Elevating Device Safety: Advanced Clinical Survey Strategies

Strategies to Achieve Higher Clinical Evidence Rankings

Under the EU-MDR, clinical evidence is scrutinized and ranked, influencing a device’s market longevity and trustworthiness. To navigate this rigorously:

• Rank 8 Clinical Evidence: Rank 8 is assigned to proactive PMS data typically derived from surveys. While this data is recognized under MDR Article 2(48), it is not generally considered a high-quality source due to inherent limitations such as potential biases and issues in data collection quality. The classification under Rank 8 indicates that while useful, the data must be scrutinized and handled with an understanding of its limitations.
• Transitioning to Rank 4: Achieving a higher classification, such as Rank 4, involves overcoming the methodological flaws that might plague Rank 8 data. Rank 4 is attributed to outcomes from studies that, despite potential methodological flaws, provide data that can still be quantified and justified. For legacy devices, achieving Rank 4 with clinical evidence suggests that the data, while not flawless, has been sufficiently appraised and the gaps adequately addressed.

Achieve Rank 4 Clinical Evidence

Achieving Rank 4 for clinical evidence necessitates a robust methodology that ensures compliance and maximizes the reliability of the data collected. At Cetas Healthcare, our recommended methodology to do this is through the use of online surveys coupled with retrospective patient case forms and systematic back-checks.

• PMCF Online Surveys: At Cetas Healthcare, online surveys are increasingly recommended for PMCF due to their compliance with quality processes such as GDPR, HIPAA, and ISO standards (ISO 20252 and ISO 3534-4). These surveys offer a faster (~10 weeks vs. 12 months), more manageable, and bias-minimized approach compared to traditional offline methods. This digital approach enables easier auditing, tracking, and measuring of follow-up data, ensuring a streamlined process that adheres to regulatory standards.
• Design Questionnaires: Designing Post-Market Clinical Follow-up (PMCF) questionnaires requires clear objectives, informed consent, and ethical considerations. The questionnaire should use validated tools, clear language, and appropriate response options while avoiding bias. Logical flow, skip patterns, and concise length are crucial. Pilot testing and expert review ensure effectiveness, enhancing data collection for post-market assessment of medical devices.
• Utilizing Retrospective Patient Case Forms: Retrospective patient case forms mimic the structure of Patient Case Record Forms (CRF), capturing essential clinical end-points in accordance with ISO 14155. This method enhances the accuracy and authenticity of the data by relying less on respondent memory and more on documented evidence, which is crucial for long-term clinical assessments.
• Importance of Back-Checks: The reliability of PMCF data is further reinforced through telephonic or web-based back-checks. These checks ensure the authenticity and validity of the collected data and the respondents’ integrity. Adhering to ISO 20252 and ISO 14155 through back-checks is vital for maintaining the credibility of the clinical evidence, which is instrumental in making informed regulatory and clinical decisions.

Benefits of Enhanced Monitoring Through PMCF Surveys

The value of PMCF surveys extends across several critical areas:

• Cost Efficiency: Traditional clinical trials are both time-intensive and costly. PMCF surveys, on the other hand, offer a more economical alternative. They allow for the ongoing collection of pertinent data without the need for large-scale, controlled trials.
• Regulatory Adherence: Compliance with EU MDR regulations is no longer negotiable. PMCF surveys help ensure that continuous data on device performance and safety is collected, helping manufacturers meet these stringent requirements over the product’s lifecycle.
• Targeted Data Collection: Each medical device serves a unique purpose and population. PMCF surveys can be specifically designed to target particular demographic or disease characteristics, ensuring that the data collected is both relevant and robust.

Conclusion

Post-market clinical surveys are not just procedural necessities; they are pivotal in driving the continuous evolution and safety of medical devices. By strategic survey execution, manufacturers can ensure that their products not only comply with regulatory standards but also meet the highest benchmarks of quality and reliability. A multi-faceted approach to gathering clinical evidence enables manufacturers to stay ahead in a competitive and heavily regulated market, ensuring that medical devices remain effective and safe throughout their lifecycle. Ultimately, these ongoing efforts in post-market surveillance enhance patient outcomes, and foster innovation in the medical technology landscape.