The new article explains in detail the approach to be followed with respect to safety reporting in the context of clinical investigations conducted in order to assess the safety and effectiveness of medical devices intended to be marketed and used in Egypt.
Table of content
The Egyptian Drug Authority (EDA), the country’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to preclinical testing and clinical investigation for medical devices. The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance.
At the same time, it is important to mention that provisions of the guidance are non-binding in their legal nature, nor they are intended to introduce new rules or impose new obligations. Moreover, recommendations provided in the guidance could be subject to changes, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
Reportable Events in Clinical Investigations
In accordance with the applicable regulatory requirements clinical investigations involving medical devices are subject to, reportable events (incidents) include:
- Serious Adverse Events (SAEs): Affect subjects in the investigation regardless of causality.
- Device Deficiencies: Issues that could lead to serious adverse events.
- New Findings: Related to SAEs or device deficiencies.
- SAEs in Post-Market Clinical Follow-Up (PMCF): Occurring when devices are used for new indications, populations, or after design changes.
- Global Safety Reporting: SAEs from clinical investigations worldwide must be reported biannually to Egyptian authorities if the clinical research is authorized in Egypt, even if local participation has ceased.
Special attention is given to events arising from malfunctioning devices, inaccurate labeling, incorrect diagnostics, or unforeseen interactions.
Seriousness Criteria
As further explained by the EDA, an event is considered serious if it results in or might lead to:
- Life-threatening illness.
- Permanent disability or impairment.
- Hospitalization or prolonged hospitalization.
- Medical or surgical intervention to prevent serious outcomes.
- Public health threats (e.g., disease spread, false diagnostics leading to harm).
- Fetal distress, or birth defects.
It is also important to mention that planned procedures without health deterioration are not considered SAEs.
Causality Assessment
According to the guidance, the relationship between the event and the device or procedure is categorized into six levels:
- Certain: Direct evidence links the event to the device or procedure.
- Probable/Likely: Evidence strongly suggests a connection.
- Possible: A connection cannot be ruled out, but alternative causes exist.
- Unlikely: Other causes are more plausible.
- Not Related: No plausible link to the device or procedure.
- Unassessable: Insufficient or contradictory information prevents judgment.
The assessment considers factors such as device functionality, procedural issues, and patient conditions. Confounding variables, like concurrent treatments, are accounted for.
Timing of Reporting
The document also outlines specific timelines for reporting the parties responsible for clinical investigations should follow in order for the information about incidents involving medical devices subject to investigation to be communicated without undue delay.
Life-Threatening Events:
- Immediate notification within 24 hours of awareness.
- Initial detailed report within 7 calendar days.
- Follow-up and final reports as additional information becomes available.
Non-Life-Threatening Events:
- Reported within 7 days of awareness.
- Detailed follow-up report within 8 additional days.
Field Safety Corrective Actions (FSCA)
An FSCA is a manufacturer-initiated action to reduce risks associated with devices already on the market.
Examples include:
- Device recall or destruction.
- Modifications or design changes.
- Updates to instructions for use or analytical specifications.
Field Safety Notifications: Issued to authorities globally, including Egypt, detailing affected devices, the manufacturer, and the rationale for the FSCA.
Reporting Formats
Under the general rule, reports related to clinical investigations and incidents associated thereto are categorized as:
- Initial Reports: Preliminary information with supplementary data to follow.
- Follow-Up Reports: Updates on previously reported incidents.
- Final Reports: Conclusive documentation of outcomes and actions taken.
All reports must comply with the Egyptian Drug Authority (EDA) guidelines.
Special Conditions
The document also mentions certain special conditions to be taken into consideration by the parties involved in clinical investigations in order to ensure compliance with the relevant regulatory requirements.
- Combination Products: SAEs for drug/device or biologic/device combinations are reported per this guideline.
- Controlled Clinical Investigations: SAEs in control arms (even with marketed devices) are reported.
- Implantable Devices: All SAEs and deficiencies involving implants are reportable.
General Principles of Safety Reporting
According to the guidance, the general principles include:
- Focus on minimizing risks to subjects and ensuring device safety.
- Monitor incidents globally and continue reporting even after study sites in Egypt close.
- Reports must align with the clinical investigation plan and regulatory standards.
Conclusion
In summary, safety reporting in clinical investigations ensures the continuous monitoring of risks associated with medical devices. Medical device manufacturers and investigators can maintain high safety standards and contribute to the reliable assessment of medical devices in clinical and market settings by following structured timelines, comprehensive reporting, and international coordination.
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