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Re-engineering the elective surgical service of a tertiary hospital: a historical controlled trial.

OBJECTIVE: To study the clinical effects of re-engineering the processes associated with elective surgery. DESIGN: A prospective, historical controlled trial. Control patients were enrolled from March 1995 to January 1996, and postintervention patients from February 1996 to October 1996. SETTING: A major teaching, tertiary care hospital (Prince of Wales Hospital, Sydney). PATIENTS: 224 patients (123 before and 101 after the intervention) undergoing elective herniorrhaphy of laparoscopic cholecystectomy who lived in the local area. INTERVENTION: Introduction of a re-engineered surgical service consisting of preadmission assessment and education, admission on day of surgery, and postacute care after discharge. There were no changes to the operative methods or infection control procedures. MAIN OUTCOME MEASURES: Length of stay, operative complications, pain scores and patient satisfaction. RESULTS: The risk of a patient suffering one or more complications was reduced in the postintervention group (postintervention v. control patients: 25.7% v. 38.2%; relative risk [RR], 0.66; 95% confidence interval [CI], 0.44-0.98; P = 0.035) because of a reduced risk of wound infections (5.0% v. 16.3%; RR, 0.30; 95% CI, 0.12-0.78; P = 0.0075). Other complications (perioperative or postoperative) and pain scores were unchanged. Patients treated by the re-engineered service had a significantly shorter length of stay, reported a higher level of satisfaction with the preoperative and postdischarge care, and were more likely to say that they would have the same treatment again (92.9% v 82.6%; P = 0.037). CONCLUSIONS: Re-engineering surgical services, with an associated reduction in length of stay, does not lead to a deterioration in care and may decrease postoperative complications and increase patient satisfaction.

Australia↗

Metabolic engineering through cofactor manipulation and its effects on metabolic flux redistribution in Escherichia coli.

Applications of genetic engineering or metabolic engineering have increased in both academic and industrial institutions. Most current metabolic engineering studies have focused on enzyme levels and on the effect of the amplification, addition, or deletion of a particular pathway. Although it is generally known that cofactors play a major role in the production of different fermentation products, their role has not been thoroughly and systematically studied. It is conceivable that in cofactor-dependent production systems, cofactor availability and the proportion of cofactor in the active form may play an important role in dictating the overall process yield. Hence, the manipulation of these cofactor levels may be crucial in order to further increase production. We have demonstrated that manipulation of cofactors can be achieved by external and genetic means and these manipulations have the potential to be used as an additional tool to achieve desired metabolic goals. We have shown experimentally that the NADH/NAD(+) ratio can be altered by using carbon sources with different oxidation states. We have shown further that the metabolite distribution can be influenced by a change in the NADH/NAD(+) ratio as mediated by the oxidation state of the carbon source used. We have also demonstrated that the total NAD(H/(+)) levels can be increased by the overexpression of the pncB gene. The increase in the total NAD(H/(+)) levels can be achieved even in a complex medium, which is commonly used by most industrial processes. Finally, we have shown that manipulation of the CoA pool/flux can be used to increase the productivity of a model product, isoamyl acetate.

Acetyl Coenzyme A↗

Tissue engineering and its potential impact on surgery.

The loss or failure of an organ or tissue is one of the most frequent, devastating, and costly problems in healthcare. Current treatment modalities include transplantation of organs, surgical reconstruction, use of mechanical devices, or supplementation of metabolic products. A new field, tissue engineering, applies the principles and methods of engineering, material science, and cell and molecular biology toward the development of viable substitutes which restore, maintain, or improve the function of human tissues. In this review, we outline the opportunities and challenges of this emerging interdisciplinary field and its attempts to provide solutions to tissue creation and repair. Within this context, we present our experience using the basic tools of tissue engineering to guide regeneration of diverse tissues that include the liver, small intestine, cardiovascular structures, nerve, and cartilage. And in addition, we discuss the necessity of finding new strategies to achieve vascularization of complex tissues for transplant and present our approaches utilizing MicroElectroMechanical Systems (MEMS) technology and three-dimensional printing.

Artificial Organs↗

Electrospun protein fibers as matrices for tissue engineering.

Electrospinning has recently emerged as a leading technique for generating biomimetic scaffolds made of synthetic and natural polymers for tissue engineering applications. In this study, we compared collagen, gelatin (denatured collagen), solubilized alpha-elastin, and, as a first, recombinant human tropoelastin as biopolymeric materials for fabricating tissue engineered scaffolds by electrospinning. In extending previous studies, we optimized the shape and size (diameter or width) of the ensuing electrospun fibers by varying important parameters of the electrospinning process, such as solute concentration and delivery rate of the polymers. Our results indicate that the average diameter of gelatin and collagen fibers could be scaled down to 200-500 nm without any beads, while the alpha-elastin and tropoelastin fibers were several microns in width. Importantly, and contrary to any hitherto reported structures of electrospun polymers, fibers composed of alpha-elastin, especially tropoelastin, exhibited "quasi-elastic" wave-like patterns at increased solution delivery rates. The periodicity of these wave-like tropoelastin fibers was partly affected by the delivery rate. Atomic force microscopy was utilized to profile the topography of individual electrospun fibers and microtensile testing was performed to measure their mechanical properties. Cell culture studies confirmed that the electrospun engineered protein scaffolds support attachment and growth of human embryonic palatal mesenchymal (HEPM) cells.

Animals↗

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↗

Tissue engineering: advances in in vitro cartilage generation.

Damaged or diseased articular cartilage frequently leads to progressive debilitation resulting in a marked decrease in the quality of life. Tissue engineering, a budding field in modern biomedical sciences, promises creation of viable substitutes for failing organs or tissues. It represents the amalgamation of rapid developments in cellular and molecular biology on the one hand and material, chemical and mechanical engineering on the other. Current tissue engineering approaches are mainly focused on the restoration of pathologically altered tissue structure based on the transplantation of cells in combination with supportive matrices and biomolecules. The ability to manipulate and reconstitute tissue structure and function in vitro has tremendous clinical implications and is likely to have a key role in cell and gene therapies in coming years.

Biocompatible Materials↗

Using "no problem found" in infusion pump programing as a springboard for learnning about human factors engineering.

BACKGROUND: A hospital took a second look at a device error with a syringe pump in which a dose of fentanyl was delivered in half the anticipated time. When the nursing staff could not reproduce the error, the pump was sent to biomedical engineering where "no problem was found." The biomedical staff subsequently performed another analysis, which led to discovery of the possible cause of the problem. MOBILIZING FOR HFE: A human factors engineering (HFE) task force, in considering the fentanyl delivery issue, identified a need to educate nursing and engineering on such incidents and to consider the consequences of override features. The HFE task force then reviewed a tool kit for briefing clinical units on education of staff on clinical safety issues. HFE ANALYSIS: Efforts to maximize device customization or simplification can have negative HFE consequences. The decision to allow for function overrides or nontraditional equipment use must be weighed against the potential compromises in patient safety. SUMMARY: The problems that arise from the interface between humans and devices are not limited to intravenous pumps or even medical devices. Awareness of the potential for HFE design flaws can be critical in reducing harm in health care.

Analgesics, Opioid↗

Effective enhancement of short-chain-length-medium-chain-length polyhydroxyalkanoate copolymer production by coexpression of genetically engineered 3-ketoacyl-acyl-carrier-protein synthase III (fabH) and polyhydroxyalkanoate synthesis genes.

Polyhydroxyalkanoates (PHAs) are biodegradable polyesters that have a wide variety of physical properties dependent on the lengths of the pendant groups of the monomer units in the polymer. PHAs composed of mostly short-chain-length (SCL) monomers are often stiff and brittle, whereas PHAs composed of mostly medium-chain-length (MCL) monomers are elastomeric in nature. SCL-MCL PHA copolymers can have properties between the two states, dependent on the ratio of SCL and MCL monomers in the copolymer. It is desirable to elucidate new and low cost ways to produce PHA composed of mostly SCL monomer units with a small mol % of MCL monomers from renewable resources, since this type of SCL-MCL PHA copolymer has superior qualities compared to SCL homopolymer. To address this issue, we have created strains of recombinant E. coli capable of producing beta-ketothiolase (PhbA) and acetoacetyl-CoA synthase (PhbB) from Ralstonia eutropha, genetically engineered 3-ketoacyl-ACP synthase III (FabH) from Escherichia coli, and genetically engineered PHA synthases (PhaC) from Pseudomonas sp. 61-3 to enhance the production of SCL-MCL PHA copolymers from glucose. The cumulative effect of having two monomer-supplying pathways and genetically engineered PHA synthases resulted in higher accumulated amounts of SCL-MCL PHA copolymer from glucose. Polymers were isolated from two recombinant E. coli strains, the first harboring the phbAB, fabH(F87T), and phaC1(SCQM) genes and the second harboring the phbAB, fabH(F87W), and phaC1(SCQM) genes. The thermal and physical properties of the isolated polymers were characterized. It was found that even a very low mol % of MCL monomer in a SCL-MCL PHA copolymer had dramatic effects on the thermal properties of the copolymers.

3-Oxoacyl-(Acyl-Carrier-Protein) Synthase↗

Genetically engineered fluorescent cell marker for labeling CD34+ hematopoietic stem cells.

To address the challenge of labeling and tracking stem cells in vivo, we have engineered a fluorescent cell marker CD34EGFP by utilizing the mechanism of the cell-specific activity of CD34 promoter in CD34(+) stem cells. A retroviral vector derived from a murine stem cell virus was constructed to integrate the CD34EGFP gene into the genome of the cells for labeling. Our experiment demonstrates that the 454 bp segment upstream of the murine CD34 cDNA sequence has full function of promoter activity and can serve as a cell-specific promoter for driving the expression of EGFP in CD34(+) hematopoietic stem cells (HSC), providing a living color for labeling stem cells. The CD34EGFP marker was tested in various types of cells, including terminally differentiated cells, CD34(+) mouse myeloid leukemia progenitor cells, CD34(-) hematopoietic cells, and CD34(+) HSCs. We show that the engineered CD34EGFP cell marker is expressed in the CD34(+) stem or progenitor cells but not in CD34(-) or terminally differentiated cells. RT-PCR assay indicates that the transcription level of the CD34EGFP gene from CD34 promoter is almost the same as that from CMV promoter in CD34(+) progenitor cells. The approach we present here offers a framework for genetic engineering of fluorescent cell markers for labeling and tracking stem cells in vivo. We anticipate that a variety of cell markers could be generated by coupling variants of fluorescent proteins with various cell-specific promoters.

Animals↗

The relevance of large strains in functional tissue engineering of heart valves.

BACKGROUND: Exposing the developing tissue to flow and pressure in a bioreactor has been shown to enhance tissue formation in tissue-engineered heart valves. Animal studies showed excellent functionality in these valves in the pulmonary position. However, they lack the mechanical strength for implantation in the high-pressure aortic position. Improving the in vitro conditioning protocol is an important step towards the use of these valves as aortic heart valve replacements. In this study, the relevance of large strains to improve the mechanical conditioning protocol was investigated. METHODS: Using a newly developed device, engineered heart valve tissue was exposed to increasing cyclic strain in vitro. Tissue formation and mechanical properties were analyzed and compared to unstrained controls. RESULTS: Straining resulted in more pronounced and organized tissue formation with superior mechanical properties over unstrained controls. Overall tissue properties improved with increasing strain levels. CONCLUSIONS: The results demonstrate the significance of large strains in promoting tissue formation. This study may provide a methodological basis for tissue engineering of heart valves appropriate for systemic pressure applications.

Absorbable Implants↗

Skills required for clinical engineering practice: results of a survey.

In order to provide information to individuals conducting or planning educational programs in clinical engineering, a survey of skills required for practice in this field was carried out. A total of 127 responses from university-based (44) and practicing (83) clinical engineers were received. The results were tabulated separately for these two groups. The survey form was divided into two parts: basic skills and clinical engineering skills. The responses indicated an emphasis on medical instrumentation, basic life science (physiology and anatomy) information, and organizational and quipment control skills.

Biomedical Engineering↗

Focus on: Watsonville Community Hospital Biomedical Engineering Department.

The Journal of Clinical Engineering is pleased to present this FOCUS on the Biomedical Engineering Department of Watsonville Community Hospital (Watsonville, CA). Since the Department's inception in 1983, the growth of the hospital and the surrounding area has resulted in the expansion of the Department and its duties. This paper describes the responsibilities of the two-man Biomedical Engineering Department, which serves this 130-bed hospital and oversees the preventive maintenance and repair of approximately 800 pieces of equipment. In addition, the Department is involved with staff education, equipment inventory control, new equipment purchases, technical consultations, and special projects.

Biomedical Engineering↗

Are productivity and cost-effectiveness comparisons between in-house clinical engineering departments possible or useful?

Inter-institutional comparisons of productivity and cost-effectiveness can be a valuable source of feedback to the in-house biomedical or clinical engineering services manager. But for such comparisons to be valid, all institutions must use the same criteria. As yet, there are no standard definitions for such criteria and, in most cases, the necessary data are not kept. Therefore, reliable comparisons are not possible. It is possible, however, to keep data on the variety of tasks common to all clinical engineering departments that can then be compared inter-institutionally. As task comparisons become more common, "norms" will evolve that can become standards for the profession. From there, it is a realizable step to standards that permit comparison of productivity and cost-effectiveness. A national organization, like the American Hospital Association could help by including clinical engineering data as part of their annual hospitals survey.

Biomedical Engineering↗

Focus on: Johnson City Medical Center Hospital Biomedical Engineering Department.

The Biomedical Engineering Department at Johnson City Medical Center Hospital, Johnson City, Tennessee, is responsible for servicing over 2,500 pieces of equipment. The department also provides biomedical services, on a contract basis, to six area hospitals and ten physicians' offices. The department is extensively involved in pacemaker implants and participates in the hospital's system of equipment specification and selection. The department was established in 1974, as the region's first hospital-based biomedical engineering department with a staff of one. It has grown to a staff of five including two certified BMET's and one certified clinical engineer. Affiliation with a medical school brings new technology which challenges the department to future growth.

Biomedical Engineering↗

1989 Survey of hospital salaries & job responsibilities for clinical engineers & biomedical technicians.

The Journal of Clinical Engineering has conducted its fourth survey of the salaries paid to Clinical Engineers and Biomedical Equipment Technicians in U.S. hospitals. This paper reports the salary and work responsibility data obtained from 1,350 professionals in relationship to: Certification; Region of the U.S.; Teaching Versus Nonteaching Facilities; Years of Experience; Education; Union Membership; and Gender. Data are included on Wage Increases and Job Responsibilities. All data are as of 12/31/88. The average BMET I has 2.8 years of experience and earns $19,494 +/- $4,069 (Std. Dev.). The average BMET II has 6.1 years of experience and earns $25,743 +/- $5,176. The average BMET III has 10.5 years of experience and earns $30,434 +/- $5,432. The average BMET Supervisor has 13.0 years of experience and earns $34,339 +/- $5,896. The average Clinical Engineer has 9.8 years of experience and earns $35,605 +/- $4,345. CE Supervisors are the highest paid in the field with an average 12.9 years of experience and an average salary of $45,461 +/- $11,831. Wages remain the highest on the West Coast and lowest in the Southeast. From 1987 to 1988, the wages ranges for all job types increased: BMET Is, +.52%; BMET IIs, +5.3%; BMET IIIs, +3.8%; BMET Supervisors, +2.1%; CEs, +6.3%; and CE Supervisors, +3.6%. The highest quartile of CE Supervisors now earns between $52,200 and $117,700 per year. While certified individuals earn $1,108 to $4,619 more than noncertified, this is attributable in part to years of experience.

Biomedical Engineering↗

Clinical engineering department staffing: analysis of two surveys.

In this brief paper, the author analyzes the nationwide 1985 Journal of Clinical Engineering department survey data and 1988 Pennsylvania data in relationship to clinical or biomedical department staffing. The 1988 Pennsylvania data yield a relationship between the total facility engineering department staffing and the hospital bed count. The 1985 journal survey data provide relationships between the smaller clinical/biomedical staffing and bed count, number of devices, and budgets. While the linear correlation coefficients were higher for the Pennsylvania total facility engineering department data, none of the relationships presented here should be considered to be absolute predictors. Departments differ in their responsibilities, work load, and types of equipment serviced. These differences make absolute analysis or prediction of staffing problematic. The results presented here may be useful, however, as general indicators when applied with caution.

Biomedical Engineering↗

Hospital technology management: the Tao of clinical engineering.

Planning a profession's future is a formidable task that must be based on both what the members want to become and what is natural to the marketplace. The hospital industry, however, will not wait for clinical engineering to establish its profession. Competition will arise and push aside the unprepared. Clinical engineering's leadership has not created a clear vision of their profession's role in improving healthcare, nor have they helped others to internalize a sincere professional purpose and to share the responsibility for change. This paper examines the profession and articulates action that only clinical engineers can take to increase their value in the hospital industry.

Biomedical Engineering↗

Focus on: Boston City Hospital Department of Clinical Engineering.

This paper describes the Clinical Engineering Department at the Boston City Hospital, Boston, Massachusetts. Boston City Hospital is the largest component of the City of Boston's Department of Health and Hospitals. The Clinical Engineering Department maintains in excess of 2,700 devices located at Boston City Hospital, Long Island Hospital, Mattapan Chronic Disease Hospital, and three neighborhood health centers that operate under the License of the Department of Health and Hospitals. The Clinical Engineering Department is responsible for the management, repair, testing, calibration, modification, and installation of medical equipment at each of the facilities. The department is also active in the training of clinical and professional staff members, and participates in anesthesia and laser research.

Biomedical Engineering↗