Beijing: implantable medical consumables must be recorded in the patient record
by:Celecare
2020-05-31
On August 1, September 1, the city medical institutions at all levels of the dynamic monitoring of medical consumable materials dosage, and recorded in the patient record plant involved in class medical consumables relevant information.
City WeiJianWei according to the measures for the management of medical consumables of medical institutions, clear medical institutions shall not use medical consumables purchase conditions as the basis of economic department, personnel distribution.
According to the method, medical institutions should be clear medical consumables management responsibilities, establish and perfect the system of medical consumables procurement.
Medical consumables purchase related transactions by the unified management of medical consumables management department, other department or departments shall not be engaged in medical consumables procurement activities, shall not use of medical consumables procurement supply of medical consumables management department.
Medical institutions to establish a strict medical consumables production and operation of the enterprise qualification and product qualification system, the medical consumables production and operation enterprises submitted by the medical device manufacturing license of the medical device registration certificate shall be the medical equipment business license certificate and product data audit inspection shall be carried out in accordance with the relevant regulations, to ensure product legitimacy.
Medical institutions to promote the information management system of medical consumables, establish and improve the medical consumables procurement, inbound, outbound, use, scrap verification system, a detailed record product category, name, specification, model, origin, validity, production date, batch number/serial number, purchase price, the purchase amount and related information.
In order to ensure the safety of medical quality, medical institutions should strictly, strengthening the safety management in clinical rational use of medical consumables and the dosage of medical consumables dynamic monitoring, evaluation and quality of medical consumables for medical consumables bidirectional traceability management.
Analysis of the abnormal use of medical consumables and timely rectification, and the analysis results and corrective feedback related clinical departments in a timely manner.
City WeiJianWei requirements, medical institutions should be implanted medical consumables used in preoperative discussion, medical consumables to be used including the necessity, feasibility and economical efficiency, etc.
At the same time, request medical staff before planting in class medical consumables used to check the information on products, used in strict accordance with the relevant diagnostic codes, and to fulfill its obligation to inform the patients or their family members, signed informed consent form, at the same time record plant involved in class in the medical record information of medical consumables.
Medical institutions to strictly implement medical consumables adverse event reporting system, the adverse events in clinical use, to be in accordance with the drug regulatory agency of the medical device adverse event reporting program report in a timely manner, and in the products shall be sealed.
At the same time, but also cooperate with medical device manufacturing enterprise to do a good job of recall defective products.
Medical institutions use of medical consumables to qualify for the agency qualification requirements, not registered according to law, shall not be used without qualification, expired, failure and elimination of medical consumables.
For single use shall not re-use medical consumables
For reusable medical consumables, in strict accordance with the requirements for cleaning, disinfection or sterilization.
City WeiJianWei requires medical institutions to strictly implement the relevant provisions of the medical and health field enhancement of management, be honest, purchase and use shall not use medical consumables purchase situation as the basis of economic department, personnel distribution, shall not be in the work of purchase and use for medical consumables to seek improper economic interests.
Regularly carry out this unit the use and management of medical consumables procurement and situation check list, to find problem timely rectification.
Health administrative departments at all levels to guide medical institutions of Beijing medical institutions within their respective jurisdictions in accordance with the law practice self checking system, to develop good self audits of medical consumables management, for not carefully, according to the facts, conduct self audits 'on a practice of medical institutions in accordance with the law, strengthen the supervision and inspection, and frequency.
More excessive examination, excessive treatment to the medical personnel and in violation of the provisions of nine is allowed to conduct the investigation dynamics, to the serious problems of medical institutions to pursue the responsibility of leaders.
To found in the daily regulation to reduce the related medical institutions in medical consumables purchase and use the management problems, immediately instruct rectification within a time limit of medical institutions, once found violation behavior, investigate or transferred to other relevant government departments in accordance with the law.
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