Medical Devices Risk Assessment and Evaluation Process Prior to Human Trial
Care Process & Redesign
Singapore Healthcare Management Congress
SingHealth
31 December 2021
To achieve a more systematic and critical assessment of safety risk levels and reduce harm during human trials. The workflow streamlined risk assessments, reducing potential harm during medical device trials.
Year Submitted: 2021
Published Date: 31 December 2021
Tags: Care Process ＆ Redesign, Quality Improvement, Workflow Redesign, Value Based Care, Risk Management, Preventive Approach, Product Development, Product Evaluation, Safety Evaluation
About this Content
Aims
To achieve a more systematic and critical assessment of safety risk levels and reduce harm during human trials.
Background
Risk assessment workflows for medical device prototypes were lacking systematic evaluation prior to human trials.
Methods
Developed a risk assessment workflow using DFMEA principles, integrated with CIRB application processes.
Results
Workflow piloted on 3 projects, improving safety risk assessments and ensuring acceptable device safety levels.
Conclusion
The workflow streamlined risk assessments, reducing potential harm during medical device trials.
Lessons Learnt
Early integration of risk evaluation ensures safety and compliance for human-facing trials.
Additional Information
Singapore Healthcare Management 2021 – Shortlisted Project (Risk Management Category).
Keywords
Medical Device Prototype Assessments, Design Failure Mode and Effect Analysis, Risk Classification.
Innovators' Details
Innovators' Details
Healthcare Cluster(s) | SingHealth |
Organization(s) Involved | Singapore Health Services, Singapore General Hospital |
Platform(s) | Singapore Healthcare Management Congress |
Healthcare Professional Group(s) | Healthcare Administration |
Applicable Specialty or Discipline | Healthcare Administrators, Medical ＆ Laboratory Technology |
Project Lead(s) | Siti Hajar Arina Kamari |
Project Member(s) | Woo Siang Si Matthew |
Connect with this contributor!
Siti Hajar Arina Kamari - singaporehealthcaremanagement@singhealth.com.sg
Project Attachment
C641_SHHQ_SHM2021_Medical_Devices_Risk_Assessment_and_Evaluation_Process_Prior_to_Human_Trial.pdf