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Product Launch Presentation . January 2008. Gammex ® PF XP™ Extra protection for handling cytostatic agents January 2008, Ansell Healthcare Europe Marcus Heimann, Group Product Manager Professional Healthcare. Ansell Europe 2008. Gammex ® PF XP™ - PowerPoint PPT Presentation

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  • Product Launch Presentation January 2008Gammex PF XP Extra protection for handling cytostatic agents

    January 2008, Ansell Healthcare EuropeMarcus Heimann, Group Product Manager Professional Healthcare

    Ansell Europe 2008

  • Agenda

    Gammex PF XP

    Technical Features and Benefits

    Healthcare risks associated with cytostatics

    Leading the research on cytostatic permeation

    ACPP: Results corresponding to real life conditions

    AnsellCares Support Documentation

    Regulatory Requirements (Personal Protective Equipment)

    Promotion & Launch Pack

    January 2008Ansell Europe 2007

  • Technical Features & Benefits

    Indigo blue colour for easy identification of personal protection in a high risk environment

    - Optimized wall thickness (10% thicker) secures ACPP permeation times for effective barrier protection Low risk of pin-holes due to increased wall thickness, visual inspection and water leak testing before packing GL I AQL 0.65 leads to high barrier protection (1)

    Polyurethane lining with hydrophilic and hydrophobic elements facilitates damp donning and double gloving (1)

    Improved grip level to secure safe handling of laboratory equipment

    Provides superior comfort to avoid hand fatigue (specifically against Z+ from Berner)

    January 2008Ansell Europe 2008PPE Pictograms!

  • Low allergenic profile of Gammex Technology.

    Protein and Endogenous Allergen Reduction Leaching (P.E.A.R.L.) Technology that delivers a glove with extremely low extractible proteins, reducing risk of latex sensitization (Typical values are below < 10 g/g (Modified Lowry / HPLC). Fitkit : Non detectible (very low allergenicity) Sum of the four clinically relevant allergens measured below > 0.03 g/g (9, 10, 11, 12)

    - Unique (PV100) accelerator becomes gases which are completely consumed during processing leaving non detectable chemical accelerator residue thereby reducing the risk of contact dermatitis.

    January 2008Ansell Europe 2008

  • January 2008Ansell Europe 2008Healthcare risks associated with CytostaticsDrugs known to be likely: MutagenCarcinogenTeratogenic or foetotoxicDecrease the fertilityInduce foetal malformation Induce abortionInduce extra uterine pregnancyHigh toxicity for certain organs

    Remember : One (carcinogen) molecule is able to induce cancer ! Dr J.M.Sessink GERPAC 2004

  • January 2008Ansell Europe 2008Cancer rates could further increase by 50% to 15 million new cases in the year 2020 Steadily ageing populations smoking habits and the growing adoption of unhealthy lifestyles

    The proportion of protective gloves used for chemotherapy ranges from 3 to 5 % of the total consumption

  • January 2008Ansell Europe 2008Leading the research on cytostatics permeability

    http://www.ansell.eu

    ACPP Brochure (2) Cytostatic handling and glove handling (5)Ansell Cares

  • January 2008Ansell Europe 2008

  • January 2008Ansell Europe 2008Dynamic simulation deviceFull training presentation on ACPP in launch pack included!

  • January 2008Ansell Europe 20081.Reproduce as closely as possible real life physical constraints on gloves to be analyzed for permeation, Incl.: - Rubbing- Stress Tension

    2. Scientific approach3. Reproducible

    Dynamic versus static testing

  • January 2008Ansell Europe 2008Presenting results corresponding to real life conditions pared with product recommendationfor all application steps

    Now test results available after alcohol disinfection!ACPP Tests (4)

  • January 2008Ansell Europe 2008"Council Directive" of 21 Dec. 1989 on the approximation of the laws of the Member States relating to personal protective equipment (89/686/EEC) Personal Protective Equipment" means any device or appliance designed to be worn or held by an individual for protection against one or more health & safety hazards"

    The primary intention is to protect the worker, no direct contact between the worker and the patientRegulatory Requirements (Personal Protective Equipment)

  • January 2008Ansell Europe 2008

    Product Codes:353081Size 5.5 40 pairs per box / 240 pairs per case353082Size 6.0 40 pairs per box / 240 pairs per case353083Size 6.5 40 pairs per box / 240 pairs per case353084Size 7.0 40 pairs per box / 240 pairs per case353085Size 7.5 40 pairs per box / 240 pairs per case353086Size 8.0 40 pairs per box / 240 pairs per case353087Size 8.5 40 pairs per box / 240 pairs per case353088Size 9.0 40 pairs per box / 240 pairs per caseCE mark CE0493 Personal Protective EquipmentMade in Sri Lanka, 3 years shelf-lifeAnsell launches Gammex PF XP: April 2008

  • January 2008Ansell Europe 2008Promotion Mix / Launch Pack

    Product Leaflet Technical Datasheet How to prepare cytostatic drugs safely Updated ACPP Brochure Press release Give-a-way On-line support: Web-Site (New banner) In Touch Newsletter e-mail alert

  • January 2008Ansell Europe 2008Test reports and clinical literature

    Gammex PF XP Technical Datasheet, Ansell Healthcare Europe, Belgium 2008Ansell Cares: ACPP Brochure 2008Safe handling of cytostatic agents, Broschure 2008ACPP test performed at the University of St. Luc, Belgium 2007Cytotoxic handling and the importance of appropriate gloving - Johan Vandenbroucke April 2007Permeability of 13 different gloves to 13 cytotoxic agents under controlled dynamic conditions PIERRE E. WALLEMACQ, ARNAUD CAPRON, ROGER VANBINST, ERIC BOECKMANS,JEAN GILLARD, AND BERTRAND FAVIEREN 374-3 Permeation of liquid chemical through protective clothing, 2007EN 388 Cytostatic Glove testing, 2007Cytotoxity Study, PendingIso Sensitization Study, PendingPrimary Skin Irritation Study, PendingFitkit by Quatromed, 2007

    Fine more information: http//:www.ansell.eu