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An appraisal of ongoing experimental procedures in human spinal cord injury.

Clinicians and scientists in the field of spinal cord injury research and medicine are poised to begin translating promising new experimental findings into treatments for people. Advances in experimental regeneration research have led to several transplantation strategies that promote axonal regrowth and partial functional recovery in animal models of injury. In this review, we summarize current knowledge regarding various invasive experimental treatments that have been or are now being applied clinically. Various questions about the timeliness, safety, and benefits of the procedures are under discussion within the spinal cord injury (SCI) research community. We also describe guidelines for carrying out optimal clinical trials and efforts to establish specific international guidelines to translate preclinical treatment strategies into clinical trials in SCI. The clinical trial process and the role that clinical professionals have in advising individuals regarding participation in experimental procedures also is discussed.

Biomedical Research↗

Clinical engineering in today's hospital: perspectives of the administrator and the clinical engineer.

In 1987-88, the first of two surveys conducted questioned the administrator's viewpoint on choice of reporting authority for plant operations and clinical engineering departments as well as the job satisfaction and prestige associated with these responsibilities. The second tested the response of clinical engineers on similar issues as well as the effect of certain organizational factors on their degree of functional involvement in the equipment-management process. In the first survey, two-thirds of the administrators chose a structure that, as shown in the second survey, leads to a higher degree of involvement and satisfaction for clinical engineers. Other organizational factors that have an effect are: the type of hospital (teaching and nonteaching), the presence of qualified university-degree engineers, and ensuring that the clinical engineering role within the health care institution is recognized and supported. Teaching hospitals are found to provide a better climate than nonteaching ones for the support of the research and education activities. Clinical engineering departments, whose role has been recognized and supported by their institution, are more substantially involved in all aspects of the equipment-management process than those who are still seeking this recognition. Finally, departments where university-degree engineers have been hired again show more involvement and commitment to the quality and efficiency of their operation.

Attitude of Health Personnel↗

An opportunity for exploitation of research in biomedical engineering: the EC Life Sciences Demonstration Projects.

To validate clinically a new stereotactic device for real-time monitored minimally-invasive brain surgery; to perform the first European phase I clinical trials of Boron Neutron Capture Therapy (BNCT) for treatment of glioblastoma, using the facility of the Community Joint Research Centre (JRC) in Petten, on forty patients from six different European centres. These are typical objectives of the current EC BIOMED 2 demonstration projects. The number of supported projects under BIOMED is now 16 in 1998, and will be in total around 80 for the three Life Sciences and Technologies Programmes. Demonstration is expected to play a major role in the Fifth Framework Programme, particularly in its so-called "Key Actions". This article addresses three of the main issues for potential applicants: the readiness for demonstration, the content of the consortium, and the dissemination strategy.

Biomedical Engineering↗

Decisions to adopt new technologies at the hospital level: insights from Israeli medical centers.

OBJECTIVES: New medical technologies have been identified as the leading cause of increasing health-care expenditures. Adoption of a new technology is one of the most important decisions in medical centers. The objectives of this study were to map and describe the function of hospital decision-makers within the area of new technology assessment and adoption, and to examine relevant considerations, sources of information, and decision-making processes in the adoption of a new technology. METHODS: A questionnaire was mailed to hospital executives and referred to (i) the considerations for and against adoption of a new technology, (ii) the decision-making process, (iii) information sources used in the decision-making process. RESULTS: The most frequent criteria favoring adoption included increased cost-effectiveness, increased efficacy, and decrease in complication rates. An increase in complication rates or side effects and decreased efficacy were the top ranked criteria against adoption. The final decision-making responsibility varied among technologies; the medical director frequently made the final decision when a new device was involved, but this responsibility decreased when a new drug or a new procedure was considered, Participation in scientific meetings, opinions of local experts, medical journals, and Food and Drug Administration clearance documents were the most important information sources used in the decision-making process. However, these were not necessarily the optimal sources of information. Significant barriers in adoption decision-making are lack of timely data regarding the safety of the new technology, its cost-effectiveness, and efficacy. CONCLUSION: To improve the adoption decisions, hospitals must develop criteria upon which the decision-making will be based.

Biomedical Technology↗

Surgical video systems used in laparoscopy.

A significant amount of minimally invasive surgery (MIS) is now being performed using surgical video systems (SVSs), and with the increased application and sales of SVS equipment, many new SVS manufacturers and products have entered the medical device market. Consequently, the challenge of selecting an appropriate SVS has increased significantly, in part because of the complexity of the latest generation of equipment, which has evolved from solely optical endoscopes to mostly video electronics used with various types of endoscopes. When describing their products, manufacturers often present technical characteristics of their systems that can be complex and, many times, confusing. Although purchasers often rely on technical specifications when selecting an SVS, they actually need information that will illustrate the system's applicability in their clinical setting, which can be assessed only through clinical evaluation at the hospital. Also, the lack of standardized methods of specifying SVS performance and the difficulties in relating technical characteristics to clinical performance should diminish the emphasis that is often placed on specifications when selecting a system. In this article, we review and explain many common specifications of SVSs, focusing on their use with laparoscopes, and provide guidance on the limitations of each specification and the extent to which it may be useful. This information will help clinical engineers, biomedical technicians, and other readers participate in the technical aspects of selecting and managing an SVS for use with many types of endoscopes.

Humans↗

Innovative communication in a biomedical engineering department.

Effective communication is one of the most important and often overlooked components of the functioning of a biomedical engineering department. The Biomedical Engineering Department (Biomed) at the VA Medical Center, Boston, Massachusetts uses innovative methods and resources to improve communication between Biomed and the Medical Center staff. While some changes have dealt directly with the information content communicated by Biomed, many improvements have also been made to the format in which information and ideas are presented. The latter changes serve the purpose of improving communication by ensuring that the presented information is both understood and retained. Improvements have been made in the areas of operator training, alerting users to actual and potential hazards and recalls, and staff education concerning Biomed's role in the Medical Center and the availability of Biomed to assist in technology issues.

Audiovisual Aids↗