Manufacturers of medical masks asked the prosecutor’s office to check government purchases of respirators. Life-threatening products may have ended up in hospitals
As part of the state procurement of personal protective equipment for Russian medical institutions, uncertified respirators, posing a threat to life and health, could get into hospitals. This, writes RBC, warns the Association of Developers, Manufacturers and Suppliers of Personal Protective Equipment (ASIZ), which includes more than 500 enterprises.
ASIZ appealed to the Prosecutor General’s Office and the Federal Antimonopoly Service (FAS) with a request to conduct a comprehensive audit of government purchases of FFP2 and FFP3 respirator masks.
The letters were sent to the supervisory authorities after representatives of several hospitals from the Moscow and Leningrad regions approached the ASIZ with a request for an independent examination of respirators supplied under public procurement. The experts found possible discrepancies between the respirators that the hospitals purchased with the declared levels of protection.
In particular, representatives of the association point out that hospitals purchase such respirators at a price of 4 to 9 rubles per unit of goods, while the cost of their production starts from 60 rubles per item. “This may indicate the discrepancy between the goods and the quality presented to it,” the ASIZ believes. Presumably, they have not passed the required certification and will not be able to provide the required degree of protection.
In the spring of 2020, against the background of a shortage of personal protective equipment, the rules for state registration of medical devices were simplified. Now the manufacturer in the registration application has the right not to indicate the documents confirming the results of technical tests, the quality and safety of the product in accordance with GOST. These documents must be sent to Roszdravnadzor within 150 days after registration. If any inconsistencies are found, the marketing authorization may be canceled. The ASIZ assumes that unscrupulous manufacturers or suppliers can bid during these 150 days.
Representatives of the companies mentioned in the association’s appeal due to the low price per unit of goods explained their pricing policy in different ways, but assured that their products fully comply with the requirements, including GOST standards.