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：
  
  1.Affiliated Hospital of Nantong University, 226000, Nantong, Jiangsu, China
- Author bio：
- Funds：
- DOI：10.11910/j.issn.2791-2043.2022.3.04
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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,2,To explore the effectiveness of using the failure mode and effect score (FMEA) method for risk management of orthopaedicss non-sterile implants (NSI).,Methods,2,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,2,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,P,<,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,P,<,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,P,<,0.001, with statistically significant differences.,Conclusion,2,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

FMEANon-sterile implantsRewash rateWear rateSatisfactionSPD

references

Ministry of Health of the People’s Republic of China. Hospital sterile supply centres [S]. Beijing: Ministry of Health of the People’s Republic of China, 2016.

Chen D, Zhou Pu, Liu Yachenet al. Study on the effect of joint multi-departmental standardized management of foreign instruments and implants[J]. Chinese Journal of Hospital Infection,2015,(22).

Alyssa G Ashbaugh, Xuesong Jiang, Jesse Zheng,et al. Polymeric nanofiber coating with tunable combinatorial antibiotic delivery prevents biofilm -associated infection in vivo[J].Proc Natl Acad Sci U S A. 2016 Nov 8;113(45):E6919-E6928.

Cai Yinhua,Wang Shaoxin,Ye Huaet al. A survey on the current status of management of foreign medical devices and implants in Shanghai medical institutions[J]. Shanghai Preventive Medicine,2019,31(7)

Zhang Q, Gao H, Zhu T, et al. A survey on the current situation of handling foreign medical devices and implants in 764 hospitals across China[J]. China nursing management,2019,19(1)

Liu Y,Liang Xiuhong,Wei Fengpinget al. The application of seamless nursing management model in the management of foreign instruments in the operating room[J]. Chinese Journal of Modern Nursing,2014,20(3).

Lv Xiujuan,Huang Qionghui. The application of double closed-loop management model in the management of foreign instruments and implants[J]. Nursing Practice and Research,2020,17(18)

An YH, Alvi FI, Kang Q, Laberge M, Drews MJ, Zhang J, Matthews MA, Arciola CR. Effects of sterilization on implant mechanical property and biocompatibility. Int J Artif Organs. 2005 Nov;28(11):1126-37.

Doi T,Kawamura N,et al. The usefulness of neutro-phil CD64 expression for diagnosing infection after orthopae- dic surgery in dialysis patients[J]. .J Orthop Sci,2016,21(4):546-551.

Kok TW,Agrawal N,Sathappan SS,et al. Risk factors for early implant-related surgical site infection[J].J Orthop Surg(Hong Kong),2016,24(1):72 -76.

Yang N, Ma X X X, Yang W X, et al. Study on clinical characteristics of hospital-acquired infections in patients after orthopaedics implantation and the control of implementing process-based management[J]. Chinese Journal of Hospital Infection,2015,25(23):5444-5446.

Jia Man,Jin Wenji,Li Na,et al. Analysis and prevention of factors associated with surgical implant infection in orthopaedics patients[J]. Chinese Journal of Hospital Infection,2017,27(23):5391-5394.

Carlo Luca Romanò,Sara Scarponi,Enrico Gallazzi,et al. Antibacterial coating of implants in orthopaedicss and trauma: a classification proposal in an evolving panorama[J].J Orthop Surg Res. 2015 Oct 1;10:157.

Schömig F, Perka C, Pumberger M, Ascherl R. Implant contamination as a cause of surgical site infection in spinal surgery: are single-use implants a reasonable solution? - a systematic review. BMC Musculoskelet Disord. 2020 Sep 25;21(1):634.

Costa DM, Lopes LKO, Vickery K, Watanabe E, Vasconcelos LSNOL, de Paula MC, Melo DS, Hu H, Deva AK, Tipple AFV. Reprocessing safety issues associated with complex-design orthopaedics loaned surgical instruments and implants.Injury.2018 Nov;49(11):2005-2012.

Agarwal A, Lin B, Elgafy H, Goel V, Karas C, Schultz C, Anand N, Garfin S, Wang J, Agarwal A. Updates on Evidence-Based Practices to Reduce Preoperative and Intraoperative Contamination of Implants in Spine Surgery: a Narrative Review. Spine Surg Relat Res. 2019 Jun 21;4(2):111-116.

Lin S-Y, Yu K-Y, Xu J-Jet al. Study on the management of foreign medical devices and implants by specialty classification[J]. Chinese Journal of Hospital Infection,2015,(6)

Burns H.H. Migration to single-use pre-sterilized individually wrapped small orthopaedics implants in NHS Scotland.2006. http://www.‍scot.‍nhs.‍uk//sehd/cmo/CMO(2006)13.pdf. Accessed 25 Sep 2019http://www.‍scot.‍nhs.‍uk//sehd/cmo/CMO(2006)13.pdf.Accessed25Sep2019.

Huynh E, Klouche S, Martinet C, Le Mercier F, Bauer T, Lecoeur A. Can the number of surgery delays and postponements due to unavailable instrumentation be reduced? Evaluating the benefits of enhanced collaboration between the sterilization and orthopedic surgery units. Orthop Traumatol Surg Res. 2019 May;105(3):563-568.

Agarwal A, Schultz C, Agarwal AK, Wang JC, Garfin SR, Anand N. Harboring Contaminants in Repeatedly Reprocessed Pedicle Screws. Global Spine J. 2019 Apr;9(2):173-178.

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