A Clinical Risk Assessment of a 3D-Printed Patient-Specific Scaffold by Failure Modes and Effects Analysis
This study aims to carry out a risk assessment to identify and rectify potential clinical risks of a 3D-printed patient-specific scaffold for large-volume alveolar bone regeneration. A survey was used to assess clinicians’ perceptions regarding the use of scaffolds in the treatment of alveolar defec...
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| Format: | Article |
| Language: | English |
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MDPI AG
2022-08-01
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| Series: | Materials |
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| Online Access: | https://www.mdpi.com/1996-1944/15/15/5442 |
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| author | Ping Qi Lim Sue Huey Lim Maria Sherilyn Tulio Fernandez-Medina Sašo Ivanovski Sepanta Hosseinpour |
| author_facet | Ping Qi Lim Sue Huey Lim Maria Sherilyn Tulio Fernandez-Medina Sašo Ivanovski Sepanta Hosseinpour |
| author_sort | Ping Qi Lim |
| collection | DOAJ |
| description | This study aims to carry out a risk assessment to identify and rectify potential clinical risks of a 3D-printed patient-specific scaffold for large-volume alveolar bone regeneration. A survey was used to assess clinicians’ perceptions regarding the use of scaffolds in the treatment of alveolar defects and conduct a clinical risk assessment of the developed scaffold using the Failure Modes and Effects Analysis (FMEA) framework. The response rate was 69.4% with a total of 41 responses received. Two particular failure modes were identified as a high priority through the clinical risk assessment conducted. The highest mean Risk Priority Number was obtained by “failure of healing due to patient risk factors” (45.7 ± 27.7), followed by “insufficient soft tissue area” (37.8 ± 24.1). Despite the rapid developments, finding a scaffold that is both biodegradable and tailored to the patient’s specific defect in cases of large-volume bone regeneration is still challenging for clinicians. Our results indicate a positive perception of clinicians towards this novel scaffold. The FMEA clinical risk assessment has revealed two failure modes that should be prioritized for risk mitigation (safe clinical translation). These findings are important for the safe transition to in-human trials and subsequent clinical use. |
| first_indexed | 2024-03-09T10:07:53Z |
| format | Article |
| id | doaj.art-d4d19b62755940c49b100800efe77167 |
| institution | Directory Open Access Journal |
| issn | 1996-1944 |
| language | English |
| last_indexed | 2024-03-09T10:07:53Z |
| publishDate | 2022-08-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Materials |
| spelling | doaj.art-d4d19b62755940c49b100800efe771672023-12-01T23:01:40ZengMDPI AGMaterials1996-19442022-08-011515544210.3390/ma15155442A Clinical Risk Assessment of a 3D-Printed Patient-Specific Scaffold by Failure Modes and Effects AnalysisPing Qi Lim0Sue Huey Lim1Maria Sherilyn2Tulio Fernandez-Medina3Sašo Ivanovski4Sepanta Hosseinpour5School of Dentistry, The University of Queensland, Brisbane 4006, AustraliaSchool of Dentistry, The University of Queensland, Brisbane 4006, AustraliaSchool of Dentistry, The University of Queensland, Brisbane 4006, AustraliaSchool of Dentistry, The University of Queensland, Brisbane 4006, AustraliaSchool of Dentistry, The University of Queensland, Brisbane 4006, AustraliaSchool of Dentistry, The University of Queensland, Brisbane 4006, AustraliaThis study aims to carry out a risk assessment to identify and rectify potential clinical risks of a 3D-printed patient-specific scaffold for large-volume alveolar bone regeneration. A survey was used to assess clinicians’ perceptions regarding the use of scaffolds in the treatment of alveolar defects and conduct a clinical risk assessment of the developed scaffold using the Failure Modes and Effects Analysis (FMEA) framework. The response rate was 69.4% with a total of 41 responses received. Two particular failure modes were identified as a high priority through the clinical risk assessment conducted. The highest mean Risk Priority Number was obtained by “failure of healing due to patient risk factors” (45.7 ± 27.7), followed by “insufficient soft tissue area” (37.8 ± 24.1). Despite the rapid developments, finding a scaffold that is both biodegradable and tailored to the patient’s specific defect in cases of large-volume bone regeneration is still challenging for clinicians. Our results indicate a positive perception of clinicians towards this novel scaffold. The FMEA clinical risk assessment has revealed two failure modes that should be prioritized for risk mitigation (safe clinical translation). These findings are important for the safe transition to in-human trials and subsequent clinical use.https://www.mdpi.com/1996-1944/15/15/5442bone substitutesscaffoldalveolar bone graftingguided tissue regenerationadditive manufacturingrisk analysis |
| spellingShingle | Ping Qi Lim Sue Huey Lim Maria Sherilyn Tulio Fernandez-Medina Sašo Ivanovski Sepanta Hosseinpour A Clinical Risk Assessment of a 3D-Printed Patient-Specific Scaffold by Failure Modes and Effects Analysis Materials bone substitutes scaffold alveolar bone grafting guided tissue regeneration additive manufacturing risk analysis |
| title | A Clinical Risk Assessment of a 3D-Printed Patient-Specific Scaffold by Failure Modes and Effects Analysis |
| title_full | A Clinical Risk Assessment of a 3D-Printed Patient-Specific Scaffold by Failure Modes and Effects Analysis |
| title_fullStr | A Clinical Risk Assessment of a 3D-Printed Patient-Specific Scaffold by Failure Modes and Effects Analysis |
| title_full_unstemmed | A Clinical Risk Assessment of a 3D-Printed Patient-Specific Scaffold by Failure Modes and Effects Analysis |
| title_short | A Clinical Risk Assessment of a 3D-Printed Patient-Specific Scaffold by Failure Modes and Effects Analysis |
| title_sort | clinical risk assessment of a 3d printed patient specific scaffold by failure modes and effects analysis |
| topic | bone substitutes scaffold alveolar bone grafting guided tissue regeneration additive manufacturing risk analysis |
| url | https://www.mdpi.com/1996-1944/15/15/5442 |
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