Post on 21-Apr-2017
transcript
REVIEWING PROGRESS IN SWITCHING FROM DEHP IN MEDICAL DEVICESOle Grøndahl HansenPVCMed AlliancePVC Formulation 2017, Düsseldorf
Conclusions
Content
PVC in medical devices
DEHP in medical devices
Justification now required
Reasons for replacement
Circular Economy Package
Recycling of PVC medical waste
Alternatives available
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DEHP in Medical Devices
Due to cost and performance DEHP has for many years been the preferred plasticiser
However:Growing environmental and health concerns make it clear that DEHP replacement now is inevitable
In the EU DEHP is classified as toxic to reproduction
The ECHA Member State Committee agreed that DEHP is a Substance of Very High Concern
International Agency for Research on Cancer has indicated that there is sufficient evidence that DEHP is carcinogenic
DEHP in Medical Devices
The reasons for replacement are manifold:
In 2016 The European Council adopted a political agreement on the new Medical Device Regulation
Justification required
In 2020 these justification requirements will go into force
As a consequence the use of DEHP in medical devices will in the future require robust justification
Justification required
MAIN POINTS OF THE JUSTIFICATION INCLUDES:
An analysis of potential patient exposure to the substance
An analysis of possible alternative substances
Argumentation of why possible alternative substances are inappropriate to use
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Circular Economy Package
In 2015 the European Commission adopted a Circular Economy Package
The Circular Economy Package includes a PLASTIC STRATEGY
The PLASTIC STRATEGY covers issues such as the presence of hazadous substances (like DEHP) in plastics in the context of waste and recycling
Circular Economy Package
The presence of DEHP in medical devices is a burden to the waste management and recycling of these devices
VinylPlus has put together a PVC medical device waste management programme in the UK
However by using alternatives to DEHP in the PVC, these devices can be designed for a circular economy
Positive feedback from hospitals – appreciate cost savings
Recycling of medical devices today
RecoMed project in UK is based on succesful recycling scheme in Australia
Funded by VinylPlus
Oxygen and anaesthetic mask, tubing and IV fluid bags are recycled
Seven hospitals currently enrolled
Alternatives available
The Danish EPA asked the PVC industry why substitution is progressing
slowly
Partnership established
Report published International conference in Copenhagen
“Overall, the report identified 10 potential Alternatives to DEHP in medical devices.The alternatives have been studied for their inherent environmental and health properties.Most of the considered alternatives show a better toxicological profile than DEHP, and are thus preferable to DEHP.”Danish EPA – press release, 27 March 2014
WHY CHOOSE USConclusions from report1
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PVC is the most popular polymer for medical devicesRecycling of PVC-based medical devices establishedDEHP under constant pressure
DEHP a barrier to recycling
There is a shift from DEHP but the pace should be faster
Conclusions
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