25 July 2023 : Clinical Research
Optimizing Sterilization Packaging through Root Cause Analysis: An Exploration into Sealing Defects of Paper-Plastic Pouches
Sixin Jiang12ABCE, Liangying Yi12ABCE*, Yanhua Chen32E, Ruixue Hu32EDOI: 10.12659/MSM.940342
Med Sci Monit 2023; 29:e940342
Table 1 Root cause analysis of sealing defects of paper-plastic pouches.
| Risk factors | Potential risk factors | Severity score | Occurrence score | Detectability score | Hazard index |
|---|---|---|---|---|---|
| Imperfections in the procedure; a careless attitude towards work, and fixed mindset | 9 | 9 | 8 | 26 | |
| The packing table was small | The guidelines specifying the placement of sealed pouches on the right side and placement of unsealed ones on the left side were not strictly followed, resulting in sealed and unsealed pouches being mixed together | 9 | 9 | 7 | 25 |
| Missed inspections by the inspector | Unsealed pouches not sighted by the inspector | 9 | 7 | 8 | 24 |
| Incorrect distribution procedures | Distribution of sterile packages is the last line of sterile item management in the CSSD. Incorrect distribution procedures would lead to the distribution of packages with sealing defects to clinical departments | 7 | 7 | 4 | 18 |
| Insufficient training | The packaging personnel were not familiar with the plastic sealing procedure; there were no effective inspections | 8 | 7 | 6 | 21 |
| Insufficient light through the pass-through window between the storage and distribution rooms | Poor lighting. Under this condition, the distribution personnel might not always identify sealing defects | 8 | 9 | 7 | 21 |
| CSSD – Central Sterile Supply Department. | |||||