Reprocessing safety issues associated with complex-design orthopaedic loaned surgical instruments and implants

Dayane de Melo Costa, Lillian Kelly de Oliveira Lopes, Karen Vickery, Evandro Watanabe, Lara Stefania Netto de Oliveira Leão Vasconcelos, Milena Cristina de Paula, Dulcelene Sousa Melo, Honghua Hu, Anand Kumar Deva, Anaclara Ferreira Veiga Tipple

Research output: Contribution to journalArticleResearchpeer-review

Abstract

Background: The acquisition of reusable surgical instruments (RSIs) through loaner system is a worldwide phenomenon, particularly in orthopaedic surgeries. Loaner sets contain high-complex design RSIs, which are very difficult to clean, and also include single use implants, such as screws, that remain in the surgical tray and are subjected to multiple reprocessing until they are implanted. Inadequate cleaning of SI and various exposures of single-use implants to physical, chemical and biological agents can compromise their quality/safety and promote biofilm formation. The difficulty in cleaning is compounded in middle and low-income countries where automated cleaning infrastructure at sterilizing service units is often unavailable, and thus manual cleaning only is performed. Thus, we aimed to determine the condition of orthopaedic loaned sets when delivered to the hospital, assess the quality of complex-design RSIs reprocessed by manual cleaning, and evaluate the effect of multiple reprocessing on single-use implant (screw). Methods: Flexible medullary reamers (FMRs), depth gauges and screws used for femur intramedullary nailing, in clinical use for >1 year, were obtained from three Brazilian loaner companies and assessed for residual ATP, protein, bacterial contamination, endotoxin and/or biofilm at delivery at the hospital, following cleaning and steam sterilisation. Results: Before cleaning, blood was visible on a RSIs tray, and RSIs/screws were contaminated with high amounts of ATP, protein and bacteria. Visible soil was released during brushing of a FMR lumen and, following cleaning, the inner layer of 34/40 were visible soiled, and over 5/8 were protein test positive. Following sterilisation, biofilm and soil, including fragments appearing to be bone, were detected by scanning electron microscopy on RSIs/screws. A sterilised FMR revealed visible soil on the inner layer. Endotoxin tests were negative. Conclusion: The contaminated condition of loaned-complex-designed RSIs/screws upon arrival at the hospital and after reprocessing points to the insufficiency of manual reprocessing and management practices related to this instruments/implants. A multidisciplinary approach involving expert in design/manufacture, regulating, managing, reprocessing and surgeons is suggested to improve RSIs manufacture that enables complete decontamination and maintain the surgical patient safety.

LanguageEnglish
Pages2005-2012
Number of pages8
JournalInjury
Volume49
Issue number11
DOIs
Publication statusPublished - 1 Nov 2018

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Surgical Instruments
Orthopedics
Safety
Biofilms
Soil
Endotoxins
Adenosine Triphosphate
Intramedullary Fracture Fixation
Bacterial Proteins
Decontamination
Practice Management
Steam
Biological Factors
Patient Safety
Electron Scanning Microscopy
Femur
Proteins
Bacteria
Bone and Bones

Keywords

  • Biofilms
  • Cleaning
  • Implants
  • Loaner instrumentation
  • Sterilisation
  • Surgical instruments

Cite this

Costa, D. D. M., Lopes, L. K. D. O., Vickery, K., Watanabe, E., Vasconcelos, L. S. N. D. O. L., de Paula, M. C., ... Tipple, A. F. V. (2018). Reprocessing safety issues associated with complex-design orthopaedic loaned surgical instruments and implants. Injury, 49(11), 2005-2012. https://doi.org/10.1016/j.injury.2018.09.006
Costa, Dayane de Melo ; Lopes, Lillian Kelly de Oliveira ; Vickery, Karen ; Watanabe, Evandro ; Vasconcelos, Lara Stefania Netto de Oliveira Leão ; de Paula, Milena Cristina ; Melo, Dulcelene Sousa ; Hu, Honghua ; Deva, Anand Kumar ; Tipple, Anaclara Ferreira Veiga. / Reprocessing safety issues associated with complex-design orthopaedic loaned surgical instruments and implants. In: Injury. 2018 ; Vol. 49, No. 11. pp. 2005-2012.
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abstract = "Background: The acquisition of reusable surgical instruments (RSIs) through loaner system is a worldwide phenomenon, particularly in orthopaedic surgeries. Loaner sets contain high-complex design RSIs, which are very difficult to clean, and also include single use implants, such as screws, that remain in the surgical tray and are subjected to multiple reprocessing until they are implanted. Inadequate cleaning of SI and various exposures of single-use implants to physical, chemical and biological agents can compromise their quality/safety and promote biofilm formation. The difficulty in cleaning is compounded in middle and low-income countries where automated cleaning infrastructure at sterilizing service units is often unavailable, and thus manual cleaning only is performed. Thus, we aimed to determine the condition of orthopaedic loaned sets when delivered to the hospital, assess the quality of complex-design RSIs reprocessed by manual cleaning, and evaluate the effect of multiple reprocessing on single-use implant (screw). Methods: Flexible medullary reamers (FMRs), depth gauges and screws used for femur intramedullary nailing, in clinical use for >1 year, were obtained from three Brazilian loaner companies and assessed for residual ATP, protein, bacterial contamination, endotoxin and/or biofilm at delivery at the hospital, following cleaning and steam sterilisation. Results: Before cleaning, blood was visible on a RSIs tray, and RSIs/screws were contaminated with high amounts of ATP, protein and bacteria. Visible soil was released during brushing of a FMR lumen and, following cleaning, the inner layer of 34/40 were visible soiled, and over 5/8 were protein test positive. Following sterilisation, biofilm and soil, including fragments appearing to be bone, were detected by scanning electron microscopy on RSIs/screws. A sterilised FMR revealed visible soil on the inner layer. Endotoxin tests were negative. Conclusion: The contaminated condition of loaned-complex-designed RSIs/screws upon arrival at the hospital and after reprocessing points to the insufficiency of manual reprocessing and management practices related to this instruments/implants. A multidisciplinary approach involving expert in design/manufacture, regulating, managing, reprocessing and surgeons is suggested to improve RSIs manufacture that enables complete decontamination and maintain the surgical patient safety.",
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Costa, DDM, Lopes, LKDO, Vickery, K, Watanabe, E, Vasconcelos, LSNDOL, de Paula, MC, Melo, DS, Hu, H, Deva, AK & Tipple, AFV 2018, 'Reprocessing safety issues associated with complex-design orthopaedic loaned surgical instruments and implants', Injury, vol. 49, no. 11, pp. 2005-2012. https://doi.org/10.1016/j.injury.2018.09.006

Reprocessing safety issues associated with complex-design orthopaedic loaned surgical instruments and implants. / Costa, Dayane de Melo; Lopes, Lillian Kelly de Oliveira; Vickery, Karen; Watanabe, Evandro; Vasconcelos, Lara Stefania Netto de Oliveira Leão; de Paula, Milena Cristina; Melo, Dulcelene Sousa; Hu, Honghua; Deva, Anand Kumar; Tipple, Anaclara Ferreira Veiga.

In: Injury, Vol. 49, No. 11, 01.11.2018, p. 2005-2012.

Research output: Contribution to journalArticleResearchpeer-review

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T1 - Reprocessing safety issues associated with complex-design orthopaedic loaned surgical instruments and implants

AU - Costa, Dayane de Melo

AU - Lopes, Lillian Kelly de Oliveira

AU - Vickery, Karen

AU - Watanabe, Evandro

AU - Vasconcelos, Lara Stefania Netto de Oliveira Leão

AU - de Paula, Milena Cristina

AU - Melo, Dulcelene Sousa

AU - Hu, Honghua

AU - Deva, Anand Kumar

AU - Tipple, Anaclara Ferreira Veiga

PY - 2018/11/1

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N2 - Background: The acquisition of reusable surgical instruments (RSIs) through loaner system is a worldwide phenomenon, particularly in orthopaedic surgeries. Loaner sets contain high-complex design RSIs, which are very difficult to clean, and also include single use implants, such as screws, that remain in the surgical tray and are subjected to multiple reprocessing until they are implanted. Inadequate cleaning of SI and various exposures of single-use implants to physical, chemical and biological agents can compromise their quality/safety and promote biofilm formation. The difficulty in cleaning is compounded in middle and low-income countries where automated cleaning infrastructure at sterilizing service units is often unavailable, and thus manual cleaning only is performed. Thus, we aimed to determine the condition of orthopaedic loaned sets when delivered to the hospital, assess the quality of complex-design RSIs reprocessed by manual cleaning, and evaluate the effect of multiple reprocessing on single-use implant (screw). Methods: Flexible medullary reamers (FMRs), depth gauges and screws used for femur intramedullary nailing, in clinical use for >1 year, were obtained from three Brazilian loaner companies and assessed for residual ATP, protein, bacterial contamination, endotoxin and/or biofilm at delivery at the hospital, following cleaning and steam sterilisation. Results: Before cleaning, blood was visible on a RSIs tray, and RSIs/screws were contaminated with high amounts of ATP, protein and bacteria. Visible soil was released during brushing of a FMR lumen and, following cleaning, the inner layer of 34/40 were visible soiled, and over 5/8 were protein test positive. Following sterilisation, biofilm and soil, including fragments appearing to be bone, were detected by scanning electron microscopy on RSIs/screws. A sterilised FMR revealed visible soil on the inner layer. Endotoxin tests were negative. Conclusion: The contaminated condition of loaned-complex-designed RSIs/screws upon arrival at the hospital and after reprocessing points to the insufficiency of manual reprocessing and management practices related to this instruments/implants. A multidisciplinary approach involving expert in design/manufacture, regulating, managing, reprocessing and surgeons is suggested to improve RSIs manufacture that enables complete decontamination and maintain the surgical patient safety.

AB - Background: The acquisition of reusable surgical instruments (RSIs) through loaner system is a worldwide phenomenon, particularly in orthopaedic surgeries. Loaner sets contain high-complex design RSIs, which are very difficult to clean, and also include single use implants, such as screws, that remain in the surgical tray and are subjected to multiple reprocessing until they are implanted. Inadequate cleaning of SI and various exposures of single-use implants to physical, chemical and biological agents can compromise their quality/safety and promote biofilm formation. The difficulty in cleaning is compounded in middle and low-income countries where automated cleaning infrastructure at sterilizing service units is often unavailable, and thus manual cleaning only is performed. Thus, we aimed to determine the condition of orthopaedic loaned sets when delivered to the hospital, assess the quality of complex-design RSIs reprocessed by manual cleaning, and evaluate the effect of multiple reprocessing on single-use implant (screw). Methods: Flexible medullary reamers (FMRs), depth gauges and screws used for femur intramedullary nailing, in clinical use for >1 year, were obtained from three Brazilian loaner companies and assessed for residual ATP, protein, bacterial contamination, endotoxin and/or biofilm at delivery at the hospital, following cleaning and steam sterilisation. Results: Before cleaning, blood was visible on a RSIs tray, and RSIs/screws were contaminated with high amounts of ATP, protein and bacteria. Visible soil was released during brushing of a FMR lumen and, following cleaning, the inner layer of 34/40 were visible soiled, and over 5/8 were protein test positive. Following sterilisation, biofilm and soil, including fragments appearing to be bone, were detected by scanning electron microscopy on RSIs/screws. A sterilised FMR revealed visible soil on the inner layer. Endotoxin tests were negative. Conclusion: The contaminated condition of loaned-complex-designed RSIs/screws upon arrival at the hospital and after reprocessing points to the insufficiency of manual reprocessing and management practices related to this instruments/implants. A multidisciplinary approach involving expert in design/manufacture, regulating, managing, reprocessing and surgeons is suggested to improve RSIs manufacture that enables complete decontamination and maintain the surgical patient safety.

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KW - Cleaning

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KW - Sterilisation

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