Journal of health care technology最新文献

Reuse and reprocessing of disposable medical devices raises issues of legal liability, especially among physicians, hospitals, and device manufacturers. The practice of reuse has been, at least informally, reported to be fairly widespread. However, the medical risks associated with reuse are unresolved in most cases, which may lead to circumstances conducive to litigation. In this paper, the characteristics of reuse pertaining to legal liability, the parties potentially subject to civil liability suits as a result of reuse, the legal theories underlying claims of injury, and the legal implications of possible policy actions will be examined.

Decisions about Medicare payment for new technologies are made by a multiagency process that became even more complex with the advent of DRG-based payments for inpatient care. Numerous problems with this decision-making process are widely acknowledged to exist but difficult to solve because of inherent conflicting goals. This report proposes consideration of basic improvements to the process, including: increased support for clinical and cost studies, particularly from manufacturers of new technologies; approval of provisional payments to providers who agree to collect effectiveness and cost data; additional research into technology assessment methods; clarification of decision-making criteria; opening of the coverage-decision process to greater public scrutiny; according more weight to recommendations of the Prospective Payment Assessment Commission; submission of additional data to the Food and Drug Administration; and increasing the flow of information among Medicare coverage-decision agencies and other third-party payers. Many of these modifications can be accomplished without congressional action, if the interested parties are willing to work together to improve the coverage-decision process.

The increase in both the numbers of physician office laboratories (POLs) and the range of tests they offer may have significant impact on hospital laboratories. Their profitability already weakened by prospective payment systems, hospital laboratories face a serious competitor in physicians' offices. Concerns about the quality of testing performed in POLs do not seem to be impeding their growth, but are stimulating various regulatory or legislative proposals, which would remove some of their economic incentives. Physicians will always need referral laboratories, and hospitals will need to cultivate this market by improving services to physicians. One such service--consultation by hospitals' clinical laboratory staffs--has the added feature of helping to improve the quality of POLs.

Examination of the urine, possibly the earliest diagnostic test in medicine, has only recently benefited from automation; one previous twentieth-century advance was substitution of specific reagents for earlier nonspecific chemical tests that were subject to interferences. In the mid-1970s, semiautomated urinalysis instruments were developed to read and record chemical test reactions used in manual urinalysis. Further, in 1984 the first instrument coupling automated intelligent microscopy (AIM) with a dipstick reader became available, fully automating both the biochemical screening and microscopic examination of urine specimens. This assessment describes AIM, as embodied in the Yellow IRIS instrument, and also discusses alternative strategies that laboratorians are developing to improve the cost effectiveness of conventional urinalysis.

Growing numbers of diagnostic images are being produced electronically and filmed only for storage, or sometimes also for interpretation. However, in most imaging centers, transmission of images from one location to another is still being accomplished manually. Almost 40 years ago, x-rays were first transmitted over telephone lines, and this form of "teleradiology" has been increasingly used to link isolated hospitals and clinics to larger facilities so that radiologists can interpret the images. Continuing improvement of the various electronic image-processing technologies has produced faster means of transmission, and increasingly sophisticated computer algorithms for "compressing" the image data have further improved both transmission speed and the quality of the transmitted images. To date, only a few imaging research centers and teaching hospitals have integrated these techniques into a comprehensive picture archiving and communications system (PACS) or digital image management system (DIMS), and a number of factors are restraining these systems' spread. However, electronic transmission of images for interpretation by specialists at a central facility is likely to increase, and truly "filmless" radiology may someday become a reality, if image transmission and data compression techniques are eventually determined to create images of acceptable quality in all imaging modalities.

Many hospitals are considering acquiring the capability to do single photon emission computed tomography (SPECT) studies. An outgrowth of planar nuclear medicine imaging, combined with computerized methods for gathering and processing data, SPECT can provide three-dimensional radionuclide imaging information, determine regional blood flow, and measure organ volumes. The past decade's record of research using SPECT, coupled with improvements in instrumentation and the development of additional clinically useful radiopharmaceuticals, has fueled the interest in SPECT. It is apparent that SPECT, with recognized applications in cardiac, liver, and bone imaging, offers improvements over planar scanning and provides unique contributions when compared with other imaging techniques. Preliminary research, both about SPECT and in the development of new radiopharmaceuticals that can cross the blood/brain barrier, points to dramatic potential uses in neurology, including measuring brain physiology. There are, however, less data on the effect SPECT imaging can have on patient care outcomes and about its relative clinical and cost effectiveness. Until further research provides these data, SPECT will remain a difficult acquisition decision. If SPECT capability can be acquired relatively inexpensively through add-ons to existing equipment, or if a hospital has a burgeoning nuclear medicine or nuclear cardiology service, the decision is easier. Pending further information, other hospitals can facilitate future acquisition of SPECT by ensuring that any newly purchased gamma cameras and nuclear medicine computers can be upgraded and incorporated into a SPECT system. Hospitals should also follow the growing body of research about SPECT's clinical usefulness.

Interpretive reporting encompasses a range of efforts by the clinical laboratory community to develop improved methods of transferring information from laboratories to physicians in a form that they can understand and use. The purpose of laboratory tests is to provide clinically useful information that can be used to answer a specific question for the clinician. However, growing physician reliance on laboratory and other diagnostic tests and the increased testing volumes made possible by laboratory automation have yielded some unintended negative effects. Laboratories can now provide more information than can be effectively assimilated. The resulting "information overload" can cause clinicians to misinterpret tests, ignore significant results, or fail to act appropriately when results indicate a treatable condition. Research indicates, however, that interpretive reporting improves information transfer and thus increases clinicians' understanding of the significance of laboratory test results.

With increased public awareness of the hazards--and possible prevention--of osteoporotic fractures, the demand for bone mineral measurement procedures has also increased. The early methods for assessing bone mass noninvasively were based on radiography; recently, radioisotope and computed tomography techniques have been developed to overcome the technical limitations of plain radiographs. The available technologies can be distinguished by their ability to measure either the vertebrae or limbs, areas of the body with markedly different bone physiology. Now, the selection of a bone mineral assessment modality for a particular individual depends upon the importance the physician places on the need to measure the potential fracture site directly. In those instances in which the examination of the forearm provides sufficient information, such as in screening the elderly, single photon absorptiometry is likely to be chosen. Where a more direct measurement of vertebral or femoral bone mineral content is required, such as for diagnosis of disease or monitoring therapy, either dual photon absorptiometry or quantitative computed tomography will be the final choice, depending on which is ultimately proven the better predictor of hip and spinal fractures.