Latest Fimea News
Aug 28, 2021
August 28, 2021 One of the largest mask manufacturers in Finland Lifa Airin founder, CEO and Chairman of the Board Vesa Mäkipää says that there are shortcomings in the control of masks coming to Finland from abroad. According to Mäkpää, masks with forged certificates, for example, can end up in Finland from around the world. The consumer cannot know from the appearance of the mask whether the cover actually meets all EU quality requirements. “Authorities do not have the resources or ability to determine whether a certificate is forged. At the moment, Customs is not able to control the matter and Finland is leaving the world with remnants of masks, ”Mäkipää shoots. “If the Finnish authorities did their job, domestic mask manufacturers would not have a day of need. Now this is a wild west, all kinds of obscure players have nested in the market. ” Finland control of the mask market is divided between several different authorities. No one has overall responsibility, as the masks are divided into different products according to the intended use. Surgical, disposable mouth and nose pads are guarded by the Pharmaceutical Safety and Development Center Fimea. Commercial particle masks, such as the FFP2 and FFP3 masks, are again monitored by regional government agencies. Fabric folk masks are jointly supervised by the Security and Chemicals Agency Tukes and Customs. In addition, Customs provides information on consignments arriving in Finland from outside the EU to Fimea and regional government agencies. At the beginning of the year, a total of about 91 million masks a month were imported to Finland. Talouselämä magazine asked the authorities if Lifa Air’s allegations in Mäkpää were correct. “I wouldn’t see a serious risk” Chief Inspector of Fimea Jari Knuuttila does not swallow the doubt that the remnants of the masks ended up in Finland: “At least I don’t have any such information.” Instead, he estimates that since the early stages of the coronary crisis, there has been a predominance of high-quality surgical nose pads on the market. “At least I can’t say I see a serious risk in using these. Of course, there is definitely under-reporting of incidents (in healthcare), ”Knuuttila says. Healthcare users have a duty to notify Fimea if there is a danger from a medical device. This can be, for example, a severe allergic reaction when using the mask. The incident database covering Fimea’s medical devices has contained only a few dozen incident reports on masks, with a total of at least millions of masks in use. “Neither complaints from competitors nor contacts from the public suggest that there is poor quality goods on the market.” Last December, Fimea studied the breathability and bacterial filtration of surgical masks sold in consumer stores. Surgical face masks are classified as the lowest risk medical devices. This means that it is the sole responsibility of the manufacturer to prove their conformity. Conformity must be proven at the request of the market supervisor, there is no prior approval. When the pandemic struck, there were problems with the quality of the masks, Knuuttila admits. Fimea investigated problems with Customs. “Goods entered the (Finnish) market that were not what it was claimed to be. The shop had goods marked incorrectly. ” Although the situation has now improved, Knuuttila says consumers should be critical of what they buy: “If someone is infinitely cheap, it may not be good.” Avi noticed the scams Avi, on the other hand, has repeatedly found shortcomings in his supervision of, for example, FFP2 and FFP3 half masks suitable for professional use. There are observations of the chief inspector Mika Piirainen despite the fact that manufacturers have to type-inspect their products. The quality of the production is monitored by a notified external body, which can also cancel the type examination if the quality of the masks varies a lot. Among other things, Avi monitors whether the masks bear the CE mark and whether the packaging is properly marked. “Yes, we constantly notice flaws in masks. Most of them are small flaws, but there have also been products among them that are so-called zero products: they have nothing that they should have, ”he says. Untested products have been found. In addition, Avi has found that some manufacturers have tried to trick their products by using the names and fake certificates of European respirator type inspectors. However, according to Piirainen, these serious problems were mainly in the early stages of the corona crisis. “The market had the same (fake) certificates and, for example, a lot of such (scams) were done on behalf of one Polish notified type inspection body. They were not actually a type inspector for respirators and stated on their website that they were aware of the misuse of their name.” Incorrectly labeled or otherwise defective products are returned to the manufacturer or end up in the incinerator. He estimates that the situation in the market is better than in the early days of the interest rate crisis, and the consumer can obtain masks with reasonable peace of mind. However, Piirainen urges that it be considered that filterable half masks always bear the CE mark and that the product bears a four-digit symbol of the notified body. Maskikilpailua. Lifa Air’s founder Vesa Mäkipää believes that low-quality masks can also enter the Finnish market. MEERI UTTI No adverse effects were observed from folk masks Tukes Superintendent Asta Koiviston according to the center, there have been no public masks that have caused harm to consumers. Fabric folk masks are common consumer goods, ie the only requirement is that they must not endanger their wearer. Tukes examines products on a random basis and on the basis of feedback from consumers. “In the earlier stages of the pandemic, the market has come across products that have been sold with personal protection claims. Once the matter has been clarified, it has not been possible to provide the documents required for personal protective equipment, ”he says. “However, the follow-up shows that the situation has improved.” Tukes last studied folk mask chemicals in the spring. At that time, the situation on the market looked good, according to Koivisto. In addition, towards the end of last year, Tukes investigated the filtration efficiency and respiratory resistance of folk masks. At that time, there was a lot of variation in the characteristics of folk masks. Customs does not indicate the number of inspections Customs is also told that no public masks dangerous to health have been detected during the inspections. However, there were shortcomings, for example, in the document required for masks and in the labeling of sales packages, says the customs inspector Sofia Lindbäck. Finnish and Swedish texts, for example, may have been missing from the mask packaging. Customs Mask Control operates on the basis of a risk analysis and international risk information performed by the Analysis and Intelligence Unit of the Customs Control Department. According to Lindbäck, mask control is part of normal product control in Customs and is not staffed separately. At the beginning of the year, about 91 million different types of masks arrived in Finland every month. Lindbäck does not say how much of the masks coming from abroad are inspected by Customs.