Study on the application of FMEA method in risk management of non-sterile implants in orthopaedicss

Yayun Zhang; Dongping He; Jianfang Bao; Guofang Jiang; Xu Min

doi:10.11910/j.issn.2791-2043.2022.3.04

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Study on the application of FMEA method in risk management of non-sterile implants in orthopaedicss

MONOGRAPHIC STUDY | Updated：2023-02-22

- Study on the application of FMEA method in risk management of non-sterile implants in orthopaedicss
- Sterile Supply Vol. 1, Issue 3, (2022)
- Affiliations：
  
  Affiliated Hospital of Nantong University, 226000, Nantong, Jiangsu, China
- Author bio：
- Funds：
- DOI：10.11910/j.issn.2791-2043.2022.3.04
  CLC：
- Published：15 December 2022
- Accepted：
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Zhang Yayun,He Dongping,Bao Jianfang,et al.Study on the application of FMEA method in risk management of non-sterile implants in orthopaedicss[J].Sterile Supply,2022,01(03):98-104.
DOI：

Zhang Yayun,He Dongping,Bao Jianfang,et al.Study on the application of FMEA method in risk management of non-sterile implants in orthopaedicss[J].Sterile Supply,2022,01(03):98-104. DOI： 10.11910/j.issn.2791-2043.2022.3.04.

摘要

Abstract

Objective

To explore the effectiveness of using the failure mode and effect score (FMEA) method for risk management of orthopaedicss non-sterile implants (NSI).

Methods

The FMEA quality control group was established in January 2021

and the department created the "Risk Assessment Form for Implant Sensory Control in Sterile Supply Centre" to assess the risk of orthopaedics NSI handling process

and selected the risk factor (RPN

which is the product of frequency

severity and detection level) score according to the "two-eight rule". Risk factors in the top 20% of the risk factor scale are selected for priority attention and improvement. In this study

the NSI handled in our department for traumatic orthopaedics implant surgery were managed prospectively

with the conventional process of handling NSI from 02 to 07 February 2021 as the control group and the SPD logistics management method for NSI from 08 2021 to 01 2022 as the experimental group. The results were collected and analyzed.

Results

The rewash rate was 91.27% in the control group and 9.28% in the experimental group

the experimental group was significantly lower than the control group

0.001

the difference was statistically significant; the surface wear rate was 2.95% in the control group and 0.61% in the experimental group

the experimental group was significantly lower than the control group

0.005

the difference was statistically significant; the results of the satisfaction survey of surgeons

surgical nurses

CSSD nurses

SPD staff and supply staff satisfaction survey results were 68.75% for the control group and 99.45% for the experimental group

0.001

with statistically significant differences.

Conclusion

The FMEA method applied to NSI management improved the quality of NSI handling

effectively reduced the rewash rate and wear rate of NSI through the identification

analysis and optimization of the handling process of each link; improved the satisfaction of surgeons nurses and related personnel on NSI management

and effectively guaranteed the safety of surgery and patients.

关键词

Keywords

references

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