The South African Health Products Regulatory Authority (SAHPRA) has issued comprehensive guidelines to streamline the reporting of medical device adverse events (MDAEs). These guidelines aim to enhance post-market surveillance, ensuring the safety and efficacy of medical devices, including In Vitro Diagnostics (IVDs), within South Africa.
By combining best practices for reporting, completing forms, and adhering to regulatory compliance, SAHPRA provides a structured approach for manufacturers, distributors, and license holders.
1. Medical Device Adverse Event Reporting Form
SAHPRA Medical Device Adverse Event Reporting Form provides the standard template for reporting adverse events related to medical devices or IVDs. This form is critical for documenting and communicating any events that may impact the safety or performance of these products.
Key Components of the Form
Device Information: Includes details about the medical device or IVD, such as its make, model, and registration certificate.
Event Description: A thorough account of the adverse event, including date, location, and suspected cause.
Reporter Details: Information about the individual submitting the report, ensuring accountability and traceability.
Patient Impact: Highlights the degree of harm caused to patients or users, if applicable.
Action Taken: Describes any corrective or preventive actions implemented to address the issue.
Manufacturers, license holders, or healthcare professionals are expected to submit this form promptly to SAHPRA to initiate the investigation process.
2. Guideline for Completing the Medical Device Adverse Event Form
The Guideline for Completing Medical Device Adverse Event Form serves as a detailed user manual for filling out the reporting form accurately and efficiently.
Key Instructions
Clarity in Reporting: Ensures precise documentation of adverse events with a focus on device traceability.
Mandatory Fields: Highlights critical sections that must be completed, including device identifiers and patient safety details.
Submission Channels: Provides contact information and electronic submission pathways, ensuring timely delivery of reports.
Common Errors to Avoid: Emphasizes the importance of avoiding incomplete or ambiguous submissions that could delay investigations.
This guideline is designed to reduce inconsistencies in reporting, ensuring that the data provided to SAHPRA is actionable and reliable.
3. Guideline for Medical Device Adverse Event Reporting
The Guideline for Medical Device Adverse Event Reporting outlines the overarching framework for adverse event reporting in South Africa, focusing on roles and responsibilities, timelines, and follow-up actions.
Scope and Purpose
This guideline applies to:
Manufacturers.
License holders.
Healthcare professionals and users who encounter adverse events linked to medical devices or IVDs.
Key Highlights
Definition of an Adverse Event: Explains events such as device malfunction, deterioration in performance, and incorrect labeling that could harm patients or users.
Timelines for Reporting: Specifies deadlines for submitting reports based on the severity of the adverse event, such as:
Serious Threats to Public Health: Reported within 2 days.
Death or Serious Deterioration: Reported within 10 days.
Other Events: Reported within 30 days.
Follow-Up Actions: Describes post-reporting steps such as corrective action plans, root cause analysis, and regulatory decisions.
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