The new article highlights the aspects related to the specific associated with certain types of medical devices, including consumer-level and implantable ones.
The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to field safety corrective actions (FSCA) to be taken by medical device manufacturers and other parties responsible for medical devices available in the country in order to ensure their continued safety and public health protection. The document describes in detail the applicable regulatory requirements and also provides additional clarifications and recommendations to be considered by the parties involved in order to ensure compliance thereto. At the same time, provisions of the guidance are non-binding in their nature, nor are intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes to the guidance, should such changes be reasonably necessary to reflect corresponding amendments to the underlying regulations.
The scope of the guidance covers, inter alia, the aspects related to the FSCA taken with respect to specific types of medical devices, such as consumer-level or implantable ones.
FSCA for Consumer-Level Medical Devices
With respect to medical devices supplied at the consumer level, such as contact lenses or blood glucose test strips, the authority requires the responsible parties to submit a draft print advertisement – it should be included as a part of a Notification Report submission. In particular, for consumer-level FSCA, a print advertisement in public media to the general public is deemed necessary for effective risk communication to all affected consumers of the FSCA. The authority will expect the appropriate communication to be published in daily newspapers in each of the official languages. Moreover, the authority may also require a press-release to be issued – such a request could be communicated by the authority via the FSCA Acknowledgement Notice.
As further explained by the authority, such a press-release should include, inter alia, the following information:
- Reason for FSCA;
- Affected product identifier(s);
- Pictoral information on how affected products can be identified (in layman terms);
- Information on returns procedure (e.g., to exchange affected units with non-affected stock);
- Dealer contact hotline (including operating hours) and email address for enquiries.
The authority additionally emphasizes that the above list is non-exclusive, and also applies to print advertisements.
It is also stated that any and all communications related to consumer-level devices should be subject to prior clearance from the HSA. Furthermore, it is also stated that the field safety corrective actions related to consumer-level products are time-sensitive and should be taken without undue delay. Thus, the authority expects the parties responsible for medical devices to take necessary actions in a fast and efficient way.
FSCA for Implantable Medical Devices
Another specific category of products described in the guidance is implantable ones based on the specific risks associated thereto. In this respect, the authority states that for FSCAs involving implantable medical devices, dealers shall be required to prepare a “Dear Healthcare Professional” Letter (DHCPL) for dissemination to qualified practitioners who have been supplied or performed implantations using the devices affected by the FSCA. According to the guidance, the said letter should provide information related to the product owner’s clinical management advice to qualified practitioners with regard to patients who have been implanted with medical devices affected by the FSCA.
The authority additionally emphasizes that the aforementioned letters should be released and distributed only after the appropriate approval is granted by the HSA. At the same time, before such approval is granted, the party responsible for an affected medical device is obliged to inform all the parties involved in operations with the said device by the virtue of the appropriate notice. With respect to the content of a DHCPL, the authority refers to the separate guidance document.
In order to ensure the proper effectiveness of corrective actions related to implantable medical devices, the authority obliges the parties involved in operations with such products to report the under of implantations conducted within the country using the medical device subject to the FSCA.
According to the guidance, the aforementioned letter should be duly delivered to any and all healthcare professionals conducting operations with the affected medical device. Moreover, a party initiating such an action should obtain the confirmation of receipt in each particular case by asking for an acknowledgment to be signed by a healthcare professional. It is also stated that in cases where the qualified practitioner has left his practice, the facility where the implantation occurred shall acknowledge receipt of the DHCPL on behalf of the qualified practitioner. Apart from healthcare professionals using the devices, the said letter should also be communicated to the staff responsible for procurements.
With respect to the aforementioned acknowledgment, the authority states that acknowledgment of the DHCPL constitutes a confirmation that the qualified practitioner involved has received a copy of the DHCPL or other risk communication associated with the FSCA; this is a form of effectiveness check that the authority performs; FSN acknowledgment receipts will not be requested by the authority for cases where DHCPL is required.
In summary, the present HSA guidance provides an overview of certain device-specific requirements for field safety corrective actions to be taken by the parties responsible for the products allowed for marketing and use in the country in order to mitigate the newly identified risks and ensure the safety of patients. The document describes in detail the specific aspects associated with medical devices supplied on a consumer level, and also the implantable ones, based on the risks associated thereto.
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