Evaluation of Glove Performance after Decontamination.

Studies of healthcare providers doffing personal protective equipment, especially gloves, indicate that self-contamination does occur. Although generally this is not hazardous, working with particularly pathogenic organisms, such as Ebola virus and Clostridium difficile, can present a serious health risk. Decontaminating medical gloves before removal can reduce self-contamination and mitigate the spread of these types of pathogens. Also, in cases of extreme shortage, the Centers for Disease Control and Prevention (CDC) has specific recommendations for decontaminating gloves for extended use. Reuse of medical gloves is strongly discouraged by both the CDC and Food and Drug Administration. This work seeks to lay a foundation of testing to evaluate whether a decontamination method is compatible for a given glove type and material. Four potential methods of decontamination (commercial hand soap, alcohol-based hand sanitizer, commercial bleach, and quaternary ammonium solution) were tested on a variety of surgical and patient examination gloves. The method of barrier performance evaluation was ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves. Our results indicated that the performance of the gloves after treatment was highly dependent on the composition of the medical gloves. In general, the surgical gloves in this study performed better than the patient examination gloves, regardless of the material from which they were made. Specifically, vinyl examination gloves tended to have poorer performance. In this study, the number of gloves available to test were limited and therefore statistical significance is beyond the scope of this project.

Influence of topology optimization parameters on the mechanical response of an additively manufactured test structure.

Topology Optimization (TO) determines a material distribution within a domain under given conditions and design constraints, and generally generates complex geometries as a result. Complementary to TO, Additive Manufacturing (AM) offers the ability to fabricate complex geometries which may be difficult to manufacture using traditional techniques such as milling. AM has been used in multiple industries including the medical devices area. Hence, TO may be used to create patient-matched devices where the mechanical response is catered to a particular patient. However, during a medical device regulatory 510(k) pathway, demonstrating that worst-cases are known and tested is critical to the review process. Using TO and AM to predict worst-case designs for subsequent performance testing may be challenging and does not appear to have been thoroughly explored. Investigating the effects of TO input parameters when AM is employed may be the first step in determining the feasibility of predicting these worst-cases. In this paper, the effect of selected TO parameters on the resulting mechanical response and geometries of an AM pipe flange structure are investigated. Four different input parameters were chosen in the TO formulation: (1) penalty factor, (2) volume fraction, (3) element size, and (4) density threshold. Topology optimized designs were fabricated using PA2200 polyamide and the mechanical responses (reaction force, stress, and strain) were observed through experiments (universal testing machine and 3D Digital Image Correlation) and in silico environments (finite element analysis). In addition, 3D scanning and mass measurement were performed to inspect the geometric fidelity of the AM structures. A sensitivity analysis is performed to examine the effect of each TO parameters. The sensitivity analysis revealed mechanical responses can have non-monotonic and non-linear relationships between each tested parameter.

Research: Using Clinically Relevant Test Soils to Evaluate Personal Protective Materials.

Effective personal protective equipment (PPE) is critically important to preventing the spread of infectious diseases. Appropriate test systems and test soils are needed to adequately evaluate PPE. ASTM test method F903, which specifies the test method setup also used in ASTM F1670/F1670M-17a and ASTM F1671/F1671M-13, has been used for decades to test liquid penetration resistance of fabrics. All three standards require at least 60 mL of challenge liquid, such as synthetic blood solution (F1670) or bacteriophage in nutrient broth (F1671). The three ASTM test methods also are labor intensive and prone to exhibiting problems with leakage around the gaskets. Previous work comparing the F903 test apparatus with a modified dot-blot apparatus to evaluate the visual penetration of a blood test soil in series of commercially available gowns and drapes demonstrated that the methods are comparable and revealed that penetration through PPE material may depend on the test solution. The study described here evaluated a series of clinically relevant test soils (blood, vomit, urine, and feces) in penetration of PPE garments using the modified dot-blot apparatus. The results indicated that a vomit test soil penetrates PPE material more often than blood, urine, or fecal test soils and that the blood test soil has the least number of PPE failures. Incorporating clinically relevant, chemically defined test soils to evaluate PPE material should be considered to protect healthcare workers and reduce the spread of infectious material.

Evaluation of Apparatus Used to Test Liquid through Protective Materials: Comparison of a Modified Dot-Blot Apparatus to the ASTM Penetration Cell.

Personal protective equipment (PPE), such as gowns used in the latest Ebola outbreak in Western Africa, are critical in preventing the spread of deadly diseases. Appropriate test systems and test soils are needed to adequately evaluate PPE. ASTM F903, Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Liquid, has been used for decades to test fabrics' resistance to liquid penetration. However, this test apparatus requires at least 60 mL of test solutions, is labor intensive, and has problems with leakage around the gaskets. We compared the F903 test apparatus to a modified dot-blot apparatus to evaluate the visual penetration of a blood test soil. A series of commercially available gowns and drapes were tested in each apparatus. Using blood test soil at 2 psi, there was no statistically significant difference between the two methods except for in one gown. By comparing this gown in the ASTM test apparatus with and without a screen, the particular screen selected did not account for the difference between the dot-blot and F903 apparatuses; however, it is conceivable that a particular screen/fabric combination could account for this difference. The modified dot-blot apparatus was evaluated using three different test solutions: blood, vomit, and a labeled protein (goat anti-rabbit immunoglobulin G-horseradish peroxidase [GaR IgG-HRP]) in a blood test soil solution. This testing revealed significant difference in penetration for some of the PPE garments. The modified dot-blot had several large advantages over the ASTM apparatus-over six times less specimen volume and no edge or gasket leakage. In addition, nitrocellulose can be easily incorporated into the modified dot-blot apparatus, enabling the trapping of viruses and proteins that penetrate PPE-thus permitting the use of antibodies to quickly and sensitively detect penetration.

Exposure of natural rubber to personal lubricants--swelling and stress relaxation as potential indicators of reduced seal integrity of non-lubricated male condoms.

BACKGROUND: Male condoms act as mechanical barriers to prevent passage of body fluids. For effective use of condoms the mechanical seal is also expected to remain intact under reasonable use conditions, including with personal lubricants. Absorption of low molecular weight lubricant components into the material of male condoms may initiate material changes leading to swelling and stress relaxation of the polymer network chains that could affect performance of the sealing function of the device. Swelling indicates both a rubber-solvent interaction and stress relaxation, the latter of which may indicate and/or result in a reduced seal pressure in the current context. METHODS: Swelling and stress relaxation of natural rubber latex condoms were assessed in a laboratory model in the presence of silicone-, glycol-, and water-based lubricants. RESULTS: Within 15 minutes, significant swelling (≥6 %) and stress reduction (≥12 %) of condoms were observed with 2 out of 4 silicone-based lubricants tested, but neither was observed with glycol- or water-based lubricants tested. Under a given strain, reduction in stress was prominent during the swelling processes, but not after the process was complete. CONCLUSIONS: Lubricant induced swelling and stress relaxation may loosen the circumferential stress responsible for the mechanical seal. Swelling and stress relaxation behavior of latex condoms in the presence of personal lubricants may be useful tests to identify lubricant-rooted changes in condom-materials. IMPLICATION: For non-lubricated latex condoms, material characteristics--which are relevant to failure--may change in the presence of a few silicone-based personal lubricants. These changes may in turn induce a loss of condom seal during use, specifically at low strain conditions.

Abrasion resistance of medical glove materials.

Due to the increasing demand for nonlatex medical gloves in the health-care community, there is a need to assess the durability of alternative glove materials. This study examines durability characteristics of various glove materials by abrasion resistance testing. Natural rubber latex (latex), polyvinyl chloride (vinyl), acrylonitrile butadiene (nitrile), polychloroprene (neoprene), and a styrene-ethylene/butylene-styrene block copolymer (SEBS) were tested. All test specimens, with the exception of the vinyl, were obtained from surgical gloves. Unaged out-of-the-box specimens as well as those subjected to various degrees of artificial aging were included in the study. After the abrasion sequence, the barrier integrity of the material was assessed through the use of a static leak test. Other traditional tests performed on these materials were viral penetration to validate the abrasion data and tear testing for comparative purposes. The results indicate that specific glove-material performance is dependent upon the particular test under consideration. Most notably, abrasion, even in controlled nonsevere conditions, may compromise to varying degrees the barrier integrity of latex, vinyl, SEBS, nitrile, and neoprene glove materials. However, as evidenced by the results of testing three brands of neoprene gloves, the abrasion resistance of any one glove material may be significantly affected by variations in production processes.

Biaxial flex-fatigue and viral penetration of natural rubber latex gloves before and after artificial aging.

Barrier integrity of unaged and oven-aged (at 70 degrees C) natural rubber latex examination gloves was assessed with a biaxial flex-fatigue method where failure was detected electronically, and by live viral penetration testing performed according to a modified version of ASTM F1671-97a. When no change in barrier properties was detected during flex testing, no virus passage was found after viral challenge. Conversely, when a change in the barrier properties was indicated by the electrical signal, virus passage was found in 74% of the specimens. Flex-fatigue results indicated that unaged test specimens from powdered (PD) and powder-free (PF) nonchlorinated gloves had significantly longer fatigue lives than powder-free chlorinated (CL) gloves from the same manufacturer. Biaxial flexing of oven-aged glove specimens showed a marginal increase in fatigue life for the PF gloves, but no increase for the PD gloves. The fatigue life of the CL gloves was observed to increase significantly after oven aging. However, this appears to be due to a design feature of the test apparatus, wherein peak volume displacement of the worked specimen is held constant. An aging-induced change in the viscoelastic properties of the CL gloves-permanent deformation of the specimens early in the fatigue test-relieves the stress magnitude applied as the test progresses. Thus, permanent deformation acts as a confounding factor in measuring durability of latex gloves by fixed displacement flex-fatigue.