Since the US Food and Drug Administration in Tiexi District organized a mobilization meeting to improve the quality and safety of drugs and medical devices in Tiexi District, our hospital actively participated in the cooperation and immediately organized a self-inspection team to conduct a comprehensive inspection of the quality and safety of drugs and medical devices in the hospital. The results of self-inspection are now reported as follows: 1. Personnel management: all drugs and medical devices in our hospital are in the charge of professional and technical personnel, who regularly train medical laws, regulations and related systems 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 storehouse management: the division of drug storehouse in our hospital is clear and reasonable, and the storage distance of drugs is appropriate, so that drugs can be stored at room temperature according to the requirements of classification and dosage form; Managers can keep drugs in strict accordance with the requirements; Follow the principle of first-in first-out when leaving the warehouse, and keep complete records.
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.
2.202 1 self-inspection report of medical devices
According to the spirit of document 19971February 15, No.20 _ _ 27 and No.X-29, our hospital organized relevant personnel to conduct a comprehensive inspection of medicines and medical devices in the hospital. The specific situation is now 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 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 medical devices, so as to make the hospital a good hospital with satisfactory patients, recognized by peers and reassured by the government.
3.202 1 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 reported as follows: First, the hospital established 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 at the top of the hospital's 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 increase 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 and serving patients, and constantly build hospitals that are satisfactory to the people.
3. Continue to actively cooperate with the higher authorities, consolidate the achievements made in the safety work of drugs and medical devices in hospitals, create a good atmosphere for drugs and medical devices, and make greater contributions to building a harmonious society.
4.202 1 self-inspection report of medical devices
According to the spirit of the provincial medical device supervision and management work conference and the Notice of the Provincial Bureau on Special Supervision of Medical Device Operation and Use Units (Ji Food and Drug Administration [2004]10/No.). 20 1 1 108), and carry out special supervision and inspection on medical device operating and using units within the jurisdiction for three months. In order to implement the spirit of the work conference on the supervision and management of medical devices in the whole province and the Notice on Carrying out Special Supervision of Medical Device Operating Units, and to ensure the safe and effective use of medical devices by the people, our hospital decided to carry out self-examination and self-correction on the operation and use of medical devices in our hospital, and this self-examination report is specially formulated.
First, the guiding ideology:
Focusing on the central task of ensuring the safety and effectiveness of people's machines, we practice the core concepts of supervision for the people, science and legality, long-term harmony, further strictly regulate the operation and use of medical devices through self-examination and self-correction, comprehensively improve the quality management level, and ensure that major medical device quality accidents do not occur.
Second, the purpose of the inspection:
It is necessary to strengthen the management of the operation and use of medical devices, and put an end to the sale and use of expired, invalid and eliminated medical devices and various behaviors. Through this special self-examination and self-correction inspection, we will ensure the people to use safe and secure medical devices, reduce the incidence of medical accidents and improve the visibility of the hospital.
Third, the focus of self-examination and self-correction:
Focus on the implementation of the quality management system of disposable sterile medical devices, in vitro diagnostic reagents, sterile sanitary materials and other medical devices sold and used since 20 10, and check whether the products have production license, product registration certificate and product certificate; Purchase records of products; The use record of the product and whether the product adverse event reporting system has been established and reported.
Four, according to the specific situation of our hospital, the self-examination and self-correction results are reported as follows:
1. The types of self-examination include: disposable sterile medical devices, in-vitro diagnostic reagents and sterile sanitary materials.
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