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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