Product Launch Presentation

Product Launch Presentation

January 2008

Gammex® PF XP™ Extra protection for handling cytostatic agents

January 2008, Ansell Healthcare EuropeMarcus Heimann, Group Product ManagerProfessional Healthcare

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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

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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)

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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.

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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

ableto induce cancer !Dr J.M.Sessink – GERPAC 2004


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Cancer 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

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Leading the research on cytostatics permeability

http://www.ansell.eu

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

Ansell Cares


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Dynamic simulation device

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Full training presentation on ACPP in launch pack included!

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1.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

http://www.ansellpartnerprogram.com/en/media/files/DVD/Eng%20-%20Germ%20-%20Fr%20-%20NL%20-%20Sp%20-%20It/VIDEO_TS/VIDEO_TS.IFO

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Presenting results corresponding to real life conditions – pared with product recommendationfor all application steps

Now test results available after alcohol disinfection!

ACPP Tests (4)

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"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 “patient”


Regulatory Requirements (Personal Protective Equipment)

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Product Codes:

353081 Size 5.5 40 pairs per box / 240 pairs per case353082 Size 6.0 40 pairs per box / 240 pairs per case353083 Size 6.5 40 pairs per box / 240 pairs per case353084 Size 7.0 40 pairs per box / 240 pairs per case353085 Size 7.5 40 pairs per box / 240 pairs per case353086 Size 8.0 40 pairs per box / 240 pairs per case353087 Size 8.5 40 pairs per box / 240 pairs per case353088 Size 9.0 40 pairs per box / 240 pairs per case

CE mark – CE0493 Personal Protective EquipmentMade in Sri Lanka, 3 years shelf-life

Ansell launches Gammex® PF XP™:

April 2008


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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 e-mail alert


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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 374-3 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//:www.ansell.eu


Product Launch Presentation

Documents

Transcript of Product Launch Presentation