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PubMed1985

New obstacles in the path of marketing new medical devices.

Approval of a new medical device's safety and effectiveness by the Food and Drug Administration (FDA) is only one step in the typical device's passage into the marketplace. A review of 10 new Class II and III devices found an average of 62 months elapsing between the beginning of FDA-approved clinical trials and the device's final approval for general marketing. However, FDA marketing approval does not mean a new device can be sold because, for many new devices, the Health Care Financing Administration (HCFA) requests a technology assessment from the Office of Health Technology Assessment (OHTA) in order to determine whether the device's use is "reasonable and necessary" and thus appropriate for Medicare payment. The Medicare decision often guides other third parties. OHTA assessments of 93 devices and procedures required an average of 26 months to complete; of 16 FDA-approved Class III devices, OHTA reported to HCFA that insufficient data existed to recommend coverage for 12 (75 percent). Under the Medicare prospective payment system (PPS) for hospital care, a third step has been added to the process, consideration by the Prospective Payment Assessment Commission (ProPAC) and HCFA of the new device's impact on PPS payment rates. Further, under recent legislation, OHTA is mandated also to consider a device's cost effectiveness. Duplicative reviews of new devices should be eliminated, and until they are, medical equipment developers must recognize that delays and conflicting payment rulings may have serious impacts on the ability to market a new device.

Centers for Medicare and Medicaid Services, U.S.↗
PubMed1991

Obstacles to Adolescent Care in General Practice.

The physician who provides care for the adolescent must integrate a number of issues outside the usual framework of medical practice. The adolescent alternates between the child and young adult, and so creates a series of challenges for his or her physician relative to the young person's autonomy and the continued legal role of the family. This article outlines several problems inherent in work with adolescents. ADOLESC MED 2:389-396, 1991

Journal Article↗
PubMed1991

Overcoming Obstacles to Care: Ethical Issues.

The focus of this article is the conflict between the principle of autonomy and the principle of beneficence as they relate to the medical care of teenagers, and more specifically the thoughts involved in deciding which one applies more appropriately in a given circumstance.

Journal Article↗
PubMed1999

Tuberculosis elimination revisited: obstacles, opportunities, and a renewed commitment. Advisory Council for the Elimination of Tuberculosis (ACET).

In 1989, CDC and the Advisory Council for the Elimination of Tuberculosis (ACET) issued A Strategic Plan for the Elimination of Tuberculosis in the United States. Since then, the United States has experienced a resurgence of tuberculosis (TB) followed by a successful mobilization against the epidemic. Because the nature of this disease has changed during the past decade, ACET has reassessed its 1989 plan. Recent progress against TB should reinforce the nation's confidence that the disease can be controlled and ultimately eliminated. However, existing TB-control efforts must be sustained and enhanced, and new and improved diagnostic, treatment, and prevention methods, including a new vaccine, must be developed and applied. Support for these efforts should be broad-based and include the establishment of new partnerships. Because eliminating TB in the United States will have widespread economic, public health, and social benefits, committing to this action will also fulfill an obligation to persons throughout the world who have this preventable and curable disease. With this reassessment, ACET reaffirms its call for the elimination of TB in the United States.

Communicable Disease Control↗
PubMed1999

Hospital information systems: chances and obstacles on the way to integration.

Today, most large hospital information systems (HIS) comprise many heterogeneous application systems, loosely coupled via interfaces. Integration could offer many advantages, like the support of interdepartmental workflows or a consistent patient record. This cannot be achieved, however, by simply interfacing originally unrelated component systems. In this paper, we present relevant concepts of integration, the autonomy/consistency tradeoff, and technical alternatives in some detail. Based on our recent experiences in analyzing an existing HIS and selecting adequate vendors for the needs of our 1250-bed hospital, we then discuss strategies and tradeoffs on the way to a HIS that utilizes state-of-the-art technology to fill the users' needs.

Hospital Information Systems↗
PubMed1999

Obstacles to victims' cooperation with the criminal prosecution of their abusers: the role of social support.

Over the last 20 years, diminishing tolerance for domestic violence has triggered significant criminal justice reforms designed to facilitate the prosecution of abusers. Prosecutors, for example, have adopted policies requiring that cases go forward even if the victim later has second thoughts. Although increasingly common, these "no drop" policies reflect a profound irony about domestic cases that is well known but little understood: the most formidable problem in prosecuting such cases is often the victim's own unwillingness to bring the abuser to justice. This prospective study explored a range of factors potentially predictive of domestic violence victims' cooperation with the prosecution of their abusers. Although the study focused on interpersonal and institutional social support, it also investigated the influence of violence severity, victim demographic factors, and victim mental health characteristics, including the presence of depressive symptoms, emotional dependence on the abuser, and substance abuse. Findings showed that tangible support, severity of violence in the relationship, and the presence of children in common with the abuser all significantly predicted victims' cooperation with the prosecution of their abusers. Substance abuse significantly predicted victims' noncooperation with prosecution. The research and policy implications of these findings are discussed.

Adolescent↗