Abstract:
OBJECTIVE To investigate the current status of management of foreign medical devices and implants in central sterilization and supply centers in China.
METHODS With reference to the industry standards for hospital sterilization supply centers and the "Operation guide for cleaning, disinfection and sterilization technology of foreign medical devices" and other related requirements, a questionnaire was developed to investigate the current status of management of foreign medical devices and implants in 311 hospitals in China.
RESULTS A total of 311 valid questionnaires were retrieved. Of the 311 hospitals across the country, 27.01% of the hospitals did not sign a service agreement, 27.65% of the hospitals did not establish a multi-department joint foreign device and implant access system; 15.11% of the hospitals have not established a quality traceability management system for foreign devices and implants; 36.01% of the hospitals have not established special posts for handling foreign devices; 20.58% of the hospitals have not carried out special training for foreign devices; 46.95% of the hospitals did not use foreign devices and implants for the first time that were delivered at 15:00 before the day of surgery; the manufacturers instructions for foreign devices and implants could not be available in 44.69% of the hospitals; 64.63% of the hospitals had unverified sterilization procedures for foreign devices and implants; 65.28% of the hospital had incomplete methods for testing the validity of sterilization parameters for foreign devices and implants.
CONCLUSION The industrial standards of disinfection supply center and the "Operation guide for cleaning, disinfection and sterilization technology of foreign medical devices" have not been fully implemented in the management of foreign devices and implants. It is necessary to further strengthen the standardized management, establish and complete various rules and regulations and quality traceability system, raise the acquisition proportion of instructions of external devices and implants and standardize the treatment process and sterilization effectiveness verification so as to continuously improve the management quality of foreign devices and implants and guarantee the safety of use.