Optical testing of condoms.

Condoms provide one of the most important means of preventing pregnancy and the spread of human immunodeficiency virus (HIV) and other sexually transmitted diseases. Pinhole defects may lead to the passage of sperm or viruses through the condom wall. Embedded particles, which may become dislodged in handling or use, may represent latent pinhole defects. Thin regions in the condom wall may lead to breakage in use. Testing for such defects in regulatory laboratories, or in the factories as part of production screening or quality assurance efforts, is a major tool for ensuring condom reliability. A new optical method for testing condoms is presented, sensitive to pinholes, thin regions, and embedded particles. The method could supplement or replace the existing, less powerful, electrical test techniques in either regulatory testing laboratories or in the factory. The optical techniques presented provide quantitative data on the condoms tested, rather than just accept/reject decisions. They thus support detailed monitoring of production or lot characteristics that is generally not possible with existing electrical techniques. The ability of the optical techniques to separately test for and identify not only pinholes, but also thin regions and embedded particles, which are not separately tested for with the electrical technologies, is an especially important new capability. Further, the new optical techniques allow the locations of defects found to be precisely marked, making possible a microscopic examination of defects useful in studying their structure and possible causes. The optical technique is also totally nondestructive, in that it does not alter the defects whose structures are of interest. Initial results are reported on the testing of latex condoms purchased in retail stores. Condoms identified optically as being potentially defective were subjected to industry standard leak and burst testing. Results of the various tests are summarized. The data suggest that use of the new optical test techniques could have prevented an unexpectedly large number of condoms with significant pinhole and thin region defects from reaching the public. Optical test systems could be used to support either regulatory, quality assurance, or clinical field testing of latex or nonlatex condoms. Due to their high rate capability and level of automation, they could also be applied to 100% screening testing in the factory. The new test techniques could also be used to detect defects in a wide range of other thin sheets and membranes.

PIP: Testing of latex condoms in factories and regulatory laboratories for pinhole defects, embedded particles, and thin regions represents a major strategy for ensuring condom reliability. A new optical method for testing condoms could supplement or even replace existing, less powerful electrical test techniques that require extensive manual handling. Optical techniques provide quantitative data on the condoms tested rather than simple accept/reject decisions, thereby enabling detailed monitoring of production or lot characteristics. This paper presents initial findings on the optical testing of 1813 nonlubricated latex condoms purchased in US retail stores. An extremely high level of correlation was found between the optical test results and the outcomes of standard leak-and-burst testing. Optical screening followed by leak testing produced 12 confirmed failures in this series. The majority of confirmed leaks resulted from holes substantially larger than the detection limits of both testing systems. The large pinhole and thin-region defects identified optically are of serious public health concern, even if the defects were incipient and only realized after handling.

The use of double latex gloves during hip fracture operations.

A prospective study was undertaken to determine the perforation rate of surgical gloves when double-gloving techniques were employed in 120 hip fracture operations. One or more perforations occurred in 30 operations (25%). In 10 operations (8.3%), perforations of both the outer and inner gloves occurred at corresponding sites. The surgeons were able to recognize the perforations during the surgery on five occasions only. Of the 64 perforations identified, 41 (64%) occurred in the left (nondominant) hands, and 42 (65.6%) occurred at the tips of thumbs and index fingers. Nearly half of the perforations (46.9%) occurred at the thumb and index finger of left (nondominant) hands. To reduce the perforation rate, further protection of the thumb and index finger of the nondominant hand of surgeons is therefore required.

High frequency pressure propagation in viscoelastic tubes: a new experimental approach.

A new method for estimating the high-frequency characteristics of wave propagation (phase velocity and attenuation per wavelength) in hydraulic lines is presented in this work. It consists of measuring the ratio of pressure amplitudes at two distinct sections of an occluded tube at different frequencies, and minimizing the difference between the experimental pattern and the theoretical one predicted on the basis of the transmission line theory. In this work the method is used for estimating the high frequency propagation characteristics of two different latex tubes. The values obtained are then compared with those provided by the more traditional three-point pressure method. The results of our trials demonstrate that the new method furnishes reliable estimations of the asymptotic values of phase velocity and attenuation per wavelength, provided the frequencies used during the experiment are sufficiently high. Moreover, the method turns out quite robust as to the influence of noise and possible measurement errors. For this reason it seems particularly suitable for studying wave propagation under difficult experimental conditions, such as those met with when measurements are performed on blood vessels in vivo. Finally, some discrepancies between our experimental results and the predictions of the transmission line theory are pointed out, and their possible origin examined.

Biomechanical performance of silicone and latex external condom catheters.

Standard in vivo biomechanical performance tests and a pilot clinical study of latex external condom catheters (ECCs) and silicone ECCs demonstrated the superior performance of the silicone ECC over that of the latex ECC. The silicone ECC has a self-adhesive that binds more securely to human skin than the self-adhesive of latex ECC. In addition, the moisture vapor transmission through silicone is significantly greater than through latex. The aggressive self-adhesive of the silicone ECC significantly reduced ECC catheter pop-off compared to that of latex ECC. Silicone ECC removal can be facilitated by the application of a warm, wet cloth to the exterior surface of the silicone ECC, which significantly reduces its self-adhesive force. Constant, gentle traction is then applied to the silicone catheter outlet end to achieve atraumatic silicone ECC removal. On the basis of the results of these standardized tests and pilot study, the silicone ECC is recommended for incontinent men without obstructive uropathy.

Técnicas anatômicas no ensino da prática de anatomia animal / Anatomical techniques in the animal anatomy practice teaching

A preocupação quanto a conservação de peças anatômicas existe a mais de 5 mil anos, pois o uso de peças cadavéricas são indispensáveis para o ensino, contribuindo com a melhora das habilidades aplicativas, assimilativas e compreensivas da disciplina. Esse trabalho propõe maior utilização das técnicas apresentadas em laboratórios de anatomia, visando abolir o uso do formol como conservante, permitindo um ambiente agradável para a prática da relação ensino-aprendizagem. Para isso foram utilizadas quatro técnicas anatômicas, a criodesidratação, glicerinação, injeção de látex e injeção de vinilite seguido de corrosão, que foram executadas utilizando cães, gatos e órgãos provenientes de doações. Com a criodesidratação e glicerinação os materiais anatômicos ficaram consideravelmente mais leves do que eram quando mantidos em formol, mantendo-se inodoros, diferente do evidenciado na utilização de formol e outros conservantes. As estruturas de estudo das peças ficaram intactas, de fácil visualização e o armazenamento passou a ser feito em caixas fechadas sem qualquer tipo de liquido, mantendo-se assim por até 3 anos. As técnicas de injeção de látex e vinilite seguido de corrosão mostraram total eficiência preenchendo os sistemas injetados, podendo visualizar as ramificações e todo caminho percorrido no sistema circulatório. As quatro técnicas anatômicas estudadas nesse trabalho mostraram ser suficientes para atender as necessidades dos estudantes quanto ao estudo da anatomia, devido à perfeita evidenciação de estruturas externas e internas dos animais.

The concern about preservation of anatomical specimens in existence for over 5000 years, since the use of anatomical parts, are indispensable for teaching and contribute for the improvement of applicative, assimilative skills and understanding of the discipline. This paper proposes better use of techniques in anatomy laboratories, to abolish the use of formaldehyde as preservative, allowing a pleasant environment for the practice of teaching/learning relationship. For this purpose, we used four anatomical techniques, (1) the cryodehydration, (2) glycerin conservation, (3) latex injection and (4) vinylite injection followed corrosion, we executed using dogs, cats and organs from donations. With cryodehydration and glycerin conservation the anatomical materials were considerably lighter than when kept in formaldehyde, odorless unlike in the use of formaldehyde and other preservatives. The structures to be studied were kept intact, easily to view, and the specimens could be stored in closed boxes without any liquid, thus remaining for up to 3 years. The Injection techniques (latex and vinylite followed by corrosion) showed total efficiency to inject filling systems, and allowed a clear view of all ramifications and paths of the circulatory system. The four anatomical techniques studied were shown to be sufficient to meet the needs of students to study anatomy due to the perfect disclosure of external and internal animal structures.

Burst testing of condoms. I. Basic features of the force-deformation curve of latex-rubber condoms.

Inflation of a rubber condom involves biaxial deformation of the material which can be modeled by the use of an appropriate strain-energy function. Force versus deformation data for uniaxial extension of strips of condoms were used to determine the parameters for Ogden's form of a strain-energy function. These parameters were then used to fit experimentally obtained burst test data to a stress-strain equation formulated for inflation of condoms in a burst test. Experimental data on inflation of condoms agree well with theoretical curves verifying the applicability of the biaxial stress-strain equation to the particular strain-energy function on which it is based.

Leakage of latex and vinyl exam gloves in high and low risk clinical settings.

The purpose of this study was to compare leakage rates of used latex and vinyl examination gloves from high and low risk clinical units. A total of 4838 latex and 1008 vinyl examination gloves were collected and tested by the Food and Drug Administration (FDA) watertight leak test: three brands of latex [Brand A: n = 2920; Brand B: n = 284; Brand C: n = 1634; and one brand of vinyl gloves (Brand D: n = 1008]. Seventy percent of latex gloves and 46.7% of vinyl gloves were collected from the high risk units. In general, there were no significant differences in leakage rates for vinyl gloves between high and low risk units. However, latex gloves leaked significantly more often at stress levels 2 and 3 from the high risk units as compared to the low risk units (X2 = 24.6, p < .0001). Regardless of level of stress and duration worn, 85.3% (860/1008) of used vinyl gloves and 18.4% (891/4838) of used latex gloves leaked, p < .001). There were significant differences in leakage rates between the three brands of latex gloves (Brand A, 9.8%; Brand B, 25.1%; Brand C, 30.9%, p < .001). Although latex gloves leaked slightly more frequently as stress level increased, glove material (latex or vinyl) and brand of glove were the most important predictors of leakage.

Evaluation of drug-containing polymer films prepared from aqueous latexes.

Polymeric films containing salicylic acid or propranolol HCl were prepared by casting and drying a drug-containing, aqueous colloidal polymer dispersion (Eudragit NE 30D) as an alternative to films cast from organic polymer solutions. The drug was either dissolved (salicylic acid) or dissolved/dispersed (propranolol HCl) in the polymeric matrix. Incompatibilities (flocculation or coagulation) between salts of basic drugs and two ethylcellulose latexes were overcome by substituting the anionic surfactants with a nonionic surfactant (Pluronic P103). The drug release was studied as a function of drug loading, film thickness, amount of hydrophilic additive (hydroxypropyl methylcellulose), and storage humidity. The release of propranolol HCl (monolithic dispersion) was a combination of diffusion through the polymer and pores or channels; the extent of each release mechanism depended on the drug loading. On DSC thermograms, melting transitions were obtained with monolithic dispersions but not with monolithic solutions. The heat of fusion was linearly correlated to the amount of drug in the films. The amount of drug remaining in the film after the dissolution study was not detectable and corresponded to the drug dissolved in the polymer. The drug release increased with increased drug loading and increased amount of hydroxypropyl methylcellulose but was independent of film thickness and relatively insensitive to different storage humidities.

Development of a monoclonal antibody-based sandwich ELISA for detection of the latex allergen Hev b 1.

BACKGROUND: Natural rubber latex (NRL) products are complex mixtures consisting of different allergenic components. Among them, Hev b 1 belongs to the important and well-characterized ones. To quantify the relevant allergen Hev b 1 in NRL products, a two-site monoclonal antibody (mAb)-based assay was developed. METHODS: Two Hev b 1-specific mAbs with different epitope recognition and ability to bind simultaneously to an Hev b 1 molecule were used in the study. Both mAbs (II4F9 and II4G9) were enriched by in vitro production in a modular minifermenter and affinity purified. Wells of micro-ELISA plates coated with captured mAb II4G9 were incubated with samples containing Hev b 1. Bound Hev b 1 was detected by a combination of biotinylated mAb II4F9 as detection antibody and peroxidase-labeled avidin. RESULTS: The optimized sandwich ELISA was highly reproducible in the linear range of the standard curve and Hev b 1 concentrations ranging from 12.5 to 400 ng/100 microl could be detected. The assay was suitable for the detection of Hev b 1 concentrations in latex sap and latex products, e.g. gloves, with a detection limit of 1.25 microg of Hev b 1/g of rubber. In a preliminary study with five different brands of latex gloves, Hev b 1 concentrations were found to be in the range of 18-40 microg per gram of rubber material, corresponding to 2-4% of the total extractable protein content in latex glove extracts. CONCLUSIONS: A sensitive sandwich assay was developed to quantify the latex allergen Hev b 1. This assay can be used to standardize latex extracts with regard to the content of the major allergen Hev b 1.

Latex allergy diagnosis: in vivo and in vitro standardization of a natural rubber latex extract.

For the diagnosis of IgE-mediated (immediate) hypersensitivity to natural rubber latex (NRL), skin prick testing with extracts of latex gloves has been widely used, but such extracts are difficult to standardize. The present study aimed to produce on an industrial scale an NRL extract from freshly collected NRL and to evaluate, calibrate, and standardize the extract by both in vivo and in vitro testing. The source material, latex of the rubber tree, Hevea brasiliensis (clone RRIM 600), was frozen immediately after collection in Malaysia and shipped in dry ice to Stallergènes SA, France. Protein and allergen profiles were analyzed by sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS-PAGE), immunoblotting, isoelectric focusing (IEF), crossed immunoelectrophoresis (CIE), and crossed radioimmunoelectrophoresis (CRIE). Allergen quantification was effected by RAST inhibition. The capacity of the preparation to elicit immediate hypersensitivity reactions in vivo was measured by skin prick testing in 46 latex-allergic patients and 76 nonallergic control subjects. SDS-PAGE and immunoblot profiles of the extract and an NRL standard (E8) provided by the US Food and Drug Administration were almost identical, disclosing several distinct IgE-binding proteins with apparent molecular weights of 14, 20, 27, 30, and 45 kDa, conforming to reported molecular weights of several significant NRL allergens. An arbitrary index of reactivity (IR) of 100 was assigned to the extract at 1:200 dilution (w/v), having a protein content of 22 micrograms/ml. Skin prick testing of latex-allergic patients and controls using the extract at 100 IR revealed 93% sensitivity, 100% specificity, 100% negative predictive value, and 96% positive predictive value. In conclusion, a skin prick test reagent for diagnosis of type I NRL allergy was successfully standardized. The reagent was demonstrated to contain most, if not all, of the currently known clinically significant NRL allergens, and it showed high sensitivity and specificity.