Safety of toys. National translations of warnings and instructions for use in the EN 71 series

2020 ◽  
Keyword(s):  
Instructions For Use

Characteristics of Physics Module about Mechanics-Based on Multi Representation to Improve Students of Senior High School Reasoning Ability

2017 ◽  
Vol 6 (3) ◽  
Author(s):  
Dimas Fawahid Tamimi Anwar ◽  
I Ketut Mahardika ◽  
S Supeno (Page 14-23)
Keyword(s):  
High School ◽  
High School Students ◽  
Physical Phenomenon ◽  
Senior High School ◽  
Reasoning Ability ◽  
School Students ◽  
Material Sample ◽  
Instructions For Use ◽  
Module Development ◽  
Method Model

This study is about the characteristics of Physics Module to improve students of Senior High School reasoning ability-based on Multirepresentation. The problem of study is how characteristics of Physics Modules Based on Multirepresentation to improve students ability to reason? This problem is described in two study questions. First, is the Physics Module based on Multirepresentation contains examples of the application context of the image phenomenon ofphysics? Second, how is the writing pattern of Physics Module? This study is about Physics module development based on Multirepresentation, using the mix method model of investigation that collecting qualitative data, then construct the draft Module Physics, so the Module Physics ready to be validated. Subjects in this study is a Physics module which can improve the reasoning ability of students in Senior High School. While respondents were Senior High School students majoring in science at the students in Senior High School. Data collection techniques are observations, questionnaires, and documents. Data described in qualitative research. The results showed that the physics module based on Multirepresentation contains examples of application of the principle of material in the context of the image physical phenomenon ; and has a certain writing pattern, which has a chapter title sequence, sub-chapter title, instructions for use, a description of the material, sample questions, questions test capabilities, and bibliography.

scholarly journals The Wild West of Emergency Use Authorizations for SARS-CoV-2 Testing: What Could Be the True Sensitivity?

2020 ◽  
Vol 154 (Supplement_1) ◽  
pp. S142-S143
Author(s):  
S Dalal ◽  
S Patel ◽  
J M Petersen ◽  
D Jhala
Keyword(s):  
Medical Center ◽  
Initial Result ◽  
Reference Laboratory ◽  
Test Results ◽  
Rt Pcr ◽  
Repeat Testing ◽  
Parallel Testing ◽  
Percent Agreement ◽  
Instructions For Use ◽  
Multiple Reference

Abstract Introduction/Objective SARS-CoV-2 is a pandemic that has required mobilization to meet urgent needs. In this mobilization, emergency use authorizations (EUA) have been issued by the FDA to expedite the deployment of these tests. This has led to a situation whereby sensitivity has not been rigorously studied for any of the assays with EUAs. Estimates can be extrapolated from the limited samples documented by the company in their instructions for use (IFU). Although the nationwide shortage of testing reagents prevent parallel testing of multiple platforms on all specimens, observations of repeat specimens at the Veteran Affairs Medical Center (VAMC) provides the first study in the literature of more complete data for SARS-CoV-2 nucleic acid (RT-PCR) assay on sensitivity on the Abbott (Abbott Park Ill) and Cepheid (Sunnyvale CA) assays. Methods A retrospective search was performed for all test results for SARS-CoV-2 by RT-PCR from 3/1/2020 to 4/14/2020 at Corporal Michael J. Crescenz Medical Center, in order to evaluate the sensitivity on Abbott m2000 and Cepheid platforms. Results across multiple reference laboratories and in-house testing platforms were collated in a table with all patients clinically requiring repeat testing recorded. Results 114/863 patients had repeat testing. The tests were performed initially by outside reference laboratories (25 patients), on the Abbott m2000 (63 patients), and Cepheid Infinity (26 patients). 15/114 (13%) had discordant results on repeat testing. This included 1 test initially done by a reference laboratory. 8 days after the initial result from the reference lab, a positive for the same patient was identified on the Abbott platform. 11 initial Abbott results were discordant on further repeat testing on two platforms - Abbott (6 patients) and Cepheid (5 patients) 1-6 days later. In addition, 3 initial Cepheid were discordant on further repeat testing by the same Cepheid platform (1-16 days later). Conclusion While the instructions for use for both platforms suggest 100% sensitivity and specificity (due to the 100% positive and negative percent agreement in limited specimens), the true sensitivity is less than 100%, particularly early in the course of the infection. In our study, the positive percent agreement (surrogate for sensitivity) was 83% for initial Abbott tests, 88% for initial Cepheid tests, and 95% by Reference laboratory platform.

Sex-Related Anatomical Feasibility Differences in Endovascular Repair of Thoracoabdominal Aortic Aneurysms With Multibranched Stent-Grafts

2020 ◽  
pp. 152660282096491
Author(s):  
Alessandro Grandi ◽  
Niccolò Carta ◽  
Tommaso Cambiaghi ◽  
Victor Bilman ◽  
Germano Melissano ◽  
...  
Keyword(s):  
Vascular Access ◽  
Endovascular Repair ◽  
Odds Ratio ◽  
Multivariable Analysis ◽  
Aortic Aneurysms ◽  
Clinical Factors ◽  
Stent Grafts ◽  
Single Institution ◽  
Confounding Variables ◽  
Instructions For Use

Purpose: To evaluate the potential anatomical feasibility of using the off-the-shelf multibranched Zenith t-Branch for the treatment of thoracoabdominal aortic aneurysms (TAAAs) in female patients. Materials and Methods: A total of 268 patients (median age 68 years; 69 women) with degenerative TAAA treated at a single institution by means of open or endovascular repair between 2007 and 2019 were retrospectively analyzed to determine the feasibility of using the Zenith t-Branch based on the manufacturer’s instructions for use. The factors determining overall anatomical feasibility were divided into vascular access, aortic anatomy, and visceral vessels. The results were stratified by sex and compared. A logistic regression model was constructed to determine any association between feasibility and clinical factors or potential confounding variables; results are expressed as the odds ratio (OR) with 95% confidence interval (CI). Results: The overall anatomical feasibility was 39% (22% women vs 45% men, p=0.001). The feasibility was negatively influenced by female sex (p<0.001) in multivariable analysis (OR 2.9, 95% CI 1.5 to 5.4, p=0.001). Vascular access feasibility was 82% (61% women vs 89% men, p<0.001). Aorta feasibility was 65% (52% women vs 69% men, p<0.001), and visceral vessel feasibility was 74% (78% women vs 73% men, p=0.260). An access diameter ≤8.5 mm excluded 17% of the patients (39% women vs 9% men, p<0.001). The aortic feasibility was limited by the infrarenal aortic diameter in 16% of patients (45% women vs 6% men, p<0.001) and the aortic lumen at the visceral vessels in 17% patients (19% women vs 17% men, p=0.741). The visceral vessel feasibility was mainly limited by inadequate numbers or diameters of target vessels. Location and orientation of the target vessels were adequate in 96% of patients. Conclusion: A little more than a third of an all-comers cohort of patients with degenerative TAAA could have been treated with on-label use of the Zenith t-Branch. However, only 22% of women could have been treated because of sex-related anatomical limitations. New generations of multibranched devices should address these differences.

scholarly journals Performing Transcarotid Artery Revascularization Outside of Manufacturer's Instructions for Use Is Safe but Has Higher Reintervention Rates

2021 ◽  
Vol 73 (3) ◽  
pp. 44
Author(s):  
Stephen Hayes ◽  
Christopher Murter ◽  
David Dexter ◽  
Animesh Rathore ◽  
Rasesh Shah ◽  
...  
Keyword(s):  
Instructions For Use

scholarly journals Evaluation of MicroScan Bacterial Identification Panels for Low-Resource Settings

Diagnostics ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. 349
Author(s):  
Sien Ombelet ◽  
Alessandra Natale ◽  
Jean-Baptiste Ronat ◽  
Olivier Vandenberg ◽  
Liselotte Hardy ◽  
...  
Keyword(s):  
Bacterial Species ◽  
Ease Of Use ◽  
Bacterial Identification ◽  
Gram Positive ◽  
Gram Negative ◽  
Low Resource Settings ◽  
Low Resource ◽  
Bacillus Spp ◽  
Gram Negative Organisms ◽  
Instructions For Use

Bacterial identification is challenging in low-resource settings (LRS). We evaluated the MicroScan identification panels (Beckman Coulter, Brea, CA, USA) as part of Médecins Sans Frontières’ Mini-lab Project. The MicroScan Dried Overnight Positive ID Type 3 (PID3) panels for Gram-positive organisms and Dried Overnight Negative ID Type 2 (NID2) panels for Gram-negative organisms were assessed with 367 clinical isolates from LRS. Robustness was studied by inoculating Gram-negative species on the Gram-positive panel and vice versa. The ease of use of the panels and readability of the instructions for use (IFU) were evaluated. Of species represented in the MicroScan database, 94.6% (185/195) of Gram-negative and 85.9% (110/128) of Gram-positive isolates were correctly identified up to species level. Of species not represented in the database (e.g., Streptococcus suis and Bacillus spp.), 53.1% out of 49 isolates were incorrectly identified as non-related bacterial species. Testing of Gram-positive isolates on Gram-negative panels and vice versa (n = 144) resulted in incorrect identifications for 38.2% of tested isolates. The readability level of the IFU was considered too high for LRS. Inoculation of the panels was favorably evaluated, whereas the visual reading of the panels was considered error-prone. In conclusion, the accuracy of the MicroScan identification panels was excellent for Gram-negative species and good for Gram-positive species. Improvements in stability, robustness, and ease of use have been identified to assure adaptation to LRS constraints.

scholarly journals Adherence to endovascular aortic aneurysm repair device instructions for use guidelines has no impact on outcomes

2015 ◽  
Vol 61 (5) ◽  
pp. 1151-1159 ◽  
Author(s):  
Joy Walker ◽  
Lue-Yen Tucker ◽  
Philip Goodney ◽  
Leah Candell ◽  
Hong Hua ◽  
...  
Keyword(s):  
Aortic Aneurysm ◽  
Endovascular Aortic Aneurysm Repair ◽  
Instructions For Use ◽  
Aneurysm Repair ◽  
Aortic Aneurysm Repair
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