that sphere.
  4. Arc-Phantom Systems: An aiming bow attaches to the head ring, which is fixed to the patient's skull, and can be transferred to a similar ring that contains a simulated target. In this system, the phantom target is moved on the simulator to 3D coordinates. After adjusting the probe holder on the aiming bow so that the probe touches the desired target on the phantom, the transferable aiming bow is moved from the phantom base ring to the base ring on the patient. The probe is then lowered to the determined depth in order to reach the target point deep in the patient's brain.

Treatment

Stereotactic radiosurgery

A doctor performing Gamma Knife Radiosurgery

Stereotactic radiosurgery utilizes externally generated ionizing radiation to inactivate or eradicate defined targets in the head or spine without the need to make an incision. This concept requires steep dose gradients to reduce injury to adjacent normal tissue while maintaining treatment efficacy in the target. As a consequence of this definition, the overall treatment accuracy should match the treatment planning margins of 1-2 millimeter or better. To use this paradigm optimally and treat patients with the highest possible accuracy and precision, all errors, from image acquisition over treatment planning to mechanical aspects of the delivery of treatment and intra-fraction motion concerns, must be systematically optimized. To assure quality of patient care the procedure involves a multidisciplinary team consisting of a radiation oncologist, medical physicist, and radiation therapist. Dedicated, commercially available stereotactic radiosurgery programs are provided by the irrespective Gamma Knife, CyberKnife, and Novalis Radiosurgery devices.

Stereotactic radiosurgery provides an efficient, safe, and minimal invasive treatment alternative for patients diagnosed with malignant, benign and functional indications in the brain and spine, including but not limited to both primary and secondary tumors. Stereotactic radiosurgery is a well-described management option for most metastases, meningiomas, schwannomas, pituitary adenomas, arteriovenous malformations, and trigeminal neuralgia, among others.

Irrespective of the similarities between the concepts of stereotactic radiosurgery and fractionated radiotherapy and although both treatment modalities are reported to have identical outcomes for certain indications, the intent of both approaches is fundamentally different. The aim of stereotactic radiosurgery is to destroy target tissue while preserving adjacent normal tissue, where fractionated radiotherapy relies on a different sensitivity of the target and the surrounding normal tissue to the total accumulated radiation. Historically, the field of fractionated radiotherapy evolved from the original concept of stereotactic radiosurgery following discovery of the principles of radiobiology: repair, reassortment, repopulation, and reoxygenation. Today, both treatment techniques are complementary as tumors that may be resistant to fractionated radiotherapy may respond well to radiosurgery and tumors that are too large or too close to critical organs for safe radiosurgery may be suitable candidates for fractionated radiotherapy.

A second, more recent evolution extrapolates the original concept of stereotactic radiosurgery to extra-cranial targets, most notably in the lung, liver, pancreas, and prostate. This treatment approach, entitled stereotactic body radiotherapy or SBRT, is challenged by various types of motion. On top of patient immobilization challenges and the associated patient motion, extra-cranial lesions move with respect to the patient's position due to respiration, bladder and rectum filling. Like stereotactic radiosurgery, the intent of stereotactic body radiotherapy is to eradicate a defined extra-cranial target. However, target motion requires larger treatment margins around the target to compensate for the positioning uncertainty. This in turn implies more normal tissue exposed to high doses, which could result in negative treatment side effects. As a consequence, stereotactic body radiotherapy is mostly delivered in a limited number of fractions, thereby blending the concept of stereotactic radiosurgery with the therapeutic benefits of fractionated radiotherapy. To monitor and correct target motion for accurate and precise patient positioning prior and during treatment, advanced image-guided technologies are commercially available and included in the radiosurgery programs offered by the CyberKnife and Novalis communities.

Parkinson's disease

Frame for Stereotactic Thalamotomy on display at the Glenside Museum

Functional neurosurgery comprises treatment of several disorders such as Parkinson's disease, hyperkinesia, disorder of muscle tone, intractable pain, convulsive disorders and psychological phenomena. Treatment for these phenomena was believed to be located in the superficial parts of the CNS and PNS. Most of the interventions made for treatment consisted of cortical extirpation. To alleviate extra pyramidal disorders, pioneer Russell Meyers dissected or transected the head of the caudate nucleus in 1939, and part of the putamen and globus pallidus. Attempts to abolish intractable pain were made with success by transection of the spinothalamic tract at spinal medullary level and further proximally, even at mesencephalic levels.

In 1939-1941 Putnam and Oliver tried to improve Parkinsonism and hyperkinesias by trying a series of modifications of the lateral and antero-lateral cordotomies. Additionally, other scientists like Schurman, Walker, and Guiot made significant contributions to functional neurosurgery. In 1953, Cooper discovered by chance that ligation of the anterior chorioidal artery resulted in improvement of Parkinson's disease. Similarly, when Grood was performing an operation in a patient with Parkinson's, he accidentally lesioned the thalamus. This caused the patient's tremors to stop. From then on, thalamic lesions became the target point with more satisfactory results.

More recent clinical applications can be seen in surgeries used to treat Parkinson's disease, such as Pallidotomy or Thalamotomy (lesioning procedures), or Deep Brain Stimulation (DBS). During DBS, an electrode is placed into the thalamus, the pallidum of the subthalmamic nucleus, parts of brain that are involved in motor control, and are affected by Parkinson's disease. The electrode is connected to a small battery operated stimulator that is placed under the collarbone, where a wire runs beneath the skin to connect it to the electrode in the brain. The stimulator produces electrical impulses that affect the nerve cells around the electrode and should help alleviate tremors or symptoms that are associated with the affected area.

In Thalamotomy, a needle electrode is placed into the thalamus, and the patient must cooperate with tasks assigned to find the affected area- after this area of the thalamus is located, a small high frequency current is applied to the electrode and this destroys a small part of the thalamus. Approximately 90% of patients experience instantaneous tremor relief.

In Pallidotomy, an almost identical procedure to thalamotomy, a small part of the pallidum is destroyed and 80% of patients see improvement in rigidity and hypokinesia and a tremor relief or improvement comes weeks after the procedure.

History

The stereotactic method was first published in 1908 by two British scientists, Victor Horsley, a physician and neurosurgeon, and Robert H. Clarke, a physiologist and was built by Swift & Son; the two scientists stopped collaborating after the 1908 publication. The Horsley–Clarke apparatus used a Cartesian (three-orthogonal axis) system. That device is in the Science Museum, London; a copy was brought to the US by Ernest Sachs and is in the Department of Neurosurgery at UCLA. Clarke used the original to do research that led to publications of primate and cat brain atlases. There is no evidence it was ever used in a human surgery. The first stereotactic device designed for the human brain appears to have been an adaptation of the Horseley–Clarke frame built at Aubrey T. Mussen's behest by a London workshop in 1918, but it received little attention and does not appear to have been used on people. It was a frame made of brass.

The first stereotactic device used in humans was used by Martin Kirschner, for a method to treat trigeminal neuralgia by inserting an electrode into the trigeminal nerve and ablating it. He published this in 1933.

In 1947 and 1949, two neurosurgeons working at Temple University in Philadelphia, Ernest A. Spiegel (who had fled Austria when the Nazis took over) and Henry T. Wycis, published their work on a device similar to the Horsley–Clarke apparatus in using a cartesian system; it was attached to the patient's head with a plaster cast instead of screws. Their device was the first to be used for brain surgery; they used it for psychosurgery. They also created the first atlas of the human brain, and used intracranial reference points, generated by using medical images acquired with contrast agents.

The work of Spiegel and Wycis sparked enormous interest and research. In Paris, Jean Talairach collaborated with Marcel David, Henri Hacaen, and Julian de Ajuriaguerra on a stereotactic device, publishing their first work in 1949 and eventually developing the Talairach coordinates. In Japan, Hirotaro Narabayashi was doing similar work.

In 1949, Lars Leksell published a device that used polar coordinates instead of cartesian, and two years later he published work where he used his device to target a beam of radiation into a brain. Leksell's radiosurgery system is also used by the Gamma Knife device, and by other neurosurgeons, using linear accelerators, proton beam therapy and neutron capture therapy. Lars Leksell went on to commercialize his inventions by founding Elekta in 1972.

In 1979, Russell A. Brown proposed a device, now known as the N-localizer, that enables guidance of stereotactic surgery using tomographic images that are obtained via medical imaging technologies such as X-ray computed tomography (CT), magnetic resonance imaging (MRI), or positron emission tomography (PET). The N-localizer comprises a diagonal rod that spans two vertical rods to form an N-shape that allows tomographic images to be mapped to physical space. This device became almost universally adopted by the 1980s and is included in the Brown-Roberts-Wells (BRW), Kelly-Goerss, Leksell, Cosman-Roberts-Wells (CRW), Micromar-ETM03B, FiMe-BlueFrame, Macom, and Adeor-Zeppelin stereotactic frames and in the Gamma Knife radiosurgery system. An alternative to the N-localizer is the Sturm-Pastyr localizer that is included in the Riechert-Mundinger and Zamorano-Dujovny stereotactic frames.

Other localization methods also exist that do not make use of tomographic images produced by CT, MRI, or PET, but instead conventional radiographs.

The stereotactic method has continued to evolve, and at present employs an elaborate mixture of image-guided surgery that uses computed tomography, magnetic resonance imaging and stereotactic localization.

History in Latin America

In 1970, in the city of Buenos Aires, Argentina, Aparatos Especiales company, produced the first stereotactic system in Latin America. Antonio Martos Calvo, together with Jorge Candia and Jorge Olivetti (figure 38 A) through the request of the neurosurgeon Jorge Schvarcz (1942-2019), developed an equipment based on the principle of the Hitchcock stereotactic system. The patient was seated in an adapted chair with two telescopic arms attached at it base, which fixed the stereotactic frame preventing the patient's movement (Figure 38B). A double radiopaque ruler attached to the side of the frame made it possible to obtain the antero-posterior and latero-lateral X-ray images without the need of moving the radiopaque ruler (Figure 38B). The thermal coagulation lesion was performed using tungsten monopole electrodes of 1,5mm of diameter (without temperature control) with a 3mm active tip, utilizing an electrical bipolar coagulator. The lesion size was previously determined by testing the electrode in egg albumin. Coagulation size was the results of the of the electrical coagulator power regulation and the application time of the radiofrequency. The first surgery performed with this system was a Trigeminal Nucleotractothomy (Fig. 38 B,C). Jorge Schvarcz performed more than 700 functional surgeries until 1994 when, due to health problems he stopped exercising his profession. But the equipment developed kept improving on neurosurgery history. This was the beginning of the developing of technology to produce stereotactic devices in Latin America. This was the beginning of the first stereotactic manufacturer of Latin America - the Brazilian Micromar.

Research

Stereotactic surgery is sometimes used to aid in several different types of animal research studies. Specifically, it is used to target specific sites of the brain and directly introduce pharmacological agents to the brain which otherwise may not be able to cross the blood–brain barrier. In rodents, the main applications of stereotactic surgery are to introduce fluids directly to the brain or to implant cannulae and microdialysis probes. Site specific central microinjections are used when rodents do not need to be awake and behaving or when the substance to be injected has a long duration of action. For protocols in which rodents’ behaviors must be assessed soon after injection, stereotactic surgery can be used to implant a cannula through which the animal can be injected after recovery from the surgery. These protocols take longer than site-specific central injections in anesthetized mice because they require the construction of cannulae, wire plugs, and injection needles, but induce less stress in the animals because they allow for a recovery period for the healing of trauma induced to the brain before injection. Surgery can also be used for microdialysis protocols to implant and tether the dialysis probe and guide cannula.

See also

Biomedical engineering

From Wikipedia, the free encyclopedia

Ultrasound representation of urinary bladder (black butterfly-like shape) a hyperplastic prostate. An example of practical science and medical science working together.
 
Hemodialysis a process of purifying the blood of a person whose kidneys are not working normally.

Biomedical engineering (BME) or medical engineering is the application of engineering principles and design concepts to medicine and biology for healthcare purposes (e.g., diagnostic or therapeutic). BME is also traditionally known as "bioengineering", but this term has come to also refer to biological engineering. This field seeks to close the gap between engineering and medicine, combining the design and problem-solving skills of engineering with medical biological sciences to advance health care treatment, including diagnosis, monitoring, and therapy. Also included under the scope of a biomedical engineer is the management of current medical equipment in hospitals while adhering to relevant industry standards. This involves making equipment recommendations, procurement, routine testing, and preventive maintenance, a role also known as a Biomedical Equipment Technician (BMET) or as clinical engineering.

Biomedical engineering has recently emerged as its own study, as compared to many other engineering fields. Such an evolution is common as a new field transition from being an interdisciplinary specialization among already-established fields to being considered a field in itself. Much of the work in biomedical engineering consists of research and development, spanning a broad array of subfields (see below). Prominent biomedical engineering applications include the development of biocompatible prostheses, various diagnostic and therapeutic medical devices ranging from clinical equipment to micro-implants, common imaging equipment such as MRIs and EKG/ECGs, regenerative tissue growth, pharmaceutical drugs and therapeutic biologicals.

Bioinformatics

Example of an approximately 40,000 probe spotted oligo microarray with enlarged inset to show detail.

Bioinformatics is an interdisciplinary field that develops methods and software tools for understanding biological data. As an interdisciplinary field of science, bioinformatics combines computer science, statistics, mathematics, and engineering to analyze and interpret biological data.

Bioinformatics is considered both an umbrella term for the body of biological studies that use computer programming as part of their methodology, as well as a reference to specific analysis "pipelines" that are repeatedly used, particularly in the field of genomics. Common uses of bioinformatics include the identification of candidate genes and nucleotides (SNPs). Often, such identification is made with the aim of better understanding the genetic basis of disease, unique adaptations, desirable properties (esp. in agricultural species), or differences between populations. In a less formal way, bioinformatics also tries to understand the organizational principles within nucleic acid and protein sequences.

Biomechanics

Biomechanics is the study of the structure and function of the mechanical aspects of biological systems, at any level from whole organisms to organs, cells and cell organelles, using the methods of mechanics.

Biomaterial

A biomaterial is any matter, surface, or construct that interacts with living systems. As a science, biomaterials is about fifty years old. The study of biomaterials is called biomaterials science or biomaterials engineering. It has experienced steady and strong growth over its history, with many companies investing large amounts of money into the development of new products. Biomaterials science encompasses elements of medicine, biology, chemistry, tissue engineering and materials science.

Biomedical optics

Biomedical optics refers to the interaction of biological tissue and light, and how this can be exploited for sensing, imaging, and treatment.

Tissue engineering

Tissue engineering, like genetic engineering (see below), is a major segment of biotechnology – which overlaps significantly with BME.

One of the goals of tissue engineering is to create artificial organs (via biological material) for patients that need organ transplants. Biomedical engineers are currently researching methods of creating such organs. Researchers have grown solid jawbones and tracheas from human stem cells towards this end. Several artificial urinary bladders have been grown in laboratories and transplanted successfully into human patients. Bioartificial organs, which use both synthetic and biological component, are also a focus area in research, such as with hepatic assist devices that use liver cells within an artificial bioreactor construct.

Micromass cultures of C3H-10T1/2 cells at varied oxygen tensions stained with Alcian blue.

Genetic engineering

Genetic engineering, recombinant DNA technology, genetic modification/manipulation (GM) and gene splicing are terms that apply to the direct manipulation of an organism's genes. Unlike traditional breeding, an indirect method of genetic manipulation, genetic engineering utilizes modern tools such as molecular cloning and transformation to directly alter the structure and characteristics of target genes. Genetic engineering techniques have found success in numerous applications. Some examples include the improvement of crop technology (not a medical application, but see biological systems engineering), the manufacture of synthetic human insulin through the use of modified bacteria, the manufacture of erythropoietin in hamster ovary cells, and the production of new types of experimental mice such as the oncomouse (cancer mouse) for research.

Neural engineering

Neural engineering (also known as neuroengineering) is a discipline that uses engineering techniques to understand, repair, replace, or enhance neural systems. Neural engineers are uniquely qualified to solve design problems at the interface of living neural tissue and non-living constructs.

Pharmaceutical engineering

Pharmaceutical engineering is an interdisciplinary science that includes drug engineering, novel drug delivery and targeting, pharmaceutical technology, unit operations of Chemical Engineering, and Pharmaceutical Analysis. It may be deemed as a part of pharmacy due to its focus on the use of technology on chemical agents in providing better medicinal treatment.

Medical devices

Schematic of silicone membrane oxygenator

This is an extremely broad category—essentially covering all health care products that do not achieve their intended results through predominantly chemical (e.g., pharmaceuticals) or biological (e.g., vaccines) means, and do not involve metabolism.

A medical device is intended for use in:

  • the diagnosis of disease or other conditions
  • in the cure, mitigation, treatment, or prevention of disease.

Some examples include pacemakers, infusion pumps, the heart-lung machine, dialysis machines, artificial organs, implants, artificial limbs, corrective lenses, cochlear implants, ocular prosthetics, facial prosthetics, somato prosthetics, and dental implants.

Biomedical instrumentation amplifier schematic used in monitoring low voltage biological signals, an example of a biomedical engineering application of electronic engineering to electrophysiology.

Stereolithography is a practical example of medical modeling being used to create physical objects. Beyond modeling organs and the human body, emerging engineering techniques are also currently used in the research and development of new devices for innovative therapies, treatments, patient monitoring, of complex diseases.

Medical devices are regulated and classified (in the US) as follows (see also Regulation):

  • Class I devices present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices. Devices in this category include tongue depressors, bedpans, elastic bandages, examination gloves, and hand-held surgical instruments, and other similar types of common equipment.
  • Class II devices are subject to special controls in addition to the general controls of Class I devices. Special controls may include special labeling requirements, mandatory performance standards, and postmarket surveillance. Devices in this class are typically non-invasive and include X-ray machines, PACS, powered wheelchairs, infusion pumps, and surgical drapes.
  • Class III devices generally require premarket approval (PMA) or premarket notification (510k), a scientific review to ensure the device's safety and effectiveness, in addition to the general controls of Class I. Examples include replacement heart valves, hip and knee joint implants, silicone gel-filled breast implants, implanted cerebellar stimulators, implantable pacemaker pulse generators and endosseous (intra-bone) implants.

Medical imaging

Medical/biomedical imaging is a major segment of medical devices. This area deals with enabling clinicians to directly or indirectly "view" things not visible in plain sight (such as due to their size, and/or location). This can involve utilizing ultrasound, magnetism, UV, radiology, and other means.

An MRI scan of a human head, an example of a biomedical engineering application of electrical engineering to diagnostic imaging. Click here to view an animated sequence of slices.

Imaging technologies are often essential to medical diagnosis, and are typically the most complex equipment found in a hospital including: fluoroscopy, magnetic resonance imaging (MRI), nuclear medicine, positron emission tomography (PET), PET-CT scans, projection radiography such as X-rays and CT scans, tomography, ultrasound, optical microscopy, and electron microscopy.

Implants

An implant is a kind of medical device made to replace and act as a missing biological structure (as compared with a transplant, which indicates transplanted biomedical tissue). The surface of implants that contact the body might be made of a biomedical material such as titanium, silicone or apatite depending on what is the most functional. In some cases, implants contain electronics, e.g. artificial pacemakers and cochlear implants. Some implants are bioactive, such as subcutaneous drug delivery devices in the form of implantable pills or drug-eluting stents.

Artificial limbs: The right arm is an example of a prosthesis, and the left arm is an example of myoelectric control.
 
A prosthetic eye, an example of a biomedical engineering application of mechanical engineering and biocompatible materials to ophthalmology.

Bionics

Artificial body part replacements are one of the many applications of bionics. Concerned with the intricate and thorough study of the properties and function of human body systems, bionics may be applied to solve some engineering problems. Careful study of the different functions and processes of the eyes, ears, and other organs paved the way for improved cameras, television, radio transmitters and receivers, and many other tools.

Biomedical sensors

In recent years biomedical sensors based in microwave technology have gained more attention. Different sensors can be manufactured for specific uses in both diagnosing and monitoring disease conditions, for example microwave sensors can be used as a complementary technique to X-ray to monitor lower extremity trauma. The sensor monitor the dielectric properties and can thus notice change in tissue (bone, muscle, fat etc.) under the skin so when measuring at different times during the healing process the response from the sensor will change as the trauma heals.

Clinical engineering

Clinical engineering is the branch of biomedical engineering dealing with the actual implementation of medical equipment and technologies in hospitals or other clinical settings. Major roles of clinical engineers include training and supervising biomedical equipment technicians (BMETs), selecting technological products/services and logistically managing their implementation, working with governmental regulators on inspections/audits, and serving as technological consultants for other hospital staff (e.g. physicians, administrators, I.T., etc.). Clinical engineers also advise and collaborate with medical device producers regarding prospective design improvements based on clinical experiences, as well as monitor the progression of the state of the art so as to redirect procurement patterns accordingly.

Their inherent focus on practical implementation of technology has tended to keep them oriented more towards incremental-level redesigns and reconfigurations, as opposed to revolutionary research & development or ideas that would be many years from clinical adoption; however, there is a growing effort to expand this time-horizon over which clinical engineers can influence the trajectory of biomedical innovation. In their various roles, they form a "bridge" between the primary designers and the end-users, by combining the perspectives of being both close to the point-of-use, while also trained in product and process engineering. Clinical engineering departments will sometimes hire not just biomedical engineers, but also industrial/systems engineers to help address operations research/optimization, human factors, cost analysis, etc. Also, see safety engineering for a discussion of the procedures used to design safe systems. The clinical engineering department is constructed with a manager, supervisor, engineer, and technician. One engineer per eighty beds in the hospital is the ratio. Clinical engineers are also authorized to audit pharmaceutical and associated stores to monitor FDA recalls of invasive items.

Rehabilitation engineering

Rehabilitation engineering is the systematic application of engineering sciences to design, develop, adapt, test, evaluate, apply, and distribute technological solutions to problems confronted by individuals with disabilities. Functional areas addressed through rehabilitation engineering may include mobility, communications, hearing, vision, and cognition, and activities associated with employment, independent living, education, and integration into the community.

While some rehabilitation engineers have master's degrees in rehabilitation engineering, usually a subspecialty of Biomedical engineering, most rehabilitation engineers have an undergraduate or graduate degrees in biomedical engineering, mechanical engineering, or electrical engineering. A Portuguese university provides an undergraduate degree and a master's degree in Rehabilitation Engineering and Accessibility. Qualification to become a Rehab' Engineer in the UK is possible via a University BSc Honours Degree course such as Health Design & Technology Institute, Coventry University.

The rehabilitation process for people with disabilities often entails the design of assistive devices such as Walking aids intended to promote the inclusion of their users into the mainstream of society, commerce, and recreation.

Schematic representation of a normal ECG trace showing sinus rhythm; an example of widely used clinical medical equipment (operates by applying electronic engineering to electrophysiology and medical diagnosis).

Regulatory issues

Regulatory issues have been constantly increased in the last decades to respond to the many incidents caused by devices to patients. For example, from 2008 to 2011, in US, there were 119 FDA recalls of medical devices classified as class I. According to U.S. Food and Drug Administration (FDA), Class I recall is associated to "a situation in which there is a reasonable probability that the use of, or exposure to, a product will cause serious adverse health consequences or death"

Regardless of the country-specific legislation, the main regulatory objectives coincide worldwide. For example, in the medical device regulations, a product must be: 1) safe and 2) effective and 3) for all the manufactured devices

A product is safe if patients, users, and third parties do not run unacceptable risks of physical hazards (death, injuries, ...) in its intended use. Protective measures have to be introduced on the devices to reduce residual risks at an acceptable level if compared with the benefit derived from the use of it.

A product is effective if it performs as specified by the manufacturer in the intended use. Effectiveness is achieved through clinical evaluation, compliance to performance standards or demonstrations of substantial equivalence with an already marketed device.

The previous features have to be ensured for all the manufactured items of the medical device. This requires that a quality system shall be in place for all the relevant entities and processes that may impact safety and effectiveness over the whole medical device lifecycle.

The medical device engineering area is among the most heavily regulated fields of engineering, and practicing biomedical engineers must routinely consult and cooperate with regulatory law attorneys and other experts. The Food and Drug Administration (FDA) is the principal healthcare regulatory authority in the United States, having jurisdiction over medical devices, drugs, biologics, and combination products. The paramount objectives driving policy decisions by the FDA are safety and effectiveness of healthcare products that have to be assured through a quality system in place as specified under 21 CFR 829 regulation. In addition, because biomedical engineers often develop devices and technologies for "consumer" use, such as physical therapy devices (which are also "medical" devices), these may also be governed in some respects by the Consumer Product Safety Commission. The greatest hurdles tend to be 510K "clearance" (typically for Class 2 devices) or pre-market "approval" (typically for drugs and class 3 devices).

In the European context, safety effectiveness and quality is ensured through the "Conformity Assessment" which is defined as "the method by which a manufacturer demonstrates that its device complies with the requirements of the European Medical Device Directive". The directive specifies different procedures according to the class of the device ranging from the simple Declaration of Conformity (Annex VII) for Class I devices to EC verification (Annex IV), Production quality assurance (Annex V), Product quality assurance (Annex VI) and Full quality assurance (Annex II). The Medical Device Directive specifies detailed procedures for Certification. In general terms, these procedures include tests and verifications that are to be contained in specific deliveries such as the risk management file, the technical file, and the quality system deliveries. The risk management file is the first deliverable that conditions the following design and manufacturing steps. The risk management stage shall drive the product so that product risks are reduced at an acceptable level with respect to the benefits expected for the patients for the use of the device. The technical file contains all the documentation data and records supporting medical device certification. FDA technical file has similar content although organized in a different structure. The Quality System deliverables usually include procedures that ensure quality throughout all product life cycles. The same standard (ISO EN 13485) is usually applied for quality management systems in the US and worldwide.

Implants, such as artificial hip joints, are generally extensively regulated due to the invasive nature of such devices.

In the European Union, there are certifying entities named "Notified Bodies", accredited by the European Member States. The Notified Bodies must ensure the effectiveness of the certification process for all medical devices apart from the class I devices where a declaration of conformity produced by the manufacturer is sufficient for marketing. Once a product has passed all the steps required by the Medical Device Directive, the device is entitled to bear a CE marking, indicating that the device is believed to be safe and effective when used as intended, and, therefore, it can be marketed within the European Union area.

The different regulatory arrangements sometimes result in particular technologies being developed first for either the U.S. or in Europe depending on the more favorable form of regulation. While nations often strive for substantive harmony to facilitate cross-national distribution, philosophical differences about the optimal extent of regulation can be a hindrance; more restrictive regulations seem appealing on an intuitive level, but critics decry the tradeoff cost in terms of slowing access to life-saving developments.

RoHS II

Directive 2011/65/EU, better known as RoHS 2 is a recast of legislation originally introduced in 2002. The original EU legislation "Restrictions of Certain Hazardous Substances in Electrical and Electronics Devices" (RoHS Directive 2002/95/EC) was replaced and superseded by 2011/65/EU published in July 2011 and commonly known as RoHS 2. RoHS seeks to limit the dangerous substances in circulation in electronics products, in particular toxins and heavy metals, which are subsequently released into the environment when such devices are recycled.

The scope of RoHS 2 is widened to include products previously excluded, such as medical devices and industrial equipment. In addition, manufacturers are now obliged to provide conformity risk assessments and test reports – or explain why they are lacking. For the first time, not only manufacturers but also importers and distributors share a responsibility to ensure Electrical and Electronic Equipment within the scope of RoHS complies with the hazardous substances limits and have a CE mark on their products.

IEC 60601

The new International Standard IEC 60601 for home healthcare electro-medical devices defining the requirements for devices used in the home healthcare environment. IEC 60601-1-11 (2010) must now be incorporated into the design and verification of a wide range of home use and point of care medical devices along with other applicable standards in the IEC 60601 3rd edition series.

The mandatory date for implementation of the EN European version of the standard is June 1, 2013. The US FDA requires the use of the standard on June 30, 2013, while Health Canada recently extended the required date from June 2012 to April 2013. The North American agencies will only require these standards for new device submissions, while the EU will take the more severe approach of requiring all applicable devices being placed on the market to consider the home healthcare standard.

AS/NZS 3551:2012

AS/ANS 3551:2012 is the Australian and New Zealand standards for the management of medical devices. The standard specifies the procedures required to maintain a wide range of medical assets in a clinical setting (e.g. Hospital). The standards are based on the IEC 606101 standards.

The standard covers a wide range of medical equipment management elements including, procurement, acceptance testing, maintenance (electrical safety and preventive maintenance testing) and decommissioning.

Training and certification

Education

Biomedical engineers require considerable knowledge of both engineering and biology, and typically have a Bachelor's (B.Sc., B.S., B.Eng. or B.S.E.) or Master's (M.S., M.Sc., M.S.E., or M.Eng.) or a doctoral (Ph.D.) degree in BME (Biomedical Engineering) or another branch of engineering with considerable potential for BME overlap. As interest in BME increases, many engineering colleges now have a Biomedical Engineering Department or Program, with offerings ranging from the undergraduate (B.Sc., B.S., B.Eng. or B.S.E.) to doctoral levels. Biomedical engineering has only recently been emerging as its own discipline rather than a cross-disciplinary hybrid specialization of other disciplines; and BME programs at all levels are becoming more widespread, including the Bachelor of Science in Biomedical Engineering which actually includes so much biological science content that many students use it as a "pre-med" major in preparation for medical school. The number of biomedical engineers is expected to rise as both a cause and effect of improvements in medical technology.

In the U.S., an increasing number of undergraduate programs are also becoming recognized by ABET as accredited bioengineering/biomedical engineering programs. Over 65 programs are currently accredited by ABET.

In Canada and Australia, accredited graduate programs in biomedical engineering are common. For example, McMaster University offers an M.A.Sc, an MD/PhD, and a PhD in Biomedical engineering. The first Canadian undergraduate BME program was offered at Ryerson University as a four-year B.Eng. program. The Polytechnique in Montreal is also offering a bachelors's degree in biomedical engineering as is Flinders University.

As with many degrees, the reputation and ranking of a program may factor into the desirability of a degree holder for either employment or graduate admission. The reputation of many undergraduate degrees is also linked to the institution's graduate or research programs, which have some tangible factors for rating, such as research funding and volume, publications and citations. With BME specifically, the ranking of a university's hospital and medical school can also be a significant factor in the perceived prestige of its BME department/program.

Graduate education is a particularly important aspect in BME. While many engineering fields (such as mechanical or electrical engineering) do not need graduate-level training to obtain an entry-level job in their field, the majority of BME positions do prefer or even require them. Since most BME-related professions involve scientific research, such as in pharmaceutical and medical device development, graduate education is almost a requirement (as undergraduate degrees typically do not involve sufficient research training and experience). This can be either a Masters or Doctoral level degree; while in certain specialties a Ph.D. is notably more common than in others, it is hardly ever the majority (except in academia). In fact, the perceived need for some kind of graduate credential is so strong that some undergraduate BME programs will actively discourage students from majoring in BME without an expressed intention to also obtain a master's degree or apply to medical school afterwards.

Graduate programs in BME, like in other scientific fields, are highly varied, and particular programs may emphasize certain aspects within the field. They may also feature extensive collaborative efforts with programs in other fields (such as the university's Medical School or other engineering divisions), owing again to the interdisciplinary nature of BME. M.S. and Ph.D. programs will typically require applicants to have an undergraduate degree in BME, or another engineering discipline (plus certain life science coursework), or life science (plus certain engineering coursework).

Education in BME also varies greatly around the world. By virtue of its extensive biotechnology sector, its numerous major universities, and relatively few internal barriers, the U.S. has progressed a great deal in its development of BME education and training opportunities. Europe, which also has a large biotechnology sector and an impressive education system, has encountered trouble in creating uniform standards as the European community attempts to supplant some of the national jurisdictional barriers that still exist. Recently, initiatives such as BIOMEDEA have sprung up to develop BME-related education and professional standards. Other countries, such as Australia, are recognizing and moving to correct deficiencies in their BME education. Also, as high technology endeavors are usually marks of developed nations, some areas of the world are prone to slower development in education, including in BME.

Licensure/certification

As with other learned professions, each state has certain (fairly similar) requirements for becoming licensed as a registered Professional Engineer (PE), but, in US, in industry such a license is not required to be an employee as an engineer in the majority of situations (due to an exception known as the industrial exemption, which effectively applies to the vast majority of American engineers). The US model has generally been only to require the practicing engineers offering engineering services that impact the public welfare, safety, safeguarding of life, health, or property to be licensed, while engineers working in private industry without a direct offering of engineering services to the public or other businesses, education, and government need not be licensed. This is notably not the case in many other countries, where a license is as legally necessary to practice engineering as it is for law or medicine.

Biomedical engineering is regulated in some countries, such as Australia, but registration is typically only recommended and not required.

In the UK, mechanical engineers working in the areas of Medical Engineering, Bioengineering or Biomedical engineering can gain Chartered Engineer status through the Institution of Mechanical Engineers. The Institution also runs the Engineering in Medicine and Health Division. The Institute of Physics and Engineering in Medicine (IPEM) has a panel for the accreditation of MSc courses in Biomedical Engineering and Chartered Engineering status can also be sought through IPEM.

The Fundamentals of Engineering exam – the first (and more general) of two licensure examinations for most U.S. jurisdictions—does now cover biology (although technically not BME). For the second exam, called the Principles and Practices, Part 2, or the Professional Engineering exam, candidates may select a particular engineering discipline's content to be tested on; there is currently not an option for BME with this, meaning that any biomedical engineers seeking a license must prepare to take this examination in another category (which does not affect the actual license, since most jurisdictions do not recognize discipline specialties anyway). However, the Biomedical Engineering Society (BMES) is, as of 2009, exploring the possibility of seeking to implement a BME-specific version of this exam to facilitate biomedical engineers pursuing licensure.

Beyond governmental registration, certain private-sector professional/industrial organizations also offer certifications with varying degrees of prominence. One such example is the Certified Clinical Engineer (CCE) certification for Clinical engineers.

Career prospects

In 2012 there were about 19,400 biomedical engineers employed in the US, and the field was predicted to grow by 5% (faster than average) from 2012 to 2022. Biomedical engineering has the highest percentage of female engineers compared to other common engineering professions.

Notable figures

See also

 

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