Since the outbreak of the epidemic, masks, as a must-have for going out, have played a very important role in the daily protection of citizens. Recently, the Modern Express reporter found that there is an "antibacterial and antiviral" mask for sale, saying that it can be antibacterial and bacteriostatic, so as to achieve the effect of double protection. Is this mask really as reliable as described? A few days ago, the Medical Device Technical Evaluation Center of the State Drug Administration responded that the risk benefit ratio of the continuous and long-term use of such products is insufficient, and it does not have significant clinical significance, and the effectiveness and safety of the product need to be studied more systematically and deeply.
"Antibacterial and antiviral" masks are available for sale, saying they can inactivate the virus
Masks have become an indispensable protective product for citizens to go out. The Modern Express reporter learned that most of the medical surgical masks often used by everyone are self-priming filter masks, and their working principle is to make the air containing harmful substances filter through the filter material of the mask, and then be inhaled or exhaled. According to the standard of YY0469-2011 "Technical Requirements for Medical Surgical Masks", the masks produced are all medical surgical masks, which are mainly suitable for invasive operation and use, low resistance, obstruction of blood, body fluids, and bacterial filtration efficiency ≥ 95%.
Compared with physical barrier and electrostatic adsorption to block the virus on the surface of the mask, the "antibacterial and antiviral" mask is said to directly inactivate the virus.
The reporter inquired on several online shopping platforms that there are not many merchants selling "antibacterial and antiviral" masks, and the brands are relatively small. In a link to a brand of antiviral masks, the product introduction page describes the bacteriostatic rate of the mask as greater than 99.99%, and the antiviral (H1N1) activity rate of 99.9% using silver ion antibacterial technology. The principle is "to inactivate the virus (effect) by coating the outer nonwovens with a silver ion antibacterial agent". The reporter browsed multiple platforms and found that the brand's anti-virus masks, a box of 7, were priced at about 20 yuan. However, customer service said that this mask is a disposable daily antiviral mask, not a medical one, nor a medical surgical mask. In terms of sales, some stores sell more than 1,000 orders a month.
There are also stores selling "quaternary ammonium inactivated" masks on the Internet, and the middle layer of cloth in the mask is a meltblown cloth containing quaternary ammonium salts, and the product display page introduces quaternary ammonium salts that can destroy the structure of bacteria and viruses, thus playing a role in disinfection and sterilization.
The reporter also consulted the situation of offline sales, Qinhuai District, Xuanwu District and Yuhuatai District 5 different brands of pharmacy staff said that there is no "antibacterial and antiviral" masks for sale, only two people have some understanding of this mask.
State Food and Drug Administration: Its effectiveness and safety need to be studied more systematically and deeply
A few days ago, the Medical Device Technology Evaluation Center of the State Drug Administration responded that some medical device manufacturers turned to functional product development such as "antibacterial and antiviral masks". Related issues such as how to effectively verify related products and whether they can achieve declared functions have aroused industry discussion and social concern. The Device Evaluation Center of the State Food and Drug Administration has conducted many investigations and studies on this issue, and held expert seminars to solicit the opinions of experts in relevant industries. Experts who participated in the discussion included experts in the research and development and production of meltblown cloth, clinical infection control, virology, disease control, disinfection, protective product testing, and drug evaluation.
At present, there are non-medical masks that claim to be "antibacterial and antiviral", generally adding various types of antibacterial agents through blending, spraying, etc., the main additives include nano titanium dioxide, nano silver, quaternary ammonium salts, copper ions / copper oxide, etc.
In terms of the combination of antibacterial ingredients and masks, the current antibacterial agents are mainly added to the meltblown cloth layer through particle blending, powder/solution spraying, etc. However, the method and process of mixing the antibacterial agent into the meltblown cloth are different, resulting in the possibility of further risks of falling off and entering the respiratory tract. In terms of the toxicity of antimicrobial agents themselves, the current evaluation methods and evaluation content studies are not mature or effectively established. For example, some mask products achieve the declared effect by adding nano-silver or other nanomaterials, but a systematic way to evaluate the toxicological risks of nanomaterials is still being established.
Studies have shown that different types of antibacterial agents and different addition processes may have a certain negative effect on the electrostatic adsorption effect of the meltblown cloth, resulting in the attenuation or premature attenuation of its filtration effect, which needs further verification. In addition, due to the continuous and dynamic gas inhalation of mask products, the use scenarios and use methods are different from conventional disinfection products, and the conventional "antibacterial/bacteriostatic" evaluation method is not applicable to mask products.
The Device Evaluation Center of the State Food and Drug Administration believes that at present, under the premise that the clinical effectiveness of such mask products has not been fully verified, the addition of antibacterial agents introduces new risks, and when the pre-market evaluation of medical devices, the risk benefit ratio of continuous and long-term use of such products is insufficient, and it does not have significant clinical significance, and the effectiveness and safety of the products need to be studied more systematically and deeply.
Intern Zhang Na Modern Express + reporter Ma Zhuangzhuang