Since the United States Food and Drug Administration in Tiexi organized the "Tiexi District Drug and Medical Device Quality and Safety Remediation Mobilization Conference", our hospital actively participated in the cooperation and immediately organized a self-inspection team to conduct a comprehensive investigation on the quality and safety of drugs and medical devices in the hospital. The results of self-examination are reported as follows: 1 personnel management: all drugs and medical devices in our hospital are in the charge of professional and technical personnel, and regular training on medical laws, regulations and related systems is carried out to ensure the smooth progress of the work; Organize the staff who are in direct contact with drugs and medical devices to carry out health examination every year and establish health records.
2. Responsibility management: The established management system in our hospital includes: the procurement and acceptance system of drugs and medical equipment; Drug delivery and storage system; Adverse drug reactions (events) monitoring and reporting system; Drug distribution and review system; The custody and maintenance system of drugs and medical equipment; Post responsibility system for medical staff; Safety and health management system. The above system is complete, reasonable and feasible, and there are corresponding implementation records.
3. Purchase and sale management of drugs and medical devices: our hospital is divided into procurement and quality acceptance by professionals; Being able to purchase drugs and medical devices from legal production and operation enterprises, and signing quality agreements with suppliers, with legal bills; Acceptance personnel can accept drugs and medical devices in strict accordance with the established warehousing acceptance system and operating procedures, and keep complete procurement acceptance records.
4 pharmacy management: our hospital has a comprehensive pharmacy, which is safe and hygienic with eye-catching signs; Pharmacy is divided into corresponding functional areas, so that drugs can be placed in an orderly manner according to dosage forms; There are anti-rodent and anti-mosquito facilities in the bureau; Pharmacists can strictly review prescriptions when dispensing, allocate drugs according to dispensing system and operating specifications, and check drugs daily as required. In case of damaged or expired drugs, it will be reported to a special person for unified treatment and registered carefully.
5. Drug storeroom management: The drug storeroom in our hospital is clearly divided and reasonable, and the storage distance of drugs is suitable, so drugs can be stored at room temperature according to the requirements of classification and dosage forms; Managers can keep drugs in strict accordance with the requirements; The principle of "first-in, first-out" should be followed when the drugs are out of the library, and the records should be complete.
The above is the present situation of the quality and safety of drugs and medical devices in our hospital, and we will further improve it in the future work.
Article 2 Self-inspection report of medical devices
In order to ensure the effectiveness of the use of drugs and medical devices by the people in the county, our hospital specially organized relevant personnel to conduct a comprehensive inspection of drugs and medical devices in the hospital according to the spirit of the superior document and the Work Plan for Special Inspection of the Use of Drugs and Medical Devices in Medical Institutions of Luanchuan County Drug and Medical Device Supervision and Administration issued by the superior document. The specific situation is now reported as follows: 1. Strengthen leadership, strengthen responsibility and enhance the sense of quality responsibility.
At first, the hospital set up a safety management organization with the dean as the team leader and the directors of various departments as members, and put the safety management of drugs and medical devices into the top priority of hospital work. Strengthen leadership, strengthen responsibility, and enhance the sense of quality responsibility. The hospital has established and improved a series of systems related to drugs and medical devices, including the unqualified treatment system of drugs and medical devices, the disposable medical supplies management system, the supervision and management system of medical device adverse events, and the storage, maintenance, use and repair system of medical devices, which ensured the safe and smooth development of clinical work in the hospital.
Second, in order to ensure the quality and safety of purchased drugs and medical devices, and prevent unqualified drugs and medical devices from entering, our hospital has formulated a procurement management system for drugs and medical devices. Strict regulations have been made on the conditions for purchasing drugs and medical devices and the qualifications of suppliers.
Three. In order to ensure the legality and quality of drugs and medical devices in storage, our hospital conscientiously implements the drug and medical device storage system to ensure the safe use of medical devices.
Fourth, do a good job in daily custody.
Five, in order to ensure the quality of drugs and medical devices in storage, we also organize special personnel to do the daily maintenance of drugs and medical devices.
Vi. Strengthen the management of unqualified drugs and medical devices to prevent unqualified drugs and medical devices from entering the clinic. Our hospital has formulated an adverse event reporting system. If 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 county-level drug and medical device supervision and management bureau quickly.
Seven, the focus of the future work of drugs and medical devices in our hospital.
Effectively strengthen the safety of drugs and medical devices in hospitals, put an end to the occurrence of safe time of drugs and medical devices, and ensure the safety of patients using drugs and medical devices. In our future work, we intend to:
1, further strengthen the publicity of drug and medical device safety knowledge, implement relevant systems, and improve the hospital's awareness of drug and medical device safety responsibility.
2. Increase the frequency of daily inspection and supervision on the safety of drugs and medical devices in hospitals, timely investigate the hidden dangers of drugs and medical devices, firmly establish the awareness of "safety first", serve patients, and constantly build hospitals that are satisfactory to the people.
Article 3 Self-inspection report of medical devices
Our hospital organized relevant personnel to conduct a comprehensive inspection of medicines and medical devices in the hospital, and now the specific situation is reported as follows: 1. 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 and punish those who break their promises.
Strengthen 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 potential safety hazards 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 medical devices, so as to make the hospital a good hospital with satisfactory patients, recognized by peers and reassured by the government.
Article 4 Self-inspection report of medical devices
According to the Notice of the US Food and Drug Administration on Carrying out Special Remediation of the Use Safety of Medicines and Medical Devices in Township Hospitals, Village Clinics and Individual Clinics in XX County, our hospital actively participated in cooperation and immediately organized a self-inspection team to conduct a comprehensive investigation of the use of medicines and medical devices in the hospital. Now the self-inspection results are reported as follows: 1. Responsibility management.
The management system established in our hospital includes: the procurement and acceptance system of drugs and medical equipment; Drug delivery and storage system; The custody and maintenance system of drugs and medical equipment; Post responsibility system for medical staff; Safety and health management system.
Two, the purchase and sale of drugs and medical devices management
There is no procurement of drugs and medical devices from unqualified units or individuals in our hospital; According to the provisions of the acceptance and fill in the true and complete acceptance records, check and obtain relevant information; Did not use expired drugs and medical devices.
Third, pharmacy management
The drug storeroom in our hospital is safe and hygienic, and the logo is eye-catching. The division of drug storeroom is clear and reasonable, and the drugs are placed neatly and orderly according to dosage forms. Drugs are stored according to the specified conditions, which are dustproof, moisture-proof, heat-proof, moth-proof and anti-theft. , and is equipped with a refrigerator for storing medicines. There are corresponding pharmacy drug quality management systems and implementation records.
Article 5 Self-inspection report of medical devices
Our company attaches great importance to it. On July 8, 20xx, the quality management department of the company organized employees in relevant positions to carry out self-inspection item by item according to the contents of the announcement and the actual situation of the company. The self-inspection is hereby notified as follows: (1) The business enterprise engages in the wholesale business of medical devices and sells them to unqualified business enterprises or users; Medical device management enterprises purchase medical devices from unqualified production and management enterprises.
Self-examination: our company's purchase and sale channels are legal, and the legal qualifications of suppliers and buyers are reviewed in strict accordance with relevant national requirements. The qualifications of all suppliers and procurement personnel of the company are legal and valid.
(two) the operating conditions have changed, which no longer meet the requirements of medical device quality management standards, and have not been rectified in accordance with the provisions; Changing the address of business premises or warehouses, expanding the business scope or setting up warehouses without authorization. Self-inspection: Our company conducts business in strict accordance with the requirements of the Quality Management Standard for Medical Device Operation, and there is no illegal act of changing the address of business premises or warehouses, expanding business scope or setting up warehouses without authorization.
(3) Providing false information or obtaining the Medical Device Business License by other deceptive means; Providing false information without filing or filing; Forge, alter, buy, sell, lease or lend the Medical Device Business License or the Medical Device Business Record Certificate.
Self-examination: Our company solemnly declares that the information provided in the Medical Device Business License is true, accurate and complete, and there is no illegal act of forging, altering, buying, selling, renting or lending the Medical Device Business License.
(4) engaging in the business activities of Class III medical devices without permission, or continuing to engage in the business activities of medical devices after the expiration of the Medical Device Business License.
Self-examination: Our medical device business license is valid until September 27th, 20xx. At present, our company is actively preparing for the replacement.
(5) Operating Class II and Class III medical devices without medical device registration certificate, especially domestic agents of imported medical devices operating unlicensed products.
Self-examination: our company's purchase and sale channels are legal and not beyond the business scope.
(six) operating medical devices that do not meet the mandatory standards or the technical requirements of registered or filed products; Operating medical devices without certificates, expired, invalid or eliminated.
Self-inspection: our company operates medical devices according to the approved business mode and business scope; Medical devices that are not operated without a license, expired, invalid or eliminated.
(seven) the instructions and labels of medical devices do not meet the relevant provisions; Failing to transport and store medical devices according to the requirements of medical device instructions and labels, especially failing to implement full chain cold chain management for medical devices that need to be refrigerated at low temperature.
Self-inspection: the instructions and labels of medical devices operated by our company comply with relevant regulations; Our company does not deal in medical devices that need to be refrigerated.
(eight) failing to establish and implement the medical device purchase inspection record system according to the regulations; Business enterprises engaged in the wholesale business of Class II and Class III medical devices and the retail business of Class III medical devices fail to establish and implement the sales record system as required.
Self-inspection: The system of incoming inspection and sales record of medical devices was implemented according to regulations.
Through this self-examination and self-correction, we will standardize and urge our own business behavior, and for the healthy and sustainable development of the company and better serve the people, we will, as always, carry out our work in strict accordance with the deployment requirements of the food and drug supervision and administration department to ensure good quality and ensure the people to use machinery safely and effectively.