Challenges Associated with the Safety Signal Detection Process for Medical Devices

Area of Science:

• Medical device safety
• Pharmacovigilance
• Regulatory science

Background:

• Previous medical device safety issues highlight the need for enhanced safety signal detection.
• European Union (EU) regulations mandate active monitoring of medical device safety signals.
• National competent authorities are increasing focus on vigilance data analysis.

Purpose of the Study:

• To synthesize the current knowledge on medical device safety signal detection.
• To investigate existing tools and methodologies for detecting safety signals in medical devices.

Main Methods:

• Systematic literature review conducted across multiple databases (Embase, Medline, Cochrane, Web of Science, Google Scholar) until January 2017.
• Article selection based on terms related to medical devices and safety, followed by abstract and full-text review.
• Data extraction and completeness scoring of included articles.

Main Results:

• 24 out of 20,819 articles met inclusion criteria.
• Diverse data sources, including spontaneous reporting systems and registries, are used for medical device safety surveillance.
• Significant heterogeneity exists in coding practices, with no universally agreed-upon methods or a gold standard for signal detection.

Conclusions:

• Recommendations include harmonizing data sources, developing gold standard signal detection methodologies, and standardizing coding dictionaries.
• Implementation of a new proactive approach to signal detection is supported by these recommendations.
• The envisioned safety surveillance system will leverage real-world evidence for regulatory decision-making across jurisdictions.