The new article highlights the aspects related to field safety corrective actions including, inter alia, the record-keeping requirements, and publication of field safety notices informing the parties involved about the safety-related concerns identified and communicating instructions on the actions to be taken in order to ensure the safety of patients and users.
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 (FSCAs) to be taken by the parties responsible for medical devices in order to address safety-related concerns identified, and also to ensure public health protection. The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be considered by medical device manufacturers and other parties involved in order to ensure compliance thereto. At the same time, provisions of the guidance are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes thereto, should such changes be reasonably necessary to reflect corresponding amendments to the underlying regulations.
The scope of the guidance covers, inter alia, specific aspects related to field safety corrective actions, such as compliance to notices, the publication of field safety notices on the authority’s website, as well as completion of the respective reporting obligations.
Compliance to Notices
In accordance with the applicable regulatory requirements set forth by the Health Products (Medical Devices) Regulations 2010, failure to comply with the notices issued by the HSA constitutes an offense and could result into sanctions and penalties being imposed against the entity involved and/or the responsible persons.
Publication of Field Safety Notices on the Official Website
Under the general rule, safety communications of FSCAs reported to the authority are publicly accessible as field safety notices (FSN) on the HSA website; accessibility to safety information regarding medical devices will facilitate timely identification and management of risks posed by medical devices affected by FSCAs. As further explained by the HSA, the said notices are to be issued by the parties responsible for medical devices, consequently, these parties are also responsible for ensuring the accuracy and reliability of the information provided. The entities involved in operations with the affected medical devices are obliged to follow the instructions communicated by the product owner by the virtue of an FSN, while the publication of the latter on the authority’s website takes place for information purposes only. Should the entity engaged in activities with medical devices have any questions, it should contact the party responsible for an affected medical device directly.
The guidance further describes the requirements an FSN should meet in order to be published. According to the guidance, such a notice 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 authorized by the product owner or the Authority;
- 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); and
- 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 and strongly discouraged.
Apart from the general points described hereabove, the document also outlines certain specific aspects to be taken into consideration with respect to field safety corrective actions and field safety notices associated thereto. In particular, the authority emphasizes the following:
- Any sensitive information should be removed from the notice before it will be submitted for publication since the authority will publish it “as is” – exactly the version provided by the responsible party;
- The main purpose of having field safety notices published by the authority is to ensure that important safety-related information is available to all the parties involved in operations with medical devices and is duly communicated to the ones who may benefit from it.
Completion of Reporting Obligations
Another important aspect addressed in the guidance relates to the completion of reporting obligations associated with the field safety corrective notices. Under the general rule, the FSCA reporting obligation will be considered completed when all appropriate corrective actions have been undertaken by the dealer, subject to the concurrence of the authority. The latter additionally emphasizes that the said actions will be considered completed only provided the appropriate written notice from the HSA has been received.
In accordance with the applicable record-keeping requirements, a party involved in operations with medical devices is obliged to keep the records related to the field safety corrective actions for the entire projected useful life of the affected device, but at least for 2 years. This applies to such documents as the field safety notice itself, the list of affected parties, as well as acknowledgment receipts for dissemination or the appropriate service reports whereby the corrective actions taken with respect to the affected device are duly documented.
Moreover, it is also important to mention that even when the above obligations are duly fulfilled and the field safety corrective action is deemed completed, the HSA is still entitled to request additional information to be provided if the authority deems such information to be necessary.
In summary, the present HSA guidance provides additional clarifications regarding the specific aspects associated with field safety corrective actions to be taken with respect to affected medical devices. The document describes the way field safety notices will be published and also outlines the applicable reporting and record-keeping requirements.
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