[Hospital-based health technology assessment in France: how to proceed to evaluate innovative medical devices?]. / Évaluation des technologies de santé en milieu hospitalier : quelle organisation pour évaluer et acquérir des dispositifs médicaux innovants ?

Innovative medical devices offer solutions to medical problems and greatly improve patients' outcomes. Like National Health Technology Assessment (HTA) agencies, hospitals face numerous requests for innovative and costly medical devices. To help local decision-makers, different approaches of hospital-based HTA (HB-HTA) have been adopted worldwide. The objective of the present paper is to explore HB-HTA models for adopting innovative medical devices in France and elsewhere. Four different models have been conceptualized: "ambassador" model, "mini-HTA" model, "HTA unit" model and "internal committee". Apparently, "HTA unit" and "internal committee" (or a mixture of both models) are the prevailing HB-HTA models in France. Nevertheless, some weaknesses of these models have been pointed out in previous works. Only few examples involving hospital pharmacists have been found abroad, except in France and in Italy. Finally, the harmonization of the assessment of innovative medical devices in France needs a better understanding of HB-HTA practices.

Managing organ transplant issues. A guide for approaching controversial, high tech procedures.

With the increase in the requests for high intensity medical procedures such as organ transplantation, the physician executive often is placed in the middle between competing interests. Whether he or she represents the provider or payer side, there is frequently great pressure to make decisions involving complex medical situations in short time-frames. It is necessary to have in place a fair, consistent approach to handling such issues in order to withstand both medical and ethical scrutiny. A process is detailed that will lead the organization to developing such an approach. Although presented in the context of transplant issues, this process can be applied to any similar high technology procedure.

Changing health needs of the elderly demand new policies.

As the U.S. population ages, the use of costly medical technology, especially in the last days of life, has been cited as a major factor contributing to our spiraling health care costs. Yet a growing body of evidence indicates that fewer elderly are disabled and that many survive--even thrive--after treatment of a serious illness or condition. The current debate over Medicare funding cutbacks needs to reflect the reality that high-technology care for the elderly is not inappropriate or wasteful in and of itself. In addition, policymakers should take into account the decreasing numbers of elderly people with disabilities by redirecting long term care resources toward quality community-based care, which can contribute to more timely, effective, and affordable treatment of major diseases.

Using quality improvement to manage the installation of capital equipment.

The traditional process for capital equipment installation in healthcare settings is often not managed to maximum effectiveness. Cost overruns from unplanned construction or from construction change orders are frequently caused by breakdowns in communications between architects, equipment vendors, building contractors, and managers of healthcare services. Through the use of a continuous quality improvement philosophy, it is possible to redefine the installation process and thereby enable the healthcare facility to streamline the costs of capital acquisition.

Clinical and economic evaluation of health care technologies: a joint and sequential approach.

Promising new technologies have to be carefully analyzed before their integration into clinical practice. Moreover, the existing technologies need to be confronted with the new ones in terms of effectiveness and efficiency. Logical guidelines for both clinical and economic evaluation are described in the present review paper which mainly deals with diagnostic technology. All the proposed steps are not instrumental for each technology assessment but they provide a more rational approach to the acceptance and diffusion of technology.

Institutes of Quality experience uneven volume.

The Prudential Insurance Company's plan to shuttle patients needing high-tech care to designated Institutes of Quality was announced with great fanfare and has been under way for more than a year now. Yet the prestige of the designation has been greater than any increases in patient volume for all but a few hospitals involved in the program. Still, according to Prudential, the program has saved the Newark-based company close to $1 million.

The promotion has gone high-tech; the results haven't.

Where the legendary charlatan used showmanship to sell his snake oil, today's promoter of unorthodox medicine uses science. Many are scientifically trained yet are reluctant to put their wares to a clinical trial--a gap that leaves physicians who specialize in ferreting out fraud saying it may be nothing but high-tech hokum.

A framework for clinical evaluation of diagnostic technologies.

Most new diagnostic technologies have not been adequately assessed to determine whether their application improves health. Comprehensive evaluation of diagnostic technologies includes establishing technologic capability and determining the range of possible uses, diagnostic accuracy, impact on the health care provider, therapeutic impact and impact on patient outcome. Guidelines to determine whether each of these criteria have been met adequately are presented. Diagnostic technologies should be disseminated only if they are less expensive, produce fewer untoward effects and are at least as accurate as existing methods, if they eliminate the need for other investigations without loss of accuracy, or if they lead to institution of effective therapy. Establishing patient benefit often requires a randomized controlled trial in which patients receive the new test or an alternative diagnostic strategy. Other study designs are logistically less difficult but may not provide accurate assessment of benefit. Rigorous assessment of diagnostic technologies is needed for efficient use of health care resources.

[Policy guidelines and practical considerations for the development of technology at the Instituto Nacional de Cardiología de México]. / Lineamientos doctrinarios y consideraciones prácticas para el desarrollo de tecnología que se realiza en el Instituto Nacional de Cardiología de México.

In order to face the current economical problems of the country, our Institute has intensified its efforts to replace the imports of medical goods by developing its own medical technology. This article summarizes what we have achieved in this field and describes the rules to be followed in the future. We describe the program on the designing and development of heart valve prosthesis together with an hydraulic-electrical system to test them. In the field of computed instruments, we have developed a system of "synchronos color pictures" to be applied in nuclear medicine. In the field of electrocardiography; an EKG paste, a computed program for automatic EKG interpretation and a "filter" of the 60 cycle interference. The Institute is engaged in the designing of a sophisticated EKG machine at low cost, and EKG tracing simulator for teaching purposes. These programs have been shared with others institutions of the country.