The design and testing of a dual fiber textile matrix for accelerating surface hemostasis

The standard treatment for severe traumatic injury is frequently compression and application of gauze dressing to the site of hemorrhage. However, while able to rapidly absorb pools of shed blood, gauze fails to provide strong surface (topical) hemostasis. The result can be excess hemorrhage-related morbidity and mortality. We hypothesized that cost-effective materials (based on widespread availability of bulk fibers for other commercial uses) could be designed based on fundamental hemostatic principles to partially emulate the wicking properties of gauze while concurrently stimulating superior hemostasis. A panel of readily available textile fibers was screened for the ability to activate platelets and the intrinsic coagulation cascade in vitro. Type E continuous filament glass and a specialty rayon fiber were identified from the material panel as accelerators of hemostatic reactions and were custom woven to produce a dual fiber textile bandage. The glass component strongly activated platelets while the specialty rayon agglutinated red blood cells. In comparison with gauze in vitro, the dual fiber textile significantly enhanced the rate of thrombin generation, clot generation as measured by thromboelastography, adhesive protein adsorption and cellular attachment and activation. These results indicate that hemostatic textiles can be designed that mimic gauze in form but surpass gauze in ability to accelerate hemostatic reactions

Safety evaluation in the development of medical devices and combination products

Capturing the growth of the global medical device market in recent years, this practical new guide is essential for all who are responsible for ensuring safety in the use and manufacture of medical devices. It has been extensively updated to reflect significant advances, incorporating combination products and helpful case examples of current real-life problems in the field.The Third Edition explores these key current trends:global device marketscontinually advancing technologythe increasing harmonization of device safety regulation worldwideEach aspect of safety evaluation is considered in te

Single serum progesterone as a screen for ectopic pregnancy: exchanging specificity and sensitivity to obtain optimal test performance

To investigate the diagnostic accuracy of screening serum P in diagnosis of ectopic pregnancy (EP) and to identify a cutoff value that provides the best compromise between test sensitivity and specificity. Retrospective analysis. University hospital. Observation only. First trimester pregnant women at risk for EP. Single P measurements were obtained from 3,674 pregnancies with outcomes defined as EP, viable intrauterine pregnancy (IUP), and spontaneous abortion (SAB). Diagnostic accuracy of the test was analyzed by generating receiver operating characteristic (ROC) curves, which quantify the ability of the test to distinguish EP and SAB from IUP. Diagnostic accuracy for EP versus IUP was 88.7%±0.1% (mean±SEM); for SAB versus IUP, 93.8±0.4%; and for SAB±EP versus IUP, 92.8%±0.4%. Diagnostic accuracy for SAB versus EP was only 39.4%±0.2%. In the interval of 15.0 to 19.9ng/mL (47.7 to 63.3nmol/L), P missed 5.3% of the EPs and incorrectly included 84.3% of the viable IUPs; in the interval of 20.0 to 24.9ng/mL (63.6 to 79.2nmol/L), sensitivity improved in that only 3.5% of the EPs were missed but 88.8% of viable IUPs were included incorrectly. A cutoff value of≥17.5ng/mL (55.7nmol/L), the median point of the 15.0 to 19.9ng/mL (47.7 to 63.3nmol/L) interval, missed only 35 of 423 (8.3%) total EPs in the study. Analysis of ROC curves demonstrates that single serum P has high diagnostic accuracy for differentiating accidents of pregnancy (SAB and EP) from viable IUP, both individually (SAB versus IUP and EP versus IUP) and collectively (SAB+EP versus IUP); it cannot efficiently discriminate SAB versus EP. We conclude that for P≥17.5ng/mL (55.7nmol/L), patients thought to be at risk for EP may be followed reasonably without ultrasound or further invasive diagnostic studies

Novel 3-D Spacer Textiles to Protect Crops from Insect Infestation and That Enhance Plant Growth

Pesticide-free, 3-D, spacer fabrics (Plant Armor Generation (PA Gen) 1 and 2) were investigated for proof-of-concept as an insect barrier to protect plants and improve plant agronomics for organic farming. The time to 50% penetration (TP50) for tobacco thrips, Frankliniella fusca (Hinds) adults in laboratory Petri dish bioassays was 30 and 175 min for PA Gen 1 and 2, respectively, and 12 min for the control (a commercially available, single layer-crop cover, Proteknet). PA Gen 2 was ≥90% resistant to penetration of unfed caterpillar neonates, Helicoverpa zea (Boddie), while the TP50‘s for Gen 1 and Proteknet were 3.1 and 2.35 h, respectively. In small cage studies, PA Gen 2 covered potted cabbage plants were 100% resistant to penetration by these insects through 10 d after which the study was ended. In small field plot studies for 3 summer months, cabbage plants grew approximately twice as fast when covered versus not covered with Gen 1 and Gen 2 without the need for insecticides or herbicides. This was not observed for the control crop cover. Martindale abrasion tests demonstrated Gen 1 and 2 were at least 6- and 1.8-fold more durable than the control crop cover used. Data are also presented on percentage light, water, air, and water vapor penetration across each textile and operational temperatures and humidity for cabbage plants covered and uncovered in small field plots

ImergardTMWP: A Non-Chemical Alternative for an Indoor Residual Spray, Effective against Pyrethroid-Resistant Anopheles gambiae (s.l.) in Africa

Malaria is the deadliest mosquito-borne disease and kills predominantly people in sub-Saharan Africa (SSA). The now widespread mosquito resistance to pyrethroids, with rapidly growing resistance to other insecticide classes recommended by the World Health Organization (WHO), may overturn the successes gained in mosquito control in recent years. It is of utmost importance to search for new, inexpensive, and safe alternatives, with new modes of action, that might improve the efficacy of current insecticides. The efficacy of a novel mechanical insecticidal mineral derived from volcanic rock, ImergardTMWP, was investigated to determine its efficacy as a stand-alone residual wall spray and as a mixture with deltamethrin (K-Othrine® Polyzone) in experimental huts in Cove, Benin. The evaluation was conducted with susceptible (Kisumu) and wild-type Anopheles gambiae (s.l.). Deltamethrin applied alone demonstrated 40–45% mortality (at 72 h post-exposure) during the first four months, which declined to 25% at six months for wild An. gambiae from Cove. ImergardTMWP alone and mixed with deltamethrin, under the same assay conditions, produced 79–82% and 73–81% mortality, respectively, during the same six-month period. ImergardTMWP met the 80% WHO bio-efficacy threshold for residual activity for the first five months with 78% residual activity at six months. ImergardTMWP can be used as a mixture with chemical insecticides or as a stand-alone pesticide for mosquito control in Africa

Mosquito-Textile Physics: A Mathematical Roadmap to Insecticide-Free, Bite-Proof Clothing for Everyday Life

Garments treated with chemical insecticides are commonly used to prevent mosquito bites. Resistance to insecticides, however, is threatening the efficacy of this technology, and people are increasingly concerned about the potential health impacts of wearing insecticide-treated clothing. Here, we report a mathematical model for fabric barriers that resist bites from Aedes aegypti mosquitoes based on textile physical structure and no insecticides. The model was derived from mosquito morphometrics and analysis of mosquito biting behavior. Woven filter fabrics, precision polypropylene plates, and knitted fabrics were used for model validation. Then, based on the model predictions, prototype knitted textiles and garments were developed that prevented mosquito biting, and comfort testing showed the garments to possess superior thermophysiological properties. Our fabrics provided a three-times greater bite resistance than the insecticide-treated cloth. Our predictive model can be used to develop additional textiles in the future for garments that are highly bite resistant to mosquitoes