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Focus on: Thomas Jefferson University Hospital, Department of Biomedical Instrumentation.

Technology management services at Thomas Jefferson University Hospital are provided by two distinct cost centers: The Department of Biomedical Instrumentation and Jefferson Biomedical Shared Services. The in-house division of the Department of Biomedical Instrumentation (BMI) provides clinical engineering services to the hospital, a 717-bed, tertiary care facility. BMI supports traditional patient care instrumentation, as well as dialysis machines, anesthesia machines, lasers, and the neonatal extracorporeal membrane oxygenation (ECMO) systems. In addition, the department supports over 3,000 personal computers and associated peripherals, and provides research, design, database support, device evaluation, incident investigation, and product problem investigation services. Jefferson Biomedical Shared Services, an integral component of the Department of Biomedical Instrumentation, offers a shared services program to local area hospitals. It has a current client list of 11 major healthcare institutions with annual revenues approaching $3,000,000 per year.

Biomedical Engineering↗

Biomedical Engineering at the Indian Institute of Technology, (Madras)-II.

The Biomedical Engineering Division of the Indian Institute of Technology in Madras engages in a program of research, development and teaching. A visitor to our institution would, at any time, find a considerable variety of projects and courses being followed as well as active consultation with industry and the medical profession.

Academies and Institutes↗

Use of the Internet in scanning the horizon for new and emerging health technologies: a survey of agencies involved in horizon scanning.

BACKGROUND: A number of countries worldwide have structured horizon scanning systems which provide timely information on the impact of new health technologies to decision makers in health care. In general, the agencies that are responsible for horizon scanning have limited resources in terms of budget and staff. In contrast, the number of new and emerging health technologies, i.e. pharmaceuticals, medical devices, and medical and surgical procedures, is growing rapidly. This requires the Horizon Scanning Systems (HSSs) to devise efficient procedures for identification of new health technologies. The role of the Internet for this purpose has as yet not been documented. OBJECTIVE: To describe and analyse how the Internet is used by horizon scanning systems to systematically identify new health technologies. METHODS: A questionnaire was developed and distributed among 10 agencies known to work within this specific area. The questionnaire specifically focussed on type of sites scanned, frequency of scanning, and importance of a site for the identification of a new health technology. RESULTS: A 100% response rate was obtained. Seven out of 10 agencies used the Internet to systematically identify new health technologies, of which 6 provided complete information. A total of 110 web sites were scanned by these 6 agencies. The number of sites scanned per agency ranged from 11 to 27. Most sites were scanned weekly (41%) or monthly (33%). Thirty-one percent (31%) of the total number of sites was considered as highly important. The agencies spent at least 2 hours a week and at most 8 hours per week scanning the Internet. Although each agency's remit differed somewhat in scope, on average the same types of sites were scanned. These include sites from regulatory agencies, sites with information on new drugs or new devices, and sites with news from newswires. However, within these types there was not much correlation between the individual sites that agencies judged important to scan. CONCLUSION: The use of the Internet for identifying new health technologies is increasing in the majority of horizon scanning systems around the world. At the same time there is considerable variation between individual agencies in their approach to this source of information. This can only be partially explained by differences in scope of scanning activities of the individual agencies. A coordinated effort to develop Internet search strategies for either different categories of health technologies or different clinical specialties may improve efficiency and quality of scanning in terms of the number of potentially relevant technologies identified.

Biomedical Technology↗

Laser reimbursement: who pays for progress?

Leland Kaiser, a noted health care futurist, asserts that, to the degree to which medical technology can improve human life, there is no limit. Likewise, there is no limit to the amount of money people will be willing to spend on this technology. The ASLMS is at the focal point of the debate and needs to make its voice heard clearly based on a well thought out plan, based on reliable data, and considerate of the various economic, social, legal, and ethical constraints placed on the practicing clinician. If we don't take hold of the process, the technological imperative will quickly overwhelm us.

Insurance, Health, Reimbursement↗

A fibrous-bed bioreactor for continuous production of monoclonal antibody by hybridoma.

A fibrous-bed bioreactor (FBB) has been developed to culture hybridoma cells for long-term continuous production of monoclonal antibody (MAb). A non-woven polyester fibrous matrix was used to immobilize the cells to reach a high viable cell density of 3 x 10(8) cells cm(-3) packed bed, which gave a high volumetric MAb productivity of 1 g L(-1) day(-1) under continuous feed conditions with the medium containing 10% serum. Reducing the medium serum content to 1% increased MAb production to 6.5 g L(-1) day(-1) in a repeated batch FBB culture. MAb production was higher at higher dissolved oxygen (DO) levels in the range between 10% and 70% of air saturation, although DO did not significantly affect glucose metabolism and lactate production. The medium LDH (lactate dehydrogenase) level increased dramatically when the DO level was decreased from 30% to 10%, suggesting that a critical DO level of approximately 30% is necessary for maintaining the FBB culture for long-term operation. Compared with suspension cultures in T-flasks and spinner flasks, the FBB culture had a lower lactate yield from glucose (0.80 vs. 0.91 g g(-1), produced MAb at a higher concentration (up to 442 mg L(-1) vs. 83.5 mg L(-1), and was stable for continuous long-term operation (more than 1 month). The superior FBB performance was attributed to the highly porous fibrous matrix that enabled the efficient mass transfer, cell immobilization, and continued growth and regeneration that are critical to maintaining a high density of viable and productive cell populations. The cells immobilized in the fibrous matrix had high viability (>85%) even though many of them were in growth arrest (G1/G0 phase) as indicated by their smaller cell size (<10 microm). Scanning electron microscopic studies of the cell-matrix showed that the high density of cells formed large clumps within the interstitial spaces of the fibrous matrix. Their close contact and interaction with each other might have contributed to their ability to survive well under adverse conditions such as low DO and low serum content in the medium. It was also found that the cells present inside the fibrous matrix had a higher viability and lower apoptosis than those present in the liquid suspension, indicating that the fibrous matrix had selectively retained healthy, nonapoptotic cells and dislodged apoptotic and dead cells; this also might have contributed to the stability of the long-term culture. This work demonstrated that the FBB originally developed for microbial fermentation also gave excellent results in achieving high cell density, productivity, and product concentrations, and should have a good potential for industrial animal cell culture applications.

Antibodies, Monoclonal↗

Clinical services assessment and reengineering: lessons learned.

Healthcare enterprises often "acquire and install" picture archiving and communications systems (PACS) without examining many of the care delivery processes and information flows that will be affected. Many times these unexamined factors can delay or be the cause of failure of the PACS project. This article presents issues that were worked through as part of a PACS clinical services assessment and reengineering analysis for several US military medical treatment facilities.

Alaska↗

[The role of randomised controlled trials in the medical evaluation of routine procedures].

If a demand exists for the evaluation of the favourable and adverse effects of a medical procedure, a comparison is required; this comparison should be fair. The only procedure that ensures a fair comparison is randomisation. Randomised controlled trials (RCTs) therefore represent the gold standard in the evaluation of medical procedures; the non-application of a randomisation process must be justified in detail in individual cases. Reasons presented for not conducting an RCT are mainly based on a misunderstanding of the term "randomisation". They may also be based on circumstances where the conduct of any simultaneous comparison is unsuitable (independent of the mode of allocation) or on situations where there is practically no hypothesis available for a comparison, or even for a study. These factors are taken into account by the current regulations valid in Germany on the approval of drugs and on the reimbursement eligibility of health care services by statutory health insurance.

Biomedical Technology↗

[HTA in the decision-making processes of health care institutions. Current state and relevant questions of regulatory health law].

The development of the German HTA system and the corresponding HTA law began in 2000 and was concluded for the time being with the coming into force of the law on the modernisation of statutory health insurance on 1 January 2004. This law has established the Federal Joint Committee (G-BA) and the Institute for Quality and Efficiency in Health Care (IQWiG) as "new institutions" of statutory health insurance, restructured the procedures for the assessment of health services and formulated more precise assessment criteria than hitherto provided. There are other institutions in the health care system concerned with HTA which are not dealt with here.

Biomedical Technology↗

[Effectiveness and cost effectiveness of innovative medical techniques in public health].

Electromedical technology and systems are an integral part of health services and contribute to their costs. Despite the sometimes high capital costs, they have proved to be effective and efficient for health services. Technological assessment with respect to benefit and cost aspects has been well and systematically evaluated, but requires much work in detail. In many cases less sophisticated procedures are sufficiently effective for a reliable evaluation. Corresponding results that show the cost-saving potential of advanced technology for radiology are reported.

Capital Expenditures↗

[Digital radiography. Cost-benefit analysis].

Due to its high dynamic range and contrast discernibility, digital radiography offers substantial advantages compared with conventional film-screen systems. Moreover, further advantages can be assumed for radiation protection. Digital radiography also allows conventional image data to be included in PACS (Picture Archiving Communication System). These well-known advantages are faced with legal questions which are not yet settled. Cost effectiveness in using systems of digital radiography and PACS are also under discussion. By means of examining economic efficiency and cost analysis of digital radiography systems, economic effectiveness was assessed. This was also compared with conventional alternatives. As a result, it may be assumed that amortization is reached in three to four years. Based on lower costs for films, digital systems are more cost effective than conventional systems after this period.

Cost-Benefit Analysis↗