ANY QUESTION ?
We are at your disposal for any advice or information, by telephone or mail. Do not hesitate !
You can contact us by phone from monday to friday, between 9am to 6pm non-stop.
|+33 (0)2 96 93 37 89|
|SEND US AN EMAIL|
The menstrual cup is a 'new' product that has been getting a lot of attention lately. In reality, it is not such a new product since the menstrual cup was created in the 1930s by Leona Chalmers.
Since 1930, the menstrual cup has changed, but it remains a non-regulated product in Europe. We now have bibliographic data, but no test had been performed on the product itself.
Claripharm, who has developed menstrual cups for 5 years, tests and analyses its products and has scientific data which guarantee the quality of the product and how best to use it. Claripharm performs all its tests in laboratories approved by the Ministry of Research. In other words, in a completely transparent manner, we prove what we say.
At Claripharm we feel menstrual cups deserve the status of Medical Device because they are inserted into our bodies every month for five days, every month, for 30 years, and they remain in contact with the vaginal mucosa. It is important to know that in France and Europe, menstrual cups are considered everyday consumer hygiene products, which means they are no more regulated than a pen!
As such, we have obtained ISO13485 certification, an international standard that regulates the quality management of Medical Devices. This status implies quality requirements from the product’s design until your ownership. This status allows the product and all information about the product to evolve according to known scientific data.
In the context of the constant questions on the development of Toxic Shock Syndrome, we feel it is essential to evaluate the risks of use.
That's why we decided to carry out our own test on the Claricup.
With a view to improving the product and taking into account the evolution of scientific data, in September 2017, we carried out a test on the Claricup to determine its wearing time.
The risk of developing an TSS is very rare, but for this small percentage of existing risk, we need to give you a clear answer on the wearing time.
Claripharm performed this test in an independent laboratory approved by the Ministry of Research.
This test consisted of measuring the growth of Staphylococcus aureus in the presence or absence of the Claricup menstrual cup, every hour for 12 hours.
Always in keeping with the precautionary principle and with the objective of providing you with a healthy product, we have placed ourselves in the worst-case scenario. We performed this test under conditions of use that are the most favourable for the development of Staphylococcus aureus.
We added the culture medium to bottles, bottles containing a menstrual cup and empty bottles. Then we measured how the Staphylococcus aureus develops, every hour for 12 hours, at 37°.
The toxin of the Staphylococcus aureus begins to produce toxins after a certain number of hours. This allows us to define a maximum wearing time of 6 hours.
As you can see in the graph, the curves overlap, so there is no difference in the development of Staphylococcus aureus, whether or not there is a Claricup. The Claricup, therefore, does not promote Toxic Shock Syndrome.
Based on these scientific results, Claripharm recommends a wearing time of 6 hours.
By following simple and easy hygiene rules (wash your hands before handling the cup & clean the cup before each insertion), you reduce the risk of contaminating your cup and developing TSS.
The safety of our products is at the heart of our concerns & we are already working on solutions that make your life easier, but that... to be continued in the next news!