General office of the national health and family planning commission on disinfection products manufacturing enterprises and the rectification work situation of radiological health technical service institutions

The 2016-02-17 national health and population and family planning commission of the People's Republic of China

Countries who do supervision letter [2016] no. 102

Provinces, autonomous regions and municipalities directly under the central government health and family planning commission, the xinjiang production and construction corps bureau of health, the centers for disease control and prevention, supervision center:

For the implementation of the state council and decentralization, strengthen the supervision of things after the event, the spirit of 2015 by deployed across the country to carry out the disinfection products manufacturing enterprises and rectification of radiological technology services, according to the unified requirements, combined with the actual, carry out special campaigns. In November 2015, by organization of tianjin, liaoning and other eight provinces (municipalities) work for supervision. Combined report summary and supervision situation, now the rectification work conditions are as follows:

A, the work situation

(a) to strengthen organization and leadership. Country attaches great importance to, quickly set up a leading group, issued by the work in time. Tianjin, hebei, anhui and other provinces (municipalities) to the work as a key into the annual assessment of target. Beijing, Shanghai, zhejiang, hubei and other provinces (municipalities) rectification work should be brought into the "2015 crackdown on infringement of intellectual property and produce fake and inferior commodities work" for deployment. Shanxi, shandong, hubei, guizhou, shaanxi provinces such as timely rectification work of subordinates to carry out the situation to carry on the inspection, vigorously promotes the work carries out.

(2) strengthen the publicity and training. Around, make full use of the Internet, newspapers, television and other media publicity and relevant laws and regulations and the popular science knowledge, public complaints to report telephone, special report work progress, exposure of typical cases, timely public list and illegal institutions unqualified disinfection products. Around to strengthen grass-roots supervisor, disinfection products manufacturing enterprises and radiological technology services management personnel training, to ensure the efficient work of rectification.

(3) to carry out the self-check. Disinfection products production enterprises and radiological health technical service institutions in accordance with requirements of the rectification work, contrast "disinfection products production enterprise health standards", "radiological technology services management method" and other relevant provisions, earnestly carry out self-check, earnestly implement the main body responsibility, to alter the disinfection enterprise license approved projects and technical services has been obtained qualification without authorization from behavior such as positive changes, to further standardize the production and business operation and service behavior.

(4) comprehensive supervision and inspection. Around in a production enterprise of self-check, on the basis of comprehensive carrying out supervision and inspection work, the existing problems in a timely manner to track, supervise and urge the rectification. Disinfection products production enterprises of tianjin for the tianjin record scoring system (try out) ", to the enterprise all kinds of bad score record behavior. Use of Shanghai health supervision information service platform "" health related products, will find that the illegal act and investigation of announces. Application of rapid detection equipment for production environment in wuxi city, jiangsu province on-site rapid detection, found that health security hidden danger in time.

The rectification of the national 5650 HuCi check disinfection products manufacturing enterprises, including 4117 HuCi hygiene products production enterprises, 1020 HuCi disinfectant production enterprises, 513 HuCi disinfection equipment manufacturing enterprises. Spot check 10820 disinfection products, unqualified 541, accounted for 5%. The family planning administrative department of public health to 55 of the serious problem of unqualified enterprises and 137 pieces of unqualified products to the public, fines of more than 580000 yuan. Check the radiological health technical service institutions 554, spot check of 4435 professional and technical personnel qualification. Effectively specification through special treatment, disinfection products manufacturing enterprises and radiological technology services of production management and technical service, maintain the market order and safeguard the people's health and public health security.

Second, there is a problem

(a) parts of the measures to carry out the work does not reach the designated position. Individual local lack of understanding of the importance of the rectification work, heavy post deployment, light to supervise implement, failed to organize to carry out the rectification work effectively; Individual local funds shortage due to sampling, testing and inadequate institutional capacity, disinfection products sampling observation of quality health unfinished work. Not according to stipulations individual provinces timely submit the rectification work summary and the summary table.

(2) disinfection products production enterprise main body responsibility implementation is not in place. Is a part of the enterprise would be changed without authorization license approved production conditions and facilities, the actual production projects with the licensing program. 2 it is part of the health management system of the enterprise does not reach the designated position, product batch test can't strictly implement, to evaluate health security disinfection products not according to stipulations or incomplete health safety evaluation report content. The sampling from 221 the first and the second category of disinfection products, there are 122 without health safety assessment report, accounting for 55.2%. 3 it is part of disinfection products, particularly resistant (or) bacteria preparation products label instructions, exaggerating or express, implied curative effect, etc.

(3) the radiological health technical service institutions of incompetence. Is a part of the province of radiological health technical service institutions within the jurisdiction of the number can't meet the demand of radiological diagnosis and treatment institutions, technology services, unbalanced regional distribution of individual institutions the actual number of professional and technical personnel engaged in the work of technical service and lack of ability. 2 it is individual obtain technical service qualification of provincial center for disease control and prevention of other technology services business guidance effect. There is some technical services three test report, assessment report and the original record writing is not standard, the test items is not complete and evaluation archives lack and so on.

(4) everyday supervision still exist. Is a grass-roots supervision strength is weak, disinfection products and radiological full-time supervision and the lack of professional supervision and law enforcement ability needs to improve. 2 it is parts of existing laws and regulations execution does not reach the designated position. If not in accordance with the requirements to carry out disinfection products health safety report for the record, the service scope of radiological health technical service institutions and non-standard for examination and approval of category. 3 it is to the individual places not issued radiological health technical service institutions at the provincial level management method and the inspection standards, etc. Four is inspection agencies failed to give full play to their role as the technical support. Part of the institution of disease prevention and control work enthusiasm is not high, disinfection products with a long cycle detection. Inspection organizations at the same time, there is fewer, incompetence, and so on and so forth.

Third, the next step of work requirements

(a) to consolidate rectification results. One is around to the rectification work, on the basis of comprehensively promoting health disinfection products safety evaluation and filing work, continue to strengthen the supervision and inspection, the key to the first category, the second category of disinfection products and the supervision and inspection of the enterprise, in accordance with law, investigate violation behavior. 2 it is in accordance with the law on the prevention and control of occupational diseases, the radioisotope and ray devices regulations on the safety and protection requirements, strengthen supervision and inspection, supervise the radiological health technical service institutions from strengthening legal consciousness, responsibility consciousness and service consciousness, in accordance with the regulations to carry out the technical service work in accordance with the law.

(2) to strengthen the construction of system. One is to strengthen grass-roots disinfection products supervision and law enforcement team construction, enrich staff, increasing investment, ensure the funds for working funds and sampling. The second is to strengthen professional training, and constantly improve the ability of first-line supervisors of supervision and law enforcement. Three is to strengthen disinfection product testing agencies and radiological technical service institution building, planning institutions, improve the service ability and quality.

(3) increasing regulations propaganda. Should strengthen the disinfection products manufacturing enterprises and workers in radiological technology service institution legal person and relevant laws and regulations propaganda and training, improve enterprises and institutions, law-abiding consciousness, strengthen the main body responsibility, supervise strictly in accordance with the measures for the management of disinfection, the measures for the administration of the radiological health technical service institutions engaged in production and business operation and services such as regulations.

(4) to establish a long-term supervision mechanism. Around to further improve the system of supervision and management, a positive innovation, exploring the "Internet + regulation" mode of law enforcement, strengthen the case investigation and reporting of collaboration between provinces. Build system of perfect record and "blacklist", give full play to the social supervision.

Attachment: 1. The disinfection products production enterprise supervision and inspection summary form. Docx

2. Disinfection products supervision and inspection summary form. Docx

General office of national health and family planning commission

On February 2, 2016