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PubMed2005

[Organization of the nuclear emergency plan].

The first Belgian nuclear emergency plan was drawn up in the aftermath of the Chernobyl accident and was primarily aimed at dealing with the consequences of major accidents happening in large nuclear facilities like nuclear power plants. Both the experience during a decade of nuclear emergency exercises and a changing environment with increased menace of malevolent actions by terrorists urged the modification and extension of the initial plan; The latest "Nuclear and radiological emergency plan for the Belgian territory" was published as the Royal Decree of October 17th, 2003. In contrast to what happened in other emergency situations, nuclear and radiological emergencies are, from the moment they are recognised as such and regardless of their (potential) impact, coordinated at the level of the federal authorities. They will gather at the Coordination and Crisis Centre in Brussels. Political decision making will be based both on radiological and socio-economical considerations. The radiological evaluation will take into account on-site observations such as the state and evolution of some crucial technical parameters, meteorological data (observations and forecast) and measured radiological data, where available. Protective measures may be proposed by the radiological experts, but will probably be modified in the light of socio-economical considerations such as the social and/or economical disruption that might arise from fully deploying these proposed measures. The final decision will be taken by political authorities, more particularly the Minister of the Interior. The execution of the decided protective measures will be the responsibility of one or more provinces, who can further delegate to the municipal level and/or to particular services such as the police force, fire department, civil protection, health services and communication experts. The nuclear and radiological emergency plan also deals with some common protective measures such as the installation of a dissuasion perimeter or exclusion zone, the evacuation, sheltering, protection of the food chain, the use of stable iodine and the decontamination from radioactive substances. At least some of the countermeasures ask for -often extensive- preparation in advance, which is generally done in adefined geographical area in the vicinity of a nuclear facility, referred to as "emergency planning zone" for that particular countermeasure and facility. However, the existence of these zones does in no way exclude the application of this countermeasure outside of them. The radiological evaluation is being prepared by introducing "emergency reference levels", for which the Federal Agency for Nuclear Control is responsible. This consists in pre-defining radiation doses which "generally" to "almost invariably" call for the adoption of a given countermeasure. Finally, the nuclear and radiological emergency plan includes stipulations on the required information to the population, on the education and training of (potentially) intervening parties as well as on the minimum requirements for running nuclear emergency exercises.

Disaster Planning↗

PubMed2005

[Clinical trials for medicinal products. New European and national legal rules].

With the 12th Amendment of the German Drug Law, in addition to other changes, transformation requirements resulting from the Directive 2001/20/EU of the European Parliament and the Council on clinical trials for medicinal products for humans have been fulfilled. Resulting changes in this context for competent federal authorities and other institutions involved are briefly presented and their relevance discussed. These new legal regulations provide a number of opportunities to plan clinical trials more effectively and to perform them in a more structured and better harmonized way, thus leading to increased safety for patients and more reliable results.

Clinical Trials as Topic↗

PubMed2004

[Clinical research with pharmaceutical agents in Germany: effects of the 12th amendment to the German Drug Law].

The European Clinical Trials Directive came into force on April 4th, 2001. This regulation will be implemented into the German Drug Law (AMG) through the 12th amendment to the AMG. It will impose major changes on the preparation and conduct of clinical studies with medicaments. In particular, the procedure to gain an ethical committee's approval and permission for multicentric studies from the German Federal Authority (BfArM) will increase bureaucracy and complexity for the sponsor. The new German procedures, which by far exceed the European regulation, will lead to increased costs and will require more time for the preparation of clinical studies.

Clinical Trials as Topic↗

PubMed1988

Threat to the New York City water supply--plutonium.

The mayor of the City of New York received an anonymous letter on April 1st 1985 threatening to contaminate the water supply with plutonium unless all criminal charges against Mr Bernhard Goetz, the suspect in a dramatic subway shooting incident, were dismissed by April 11th 1985. Local and Federal authorities were called upon to evaluate the credibility of the threat and to institute a "round the clock" monitoring program by New York City personnel. The Environmental Measurements Laboratory, EML, was requested by the City to analyse a composite, large volume (approximately 175 litres) drinking water sample collected by City personnel on April 16th 1985. The concentration measured was 21 fCi/l which was a factor of 100 greater than previously observed results in our data base, and the mass isotopic content of the plutonium was very unusual. Additional samples were collected one to three months later at various distribution points in the water supply system. The plutonium concentrations were much lower and comparable to EML's earlier data. Mass isotopic analysis of these samples provided more reasonable compositions but with high uncertainties due to very low plutonium concentration. Recent measurements of large volume samples, approximately 1000 litres, collected in the Fall of 1985 from the New York City and New Jersey water supplies showed identical plutonium concentrations of 0.05 fCi/l. Mass isotopic analyses indicated similar 240Pu/239Pu ratios which were slightly lower than global fallout estimates. Due to our inability to confirm the elevated plutonium concentration value for the composite sample of April 16th 1985, it is impossible to conclude whether the threat to contaminate the New York City water supply was actually carried out or whether the sample was contaminated prior to receipt at EML.

Crime↗

PubMed2005

Islet isolation and GMP, ISO 9001:2000: what do we need--a 3-year experience.

Pancreatic islet cell isolation and transplantation has been performed for many years at several institutions. Although all institutions aim to produce high-quality islets, applied standards widely deviate from standards in the pharmaceutical industry. The legal situation within the European Union has changed requirements for setting up and running such a laboratory. The process is now clearly defined as a production of a pharmaceutical and therefore must be licensed by federal authorities. Analysis of workload for establishing an islet isolation program that fulfil GMP and ISO 9001 criteria including an estimation of costs and the impact of such a system on the isolation process. The definition of quality parameters and documentation is a central issue of all islet isolation laboratories. Therefore, GMP and ISO 9001:2000 do not add additional work per se. On the other hand, clear guidelines, a clear policy, working place descriptions, forms, checklists, and, particularly standard operating procedures, are instrumental for smooth functioning within the department. Collection of data such as errors, improvement measures, and preventive measures reduces subsequent costs. A clear definition of responsibilities minimizes organizational problems. Steering of inspection devices prevents bias errors and validating the processes clearly points out incorrect assumptions. Documentation helps to prove the correctness of the production at any time and is of use also for scientific evaluations. We strongly feel that GMP criteria are mandatory and together with an ISO 9001:2000 quality management system offers significant advantages for the process of islet isolation and a continuous improvement process.

Academies and Institutes↗

PubMed2003

Temporal and local trends of PCDD/F levels in cow's milk in Switzerland.

Levels of polychlorinated dibenzo-p-dioxins and dibenzofurans (PCDD/F) were determined in 30 Swiss cow's milk samples collected at dairy farms in the vicinity to point sources, in rural/alpine areas distant to known sources, and from tanks in large industrial milk processing plants. The contaminant concentrations in samples collected in 2001 were compared to data from analyses conducted in 1984 and 1990/1991 at the same sites. In 2001, the PCDD/F levels in milk from farms near point sources (0.63+/-0.26 ng I-TEQ/kg milk fat) are slightly but significantly higher in than milk from remote areas (0.36+/-0.09 ng I-TEQ/kg milk fat). Consumer milk collected at the processing plants had intermediary levels (0.51+/-0.19 ng I-TEQ/kg milk fat). However, milk in 2001 was significantly less contaminated than the samples collected in 1990/1991 and 1984. This trend is particularly pronounced near point sources but is also apparent in consumer milk and milk from remote areas. No geographical gradient in the atmospheric input of PCDD/F in Switzerland was found. The reduction in PCDD/F levels in dairy milk is paralleled by and correlated to the remediation of known PCDD/F emitting industries, as enforced by federal authorities.

Air Pollutants↗

PubMedDate not supplied

Imaging and neural modelling in episodic and working memory processes.

Neuroimaging studies using positron emission tomography (PET) and functional magnetic resonance imaging (fMRI) have revealed the involvement of distributed brain regions in memory processes mainly by the use of subtraction strategy based data analyses. Covariance analysis based data analysis strategies have been introduced more recently which allow functional interactions between brain regions of a neuronal network to be assessed. This contribution focuses on studies aiming to (1) establish the functional topography of episodic and working memory processes in young and old normal volunteers, (2) to assess functional interactions between modules of networks of brain regions by means of covariance based analyses and systems level modelling, (3) to characterise the temporal dynamics by the use of magnetoencephalography (MEG) and (4) to relate neuroimaging data to the underpinning neural networks. Male normal young and old volunteers without neurological or psychiatric illness participated in neuroimaging studies (PET, fMRI, MEG). Studies were approved by the ethical committee and federal authorities. Our results in young volunteers show distributed brain areas that are involved in memory processes (episodic and working memory) and show much of an overlap with respect to the network components. Systems level modelling analyses support the hypothesis of bihemispheric, asymmetric networks subserving memory processes and revealed both similarities in general and differences in the interactions between brain regions during episodic encoding and retrieval as well as working memory. Changes in memory function with ageing are evident from functional topographic studies in old volunteers activating more brain regions as compared to young volunteers. There are more and stronger influences of prefrontal regions in elderly volunteers comparing the functional models between old and young subjects. We discuss the way that the systems level models of the PET and fMRI results have implications for the underlying neural network functioning of the brain. This is done by developing simplifying assumptions, which lead from the equations describing the activities of the coupled neural modules to the systems level model equations. The resulting implications for the neural interactions are then discussed, in terms of a set of synaptically coupled neural modules. Finally, we consider how a similar analysis could be extended from the spatial to the temporal domain thus including the EEG and MEG results. The implication of preliminary MEG results presented here for the temporality arising in the interaction between the coupled neural modules in a working memory paradigm is discussed in terms of the previously developed neural network models arising from the PET and fMRI data.

Adult↗

PubMed2006

Inoculating against barbarism? State medicine and immigrant policy in turn-of-the-century Argentina.

The border in turn-of-the-century Argentina was a place of heightened anxiety. State officials ignored the nation's vast land borders and focused on the port, located in the capital city of Buenos Aires, which attracted nearly six million European immigrants in the decades after 1870. Federal authorities were seeking to attract new immigrants and yet they were terrified that opening their gates would allow entry among the potential citizenry a new category of "toxins" dangerous to the national body. The authorities hired physicians as gatekeepers to identify desirable and undesirable traits that went beyond the definition of communicable disease. Science and medicine appeared to provide a means of legitimating a variety of attempts by the state to control the makeup of the population; in reality, the state's power to inspect immigrants for disease, racial toxins, social upheaval, and political instability was minimized by realistic decisions to open borders and by a weak and limited ability to control the influx of people. Alongside calls for immigrant selection there coexisted a strong trend in political discourse that sought to build a unified, homogenous national culture by accepting and assimilating the foreign masses. Both approaches, however, had similar goals--the material progress of the nation, the advancement of Argentina's "civilization," and the erasure of traces of "foreignness" among the new population.

Argentina↗

PubMed2004

[Evolution of a quality assurance programme for physiotherapy schools - results of the first quality inspections].

In cooperation with the Hochrhein-Institute for Research in Rehabilitation (HRI), the Association for Assuring the Quality of Education in Physiotherapy Schools in Germany (ISQ) has developed a quality assurance programme for physiotherapy schools. It aims at assessing the quality of physiotherapy schools in Germany, and to award a quality seal based on compliance with defined criteria. First, a catalogue of quality features and criteria relevant for education in physiotherapy was developed. It is based on the analysis of questionnaires that had been sent to all German physiotherapy schools, to selected physiotherapists and leading physiotherapists in hospitals, to competent federal authorities, and to three school-classes with group discussions. The persons addressed named 360 different quality features. They were collected in a catalogue, revised in a multi-stage Delphi procedure, and approved consensually. The final criteria were transformed into basic quality requirements, and formulated as a check-list. Assessment of the quality features is carried out by trained visitors. In addition, the satisfaction of students is assessed with a questionnaire. The results of the interviews and the questionnaires are fed back to the schools in a quality report. Schools meeting all basic quality requirements are awarded the seal of quality. The seal is valid for three years. Since January 2003, this procedure is available for all schools in Germany. Until September 2002, a pretest of visitations and student questionnaires had been carried out with 31 member schools of the ISQ; according to the resulting quality reports, none of these schools would instantly be awarded the quality seal. In all, more than half of the schools do not meet 10 of the 42 basic criteria. Fundamental deficiencies have been found in the documentation pertaining to supervision of practical training. In terms of training, further training and professional development of their teachers and associated professors, needs for improvement could be shown in more than 66 % of all visited schools. Only 9 of 31 schools could produce a written syllabus. Additionally, the requirements of teachers conferences and equipment of libraries were not met by the majority. A general problem among the schools is inadequate documentation in many fields.

Clinical Competence↗

PubMed2006

The fragmentary federation: experiences with the decentralized health system in Russia.

The Russian Federation has undergone a process of major constitutional change in the post-communist period, as a strong central government has ceded extensive powers to the regions. This has important implications for the organization of the health care system which, as with other elements of the Soviet system, had previously been highly centralized. Although it is now well-recognized that the powers of the Federal Health Ministry have weakened considerably, the precise scale and nature of the process of decentralization remain imperfectly understood. This paper provides new evidence on the nature of decentralization in the Russian Federation since the breakdown of the USSR, reporting the results of case studies undertaken in six regions of Russia (Samara, Tver, Tula, Chelyabinsk, Sverdlovsk and Moscow oblasts) to describe the organization of health care financing, regulation and delivery. It shows that while there is a common model of health system (with the exception of Samara, where an innovative model was implemented), there are many minor variations. The study confirms the limited scope for action by Federal authorities, but also shows that the power vested in the regional governments is more limited than was previously thought. Instead, the municipalities (rayons) emerge as important bodies, as they own the facilities in which much of the routine health care is delivered and, both directly and indirectly, by virtue of their contributions of insurance premiums for the non-working, provide a substantial amount of health care financing. The study demonstrates the complexity of the Russian health care system and identifies the widespread absence of mechanisms that might be used to bring about much needed change.

Delivery of Health Care↗

PubMed2006

Toronto's Health Department in action: influenza in 1918 and SARS in 2003.

This article compares the Toronto Health Department's role in controlling the 1918 influenza epidemic with its activities during the SARS outbreak in 2003 and concludes that local health departments are the foundation for successful disease containment, provided that there is effective coordination, communication, and capacity. In 1918, Toronto's MOH Charles Hastings was the acknowledged leader of efforts to contain the disease, care for the sick, and develop an effective vaccine, because neither a federal health department nor an international body like WHO existed. During the SARS outbreak, Hastings's successor, Sheela Basrur, discovered that nearly a decade of underfunding and new policy foci such as health promotion had left the department vulnerable when faced with a potential epidemic. Lack of cooperation by provincial and federal authorities added further difficulties to the challenge of organizing contact tracing, quarantine, and isolation for suspected and probable cases and providing information and reassurance to the multi-ethnic population. With growing concern about a flu pandemic, the lessons of the past provide a foundation for future communicable disease control activities.

Communicable Disease Control↗

PubMed1996

Management of intracardiac device recalls: a consensus conference. Participants of the Consensus Conference. North American Society of Cardiac Pacing and Electrophysiology (NASPE)

The incidence of cardiac device recalls seems to be increasing, in part due to increasing complexity, but also due to greater public awareness and regulatory overview. Manufacturers are responsible for postmarket surveillance of their implanted products; evidence for poor performance is usually evaluated by a Physician Advisory Committee (PAC) and unacceptable failure rates or modes prompt the issuance of a recall. A Consensus Conference was held March 6, 1995, in Toronto, Ontario, to discuss the management of cardiac device recalls after the provincial Ministry of Health issued unique guidelines regarding a recent lead problem. Various stakeholders expressed their views and concerns: the federal regulatory body, the provincial Ministry of Health and hospital association, manufacturers, hospital legal counsel, patient and media advocates, and physicians from the United Kingdom, the United States, and Canada. Specific recommendations included: the establishment of a National (or regional) Pacemaker (device/lead) Registry interposed between the manufacturer and the federal authority; the creation of a Recall Task Force (RTF) to deal with specific problems distinct from the manufacturers' PAC; emphasis on patient responsibility for obtaining regular follow-up and maintaining contact by a pacemaker passport system as exists in Europe; and the fair assignment of costs involved in a recall with specific emphasis on appropriate compensation for physicians and clinic personnel.

Defibrillators, Implantable↗

PubMed1995

Providing rehabilitative services in rural communities: report of a conference.

Rural communities have a disproportionate need for rehabilitative services, partly attributable to an aging population and higher incidence of occupational injuries. Despite increased need, many rural communities find rehabilitative services unavailable due to personnel shortages, maldistribution of health care personnel, and related recruitment and retention issues. The National Rural Health Association and the Division of Associated, Dental, and Public Health Professions of the Health Resources and Services Administration co-sponsored a conference to explore issues related to ensuring that rural communities have access to vital rehabilitation services provided by allied health professionals. The status of rehabilitative care in rural settings and the barriers to improvement in services delivery were described by consumers, providers, educators, and public and private agency representatives. Recommendations directed to state and federal authorities, educational institutions, and professional organizations centered around increasing the supply of appropriately trained allied health providers. Improving retention of rehabilitative personnel in rural areas could be achieved by specific changes to the practice climate.

Allied Health Personnel↗

PubMed1983

Diabetes services in Yugoslavia.

The Socialist Federal Republic of Yugoslavia lies in south east Europe between the Soviet block and the free enterprise countries of Western Europe. It was originally established as a confederation of independent Balkan states after the first world war; after the second world war it became an independent federation of the socialist republics of Bosnia, Herzegovnia, Montenegro, Croatia (including Dalmatia), Slovenia, and Serbia, together with the two small autonomous provinces of Kosovo and Vojvodina. In the subsequent 30 years the trend towards decentralised decision making and institutional self management has continued. Nevertheless, the federal authorities retain major control over economic decision making and policies. For example, they forbid anyone from owning more than two houses or 10 hectares of land, and no factory owner may employ more than 10 people. Capitalism in any other than this minor form is not allowed, and any businessman whose business expands must become involved in frustrating negotiations with the local government to set up a state industry. I recently visited Yugoslavia as a guest of the Institute for Diabetes, Endocrinology, and Metabolic Diseases and of the medical faculty of the University of Zagreb and visited various health care units which provide services for diabetics in Croatia. As well as Zagreb itself I visited units in Split on the Adriatic coast and at Varazdin, near the Hungarian border. Necessarily my observations are based on the diabetes services in Croatia, but although the other republics may have less developed services they follow similar principles.

Diabetes Mellitus↗

PubMed2006

Enhanced pharmacy training for counter-terrorism and disaster response.

State and federal authorities in the USA have identified pharmacists as important in terrorism detection activities. However few pharmacists are trained for disaster response planning, or providing services at disaster sites. A distance training programme was created by the College of Pharmacy at the University of Kentucky, Chandler Medical Center (UKCMC) in collaboration with an academic Medical Center, urban and rural community pharmacists, experts in pharmacy and infectious disease, and two state pharmacy associations. There was a substantial improvement in bioterrorism training knowledge as judged by pre- and post-test results. During two years of training, a total of 142 licensed pharmacists received certification (approximately 4.7% of all those in Kentucky). In addition, a network of bioterrorism-trained pharmacists was created for the state.

Bioterrorism↗

PubMed2004

An organized approach to trauma care: legacy of R Adams Cowley.

The organized approach to caring for trauma patients was introduced into the civilian setting by the innovative pioneer, R Adams Cowley. His system in Maryland has the following 11 components: (1) a State Police Aviation Division that transports patients throughout the State; (2) trained paramedics at the scene of the accident as well as on the helicopter, who will stabilize the patients en route to the Shock Trauma Center; (3) one central dispatch communication center in Baltimore that coordinates information between paramedics and the Trauma Center; (4) a Shock Trauma Center with a helicopter landing zone near the building; (5) trained trauma nurses and trauma technicians to transfer the patient from the helicopter by stretcher to the resuscitation area; if there is a special complication, such as an airway problem, the anesthesiologist and or trauma surgeon may meet the helicopter on the roof as well; (6) trauma surgeons, board-certified in surgery, with a certificate of added qualification in surgical critical care, to treat the critically ill trauma patients in the resuscitation area; (7) a CT scan and portable X-ray units in the admission area that aid in the diagnosis of the injury; (8) operating rooms adjacent to the admission area for repair of trauma injuries; (9) a surgical intensive unit to care for the trauma patient; (10) a team of specialty physicians trained in a wide variety of specialties who work as a multidisciplinary unit caring for the hospitalized patient; and (11) an ambulatory outpatient unit that allows the patient to be followed in the center after discharge. Dr. R Adams Cowley incorporated each of these 11 components for an organized trauma center into Maryland. In recognition of his landmark contributions to trauma, the eight-story Shock Trauma Center was named the R Adams Cowley Shock Trauma Center. There is growing evidence that this organized system in trauma care seen in Maryland must be replicated in every state in our nation. The results of the Health Resources and Services Administration Report in 2002 show serious limitations in our nation's organized approach to emergency and trauma care. This report indicates that many Americans do not have access to well-trained pre-hospital emergency personnel. Between 10 and 15% of the US population does not have access to basic emergency medical and communication services. Moreover, the presence of key trauma system components continues to vary throughout the country, most likely because of growing economic constraints. Emergency communication systems remain fragmented, and adequate training programs and protective equipment for health personnel remains notably absent. The threat of inadequate funding for the state manifests itself in the consistent uneasiness regarding the recruitment and continued retention of trauma care providers. Federal authorities must devise national emergency medical and organized trauma programs to save the lives of injured Americans.

Disaster Planning↗

PubMed2001

Discovering unrecognized lead-smelting sites by historical methods.

OBJECTIVES: Our objective was to enumerate unrecognized former lead smelters in the United States. METHODS: Defunct smelters were identified by historical research. The compiled list was compared with government registries of hazardous sites. Soil samples were taken from 10 sites. RESULTS: Approximately 430 sites were unknown to the federal authorities. Only 5 of 319 sites were known to authorities in the top 8 states. Nine of the 10 sites sampled exceeded residential standards for soil lead level. CONCLUSIONS: Approximately 430 former lead-smelting sites were unrecognized in the United States. Sampling results indicate that the sites may pose a threat to public health.

Air Pollutants↗

PubMed2002

The crisis in U.S. and international cancer policy.

The incidence of cancer in the United States and other major industrialized nations has escalated to epidemic proportions over recent decades, and greater increases are expected. While smoking is the single largest cause of cancer, the incidence of childhood cancers and a wide range of predominantly non-smoking-related cancers in men and women has increased greatly. This modern epidemic does not reflect lack of resources of the U.S. cancer establishment, the National Cancer Institute and American Cancer Society; the NCI budget has increased 20-fold since passage of the 1971 National Cancer Act, while funding for research and public information on primary prevention remains minimal. The cancer establishment bears major responsibility for the cancer epidemic, due to its overwhelming fixation on damage control--screening, diagnosis, treatment, and related molecular research--and indifference to preventing a wide range of avoidable causes of cancer, other than faulty lifestyle, particularly smoking. This mindset is based on a discredited 1981 report by a prominent pro-industry epidemiologist, guesstimating that environmental and occupational exposures were responsible for only 5 percent of cancer mortality, even though a prior chemical industry report admitted that 20 percent was occupational in origin. This report still dominates public policy, despite overwhelming contrary scientific evidence on avoidable causes of cancer from involuntary exposures to a wide range of environmental carcinogens. Since 1998, the ACS has been planning to gain control of national cancer policy, now under federal authority. These plans, developed behind closed doors and under conditions of nontransparency, with recent well-intentioned but mistaken bipartisan Congressional support, pose a major and poorly reversible threat to cancer prevention and to winning the losing war against cancer.

Developed Countries↗