关键词: 外来医疗器械；植入物；处理现状

Abstract: Objective: To investigate the current situation of processing loaner instrument and implants in Central Sterile Supply Department in domestic hospitals, in order to provide reference for the development of relevant regulations. Methods: A survey of loaner instrument and implants management was conducted in 764 hospitals. Results: Totally, 2.88% of the hospitals did not have certain regulations of loaner instrument and implants management. In terms of post-duty settings, 44.37% of the hospitals did not set post for personnel of processing loaner instrument and implants, and 16.23%, 17.15% and 50.65% respectively of the hospitals could get loaner instruments and implants for elective surgeries 8 hours, 12 hours or 24 hours before the surgeries. Nearly 71.34% of the hospitals did not meet the requirements of reprocessing loaner instruments and implants after the surgeries, and 63.61% of the hospitals claimed that they had overweight packages of loaner instrument and implant, while 55.50% of the hospitals indicated that they could not obtain the Instruction For Users (IFUs) of loaner instrument and implants from manufacturers. Conclusion: Developing and refining the regulations for the management and setting up specialized post for processing loaner instrument and implants, increasing the proportion of hospitals that have IFUs of loaner instrument and implants, and enhance their compliance to follow manufacturer's instructions are necessary to ensure safety, reduce the risk of hospital infection, in order to improve the quality of medical care.

Key words: loaner instrument; implant; processing status