CFPP 01-06: Decontamination of Flexible Endoscopes(PDF 782KB)

Validation and verification manual

Efficacy and safety of various combination therapies based on a calcium antagonist in essential hypertension: results of a placebo-controlled randomized trial

We tested the efficacy and safety of different combination therapies in hypertensive patients with uncontrolled blood pressure (BP) on a monotherapy with a calcium antagonist: 1,647 hypertensive patients were enrolled to receive placebo for 4 weeks followed by isradipine (ISR) 2.5 mg twice daily (b.i.d.) for 4 weeks. Nonresponders [diastolic BP (DBP) > 90 mm Hg] were randomly assigned to receive either the beta-blocker bopindolol 0.5 or 1 mg/day, the diuretic metolazone 1.25 or 2.5 mg/day, the angiotensin-converting enzyme (ACE) inhibitor enalapril 10 or 20 mg/day, ISR 5 mg b.i.d., or placebo. One hundred seventy-five receiving placebo dropped out; 93% (n = 1,376) of the 1,472 patients finished 4-week monotherapy with ISR. Sixty percent (n = 826) reached target BP, and 40% (n = 550) remained uncontrolled and were randomized. Regardless of dosage, all drugs led to a comparable reduction in BP except for the lower dosage of bopindolol and ISR 5 mg b.i.d., which were less effective in lowering systolic BP (SBP). The BP decrease achieved by combination therapy ranged from 10 to 15 mm Hg SBP and from 7 to 11 mm Hg DBP but remained unchanged with placebo. Side effects were minor, and only 2.4% of patients discontinued therapy because of side effects. The side-effect score for edema was lower with ISR plus diuretics than with other combinations, whereas the ACE inhibitor was associated with a higher score for cough. Monotherapy with a calcium antagonist normalizes BP in about two-thirds of patients when used in general practice.(ABSTRACT TRUNCATED AT 250 WORDS)

The 2004 Healthy Ageing Conference - Safety and Older People: Conference Proceedings

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Study of the safety, immunogenicity and efficacy of attenuated and killed Leishmania (Leishmania) major vaccines in a rhesus monkey (Macaca mulatta) model of the human disease

We have compared the efficacy of two Leishmania (Leishmania) major vaccines, one genetically attenuated (DHFR-TS deficient organisms), the other inactivated [autoclaved promastigotes (ALM) with bacillus Calmete-Guérin (BCG)], in protecting rhesus macaques (Macaca mulatta) against infection with virulent L. (L.) major. Positive antigen-specific recall proliferative response was observed in vaccinees (79% in attenuated parasite-vaccinated monkeys, versus 75% in ALM-plus-BCG-vaccinated animals), although none of these animals exhibited either augmented in vitro gamma interferon (IFN-g) production or positive delayed-type hypersensitivity (DTH) response to the leishmanin skin test prior to the challenge. Following challenge, there were significant differences in blastogenic responses (p < 0.05) between attenuated-vaccinated monkeys and naïve controls. In both vaccinated groups very low levels of antibody were found before challenge, which increased after infective challenge. Protective immunity did not follow vaccination, in that monkeys exhibited skin lesion at the site of challenge in all the groups. The most striking result was the lack of pathogenicity of the attenuated parasite, which persisted in infected animals for up to three months, but were incapable of causing disease under the conditions employed. We concluded that both vaccine protocols used in this study are safe in primates, but require further improvement for vaccine application.

Building a Culture of Patient Safety - Report of the Commission on Patient Safety and Quality Assurance

The Commission on Patient Safety and Quality Assurance was established in January 2007 and reported to the Minister in July 2008. The report was considered by government in January 2009 which agreed the implementation process. The overall objective of the Commission was to develop clear and practical recommendations to ensure that safety and quality of care for patients is paramount within the healthcare system. The Commission’s report set out a wide range of policy measures that will drive the safety and quality agenda in Irish healthcare in the coming years. The establishment of the Commission was prompted by an increasing awareness of patient safety issues in general and high profile health service system failures at home and abroad and in particular by the Lourdes Hospital Inquiry. These have underlined the need for an increased focus on patient safety and quality. Download document here Download summary document on the Report

First Quarterly Progress Report of the Implementation Steering Group on recommendations of the Report of the Commission on Patient Safety and Quality Assurance

First Quarterly Progress Report of the Implementation Steering Group on recommendations of the Report of the Commission on Patient Safety and Quality Assurance Click here to download PDF 56kb

Final Report of the Implementation Steering Group (ISG) on the recommendations of the Report of the Commission on Patient Safety and Quality Assurance

Final Report of the Implementation Steering Group (ISG) on the recommendations of the Report of the Commission on Patient Safety and Quality Assurance Click here to download PDF 235KB

Directive 2010/45/EU OF THE EU Parliament on standards of quality and safety of human organs intended for transplantation

Over the past 50 years organ transplantation has become an established worldwide practice, bringing immense benefits to hundreds of thousands of patients. The use of human organs (hereinafter â?~organsâ?T) for transplantation has steadily increased during the last two decades. Organ transplantation is now the most cost-effective treatment for end-stage renal failure, while for end-stage failure of organs such as the liver, lung and heart it is the only available treatment. Click here to download PDF 806kb You can read a summary of the document here

Review of Roles & Responsibilities of the Food Safety Promotion Board (FSPB/SafeFood)

The Department carried out a review during 2012 on FSPB’s work in the food safety, diet and nutrition areas. This review, approved by the Minister on 25 January 2013, provides a summary of the responses received and recommendations made. Click here to download   PDF 63KB  

Effect of a Road Safety Training Program on Drivers' Comparative Optimism

Reducing comparative optimism regarding risk perceptions in traffic accidents has been proven to be particularly difficult (Delhomme, 2000). This is unfortunate because comparative optimism is assumed to impede preventive action. The present study tested whether a road safety training course could reduce drivers' comparative optimism in high control situations. Results show that the training course efficiently reduced comparative optimism in high control, but not in low control situations. Mechanisms underlying this finding and implications for the design of road safety training courses are discussed.

www.fevertravel.ch : an online study prototype to evaluate the safety and feasibility of computerized guidelines for fever in returning travellers and migrants

Résumé Suite à la publication des recommandations de pratiques cliniques sur la prise en soins de patients fébriles au retour des tropiques, nous avons développé un site internet de consultation www.fevertravel.ch qui comprend un arbre décisionnel et des caractéristiques diagnostiques spécifiques fournissant une assistance diagnostique aux médecins de premier recours. Nous avons ensuite intégré une composante de recherche afin d'évaluer l'implémentation de ces recommandations de pratiques cliniques informatisées. De plus, le site est capable d'enregistrer : (1) le chemin parcouru par le médecin au travers de l'arbre décisionnel, (2) les tests diagnostics effectués, (3) les diagnostics initial et final ainsi que les devenirs des patients et (4) les raisons de non-adhérence lorsque les médecins divergent de l'attitude proposée. Nous croyons que la technologie internat est un moyen puissant pour atteindre des médecins provenant de différents horizons dans leur propre environnement et qu'il pourrait se montrer être un outil de recherche efficace pour disséminer les recommandations de pratiques cliniques et évaluer leur justesse-adéquation. Dans cet article, nous décrivons le design, le contenu, l'architecture et l'implémentation du système de ce prototype d'étude interactive qui vise à intégrer une recherche opérationnelle en médecine de premier recours.

Consumer Food Safety Knowledge, Microbiology &amp; Refrigeration Temperatures in Domestic Kitchens

This study examined consumer food safety knowledge on the island of Ireland. Domestic refrigerators were tested for the presence of a range of pathogenic bacteria.

A Study of Food Safety Knowledge, Microbiology and Refrigeration Temperatures in Restaurant Kitchens on the Island of Ireland

A population-based telephone survey conducted in 2002 estimated that there were 3.2 million episodes of acute gastroenteritis on the island of Ireland each year (Scallon et al., 2004). It is often very dif ficult to definitively identify the source of illness. However, of the respondents in that study suspecting food as the reason for their illness, 74% blamed food consumed from commercial premises such as restaurants, cafés, takeaways, canteens and pubs. Within the food services industry, statistics show a significant level of prosecutions, prohibition and closure orders of restaurants for food hygiene offences. The Food Safety Authority of Ireland has identified the main contributory factors to foodborne infections to be: cross-contamination, inadequate cooking, inadequate storage, inadequate reheating, delayed serving and infected food handlers (FSAI, 2000). Development of appropriate training and education campaigns to target problem areas requires initial understanding of the current level of food safety knowledge and practices in the food services industry.

Directory of Food Safety Laboratory Services

All laboratories play a key role in protecting public health by analysing the microbiological and chemical content of food so that it is safe to eat. On the island of Ireland there are many laboratories & institutions involved in food safety monitoring, surveillance, analysis and research. Some operate directly or are under the aegis of government departments, local and health authorities. Others are privately owned or within third level institutes of higher education and campus companies, and other laboratory establishments are funded or run by various national agencies. These laboratories produce high quality scientific information that benefits public health through routine testing and research encompassing a broad range of foods.

Safety and feasibility of NeuroFlo use in eight- to 24-hour ischemic stroke patients.

BACKGROUND: Acute treatment of ischemic stroke patients presenting more than eight-hours after symptom onset remains limited and largely unproven. Partial aortic occlusion using the NeuroFlo catheter can augment cerebral perfusion in animals. We investigated the safety and feasibility of employing this novel catheter to treat ischemic stroke patients eight-hours to 24 h following symptom onset. METHODS: A multicenter, single-arm trial enrolled ischemic stroke patients at nine international academic medical centers. Eligibility included age 18-85 years old, National Institutes of Health stroke scale (NIHSS) score between four and 20, within eight-hours to 24 h after symptom onset, and perfusion-diffusion mismatch confirmed by magnetic resonance imaging. The primary outcome was all adverse events occurring from baseline to 30 days posttreatment. Secondary outcomes included stroke severity on neurological indices through 90 days. This study is registered with ClinicalTrials.gov, number NCT00436592. RESULTS: A total of 26 patients were enrolled. Of these, 25 received treatment (one excluded due to aortic morphology); five (20%) died. Favorable neurological outcome at 90 days (modified Rankin score 0-2 vs. 3-6) was associated with lower baseline NIHSS (P < 0·001) and with longer duration from symptom discovery to treatment. There were no symptomatic intracranial hemorrhages or parenchymal hematomas. Asymptomatic intracranial hemorrhage was visible on computed tomography in 32% and only on microbleed in another 20%. CONCLUSIONS: Partial aortic occlusion using the NeuroFlo catheter, a novel collateral therapeutic strategy, appears safe and feasible in stroke patients eight-hours to 24 h after symptom onset.