The US Food and Drug Administration investigational device exemptions (IDE) and clinical investigation of cardiovascular devices: information for the investigator.
The conduct of a clinical investigation of a medical device to determine the safety and effectiveness of the device is covered by the investigational device exemptions (IDE) regulation. The purpose of IDE regulation is "to encourage, to the extent consistent with the protection of public health and safety and with ethical standards, the discovery and development of useful devices intended for human use, and to that end to maintain optimum freedom for scientific investigators in their pursuit of this purpose" (Federal Food, Drug, and Cosmetic Act). Conducting a clinical investigation may require an approved IDE application. The US Food and Drug Administration encourages early interaction with the agency through the pre-IDE process during the development of a device or technology and during the preparation of an IDE application. This facilitates approval of the IDE application and progression into the clinical investigation. This paper reviews the terminology and applicability of the IDE regulation and the type of study that requires an IDE application to the Food and Drug Administration. The pre-IDE process and the development of an IDE application for a significant risk study of a cardiovascular device are discussed. (+info)
Mixed signals: public policy and the future of health care R&D.
The incentives facing health care research and development (R&D) are influenced by the ambiguous signals sent by private and public insurance decisions affecting the use of, and payments for, existing technologies. Increasingly, that uncertainty is exacerbated by confusion over technologies' impact on health care costs, how costs are to be measured, and the social difficulty of determining medical "need" for purposes of insurance coverage. R&D executives appear to believe that "major" advances are more likely to win such coverage and thus to be profitable. The products that result, therefore, may make the current policy dilemma of cost containment versus service restriction more acute rather than less so. If the aim of policy is to cut costs, innovative remedies are necessary. (+info)
Measurements of muscle strength and performance in children with normal and diseased muscle.
A study has been made of two simple means of measuring muscle power in children with normal and diseased muscle. In one the length of time that the leg and the head could be held at 45 degrees above the horizontal was measured with the child supine. In the second, measurements were made of the isometric strength of six muscle groups with the newly developed Hammersmith Myometer. In the timed performance tests only 5 (8%) of a group of 61 children known to have muscle disease achieved the minimum expected values for their ages. Myometer readings of the isometric power of the children with muscle disease also have values which were below those of a comparable group of normal children. The reproducibility of muscle strength measurements in young children has been shown to be good, whereas the timed performance tests, though able to differentiate normal children from children with muscle disease, did not show sufficient reporducibility for this test to be recommended for sequential measurements. (+info)
Empiric examination of physician behavior in a changing healthcare market.
We hypothesized that, in the current healthcare environment, medical providers have strong economic incentives to introduce new technology and treat patients more extensively. We examined physician reimbursement for medical procedures in Utah in the early 1990s, a period of increasing utilization of managed care methods, using a cross-section time series and a supply side model to analyze how physician behavior changed during this period of time. Our findings suggest that physicians have acted to maintain their revenue by requesting reimbursement for more procedures as the reimbursement level per procedure decreased. We conclude that increased volatility in reimbursement levels and increased adjudication pressure from payers provide signals to physicians to act strategically to protect their revenue stream. (+info)
Differences in brain gene expression between sleep and waking as revealed by mRNA differential display and cDNA microarray technology.
The consequences of sleep and sleep deprivation at the molecular level are largely unexplored. Knowledge of such molecular events is essential to understand the restorative processes occurring during sleep as well as the cellular mechanisms of sleep regulation. Here we review the available data about changes in neural gene expression across different behavioural states using candidate gene approaches such as in situ hybridization and immunocytochemistry. We then describe new techniques for systematic screening of gene expression in the brain, such as subtractive hybridization, mRNA differential display, and cDNA microarray technology, outlining advantages and disadvantages of these methods. Finally, we summarize our initial results of a systematic screening of gene expression in the rat brain across behavioural states using mRNA differential display and cDNA microarray technology. The expression pattern of approximately 7000 genes was analysed in the cerebral cortex of rats after 3 h of spontaneous sleep, 3 h of spontaneous waking, or 3 h of sleep deprivation. While the majority of transcripts were expressed at the same level among these three conditions, 14 mRNAs were modulated by sleep and waking. Six transcripts, four more expressed in waking and two more expressed in sleep, corresponded to novel genes. The eight known transcripts were all expressed at higher levels in waking than in sleep and included transcription factors and mitochondrial genes. A possible role for these known transcripts in mediating neural plasticity during waking is discussed. (+info)
Cloning and embryonic stem cells: a new era in human biology and medicine.
The cloning of mammals using adult cells as nuclear donors has been achieved and the same procedure can be, at least theoretically, used to clone humans. Another recent technological advance, the derivation of human embryonic stem cells, opens up new possibilities in cell and tissue replacement therapy and heralds significant improvements in gene therapy. Besides suggesting new and potentially valuable medical applications, the insights gained through the use of these techniques could significantly enrich our understanding of basic mechanisms regulating human development. On the other hand, these preliminary results are viewed by many as the opening of the Pandora's box and there are loud voices clamoring that research in these areas be forbidden in perpetuity. I suggest in the following article that at present we do not know enough to make anything but an entirely emotional decision about future applications of these techniques. I try to summarize the current state of the kn owledge in the field and indicate how much further research is necessary if benefits and drawbacks are to be properly understood. (+info)
Supplying commercial biomedical companies from a human tissue bank in an NHS hospital--a view from personal experience.
NHS histopathology laboratories are well placed to develop banks of surgically removed surplus human tissues to meet the increasing demands of commercial biomedical companies. The ultimate aim could be national network of non-profit making NHS tissue banks conforming to national minimum ethical, legal, and quality standards which could be monitored by local research ethics committees. The Nuffield report on bioethics provides ethical and legal guidance but we believe that the patient should be fully informed and the consent given explicit. Setting up a tissue bank requires enthusiasm, hard work, and determination as well as coordination between professionals in the NHS trust and in the commercial sector. The rewards are exiting new collaborations with commercial biomedical companies which could help secure our future. (+info)
The changing healthcare market: outlook for the future of cardiovascular disease treatment--Part 2.
This paper, the second in a series of 2, reviews major developments and trends in the current healthcare arena that will affect cardiovascular disease (CVD) treatment over the next 10 years. The paper also discusses the implications and future outlook for cardiovascular services in a managed care environment. (+info)