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PubMed1995

Environmental monitoring programs vs Good Laboratory Practice (GLP) programs: differences and similarities.

Environmental monitoring and Good Laboratory Practice programs are similar when looked at empirically. Both address quality issues, human or environmental safety, and have set procedures to assure the concomitant results. However, when compared at the operational level, they can be best described as very different. Good Laboratory Practice programs deal basically with two governmental agencies and their divisions- the Environmental Protection Agency and Food and Drug Administration. These are administered from the federal level involving no state resources. These programs are objective driven with the procedures being defined in study plans, protocols, and standard operating procedures. The environmental monitoring testing programs deal with a profusion of federal legislation including CERCLA (also known as CLP), RCRA, CWA, CAA, SDWA, NPDES and others. These acts require analysis by specific procedures mandated by the statutes. States operate many of these programs and have been given the authority by the federal government. Many of the states require separate certifications to conduct these analyses. Environmental monitoring testing laboratories often must acquire multiple state certifications to participate in multiple state programs. This is not cost effective and often leads to conflicting requirements. Much of the direction for having a national certification program comes from problems associated with these state-operated programs.

Accreditation↗
PubMed1978

[Preventive medical measures in the federal republic of germany. Present status and problems (author's transl)].

Following brief introductory remarks on the term "preventive medicine", an outline is presented of its evolvement during the last 20 years in the Health Services of the Federal Republic of Germany. Thereby, it becomes apparent that the development of single screening efforts, e.g. to detect unknown cases of diabetes and to make special model studies, especially in Baden-Württemberg, has led to comprehensive legal motherhood care, health care for young children, early detection of cancer, and detection of diabetes cases. Problems have arisen due to the generally very low utilization of preventive medical examinations and because of the question as to whether premorbid health conditions should be included in the preventive medical program additionally. Finally, indications are given for the necessity to examine possibilities of curtailing expenditures in the present preventive medical care program, or in some of its branches, without forfeiting the efficiency of the preventive measures. Thereby, it must be considered that these measures are benefiting only that part of the population which is socially insured. The claim to measures for health protection, however, should be available to the entire population as a basic human right.

Adolescent↗
PubMed2006

Official dosimetry with personal electronic dosemeters--the framework in Germany.

In Germany, personal electronic dosemeters (AEPDs) are presently applied mainly for operational radiation protection monitoring particularly in nuclear power engineering companies, large hospitals and research centres. This is done in addition to the official dosimetry of record. Therefore, frequently, double monitoring occurs-officially and operationally. A crucial advantage of AEPDs compared with passive dosemeters is the ability to adapt the monitoring period to the working time in controlled areas and to allow an immediate readout of the dose after leaving the controlled area, e.g. a job-related monitoring is possible by correlating the readout dose with the job performed. Germany started a general research project, consisting of two parts, for an optimised implementation of personal electronic dosemeters into official dosimetry. The use of AEPDs as official dosemeters depends on an approval by Federal and Federal State ('Länder') authorities as an official dosimetry system, which has to comply with special requirements ensuring that the legal requirements are fulfilled. The formulation of these special requirements is in the focus of part one of the research project, supervised by the Federal Office for Radiation Protection (BfS) and performed by the Gesellschaft für Anlagen- und Reaktorsicherheit (GRS) mbH. As a result of part one, a framework was developed which is the basis for a future technical implementation project. Part one is described in the paper, while part two is still to be initiated and will deal with the implementation and testing phase of the introduction of personal electronic dosemeters as official dosemeters.

Electronics↗
PubMed1980

[Analysis of the therapeutic results in 1127 patients with fractures of the femur in the Federal Republic of Germany and in Switzerland (author's transl)].

Under the aspect of quality control of the surgical treatment the results of femur-fractures of 1127 patients were scrutinized. These patients were treated in 16 German and in 21 Swiss AO-hospitals. Different complications are discussed. The study shows that not so much the chosen method of osteosynthesis is of paramount importance, but the way it is performed, especially if the surgical technic is done according to standardized principles and biomechanical rules. As the injuries are in many cases very severe and as in many patients the fracture of the femur is only part of the polytrauma, the results are satisfying.

Adult↗
PubMed1980

[Results of phage typing of Salmonella typhi and Salmonella paratyphi-B in the years 1974-1978 from the Federal Republic of Germany including Berlin (West) (author's transl)].

In the period between 1.1.1974 and 31.12.1978 phage typing of 2058 strains of S. typhi and 1672 strains of S. paratyphi-B was carried out. 45 S. typhi phage types were found, 11 of these occurred in a frequency of more than 1% (relevant to foci). These were E1 a (21.6%), A (17.7%), F1 (5.8%), D1 (5.5%), C1 (4.6%), E1b (4.1%), D2 (2.5%), 40 (1.5%), 29 (1.3%), B2 (1.0%), 46 (1.0%). Among S. paratyphi-B strains 23 phage types or varieties were observed, 11 of these occurred in a frequency more than 1% (relevant to foci): Taunton (46.9%), 1 m.c. (7.8%), 3aI m.c. (7.7%), B.A.O.R. (6.5%), 3aI var. 1 (5.5%), Dundee (4.4%), 3a m.c. (3.0%), 3b m.c. (2.2%), Beccles m.c. (1.9%), Jersey (1.5%), 1 var. 1 (1.4%). In the year 1974 two epidemics of typhoid fever occurred, one with 417 cases (phage type A, subtype Tananarive) and the other with 41 cases (phage type E1a). In the year 1977 there was an outbreak of paratyphoid B fever with 53 cases (phage type 3aI var. 1). The increasing number of imported cases of typhoid and paratyphoid fever from other countries is remarkable. The age distribution of typhoid and paratyphoid bacilli carriers shows that persons who are older than 60 years represent the age group in which carriers occur most frequently.

Adolescent↗
PubMed1980

[When will x-ray diagnostic examination result in occupational radiation exposure? (author's transl)].

A Federal German x-ray directive prescribes certain precautionary measures and modes of behaviour for persons professionally, i.e. occupationally, exposed to radiation. An essential prerequisite, which may appear trivial at first sight, is that both those responsible for radiation protection and the exposed persons themselves should know who must be classified as occupationally exposed to radiation. The present article goes into this problem by examining the conditions governing four groups of x-ray examinations involving the relatively most frequent periods of stay in the x-ray room on the part of the radiologist and his staff: x-ray examinations of the internal organs, urological x-ray examinations, angiographic/neuroradiologic x-ray examinations, surgery involving use of an image intensifier. It was found that even when taking a pessimistic view, e.g. regarding the switch-on periods, the number of occupationally radioexposed persons in an x-ray department is relatively low in relation to the total staff employed in that department.

Cholecystography↗
PubMed1998

[Changes in pharmacotherapy of hypertension 1989-1996 in patients with diabetes mellitus].

The authors investigated in a retrospective study in a group of diabetics changes in the pharmacotherapy of hypertension. In 1989-1996 2308 diabetics had spa treatment in the Military Balneological Institute in Karlovy Vary and 1058 of these patients had hypertension (45.8%). The patients were from all parts of the Czech Republic and before 1993 from the whole Czechoslovak Federal Republic. The authors investigated the pharmacotherapy of hypertension and focused attention on four basic groups of antihypertensive drugs (beta-blockers, diuretics, Ca channel blockers and ACE inhibitors). They recorded a marked drop of the number of patients taking diuretics (from 62% to 24%), and a slight decline in the group taking beta-blockers). They recorded an increase in Ca channel blockers (from 7% to 54%) and in recent years of ACE inhibitors (from practically zero to 24%). They draw attention to the dominant ratio of some drugs in selected groups of antihypertensives and discuss whether they are suitable for the treatment of hypertension in patients with diabetes mellitus. The number of patients without pharmacotherapy of hypertension declined but was not statistically significant.

Antihypertensive Agents↗
PubMed1994

State cancer registries: status of authorizing legislation and enabling regulations--United States, October 1993.

Population-based cancer registries have identified cancer incidence rates indicating that the burden of cancer in the United States is substantial and varies widely by geographic location and ethnicity. However, for most existing state cancer registries, resources are inadequate for insuring minimum standards for quality and for completeness of case information. In October 1992, Congress enacted the Cancer Registries Amendment Act* that authorized CDC to establish a national program in support of cancer registries. The goal of this program is to enhance existing state cancer registries and to help establish statewide cancer registries so that all states have population-based cancer registries meeting minimum standards for completeness, timeliness, and quality. To ensure complete and timely reporting of newly diagnosed cases of cancer, the federal statute requires authorization of cancer registries under state-specific laws and promulgation of regulations that ensure case reporting and use of data for research. This report extends efforts by the National Cancer Institute to assess existing state laws and regulations to determine how they compare to state-specific legislation required in the cancer registries act.

Humans↗
PubMed1962

Emergency health planning.

This paper outlines the development of emergency health planning as a function of government. Ten provinces have the basic responsibility for the organization, preparation and operation of medical, nursing, hospital and public health services in an emergency. The Department of National Health and Welfare is responsible for the provision of advice and assistance to the provincial and municipal governments in such matters. Eight provinces have now hired full-time planning staffs to co-ordinate the health planning of the Provincial Departments of Health and Provincial Emergency Measures Organization.Four major programs have been established. The first program provides for the continuity of leadership and guidance by health authorities at the federal, provincial and municipal level. Essential records have been developed and emergency legislation prepared. This program, however, will be of little use unless health services are organized at the municipal level. In this organizational program, advice and assistance have been provided to existing hospitals and departments of health in the conduct of disaster planning. The efforts of these agencies are co-ordinated by municipal health authorities into a community disaster plan. The third program deals with information and education of the general public and the health workers. This program is designed to make the family unit self-sufficient for up to seven days and the health worker prepared to undertake his emergency role. The first three programs are directed to the organization and training of manpower; the fourth program provides the necessary supplies. From the national medical stockpile of $18,000,000, some $12,000,000 has been received, packaged for long-term storage and distributed to regional depots across the country. To ensure their ready availability in time of emergency an agreement has been reached with seven provinces for the release of hospital disaster kits.

Civil Defense↗
PubMedDate not supplied

Assistive technology for postsecondary students with learning disabilities: an overview.

The number of postsecondary students with learning disabilities has increased dramatically over the last several years. This increase, coupled with federal legislation mandating "academic adjustments" for students with disabilities, has prompted the development of postsecondary learning disability support service programs. One support service that has begun to attract considerable attention is assistive technology. The purpose of this article is to provide an overview of assistive technology as it relates to postsecondary students with learning disabilities by (a) briefly tracing the development of assistive technology service for postsecondary students with learning disabilities; (b) identifying basic models of assistive technology service delivery and specific services; (c) providing a description of specific assistive technologies; (d) reviewing research on the effectiveness of assistive technology with postsecondary students with learning disabilities, with a focus on the authors' 3-year federally funded study; and (e) concluding with a summary and recommendations.

Adult↗
PubMed1995

Position on allied health professions education and funding.

ASAHP recommends that the federal government should, as the largest consumer of health care, play a central role in partnership with state governments and private institutions in reducing shortages of allied health personnel. Furthermore, ASAHP believes that this role should encompass attracting students (particularly from minority and underserved portions of the population) both to academic allied health programs through the provision of entry-level traineeships and advanced programs which prepare allied health professionals for careers as educators and researchers. No federal programs were authorized specifically to support allied health education during the period from 1981 to 1989. PL 100-607, the Health Professions Reauthorization Act of 1988, authorized $6 million ($2 million in each of three categories), but only $737,000 was appropriated in FY 1990 for Allied Health Grants and Contracts. The Bureau of Health Professions subsequently received 122 proposals in February 1990, representing more than $10,000,000 in requests for this limited amount. Since then, the Bureau has received an average of 100 proposals for each annual funding cycle. In addition to providing continuation grants for existing projects, the Bureau is currently able to award an average of 10 new grants each year. The $3,935,000 appropriated for FY 1995 will be used to fund perhaps another 12 to 15 initiatives. ASAHP believes that substantially more financial assistance is required than what is currently being appropriated. Furthermore, the most suitable venue for the federal government to affect reductions in the shortage of allied health professionals is through the advanced training portion of the Section 766 Program, which remains unfunded.(ABSTRACT TRUNCATED AT 250 WORDS)

Aged↗
PubMed2026

Institutional data commons: a federated Data Use Certification-aware architecture for secure and scalable data use in biomedical data ecosystems.

BACKGROUND: Modern biomedical data ecosystems increasingly rely on global cloud platforms to coordinate access to large-scale genomic and clinical datasets. However, operational governance remains largely investigator-centric, shifting the responsibility for complex security, compliance, and infrastructure management to individual laboratories. As data volumes and regulatory requirements expand, this approach fails to scale across the research enterprise. This disjointed approach creates a substantial governance burden and can slow down scientific progress. In centralized cloud environments, investigators face siloed identity management and high costs, leading to inefficient data use and increased risk when integrating local and global datasets. MATERIALS AND METHODS: We examine limitations in the current infrastructure and propose reframing institutional data commons as governance-aware intermediaries to ensure secure, efficient and sustainable use of controlled-access biomedical data. RESULTS: This federated architecture decouples storage from authorization, enabling dynamic access linked to active certifications, whether data are analyzed in situ on global platforms or in local governance-aware institutional access environments. DISCUSSION: Shifting governance from investigators to institutional infrastructure ensures that biomedical research remains both secure and economically sustainable.

biomedical data ecosystems↗
PubMed2000

[Topiramate (Topamax). Pharmacological characteristics and current use in epilepsy treatment].

Topiramate (Topamax) has been registered since July 1998 and has market authorization for the Federal Republic of Germany as an additive drug for the treatment of patients (age 12 or older) suffering from intractable partial and secondarily generalized seizures. The anticonvulsant effect of topiramate is based on three mechanisms: (a) modulating the blocking of the Na channels activated by voltage, depending on status, (b) potentiation of GABAA-mediated inhibiting neurotransmission, and (c) inhibition of excitatory neurotransmission by blocking APMA glutamate receptors. Topiramate exhibits a substantial anticonvulsive effect on partial seizures both with and without secondary generalization. The median reduction in seizure frequency using topiramate as adjunct therapy was 44%. In 44% of patients, seizure frequency was reduced by more than 50%, and seizure reduction was more than 75% in nearly half of these (i.e., in 21% of all patients), while 5% of patients remained completely free of seizures. Adverse events most often caused central nervous disturbances. Weight loss, the development of renal calculi, and impairment of cognitive functions may occur. It is recommended to start therapy with topiramate at a daily dosage of 25 mg, increasing by 25 mg every week up to 200-400 mg/day but not exceeding 1000 mg/day.

Anticonvulsants↗
PubMed2000

Determination of trace amounts of ginkgolic acids in Ginkgo biloba L. leaf extracts and phytopharmaceuticals by liquid chromatography-electrospray mass spectrometry.

Ginkgolic acids (GAs) are toxic phenolic compounds present in the fruits and leaves of Ginkgo biloba L. (Ginkgoacae). Their maximum level in phytopharmaceuticals containing ginkgo extracts has been recently restricted to 5 microg/g by the Commission E of the former Federal German Health Authority. In order to detect ginkgolic acids at these low levels, a sensitive and selective analytical method, based on liquid chromatography-electrospray mass spectrometry (LC-ES-MS) has been developed. The three main phenolic acids (1-3) of the chloroform fruit extract were isolated and used as standards for quantification. In the LC-ES-MS negative ion mode, calibration curves with good linearities (r=0.9973, n=6) were obtained in the range of 0.5-10 microg/g for compounds 1, 2 and between 0.1 and 7.5 microg/g (r=0.9949, n=6) for ginkgolic acid 3. The detection limits at a SIN ratio of 3 were 0.1 (3) and 0.25 microg/g (1, 2). Recoveries were around 101% at 5 microg/g for the substances detected in the leaf extracts. Good precision was achieved with relative standard deviations of less than 4% (n=6). The optimised method was applied to verify whether the amount of gingkolic acids was below 5 microg/g in a standardised leaf extract which is a constituent of a phytopreparation.

Calibration↗
PubMed2001

Practical and legal aspects of forensic autopsy expert team operations.

Finnish forensic experts have investigated remains of the victims of alleged mass violence in the former Yugoslavia in 1996 under the mandate of the United Nations, and in 1998 and 1999 under the mandate of the European Union. The investigative documents later were surrendered to the International Criminal Tribunal for the former Yugoslavia (ICTY). The indictments issued by the ICTY include charges even against the highest authorities of the Federal Republic of Yugoslavia. This study describes the experience gained in organising forensic expert team operations in a foreign state by the Finnish team. The establishment and operation of a forensic expert team in a foreign state involve, among other things, legal issues, often related to differing legal systems. From an independent forensic expert team, great objectivity and self-constraint are expected. Moreover, a clear and sufficiently detailed agreement on the mandate of the team and on the possibility for unhindered and safe access of the experts to the alleged mass graves, as well as the assembling and briefing of the team members and provision of the necessary equipment should be completed before the beginning of the mission. Furthermore, the application of adequate and internationally recognised methods for processing and documenting the examination is essential for team's credibility.

Journal Article↗
PubMed2002

Evaluation of ambient air concentrations of polycyclic aromatic hydrocarbons in Germany from 1990 to 1998.

All available polycyclic aromatic hydrocarbon (PAH) concentration data in ambient air obtained over the past 10 years in Germany were evaluated to clarify whether it is justified to use benzo(a)pyrene (BaP) as a marker compound for the total PAH exposure. The data basis comprises annual mean concentrations from 1990 to 1998 supplied by the emission protection authorities of the federal states with additional information on the region, year and site of measurement. The data are very heterogeneous with respect to sample size, the number of individual PAHs analyzed, place of origin and year. Nine of 25 individual compounds with sufficient sample size (74<N<518) were submitted to an explorative descriptive analysis and multiple regression analysis. Six compounds were selected for factor analysis to evaluate whether associations can be related to one or several background determinants. The concentration data of BaA, BeP, BaP, DBA, BghiP, COR, BbF, BkF and INP are not normally distributed and demonstrate great variability. Location, East-West differences persisting after the German reunion and time characterize the distributive patterns, e.g., from 1991 to 1997, a significant decrease in BaP could be determined based on the data from North Rhine-Westphalia (1991, N=51, median 1.6 ng/m(3); 1997, N=45, median 0.7 ng/m(3); P<or=0.0001). The BaP concentrations in the new federal states in the East (N=80, median 2.2 ng/m(3)) are about twice as high compared to the ones in the old federal states in the West (N=438, median 1.1 ng/m(3); P<or=0.0001). BaP measurements taken at sites characterized by traffic (1.8 ng/m(3)), industrial (1.3 ng/m(3)) or urban environment (1.3 ng/m(3)) rank significantly higher compared to measurements taken at rural sites (0.92 ng/m(3); P<or=0.0001). Factor analysis of the intercorrelation matrix of BaA, BeP, BaP, DBA, BghiP and COR yields one factor to explain 92% of the variability of the six individual PAHs. BaP shows the highest factor loading. These results confirm the common practice to use BaP as marker compound for the PAH exposure in ambient air.

Air Pollutants↗