Clinical Engineering: A Handbook for Clinical and Biomedical Engineers

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    • Describe the connection issue. SearchWorks Catalog Stanford Libraries. Physical description 1 online resource xvii, pages: Find it at other libraries via WorldCat Limited preview. Contributor Taktak, Azzam F. Long, Dave Medical scientist , editor. White, Paul Medical scientist , editor. Bibliography Includes bibliographical references and index. Information technology and software engineering III. Clinical instrumentation and measurement IV. Rehabilitation engineering and assistive technology.

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

    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 [5] and tracheas [6] from human stem cells towards this end.

    Several artificial urinary bladders have been grown in laboratories and transplanted successfully into human patients. 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 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 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. The ISPE is an international body that certifies this now rapidly emerging interdisciplinary science. This is an extremely broad category —essentially covering all health care products that do not achieve their intended results through predominantly chemical e.

    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. Stereolithography is a practical example of medical modeling being used to create physical objects.

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    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, [9] treatments, [10] patient monitoring, [11] of complex diseases. Medical devices are regulated and classified in the US as follows see also Regulation:.

    This can involve utilizing ultrasound, magnetism, UV, radiology, and other means. Imaging technologies are often essential to medical diagnosis, and are typically the most complex equipment found in a hospital including: 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.

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    Clinical Engineering - 1st Edition - ISBN: , A Handbook for Clinical and Biomedical Engineers . Medical and Biomedical Engineers, plus medical and clinical professionals, involved with medical device . Presents a review of "Clinical Engineering: A Handbook for Clinical and Biomedical Engineers" (Taktak, A.F.G., Eds., et al; ). The book consists of fou .

    In some cases, implants contain electronics, e. Some implants are bioactive, such as subcutaneous drug delivery devices in the form of implantable pills or drug-eluting stents. 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 useful tools. These developments have indeed made our lives better, but the best contribution that bionics has made is in the field of biomedical engineering the building of useful replacements for various parts of the human body. Modern hospitals now have available spare parts to replace body parts badly damaged by injury or disease [Citation Needed].

    Biomedical engineers work hand in hand with doctors to build these artificial body parts. Clinical engineering is the branch of biomedical engineering dealing with the actual implementation of medical equipment and technologies in hospitals or other clinical settings. 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.

    In their various roles, they form a "bridge" between the primary designers and the end-users, by combining the perspectives of being both 1 close to the point-of-use, while 2 trained in product and process engineering.

    Also see safety engineering for a discussion of the procedures used to design safe systems. 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 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.

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

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    Regulatory issues have been constantly increased in the last decades to respond to the many incidents caused by devices to patients. 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" [12]. Regardless of the country-specific legislation, the main regulatory objectives coincide worldwide. 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 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.

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    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 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 K "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" that is defined as "the method by which a manufacturer demonstrates that its device complies with the requirements of the European Medical Device Directive ". 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.

    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 different structure.

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    The book provides a broad reference to the core elements of the subject and draws from the expertise of a range of experienced authors. In addition, manufacturers are now obliged to provide conformity risk assessments and test reports — or explain why they are lacking. Archived from the original on May 6, Protective measures have to be introduced on the devices to reduce residual risks at acceptable level if compared with the benefit derived from the use of it. Adv Drug Deliv Rev. Gynaecology Gynecologic oncology Maternal—fetal medicine Obstetrics Reproductive endocrinology and infertility Urogynecology. The Fundamentals of Engineering exam — the first and more general of two licensure examinations for most U.

    The Quality System deliverables usually includes procedures that ensure quality throughout all product life cycle. 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. 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 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 comply with the hazardous substances limits and have a CE mark on their products.

    The new International Standard IEC for home healthcare electro-medical devices defining the requirements for devices used in the home healthcare environment. IEC 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 3rd edition series. The mandatory date for implementation of the EN European version of the standard is June 1, 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.

    The standard specifies the procedures required to maintain a wide range of medical assets in a clinical setting e. The standard covers a wide range of medical equipment management elements including, procurement, acceptance testing, maintenance electrical safety and preventative maintenance testing and decommissioning.

    Biomedical engineers require considerable knowledge of both engineering and biology, and typically have a Bachelor's B. As interest in BME increases, many engineering colleges now have a Biomedical Engineering Department or Program, with offerings ranging from the undergraduate B.