A Safety Warning Notice or Field Safety Corrective Action (FSCA) is an action taken by a manufacturer to minimise the risk that may lead to death or deterioration in the health condition of patients and / or users, of a medical device or In-Vitro Diagnostic (IVD) that are already placed in the market.
The South African Health Products Regulatory Authority (SAHPRA) publishes Field Safety Notices or Safety Warning Notices to ensure that patients, healthcare professionals, users and all the relevant stakeholders are informed in time of the safety information of medical devices and IVDs.
What is a FSN (Field Safety Notification) or Safety Warning Notice
A notice issued or shared with the public and healthcare professionals warning them of safety risk and action taken regarding a medical device, including IVDs, to minimise risks and protect patients and healthcare professionals.
A Field Safety Corrective Action or Safety Warning Notice may include:
- Product removal from the market (recall)
- Product replacement
- Software updates
- Labelling changes and/or updates
- Instructions for use updates
- Device modification
Difference between FSCA/Safety Warning Notice and Recall
Safety Warning Notice or FSCA (Field Safety Corrective Action) is the regulatory action taken to minimise safety risk against patients and healthcare professionals regarding a medical device or IVD.
A recall is a regulatory action taken by SAHPRA to remove a medical device or IVD from the market or users to protect patients from safety risk.
Please note that recalls will be published on the recalls landing page.
When to initiate FSCA/Safety Warning Notice
A FSCA or Safety Warning Notice can be initiated if there is one or more adverse incidents that took place as a result of the medical device or IVD that is already in the market and has potential to cause harm or safety risk if it is used.
The adverse incidents may include the following:
- Device malfunctions or failures
- Design or manufacturing defects
- Labelling, instructions, or packaging errors
- Adverse events and complaints
- Post-market surveillance findings
- Regulatory inspections or audits
How does SAHPRA enforce a FSCA?
When a licence holder or holder of certificate of registration initiates an FSCA or Safety Warning Notice, SAHPRA will provide regulatory oversight and ensure there is compliance with the Medicines and Related Substances Act and its regulations regarding medical devices and IVDs.
Safety Warning Notices or FSCAs will be determined based on the medical device or IVD involved and extent of the safety risk on public health. SAHPRA may require the immediate discontinuation of the use of a medical device or IVD or permit its continued use while ensuring that appropriate risk information and corrective measures are communicated to patients, healthcare professionals, and other affected stakeholders.
Based on the outcome of the medical device or IVD risk assessment, Safety Warning Notice or FSN may be published and communicated through SAHPRA’s website and social media platforms, and mainstream media where applicable.
Furthermore, the public, patients and healthcare professionals may be informed about the safety risks associated with the medical device or IVD and provides guidance on how the affected batches should be handled.