Medical mask manufacturers urge SAM to take action on poor quality products

Nordmed and Litdent note that the public procurement contracts published on the central public procurement portal show that the minister’s order allowing the commercialization of non-compliant devices has allowed the use of untested safety and quality requirements in many Lithuanian healthcare institutions. Non-compliant medical masks, the report says.

“In recent weeks, we have heard of new coronavirus outbreaks in medical facilities; medical facilities are becoming hotspots for coronavirus. Examining the results of public procurement in recent months, the question arises as to why the medical sector Lithuanian has non-medical devices, which in principle are not subject to safety or quality requirements.

Therefore, it is not possible to guarantee the required bacterial filtration properties, which is one of the most important factors for certifying masks according to EN14683 (medical masks) ”, says Marijus Kontrimas, representative of the Nordmed company for medical masks with headquarters in Klaipeda.

According to the companies that prepared the application, the situation of the spring, when due to the increase in demand for certified medical masks and the lack of supply, an order to liberalize the regulation of medical devices was necessary to guarantee at least minimal protection , it already happened. meet the needs of the Lithuanian healthcare system by providing high quality certified measures.

Turning to A.Verygas, it is notable that in Lithuania alone, four local manufacturers of medical masks that meet the requirements of the Technical Regulation on the Safety of Medical Devices have started operating this spring, and that they can contribute significantly to the supply of masks. safe and effective medical treatment to the Lithuanian health system. because in total, all these manufacturers can offer and market up to 10 million masks per month according to their available production capacity.

“We believe that since the scale of the pandemic in Lithuania is not decreasing and the employment of medical institutions is growing, it is important to assess the importance of providing Lithuanian doctors with high-quality protective equipment. With our appeal, we hope to push forward decisive decisions by the Ministry of Health, abandoning the 2020 system, which is detrimental to the Lithuanian health system in the current circumstances. March 12 Order No. of the Minister of Health V-334 and the adjustment requirements for medical device providers ”, says Renatas Petkevičius, representative of Litdent.

Minister of Health of the Republic of Lithuania 2020 March 12 The Order on the placing on the market and the use of medical devices (devices) at the state level in the national emergency due to the new spread of the disease COVID-19 (infection by coronavirus) in the threat period, non-sterile disposable medical clothing (hats, gowns, booties, hooded overalls), non-sterile disposable medical gloves to which the Technical Safety Regulations of the Sanitary Products approved by the Ministry of Health in 2009. January 19 by order no. V-18 “On the Approval of the Technical Regulation on the Safety of Medical Devices (Devices)”, Conformity Assessment Procedures.