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Parliamentary questions
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14 April 2010
Answer given by Mr Dalli on behalf of the Commission
Question reference: E-6633/2009

The Commission has taken the concerns expressed by the Honourable Member very seriously and has analysed the problem of contamination from the plunger rod.

As the Commission informed the Committee on Petitions on 1 December 2008, petition 637/2008 was transmitted to the Member States. However, none of the Member States identified a need for action. Only one Member State responded, expressing the opinion that the likelihood of contamination was extremely low and thus no action was needed.

The Commission has also been in contact with the secretariat of the relevant standardisation body, the European Committee for Standardisation (CEN). CEN shares the view that the risk deriving from contact with the plunger rod is appropriately covered by the applicable harmonised standard relating to sterile hypodermic syringes for single use which provides that it should not be possible to easily withdraw the plunger completely from the barrel and requires information for handling, storage and transportation of the contents to be placed on the packaging. The Commission is confident that CEN will appropriately examine, on the basis of the information transmitted by the Honourable Member, whether the requirements contained in this standard should be fine-tuned.

Further progress might be achieved at the level of training and awareness-raising of medical staff. Experts stated that it is an essential part of any training on the use of syringes to instruct users not to touch the plunger rod and not to use the syringe once the plunger is pulled out of the barrel of the syringe. As the Honourable Member is aware, the Commission has, on 26 October 2009, adopted a proposal for a Council directive(1) implementing the framework Agreement on prevention from sharp injuries in the hospital and healthcare sector concluded by European hospital and healthcare employers' association (HOSPEEM) and European Federation of Public Service Unions (EPSU). The proposal was adopted by the Council on 8 March 2010. The European Commission is confident that this directive will strengthen the training of medical staff on the use of syringes, to the benefit of both healthcare workers and patients. Thus this directive will also reduce the risk of contamination via the plunger rod of syringes.

(1)COM(2009)577 final.

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