I. In order to ensure medical safety and eliminate medical hazards, implants and foreign instruments should be strictly regulated management.
Second, according to the "Hospital Infection Management Measures" and "Henan Province, the second cycle of hospital accreditation and comprehensive evaluation standards" requirements, to develop a system to ensure the safety of surgical patients.
Third, before foreign devices enter the hospital, they must be viewed by the Department of Instruments or the Procurement Center to check the relevant information, complete documentation, and shall not use unregistered, expired or obsolete medical devices.
Fourth, regular professional training for surgeons and operating room nurses on the use of foreign surgical instruments, in order to master the basic performance and operation of the instruments.
V. Strengthen the management of the operating room, when the clinical need to use foreign instruments, should be 24 hours -48 hours in advance of the instruments sent to the disinfection supply room for cleaning and disinfection sterilization.
Sixth, strict handover procedures, check the correct registration of instruments, both parties signed a perfect record. For rust or defective instruments are not cleaned and disinfected sterilization, strictly prohibited for use in the operating room.
VII, disinfection and supply center received instruments, in accordance with the process of cleaning and disinfection (10 steps) to deal with, and biological monitoring, to be monitored only after the results are qualified to be issued for use in the operating room, a detailed record.
Eight, the establishment of standardized operating procedures, quality control and traceability mechanism, found that the problem immediately start the traceability system.
IX, the operating room before use, again check the integrity of the instrument package, the package package outside the indication card of the situation is in line with the sterilization requirements, and then use. And save the sterilization instruction card in the medical record for inspection.
X. Emergency surgery must be used when the use of foreign instruments, must perform the above procedures, the operating room, disinfection and supply center and the operating room staff strictly abide by this system, and record comprehensive. Otherwise, the consequences.
XI, instrument suppliers are not allowed to enter the operating room in principle, such as technicians, must be on-site guidance for the use of instruments, should be arranged in advance after the operating room training program, a preliminary understanding of the surgical environment and aseptic requirements before applying for and obtaining the consent of the head nurse of the operating room to enter the limit of one person at a time.
XII, the operating room or sterilization supply center is not responsible for the custody of manufacturers of surgical instruments, the end of the operation, the initial processing of the instruments to be handed over to the instrument supplier and have handover procedures.
XIII, medical staff in the implant before use, should be strictly verified, check the integrity of its packaging, validity, complete and clear identification before use.
xiv. It is strictly prohibited for surgical personnel to use implants that have not been inspected by the Hospital Instrumentation Department or Procurement Center, or else they will be seriously dealt with once discovered; once problems occur, they will be responsible for their own consequences and will hold the relevant personnel accountable.
Attachment: foreign devices (including implants) must be strictly monitored by the hospital, the Department of Instrumentation or Purchasing Center should check the relevant information, in line with the "Supervision and Administration of Medical Devices Regulations," Article 26: medical device business enterprises and medical institutions from the "medical device production license" of the manufacturer or "medical device business license" of the business enterprise to purchase qualified medical devices, and verify the product qualification certificate, import license, and the medical device business license, the medical device business enterprise. And check the product certification, import registration certificate, permit to sell the certificate and other health authority's certificate of approval, shall not use unregistered, expired or obsolete medical devices.