Ansell Medical Gloves Pass New Dynamic Viral Penetration Test
22 May 2007
Ansell Healthcare, the global leader in hand barrier protection, announces that its 20 key medical gloves (surgical and examination) have been successfully tested on a stringent new viral penetration test method. All Ansell gloves tested passed this new protocol, which dynamically simulates the rubbing and stretching of gloves during use. No viral penetration was detected, resulting in an additional safety guarantee for healthcare professionals using Ansell gloves. The testing is the result of collaboration between the department of toxicology and special chemistry and the virology lab at Belgium's Université Catholique de Louvain (UCL) and Ansell Healthcare Europe.
Healthcare workers are in daily contact with patients' body fluids and blood capable of transmitting disease. Of particular concern are the blood-borne viruses which cause Hepatitis B (HBV) and C (HCV) and AIDS (HIV). During exposure to fluids, viral penetration may occur through imperfections such as pinholes, porous materials, tears, or other imperfections or manufacturing defects in glove material.
Glove manufacturers in Europe generally use the ASTM 1671 standard for testing for penetration to blood-borne pathogens, despite self-proclaimed limitations that "[it] does not simulate all the physical stress and pressures that might be exerted on protective clothing materials during use. The integrity of the protective barrier may also be compromised during use by such effects as flexing and abrasion."
In order to more closely simulate real-life, dynamic situations, Ansell Healthcare developed the Ansell Viral Penetration Programme (AVPP), involving a unique test device for permeation / penetration level testing. Originally developed for testing permeation to cytostatic chemicals, the machine reproduces rubbing, stress, exposure and tension, which medical gloves endure in daily work manipulations. The result is a more accurate indication of how long gloves remain resistant to penetration by viruses and goes a step further than the ASTM 1671 test method.
The Université Catholique de Louvain assessed the resistance of 20 Ansell surgical or examination gloves to dynamic penetration by blood-borne pathogens, using the same surrogate micro-organism as for the ASTM 1671: the Phi-X174. The Phi-X174 bacteriophage is 27nm in diameter - smaller than HCV (30nm to 38nm), HBV (42nm to 47nm) and HIV (110nm to 128nm). Measurement methods are also identical to those of the ASTM, but exposure to the virus more closely simulates real-life glove use, using the Ansell Dynamic Testing Device. Viral penetration is assessed on a "pass or fail" basis. For surgical gloves, testing occurred after 30, 60, and 120 minutes of exposure. For examination gloves, testing occurred after 30 and 60 minutes of exposure. Even at twice the maximum recommended glove usage times, all Ansell gloves passed the AVPP test. 3
AVPP represents an additional step Ansell Healthcare is taking to ensure the quality of its medical gloves. To increase safety, Ansell maintains strict on/off-line controls and tests on resistance values. Safety is checked beyond required standards. For pinhole detection, Ansell Healthcare's pre-packaging Acceptable Quality Level (AQL) is stricter than the European standard (EN-455-1) for many of its surgical gloves. Ansell's state-of-the-art Advanced Rheology Technology (ART) process improves film strength and further reduces the risk of pinholes. As part of its commitment to addressing the concerns of healthcare professionals, Ansell will test all its new gloves for penetration to viruses and permeation to cytostatic chemicals according to its exclusive new testing methodologies.
