The new article highlights additional aspects related to clinical evidence for joint prostheses in terms of post-market surveillance, which become especially important since such devices are intended to be used for a long period, so their long-term safety and performance should be subject to additional assessment.
The Therapeutic Goods Administration (TGA), an Australian authority in the sphere of healthcare products, has published a guidance document dedicated to clinical evidence for medical devices. The document provides an overview of the policy to be applied concerning clinical evidence for various types of medical devices including, inter alia, the aspects related to magnetic resonance imaging considerations, comparable devices, as well as personalized and in vitro diagnostic devices.
The document is intended to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered by medical device manufacturers and other parties involved to ensure compliance thereto. At the same time, provisions of the guidance are non-binding, nor are intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes to the guidance and recommendations provided therein, should it be reasonably necessary to reflect corresponding amendments to the underlying legislation.
Post-Market Surveillance of Joint Prostheses: Key Points
According to the Therapeutic Goods Act 1989, post-market surveillance should be undertaken to ensure continuous compliance of medical devices with the Essential Principles throughout the whole lifecycle of the product, and also to identify the issues subject to additional investigation. In this respect, the authority additionally emphasizes the importance of considering Essential Principles 1, 2, 3, 4, 6, and 14.
The authority further explains that the importance of post-market surveillance is based on the idea that the position concerning the safety and effectiveness of a medical device could change over time, so even if the device has been initially approved for marketing and use in the country, new concerns may arise. Should it be identified that the benefits resulting from the use of the device for its intended purpose no longer outweigh the risks associated thereto, additional actions will be required to ensure the public health protection and safety of patients and users.
AOANJRR Annual Report
According to the guidance, the AOANJRR Annual Report constitutes one of the most important sources of post-market data the authority is going to use in the course of surveillance activities for joint prostheses. The AOANJRR stands for the Australian Orthopedic Association National Joint Replacement Registry, which is an organization funded by the government, its primary activity is the collection of data related to joint replacement and revision procedures carried out in the country. For instance, according to the guidance, the AOANJRR has collected data on 98 to 100% of hip and knee joint replacement procedures performed in Australia since 2003; the information that is collected for the primary joint replacement procedure includes, but is not limited to, de-identified baseline patient demographics, the name and brand of the device implanted, method of prosthesis fixation, surgical technique, the indication for the joint replacement and the date and location of the procedure. The authority also mentions that in case of a revision, a similar set of information is to be collected.
As further explained by the TGA, when collecting and analyzing the data related to joint prostheses replacement and revision procedures, the AOANJRR is using statistical methods to be able to identify an estimate of the revision rate for each specific product. This information makes it possible to compare different products and the way they operate in time. At the moment, the revision rate is used as a key performance and safety indicator for medical devices of this type. To assist all the parties involved, the AOANJRR publishes reports on an annual basis, sharing the information collected. In particular, such reports contain details about revision rates for joint prostheses used, as well as about the reasons for the revision. Apart from this, the said annual reports identify the products as having a “Higher Than Anticipated Revision Rate”.
The information prepared by the AOANJRR is widely used by TGA, the country’s regulating authority, together with the data deriving from other sources – for instance, from post-market surveillance activities undertaken by all the parties involved in operations with medical devices, or literature review. This information and data are used by the authority to monitor the actual safety and performance of the products covered by the scope of the present guidance. It is also important to mention that apart from the information published by the AOANJRR in their Annual Reports, the authority is also entitled to request the organization to provide additional analysis concerning a specific device.
Actions to be Taken
As it was mentioned before, post-market surveillance activities are undertaken to ensure the identification of the safety-related issues associated with joint prostheses promptly, and also to ensure that all the actions reasonably necessary to ensure the public health protection and safety of patients are duly taken when necessary. For instance, in the course of post-market surveillance, it could be identified that additional intervention is required to mitigate the risks associated with a specific device. These additional actions could be initiated by a party responsible for a medical device itself, or by the authority. According to the guidance, such actions include, inter alia, the following ones:
- Cancellation from the ARTG,
- A product recall,
- Product Defect Correction,
- Hazard Alert.
Additional information regarding the above mentioned actions and the way they should be undertaken is provided on separate pages of the official website.
In summary, the present TGA guidance provides an overview of the approach to be applied concerning post-market surveillance activities in the context of joint prostheses. The document describes the main sources of data to be taken into consideration and also outlines the actions to be taken in case safety-related issues are identified.
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