AVPP: Ansell Viral Penetration Program - Ansell Healthcare Europe

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Why the AVPP? As a worldwide leader in hand protection for healthcare practitioners, Ansell is committed to taking safety a step further. With this new AVPP programme, Ansell addresses a concern that all healthcare professionals have in their daily practice. Medical concerns Globally, an estimated 170 million people (3% of the global population) are infected with the hepatitis C virus (HCV). According to the latest assessments, over 40 million people are currently virally infected with HIV, and 350 million suffering from chronic HBV infection with hepatitis B. Insufficient regulation In Europe, there is no regulation regarding viral penetration through medical gloves. The EN-455 Part I standard (‘Requirements and testing for freedom from holes’) merely requires the statistical testing of glove impermeability (AQL measurement). This testing is carried out through a static methodology involving water contact. However, glove manufacturers in Ansell Viral Penetration Program (AVPP) Penetration versus Permeation By 2004, Ansell had already launched the Ansell Cytostatic Permeation Program (ACPP). This permeation assessment protocol has resulted in safer guidelines for handling high-risk chemicals, such as drugs used in chemotherapy. With Ansell’s newly introduced and exclusive AVPP testing pro- Obviously, throughout their daily practice healthcare professionals are in contact with patients who are potentially virus-contaminated. Of all the viruses, hepatitis B and C, along with AIDS, cause the greatest concern and, as a result, healthcare professionals want to be certain they are using the best possible materi- Europe apply the American standard ASTM F 1671-97b, which uses a standard methodology to test the resistance of protective clothing materials against penetration by blood-borne pathogens and which utilises the Phi-X174 bacteriophage penetration as a test system. This testing methodology has its own limitations, as the standard itself describes: “…this test method does gramme, a similar ‘dynamic’ methodology is applied in order to measure potential viral penetration through medical gloves and provide better protection for healthcare professionals. The AVPP uses the Ansell Dynamic Testing Device (Ansell exclusivity) , which simulates the real-life, dynamic situations such as rubbing, stress, exposure and the tension that med- Penetration is defined as the movement on a non-molecular level of a chemical or microorganism through a protective glove’s porous materials, tears, pinholes or other imperfections or manufacturing defects. als to prevent viral contamination. More and more, they question glove manufacturers about the level of protection provided by their products against blood-borne viruses because viral penetration may, potentially, occur through any glove imperfections, such as pinholes. not simulate all the physical stress and pressures that might be exerted on protective clothing materials during use” and “The integrity of the protective barrier may also be compromised during use by such effects as flexing and abrasion.” Because of their commitment to improving safety for the healthcare practitioners, Ansell has decided to develop the AVPP programme. ical gloves endure in daily work manipulations. The result is a far more accurate evaluation of glove resistance to viral penetration. The AVPP is the result of the collaboration between the Université Catholique de Louvain’s department of toxicology and special chemistry, their virology lab and Ansell Europe’s medical business group. Permeation is the process by which a chemical moves through a protective glove’s material on a molecular level.
The AVPP methodology We have assessed the resistance of Ansell’s surgical or examination gloves to dynamic penetration by blood-borne pathogens, using the Phi-X174 bacteriophage as a surrogate and non-pathogenic micro-organism to simulate Ansell Dynamic Testing Device Testing protocol Viral penetration has been assessed on a ‘pass or fail’ basis. Taking into account Ansell’s recommendations for surgical gloves (i.e. to be changed after one hour maximum usage) and for examination gloves (to be changed after 30 minutes maximum usage), the following exposure times have been used: • for surgical gloves: testing occurred after 0, 30, 60 and 120 minutes of exposure • for examination gloves: testing occurred after 0, 30 and 60 minutes of exposure. Twenty key medical gloves (surgical and examination) have been tested but the vinyl examination gloves were excluded because scientific evidence shows that vinyl’s protection barrier is relatively weak compared to other glove materials. pathogenic viruses. The diameter of this bacteriophage is much smaller than HIV, HBV or HCV viruses. This surrogate is the same bacteriophage as used for the ASTM 1671 standard. The virus concentration in cultures that are in contact with gloves and the measuring methods of viral penetration are also the same as for the ASTM standard. However, the exposure to a virus follows a different methodology using the Ansell Dynamic Testing Device to simulate the reality of daily usage.
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AVPP: Ansell Viral Penetration Program - Ansell Healthcare Europe

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