Transcript No Slide Title

Product Launch Presentation
January 2008
Gammex® PF XP™
Ansell Europe 2008
Extra protection for handling cytostatic agents
January 2008, Ansell Healthcare Europe
Marcus Heimann, Group Product Manager
Professional Healthcare
Gammex® PF XP™
Extra protection for handling cytostatic agents.
January 2008
Agenda
Gammex® PF XP™
Technical Features and Benefits
Healthcare risks associated with cytostatics
Leading the research on cytostatic permeation
Ansell Europe 2007
ACPP: Results corresponding to real life conditions
AnsellCares Support Documentation
Regulatory Requirements (Personal Protective Equipment)
Promotion & Launch Pack
Gammex® PF XP™
Extra protection for handling cytostatic agents.
January 2008
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
Ansell Europe 2008
GL I AQL 0.65 leads to high barrier protection
PPE Pictograms!
(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)
Gammex® PF XP™
Extra protection for handling cytostatic agents.
January 2008
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)
Ansell Europe 2008
- Unique (PV100) accelerator becomes gases which are completely consumed during
processing leaving non detectable chemical accelerator residue thereby reducing
the risk of contact dermatitis.
Gammex® PF XP™
Extra protection for handling cytostatic agents.
January 2008
Healthcare risks associated with Cytostatics
Ansell Europe 2008
Drugs known to be likely:
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Remember :
One (carcinogen) molecule is
able
to induce cancer !
Mutagen
Carcinogen
Teratogenic or foetotoxic
Decrease the fertility
Induce foetal malformation
Induce abortion
Induce extra uterine pregnancy
High toxicity for certain organs
Dr J.M.Sessink – GERPAC 2004
Gammex® PF XP™
Extra protection for handling cytostatic agents.
January 2008
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
Ansell Europe 2008
unhealthy lifestyles
The proportion of protective gloves used for
chemotherapy ranges from 3 to 5 % of the total
consumption
Gammex® PF XP™
Extra protection for handling cytostatic agents.
January 2008
Leading the research on cytostatics permeability
http://www.ansell.eu
Ansell Europe 2008
Ansell Cares
ACPP Brochure
(2)
Cytostatic handling and glove
handling
(5)
Gammex® PF XP™
Extra protection for handling cytostatic agents.
Ansell Europe 2008
January 2008
Gammex® PF XP™
Extra protection for handling cytostatic agents.
Ansell Europe 2008
Movement
Dynamic simulation device
Full training presentation on ACPP in launch pack included!
January 2008
Gammex® PF XP™
Extra protection for handling cytostatic agents.
Dynamic versus static testing
1.Reproduce as closely as possible
real life physical constraints on gloves
to be analyzed for permeation, Incl.:
- Rubbing
- Stress
Ansell Europe 2008
- Tension
2. Scientific approach
3. Reproducible
January 2008
Gammex® PF XP™
Extra protection for handling cytostatic agents.
Ansell Europe 2008
January 2008
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)
Gammex® PF XP™
Extra protection for handling cytostatic agents.
Regulatory Requirements
January 2008
(Personal Protective Equipment)

Ansell 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
“patient”
Gammex® PF XP™
Extra protection for handling cytostatic agents.
January 2008
Ansell launches Gammex® PF XP™:
April 2008
Ansell Europe 2008
Product Codes:
353081
353082
353083
353084
353085
353086
353087
353088
Size
Size
Size
Size
Size
Size
Size
Size
5.5
6.0
6.5
7.0
7.5
8.0
8.5
9.0
40
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pairs
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CE mark – CE0493 Personal Protective Equipment
Made in Sri Lanka, 3 years shelf-life
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Gammex® PF XP™
Extra protection for handling cytostatic agents.
Promotion Mix / Launch Pack
 Product Leaflet
 Technical Datasheet
 How to prepare cytostatic
drugs safely
 Updated ACPP Brochure
 Press release
 Give-a-way
Ansell Europe 2008
On-line support:
 Web-Site (New banner)
 In Touch Newsletter
 e-mail alert
January 2008
Gammex® PF XP™
Extra protection for handling cytostatic agents.
January 2008
Test reports and clinical literature
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
(12)
Gammex PF XP Technical Datasheet, Ansell Healthcare Europe, Belgium 2008
Ansell Cares: ACPP Brochure 2008
Safe handling of cytostatic agents, Broschure 2008
ACPP test performed at the University of St. Luc, Belgium 2007
Cytotoxic handling and the importance of appropriate gloving - Johan Vandenbroucke – April 2007
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
EN 374-3 Permeation of liquid chemical through protective clothing, 2007
EN 388 – Cytostatic Glove testing, 2007
Cytotoxity Study, Pending
Iso Sensitization Study, Pending
Primary Skin Irritation Study, Pending
Fitkit by Quatromed, 2007
Ansell Europe 2008
Fine more information: http//:www.ansell.eu