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
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 2008 Ansell Europe 2007 Gammex ® PF XP™ Extra protection for handling cytostatic agents.
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 2008 Ansell Europe 2008 Gammex ® PF XP™ Extra protection for handling cytostatic agents. PPE 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 µg/g (Modified Lowry / HPLC). Fitkit ™: Non detectible (very low allergenicity) – Sum of the four clinically relevant allergens measured below > 0.03 µg/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 2008 Ansell Europe 2008 Gammex ® PF XP™ Extra protection for handling cytostatic agents.
January 2008 Ansell Europe 2008 Healthcare risks associated with Cytostatics Drugs known to be likely: –Mutagen –Carcinogen –Teratogenic or foetotoxic –Decrease the fertility –Induce foetal malformation –Induce abortion –Induce extra uterine pregnancy –High toxicity for certain organs Remember : One (carcinogen) molecule is able to induce cancer ! Dr J.M.Sessink – GERPAC 2004 Gammex ® PF XP™ Extra protection for handling cytostatic agents.
January 2008 Ansell Europe 2008 Gammex ® PF XP™ Extra protection for handling cytostatic agents. Cancer rates could further increase by 50% to 15 million new cases in the year 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 2008 Ansell Europe 2008 Leading the research on cytostatics permeability ACPP Brochure (2) Cytostatic handling and glove handling (5) Ansell Cares Gammex ® PF XP™ Extra protection for handling cytostatic agents.
January 2008 Ansell Europe 2008 Gammex ® PF XP™ Extra protection for handling cytostatic agents.
January 2008 Ansell Europe 2008 Gammex ® PF XP™ Extra protection for handling cytostatic agents. Dynamic simulation device Movement Full training presentation on ACPP in launch pack included!
January 2008 Ansell Europe 2008 Gammex ® PF XP™ Extra protection for handling cytostatic agents. 1.Reproduce as closely as possible real life physical constraints on gloves to be analyzed for permeation, Incl.: - Rubbing - Stress - Tension 2. Scientific approach 3. Reproducible Dynamic versus static testing
January 2008 Ansell Europe 2008 Gammex ® PF XP™ Extra protection for handling cytostatic agents. Presenting results corresponding to real life conditions – pared with product recommendation for all application steps Now test results available after alcohol disinfection! ACPP Tests (4)
January 2008 Ansell Europe 2008 n "Council Directive" of 21 Dec on the approximation of the laws of the Member States relating to personal protective equipment (89/686/EEC) n “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 “patient” Gammex ® PF XP™ Extra protection for handling cytostatic agents. Regulatory Requirements (Personal Protective Equipment)
January 2008 Ansell Europe 2008 Product Codes: Size pairs per box / 240 pairs per case Size pairs per box / 240 pairs per case Size pairs per box / 240 pairs per case Size pairs per box / 240 pairs per case Size pairs per box / 240 pairs per case Size pairs per box / 240 pairs per case Size pairs per box / 240 pairs per case Size pairs per box / 240 pairs per case CE mark – CE0493 Personal Protective Equipment Made in Sri Lanka, 3 years shelf-life Ansell launches Gammex ® PF XP™: April 2008 Gammex ® PF XP™ Extra protection for handling cytostatic agents.
January 2008 Ansell Europe 2008 Promotion 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 alert Gammex ® PF XP™ Extra protection for handling cytostatic agents.
January 2008 Ansell Europe 2008 Test reports and clinical literature (1)Gammex PF XP Technical Datasheet, Ansell Healthcare Europe, Belgium 2008 (2)Ansell Cares: ACPP Brochure 2008 (3)Safe handling of cytostatic agents, Broschure 2008 (4)ACPP test performed at the University of St. Luc, Belgium 2007 (5)Cytotoxic handling and the importance of appropriate gloving - Johan Vandenbroucke – April 2007 (6)Permeability 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 FAVIER (7)EN Permeation of liquid chemical through protective clothing, 2007 (8)EN 388 – Cytostatic Glove testing, 2007 (9)Cytotoxity Study, Pending (10)Iso Sensitization Study, Pending (11)Primary Skin Irritation Study, Pending (12)Fitkit by Quatromed, 2007 Fine more information: http//: Gammex ® PF XP™ Extra protection for handling cytostatic agents.