Journal of health care technology最新文献

Freestanding diagnostic imaging centers represent one of the new types of ambulatory care facilities providing health services today. Like those offering surgical and urgent care to outpatients, centers offering imaging services present an economic challenge to nearby hospitals that now provide outpatient imaging. However, unlike other ambulatory facilities, imaging centers rely precariously upon both expensive, high-technology equipment and other physicians who refer patients. This dependence creates a unique set of relationships among the hospitals, radiologists, referring physicians, and individual consumers in a community, particularly when some of the physicians have financial interests in the success of a freestanding center. This assessment examines many aspects of hospitals' and radiologists' responses to these new, competing imaging centers, and pays particular attention to the legal, ethical, and economic dimensions of several possible alternative strategies.

The interfacing of two-dimensional and Doppler ultrasound of the heart in a single piece of equipment is a technological development that may change the way in which cardiac conditions are diagnosed and monitored. The device's two-dimensional capabilities create images of the heart at virtually the same time that its Doppler capabilities are providing information on the blood flowing through the heart. As a complete assessment of cardiac disease requires information on both the heart's structure and its function, two-dimensional Doppler ultrasound enables a fairly comprehensive view of a cardiac condition to be achieved with one noninvasive and relatively inexpensive procedure. While cardiac catheterization may as yet be more efficacious, there are many instances--such as in the emergency department or coronary care unit--in which examination by two-dimensional Doppler echocardiography may provide sufficient information to be the modality of choice. While neither its optimal location in the hospital nor its appropriate departmental sponsorship will be easily decided, two-dimensional Doppler ultrasound is clearly a technology that warrants investment by hospitals with substantial numbers of cardiac patients. This assessment examines the new roles created for echocardiography by recent technological developments, and provides hospital decisionmakers with insights into many of the complex issues involved in acquiring two-dimensional Doppler echocardiography services.

When it was introduced in 1979, digital subtraction angiography (DSA) was greeted with open arms as a minimally invasive, relatively inexpensive, ambulatory procedure by which to diagnose carotid artery disease, a major cause of stroke. Although the technology for DSA has diffused quickly through the medical community, DSA using intravenously injected contrast material is gradually being recognized as inadequate either to screen asymptomatic patients for disease or to assess the degree of stenosis and indicate surgery. Recent research efforts are pointing towards a promising future for both the intra-arterial injection of contrast material for DSA examinations and the possibility of performing some conventional angiographic procedures on an outpatient basis. As a result, digital subtraction angiography will continue to play a role in visualizing the carotid arteries. Nevertheless, because the applications of DSA have been shown to be far fewer than expected, it will be vital for any hospital or freestanding center that has not yet invested in such a system to evaluate carefully the level of utilization it can achieve for such a technology.

Microbiology is the last of the major labor-intensive sections remaining in the clinical laboratory; other large, previously labor-intensive areas--chemistry and hematology--were automated over the last two decades. Only in recent years has technology been developed to permit automation of microbiology techniques. This assessment describes the historical development and technological aspects of automated microbiology systems. Patient care can be improved by earlier treatment and reduced lengths of stay when clinicians use the rapidly reported information provided by automated microbiology systems. Automated systems may reduce the cost of microbiology testing; whether savings are realized depends both on the manual methods to which the automated technology is compared and also on the particular automated system under consideration. Some studies indicate that the technology is cost saving when used on a large scale; other studies show that, while automated microbiology technology extends laboratories' capabilities, the technology can increase laboratory testing costs. Since automated microbiology systems cannot result in cost savings in every application, it is a technology that should be carefully evaluated in its intended setting, before a decision is made to acquire such a system. Adoption of the technology in hospital laboratories has been relatively limited; problems in perfecting the technology have slowed its acceptance. In states with prospective payment systems in place prior to 1983, hospitals' acquisition of automated microbiology systems has been even more limited.

Recent changes in Medicare financing policy and in state certificate of need (CON) policies have greatly altered the environment in which hospitals and physicians must operate. These policy changes likely will influence the development, adoption, and use of new technologies, including those employed in clinical laboratories. Some hospitals, particularly large academic health centers, are responding to the new incentives under Medicare prospective payment by (1) implementing integrated case mix and financial information systems, (2) monitoring and evaluating physician practice patterns, (3) improving the quality of analyses underlying their technology acquisition decisions, and (4) striving toward improved relations with medical staff. Clinical laboratories are also responding to these financial pressures through (1) more cautious adoption of new technologies, (2) selective automation of tests that reduce direct costs, (3) more prudent "make-or-buy" decisions regarding test performance sites, and (4) focused effort to improve turnaround times for inpatient testing and reporting.

Cancer is the second leading cause of death in the Western world, exceeded only by cardiovascular disease. Twenty percent of American deaths result from the spectrum of diseases known as cancer. Strategies to decrease cancer mortality include prevention, early detection, a wide variety of therapies, and more effective monitoring of treatment. This assessment focuses on the clinical laboratory aspects of two such strategies--early cancer diagnosis and development of more effective cancer therapy. Laboratory detection of tumor markers helps to confirm the diagnosis early, allowing treatment to begin when the disease is most amenable to therapy. Tumor markers, the specific biochemical substances synthesized by cancer cells, can be measured in body fluids by common laboratory test methods. Laboratory detection and monitoring of tumor marker levels are being used increasingly with growing effectiveness in the campaign against cancer.

Magnetic resonance imaging (MRI) is a diagnostic modality that permits images of a variety of pathologic conditions to be acquired safely and painlessly with remarkable anatomic detail. In research sites and in a few clinical locations, MRI has become the definitive diagnostic tool for many neurological conditions and promises to become a valuable modality for diagnosing thoracic, abdominal, pelvic, and perhaps even breast and eye diseases. Despite its accolades, MRI's diffusion and adoption are at the center of a storm of controversy. The spread of MRI to non-research hospitals throughout the country--even to those with large neurology services--has not yet been shown to be clinically appropriate or cost effective. This article examines the accumulated information on MRI in order to help the administrator and trustees of a typical acute-care hospital to decide whether their community needs--and is able to support--an MRI service. Rather than reviewing the ever-changing frontiers of MRI research, this assessment considers the issues that are of immediate concern to hospital decisionmakers who must answer the question, "Should we plan to buy an MRI system in 1985?"

More than 2,000 healthy Americans die each year during general anesthesia, and at least half of these deaths may be preventable. Anesthetists and equipment manufacturers have made considerable progress in improving anesthesia safety. However, much more needs to be done, especially in "human-factors" areas such as improved training, consistent use of preanesthesia checklists, and anesthetists' willingness to enhance their vigilance by using appropriate monitoring equipment. While defective equipment and supplies are the direct cause of relatively few deaths, inexpensive oxygen analyzers and disconnect alarms could, if available in more ORs, warn anesthetists in time to convert many deaths to near misses. Some anesthetists are using other monitoring technologies that are more costly, but can detect a wider range of problems. The anesthesia community could expand its anesthesia-safety leadership and guidance, by improving technology-related training and by developing practice standards for anesthetists and safety standards for equipment. The Joint Commission on Accreditation of Hospitals could impose specific safety requirements on hospitals; malpractice insurance carriers could require anesthetists and hospitals to use monitors and alarms during all procedures; and the Food and Drug Administration could actively stimulate and oversee these efforts and perhaps provide seed money for some of them. The necessary equipment costs would likely be offset by long-term savings in malpractice premiums, as anesthesia incidents are the most costly of all types of malpractice claims. Concerted efforts such as these could greatly reduce the number of avoidable anesthesia-related deaths.

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.

A detailed review of records and documentation considered more than 100 technology evaluations performed in conjunction with coverage decisions by the Medicare program and by a major Blue Cross/blue Shield plan. Medicare evaluations were highly structured, synthesizing thorough literature reviews, recommendations from the National Institutes of Health and other governmental agencies, and information solicited from medical specialty societies and independent practitioners; however, the material supplied by nongovernmental sources seldom influenced the coverage recommendations. In contrast, the Blue plan's evaluations were based largely on presentations and discussions at advisory committee meetings, after receiving informational inputs that were more limited than those used in Medicare evaluations. The fraction of technologies recommended for coverage was slightly over 50% for each carrier. If information was strongly positive about either a technology's safety, its effectiveness, or both, then coverage was nearly always recommended. Still, the carriers differed significantly in the stage of development of the practices evaluated and in their willingness to make a coverage decision in the face of both safety and effectiveness data that were regarded as tentative. Because coverage decisions, and the speed with which they are conducted, may be crucial to the rate of a technology's diffusion--and possibly even to the rate of innovation--the authors conclude that it is important to understand clearly the process by which this type of technology assessment is performed.