Which lessons can we learn from the European Union legal framework of medicines for the regulation of direct to consumer genetic tests?

El marco legal de la Unión Europea (UE) que regula el acceso y la oferta de pruebas genéticas dirigidas al consumidor (DTC) es muy liberal en comparación con las leyes y normativas aplicables a productos médicos (Internet). Si embargo ambos productos relacionados con la sanidad humana pueden causar perjuicios igualmente graves en el bienestar del individuo. En este artículo examinamos si el marco legal de la Unión Europea para la utilización responsable de productos de medicina (Internet) puede servir como ejemplo para regular las pruebas genéticas caseras. Las leyes de la Unión Europea que rigen el área de productos de medicina pueden servir como ejemplo para regular las pruebes genéticas caseras. Las leyes de la Unión Europea que rigen el área de productos de medicina pueden servirnos de ejemplo, a pesar de contener algunos defectos, para modelar la autorización (a nivel comunitario) del marketing en las pruebas genéticas caseras (DTC) sobre el mercado interno, en consonancia con los estrictos criterios sobre valores preditivos y utilidad clínica. Además, el marco legal que regule las pruebas genéticas caseras debería también introducir la supervisión del sistema, así como los criterios de calidad con respecto a la información que se ofrece al consumidor, con el objeto de ampliar la protección sanitaria. No obstante, resulta difícil supervisar, para cualquier agencia que se anime a ello, las pruebas genéticas caseras adquiridas por Internet. Ofrecer protección adecuada al individuo frente a kits de pruebas de calidad discutible requiere vigilancia internacional y a adopción de medidas globales adaptadas por la comunidad internacional. Para Europa es importante incluir la regulación de pruebas genéticas caseras dentro de la agencia legisladora europea (AU)

The legal framework of the European Union (EU) for regulating Access to and supply of direct to consumer (DTC) genetic tests is very liberal compared to the legal and regulatory framework for (internet) medicines. Nevertheless, both health related products can cause equally serious damage to the well being of individuals. In this contribution we examine whether the legal framework of the EU for the safety and responsible use of (internet) medicines could be an example for regulating access to and supply of DTC genetic tests. The EU laws governing medicines can, notwithstanding their shortcomings, serve as an example for (central) authorizing the marketing of DTC genetic tests on the internal market in accordance with strict criteria regarding predictive value and clinical usefulness. Furthermore, a legal framework controlling DTC genetic tests also should introduce system supervision as well as quality criteria with respect to the information to be provided to consumers in order to enhance health protection. However, DTC genetic test purcharsed through online ordering are difficult to supervise by any agency. Adequately protecting individuals against questionable testing kits calls for international vigilance and comprehensive measures by the international community. For Europe, it is important to rank the regulation of DTC genetic test on the European regulatory agenda (AU)

[Systemic approach to ecologic safety at objects with radiation jeopardy, involved into localization of low and medium radioactive waste].

The article deals with specifying systemic approach to ecologic safety of objects with radiation jeopardy. The authors presented stages of work and algorithm of decisions on preserving reliability of storage for radiation jeopardy waste. Findings are that providing ecologic safety can cover 3 approaches: complete exemption of radiation jeopardy waste, removal of more dangerous waste from present buildings and increasing reliability of prolonged localization of radiation jeopardy waste at the initial place. The systemic approach presented could be realized at various radiation jeopardy objects.

NRC inspections: risk-informed and performance-based.

In 2002, the U.S. Nuclear Regulatory Commission (NRC) revised its regulations governing the use of byproduct materials for medical purposes (10 CFR Part 35). These changes were the result of a detailed, 4-year examination of the issues surrounding the medical use program of the NRC and are stated in the latest revision to its medical policy statement, published in the Federal Register on August 3, 2000. As part of an overall program for revising its regulatory framework for medical use, the NRC revised its medical policy statement in keeping with the goal of focusing regulation on those medical procedures that pose the highest risk and structuring the regulations to be risk-informed. NRC inspection procedures were also revised to focus on high-risk activities through a performance-based approach, that is, through observations and interviews with licensee personnel performing NRC-regulated tasks. The purpose of this article is to inform the radiation worker (nuclear medicine technologist or authorized user physician) of the revised focus of the medical use program of the NRC and inspection procedures relative to nuclear medicine-licensed activities. After reading this article, the radiation worker should be able to describe the concept of risk-informed, performance-based regulations and inspections, identify areas of high-risk activities in the nuclear medicine laboratory, and describe techniques used by the NRC inspector to determine the licensee's compliance with the regulations.

Where is the pilot? The changing shapes of governance in the European hospital sector.

Hospital governance refers to the complex of checks and balances that determine how decisions are made within the top structures of hospitals. This article explores the essentials of the concept by analysing the root notion of governance and comparing it with applications in other sectors. Recent developments that put pressure on the decision-making system within hospitals are outlined. Examples from the UK, France and the Netherlands are presented. Based on an evaluation of the current state of affairs, a research framework is developed, focusing on the determinants of governance configurations within the national healthcare systems and the wider legal and socio-economic context, as well as on the impact of governance configurations on the efficiency of the governing bodies and overall hospital performance. The article concludes with a preview of the European Hospital Governance Project, which follows the outlines of the described research framework. New techniques of data mining that are used in this project are explained by means of a real data example.

Sobre sistemas de inspección y sistemas de prevenciónç / Tittle

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Diagnostic X-ray facilities as per quality control performances in Tanzania.

Without appropriate quality control (QC) and preventative maintenance (PM) measures for X-ray machines in place, the benefits of reduced dose to the patient and early diagnosis will not be realized. Quality control and PM also make it possible to unify X-ray-imaging practices in the country using international image quality guidelines. The impetus for the present work resulted from the concern that with the recent increase in the numbers of X-ray machines in Tanzania, but with limited technical support to maintain and operate them, can increase radiation risk to patients and lower diagnostic accuracy. The aim of this work is to report on the current status of diagnostic X-ray machines in Tanzania in order to produce the data needed to formulate QC and PM policies and strategies. These policies and strategies are needed to ensure that patients receive the lowest possible radiation risk and maximum health benefits from X-ray examinations. Four QC tests were performed on a total of 196 X-ray units. Accurate beam alignment and collimation were tested on 80 (41%) units, the timer accuracy was tested on 120 (61%) units, and a radiation leakage test was performed on 47(24%) units. Preventative maintenance tests were performed on all 196 X-ray units. The results showed that of the units tested for QC, 59% failed the kilovoltage (kVp) test, 57% failed the timer accuracy test, 60% failed the beam alignment test, and 20% failed the radiation leakage test. Only 13% of the units passed the PM test: 53% of the units were defective, and 34% were out of order. As a result of the PM findings, the government has introduced a rehabilitation project to service X-ray units and replace nonoperational X-ray units. The new units have full support service contracts signed by their suppliers. As a result of the QC findings, X-ray maintenance retraining programs have been introduced.

Out of the frying pan: New York City hospitals in an age of deregulation.

For several decades New York City hospitals had been distinguished by their tightly regulated environment, chronically weak finances, high occupancy rates, teaching intensity, dependency on public payers, low managed care penetration, and minimal merger activity. Then in the late 1990s a rapid convergence of forces--the Balanced Budget Act, managed care growth, state deregulation of commercial rates, escalating costs, and plunging hospital occupancy rates--threw the city's hospital industry into turmoil. In this paper we describe this period of turbulent change that has left most of the city's safety-net and small community hospitals near bankruptcy.

External threats and nursing home administrator turnover.

External threats and volatility in the long-term-care sector in recent decades have posed serious challenges for nursing home administrators. Greater job complexity and administrative responsibilities resulting from public policies and more specialization and competitiveness in nursing home markets have made turnover a significant issue. This article examines administrator turnover from 1970 through 1997 in New York State and describes how turnover increased markedly in the late 1980s and early 1990s.