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PubMed1988

Update on assessment activities. United States perspective.

The purpose of this paper is to present an update on biomedical technology assessment activities from a United States perspective. In 1985, I described in detail (a) a primary vehicle for technology assessment--the Consensus Development Program (CDP) of the National Institutes of Health (NIH)--and also discussed, in a second paper, (b) the transfer of consensus-enhanced scientific information and some of its impact on U.S. medical practice. Here, I focus on what has transpired during the past year: the changes in the climate in which U.S. technology assessment efforts are being conducted, the consequences of these changes, and the challenges that they pose for all concerned with the provision of quality health care. The first part of this paper centers on the broader framework within which technology assessment plays a role in the United States. Later, it addresses the specific technology assessment and transfer activities in which the NIH is engaged.

Consensus Statements as Topic↗
PubMed1997

Wound healing management: enhancing patient outcomes and reducing costs.

Biomedical technology as applied to wound healing management allows specific evaluations of the oxygen-related pathophysiology of non-healing wounds. In many of these cases the use of transcutaneous oxygen mapping of the skin and hyperbaric oxygen (HBO) therapy as an adjunctive treatment for non-healing wounds speeds the healing process. While HBO treatment has remained a covered service for hospital-based care, only recently have treatment algorithms for its application in an outpatient setting been available. This technological advancement has also been a factor in the development of cost effective wound healing centers (WHC) in community hospitals. Better outcomes for many chronic wounds are achieved by combining a multidisciplinary team approach using advanced technologies. In this article the case of a soft-tissue radiation necrosis ulceration of the leg successfully treated with adjunctive HBO is presented. In this example, a reduction in patient charges of greater than 30% was achieved as compared to costs associated with traditional surgical/hospital management of the condition.

Cost Savings↗
PubMedDate not supplied

[Neural stem and progenitor cells of human embryos and fetuses as a basis of biomedical new technologies].

Isolation and cultivation of stem and progenitor cells of human embryos and fetuses at the age of 7-12 weeks of gestation have been described. The embryonic cells of human brain formed neurospheres with heterogenous composition. Cell differentiation took place not only in the presence of serum or as a result of attachment of neurosphere to a sublayer, but also in floating neurospheres in the presence of mitogens. In most neurospheres, the nestin-immunopositive cells were located near the surface while the cells stained for beta-tubulin III and glial fibrillar acid protein, as compact groups inside the neurospheres.

Biotechnology↗
PubMed1992

The physician and the social contract.

Expenditures for health care are growing at a staggering rate, yet over 30 million Americans lack access to care. A growing population with needs, increasing administrative costs, expanding biomedical technology, and the ever-increasing expectations of patients are among the explanations for this cost. To resolve the problem, we must establish priorities, evaluate technology more carefully before application, reassess our fees as they relate to effort, and evaluate what we do for our patients as it relates to society generally. Many of the problems in health care are societal problems, but physicians as a particularly responsible and knowledgeable part of society must take the lead in finding and implementing the solutions.

Health Care Costs↗
PubMed2004

Is it ethical to use enhancement technologies to make us better than well?

BACKGROUND TO THE DEBATE: A variety of biomedical technologies are being developed that can be used for purposes other than treating disease. Such "enhancement technologies" can be used to improve our appearance and regulate our emotions, with the goal of feeling "better than well." While these technologies can help people adapt to their rapidly changing lifestyles, their use raises important ethical issues.

Biomedical Technology↗
PubMed1986

Teaching biomedical policy to undergraduates.

Biomedical choices are emerging as critical policy issues of the 1980s. Political pressures for cost containment, trends toward corporate medicine, and continuing problems of access and equity ensure biomedical issues a prominent place on the policy agenda. Students of political science should be familiar with the array of biomedical technologies that currently are challenging the tenets of medicine as well as the capacity of political institutions to resolve the resulting policy dilemmas. Based on this, a course in biomedical policy is overdue. This article outlines a course which is designed to clarify the public policy dimensions of biomedicine and develop analytical skills in the students so that they can better cope with these issues of public and personal importance. It describes some of the approaches and methods that I have found useful and summarizes a few of the problems one might expect to encounter in teaching biomedical policy.

Bioethical Issues↗
PubMed2006

Force-controlled inorganic crystallization lithography.

Lithography plays a key role in integrated circuits, optics, information technology, biomedical applications, catalysis, and separation technologies. However, inorganic lithography techniques remain of limited utility for applications outside of the typical foci of integrated circuit manufacturing. In this communication, we have developed a novel stamping method that applies pressure on the upper surface of the stamp to regulate the dewetting process of the inorganic buffer and the evaporation rate of the solvent in this buffer between the substrate and the surface of the stamp. We focused on generating inorganic microstructures with specific locations and also on enabling the ability to pattern gradients during the crystallization of the inorganic salts. This approach utilized a combination of lithography with bottom-up growth and assembly of inorganic crystals. This work has potential applications in a variety of fields, including studying inorganic material patterning and small-scale fabrication technology.

Buffers↗
PubMed2004

The precautionary principle: a dialectical reconsideration.

This essay examines an overlooked element of the precautionary principle: a prudent assessment of the long-range or remote catastrophes possibly associated with technological development must include the catastrophes that may take place because of the absence of such technologies. In short, this brief essay attempts to turn the precautionary principle on its head by arguing that, (1) if the long-term survival of any life form is precarious, and if the survival of the current human population is particularly precarious, especially given contemporary urban population densities, and (2) if technological innovation and progress are necessary in order rapidly to adapt humans to meet environmental threats that would otherwise be catastrophic on a large scale (e.g., pandemics of highly lethal diseases), then (3) the development of biomedical technologies in many forms, but in particular including human germ-line genetic engineering, may be required by the precautionary principle, given the prospect of the obliteration of humans in the absence of such enhanced biotechnology. The precautionary principle thus properly understood requires an ethos that should generally support technological innovation, at least in particular areas of biotechnology.

Bioethical Issues↗
PubMedDate not supplied

Technology assessment in health care: group process and decision theory.

As biomedical technologies proliferate, it is incumbent upon the scientific community to monitor, validate, and encourage adoption of worthwhile procedures, drugs, and devices across the interface from research to practice. As the largest U.S. sponsor of biomedical research, the National Institutes of Health (NIH) formally established the Consensus Development Program and the Office of Medical Applications of Research (OMAR), in order to foster and improve the translation of biomedical research results into knowledge useful in the practice of medicine and public health. Individual technology assessments are conducted through a succession of consensus development conferences, which convene expert biomedical scientists, practicing clinicians, and public representatives in an effort to assess safety and efficacy, and to recommend clinical application of important medical technologies. The Consensus Development Program has evolved through three distinct stages. The "first generation," from 1977-82, initiated the experimental, untested concept of consensus development; the "second generation" (1982-84) stressed formulation of the code of standard operating principles enunciated above; and the ongoing "third generation" is testing the utility of formal data synthesis to augment assessments. OMAR is experimenting with an explicit, normative and analytic approach to aid technology assessments. Real-time microcomputer-based decision models are created to help the panel explore the implications of the data. This paper describes and discusses decision analysis and its potential applicability to medical technology assessment and consensus development. It explores OMAR's experience in testing the model during several consensus development conferences, as well as plans and projections for future investigation and implementation.

Decision Theory↗
PubMed2001

Deciding about your health care: the ethicist as policy-maker.

The author demonstrates that professional bioethics is culturally very risk averse when it comes to evaluating the possible ethical consequences of new technologies such as genetic testing, human embryonic stem cells, and reproductive cloning. Deeper involvement in the Federal regulatory process by bioethicists will exacerbate this tendency toward risk aversion. This cultural bias toward caution will tempt many bioethicists to look to the so-called precautionary principle for policy guidance. Adopting the precautionary principle would harm patients by slowing the development of new therapies. The author argues that bioethicists should reject the precautionary principle and instead rely on conscientious trial and error as a superior way to approach implementing new biomedical technologies ethically.

Bioethics↗
PubMedDate not supplied

Technology assessment: measuring the outcomes of laboratory practice.

The collision of explosive growth in biomedical technology and pressure to contain cost requires that managers of health-care services base decisions to introduce new technology on hard evidence that the benefits outweigh the costs of the new technology. Outcomes research measures the impact of new technology and changes in clinical practice on patient well-being or financial performance. Outcomes research in the clinical laboratory requires a systematic collection of data that is best accomplished in conjunction with a broader health services research effort that includes a multi-disciplinary team of laboratorians, clinicians, administrators, and statisticians. The major requirement for successful outcomes research is an integrated information system that includes clinical, demographic, administrative, claims, financial, and survey information.

Cost-Benefit Analysis↗
PubMed2001

Postmodern negotiations with medical technology: the role of midwifery clients in the new midwifery in Canada.

In 1994, after more than a century of uncertain legal status, the Province of Ontario legalized midwifery and incorporated midwives into the formal health care system. Midwifery is now accessible and publicly funded for all women experiencing "normal" uncomplicated pregnancy and birth. Yet midwifery's move from the margins into the mainstream health care system has brought many new challenges. Midwives must now contend with an expanded scope of practice; they use more medical technology both to fulfill their professional obligations and to respond to the choices of women. This and an increased accessibility to a wider clientele seem to work against midwifery as a critical, low-tech alternative to "technocratic birth." In this article, through re-telling and analyzing women's narratives of pregnancy and birth, I explore the role of midwifery clients in re-shaping midwifery's relationship to medical technology. Steering away from essentialist explanations that hold that women are either inherently opposed to technology by virtue of their closeness to nature or wholly oppressed by technology and the systems within which it is imbedded, my analysis focuses on women's agency (on what women do rather than on what is done to them). My study suggests that women act pragmatically both with regard to biomedical technology and to midwifery. I argue that women's negotiations with medical technology have been instrumental in re-shaping midwifery as a postmodern phenomenon.

Biomedical Technology↗
PubMedDate not supplied

When HIPAA finally comes, will clinical engineering be ready?

We live in interesting times. Recognize that HIPAA will impact nearly everyone in every health care organization and fundamentally change the health care industry. Implementation of HIPAA standards as well as ongoing developments in telemedicine, e-health and the Internet will continue to have a synergistic effect and further transform our industry. Biomedical technology will evolve and combine into ever-larger integrated networks. These networks will extend not only throughout the hospitals but also into the clinics, doctors' offices, and even patients' homes and workplaces. As clinical engineers, we need to stay ahead of the curve, anticipate and be prepared for these developments. We need to understand HIPAA and the implications it has for the technology we manage. We must ensure that the organizations we represent are prepared for what will undoubtedly be an exciting future.

Biomedical Engineering↗
PubMed1982

Ethics and technology: crossroads in decision making.

Few institutional controls exist on the development and application of new biomedical technology. Possible methods of technology control include the use of peer review, an institutional approach, the establishment of a hospital committee to review new and existing technologies, or a rationing system imposed by the federal government or local health planning agencies.

Decision Making↗
PubMed2000

Social and professional influences of the technology of electronic fetal monitoring on obstetrical nursing.

Electronic fetal monitoring (EFM) is one example of a biomedical technology that rapidly diffused from an experimental innovation into a standard medical practice. First developed in the 1950s, EFM became commercially available in the early 1970s and quickly transformed intrapartum obstetrical practice. Assessments and interventions, which practitioners had previously based primarily on laboring women's subjective reports of bodily sensations, were now being based on quantifiable objective data from uterine activity and fetal heart rate transducers. Despite concerns of over-medicalization of the natural event of birth, iatrogenesis related to the increased incidence of operative deliveries, and escalating costs, EFM became widely accepted as routine and necessary by both practitioners and patients. By presenting the confident expectations and cautious reservations of various practitioners and patients to EFM, this article explores the rapid diffusion of EFM within the social context of the 1970s. A special focus is given to the perspective of intrapartum obstetrical nurses, because they have been the primary users of this perinatal technology since its introduction.

Diffusion of Innovation↗
PubMed2006

Nanomedicine-emerging or re-emerging ethical issues? A discussion of four ethical themes.

Nanomedicine plays a prominent role among emerging technologies. The spectrum of potential applications is as broad as it is promising. It includes the use of nanoparticles and nanodevices for diagnostics, targeted drug delivery in the human body, the production of new therapeutic materials as well as nanorobots or nanoprotheses. Funding agencies are investing large sums in the development of this area, among them the European Commission, which has launched a large network for life-sciences related nanotechnology. At the same time government agencies as well as the private sector are putting forward reports of working groups that have looked into the promises and risks of these developments. This paper will begin with an introduction to the central ethical themes as identified by selected reports from Europe and beyond. In a next step, it will analyse the most frequently invoked ethical concerns-risk assessment and management, the issues of human identity and enhancement, possible implications for civil liberties (e.g. nanodevices that might be used for covert surveillance), and concerns about equity and fair access. Although it seems that the main ethical issues are not unique to nanotechnologies, the conclusion will argue against shrugging them off as non-specific items that have been considered before in the context of other biomedical technologies, such as gene therapy or xenotransplantation. Rather, the paper will call on ethicists to help foster a rational, fair and participatory discourse on the different potential applications of nanotechnologies in medicine, which can form the basis for informed and responsible societal and political decisions.

Biomedical Technology↗