Release date: 2009-11-12 I. Online investigation of anti-A H1N1 influenza anti-virus masks. Recently, an anti-viral mask developed by Tianjin Mingda Technology Development Co., Ltd., which can effectively inhibit the influenza A (H1N1) virus, has been successfully reproduced. Available. In this regard, the State Food and Drug Administration attached great importance to it, immediately contacted Tianjin and Hebei Food and Drug Administration to understand the situation, and instructed the company's production base in Langfang City Food and Drug Administration to go to the scene for investigation. Used for impotence due to kidney deficiency, premature ejaculation due to spermatorrhea, flaccidity of waist and knee, cold and cold limbs. For the treatment of impotence and catharsis, it can be used with fairy grass, cornel meat, Cistanche deserticola and other products; for the treatment of lumbar and knee impotence, it can be used with Eucommia ulmoides, Morinda officinalis, Dogji and other products. Epimedium Extract,Epimedium Sagittatum,Epimedium Grandiflorum,Epimedium Sagittatum Seeds Lixian Spring Pharmaceutical Co., Ltd. , https://www.lxctyy.com
According to the survey, the production base of Tianjin Mingda Technology Development Co., Ltd. is Yongqing County Daxinge Mingda Knitting Factory, located in Zhaogezhuang Village, Daxinge Township, Yongqing County, Hebei Province. It is an individual enterprise mainly engaged in textile processing and sales. The business license of individual industrial and commercial households. Tianjin Mingda Company and Yongqing Mingda Knitting Factory have not obtained the "Medical Device Manufacturing Enterprise License", and the mask product has not obtained the "Medical Device Registration Certificate". On-site inspection found that as of November 9, the factory produced a total of 8012 anti-flu sterilization cosmetic masks, sold 5,000, each selling for 9.5 yuan; on the site found 3012 anti-flu sterilization cosmetic masks, 2,652 semi-finished products, 6500 raw materials (mask cloth), 1000 packaging bags, and a number of production equipment were sealed up.
According to the Regulations on the Supervision and Administration of Medical Devices, the State implements a product production registration system for medical devices. The production and sale of medical device products shall be submitted to the relevant food and drug supervision and administration department in accordance with the regulations, and its technical indicators, test reports and clinical After the test and other examinations are passed, the medical device registration certificate is issued before production and sales. At present, the food and drug supervision department has requested Tianjin Mingda Technology Development Co., Ltd. and its production enterprises to recover the anti-flu sterilization beauty masks that have been sold, and actively delete relevant information on the company's website. Products seized on site will be dealt with according to law after further investigation and evidence collection.
Second, the examination and approval standards and product types of medical masks At present, the State Food and Drug Administration has not approved anti-virus masks that inhibit influenza A virus. Medical masks that have been approved for medical device marketing include medical respirators, medical surgical masks, and general medical masks. Ordinary absorbent gauze masks are not managed as medical devices. As a medical mask approved for medical devices, the important technical indicators and applicable scope of the approval standards are as follows:
(1) Standards and important technical indicators for medical masks 1. Medical protective masks In line with GB19083-2003 "Technical requirements for medical protective masks", important technical indicators include non-oily particulate filtration efficiency and airflow resistance:
(1) Filtration efficiency: under the condition of air flow rate (85±2) L/min, the filtration efficiency of the aerodynamic median diameter (0.24±0.06) μm sodium chloride aerosol is not less than 95%, that is, in line with N95. (or FFP2) and above.
(2) Inspiratory resistance: Under the above flow conditions, the suction resistance does not exceed 343.2 Pa (35 mmH2O).
2. Medical surgical masks In line with YY 0469-2004 "Technical requirements for medical surgical masks", important technical indicators include filtration efficiency, bacterial filtration efficiency and respiratory resistance:
(1) Filtration efficiency: under the condition of air flow rate (30±2) L/min, the filtration efficiency of aerodynamic median diameter (0.24±0.06) μm sodium chloride aerosol is not less than 30%;
(2) Bacterial filtration efficiency: under the specified conditions, the filtration efficiency of the Staphylococcus aureus aerosol having an average particle diameter of (3 ± 0.3) μm is not less than 95%;
(3) Respiratory resistance: Under the condition of filtration efficiency flow rate, the inspiratory resistance does not exceed 49Pa, and the expiratory resistance does not exceed 29.4Pa.
3. Ordinary medical masks In line with the relevant registered product standards (YZB), generally lack of filtration efficiency requirements for particles and bacteria, or filtration efficiency requirements for particles and bacteria is lower than medical surgical masks and medical protective masks.
(2) Applicable scope of medical masks According to the standards and important technical indicators that all kinds of medical masks meet:
1. Medical protective masks are suitable for medical personnel and related staff to protect against airborne respiratory infectious diseases with high degree of protection;
2. Medical surgical masks are suitable for the basic protection of medical personnel or related personnel, as well as protection against the spread of blood, body fluids and spatter during invasive operation;
3. Ordinary medical masks have ineffective protection against pathogenic microorganisms and can be used for disposable health care in general environments or for blocking or protection of particles other than pathogenic microorganisms such as pollen.
Third, the implementation of A-type H1N1 influenza prevention and control medical equipment related work According to the urgent need for prevention and control, the State Food and Drug Administration issued relevant working documents in a timely manner, launched the emergency approval procedures, and accelerated the examination and approval of the urgent need for medical device products Strengthen the production and circulation supervision of protective products. The “Notice on Investigating and Controlling the Relevant Medical Devices and Production Permits Related to Infection with Swine Flu†(Food and Drug Administration Letter [2009] No. 32), “On Strengthening Medical Protective Masks, Medical Protective Clothing, Ventilator, etc.†Notice on Medical Device Supervision Work (Food and Drug Administration [2009] No. 39), "Notice on Strengthening the Supervision of Medical Masks" (Food and Drug Administration [2009] No. 95), "Emergency Approval Procedure for Medical Devices" (National Food and Drug Administration [2009] No. 565) and a series of working documents, from the registration, production, circulation and other links to strengthen the protection products supervision and protection requirements. Among them, the "Notice on Strengthening the Supervision of Medical Masks" clearly requires the food and drug supervision and administration departments of all provinces, autonomous regions, and municipalities directly under the Central Government to strengthen the supervision of the use of approved medical masks in their jurisdictions; all relevant enterprises shall strictly follow national standards and industry standards. Or register a product standard organization to produce and standardize instructions for use and packaging.
In addition, according to the "medical device emergency approval procedures", experts in virology, laboratory medicine, preventive medicine, technical review, product testing, etc. have been organized twice, and the protective mask products of relevant enterprises have been evaluated and reviewed. The 3860 medical protective masks of 3M Company have been approved in September and approved for listing.