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We have already written about respirators for which issued documents can create the illusion of product quality. But this story is different. After all, a company whose name has a certificate sent to the Klaipėda municipality not only has no right to certify personal protective equipment, but also claims to have 30,000. the document presented for the sale of the respirators is falsified.
It is not only this shipment that is in doubt. Another 30 thousand. The respirators, most of which have already been distributed to doctors and have reached risk areas such as the Klaipėda Hospital or the Fever Clinic, for sale by submitting a document that does not confirm compliance with the regulations. It is also difficult to determine if they were actually produced by the same company as the one mentioned in the purchase documents.
According to the Office of Public Procurement (PPA), these and other acquisitions that explicitly required respirators to meet safety standards raise serious questions. After all, if compliance with the standards required by the contract has not been confirmed, suppliers are at risk of being blacklisted.
Another problem is informing health institutions about documents that may have given the false impression that the products sold are safe and of high quality. The Ministry of Health was aware of certificates of dubious value distributed throughout Europe, but did not warn medical institutions. According to the ministry, this is not their role.
30,000 “love surprises”
Klaipeda Municipality, like many public sector institutions, provided respirators independently. The port city municipality required respirators with the CE mark and that comply with the EN149 standard for respirators. The Vadasiga company, which sold the respirator, delivered these goods. But certified, they appeared only at first glance.
Vadasiga supplied the municipality of Klaipeda with two types of respirators. The packaging of both is marked with the CE symbol. In both cases, documents named with certificates with a clearly written EN149 standard are attached. And both documents presented do not prove the quality of the products. Especially one.
The first 30 thousand. Italian company Ente Certificazzione Macchine (ECM) provided a “certificate of conformity” for a shipment of respirators to Vadasiga. We already wrote about these documents last week: they were used to deliver tens or even hundreds of thousands of KY2020 respirators to Lithuania, the sale of which is prohibited in Portugal due to possible product safety, and similar measures have been applied in Estonia and Malta. The State Consumer Rights Protection Service assured Siena that the ECM certificates are not valid and do not confirm compliance with the EN149 standard. However, the documentation for the second batch of respirators is even more interesting.
The second 30 thousand. The respirator shipment consisted of products called Love Surprise. Dongguan KEN95 Medical Instrument Technology Co., Ltd, a Chinese company that makes these respirators, was established only in late February of this year. Despite the company’s young age, the CE symbol is already on the packaging of respirators manufactured in March. And the signature of a man named Kevin, whatever that means.
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Forgery of invalid documents
Vadasiga delivered a shipment of Love Surprise respirators to Klaipeda of the Polish company ICR Polska. Like the Italian ECM, this body does not have the right to certify personal protective equipment, so this document does not confirm compliance with the EN149 standard and does not entitle the product to bear the CE mark. Furthermore, the document submitted to the Klaipėda municipality is likely to be falsified.
In the event of confusion over potentially misleading ICR Polska documents, the Polish company announced the revocation of all certificates issued from March 1 to 26. ICR Polska also allows you to verify in an open database whether a specific certificate has been issued by this company.
After entering the certificate number provided by Vadasigos, we obtained the following result.
After calling the ICR Polska general phone, a company representative replied that the company is unwilling to comment on the certificate issues. However, he agreed to explain what the “invalid or false” mark means next to the certificate number in “Vadasigos”.
“It just came to our attention then. (…) This means that we have previously received information from someone who also had this document and asked about its authenticity. We reported it and included it [informaciją] to our database, “said the interlocutor.
Why falsify a document that the Lithuanian and European services consider invalid? The answer is quite simple. Documents from ICR Polska, ECM and other similar institutions give the impression that the product is safe and of high quality; We became convinced of this by interviewing representatives of the Klaipėda Municipality and other contracting authorities.
Other European countries have faced a similar problem: More than once and twice, international research partners have discovered respirators that have been sold using ECM or ICR Polska certificates, which have not been issued by these institutions.
We wrote to the Chinese company that manufactures Love Surprise respirators, asking for an explanation of ICR Polska’s position that the certificate that had been established in Klaipeda was falsified. We have not yet received a response.
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Municipality: “Surprises” remained in stock
According to the Klaipeda municipality, respirators purchased from Vadasiga were used at various high-risk points. From the port where the compatriots who returned due to quarantine were received at the hospitals, the fever clinic and the Klaipėda Hospital, where three people died from COVID-19.
However, the municipality says the Love Surprise respirators, which may have been counterfeited with quality documents, remained in stock. Respirators from another Vadasiga shipment, not Love Surprise, were the most widely used as they had been received by the municipality earlier.
“We basically divided those into which we packed three units (Love Surprise is delivered in packages of 15 units – ed.), Because we received them first. In total, over 28,000 respirators were distributed somewhere, and we still have some of the that we bought from Vadasiga in the warehouse, ”Lukas Jonušas, head of the General Department of the Municipality of Klaipėda, told Sienai.
The “Vadasiga” respirators distributed by the municipality to high-risk doctors and workers also raise some concerns. In particular, neither the packaging nor the product itself indicates its manufacturer.
‘The manufacturer must be indicated on the product or, if this is not possible, on the packaging. The manufacturer’s name is usually there and there, ”said Hank Vanhoutte, Secretary General of the European Safety Federation (ESF), who was familiar with the photos of the respirators.
For this purchase, Vadasiga also submitted documents sent by Chinese suppliers, which do not prove the quality of the product. It was the “certificate of conformity” of the Italian company ECM, which does not confirm compliance with safety standards and does not allow the product to be marked with the CE symbol. Unlike the Love Surprise case, this document has no signs of counterfeiting: it is in the ECM certificate database, so the Italian company issued it.
On its website, ICR Polska pays additional attention to laboratory tests by the Chinese company Shanghai MICEZ Equipment Testing & Technical Co., Ltd., on the basis of which the Polish company has issued part of the currently revoked certificates. The Polish company says it has started a recertification process for revoked certificates, but those based on Shanghai MICEZ research remain “invalid or falsified.” This lab is listed on a possibly forged Love Surprise certificate.
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The MICEZ name also flashes on the ECM certificate, which was used to sell 30,000. respirators actually used at high risk points in Klaipeda. It is difficult to say if it is the same laboratory in Shanghai because its full name is not on the document.
The manufacturer of the respirator is not indicated on the package, but the CE symbol is present. It is true, in addition to a unique code that identifies which body allegedly confirmed the product’s compliance with European standards.
Vaclovas Daukintis, director of UAB Vadasiga, a company that sold 60,000 respirators to the Klaipėda municipality, told Sienai that the certificates did not cause him suspicion, and the customs inspection passed smoothly.
“We have all the documentation, because there are customs, otherwise the goods would not have arrived and would not have been cleared by customs,” said V. Daukintis, adding that the product certificates did not cause any suspicion. “Well, no, nothing suspicious. (…) The plants are large, produced at the request of the Chinese government (…) and are included in the lists of certified and authorized Chinese export plants. This is mainly reviewed by the customs, so if someone suspicious had caught up with customs, they could have heard more information, “said V. Daukintis.
The interlocutor said he did not know that the company that manufactured the Love Surprise respirator was established only in late February of this year.
V. Daukintis declined to name the Chinese factories that delivered the respirators, arguing that this is public information and that journalists can find it themselves. However, when asked if the manufacturerless respirators in the packaging came from the company to which the ECM certificate was attached in the contract, the businessman said he was not sure of that.
For both respirator shipments, the businessman said he intended to speak to his suppliers.
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VPN: providers risk being blacklisted
The Public Procurement Office (PSA) points out that the provision of unreliable quality documents in the award of public contracts can have very serious consequences.
“If the public procurement contract stipulates product quality as an essential condition of the contract, the contracting authority, having received low-quality products, especially if incorrect information was provided, could include that supplier in the list of unreliable suppliers, eliminating their possibility of participating in public procurement for 3 years. ” Consequently, the contracting authority would probably switch to the institutions that supervise commercial entities or the police if fraud or abuse of the supplier were detected in the execution of the contract, ”Jovita Petkuvienė, acting head of the VPN, told Sienai.
When asked who is responsible for determining the quality of the products purchased, the interviewee indicated that both buyers and sellers are equally responsible for this.
“In particular, the contracting authority will examine the market, the suppliers and the products they offer, in particular through open negotiations, and will then communicate with those suppliers who can properly execute the contract. If the contracting authority imposes qualitative requirements on products purchased, it is the supplier’s responsibility to ensure that the supplier has adequately fulfilled its obligations upon receipt.
Meanwhile, the supplier is responsible for the adequate and timely delivery of the goods that he has undertaken at the conclusion of the contract. If there are requirements for products sold across the country, then the supplier could not even market products that do not meet those requirements, “said J. Petkuvienė.
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He knew about the problem but did not tell the doctors
Certificates from ICR Polska, ECM and other similar entities are a headache not only for Lithuanians, but also for European services. The European Security Federation began publishing examples of untrusted or forged certificates in March. The Ministry of Health (SAM) was also aware of this problem during respiratory purchase fever. As can be seen from the specific examples, hospital specialists and other contracting authorities were generally not informed that the product quality was not confirmed by the ICR Polska or the ECM certificate.
SAM was directly confronted with products of questionable reliability and decided not to purchase such products.
“When purchasing equipment, any contracting authority must provide the specifications for the goods and ensure that the purchased goods actually comply with them. In other words, the contracting authorities are responsible for buying quality goods in the first place. When purchasing self-evaluate offers received, if appropriate, etc. “Before purchasing, SAM verified and found publicly available information about unsafe measures. After finding discrepancies, the ministry refused to buy these products, “SAM said in a written comment.
When asked if the ministry had alerted health care institutions to problematic quality documents, SAM indicated that another institution should have.
“We note that SAM is not a market surveillance authority. This function is performed by the State Consumer Rights Protection Service (SCRPA), which monitors whether the non-food products being marketed meet safety and quality requirements. “Says the Ministry.
The Consumer Protection Service has opposed the opposite. “The Office is not competent to assess the content, solutions and consequences of problems (…) arising from the award of public contracts and to warn the contracting authorities and / or the SAM of the risks associated with certificates . Informing medical institutions is the responsibility of SAM, ”said SCRPA in a written comment.
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