Effect of hazard analysis critical control points system in the assembly of reusable medical devices

This study aimed to investigate the effect of hazard analysis critical control points (HACCP) system in the assembly of reusable medical devices. A total of 35,841 packages containing reusable medical devices assembled in our hospital's CSSD before implementation of the HACCP system (from January 2023 to June 2023) were classified into the control group, and 36,159 packages containing reusable medical devices assembled in our hospital's CSSD after implementation of the HACCP system (from July 2023 to December 2023) were classified into the experimental group. The incidences of assembly defects in the devices and satisfaction rates among device users before and after implementation of the HACCP system were compared. After improvement in staff training, work processes and traceability system during the application of the HACCP system, the incidence of assembly defects decreased from 2.59 to 0.24% (P < 005). Satisfaction rates among device users increased from 95.52 to 97.61% (P < 0.05). Application of the HACCP system to the assembly of reusable medical devices could effectively reduce the rate of assembly defects and improve satisfaction among device users. This could help improve the supply quality of these devices.