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1.
Materials (Basel) ; 16(12)2023 Jun 08.
Article in English | MEDLINE | ID: mdl-37374429

ABSTRACT

The paper presents the results of tensile adhesion strength measurements of ceramic tile adhesive (CTA) stored in various conditions performed by ten operators in one laboratory using the same equipment and auxiliary materials. The obtained results allowed the authors to estimate the repeatability and reproducibility of the tensile adhesion strength measurement method using the methodology following ISO 5725-2:1994+AC1:2002. Standard deviations of repeatability ranging from 0.09 to 0.15 for the general means value in the range of 0.89-1.76 MPa and standard deviations of reproducibility ranging from 0.14 to 0.21 for the same general means content indicate that the accuracy of tensile adhesion strength measurement method is not high enough. From the group of ten operators, five perform tensile adhesion strength measurements daily, the remaining five perform other measures, and the results obtained by professionals and non-professionals showed no significant differences. In light of the obtained results, compliance assessment with this method with the criteria set out in the harmonized standard EN 12004:2007+A1:2012 carried out by different operators may be divergent, and there is a significant risk of incorrect assessments. This risk is additionally increasing in the case of the evaluation conducted by market surveillance authorities, which use the simple acceptance rule that does not consider measurement variability.

2.
Materials (Basel) ; 15(17)2022 Sep 05.
Article in English | MEDLINE | ID: mdl-36079553

ABSTRACT

This article presents the results of the interlaboratory comparison (ILC) study of the following four characteristics of ceramic tile adhesives (CTAs): initial tensile adhesion strength, tensile adhesion strength after heat ageing, tensile adhesion strength after immersion in water, and tensile adhesion strength after freeze-thaw cycles. The results showed that the objective of the ILC was achieved-the z-score analysis carried out following ISO 13528 allowed for classifying all results obtained by 23 laboratories out of 27 as satisfactory. The results of the remaining four laboratories were rated worse. Despite the achieved goal, the ILC notes high heterogeneity of the results in terms of failure patterns, as well as significant differences between the lowest and the highest values of tensile adhesion strength for various measurement conditions. The results of the ILC were discussed in terms of the possibility of including them in the risk analysis conducted by the manufacturer. The results of the ILC are also valuable information for market surveillance authorities, who, in the authors' opinion, should be more cautious about results on samples taken from the market. The ILC results for CTAs are also a valuable recommendation for a possible revision of EN 12004.

3.
Zentralbl Chir ; 146(5): 498-505, 2021 Oct.
Article in English | MEDLINE | ID: mdl-34666357

ABSTRACT

INTRODUCTION: Endovascular aneurysm sealing (EVAS) was commercially introduced in 2013. The initial results of EVAS were positive, leading to its widespread use. The mid- and long-term reports showed greater than expected rates of migration, which led to a recall of the device. In the present article, we describe our experience in managing type Ia endoleaks and migration occurring with the Nellix system in three different ways: open repair with Nellix explantation, Nellix-in-Nellix application (NINA technique), and the use of the multibranched Colt device originally dedicated to the treatment of thoracoabdominal aneurysms. MATERIALS AND METHODS: From February 2014 to June 2021, we performed 20 procedures for failed EVAS or ChEVAS (migration, type Ia endoleak, secondary aneurysm rupture). All patients treated for EVAS failure were male, aged 65 - 79. RESULTS: Seven Nellix explantations were performed. Three patients were admitted to our hospital with ruptured aneurysms that occurred 3 weeks to 4 years (mean 124 weeks) after EVAS, and another four with type Ia endoleak. In all but one case, removal of the Nellix system was easy. In two patients, tube grafts were implanted and in the remaining five cases, bifurcated grafts were implanted. In four patients, graft legs were anastomosed with the internal iliac arteries. One patient with secondary aneurysm rupture died from multiorgan failure on the 4th postoperative day. In two cases, transient renal failure was noticed in the perioperative period. All patients were admitted to the intensive care unit for 1 to 4 days (mean 2 days). The mean hospital stay was 9 days. All patients stayed in follow-up (3 - 56 months), but no other complications occurred. Eight patients were treated with the NINA technique: five for distal migration of the Nellix and three for failed ChEVAS. Four patients had a NINA procedure performed with three chimneys, three with two and one with one chimney. In one case, two iliac limbs were implanted to avoid kinking of the external iliac arteries. The median hospitalization time after the procedure was 9 days (range 3 - 12). Four patients developed transient acute renal insufficiency in the perioperative period. The follow-up ranged between 4 and 72 months. In one patient, deterioration of preexisting chronic renal insufficiency developed 5 months after the procedure, but dialysis was not required. One patient died from exacerbation of heart failure 7 months after the NINA procedure. The Colt device was implanted in five patients for the treatment of distal migration with type Ia endoleaks. None of the patients developed any signs of spinal cord ischemia. All patients were admitted to the intensive care unit for 1 or 2 days. In two cases, transient acute renal failure was noticed in the perioperative period. The mean hospital stay was 9 days. All patients remained in follow-up (6 - 22 months). In one case, the occlusion of the celiac trunk branch was found in contrast computed tomography 1 month after implantation of the Colt device, but without any symptoms. No other complications occurred. CONCLUSIONS: Normal strategies for the management of complications for late failure of EVAR, including stent-graft extensions, are not suitable after EVAS; therefore, alternatives are necessary. Conversion to open repair carries an extensive burden on the patient, so it is not recommended for patients with high surgical risk. The use of a Nellix-in-Nellix application to treat late failure of EVAS is not within the instructions for use but could be an effective strategy for a type Ia endoleak with or without migration. The use of this technique has been extremely limited since the Nellix system was recalled from the market. The use of the Colt multibranched device may be an alternative option, but due to the small number of patients, this method needs further evaluation.


Subject(s)
Aortic Aneurysm, Abdominal , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Animals , Aortic Aneurysm, Abdominal/surgery , Aortography , Blood Vessel Prosthesis , Endoleak/etiology , Endoleak/surgery , Horses , Humans , Male , Prosthesis Design , Stents , Treatment Outcome
4.
Materials (Basel) ; 15(1)2021 Dec 29.
Article in English | MEDLINE | ID: mdl-35009399

ABSTRACT

In this study, the results obtained by 19 laboratories participating in 2 editions of the interlaboratory comparison (ILC) determining 2 properties of ceramic tiles adhesives (CTAs), i.e., initial tensile adhesion strength and tensile adhesion strength after water immersion following EN 12004, were analyzed. The results show that participating laboratories maintain a constant quality of their work. The use of z-score analysis, under ISO 13528, allows for classifying 89.5% to 100% of laboratories as satisfactory, depending on the measurement's kind and edition. The remaining laboratories are classified as questionable. The investigation of the predominant mode of failure of the CTA's samples tested in the two editions shows significant differences. From the perspective of laboratories, the goal of the ILC has been achieved. From the standpoint of a manufacturer who evaluates a product's properties when placing it on the market, the results indicate the necessity of a particular treatment of the product evaluation process because the variability of the obtained results is significant. It increases the possibility of the product failing to meet the assessment criteria verified by the construction market supervision authorities. The manufacturer must consider all possible variations in the risk analysis, including the ILC results, to improve the assessment process of CTAs.

5.
Pol J Pathol ; 61(4): 185-91, 2010.
Article in English | MEDLINE | ID: mdl-21290340

ABSTRACT

Carcinogenesis is a multistep process resulting from mutations in genes controlling the cellular growth, differentiation, apoptosis, and genome integrity maintenance. We investigated relationships between the PTEN and MLH1 immunoreactivity in the cancer cells and the histological subtypes of endometrial carcinoma as well as the survival times of the affected women. The PTEN and MLH1 protein immunoexpression was also examined separately in both clinicopathological groups of endometrial carcinoma. We estimated the practical use of the proteins as diagnostic and predictive markers. The histoclinical analysis was performed on 104 patients. The follow-up in all the cases was well known. To assess the expression of both proteins in the cancer cells we adopted a semiquantitative immunohistochemical analysis. We proved that the incidence of the PTEN and MLH1 nuclear positive cells was significantly higher in the serous type than in the endometrioid one. We also demonstrated a strong correlation between both cytoplasmic and nuclear PTEN immunoexpression and the survival times in the entire cohort. In conclusion, the PTEN and MLH1 immunohistochemical analysis broadens the microscopic diagnosis of the endometrial carcinomas. However, the PTEN and MLH1 antibodies tests cannot determine the recognition of the cancer, and they should not be regarded as independent prognostic factors.


Subject(s)
Adaptor Proteins, Signal Transducing/metabolism , Adenocarcinoma, Clear Cell/diagnosis , Adenocarcinoma/diagnosis , Endometrial Neoplasms/diagnosis , Nuclear Proteins/metabolism , PTEN Phosphohydrolase/metabolism , Adenocarcinoma/metabolism , Adenocarcinoma/mortality , Adenocarcinoma, Clear Cell/metabolism , Adenocarcinoma, Clear Cell/mortality , Adenocarcinoma, Mucinous/diagnosis , Adenocarcinoma, Mucinous/metabolism , Adenocarcinoma, Mucinous/mortality , Biomarkers, Tumor/metabolism , Carcinoma, Endometrioid/diagnosis , Carcinoma, Endometrioid/metabolism , Carcinoma, Endometrioid/mortality , Cell Nucleus/metabolism , Cell Nucleus/pathology , Cystadenocarcinoma, Serous/diagnosis , Cystadenocarcinoma, Serous/metabolism , Cystadenocarcinoma, Serous/mortality , Endometrial Neoplasms/metabolism , Endometrial Neoplasms/mortality , Female , Humans , MutL Protein Homolog 1 , Neoplasm Invasiveness , Poland/epidemiology , Survival Rate
6.
Angiology ; 56(1): 9-17, 2005.
Article in English | MEDLINE | ID: mdl-15678251

ABSTRACT

The objective of this study was to assess the efficacy and safety of liposomal heparin spray-a new formula of topical heparin delivery. This was a randomized, multicenter, controlled open clinical trial with 2 parallel groups. Forty-six outpatients with clinical signs of superficial venous thrombosis (SVT) were treated with either topical liposomal heparin spraygel (LHSG) (Lipohep Forte Spraygel, 4 puffs of 458 IU tid (n = 22) or with low-molecular-weight heparin (LMWH) (Clexane 40 mg once a day (n = 24), administered subcutaneously (sc). Main outcome measures were efficacy parameters (improvement of local symptoms-pain control and planimetric evaluation of erythema size, duplex Doppler assessment of thrombus regression) and safety parameters (documentation of adverse events, with particular reference to deep vein thrombosis [DVT] by duplex sonography, and patients' and investigators' assessment of drug tolerance). Patients' and investigators' subjective assessment of efficacy of treatment and change in basic biochemical parameters were defined as secondary outcome measures. Statistical analysis was performed with use of Wilcoxon test, Mann-Whitney U-test and Chi-square test. Regression of SVT-related symptoms, including pain, erythema, and thrombus presence, was shown as comparable in LHSG and LMWH groups. These results were corroborated by efficacy assessment by investigators and patients. Three cases of deep venous thrombosis in heparin spraygel and 1 in heparin sc group were reported. No significant adverse reactions were observed in the spraygel group, but 1 serious allergic reaction was observed in the LMWH group. Tolerance of new formula heparin was assessed as good. Heparin spraygel-a new topical mode of heparin application, seems a promising method of heparin delivery. This initial study has demonstrated comparable efficacy and safety of LHSG and LMWH in local treatment of SVT. These findings should be confirmed by further extensive study that will reach appropriate statistical power to support such conclusion, for despite heparin treatment, significant risk of DVT was demonstrated in both groups.


Subject(s)
Enoxaparin/administration & dosage , Fibrinolytic Agents/administration & dosage , Heparin/administration & dosage , Thrombophlebitis/drug therapy , Venous Thrombosis/drug therapy , Administration, Topical , Adult , Aerosols , Aged , Enoxaparin/adverse effects , Female , Heparin/adverse effects , Humans , Injections, Subcutaneous , Liposomes , Male , Middle Aged , Pain Measurement , Thrombophlebitis/diagnostic imaging , Treatment Outcome , Ultrasonography, Doppler, Duplex , Venous Thrombosis/diagnostic imaging
7.
Int Arch Occup Environ Health ; 75 Suppl: S7-9, 2002 Oct.
Article in English | MEDLINE | ID: mdl-12397403

ABSTRACT

OBJECTIVES: Good practice in health, environment and safety management in enterprise (GP HESME) is the process that aims at continuous improvement in health, environment and safety performance, involving all stakeholders within and outside the enterprise. The GP HESME system is intended to function at different levels: international, national, local community, and enterprise. METHODS: The most important issues at the first stage of GP HESME implementation in the Lodz region are described. Also, the proposals of future activities in Lodz are presented. RESULTS: Practical implementation of GP HESME requires close co-operation among all stakeholders: local authorities, employers, employees, research institutions, and the state inspectorate. The WHO and the Nofer Institute of Occupational Medicine (NIOM) are initiating implementation, delivering professional consultation, education and training of stakeholders in the NIOM School of Public Health. The implementation of GP HESME in the Lodz region started in 1999 from a WHO meeting on criteria and indicators, followed by close collaboration of NIOM with the city's Department of Public Health. 'Directions of Actions for Health of Lodz Citizens' is now the city's official document that includes GP HESME as an important part of public health policy in Lodz. Several conferences were organized by NIOM together with the Professional Managers' Club, Labor Inspection, and the city's Department of Public Health to assess the most important needs of enterprises. The employers and managerial staff, who predominated among the participants, stated the need for tailored sets of indicators and economic appraisal of GP HESME activities. Special attention is paid to GP HESME in supermarkets and community-owned enterprises, e.g., a local transportation company. A special program for small- and medium-size enterprises will be the next step of GP HESME in the Lodz region. CONCLUSION: The implementation of GP HESME is possible if the efforts of local authorities; research institutions and state inspectorate are combined with the support of employers' organizations.


Subject(s)
Guideline Adherence , Occupational Health , Safety , Total Quality Management , Workplace , Environment Design , Ergonomics , Humans , Interinstitutional Relations , Poland
8.
Int J Occup Med Environ Health ; 15(2): 165-71, 2002.
Article in English | MEDLINE | ID: mdl-12216774

ABSTRACT

Various understanding of occupational health services (OHS) roles, structures and functions in European counties depends mainly on the legal, financial and organizational issues, which influence the health of employees. The OHS aims and functions are often related to public health, and/or to the management of enterprises. In consequence, quality assessment (QA) of OHS is used in the management of enterprises and the implementation of health policy. The study was performed to delineate the methods and techniques used in OHS QA and to find the most useful ones, which might be applied in Polish occupational health services. The web pages, current literature, and international reports on OHS were reviewed. The OHS tasks, activities and methods for OHS QA are different in different European countries. Numerous voluntary methods are believed to be more effective, but their effectiveness is not as yet unequivocally proven. Quality assessment methods in Polish OHS are more similar to those used in clinical medicine. Good Practice in Health Environment and Safety Management in Enterprises (GP HESME) offers a new insight into in OHS QA.


Subject(s)
Occupational Health Services/standards , Total Quality Management , Humans , Quality Indicators, Health Care
9.
Med Pr ; 53(1): 5-13, 2002.
Article in Polish | MEDLINE | ID: mdl-12051152

ABSTRACT

Poland's accession to the European Union entails the need to formulate our strategic goals also in occupational medicine. The most important trends, as well as the changes in world economy are presented with special reference to their impact on occupational medicine. The changing goals of occupational medicine and occupational hygiene in the Polish economy during the period of transition are discussed. The research priorities and the EU policy in these areas are highlighed. The intention of this paper is to initiate a general discussion in "Medycyna Pracy" on the future of occupational health service and occupational hygiene in Poland.


Subject(s)
Occupational Health , Occupational Medicine/economics , Economics , European Union/economics , European Union/organization & administration , Health Policy/economics , Health Policy/trends , Occupational Medicine/trends , Poland , Research/economics , Research/trends
10.
Wiad Lek ; 55 Suppl 1(Pt 2): 796-801, 2002.
Article in Polish | MEDLINE | ID: mdl-17474602

ABSTRACT

Collecting accurate data on performance and costs of services is recognized as the most difficult managerial problem because of limited application of medical standards and procedures as well as the different methods for costs calculation. The report presents the implementation of standardized medical procedures for referral examination, diagnosing occupational disease; and consultation in Regional Occupational Health Care Centers (ROHCC). Data on procedures were related to those on costs in cost centers and to cost structure--the time required for each task. Direct normative costs were analyzed in 6 ROHCC for managerial goals and selling the products as well. The results revealed important differences among different physicians' paid worktime spent on the same types of services. At 2 ROHCC time measurements and estimation of time gave similar results, in contrast to the rest ROHCC where those times were more prolonged. In contrast to commonly accepted opinions, the cost of physicians' work time amounted just several percent of total cost of the service. Such differences were noted not only among different ROHCC but even inside the same single ROHCC. The highest costs of production and of selling referral examinations and diagnosing occupational diseases resulted from the high percentage of indirect costs and overhead costs. The possible reasons of differentiated data on .rapid" and "slow" ROHCC were discussed. The need of right use of medical, organizational and financial data in evaluation of occupational health care efficiency is stressed.


Subject(s)
Delivery of Health Care/economics , Occupational Diseases/economics , Occupational Health Services/economics , Regional Medical Programs/economics , Costs and Cost Analysis , Delivery of Health Care/organization & administration , Health Expenditures , Humans , Occupational Diseases/prevention & control , Occupational Health Services/standards , Poland , Process Assessment, Health Care , Program Evaluation , Surveys and Questionnaires
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