A Clinical Risk Assessment of a 3D-Printed Patient-Specific Scaffold by Failure Modes and Effects Analysis

Qi Lim, Ping, Lim, Sue Huey, Sherilyn, Maria, Fernandez-Medina, Tulio, Ivanovski, Sašo, and Hosseinpour, Sepanta (2022) A Clinical Risk Assessment of a 3D-Printed Patient-Specific Scaffold by Failure Modes and Effects Analysis. Materials, 15 (15). 5442.

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Abstract

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.

Item ID: 75780
Item Type: Article (Research - C1)
ISSN: 1996-1944
Keywords: bone substitutes; scaffold; alveolar bone grafting; guided tissue regeneration; additive manufacturing; risk analysis; FMEA
Copyright Information: © 2022 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https:// creativecommons.org/licenses/by/ 4.0/).
Date Deposited: 12 Sep 2022 01:33
FoR Codes: 40 ENGINEERING > 4003 Biomedical engineering > 400302 Biomaterials @ 36%
32 BIOMEDICAL AND CLINICAL SCIENCES > 3203 Dentistry > 320306 Oral implantology @ 32%
32 BIOMEDICAL AND CLINICAL SCIENCES > 3203 Dentistry > 320310 Periodontics @ 32%
SEO Codes: 20 HEALTH > 2001 Clinical health > 200105 Treatment of human diseases and conditions @ 100%
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