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C2DS raises alarm about nano forms of titanium dioxide

The use of nanomaterials is rapidly increasing, both in industrial applications and in consumer products, even though their health and environmental effects are unknown, say C2DS. Nano forms of titanium dioxide have decontaminating qualities and are used in personal care products pharmaceuticals, food-processing, building products and the hospital sector.

Nanoparticulate forms of titanium dioxide have already been classified as "possibly carcinogenic" to humans” (carcinogenic 2B). Furthermore, recent studies insist on its "genotoxicity". The increasing use of the nanoparticulate forms of titanium dioxide in the hospital sector means healthcare professionals and the public should be aware of potential effects. Ethylene oxide: a recurrent threat

The use of ethylene oxide, which is carcinogenic, mutagenic, and reprotoxic, is becoming widespread. Its use in sterilization processes for baby’s dummies (pacifiers), feeding-bottles and nipple shields has created a public health issue. The French national directorate of nursing care supplies (La Direction Générale de l’Offre de Soins (DGOS)) has published recommendations thereby informing every French maternity hospital.

The tip of the iceberg

The French group C2DS has raised the alarm about ethylene oxide use for sterilizing medical devices (catheters, probes, enteral feeding devices), implants and prostheses (breast, orthopaedic implants and intraocular implants). While ethylene oxide is acknowledged to be toxic for baby’s dummies (pacifiers), its toxicity has yet to be recognized for enteral feeding devices. Moreover there are carcinogenic risks for professionals and users who come into contact with its residues (see Ille-de-France Regional Health Insurance Office (CRAMIF) document, September 2009, which says that ethylene oxide sterilization should be replaced by other less harmful processes, where possible).

In France, healthcare facilities follow the regulations and recommendations of governing bodies, particularly the French Office for Health Product Safety (Agence française de sécurité sanitaire des produits de santé: AFSSAPS) and the Ministry of Health. However, French healthcare professionals urgently require more information and training, and this probably also applies to healthcare professionals in other EU countries.

Companies should prove the harmlessness of their products even when they have an AMM (Market Launch Authorization). The use of ethylene oxide as a sterilization process must appear on technical data sheets, packaging and the product itself.

The French Ministry is conducting an investigation on the use of ethylene oxide for the sterilization of pacifiers, feeding bottles and nipple shields. Olivier Toma, chairman of C2DS, has met with the French Health minister, Xavier Bertrand and the General Inspectorate of Social Affairs (IGAS) about this study.

Last updated on 7 March 2012

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