Via Mercadante Saverio, 15 - 20124 MILANO (MI) - Italy

Telefono: 026704424

 

 

Via Mercadante Saverio, 15 - 20124 MILAN (MI) - Italy

Telephone: +39026704424

 

EMODREN Drain system

The PVC (polyvinylchloride) used in the production of medical devices usually contains DEHP (diethylhexylphthalate), a phthalate-based plasticiser that improves the flexibility and softness of PVC.

 

In recent years the safety of the phthalates commonly used as plasticisers, and above all DEHP, has been challenged because of their tendency in certain conditions to release particles of plastic potentially harmful to patients.

 

Plastic components in medical devices often come into direct contact with the patient’s body, as in the case of transfusion tubes, enteral feeding bags, etc.

 

Contact between a DEHP plasticiser and a liquid may cause the release of dangerous substances that deposit in the patient’s body, and especially of substances that are carcinogenic, mutagenic or toxic to reproduction.

Given the potential hazards of products containing phthalates and in compliance with an Essential Requirement of European Directive 2007/47/EC, Medicalplastic, which is constantly focused on defending patients’ health, introduced tubes with a phthalate-free plasticiser in its range of Emodren drainage tubes in September 2009.

 

We chose a new generation plasticiser developed for sensitive applications such as children’s toys, food packaging and medical devices in which PVC is used. It meets high standards of quality and safety and has undergone extremely rigorous testing.

 

Our action was one of extreme precaution in that our drainage products come into contact with the patient’s body for only limited periods of time, up to 36 hours at the most. Further, in our drainage systems, blood and exudate are only drained and not re-introduced into circulation.

 

In such conditions, the risk of release of substances hazardous to the patient, and therefore toxicological risk, is clearly remote.

 

After the introduction of these drainage tubes, Medicalplastic also gradually replaced the PVC components in its Emodren system not coming into direct contact with the patient’s body (connections, valves, plugs and bags) with products made exclusively of DEHP FREE materials.

 

 

PHTHALATE FREE (DEHP FREE) PVC COMPONENTS

ILIZAROV

Circular external fixator

 

 

ILIZAROV

Aluminium external fixator

Medicalplastic s.r.l.

 

LEGAL AND ADMINISTRATIVE OFFICE

 

Via Mercadante, 15

20124 Milan

Telephone: +39026704424

 

 

 

PRODUCTION UNIT

 

Via per San Giorgio, 65

20025 LEGNANO (Mi)

Telephone: +390331403815

 

 

 

 

 

 

P. IVA 05013610158

C.F. 00218790038

 

 

CONTACTS

 

e-mail: info@medicalplastic.it

 

e-mail: legnano@medicalplastic.it

 

web: http://www.medicalplastic.it