National health and family planning commission general office on strengthening medical planted instruments the clinical use of regulatory work

The national health and family planning committee of the People's Republic of China

The 2013-07-16

Countries who do the medical letter [2013] no. 61

        The provinces, autonomous regions and municipalities directly under the central government health bureaus (health and family planning commission), the xinjiang production and construction corps health bureau:

        Implantable medical device belongs to the high risk medical instrument. To strengthen the management of medical planted instruments, effectively guard against fake medical devices into the medical institutions, medical security, to maintain a healthy patient rights and interests, we will further strengthen the implantable medical device clinical use supervision notice is as follows:

        A, local health (family planning) health administrative departments at all levels should further standardize the centralized purchasing implantable medical devices, to the high value medical consumables centralized purchasing job specification (try out) "the implementation of, should be included in the scope of centralized purchasing of medical planted instruments to firmly into, and continuously explore expand the scope of centralized purchasing varieties. Medical institutions should be carried out in accordance with the relevant provisions of the purchase, into the government centralized procurement to work through the government centralized procurement platform within the directory for procurement.

        Second, centralized purchasing working institutions and medical institutions to establish a system of implantable medical device production enterprise qualification, the implantable medical device manufacturing enterprise to submit the medical device manufacturing enterprise license, "medical device registration certificate and the medical equipment business license and product qualification certificate, such as, the review shall be submitted in accordance with the provisions of relevant laws and regulations and in conjunction with relevant departments to crack down on all kinds of illegal behavior.

        Three, medical institutions should earnestly implement the measures for medical and health institutions management of medical equipment and the medical device in clinical use and safety management standard (try out) "requirements, perfecting the mechanism of implantable medical device in clinical use and safety management rules and regulations, implement the responsibility system for management of medical planted instruments, medical equipment in clinical use and safety management and monitoring work.

        Four, medical institutions should strengthen the information management of medical planted instruments, and establish and improve the medical planted instruments procurement, inbound, outbound, use, scrap, etc. Inspection system, detailed record product category, name, specification, model, origin, the period of validity, date of production, batch/serial number, purchase price, the purchase amount and other relevant information, realize the source of the traceability, to query, responsibility can be investigated. Encourage exploration around the information management of implantable medical device in clinical use.

        Five, medical institutions should strengthen training the implantable medical device in clinical use and clinical medical planted instruments use evaluation system is established. Before use of implantable medical device, medical staff to check the information about specification is in strict accordance with the related diagnosis and treatment, and inform the patients or their families to perform obligations, signed informed consent form, record implantable medical devices in the medical record information.

        Six, medical institutions should strictly carry out medical device adverse event reporting system. Discovered in the use of adverse events, according to the medical device adverse event reporting procedures in time report to the administrative department for health (health family planning) at the corresponding level, and shall, in accordance with the relevant regulations of medical devices shall be sealed. Fake medical apparatus and instruments is found, should timely report to the public security organ, and report to the administrative department for health (health family planning) at the corresponding level.

        Seven, the local health administration (family planning) health departments at all levels according to relevant state laws and regulations and specifications, etc., further standardize the medical institution for clinical medical planted instruments use safety management, and strengthen supervision work in accordance with the law.

        Eight, provincial health (family planning) health administrative departments to strengthen supervision and inspection, check medical planted instruments focus on supervision purchasing channels, the supplier qualification and acceptance record, use warehouse outbound registration, records, etc. Check finds violation behavior, seriously investigate and deal with according to law.

        Please each provincial administrative department of health (family planning) health will implement this circular working situation in submitted by commission before December 20, 2013.

Touch: medical hospital authority Ye Changting, Gao Xinjiang medical security and blood

Contact phone: 010-68792569, 68792732

The true: 010-68792734

E-mail: xyc@moh.gov.cn

General office of national health and family planning commission

On July 15, 2013

The original link: http://www.moh.gov.cn/yzygj/s3589/201307/d9451f2fdbdd4a36b7ea5fc78d60ab80.shtml

(this site editor Wang Zhong one)