On the 8th of March 2021, The Norwegian Medicines Agency (Statens legemiddelverk) announced that they had decided to withdraw from the market a called “Copper Inside”. The reason behind this decision was that the product was lacking necessary documentation and does not meet the requirements of the regulations for medical devices.
Not only did The Norwegian Medicines Agency withdraw the product from the market, but they also prohibited the sale of Copper Inside medical mask in Norway.
In November 2020, Provida Medical AS was approached by a distributor and asked if we could sell this product in the Nordic region. We told the distributor that we had to receive all documentation for the product and have our Regulatory Affair department to validate the documentation – before we could decide whether we would bring this product into our product portfolio or not. We had some big concerns regarding the use of dicopper oxide in the product.
After some few days with investigation and evaluation of the documentation, our Regulatory Affairs department concluded that the manufacture was unable to supply us with the requested additional information that we had asked for – and most important of all, the manufacture could not document the safety of the product nor the claims that the mask was reusable. We therefor decided not to include this product in our product portfolio, even having clients asking for this product.
The Norwegian Medicines Agency also concluded in their evaluation: “that the
manufacturer has not provided evidence that the product is sufficiently risk-assessed, how the medical mask affects the environment when discarded and sufficient
documentation that the product can be reused”.
"We discourage the use of Copper Inside medical mouthpieces, since the equipment lacks proof that it is safe and secure to use," said Tore Tørisen, chief medical officer of the Norwegian Medicines Agency.
Is the product dangerous?
A key question is of course if medical face masks with dicopper oxide are dangerous to use? The European Chemical Agency (ECHA) has given dicopper oxide a hazard classification if inhaled or swallowed. Once scenario could be that fibre or dust from production could be on the surface of the mask and thereby come into the user’s lungs. Dicopper oxide can also cause serious eye damage.
A key point in this case is exactly as The Norwegian Medicines Agency writes in their statement: “The manufacturer is responsible for providing documentation that the product is safe and safe to use, and to prove that the exposure to which the user is exposed is acceptable”.
When using products sold by Provida Medical AS, you can be assured that we have thoroughly investigated the product and the associated documentation.