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The North Regional Health Administration (ARS) was forced to order last week the return of many thousands of masks that came to be used by thousands of health professionals in more than three hundred health centers in the North region, after Infarmed have found that the team had no guarantee of quality.
This is a large quantity of respiratory protection half masks, known as FFP2, which were distributed with individual packaging that says Medical Protective Mask – ZHUSHI, plus various Chinese characters. On the plastic surrounding the equipment, there is also an indication of the technical standards that the mask supposedly adheres to and the name of a company that appears to be the manufacturer, Shandong Zhushi Pharmaceutical Group Co., Ltd. The problem is that the technical standards mentioned on the packaging are not those that define the mandatory requirements of the FFP2, those that ensure the highest level of protection and are used by health professionals, but they are the standards applicable to other types of masks, surgical, which have a lower level of filtration, that does not prevent the passage of the smallest particles.
It was after detecting this problem that Infarmed alerted ARS Norte. “From a technical-regulatory point of view, it is our opinion that this is a non-compliant product for which there is no formal evidence of conformity to guarantee its safety and performance,” he wrote on the 4th of this month in an email sent to ARS, responsible for the Department of Products for Children’s Health. The message, entitled “Urgent – Zhushi mask inspection action”, also indicated that Infarmed recommended that the product not be used and requested ARS Norte to identify the importer in question so that “it was possible to take measures to adopt restrictive conditions. market requirements ”.
That same day, at the end of the afternoon, the same person in charge of Infarmed sent a new email to a person in charge of the Supply Unit – ARS Logística thanking the “quick collaboration” and insisting that masks should not be used, which should be transmitted to the health units to which the product was delivered. Although the alert arrived on Friday, December 4, it was only a week later, that is, on Friday, December 11, that 20 of the 21 Northern Health Groups -which comprise some 375 health units- received the indication of “ immediate suspension of use ”of the masks, as well as their return to the warehouse.
It is recalled that the problems with the certificates presented in the sale of masks, that is, the respective falsification, was a situation reported in July by the PUBLIC, which had previously denounced the use of a false or null certificate in the sale of three million masks purchased by the Directorate General of Health.
The PUBLIC spoke with health professionals from these units who assured that they had used the masks for more than two weeks until they were collected. It is not yet known with certainty whether or not the masks meet the security requirements, as they are not accompanied by valid certificates. For this reason, the PUBLIC questioned Infarmado about whether some tests were performed on the masks, but the entity chose not to respond, referring to a laconic message sent by ARS Norte. This autonomous administration only confirms that the FFP2 “have already been collected and duly replaced with the units that had received them.” But he refuses to reveal how many masks he bought, from whom, how much they cost, and how many were actually used. “The entire return and compensation process by the supplier company is being duly attended to in the terms of the contract and the legislation in force for that purpose,” he adds, without answering most of the questions posed by the PUBLIC.
After ARS Norte refused to reveal who would buy the masks, the PUBLIC conducted several searches on the public procurement portal and concluded, in light of the available information, that there was only one company that sold masks to ARS Norte in 2020 This is from STREIGHTEX a small firm that is generally dedicated to the sale of building materials and furniture, with no history of selling medical devices (as surgical masks are classified) or personal protective equipment (as FFP2 is classified). The company, which at the end of 2019 had only five employees, managed to sell, through three direct adjustments, more than one million euros – 1,046,000 – of an amount not specified in the public procurement portal for surgical masks and FFP2 (value representing 70% of the company’s turnover in 2019).
The first contract, worth 95 thousand euros, was signed on September 3. Six days later, on the 9th, another contract worth 541,500 euros was signed, both for the purchase of surgical masks. None of the documents is available on the public procurement portal, as it should be. On October 20, a third contract worth 410,400 euros was signed for the acquisition of “Professional Protection Mask – FFP2”. In addition, this contract does not indicate the number of masks purchased, which would allow calculating their unit value.
The PUBLIC confronted the regional administration with this information, questioning the following: “How did ARS contract three contracts worth more than one million euros to a company that has no history of selling these products and has not even confirmed the validity? and compliance with the certificates presented? ”. The answer was laconic again. “The matter in question is being monitored by the Food and Economic Safety Authority (ASAE), so until the ongoing investigation is concluded, we will not comment on it,” justified ARS Norte. It is not clear whether the uncertification issues also affect the surgical masks sold.
After this response, PÚBLICO directed a series of questions to ASAE, which did not respond in time. Also STREIGHTEX, with whom we insist on getting a reaction and some clarification, did not send any response. This despite having managed to speak to two employees, who said they were not the right people to answer us. The salesperson from the North Zone sent us a cell phone to the general of the company, where a lady answered, refusing to divert our call to the company bosses.
