The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices and other healthcare products, has announced the ongoing improvement of its incident reporting framework in order to ensure the safety and effectiveness of any and all medical devices approved for marketing and use in Australia and to enhance post-market monitoring in general. Previous changes to the reporting system were introduced earlier in 2019 when the new online reporting system was implemented. Using the system, a responsible party can upload additional information to supplement reports that have already been submitted. Additionally, it is possible to access and check the status of the reports submitted before.
Medical Device Incident Reporting Guide
Since the new online reporting system was implemented, the TGA has also issued the appropriate guidelines intended to provide medical device manufacturers and other parties involved with additional clarifications and recommendations regarding the way the new reporting system should be used.
According to the document, the Medical Device Incident Reporting (MDIR) system could be accessed via the TGA Business Services (TBS) website. All parties responsible for medical devices that are subject to reporting requirements should use this system to submit reports on adverse events associated with medical devices. The present guidance describes step-by-step procedures to be followed in order to submit an incident report using the new system.
The authority additionally emphasizes that in order to be able to use the system, a user shall have an active TBS account, the same as used for applying for inclusion of a medical device in the Australian Register of Therapeutic Goods (ARTG).
Using the new system, the responsible parties are also able to track the incident reports, upload additional information, check the status, and make updates. Due to the electronic format of communication, all reports and submissions filed via the new system will be received by the regulating authority immediately. The authority also mentions that the password one shall use to access the services expires on a quarterly basis and should be renewed accordingly in order to ensure uninterrupted access to the system.
MDIR System: Key Points
The document further describes in detail the functionality of the new system and the way it should be used by a responsible party.
In order to create a new incident report, an interested party shall fill in the appropriate online form. Some of the fields are mandatory, and the report could not be submitted unless they are properly filled. If the relevant information is not available at the moment, the report should be saved as a draft and completed later when all necessary information is in place. Sometimes the form contains additional clarifications regarding particular information to be provided – such details are accessible by clicking symbol (?).
Mandatory fields include the indication of a report type and also details of the reporter, including:
- Full name and title,
- Company name,
- Contact details, including phone number and address.
The fields related to the healthcare facility involved are not mandatory. However, the authority encourages the reporters to provide this information as well. This would be helpful for identifying duplicate reports referring to the same adverse event that could be created by different parties involved in operations with medical devices. Additionally, it could be used to identify potential trends related to the particular healthcare institutions, transportation or storage issues, etc.
Information to be Provided
The next important block of information relates to the medical device itself. For ease of use, some of the information to be provided in this section could be uploaded from the national register of healthcare products – the ARTG. There are only two mandatory fields: “Brand/Trade Name” and “Company Name,” which refers to the name of the medical device manufacture. However, as in the case with information about healthcare institutions, the regulating authority encourages the reporters to provide additional information about the medical device in question in order to facilitate the review and improve the efficiency of post-market monitoring in general. This could also be used to identify batch-related issues. The information to be provided with regard to the medical device includes:
- Device ARTG Number,
- GMDN Code,
- GMDN Text,
- Brand/Trade Name (mandatory),
- Software Version (if applicable),
- Device Model,
- Serial Number,
- Batch Number,
- Lot Number,
- Operator at Time of Event,
- Usage of Device.
In the case of implantable medical devices, the information to be provided should also contain the indications of date of implant and explant, place of implantation, and current device location.
The authority also mentions that if an ARTG entry the reporter refers to when providing information about the medical device is linked to another entity, the information will be no longer available for the reporter after submission but will appear for the sponsor responsible for the medical device in question.
The next section is dedicated to information about the clinical event itself. The TGA additionally emphasizes that the information to be provided in this section should be related only to the incident itself and not to the healthcare institution or patient – all such information will be removed before publishing this information in the Database of Adverse Event Notifications (DAEN). This section also should not include the details provided by the medical device manufacturer upon completion of its investigation. All additional information that is not directly related to the adverse event should be provided in other relevant sections. For instance, the form contains a separate block dedicated to information about the patient.
If there are several medical devices involved in the incident, information about such devices should be provided in a special section, “Devices Involved in Event” even if the reporter is not responsible for these medical devices.
The additional section addresses the results of an investigation carried out by the medical device manufacturer. In this section, the reporter shall provide all available information about the corrective and preventive actions (CAPA) taken by the manufacturer with regard to the incident. It is also important to mention that the appropriate report should be attached if available. If the formal CAPA-related procedures were not initiated officially by the manufacturer, the fields of the section should be completed with details regarding any actions taken to address the issue. The field “Manufacturer’s Device Analysis Results” requires a complete investigation report to be provided. The results of an investigation to be carried out by the manufacturer should also contain the indication of the root cause for the issue. If that has not been established, the appropriate justification should be provided.
In summary, the present TGA guidance describes in detail how an incident report should be submitted via the appropriate online portal and also outlines the scope of information to be provided by the reporter. The document also provides additional clarifications regarding the way the incident reporting form should be completed.
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