Objective To establish standardized traceable management procedure for implanted high-value consumables in operating room.Methods The management model combining information-based system operation process and quality control process was designed,and management results before and after implementation were compared.Results There were statistically significant differences in error rates of information recording,bar code sticking and charging of implantable high-value consumables after the implementation of the process management mode (P＜0.05).At the same time,there were statistically significant differences in improvement of traceability of high-value consumables,adverse event reporting and patient satisfaction(P＜0.05).Conclusion Establishment of management model in operating room for implanted high-value consumables can ensure medical safety and increase medical quality.It was proved to improve the level of hospital management.

Objective The failure mode and effect analysis (FMEA) were used to monitor the managerial process of high-value consumables in the implantation surgery, and establish the traceable management process for high-value consumables of the implantation surgery. Methods FMEA was used to carry out risk assessment process, formulate specific measures for improvement. The risk priority number(RPN),the qualified rate of the management index of implant surgical consumables,the patients satisfaction, and the number of adverse events reported were compared before and after the implementation of this process management. Results After FMEA was used to conduct management over implant surgery consumables,the RPN value decreased dramatically due to difficulty of traceability, information recording, and imperfect management system, thereby showing that the difference was statistically significant (t=16.655, 10.664, 9.321, P<0.01). Quality management measures: the access to consumables meets the requirements,complete information record,quality of stock consumables,paste bar code standard, charge accurate, return visits and records on time, consumables traceability, patient satisfaction rate were 99.2%(373/376),96.7%(363/376),99.5%(374/376),95.6%(361/376),98.6%(371/376), 95.7% (360/376), 100.0% (376/376), 97.1% (365/376), respectively after the implementation of this process management, which were higher than 90.9% (355/390), 81.8% (319/390), 94.2% (367/390), 91.3% (356/390),84.7%(330/390),87.3%(341/390),87.5%(342/390),91.8%(358/390)before the implementation of this process management, thereby showing that the difference was statistically significant (χ2=7.149-49.371, P<0.01).The number of adverse consumables event reports increased from 0 up to 5. Conclusions It was feasible and effective to improve the level of hospital management and ensure the safety of patients by using the FMEA model in the implantation surgical high-value consumables.