US Food and Drug Administration:

According to the document spirit of 19991February 15, and X No.29 issued by the US Food and Drug Administration in Area X, our hospital organized relevant personnel to conduct a comprehensive inspection of drugs and medical devices in the hospital. The specific situation is now reported as follows:

First, improve the safety supervision system and strengthen management responsibilities.

The hospital has set up a safety management organization with the dean as the team leader and the directors of various departments as members, which puts the safety management of drugs and medical devices into the top priority of hospital work. A series of systems related to drugs and medical devices, the supervision and management system of adverse events of medical devices, and the storage, maintenance, use and maintenance system of medical devices have been established and improved to ensure the safety of clinical work in hospitals.

Two, the establishment of drugs, equipment safety files, strict management system.

The management system has been formulated, and the conditions for purchasing drugs and medical devices and the qualifications of suppliers have been strictly stipulated to ensure the quality and safety of purchased drugs and medical devices and prevent unqualified drugs and medical devices from entering the hospital. Ensure the legality and quality of drugs and medical devices in storage, conscientiously implement the outbound system, and ensure the safe use of medical devices.

Third, do a good job in daily maintenance.

Strengthen the quality management of stored drugs and devices, and have special personnel to do the daily maintenance of drugs and devices. In order to prevent unqualified drugs and medical devices from entering the clinic, an adverse event reporting system is formulated. When adverse events of drugs and medical devices occur, the location, time, adverse reactions or basic information of the adverse events should be identified, recorded and reported to the US Food and Drug Administration quickly.

Fourth, create a good development environment for honest people, punish those who break their promises, increase administrative and medical accountability, strengthen laws and regulations, business skills, work style, education and training, and implement responsibility and safety management.

Five, legal, standardized and honest to create a safe hospital.

Establish the awareness of "safety first", strengthen the inspection of the safety items of drugs and medical devices in hospitals, timely investigate the hidden dangers of drugs and medical devices, supervise the frequency, consolidate the safety achievements of drugs and medical devices in hospitals, and create a good atmosphere for drugs and devices, so as to make the hospital a good hospital with satisfactory patients, recognized by peers and reassured by the government.

Self-inspection report of medical devices in retail pharmacies Part II:

According to the requirements of Yuanmou County Medical Insurance Center and the service agreement of the designated retail pharmacies at the beginning of the year, the eighth salesroom of Yuanmou County Medicine Co., Ltd. organized our employees to conduct self-examination and item-by-item self-examination on the performance of the service agreement in the first half of the year. The self-examination and self-correction are now reported as follows:

Basic information: Our store has an operating area of 80 square meters, and the sales task was 98,000 yuan, including 27,000 yuan for medical insurance. At present, it operates more than 3,000 kinds, 10 kinds of medical devices and 20 kinds of health products. There are 2 clerks in the pharmacy, including pharmacist 1 person and pharmacist 1 person.

In the process of self-examination and self-correction, we found some good points and some shortcomings. Advantages: (1) Strictly abide by the Drug Administration Law of People's Republic of China (PRC) and the Interim Provisions on Basic Medical Care and Medical Insurance for Urban Employees in Chuxiong Prefecture; (2) Seriously organize and study the medical insurance policy, correctly publicize the medical insurance policy to the insured, and did not sell any other items that did not meet the payment scope of the medical insurance fund; (3) The clerk actively and enthusiastically serves the insured and does not sell counterfeit and inferior drugs. So far, no complaints have occurred; (4) The drugs shall be placed in an orderly manner, clean and hygienic, and the national drug price policy shall be strictly implemented, so that one sign and one price shall be clearly marked.

Existing problems and weak links: (1) Not proficient in using computer technology, especially the list of new drugs in the store is not maintained in the computer system in time and accurately; (2) In terms of policy implementation, the salesman's understanding of relevant supporting policies is not comprehensive, the understanding is not in place, and the study is not deep enough, resulting in the actual computer operation not being well implemented; (3) The service quality needs to be improved, especially for the new special drugs and health care products that have just entered the store, the understanding and publicity of their performance and efficacy are not enough; (4) The contents of the medical insurance publicity column set in the store were not changed in time.

In view of the above problems, the rectification measures of our store are as follows: (1) Strengthen the study of medical insurance policies, and often organize employees to learn relevant laws and regulations, so as to know and abide by the law; (2) Improve service quality, be familiar with drug performance, correctly introduce the usage, dosage and precautions of medical insurance drugs to customers, and give full play to the role of consultants; (3) Computer operators should speed up the skilled operation training of using computer software. (4) timely and correctly publicize the medical insurance policy to the insured and serve the insured wholeheartedly.

Finally, I hope that the higher authorities will supervise and guide the daily work of our pharmacy and give more valuable opinions and suggestions. thank you