Overview
ISO 29943-2:2017 provides comprehensive guidance for the design, execution, analysis, and interpretation of clinical function studies on female condoms. Created by the International Organization for Standardization (ISO), this standard addresses the process of comparing new female condom designs to established products during vaginal intercourse. The primary focus is the assessment of acute failure events, such as breakage or slippage, based on user self-reports during clinical studies. By codifying these methodologies, ISO 29943-2:2017 helps manufacturers, clinical researchers, and regulatory bodies ensure that female condoms meet established safety and performance benchmarks.
Key Topics
- Clinical Study Design: Guidance on planning and structuring clinical studies to evaluate female condom functionality, following the requirements set by ISO 25841.
- Risk Assessment: Recommendations for thorough risk assessment in line with ISO 14971 to identify safety and effectiveness concerns, particularly mechanisms of potential condom failure.
- Pilot Clinical Studies: Advice on conducting preliminary studies to detect and classify acute failure events, refine study methods, and ensure the feasibility of larger investigations.
- Outcome Measures: Definitions and recommended approaches for measuring and reporting acute failure events (e.g., clinical breakage, slippage, misdirection, invagination) and total clinical failure rates.
- Participant Selection: Clear inclusion and exclusion criteria for study subjects to ensure appropriate representation and data quality.
- Data Collection and Analysis: Processes for collecting self-reported data from users, ensuring data integrity, and analyzing trial outcomes, including statistical considerations for non-inferiority or superiority.
- Interpretation of Results: Guidance for manufacturers and regulatory agencies in making decisions based on study results.
Applications
ISO 29943-2:2017 is highly relevant for various stakeholders in the medical device and sexual health sector:
- Manufacturers: Enables manufacturers of female condoms to conduct robust clinical function studies, supporting product development, innovation, and regulatory submission.
- Clinical Researchers: Assists researchers in designing and executing scientifically sound clinical trials focused on user-reported functional performance and failure events.
- Regulatory Authorities: Provides a harmonized approach for evaluating clinical data submitted for product approvals, heightening consistency in product safety assessments.
- Quality Assurance Professionals: Supports continuous product monitoring and improvement by offering a framework to identify acute failure risks and product acceptability.
- Healthcare Organizations: Facilitates evidence-based recommendations for product selection by ensuring that female condoms on the market meet minimum standards for functionality and safety.
Related Standards
For a comprehensive approach to product evaluation and clinical trial management, ISO 29943-2:2017 should be used in conjunction with other key standards:
- ISO 25841: Female condoms - Requirements and test methods; foundational for both product specification and the clinical studies referenced in ISO 29943-2.
- ISO 14971: Application of risk management to medical devices; crucial for performing risk assessments in the development and testing process.
- ISO 14155: Clinical investigation of medical devices for human subjects – Good Clinical Practice; addresses broader trial design and ethical considerations not covered in ISO 29943-2.
Conclusion
ISO 29943-2:2017 is an essential standard for ensuring the reliable clinical evaluation of female condoms. By setting a framework for clinical studies based on user self-reports, it aids in demonstrating that new products perform at least as well as established benchmarks. The standard supports the safety, efficacy, and global acceptance of female condoms, ultimately benefiting users, regulatory agencies, and manufacturers alike.
Keywords: ISO 29943-2, female condoms, clinical studies, condom performance, clinical failure, self-report, medical device standards, regulatory compliance, risk assessment, product safety.
Open preview (PDF)Condoms — Guidance on clinical studies — Part 2: Female condoms, clinical function studies based on self-reports