scholarly journals 092 Safety, efficacy and tolerability of a medical device starch-based cream-to-powder formulation: in vitro and observational study from a dermatologist

2021 ◽  
Vol 141 (10) ◽  
pp. S164
Author(s):  
A. Rudnicka ◽  
R.M. Debowska ◽  
A. Kuranc ◽  
K. Rogiewicz
Keyword(s):  
Observational Study ◽  
Medical Device ◽  
Powder Formulation

scholarly journals Evaluation of Ceftaroline Alone and in Combination against Biofilm-Producing Methicillin-Resistant Staphylococcus aureus with Reduced Susceptibility to Daptomycin and Vancomycin in anIn VitroPharmacokinetic/Pharmacodynamic Model

2015 ◽  
Vol 59 (8) ◽  
pp. 4497-4503 ◽  
Author(s):  
Katie E. Barber ◽  
Jordan R. Smith ◽  
Cortney E. Ireland ◽  
Blaise R. Boles ◽  
Warren E. Rose ◽  
...  
Keyword(s):  
Staphylococcus Aureus ◽  
Medical Device ◽  
Bloodstream Infections ◽  
Methicillin Resistant ◽  
Content Type ◽  
Elimination Half ◽  
Antimicrobial Protection ◽  
Mrsa Strains ◽  
Post Hoc

ABSTRACTAnnually, medical device infections are associated with >250,000 catheter-associated bloodstream infections (CLABSI), with up to 25% mortality.Staphylococcus aureus, a primary pathogen in these infections, is capable of biofilm production, allowing organism persistence in harsh environments, offering antimicrobial protection. With increases inS. aureusisolates with reduced susceptibility to current agents, ceftaroline (CPT) offers a therapeutic alternative. Therefore, we evaluated whether CPT would have a role against biofilm-producing methicillin-resistantS. aureus(MRSA), including those with decreased susceptibilities to alternative agents. In this study, we investigated CPT activity alone or combined with daptomycin (DAP) or rifampin (RIF) against 3 clinical biofilm-producing MRSA strains in anin vitrobiofilm pharmacokinetic/pharmacodynamic (PK/PD) model. Simulated antimicrobial regimens were as follows: 600 mg of CPT every 8 h (q8h) (free maximum concentration of drug [fCmax], 17.04 mg/liter; elimination half-life [t1/2], 2.66 h), 12 mg/kg of body weight/day of DAP (fCmax, 14.7 mg/liter;t1/2, 8 h), and 450 mg of RIF q12h (fCmax, 3.5 mg/liter;t1/2, 3.4 h), CPT plus DAP, and CPT plus RIF. Samples were obtained and plated to determine colony counts. Differences in log10CFU/cm2were evaluated by analysis of variance with Tukey'spost hoctest. The strains were CPT and vancomycin susceptible and DAP nonsusceptible (DNS). CPT displayed activity throughout the experiment. DAP demonstrated initial activity with regrowth at 24 h in all strains. RIF was comparable to the drug-free control, and little benefit was observed when combined with CPT. CPT plus DAP displayed potent activity, with an average log10CFU/cm2reduction of 3.33 ± 1.01 from baseline. CPT demonstrated activity against biofilm-producing DNS MRSA. CPT plus DAP displayed therapeutic enhancement over monotherapy, providing a potential option for difficult-to-treat medical device infections.

scholarly journals Feasibility Study and Direct Extraction of Endogenous Free Metallic Cations Combining Hemodialysis and Chelating Polymer

2021 ◽  
Author(s):  
Marco Natuzzi ◽  
Coralie Grange ◽  
Thomas Gréa ◽  
Thomas Brichart ◽  
Axel Aigle ◽  
...  
Keyword(s):  
Medical Device ◽  
Feasibility Study ◽  
Water Soluble ◽  
High Mass ◽  
Direct Extraction ◽  
Healthy Sheep ◽  
Chelating Polymer ◽  
Metallic Cations ◽  
Extraction Of Metals

Abstract In this article, we report the conception and the use of dialysis based medical device for extraction of metals. The medical device is obtained by addition in the dialysate of a functionnalized chitosan that can chelate endogenous metals like iron or copper. The water soluble functionnalized chitosan is obtained after controlled reacetylation and addition of DOTAGA. Due to the high mass of chitosan, the polymer cannot cross through the membrane and the metals are trapped in the dialysate during hemodialysis. Copper captation has been evaluated in vitro using an hemodialysis protocol. Feasibility study has been performed on healthy sheep showing no acute toxicity of the whole procedure and first insights of metallic extraction even on healthy animals.

Dimensional variations of left-sided double-lumen endobronchial tubes: an observational study

2019 ◽  
Author(s):  
Niels Hegland ◽  
Sebastian Schnitzler ◽  
Jan Ellensohn ◽  
Marc P Steurer ◽  
Markus Weiss ◽  
...  
Keyword(s):  
Observational Study ◽  
Airway Management ◽  
Double Lumen ◽  
Tube Size ◽  
Size Selection ◽  
Dimensional Parameters

Abstract Background: Tube size selection is critical in ventilating patient`s lungs using double-lumen endobronchial tubes. Little information about relevant parameters is readily available from manufacturers. Methods: In this observational study in a benchmark in-vitro setup, several dimensional parameters of four sizes of left-sided double-lumen endobronchial tubes from six different manufacturers were assessed, such as distances and diameters of tube shaft, cuff lengths and diameters as well the angle at the tip. Results: Endobronchial tubes of ostensibly the same size revealed wide variation in measured parameters between brands from different manufacturers. In some parameters, there was an overlap between different sizes from the same manufacturer, i.e. diameters and distances did not increase with increasing nominal endobronchial tube size. The information about dimensions of endobronchial tubes provided by manufacturers’ leaflets is insufficient. Conclusions: Endobronchial tube size selection is complicated because clinically relevant parameters are unknown and vary considerably between different manufacturers. Keywords: Airway management, double-lumen endobronchial tubes

scholarly journals Leveraging Extraction Testing to Predict Patient Exposure to Polymeric Medical Device Leachables Using Physics-based Models

2020 ◽  
Vol 178 (1) ◽  
pp. 201-211
Author(s):  
Paul Turner ◽  
Robert M Elder ◽  
Keaton Nahan ◽  
Anne Talley ◽  
Saloni Shah ◽  
...  
Keyword(s):  
Medical Device ◽  
Chemical Constituents ◽  
A Priori ◽  
Exposure Dose ◽  
Test Results ◽  
Animal Testing ◽  
Patient Exposure ◽  
Extraction Test ◽  
Routine Basis

Abstract Toxicological risk assessment approaches are increasingly being used in lieu of animal testing to address toxicological concerns associated with release of chemical constituents from polymeric medical device components. These approaches currently rely on in vitro extraction testing in aggressive environments to estimate patient exposure to these constituents, but the clinical relevance of the test results is often ambiguous. Physics-based mass transport models can provide a framework to interpret extraction test results to provide more clinically relevant exposure estimates. However, the models require system-specific material properties, such as diffusion (D) and partition coefficients (K), to be established a priori for the extraction conditions. Using systems comprised high-density polyethylene and 4 different additives, we demonstrate that these properties can be quantified through standard extraction testing in hexane and isopropyl alcohol. The values of D and K derived in this manner were consistent with theoretical predictions for these quantities. Based on these results, we discuss both the challenges and benefits to leveraging extraction data to parameterize physics-based exposure models. Our observations suggest that clinically relevant, yet still conservative, exposure dose estimates provided by applying this approach to a single extraction measurement can be more than 100 times lower than would be measured under typical aggressive extraction conditions. However, to apply the framework on a routine basis, limiting values of D and K must be established for device-relevant systems either through the aggregation and analysis of more extensive extraction test data and/or advancements in theoretical and computational modeling efforts to predict these quantities.

scholarly journals Evaluating medical device and material thrombosis under flow: current and emerging technologies

2020 ◽  
Vol 8 (21) ◽  
pp. 5824-5845
Author(s):  
Jun Ki Hong ◽  
Lingzi Gao ◽  
Jasneil Singh ◽  
Tiffany Goh ◽  
Alexander M. Ruhoff ◽  
...  
Keyword(s):  
Medical Device ◽  
Emerging Technologies

This review highlights the importance of flow in medical device thrombosis and explores current and emerging technologies to evaluate dynamic biomaterial Thrombosis in vitro.

In vitro characterization of physico-chemical properties, cytotoxicity, bioactivity of urea-crosslinked hyaluronic acid and sodium ascorbyl phosphate nasal powder formulation

2019 ◽  
Vol 558 ◽  
pp. 341-350 ◽  
Author(s):  
Arianna Fallacara ◽  
Laura Busato ◽  
Michele Pozzoli ◽  
Maliheh Ghadiri ◽  
Hui Xin Ong ◽  
...  
Keyword(s):  
Hyaluronic Acid ◽  
Chemical Properties ◽  
Powder Formulation ◽  
In Vitro Characterization ◽  
Physico Chemical

New medical device containing verbascoside, carrageenan and glycerophosphoinositol for the treatment of dyspareunia in reproductive age women: A prospective observational study

2020 ◽  
Vol 35 ◽  
pp. 101107
Author(s):  
Marco Monti ◽  
Carmela Capone ◽  
Michele Carlo Schiavi ◽  
Chiara Di Tucci ◽  
Andrea Giannini ◽  
...  
Keyword(s):  
Observational Study ◽  
Medical Device ◽  
Prospective Observational Study ◽  
Reproductive Age ◽  
Reproductive Age Women

scholarly journals Regulatory hurdles in bringing an in vitro diagnostic device to market

1996 ◽  
Vol 42 (9) ◽  
pp. 1556-1557 ◽  
Author(s):  
K M Smith ◽  
J A Kates
Keyword(s):  
Medical Device ◽  
Drug Administration ◽  
New Products ◽  
New Product ◽  
Diagnostic Device ◽  
Regulatory Strategy ◽  
The Us ◽  
In Vitro Diagnostic ◽  
Medical Device Regulation

Abstract We discuss the hurdles that developers and manufacturers of in vitro diagnostic devices face in obtaining regulatory approval to market their products in the US. A thorough understanding of medical device regulation and the early planning of a clinical and regulatory strategy are imperative in assuring successful and timely launches of new products. Finally, it is critical for manufacturers to establish a working partnership with the Food and Drug Administration to expedite their new product applications.

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