The new article highlights the key points related to reporting adverse events associated with in vitro diagnostic medical devices and also describes the applicable reporting timelines.
The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the regulatory requirements for reporting adverse events for medical devices. The document provides additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be followed 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 the corresponding amendments to the underlying regulations.
The scope of the guidance covers, inter alia, the aspects related to reporting adverse events associated with in vitro diagnostic (IVD) medical devices.
Adverse Events Involving IVD Products: Key Points
Usually in vitro diagnostic medical devices are not designed to be in direct contact with patients, hence, it is sometimes difficult to identify the direct connection between the operations of the device and harm caused to a patient, except the cases when the product itself causes certain issues. At the same time, it is important to notice that an adverse event involving an IVD medical device could result in indirect harm as a result of an action taken or not taken on the basis of an incorrect reading obtained with an IVD medical device. Under the general rule, a report should be submitted even in case of minor concern that the device could cause a deterioration in the state of a patient’s health due to the incorrect test result, or in any other way. Furthermore, the reporting requirements also apply with respect to situations when the inadequate information provided by the medical device manufacturer and/or the actions based on it results in the harm caused. It becomes more important in the case of IVD products intended to be used by laypersons (self-testing IVD medical devices), as incorrect information could result in the use in a wrong way or misinterpretation of the results. Thus, according to the guidance, adverse events involving IVD medical devices will most likely result from a consequence of a medical decision or action taken, or not taken, on the basis of result(s) provided by the IVD medical device. As further explained by the HSA, such adverse events include, inter alia, the following ones:
- Delayed diagnosis;
- Delayed treatment;
- Inappropriate treatment;
- Transfusion of inappropriate materials.
The document also outlines the scope of potential grounds for the above adverse events, namely:
- Shortcomings in the design or manufacture of the IVD medical device itself;
- Inadequate instructions for use;
- Inadequate servicing and maintenance;
- Locally initiated modifications or adjustments;
- Inappropriate user practice;
- Inappropriate management procedures;
- Inappropriate environment in which an IVD medical device is used or stored;
- Selection of the incorrect IVD medical device for the purpose.
Apart from the aspects related to reporting adverse events associated with IVD products, the document also describes the applicable reporting timelines to be followed in order to ensure compliance with the respective regulatory requirements for adverse event reporting. Under the general rule, an adverse event report should be submitted immediately, but not later than:
- 48 hours – in case the event represents a serious threat to public health;
- 10 days – if the event resulted in severe negative consequences;
- 30 days – if the reoccurrence of the event could result in significant harm caused to a patient.
As further explained by the authority, the calculation of the said timeframe shall commence once the party responsible for a medical device becomes aware of the incident subject to reporting. Furthermore, it is also stated that in case of any concerns on whether the event should be subject to reporting, a report should be duly submitted. It is also important to mention that the appropriate report should be submitted even if the information about the event in question is incomplete. In such a case, the initial report should be submitted using the information which is already available at the moment of submission in order to avoid delays due to the need for additional information to be collected. Once the initial report has been submitted, a party responsible for a medical device will have 30 days to prepare and submit a final report containing the details regarding the investigation of an adverse event. Should it appear that the final report cannot be submitted within the said timeframe, a follow-up report should be submitted. According to the guidance, the authority is entitled to request follow-up reports to be submitted at its sole discretion.
In summary, the present HSA guidance provides an overview of the regulatory requirements to be taken into consideration when submitting adverse event reports associated with in vitro diagnostic medical devices. The document outlines potential grounds for issues, as well as the possible outcomes. Apart from this, the guidance also describes the timelines for submission of adverse event reports depending on the severity of consequences and risks associated with the issue identified.
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