The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to incident reporting for medical devices. The document describes in detail the procedures to be followed by medical devices manufacturers and other parties involved to report an incident related to a medical device placed on the market and also provides additional clarifications regarding the applicable regulatory requirements. The provisions of the guidance are non-binding, so in case of any discrepancies with the respective provisions of applicable legislation, the latter should prevail.
As it was mentioned before, the document provides additional details regarding the existing Medical Device Incident Reporting (MDIR) system employed in Australia. As is stated by the TGA, the appropriate system could be accessed by the interested parties via the TGA Business Services (TBS) portal. Under the general rule, this particular system should be used to submit information about the incidents associated with the medical devices market in the country. The present document describes the particular steps to be taken to access the system and submit the appropriate report. The TGA also reminds that to be able to do this, an interested party should already have an appropriate account accessible by using special access credentials – such a system is used to ensure the protection of information transmitted. As described in the guidance, the MDIR system has been enhanced to enable sponsors and manufacturers to monitor and track device incident reports. These reports could be submitted in electronic format to ensure the effectiveness of the information exchange. Moreover, using the appropriate system, the responsible parties are also able to update previously reported incidents with additional information, review the status of reports, update initial and follow-up reports, and view past reports. According to the guidance, any reports submitted as described herein are immediately received by the regulating authority.
Accessing the MDIR
The document further describes the way the reporting system could be accessed via the TBS portal. According to the guidance, the appropriate system could be accessed via the official website or the aforementioned portal. The TGA also reminds that the password used to access the appropriate account expires every three months, hence should be subject to updating regularly. Due to technical reasons, a user will be requested to enter login credentials twice, as the reporting system operates as a separate module.
New Incident Reports
As it was mentioned before, the present document is intended to guide a party intended to submit an incident report through the whole process describing in detail each of its steps. Once logged in, a user will have access to all reports submitted previously. To submit a new medical device incident report, a user shall provide respective information as required under existing legislation. Some of the fields are marked as mandatory, so the report would not be processed as long as these fields remain blank. If some of the information necessary is not available for the responsible entity at the moment of submission, a draft report could be saved to be finalized later.
According to the guidance, the fields to be filled by a user include, inter alia, the following ones:
- Indication of a report type;
- Information about the reporter, including the details about the responsible person submitting the report and his/her contact details, as well as the information about the company in general, including its location;
- The non-mandatory field for the information regarding the healthcare facility involved in the incident, if applicable (such information would be later used to identify potential duplicate reports submitted by different parties about the same incident, and also to analyze the respective trends and field for improvement);
- Information about the medical device in question (could be partially uploaded from the respective entry in the Australian Register of Therapeutic Goods (ARTG), the national register of medical devices), including such details as brand/trade name, model, as well as serial, batch and lot numbers (in case of implantable medical devices it would be also possible to provide additional information on the date the device has been implanted) – upon submission, the information in this section would be available only to a sponsor as a party responsible for a medical device;
- Information about the incident in question (except the details related to the patient or healthcare facility involved) – the authority additionally emphasizes that the information to be provided in this section should be solely related to the incident in question, and should not describe the results of an investigation carried out by the manufacturer;
- Additional information about the patient and healthcare facility (as it was mentioned before, such information is not mandatory and could be used, inter alia, to identify duplicate reports referring to the same event) – the authority also reserves the right to request such information from the submitter (it is important to mention that this section could also contain information about other medical devices involved in the event, even if the entity submitting the report is not a sponsor for such devices);
- Investigation results – a special section containing a summary of an investigation carried out by the medical device manufacturer to identify the root cause of the event, as well as the information regarding the corrective and preventive actions (CAPA) carried out by the manufacturer to mitigate the risks associated with the incident, and also the respective reports (according to the guidance, if a formal CAPA has not been raised by the manufacturer, a comprehensive summary of all corrective and/or preventive actions put in place to address issues related to the reported adverse event should be provided in this field);
- Details about similar events, which would be later used by the authority to identify trends (the TGA encourages manufacturers to provide information about similar incidents that occurred for three years before the incident in question), including the number of incidents that occurred and actual incident rate.
Providing Additional Documentation
The basic functionality of the system allows submitting additional documents the submitter deems necessary to substantiate the information provided. In particular, a submitter will be able to attach various files including images and documents. However, there are special file size limits (both total and per file).
In summary, the present TGA guidance covers the most important aspects related to the medical device incident reports and the way they should be submitted by the virtue of the TBS portal. The document provides additional clarifications regarding the scope of information to be provided by an entity submitting the report, as well as additional recommendations to be considered.
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