Vous avez certainement tous entendu parler du scandale du “filet de mandarine” qui aurait réussi à obtenir un marquage CE en tant que dispositif médical. Ce scandale a positionné le monde du dispositif médical au centre de toutes les attentions, notamment concernant les procédures réglementaires pour la mise sur le marché de tels dispositifs.
Dans l’article suivant, des étudiants ingénieurs en Technologies de l’Information pour la Santé de Polytech Grenoble ont analysé dans le détail cet événement afin d’apporter des éléments de réponses pertinents à la question : ce scandale est-il justifié et quelles sont les réelles procédures de mise sur le marché d’un dispositif médical ?
Les étudiants se sont appuyés sur la réaction d’un pharmacien sur son blog “La Coupe d’Hygie” où il a écrit “Le (faux ?) scandale des dispositifs médicaux”, en reprenant l’ensemble des points pouvant être commentés à propos de l’obtention du marquage CE du filet de mandarines.
L’article comprend une première partie dans laquelle le contexte est expliqué plus en détail. La deuxième partie concerne la procédure de marquage CE et la troisième partie présente une critique du système actuel de réglementation des dispositifs médicaux.
Pour voir l’article complet, consultez le fichier ci-joint :
As most of you should know, Candlemas is fast approaching, and you all must be craving to eat the famous Crêpes we all bake on February 2nd. However, do you know where this tradition comes from?
Just like every other festivity surrounding Nativity, Candlemas is linked to light.
In the pagan rites, the Romans would scarify an animal during de rite of Lupercia in order to have the blessing of the Pan God. This rite was inherited from the Festa Candelarum, a Roman celebration which would commemorate the seeking of the goddess of light Persophone, according to the Greek mythology.
However, the Church had undertaken since the end of the Roman Empire a vast project of replacing pagan rites with religious festivals. Thus, during the 5th century, Pope Gelasius I decided to replace this old pagan rite by a Candlelight Festivity: Candlemas.
This festival is held exactly 40 days after Christmas, and commemorates the purification of Mary. Indeed, according to Hebrew rites, a mother must present her new-born at a temple 40 days after his birth, which is what Mary did. In the east, it became a non-working day. In the West, torches were carried in procession, a sign of light. « Candlemas » comes from candela – the candle in Festa Candelarum – hence the Candlelight Festivity.
Christians would find themselves in a church, and would bring a blessed candle home, being careful to keep it lit, for the candle would invoke the good omens to watch over the sowing winter, allowing to produce the good harvests of the next summer. Indeed, according to the French saying: « Whoever brings home his candle lit, for sure will not die in the year. »
Therefore, Candlemas is linked to light, but also to purification, fertility and prosperity.
But what of the symbolic crêpe then? Well, “Candlemas crêpes” were eaten as early as the 5th century! Farmers used to purify their land with torches before sowing. The excess flour was used to bake crêpes, which became a symbol of prosperity for the coming year. Indeed, the shape and the colour of the crêpe evoke the sun coming back after a winter night. The first baked crêpe of the year would have to be put on top of a wardrobe with a golden coin, for it supposedly never rots, preventing mold for the entire future harvest.It is also said that pope Gelasius I would welcome pilgrims arriving in Rome with crêpes.
The legend of February 2nd was exported all the way to North America by European settlers. However, it was quickly replaced by Groundhog Day. Indeed, according to a European legend, hedgehogs predicted the arrival of spring, depending on the weather during Candlemas day. Hedgehogs being inexistent in North America, European settlers decided that Groundhogs would predict the arrival of spring. They therefore started to await the arrival of an early spring when they would see the shadow of a groundhog awakened on February 2nd .
Among all these legends, it is needed to note that the shadow in the legend is partly true. In winter, sunny days are usually associated with Arctic air, which is colder and drier. On the other hand, cloudy days are associated with maritime air, which is wetter and softer. Since weather conditions usually last for a few days, February 2nd conditions can last a few days. Hence the saying: “If Candlemas Day be fair and bright, Winter will have another fight. If Candlemas day brings cloud and rain, winter won’t come again”
So now you know all about February 2nd! Will you keep your first baked crêpe on top of your wardrobe? Will you flip it with a golden coin? Or will you eat just it because, after all, eating crêpes is life?