Prothèses PIP (suite)
Date : samedi 23 mars 2013 @ 09:34:20 :: Sujet : News générales
Dans son édition de samedi le journal LE MONDE annonce que TUV Rheinland a été assigné vendredi 22 mars devant le tribunal de commerce de Toulon par six distributeurs et près de 1500 femmes porteuses d'implants mammaires PIP, l'organisme allemand certificateur des prothèses fabriquées par la société Poly Implant .
Cet organisme lui même faisait contrôler les prothèses par deux sociétés contrôlées par…
Devinez-qui ?
Et lisez sa réponse.
Voici l’extrait de la dépêche REUTERS et cliquez ici pour lire l'article en ligne
SMOKESCREEN"
Once the Notified Body's initial job is done and a product is on the market, it's up to national regulators to keep a look out for problems and ensure the Notified Body is keeping tabs.
In the PIP case, that national regulator was the Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS), which has the power to take a medical device off the market. The Notified Body that gave PIP authorization to trade was a private German firm called TUV Rheinland.
AFSSAPS - already set for an overhaul following a scandal over diet pills which France withdrew in 2009 after they were blamed for at least 500 deaths - told Reuters that responsibility for checking medical devices like breast implants lies with the manufacturer.
It said the regulatory focus should be on TUV, whose inspectors would visit PIP's headquarters once a year, assess standards, review paperwork and then report back to the company and German authorities in case of problems.
TUV said the implants themselves were tested by two French laboratories, which were in turn authorized by another French agency called COFRAC. Both labs confirmed they had tested PIP's implants. One said its tests were only mechanical, such as rupture tests; the other said it had tested the implants' contents for toxicity, but would not give details.
COFRAC, a government-funded non-profit body, said it was not responsible for the output of a lab and could not guarantee test results. COFRAC does not answer to AFSSAPS, but is audited internally and by peer review.
|