Types of FSCA risk management processes
Recalls
Once affected devices have been recalled from the field, the dealer shall ensure that the recalled devices are quarantined or disposed. The affected devices are not permitted for further supply.
Other corrective actions
Corrections limited to labelling (e.g. advice on device precaution or addition of user warning)
New supply of affected device may be permitted with the condition that supply of affected device is accompanied by the product owner’s Field Safety Notice. We may request additional measures where deemed necessary.
Corrections not limited to labelling (including changes in indication or shelf life)
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Correction-in-progress devices
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If we concur with the dealer's or product owner's justification that sufficient interim measures have been taken to reduce or eliminate the risks identified, they may be allowed to supply these medical devices, subject to conditions such
as:
- They shall ensure that the correction-in-progress medical devices that are supplied will undergo full correction upon availability of final Corrective And Prevention Action (CAPA).
- They have provided Field Safety Notice (FSN) with each supply.
- They shall declare that full correction for all correction-in-progress medical devices have been completed.
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Corrected devices
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Supply may proceed, subject to standard regulatory requirements such as Change Notification (CN). Failure to submit a CN to us regarding changes made to registered medical devices
is an offence under the Health Products Act.
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Risk communication to device users
Field Safety Notice (FSN)
To ensure timely communication, the dealer or product owner should inform all consignees of the FSCA through a FSN. This is a communication notice sent out by a product owner to device users in relation to a FSCA.
FSNs are circulated to facilitate timely identification and management of risks posed by medical devices affected by FSCAs.
For FSCA where the affected devices have been made, imported or supplied in Singapore, the FSN can either:
- Provide the complete global list of affected identifiers identified by product owner; OR
- Only list local affected identifiers in Singapore. In such an instance, a statement should be included to inform the recipient of FSN that there may be other affected identifiers that are affected globally and that they should check with the product
owner in the event they obtained the device from an overseas dealer.
A FSN for publication on our website should:
- Be submitted as a single Adobe PDF document instead of a Microsoft Word document
- Not be tagged as "Draft"
- Not include or add information that has not been authorised by the product owner or us
- Not have information regarding the FSCA deleted, altered or concealed from
- Not be password-protected
- Not contain any third party marks (e.g. contact details of consignees)
- Be accessible to any person who may have potentially been supplied with affected devices. Therefore, the presence of "Privileged and Confidential" or "Restricted" tags in the FSN is inappropriate
List of Product Owner's Field Safety Notices
Please click on the following links to view the Field Safety Notices submitted for the FSCAs reported to HSA.
For FSCAs initiated:
- Before 6 January 2020, please click here.
- On 6 January 2020 or after, please click here.
Dear Healthcare Professional Letter (DHCPL)
For FSCAs involving implantable medical devices, dealers need to prepare a DHCPL to send out to healthcare practitioners who have been supplied the affected medical devices, or have performed implantations using them.
Note: The preparation of a DHCPL is not restricted to FSCAs involving implantable medical devices. You may need to provide new or additional safety information about other types of medical devices to healthcare practitioners on other
occasions.
The DHCPL contains the product owner’s advice on the clinical management of patients who have been implanted with affected medical devices. Dealers are required to draft the DHCPL and report the number of implants that have been performed in Singapore using the affected medical devices.
Dealers shall only send out the DHCPL after they have received written clearance from us. In the meantime, they should inform affected consignees of the FSCA through the product owner’s FSN.
Print Advertisement/ Press Release
For FSCAs that need more communication to device users or that involve devices supplied at consumer level (e.g. contact lenses, blood glucose test strips), dealers may need to prepare a print advertisement to be published in the daily newspapers of the
four official languages. In certain cases, we may also require a press release.
All consumer-level risk communications require clearance from us.
Compliance to notices
According to Regulations 46(4) of the Health Products (Medical Devices) Regulations 2010, non-compliance to notices issued by us is a serious offence. The penalties are a fine not exceeding $10,000 or imprisonment for a term not exceeding 6 months, or both.
Completion of reporting obligations
The dealer can consider his FSCA reporting obligation completed when he has taken the necessary corrective actions and after receiving written confirmation from us.
The dealer should maintain records related to the FSCA for a minimum of either 2 years from date of completion of FSCA or the projected useful life of the medical devices, whichever is longer. Such records should include:
- The FSN
- List of affected consignees
- Acknowledgement receipts for dissemination of FSN or DHCPL, or service reports documenting device corrections
If necessary, we can still ask for more information related to the FSCA even after the FSCA was deemed completed.