The Importance of Risk Management: What is Missing in ISO Standards?

The overall aim of this article is to contribute to the further development of the area of risk analysis and risk management in the International Organization for for Standardization (ISO) standards by strengthening its scientific basis. Industrial standards, especially ISO standards, are the tools organizations use to manage their risk, through following their guidance and complying with their requirements. Organizations confirm their compliance with these standards through certification, which means that they heavily depend upon the quality of the ISO standards to enable them to effectively manage their risk.

Vascular plant colonisation of Surtsey Island (1965-1990) - a dataset.

Background: The process of ecosystem development over time that takes place on a new substrate devoid of biological activity (such as, for example, lava) is called primary succession. Research on primary succession is not easy, as it is limited to rare occasions when a piece of land totally lacking in any pre-existing life occurs. The emergence of volcanic islands is such an occasion; it is a unique event that allows a natural experiment in the study of colonisation processes and primary succession.

The dynamics of intracellular water constrains glycolytic oscillations in Saccharomyces cerevisiae.

We explored the dynamic coupling of intracellular water with metabolism in yeast cells. Using the polarity-sensitive probe 6-acetyl-2-dimethylaminonaphthalene (ACDAN), we show that glycolytic oscillations in the yeast S. cerevisiae BY4743 wild-type strain are coupled to the generalized polarization (GP) function of ACDAN, which measures the physical state of intracellular water.

[Endocarditis in Iceland 2000-2009, a national survey incidence, microbiology and prognosis].

Introduction: The objective of this study was to analyze the incidence, clinical features, microbiology and prognosis of patients with infective endocarditis (IE) in Iceland, and to compare the results with a previous study made in Iceland 1976-85.

Material And Methods: A retrospective study including all patients diagnosed with IE in Iceland 2000-2009. Information was obtained from medical records.

European regulation on orphan medicinal products: 10 years of experience and future perspectives.

In 2000, regulation on orphan medicinal products was adopted in the European Union with the aim of benefiting patients who suffer from serious, rare conditions for which there is currently no satisfactory treatment. Since then, more than 850 orphan drug designations have been granted by the European Commission based on a positive opinion from the Committee for Orphan Medicinal Products (COMP), and more than 60 orphan drugs have received marketing authorization in Europe. Here, stimulated by the tenth anniversary of the COMP, we reflect on the outcomes and experience gained in the past decade, and contemplate issues for the future, such as catalysing drug development for the large number of rare diseases that still lack effective treatments.

Rofecoxib, but not celecoxib, increases the risk of thromboembolic cardiovascular events in young adults-a nationwide registry-based study.

Purpose: To examine the risk of thromboembolic cardiovascular events in users of coxibs and NSAIDs in a nationwide cohort.

Methods: Data were synchronised from three nationwide databases, the Icelandic Medicines Registry (IMR), The Icelandic National Patient Registry (INPR) and the Registry for Causes of Death at Statistics Iceland (RCD), for prescriptions for NSAIDs or coxibs with respect to hospitalisation for unstable angina pectoris, myocardial infarction and cerebral infarction over a 3-year period. The Cox proportional hazards model and Poisson regression were used to analyse the data.

Accurate microfour-point probe sheet resistance measurements on small samples.

We show that accurate sheet resistance measurements on small samples may be performed using microfour-point probes without applying correction factors. Using dual configuration measurements, the sheet resistance may be extracted with high accuracy when the microfour-point probes are in proximity of a mirror plane on small samples with dimensions of a few times the probe pitch. We calculate theoretically the size of the "sweet spot," where sufficiently accurate sheet resistances result and show that even for very small samples it is feasible to do correction free extraction of the sheet resistance with sufficient accuracy.

Endobronchial actinomycosis secondary to a tooth aspiration.

We report a middle aged smoker with recurrent pneumonia caused by endobronchial actinomycosis secondary to a tooth aspiration. Unlike previously reported cases, our patient was not chronically debilitated. The case suggests that a follow-up bronchoscopy is beneficial after the initiation of antibiotic therapy for endobronchial actinomycosis.

Evolution of hepatitis C virus variants following blood transfusion from one infected donor to several recipients: a long-term follow-up.

Variants of hepatitis C virus (HCV) from a single infected blood donor and 13 viraemic recipients who were traced were examined by sequencing and cloning to determine the extent of virus diversity in hypervariable region 1. Serum-derived viral isolates were studied from the donor when his HCV infection was discovered in 1993, in his recipients that year (0.3-5 years post-transfusion) and 5 years later in the donor and six viraemic recipients who were still alive.

Cutaneous infection caused by Paecilomyces lilacinus in a renal transplant patient: treatment with voriconazole.

Moulds belonging to the genus Paecilomyces are rare opportunistic pathogens. About 100 cases have been reported in immunocompromised hosts or in relation to surgical procedures. We describe here a cutaneous infection due to P.

[Measurements of plasma HIV-1 RNA in Iceland.].

Objective: First to measure plasma HIV-1 RNA in Icelandic HIV infected individuals and second to evaluate the initial effects of new combination regimens on viral load and CD4+ cell counts in HIV infected patients in Iceland.

Material And Methods: The cohort studied consis notted of all HIV infected individuals we received samples from during the period September 1995 to November 1996. HIV-1 RNA and CD4+ cells were measured initially and subsequently every three to six months except when a change was made in the antiretroviral regimen, when samples were measured before the change, three to four weeks later and then every three to six months.

[Analysis of antibiotic utilization review at Landspitalinn, the University Hospital in Iceland.].

Objective: To describe the application of and analyze the cost effects of antibiotic utilization review at Landspitalinn, the National University Hospital in Iceland, and review the use of prophylactic antibiotics in a general surgical ward.

Material And Methods: The study was undertaken during a two month period in 1996. Patients in wards 11-A and 11-B (general medical floors), ward 12-G (general surgery service) and 11-E (hematology service) were enrolled.

[Improved prognosis for patients with cystic fibrosis. A result of aggressive center-based treatment].

We report survival data for Danish centre-treated cystic fibrosis (CF) patients, covering the period 1974-1993 using cross-sectional cumulative survival probability based on annual age-specific mortality rates. No significant differences were noted in the survival probability when patients were grouped according to sex or absence/presence of meconium ileus. The annual mortality rate for 1989-1993 was 0-1.

[Glucose tolerance in patients with cystic fibrosis].

In order to define prevalence and incidence of diabetes mellitus in cystic fibrosis, we followed 191 unselected patients above two years of age (median 13.6) in a five-year prospective study with annual oral glucose tolerance tests. The prevalence of diabetes increased from 11 to 24% during the study period with an annual age-dependent incidence rate of 4-9%.

[Reduced concentration of insulin-like growth factor I in patients with cystic fibrosis].

Cystic fibrosis is frequently accompanied by a catabolic condition with low body mass index caused by a number of disease complications. Insulin-like growth factor I (IGF-I) is an anabolic hormone and an important marker of nutritional status, liver function and linear growth. Using radioimmunoassay we measured IGF-I once in 235 of our 240 patients (114 males, 121 females, median age 16.

[The epidemiology of AIDS in Iceland. The first ten years.].

Objective. To describe the epidemiology of AIDS and HIV infection in Iceland with demographic characteristics and associated risk factors. Design.

[Helicobacter pylori infection: the efficacy of a short course of azithromycin and fleroxacin treatment.].

The aim of this open pilot study was to assess the efficacy of a short course of fleroxacin and azithromycin in the treatment of Helicobacter pylori infection. Seventeen patients were included. All had H.

[Cytomegalovirus infections in healthy adults.].

Background: Primary cytomegalovirus (CMV) infections in healthy adults are considered extremely rare. To study the extent of this problem in Iceland we undertook a two year (1989-1990) retrospective study of all new CMV infections in adults.

Methods: All positive tests for CMV antibodies in clinical samples (194) were identified in the sole virology laboratory in Iceland.

[Human listeriosis diagnosed in Iceland 1978-1994.].

Listeriosis has been recognised in Iceland, as a distinct disease entity in sheep called silage disease (votheysveiki), since 1910. The use of silage was introduced in Iceland in the latter part of the 19th century. Because of the climatic conditions it came into widespread use and the connection between silage and listeriosis was first demonstrated in Iceland by Pálsson et al.

Hepatitis C virus genotypes among blood donors and their recipients in Iceland determined by the polymerase chain reaction.

Eight antibody-positive individuals were detected among 12,000 blood donations during the first year of screening blood donors for hepatitis C virus (HCV) antibodies in Iceland. All 8 were found to have a history of intravenous drug abuse. Six of these 8 individuals had previously donated blood to 27 patients who could be traced and examined for HCV infection.

Pharmacokinetic profile of fosfomycin trometamol.

The pharmacokinetics of fosfomycin trometamol has been assessed in 12 healthy volunteers given oral doses of 2, 3, and 4 g of fosfomycin and 3 g intravenously of fosfomycin as fosfomycin sodium, all in the fasting state. The assay was microbiological (Proteus mirabilis ATCC 21100). There was a gradual rise in both peak serum concentrations and total area under the curve by rising oral doses, from 16.

Effect of meropenem on the intestinal microflora.

Ten healthy volunteers were given 500 mg of meropenem by intravenous infusion over 30 min three times daily for seven days. Stool specimens were collected before, during and after meropenem administration. The numbers of enterobacteria and streptococci decreased during the administration period, while the numbers of enterococci increased.

Penetration of ciprofloxacin and metabolites into human lung, bronchial and pleural tissue after 250 and 500 mg oral ciprofloxacin.

Ciprofloxacin (CIP) and metabolite concentrations in lung tissue, parietal pleura and bronchial tissue were assessed in 43 adult patients who underwent lung surgery. A single oral dose of CIP was given for prophylaxis of bacterial infections. Two to 6 h prior to tissues sampling, 23 patients received 250 mg and 20 subjects 500 mg of the substance.

Disposition of alprazolam in human volunteers. Differences between genders.

The disposition of alprazolam in 16 young healthy volunteers (eight females and eight males) was investigated. All volunteers were given a 1 mg dose of alprazolam. Dose/kg was 13.