Up to 19 requirements of the European Union do not comply with the masks that the Community of Madrid made available to the population in pharmacies since Monday: ten required by the European legislation on personal protective equipment and nine related to the technical standards that indicate compliance with the masks. When the president Isabel Díaz Ayuso made the announcement, she assured that she had bought 14 million ffp2 for 32 million euros that “comply with the regulations of the European Union”, that they are “reusable” and that this use is up to “48 hours in a row, so it can be used on different occasions over several days ”. There is nothing to certify that any of this information is true. Not even that they are ffp2, for this they should have been tested in a notified laboratory and that test should go in the marking. Until this Tuesday, 1.58 million citizens of Madrid had already withdrawn it from their pharmacy, according to data from the Official College of Pharmaceuticals.
The flaws in this marking and labeling were analyzed by Asepal, the Association of Personal Protective Equipment Companies, which sent the report of that review to the Ministry of Health and to which they have not yet received a response. On the packaging, the manufacturer – the Wenzhou Haoshuo Home Textile company – included the CE mark, which indicates that the product complies with the European Union legislation that applies to the mask. But it’s not like that. Also, as has advanced Maldita.es, the certificate that endorsed that marking was false, as was the one used by the FDA (the Food and Drug Administration of the United States, for its acronym in English) and the company has deleted its official page from Alibaba, the world’s largest internet sales platform.
Cleaning, disinfection and revision instructions are not attached to these masks; nor do they carry information on the appropriate protection classes for different levels of risk and limits of use; The risk they are supposed to protect is not clarified, nor is the body that has evaluated them identified. Nor do they include what company has manufactured them or what type they are (ffp1, ffp2 or ffp3) —even though the Madrid government has repeatedly insisted that they are ffp2— nor is there an “R” printed, which is the sign that they are reusable.
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To questions from this newspaper, the Ministry of Health responds that Asepal “ignores the current legal context: Resolution of March 20, 2020, of the General Secretariat for Industry and Small and Medium-sized Enterprises, on alternative specifications to EPI masks with European CE marking. This resolution establishes that the GB 2626: 2006 Standard [la norma china] and the EN 149: 2001 + A1: 2009 standard [la que rige en España] they are harmonized, that is, they are homonymous ”.
From Asepal they are categorical: “No”. They point out that, in the first place, “the resolution to which the Ministry refers to argue was repealed by a later one, of April 23”. And they add that “it is not necessary to confuse what is a harmonized norm and one that can be equivalent”. Harmonization, which is done by the European Union, implies that the requirements that two standards meet are exactly the same, “so there is no need to do any additional verification to verify that the product in question meets those requirements,” they explain. So the masks should have been checked once they arrived in Madrid.
The objective of the distribution of these masks is, according to the Community, to protect the health of citizens, that is, they act as an individual protection team. “The EPIS must comply with a regulation, 2016/425, which specifies that the teams must respond to essential health and safety requirements,” conclude from Asepal. The list of defects found in both marking and labeling indicates that this is not the case.
Facua also “demands” “urgent” explanations from the Community of Madrid; This Monday, they affirm, they have already asked the Ministry of Health to “clarify whether they had been analyzed in Spain before distribution to confirm that they comply with the regulations and explain why it is recommending their use for up to 48 hours when international organizations warn that no more than 8 ″ should be used.
Public Health experts, opposed to the distribution of these masks
Before the distribution of the masks, there were other specialists who were against. The scientific societies that bring together Spanish specialists in Occupational Medicine —those who work in occupational risk prevention services, preventive specialists and experts in public health—, the heads of the Preventive Medicine and Public Health departments and those in Occupational Risk Prevention Madrid hospitals have already warned the Community of Madrid that these masks “are not suitable for the general population.”
They asked that this measure be “reconsidered”, which “is not supported by scientific evidence, which may confuse the population and not help control transmission, and which could again jeopardize the safety and health of health professionals They have been working against the pandemic since the beginning of the pandemic without the proper equipment.
In this sense, the Madrid Public Health Association also took part, which published a document entitled Do not waste on the masks that the population of Madrid does not need; and the Madrid Nursing Association (AME), which launched the campaign Faced with the precariousness, a health professional sponsors: “Donate your FFP2 mask to a toilet and avoid having to work without them when they are given to use it for several days in a row. “
Information about the coronavirus:
– Here you can follow the last hour on the evolution of the coronavirus.
– The coronavirus map: this is how cases grow day by day and country by country
– Coronavirus action guide
– All measures against the coronavirus in Madrid
– In case you have symptoms, the Community of Madrid recommends avoid going to the health center except in cases of extreme need, use the web coronamadrid.com and the phone 900 102 112
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