The Health Sciences Authority (HSA), Singapore’s medical device regulating authority, has published the new revision of the guidance on medical device field safety corrective actions.
General Overview of the Field Safety Corrective Action
The recent guidance published by the HSA is dedicated to the Field Safety Corrective Action (FSCA). The appropriate procedures and requirements are set forth by the Health Products Act and Health Products (Medical Devices) Regulations 2010 providing that the authority should be properly informed on field safety corrective actions taken by the manufacturer. According to the applicable regulations, the manufacturer of the device should take all actions reasonably necessary to eliminate or mitigate the potential risk or actual hazard associated with the use of the device by end-users for the intended purpose. The authority also emphasizes that such actions could be required even if the particular device is no longer marketed for any reason (e.g. withdrawal) but could be used by end-users.
The scope of the guidance covers all parties involved including medical device manufacturers, their authorized representatives, importers, and suppliers.
First of all, the document provides important definitions, including the following:
- Correction – any action intended to eliminate an issue. A correction could include making any modifications or adjustments, repairing the devices or changing a label.
- Corrective and preventive actions (CAPA) – special actions taken in order to eliminate issues. This is a general category that includes corrective actions, as well as post-market surveillance, recalls initiated by the manufacturer and preventive actions too.
- Dealer – general term applicable to any entity operating with medical devices, including the manufacturer, an authorized representative, importer or supplier.
Depending on the current status, for the purpose of the guidance the device could be:
- Affected – i.e. a device having any issues whatsoever,
- Correction-in-progress – a device subject to corrective actions, and
- Corrected device – a device where all necessary corrective and preventive measures have been properly taken. Such a device is deemed to comply with all applicable regulations.
- Field safety notices – information provided by the manufacturer (or its authorized representative) to users, including the identifier of the particular medical device.
According to the definition provided in Health Products (Medical Devices) Regulations 2010, field safety corrective action constitutes an action aimed to mitigate the risk of causing substantial harm to the patient using a medical device. Such actions include, among others, the following:
- Returning medical devices to the manufacturer,
- Replacing medical devices or their destruction,
- Additional actions related to medical devices recommended by the manufacturer,
- Special clinical measures to be taken regarding the patient using the device subject to corrective actions previously,
- Making any modifications to the device in order to restore compliance with applicable safety requirements,
- Adding supplementary elements necessary for the device to comply with applicable requirements,
- Making any changes to the labels placed on the device itself or its packaging,
- Making changes to the software operating medical devices or intended to be used with them, including the remote upgrade.
Grounds and Requirements for Field Safety Corrective Action
In accordance with the applicable regulations, the product owner (a person who directly supplies medical devices or is responsible for the development, design and manufacturing of medical devices) should be responsible for identifying the situations when field safety corrective actions are reasonably necessary. As usual, the need in FSCA is based on the information collected through the post-market surveillance, including any complaints received from healthcare facilities or end-users directly, as well as adverse events reports. At the same time, the authority is entitled to require medical device manufacturers to commence field safety corrective actions in cases when it is necessary to mitigate or eliminate the risk associated with the use of the particular device. Sometimes it could be reasonably necessary to impose additional restrictions on the use of certain devices, prohibit using them or even withdraw them from the market.
The notification rules provide that the authority should be duly notified on any FSCA taken regarding any affected device that is produced or properly placed on the domestic market in Singapore. In particular, it is required to notify the authority on any corrective actions taken against any device registered in Singapore. The party performing such actions should ensure that all FSCAs are commenced properly and in a timely manner.
The document defines the reporting person as a party responsible for reporting to the Authority. Depending on the particular case, the manufacturer, its authorized representative, supplier or importer could act as a reporting person. At the same time, if several separate parties were involved in operations with particular medical devices, each party may be required to report individually. The authority would evaluate the circumstances and define whether it is possible to obtain all information from a single reporting person.
FSCA Procedure in Singapore
If the manufacturer initiates the FSCA regarding the devices already placed on the market, all appropriate actions should be taken in a timely manner without any delay. First of all, it is required to notify the authority on any FSCA planned before the actual performance. If the authority has been duly notified, the party operating with medical devices could commence the corrective and preventive actions while the approval of the authority is not required to be allowed to conduct the FSCA. At the same time, the authority is entitled to require the party to take certain additional measures reasonably necessary under the particular conditions, as well as to amend the information provided by the manufacturer to the strategy of the actions itself. For instance, the authority could require the manufacturer to issue additional communication to provide extended clarification.
According to the applicable regulations, any party performing the FSCA is obliged to submit a report within 30 days from the day that the appropriate actions were initiated in any of the countries where the particular device is available on the market. There are several other types of reports required by the authority, namely:
- The Notification report should be submitted immediately after the initiation in any country. Upon receipt of the notification report, the authority responds by issuing the acknowledgment notice.
- The Preliminary report should be issued upon request of the HSA within 24 hours after the field safety corrective actions have been performed.
- The Follow-up (Final) report should be submitted not later than in 21 days from the date when the FSCAs were performed.
All the types of reports could be submitted online using the Online Safety, Compliance Application and Registration (OSCAR) System.
Summarizing the information provided above, the medical device manufacturer or any other party responsible for the particular medical device placed on the market should inform the authority about field safety corrective actions in the following way:
- To submit the initial Notification report immediately upon the initiation of the FSCA even if the information is partially unavailable.
- The Final report should be submitted in 21 days.
- The intermediate follow-up report should be submitted in case if all actions have not been completed during the first 21 days.
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