Medical device business self-correction report
In accordance with the province's supervision and management of medical devices work conference and the provincial bureau of the "on the operation of medical equipment, the use of units of special supervision notice" (Hebei Food and Drug Administration Measures 2011108) deployment of the jurisdiction of the medical device business, the use of units for a period of three months to carry out special supervision and inspection.
Our hospital to implement the province's supervision and management of medical devices and supervision of the work of the meeting and the "notice on the operation of medical devices, the use of units of special supervision of the" spirit of the document, to protect the people using medical equipment safety and effective, decided to carry out the operation of medical equipment in our hospital, the use of self-correction, the development of this self-check report.
First, the guiding ideology
closely around the "to ensure that the people with the safe and effective use of medical devices" as 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, harmony, through the self-corrective checks, to further standardize 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 accidents.
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 the people use safe and reliable 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 2010 sales 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
producer licenses, product registration certificates and certificates of conformity of the product; product purchase records The use of the product records and whether the establishment of the product adverse event reporting system and report.
Four, according to the specific circumstances of our hospital, the results of its self-inspection and self-correction report are as follows:
1, self-inspection categories are: 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、Purchasing records are recorded carefully and in detail to ensure that there is a place to look for problematic events, 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 easily overlooked, subtle aspects of the problem, looking to 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, strengthen the safe use of medical equipment system, standardize the operation and use of medical equipment behavior, to strengthen their quality management system, enhance the knowledge of the law and compliance with the law awareness, and to improve the overall level of hospitals.