Medical device self-examination report (a)
Since the Tiexi District Food and Drug Administration organized the "Tiexi District Drugs and Medical Devices Quality and Safety Remediation Mobilization Conference", I actively participate in the cooperation and immediately organized the establishment of a self-examination team, the hospital's pharmaceuticals and medical devices quality and safety situation to carry out a comprehensive mapping. The results of the self-examination are reported as follows:
1. Personnel management: our hospital drugs and medicines work by professional and technical personnel, and regular training in medicine laws and regulations and related systems to ensure the smooth progress of work; annual organization of direct contact with the drugs and medicines of the staff to carry out a health check, and build a health file.
2. Duty management: our hospital has established a management system including: drug and medicine procurement and acceptance system; drug and medicine storage system; drug adverse reaction (event) monitoring and reporting system; drug deployment and review system; drug and medicine storage and maintenance system; medical staff post responsibility system; safety and health management system. The above systems are complete, reasonable, feasible, and have the corresponding implementation records.
3. Drugs, medicines and equipment purchase and sale management: our hospital by the professional staff assigned to the procurement, quality inspection and acceptance of work; from the legal production and operation of enterprises to purchase drugs and medical equipment, and signed a quality agreement with the supplier enterprises, with legal bills; acceptance of personnel in strict accordance with the development of the inventory acceptance system and operating procedures for the acceptance of drugs and medicines, and to keep a complete record of the purchase and acceptance of records.
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 operating practices for the deployment, and according to the requirements of the daily inspection of medicines, such as in the event of damage or expired drugs reported by the The company's business is to provide the best possible service to its customers.
5. Pharmacy management: our hospital pharmacy partition is distinct and reasonable, the distance of drug storage is appropriate, according to the requirements of the classification, sub-dosage form at room temperature storage of drugs; management personnel can be strictly in accordance with the requirements of the custody of the 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 medical devices in our hospital, in the future work, we will further improve.
Medical device self-inspection report model (two)
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 to carry out a period of three months of special supervision and inspection.
I hospital for the implementation of the province's supervision and management of medical devices and supervision of the work of the meeting and "on the implementation of medical equipment business, the use of units of special supervision of the notification" document spirit, to protect the people to use medical equipment safety and effective, decided to carry out in our hospital medical equipment business, the use of self-correction, the development of this self-check report.
First, the guiding ideology
tightly 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. Improve the quality management level, to ensure that no major medical device quality incidents.
Second, the purpose of the inspection
To increase the operation of medical equipment, the use of management efforts to eliminate the sale, use of expired, invalid, out of diagnostic and treatment equipment and a variety of behavior. Through this special self-corrective inspection, to ensure that people use safe and reliable medical equipment, and reduce the incidence of medical errors, improve hospital visibility.
Third, the focus of self-correction
The focus of self-check since January 20** sales of sterile medical devices for single use, in vitro diagnostic reagents, sterile sanitary materials, such as the implementation of the prescribed expiration date of the quality management system of medical devices, against the check whether the product has the manufacturer's license, the product registration certificate and the product certificate of conformity; the product's purchase records; the product's use records and whether to establish the product adverse event records, and whether the product's use of the product. The company has also established an Adverse Event Reporting System (AERS), which is a system for reporting adverse events in products.
Fourth, 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 three major blocks.
2, product qualification certificates, certificates of strict verification, each procurement, receiving personnel strict control, no case of unqualified products.
3, procurement 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 integrity, 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 easy to be ignored, subtle aspects of the problem, hope that the higher leadership of the work of my 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, to strengthen the safe use of medical equipment system, standardize the operation and use of medical equipment behavior, to strengthen their own quality management system, to enhance the knowledge of law-abiding awareness, and to improve the overall level of the hospital.
Medical device self-examination report (three)
I hospital in compliance with the X District X Food and Drug Administration issued ** 27, 29 documents, the organization of relevant personnel focused on the hospital drugs, medical equipment, a comprehensive inspection, is now the specific situation reported as follows:
A sound safety monitoring system, strengthen the management of the responsibility
The hospital set up a director of the president of the group leader, the director of each department as the head of the hospital, and the director of the medical device management system, to strengthen the management of the hospital. The hospital has set up a safety management organization with the president as the leader and the directors of each department as the members, and the safety management of medicines and medical devices is included in the top priority of the hospital's work. 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
The 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, quality and use of safety, to prevent substandard drugs, medical equipment into the hospital. To ensure that the incoming drugs, medical equipment, legal and quality, and seriously implement the system of access to ensure the safe use of medical equipment.
Third, 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, an adverse incident reporting system has been formulated. If an adverse event occurs in a drug or medical device, the location, time, adverse reaction or the basic situation of the adverse event should be clarified and recorded, and promptly reported to the District Drug Administration.
Fourth, 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 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
Set up 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 of drugs and devices, the hospital into a patient satisfaction, peer recognition. The hospital has become a patient satisfaction, peer recognition, the government assured that the good hospital.