My hospital in accordance with the spirit of the X District X Food and Drug Administration issued **27, 29 documents, the organization of relevant personnel focused on the hospital's pharmaceuticals, medical devices to carry out a comprehensive inspection, the details are now reported as follows:
One, improve the safety monitoring system, strengthen the management of the responsibility
Hospital set up a dean of the safety management organization as head of the group, the director of each department as a member of the hospital's work. As the head of the hospital, the director of each department as a member of the safety management organization, the drugs, medical equipment safety management into the hospital's top priority. The establishment of a series of drugs, medical equipment related systems, medical device adverse event supervision and management system, medical equipment storage, care, use, maintenance system, etc., in order to ensure the safety of the clinical work of the hospital system.
Second, the establishment of drugs, equipment safety files, strict management system
Development of the management system, the purchase of drugs, medical equipment, the conditions and qualifications of the supplier to make strict provisions to ensure the purchase of drugs, medical equipment, the quality of drugs and medical equipment, and the use of safety, and to eliminate unqualified drugs, medical equipment into the hospital. Ensure that the incoming drugs, medical equipment, legal and quality, and conscientiously implement the entry and exit system to ensure the safe use of medical equipment.
Three, do a good job of daily maintenance and storage
Strengthen the quality management of stored medicines and equipment, there are specialized personnel to do a good job of daily maintenance of medicines and equipment. To prevent unqualified medicines and medical devices from entering the clinic, we have formulated an adverse incident reporting system. If there is an adverse event of drugs and medical devices, you should find out the location, time, adverse reactions or adverse events of the basic situation, and make a good record, and quickly reported to the District Drug Administration.
Four, for the good faith to create a good environment for the development of those who are dishonest behavior to be punished
Increase administrative and medical accountability, strengthen the laws, regulations, business skills, work style, education and training, the implementation of the responsibility for safe governance.
Fifth, legal, standardized, integrity to create a safe hospital
Establishing a "safety first" consciousness, increase the hospital drug and device safety program inspection, timely investigation of drugs and medical devices hidden problems, supervision frequency, consolidate the hospital drug and medical device safety results, create a good atmosphere for drugs and devices, the hospital into a patient satisfaction, peer recognition. The hospital into a patient satisfaction, peer recognition, the government assured that the good hospital.
Episode 2: medical device business enterprise annual summary of self-examination report
In accordance with the province's supervision and management of medical devices work conference and the provincial bureau of the "on the development of medical equipment business, the use of units of the special supervision of the notice" (Hebei Food and Drug Administration Mech. 20 ** 108) deployment of the jurisdiction of the medical device business, the use of units for a period of three months to carry out the special supervision and inspection.
My hospital to implement the province's medical device supervision and management work conference and the "notice on the development of medical equipment business, use of units of special supervision" document spirit, to protect the people to use medical devices safe and effective, decided to carry out in my hospital medical equipment business, use of self-correction, the development of this self-examination report.
I, the guiding ideology
Continuously around the "to ensure that the people with the safe and effective use of medical devices," the central task, practice supervision for the people's core concepts, and effectively do for the people, science, according to the law, the long term effect, and harmony, through the self-corrective checks, to further strictly regulate the operation and use of medical devices, and to improve the quality management level, to ensure that there is no accident, to ensure that the medical device business, use of medical devices. Improve the quality management level, to ensure that no major medical device quality accidents.
Second, the purpose of the inspection
To increase the management of medical equipment business, use management efforts to eliminate the sale, use of expired, invalid, obsolete diagnostic and treatment equipment and a variety of behavior. Through this special self-corrective inspection, to ensure that the people use safe and secure medical equipment, and reduce the incidence of medical errors, improve hospital visibility.
Three, self-inspection and self-correction focus
Focus on self-inspection since January 20 ** sales and use of single-use sterile medical devices, in vitro diagnostic reagents, sterile sanitary materials, such as the specified expiration date of the implementation of the quality management system of medical devices, against the check whether the product is the manufacturer's license, the product registration certificate and the product certificate of conformity; the product's purchase records; the use of product records and whether to establish the product adverse event records, and whether the product's use of the product. Records and whether the establishment of the product adverse event reporting system and report.
Four, according to the specific situation of our hospital, the results of its self-examination and self-correction report are as follows:
1, self-examination of the types of: one-time use of sterile medical devices, in vitro diagnostic reagents, sterile sanitary materials in three major blocks.
2, product qualification certificates and certificates are strictly verified, and each purchasing and receiving personnel are strictly controlled, and there is not a single case of unqualified products.
3, purchasing records carefully, detailed records, to ensure that the problematic events have a place to check, can be relied upon.
4, receiving personnel to check the procurement records and products, to confirm that the product is legal, correct, qualified,
5, product storage is strictly in accordance with the requirements of the product description completed.
6, product use carefully check its completeness, expiration date, sterility. Fill in the use record.
7, under the leadership of the dean is gradually improving our hospital's product adverse event reporting system, the safe use of medical devices in the further development.
8, but in the actual work and implementation, there may be some easily overlooked, subtle aspects of the problem, hope that the higher leadership of the work of our hospital to put forward valuable advice.
Fifth, through this self-examination and self-correction activities, our hospital to seriously study the law, standardize the operation and use of behavior, and further self-improvement, strengthen the safe use of medical equipment system, standardize the operation and use of medical equipment behavior, strengthen their quality management system, and enhance the knowledge of law-abiding awareness to improve the overall level of hospitals.
Episode 3: medical device business enterprises annual summary of the self-examination report
Since the Tiexi District Food and Drug Administration held the "Tiexi District Drugs and Medical Devices Quality and Safety Remediation Mobilization Conference", I actively participate in the hospital with the immediate organization of the establishment of a self-examination team, the hospital's drugs and medical equipment quality and safety situation to conduct a comprehensive mapping, is now the first time in the hospital, the hospital's medical equipment quality and safety. Safety situation to conduct a comprehensive mapping, the results of the self-examination is reported as follows:
1. Personnel management: our hospital drugs and medicines work by professional and technical personnel, and regular medical laws and regulations and the relevant system of training to ensure the smooth progress of the work; the annual organization of direct contact with the drugs and medicines staff to conduct a health check, and build a health file.
2. Duty management: the hospital has established a management system, including: drugs and medicines procurement and acceptance system; drugs and medicines in and out of the warehouse system; drugs and medicines adverse reactions (events) monitoring and reporting system; drugs and medicines deployment and review system; drugs and medicines storage and maintenance system; medical and nursing staff post responsibility system; safety and health management system, and so on. The above systems are complete, reasonable, feasible, and have the corresponding implementation records.
3. Purchase and sale of drugs and medicines management: our hospital by the professional staff assigned to the procurement, quality inspection and acceptance of the work; from the legal production and operation of drugs and medical equipment purchased from the enterprise, and the quality of the agreement signed with the supplier enterprises, with legal bills; acceptance of the staff can be strictly in accordance with the development of the access to acceptance of the system and operational procedures for acceptance of drugs and medicines, and save a complete record of the purchase and acceptance of the record.
4. Pharmacy management: our hospital has a comprehensive pharmacy, safety and hygiene, sign conspicuous; pharmacy division of the appropriate functional areas, so that the drugs according to the dosage form classified and placed in a neat and orderly manner; the bureau is equipped with anti-rodent and anti-mosquito facilities; pharmacy staff in the dispensing of prescriptions can be strictly audited in accordance with the system of dispensing and the operating norms of the dispensing, and according to the requirements of the daily inspection of medicines, such as in the case of broken or expired drugs reported to be unified treatment and carefully registered. Specialized personnel to deal with, and carefully registered.
5. Pharmacy management: the hospital's pharmacy district is distinctive and reasonable, the distance between the storage of drugs is appropriate, according to the requirements of the classification and dosage form at room temperature storage of drugs; managers can strictly in accordance with the requirements of the custody of drugs; drugs out of the warehouse to follow the principle of "first in, first out," the record is complete.
The above is the existing situation of the quality and safety of drugs and medical devices in our hospital, in the future work, we will further improve.