The Therapeutic Goods Administration (TGA), the Australian regulating authority, has published an update regarding the ongoing process of improvement of the existing regulatory framework in the sphere of post-market monitoring and surveillance. In particular, the TGA addresses the issues related to incident reporting. 

Regulatory Background 

The TGA acknowledges that despite the significant number of incident reports, approximately 20% of them are followed by the appropriate investigation. This situation resulted in numerous requests from the public regarding the effectiveness of the existing regulatory framework. In particular, the industry representatives expect the regulating authority to: 

  • Improve the level of data capture relating to adverse events associated with the use of medical devices,
  • Adopt a more systematic and transparent approach to risk assessment of adverse events reported to the regulator,
  • Enhance methods of identifying cases that require further investigation of adverse events,
  • Strengthen methods of prioritizing cases that need more timely investigation,
  • Identify and document key issues underlying decisions made by the regulator to improve the quality and safety of medical devices in Australia. 

In response to the aforementioned requests, the regulating authority has already commenced the implementation of necessary changes in order to make post-market monitoring and surveillance more effective. 

Earlier in 2019, the TGA has already started the rigorous analysis of existing regulatory practices and procedures to identify the issues and develop the approach to further improvement. During this analysis, the authority also obtained feedback from healthcare institutions and other industry representatives involved in operations with medical devices. The scope of the analysis covered the incident notification processes, as well as data systems and analytic platforms. The analysis conducted by the regulating authority also included a comparison of existing and alternative approaches to risk assessment. As the result, the TGA managed to identify the most critical issues requiring improvement.

Post-Market Enhancements 

Upon completion of the rigorous analysis described here, the Australian medical device regulating authority outlined the most important directions for improvements, and also developed the steps to be taken to implement the necessary changes. 

TGA Regulatory Improvement: Actions Taken 

The regulating authority mentions that certain actions have been already taken in order to implement the changes outlined here above. 

  1. For the purpose of making the information about medical devices available to patients and healthcare professionals, the TGA has already launched several web resources providing access to device-specific information. Moreover, now the information from the System for Australian Recall Actions (SARA) is made available to healthcare institutions using medical devices. According to the new regulatory requirements introduced recently in Australia, medical device manufacturers shall provide extensive information related to certain high-risk medical devices, and also ensure this information was duly communicated to the patients. The TGA also expands the public consultations carried out in order to collect feedback and suggestions from industry representatives and other parties involved in operations with medical devices. In particular, several working groups have been established to improve communications between the regulating authority and industry representatives, and also between the regulating authority and patients. These working groups are actively cooperating with the local authorities responsible for the safety of healthcare products. 
  2. In order to improve the way the TGA responds to identified adverse events and takes the actions necessary to address the consequences and mitigate the risks associated thereto, the authority has already revised the classifications for three levels of investigation used by the TGA to assess the adverse event and plan further actions. These improvements also include the implementation of a new database that makes data exchange more effective. 
  3. One of the goals outlined by the TGA is related to the early identification of adverse events. For this purpose, the regulating authority has updated the guidelines describing the procedures related to the adverse events reporting in order to assist all parties involved with following the applicable rules and fulfilling their obligations set forth under existing regulations. In particular, the reporting procedures become simpler and more understandable for the reporting entities since the TGA has clarified the information to be provided, as well as the way it should be submitted to the authority. 
  4. The TGA continuously analyses the regulatory approaches adopted in other countries and cooperates with foreign regulating authorities for the purpose of further harmonization of the requirements related to adverse event reporting for medical devices.
  5. The TGA also improves the processes related to the risk assessment with regard to the adverse events reported by medical device manufacturers, healthcare institutions, and other parties involved. 
  6. The cooperation with foreign regulating authorities is not limited to the harmonization of regulatory approaches: the TGA also actively implements the mechanisms necessary to ensure the effective exchange with the information regarding adverse events and special regulatory actions associated thereto.

Continuous Improvement 

According to the official notice published by the TGA, the Australian regulating authority continues its activity aimed at further improvement of the existing regulatory framework in the sphere of incident reporting for medical devices. In particular, the TGA pays special attention to the way it communicates with the industry representatives and healthcare institutions – as defined by the authority, effective communication is vitally important to ensure the safety of patients and timely actions taken in response to adverse events. The actions taken by the TGA in this sphere include, inter alia, the improvement of notifications, issuing the periodic “radar reports” describing the information collected in the course of monitoring and surveillance activities, implementation of the efficient technical solutions necessary to simplify access to the important information, including the Database of Adverse Event Notifications (DAEN). The TGA additionally emphasizes the importance of the planned extension of data exchange with the foreign regulating authorities. 

Summarizing the information provided here above, the official notice published by the TGA describes the issues related to incident reporting for medical devices identified by the authority, the suggested approach and key principles, and also the actions the Australian regulating authority has already taken or intends to take to address the identified issues and improve existing regulatory framework on adverse event reporting in general. The TGA pays special attention to the international cooperation between the national regulating authorities in the sphere of medical devices as one of the main priorities. The authority expects the additional regulatory measures developed and implemented by the TGA would simplify and streamline the procedures related to adverse events reporting, and also make the information associated thereto easily available for medical device manufacturers, healthcare institutions, and other parties involved. 

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