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What is known so far of the masks distributed by the Community of Madrid

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05/13/2020 19:57Updated: 05/13/2020 23:08

The Community of Madrid has begun to distribute millions of masks for free among the population this Monday. The decision, however, has drawn some criticism. Voices from the sector warn of irregularities in the labeling and in the approval by the manufacturer, a widespread problem in the supply of medical equipment at a time when the entire planet is looking for the same products and there is not enough supply to meet demand . In the absence of the verdict of the efficacy tests, this does not mean that the masks do not protect. But yes cast doubt on the quality of the product. This is what is known so far.

What company has manufactured them?

Inside the packaging, in a small document similar to a label, the name of the company that makes the product is attached. Wenzhou Haosuo Home Textile, which does not appear in the list of companies registered by the Chinese authorities to export supplies related to coronavirus. A spokesman for the Community of Madrid assures that this is due to the fact that the distributed masks are not a medical device -as are the surgical masks of hospitals- and, therefore, that they do not have to appear on said list.

Wenzhou Haosuo Home Textile, the mask manufacturing firm, is a company founded on November 19, 2015, with a registered capital of one million remimbís. Your legal representative is Huang Xiaoli. The company is specialized in the manufacture of home textile products. But on April 14 of this year, the company changed its corporate purpose to manufacture face masks. The only reference to the online store is a section in Alibaba (the Chinese Amazon) from which they sold all their merchandise and accredited their certifications, a section that just disappeared this Tuesday.

Who can use them?

These masks should not be confused with surgical ones. All FFPs, including this model, are not considered sanitary masks, but as an Individual Protection Element (PPE) and its use is recommended for the general population, but not for the vulnerable population (people over 60, pregnant and chronically ill), something that has not been specified with the free distribution of these materials either.

The Ministry of Health has announced this Wednesday that the prescription of these articles has been removed from the health cards of children under the age of four so that this segment of the population does not access them. The decision came after professionals from the Madrid Health Service requested it, following the recommendations for use made by the Primary Care Pediatric Coordinators.

In addition, by not complying with the EPI regulations or having certificates or tests according to the regulations, experts such as the pharmacist and biotechnology expert Gemma del Caño assure in your Twitter accounts than it would not be advisable to donate such masks to the toilets. Something that had been promoted in certain circles before the nature of these products was known.

Surgical masks serve to prevent the transmission of infectious agents by the person wearing it, therefore, its use is recommended in people diagnosed with coronavirus, to minimize contagion to people who may approach. These masks are disposable – for single use – and are not considered PPE either because they do not provide a reliable level of protection against particle inhalation. although they are considered a medical device (). On the other hand, the FFP2, which are the equivalent to the KN95 that the CAM has distributed, are masks, which if they meet the requirements, contain a microparticle filter with a minimum filtration of 92% and with a percentage of leakage towards the 8% maximum interior.

Are they safe?

On the quality of the masks, the CAM details that, originally, the manufacturer of this company certified in a laboratory that the masks of the Chinese company were suitable, they even argue that this same laboratory is recognized by the Chinese authorities to do this type of certifications. But he did not want to provide the name of the laboratory. Its use does not necessarily have to present any danger, but the CAM has not provided any documentation or evidence to confirm this.

The only laboratory analysis made public was posted on the manufacturer’s website. This analysis ensures that the mask has filtration and necessary specifications to have KN95 labeling (the Chinese FFP2 version). It is an approval that is not valid in Europe, since for this analysis to be valid it has to be carried out by a Notified Body within the EU.

What certification do they have?

The manufacturer submitted a document of conformity in which the Italian company Ente Certificazione Macchine (CEM) would certify that the Chinese company meets the requirements in accordance with the regulations. But it is a document that is not valid in Spain, according to the latest report prepared by the Ministry of Labor and Social Economy, dated last May 3 and entitled ‘Verification of certificates / reports accompanying PPE‘, in which it is verified that this transalpine entity lacks the power to authorize these masks in accordance with European regulations (EC). In fact, as reported by ‘Maldita.es’, a member of the Italian company has clarified that said body has never issued any CE certification for this type of equipment.

From the Community of Madrid they have justified this fact alleging that the Italian entity is the one that certifies the norm, but that the certifying body of the process was Bureau Veritas. A certification that, to date, it has not been supported by documentary evidence.

Do they comply with European regulations?

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news-img-figure">Click to read the technical report.
news-img-caption-def">Click to read the technical report.

A non-public report, prepared by Asepal (the Association of Individual Protection Companies), details in which points the European legislation is not being complied with so that these masks can be commercialized. This report has been sent to the Madrid health authorities.

The association indicates that The documentation should include the name, address and identification number of the body that has carried out the conformity assessment procedures. On the other hand, no URL address is specified where the EU declaration of conformity can be consulted. In fact, this statement is also not delivered together with the PPE. They point out that the CE marking it is not accompanied by the four identification digits of the notified body that has carried out the procedure provided for in the EU regulation.

They also point out that the risk against which the PPE must protect should be pointed out, and they emphasize that cleaning, revision and disinfection instructions are not attached to the packaging; no information is provided regarding the appropriate protection classes for the different levels of risk and corresponding limits of use; and tthe meaning of the markings included in the PPE is also not clarified.

The report concludes that the mask does not comply with the marketing conditions established by the Regulation of the European Union 2016/425 regarding markings and information to be supplied together with the equipment.

The Secretary General, Luis Gil, explains to this newspaper that the quality of the masks cannot be assessed, since the facial protections distributed by the CAM do not include the necessary documentation to verify the quality of this product.

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news-img-figure">Masks distributed by the Community of Madrid.Masks distributed by the Community of Madrid.
news-img-caption-def">Masks distributed by the Community of Madrid.

Added to this is the fact that, according to the distributors consulted by this means, the Chinese authorities require the name of both the manufacturer and the exporter to be detailed in order to sell to other countries, something that does not happen in this case. At the same time that the Spanish standard (UNE-EN 149: 2001 + A1) details that the marking must include “the name, registered trademark and other means of identification of the manufacturer or supplier”.

The sources consulted by El Confidencial avoid talking about any illegality, but they do affirm that there have been several irregularities that, probably, have their origin in the decision of the CAM to distribute this type of mask, instead of other simpler ones. “The one that corresponds to the FFP2 mask, the KN95 that they have delivered, does not comply with European regulation 149: 2001, complies with Chinese gb2626 “, explains a source who asks to remain anonymous.

“As can be seen in a Industry resolution of March 20, 2020, The import of KN95 has been temporarily and extraordinarily authorized, but it cannot be CE marked, and less indicating that it complies with standard 149 and less referring to anything other than 2001, a nonsense, “he adds, referring The first masks distributed by the CAM refer to the first standard on the packaging, and the second on the mask label.

The confidential

Although there are several types of protective masks, not all of them are recommended for the population, as those with high protection, for example, should be reserved for healthcare personnel.

As it became known last week, the Government ordered the Spanish Agency of Medicines and Health Products (AEMPS) to issue “as many express authorizations as possible” for the use of surgical masks and gowns that “have not satisfied the evaluation procedures” .

As this medium already reported, the Government eliminated the validation process for these medical devices to treat the coronavirus pandemic. In the event that the products have any error, the risk will be assumed by the General State Administration. But this ordinance would only be applicable to surgical masks and gowns, but not FFP2, as they are in this case.

Who is the intermediary?

This medium has attempted to locate the contract through which the Community of Madrid agreed to supply these masks, to know which entity intermediated and the price of this protection material But according to a CAM spokesperson, this contract, like the rest, “will be uploaded to the Transparency Portal, but due to the situation we are in, I know they are behind schedule.”

In the absence of knowing the details of said contract, the only thing that is known so far about the price is that, according to the CAM, the operation was closed around the 32 million euros for a total of 14 million masks.

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