Some hospitals and health centers recently received N95 protective masks, which the manufacturer from China claims are not for medical use, "Vijesti" has learned.
Health workers said that a contingent of medical equipment had been delivered to the institutions and that among them were allegedly disputed masks, of which there are enough. One of the doctors told "Vijesti" that these masks, which the manufacturer states are not for medical use, do not give them the confidence to work with patients who potentially have covid-19, or are definitely infected with the new coronavirus.
"It would be like a surgeon wearing gloves during an operation that says they are not for medical use and being carefree and convinced that they are sterile," said a doctor from a Montenegrin hospital.
From "Montefarm", which distributed these masks, they claim that as a supplier of all healthcare institutions, they are a responsible company and that such an omission could not happen to them: "Certainly, we are for our sake, then healthcare workers, our colleagues and the public in general have verified these allegations”.
Montefarma said that on the box of the mask model KN95 GB2626-2006 it really says "not for medical use".
"But it refers to the fact that they do not have a medical purpose, but are a protective means, i.e. they are intended for the protection of users and are used as personal protective equipment", Montefarma's reply reads.
This institution claims that this model has a filtration and protection efficiency against pathogenic particles, including viruses, of over 95 percent.
When asked what quantities were purchased and how much they were paid for, Montefarm said that the masks were not purchased or obtained through commercial procurement, but were part of one of the many donations.
"Everything that arrived in our warehouse has accompanying documentation, as well as evidence, i.e. certificates of product quality," they said.
Montefarm said that these statements can be found on the website of the American Center for Disease Control and Prevention (ACDC).
"The mask you are interested in is on the list of approved models, its effectiveness has been confirmed by the FDA and the list was updated on July 16, 2020," the response reads.
The National Institute for Occupational Safety and Health (NIOSH) recently received new information from stakeholders across the United States about protective masks from China that are claimed to meet the gb2626 standard.
On the website of the US Centers for Disease Control and Prevention (CDC), it is stated that the permeability of the filters on some examples of these masks did not meet the criteria.
"The results of the evaluation confirm that some of these products have poor filter efficiency and are of poor quality," according to the US CDC website.
It is also stated that they have no knowledge about the sustainability of the manufacturer's quality and the quality control of these masks.
They are not registered in Calims, they produce "other items"
In one of the halls of the former "Titeks" in Podgorica, the company FTS will start the production of protective masks for export purposes.
As reported from the capital, it is an investor from Italy, who registered the company in Podgorica in May and signed an annual lease agreement with PLC Morača AD Podgorica. According to data from the Central Register of Business Entities (CRPS), the company FTS Podgorica was founded on May 7, and the last change was reported on June 13. The activity of the company, according to the CRPS website, is the production of other items. The founder is Franćesko Meleo, who along with Stefan Meleo is also an authorized representative, while the executive director is Marko Bošković.
The company, as they announced from the Capital City, received from the Italian Ministry of Health a CE certificate for distribution on the territory of the European Union for non-sterilized medical devices type 1 with a filtration of at least 94 percent for civil use (surgical masks), as well as a CE certificate for the distribution of non-sterilized masks Type 2, with a minimum of 98 percent filtration for civil use (KN95).
From the capital, they said that based on the Rulebook on personal protective equipment, the FTS company submitted a request to the Secretariat for Entrepreneurship to report on the performance of activities, that it employs 12 workers, and that the application procedure for three more workers is underway.
The company FTS is not registered with the Agency for Medicines and Medical Devices (Calims).
"In Calims, the manufacturer of medical devices under the name FTS Podgorica is not registered, nor is any other manufacturer of medical devices registered that deals with the production of medical masks that belong to medical devices in accordance with the Law (on medical devices). At the moment, we do not even have submitted applications for the registration of manufacturers of medical masks in the procedure", the Agency told "Vijesta".
They also add that "protective masks that are not intended for medical use by the manufacturer do not belong to medical devices".
"And therefore they are not within the competence of the Agency, so our institution does not have data on the manufacturers and production of protective equipment/protective masks in Montenegro", he writes in the reply to the editors.
According to the Law, medical devices are instruments, devices, devices and products that are applied to people, in accordance with the purpose determined by the manufacturer, which do not achieve their basic effect based on pharmacological, immunological and metabolic properties.
The law also states that medical devices can be used independently or in combination, and that, among other things, to determine the diagnosis, prevention, follow-up treatment or disease mitigation.
We learned about the company after during the Prime Minister's hour the Deputy Prime Minister Milutin Simović answered the question of MP Aleksandar Damjanović who claimed that there is a factory for the production of protective masks in Podgorica.
Simović then replied that it was "protective equipment". And Assistant Director Senad Begić at IJZ said at the NKT conference yesterday that masks are protective equipment.
The Ministry of Labor to facilitate the realization of the right to care and assistance, disability benefits...
The government tasked the Ministry of Labor and Social Welfare with enabling continuity in the realization of the rights of users of basic material benefits from social protection, namely the right to allowance for care and assistance, personal disability allowance, as well as the right to material security based on incapacity for work...
These are beneficiaries whose right was established for a limited period of time, and which ended in the period from June 1 to July 7, and who during that period were not subject to the work of first-level social-medical commissions.
This right will be provided to them from the period of termination of the right until the re-establishment of the work of the commission, when the continuation of the use of said rights will be reviewed and in cooperation with the Ministry of Finance, funds will be provided for the payment of benefits for the period when the benefit was suspended.
The Association of Disabled Youth (UMHCG) recently reported to the National Coordinating Body (NKT) that these rights were violated by persons with disabilities due to individuals or services in social work centers and the Ministry of Labor who "do not do their job".
The government tasked the elders of the state administration bodies to ensure that the body temperature of civil servants and employees is measured when entering the official premises and to implement additional protection measures so that those who do not have a protective mask are not allowed to enter.
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