A proposed model for designing clinical engineering department protocols. Some ideas for implementing and augmenting your hospital's policies and procedures.
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Biomedical Engineering↗
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A systems engineering approach to technology assessment.
This paper presents a technology assessment process based on systems engineering methodologies used in the aerospace and defense industries. Systems engineering, defined in the U.S. military manual for engineering management, is a logical sequence of activities and decisions transforming an operational need into a description of system performance parameters and a preferred system configuration. Like systems engineering, technology assessment is driven by a single, clear need. The objective of systems engineering is to design a new system configuration; technology assessment assesses existing technologies to address this need. A six-step technology assessment model based on systems engineering principles is presented, including: (1) needs assessment; (2) clinical feasibility analysis; (3) systems assessment; (4) approval; (5) implementation; and (6) follow-up/CQI.
Biomedical Engineering↗
Surface and bulk modifications to photocrosslinked polyanhydrides to control degradation behavior.
A unique class of surface-eroding polyanhydrides was developed and explored for use in medical applications requiring high-strength biomaterials (e.g., orthopedics). In particular, dimethacrylated anhydride monomers were synthesized that photopolymerize quickly to render densely crosslinked polymer networks that degrade from the surface only by hydrolysis of labile anhydride linkages. Previous research on these materials has shown that the rate of hydrolysis of the degradable linkages is dependent on the hydrophobicity of the network composition. This article demonstrates the versatility in controlling the degradation process and resulting cellular response in these materials through the incorporation of new chemistries and the formation of polymer-polymer composite structures. Specifically, the rate of mass loss was controlled by the addition of hydrophobic linear polymers [e.g., poly(methyl methacrylate)] or monovinyl monomers based on hydrophobic natural components (e.g., cholesterol, steric acid). In addition, a newly established photografting method was used to modify the network surface chemistry with cholesterol- and stearic acid-based polymer grafts to control the degradation front and cellular interactions at the polymer-tissue interface. Finally, a porogen leaching method was used to form porous polyanhydride constructs, which can be subsequently filled with osteoblasts photoencapsulated in a hydrogel, as potential synthetic allograft materials for tissue engineering bone.
Anhydrides↗
Three-dimensional cultivation of human osteoblast-like cells on highly porous natural bone mineral.
In this study, we investigated the growth and extracellular matrix synthesis of human osteoblast-like cells on highly porous natural bone mineral. Human bone cells were isolated from trabecular bone during routine iliac crest biopsies. Under conventional culture conditions, trabecular bone cells were able to assume the organization of a three-dimensional structure on a porous natural bone mineral (Bio-Oss(R) Block). Scanning electron microscopy examination after 6 weeks revealed multiple cell layers on the trabecular block. Transmission electron microscopy examination after 6 weeks revealed the accumulation of mature collagen fibrils in the intracellular and extracellular spaces, and showed multilayered, rough endoplasmic reticulum as well as mitochondria-rich cells surrounded by dense extracellular matrix. These morphological observations suggest that the cell layer may resemble the natural three-dimensional structure. Biochemical analysis revealed that the hydroxylysylpyridinoline, lysylpyridinoline, and hydroxyproline content of the cell layer increased in a time-dependent manner, whereas in monolayer culture without natural bone mineral, no measurable amounts of hydroxylysylpyridinoline or lysylpyridinoline, and a barely measurable amount of hydroxyproline, were noted. Mature collagen extracted by ethylenediaminetetraacetic acid-demineralization from the cell layer on natural bone mineral showed an identical electrophoretic pattern to that observed in human bone, as evaluated by sodium dodecyl sulphate-polyacrylamide gel electrophoresis. The present study demonstrated an excellent biocompatibility of the highly porous natural bone mineral in a three-dimensional bone cell culture system, and thus its potential for tissue-engineered growth of human bone.
Amino Acids↗
Process design for microbial plastic factories: metabolic engineering of polyhydroxyalkanoates.
Implementing several metabolic engineering strategies, either individually or in combination, it is possible to construct microbial plastic factories to produce a variety of polyhydroxyalkanoate (PHA) biopolymers with desirable structures and material properties. Approaches include external substrate manipulation, inhibitor addition, recombinant gene expression, host cell genome manipulation and, most recently, protein engineering of PHA biosynthetic enzymes. In addition, mathematical models and molecular methods can be used to elucidate metabolically engineered systems and to identify targets for performance improvement.
Acyltransferases↗
Toward bioengineering anticancer drugs.
The biosynthetic route for enediyne production remained mysterious until two independent groups recently reported the genes that orchestrate enediyne synthesis in two different microorganisms. These discoveries lay the foundations for engineering this pathway to generate improved anticancer drugs.
Aminoglycosides↗
Bioengineering and spinal cord injury: a perspective on the state of the science.
There is little doubt that as technologic advances become available, people with spinal cord injuries (SCIs) are living healthier, more productive, and longer lives. Federally and privately funded research, foreign competition, and globalization appear to be factors that will drive bioengineering advances within the assistive technology (AT) industry. The seeds of bioengineering research are likely to contribute to improvements in universal design and the mainstreaming of products. The aims of AT have changed tremendously in the past 50 years. Most of the federal agencies supporting assistive and rehabilitative technology research and development did not exist 50 years ago. Indeed, the leading AT companies all were established within the past 50 years. Bioengineering has the potential to be to the 21 st century what electronic engineering was to the 20th century. Advances in power electronics, telecommunications, controls, sensors, and instrumentation have really only just begun to be applied for devices to assist people with SCI. Advancing technology for people with SCI represents a significant career and business opportunity for engineers who want to serve the public good in a meaningful and tangible way.
Biomedical Engineering↗
Options for tissue engineering to address challenges of the aging skeleton.
There will be more than 52 million Americans over the age of 65 by the year 2020 (U.S. Census Bureau). Regenerating form and function to bone defects in an elderly, osteoporotic population of this magnitude will be a daunting challenge. Tissue engineering options must be considered to answer this challenge. Options can include gene transfer technology, stem cell therapy, and recombinant signaling molecules. An additional component will be a carrier that localizes, protects, predictably releases cues and cells, as well as establishes an environment for restoring osseous form and function. The purposes of this article are to present an overview of the bone regenerating decrement affecting osteoporotic, elderly patients and to highlight some tissue engineering options that could offset this decrement.
Aged↗
Clinical engineering and hospital accreditation in Canada.
In response to the growing concern over the management of medical technology in hospitals, and in view of recent changes pertaining to medical technology that have been made by the Joint Commission on Accreditation of Hospitals in the United States, the Canadian Council on Hospital Accreditation recently asked the Canadian Medical & Biological Engineering Society (CMBES) to prepare a brief on the proper role of clinical engineering in Canadian hospitals. The brief prepared by the CMBES outlines seven basic principles associated with clinical engineering, hospital accreditation, and the proper management of medical technology in hospitals. It appears that these principles may form the initial basis for changes to the Canadian Hospital Accreditation Guide and Questionnaires. A comparative assessment of the Canadian and American approaches by clinical engineers may help to advance the cause of better health care in both countries.
Biomedical Engineering↗
The profession of clinical engineering.
This paper reviews the sociology of professions, examines the background and historical development of professions, and then reviews the present status of the profession of clinical engineering. The historical components of the professionalization process are investigated along with the societal perceptions, the role of education, and the functions of professional societies. The progress of an occupation toward professionalization involves: the appearance of training schools; establishment of university educational programs; licensure or certification; a formal code of ethics; and establishment of one or more national professional associations. A rationale is presented here for the formation of a clearly identified professional society for clinical engineers based on: (1) The need to identify the territory of the clinical engineer by defining the body of knowledge on which clinical engineering is based; (2) The need to structure the educational system of clinical engineering; (3) The need to represent the clinical engineer in the healthcare system; and (4) The need to gain status as a profession.
Biomedical Engineering↗
An open forum on: a national clinical engineering society.
An open forum was held on May 16, 1989 on the topic, A New Clinical Engineering Society? Representatives of the AAMI, IEEE/EMBS, ASHE and the SBET presented descriptions of the roles and services of their societies in support of Clinical Engineers and BMETs. Independent Clinical Engineers described their concerns regarding the development of the field; a proposal was made for the establishment of a new CE society. About 50 professionals, representing a broad cross section of clinical engineering, participated in a debate that touched on educational requirements certification, ethics, independence of action, "marketing" of the roles of CEs and BMETs, and the possible need for a new CE society. A vote was taken to represent the opinion of those present. The idea of immediately forming a new society was voted down and an ad hoc Task Force on Clinical Engineering was formed under the chairmanship of Yadin David, Ph.D. The participants called upon the AAMI, IEEE/EMBS, and the ASHE to appoint representatives to the Task Force. The new Task Force could: (1) recommend the formation of a new society; (2) call for increased cooperation between existing societies and propose long-range plans; or (3) recommend the formation of a College of Clinical Engineering or an umbrella organization to bring existing societies together.
Attitude of Health Personnel↗
Tissue engineering, morphogenesis, and regeneration of the periodontal tissues by bone morphogenetic proteins.
Tissue engineering is the emerging field of science developing techniques for fabrication of new tissues for replacement based on principles of cell and developmental biology and biomaterials. Morphogenesis is the cascade of pattern formation and the attainment of form of the various organs and the organism as a whole. The periodontium consist of the periodontal ligament, cementum, and alveolar bone. Bone has considerable potential for regeneration and therefore is a prototypic model for tissue engineering. The three main ingredients for tissue engineering are regulatory signals, responding stem cells, and extracellular matrix. Recent advances in molecular biology of the bone morphogenetic proteins (BMPs) have set the stage for tissue engineering of bone and related tissues, including the periodontium. Bone-derived BMPs, with a collagenous matrix as carrier, induced cementum and alveolar bone regeneration in surgically created furcation defects in the primate. It is noteworthy that there was morphogenesis of periodontal ligament and a faithful insertion of Sharpey's fibers into cementum. In the same furcation model, recombinant human osteogenic protein-1 (rhOP-1, also known as BMP-7), in conjunction with the collagenous carrier, induced extensive cementogenesis with insertion of Sharpey's fibers into the newly formed cementum. The observation that BMPs induce cementogenesis and periodontal ligament formation indicates that these proteins may have multiple functions in vivo not limited to cartilage and bone induction. The rapid advances in the molecular biology of BMPs and their receptors bode well for novel strategies to engineer the regeneration of the periodontal tissues.
Alveolar Process↗
A new force in biotech: tissue engineering. Understanding how mechanical force combines with cytokines and other growth factors may help shape future biotech drugs.
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Animals↗
The impact of biomolecular medicine and tissue engineering on plastic surgery in the 21st century.
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Biomedical Engineering↗
Rehabilitiation of engineering as the crow flies. Part I-Development of the biomechanics clinic team.
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Biomechanical Phenomena↗
The clinical engineering budget: how to tell the boss where the dollars went. Interview by Michael J Miller.
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Biomedical Engineering↗
Engineering principles in the control of external power by myoelectric signals.
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Artificial Limbs↗
Technology assessment and equipment planning in Kaiser Permanente, Northern California Region.
Hospitals face a significant challenge to select and appropriately place clinically warranted, safe, and cost-effective medical devices. To meet this challenge, the Kaiser Permanente, Northern California Region developed a comprehensive medical device technology assessment and equipment planning program. This paper discusses the structure of the program, physician leadership and accountability, the role of clinical engineers and other support personnel, and the program's influence on strategic planning and policy development.
Biomedical Engineering↗