The South African Health Products Regulatory Authority (SAHPRA) has released two crucial guidelines to streamline adverse event reporting for medical devices and ensure patient safety:
These documents provide detailed instructions for holders of medical device establishment licenses (Licensees) and holders of certificates of registration (HCR) to report adverse events. Below is a consolidated blog summarizing these guidelines.
Adverse event reporting is critical in safeguarding public health and ensuring the quality and performance of medical devices. A robust vigilance system facilitates the monitoring and evaluation of potential risks throughout a device's lifecycle.
Both guidelines are designed to:
Standardize adverse event reporting for medical devices, including in-vitro diagnostic (IVD) devices.
Outline mandatory legal provisions and specific timelines for reporting.
Provide clarity on what constitutes an adverse event, including classifications such as "serious injury," "near adverse events," and "serious public health threats."
The key components covered in this guidance about Adverse Event Reporting are
A. Reporting Process
Initial, Follow-Up, and Final Reports: These are used to track events as more information becomes available.
Event Classification: Events are categorized based on severity (e.g., death, minor injury, life-threatening situations).
Timelines:
48 Hours: For serious public health threats.
10 Days: For events involving death or serious injury.
30 Days: For recurring events that may lead to severe outcomes.
B. Required Information
Patient and Reporter Details: Anonymized patient identifiers and reporter contact information.
Device Information: Include details like the Unique Device Identifier (UDI), batch/lot number, and storage conditions.
Event Description: A detailed narrative of the event, omitting personal identifiers like patient names.
C. Legal and Regulatory Compliance
Reporting is mandated under the Medicines and Related Substances Act, 101 of 1965, and associated regulations.
Failure to report within the stipulated timeframes may result in regulatory actions, including license suspension or cancellation.
D. Manufacturer's Role
Manufacturers are required to:
Investigate reported adverse events.
Implement corrective or preventive measures.
Submit a risk assessment and analysis of similar adverse events globally.
A flowchart provided in Appendix 1 of SAHPGL-MD-03_v4 helps determine whether an adverse event is reportable. This visual guide simplifies the decision-making process for Licensees and HCRs. The standard form includes fields for patient details, adverse event classification, and device information. It must be submitted electronically to SAHPRA within the specified timelines.
Certain exemptions apply, such as when events are due to patient conditions or identified before device use. However, these rules do not apply to recurring events that pose a public health risk. By adhering to these standards, Licensees and HCRs can contribute significantly to public health and device performance monitoring.
For further details, refer to:
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