PPE manufacturers asked to tighten access of respirators and medical masks to the market

The Association of Developers, Manufacturers and Suppliers of Personal Protective Equipment (the PPE Association) and a similar association of manufacturers of radiation, chemical and biological protection equipment sent a joint appeal to the Chairman of the Coordination Council for Combating the Spread of New Coronavirus Infection, Prime Minister Mikhail Mishustin, with a request to reconsider the access parameters respirators and medical masks to the government order market. In particular, the associations propose to cancel the exemptions in the registration of specialized medical devices, introduced at the beginning of the pandemic – in March 2020.
As noted in the appeal (available to Vademecum), members of specialized associations analyzed the existing practice in the field of medical masks and respirators and found gaps regarding the safety of products supplied under government orders – personal protective equipment, medical masks and respirators of FFP2 and FFP3 classes. In particular, we are talking about discrepancies in GOST, labeling and the level of safety of medical devices, as well as insufficient control of regulators over the actual and declared class of PPE.

“The presence of the above contradictions and violations contributes, among other things, to the supply of RPEs to medical institutions that do not meet the established requirements for ensuring the safety of medical personnel, in particular those working in the” red zone “, which inevitably leads to an increase in morbidity and mortality among medical workers,” it is noted in circulation.

As a solution, the authors of the appeal propose to withdraw disposable and medical masks, as well as respirators from the action of the Government of the Russian Federation No. 299 dated March 18, 2020, to prohibit the supply of simplified medical devices to medical institutions that have not passed toxicological, clinical and technical tests, and also introduce the requirements of the certificate of conformity for the supply of PPE under the state order.

In connection with the spread of COVID-19, the Government of the Russian Federation on March 18, 2020 by Resolution No. 299 introduced an accelerated registration procedure for products with a low potential risk of their use – respirators, medical masks, insulating gowns and suits, as well as gloves and shoe covers, introducing a notification registration procedure subject to the provision of a package of documents within 150 days.

By October 2020, Roszdravnadzor registered a total of 1,219 items of PPE, which accounted for 73% of registered medical products for this type of nomenclature. In November 2020, the simplified registration scheme for medical devices was extended for a year, until the end of 2021.

However, already in December 2020, the department revoked the first 20 registration certificates issued under a simplified scheme, due to the applicants’ failure to provide data on the safety and effectiveness of medical devices within the prescribed period of 150 days.