Engineering standards for trauma and orthopaedic implants worldwide: a systematic review protocol.

Area of Science:

• Biomedical Engineering
• Regulatory Science
• Orthopaedic Surgery

Background:

• Premarket testing of medical implants receives limited research despite numerous scandals.
• Device complications highlight the need to assess current engineering standards against biomechanical understanding.
• Global market changes necessitate an understanding of international variations in engineering standards.

Purpose of the Study:

• To systematically collate and compare global engineering standards for trauma and orthopaedic implants.
• To provide an evidence base for patient, hospital, and surgeon choice.
• To inform future research and regulatory improvements in medical device standards.

Main Methods:

• Systematic review following Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol (PRISMA-P) guidelines.
• Inclusion of standards from governments, industry, regulatory bodies, and publications.
• Narrative synthesis with qualitative evaluation of standard homogeneity.

Main Results:

• The review will identify and compare existing engineering standards for medical implants worldwide.
• Variations in standards across different jurisdictions and manufacturers will be highlighted.
• The study will provide a comprehensive overview of the current regulatory landscape.

Conclusions:

• A clear understanding of global engineering standards is crucial for medical implant safety.
• This systematic comparison will support informed decision-making and regulatory harmonization.
• The findings will contribute to enhancing patient safety and the reliability of orthopaedic implants.