The new article describes in detail the aspects related to the clinical evidence required for meshes, patches, and tissue adhesives.
The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to clinical evidence for medical devices. The document describes the regulatory requirements to be applied based on the type of medical devices and risks associated thereto, provides additional clarifications to be considered in this respect, as well as recommendations to be followed by medical device manufacturers and other parties involved to ensure compliance with the said requirements. At the same time, provisions of the guidance are non-binding, nor are intended to introduce new rules or impose new obligations. Furthermore, they could be subject to changes, should such changes be reasonably necessary to reflect corresponding amendments to the underlying regulations.
The scope of the guidance covers, inter alia, the aspects related to supportive devices, such as meshes, patches, and tissue adhesives. This category covers a wide range of medical devices intended to hold, fix or sustain a patient’s body organs or incisions. The authority acknowledges that for products of this type various materials could be used, including those of both biological and non-biologic origin. These products could also be intended for permanent use, or be absorbable. Thus, the risk profile of each product should be rigorously assessed by the manufacturer on a case-by-case basis.
Key Recommendations: Overview
First of all, the document provides a summary of recommendations to be considered. These recommendations include, inter alia, the following ones:
- Manufacturers are advised that pre-clinical data demonstrating that the mechanical, biocompatibility and physical characteristics of the device are congruent with the intended purpose and anticipated in vivo lifespan of the surgical support.
- Concerning the clinical data used to support the claims made by the manufacturer, the following should be considered:
- The trials intended to collect additional clinical data should be designed considering the highest practical NHMRC Level of Evidence, as well as the aspects related to the safety and effectiveness of the product in question;
- In the case of permanent and biological meshes, the follow-up period should constitute at least 24 months;
- As for other types of medical devices, the information about the literature review should contain a detailed enough description of the method applied, allowing the research to be reproduced.
- The use of clinical data related to similar (comparable) medical devices is allowed, however, it should be accompanied by the appropriate justification of comparability.
- A well-documented risk analysis and management system should also be provided with the CER.
- When submitting clinical data, a responsible party should provide additional details regarding the way such data has been collected to make it possible to verify its accuracy and reliability.
- When compiling the clinical evidence, it is important to ensure the clinical data collected is reviewed and verified by an expert in the relevant field having the necessary experience.
Terms and Definitions
The document further provides definitions of the most important terms and concepts used in the context of the guidance including, inter alia, the following ones:
- Surgical mesh – a textile-based sheet (typically knotted or warp knitted) used as a temporary or permanent support for organs or other tissues. As further explained by the TGA, it could be made using materials of biological or synthetic origin, or a combination of both, and is intended to be used for various purposes. The guidance also mentions the main types of mesh. It is also stated that various methods could be used for mesh fixation in the course of its use for the intended purpose.
- Patches are impermeable adhesive membranes used in intradural neurosurgical procedures, as an alternative to using autologous grafts or cadaveric implants.
- Tissue Adhesives are an alternative to sutures and staples used for the closure of wounds and fixation of devices such as surgical mesh, patches, and scaffolding to tissues. The authority additionally mentions that this category covers all substances with a polymerization feature.
According to the guidance, the devices covered by its scope could also contain biocompatible coated materials (e.g., silver coating).
Clinical Evidence and Clinical Investigations
The guidance provides detailed clarifications regarding the scope of clinical evidence to be provided concerning supportive devices and also describes the way the evidence should be provided.
According to the guidance, the clinical evidence can be derived from clinical investigation(s) data, a comprehensive literature review, and/or post-market data (clinical experience) on the device (direct) and/or the comparable device (indirect). The authority additionally emphasizes that among other options, direct clinical evidence collected for a specific medical device will be preferable. Furthermore, it is also stated that in case of any changes to a medical device in question.
Concerning the clinical investigation(s), the study design should correspond to the key measures of safety and effectiveness. It is stated that the preferred design is a randomized controlled clinical trial and conditions should ideally represent clinical practice in Australia. A party responsible for a clinical trial should develop detailed criteria for the inclusion/exclusion of study participants. The aspects to be considered should include the design of the device in question, as well as the risks associated thereto. Apart from this, a study report should contain a comprehensive description of the device, sufficient for its identification.
In summary, the present TGA guidance provides an overview of the regulatory requirements for supportive devices and highlights the key aspects to be considered in this respect. The document also outlines the recommendations to be followed when developing a clinical study design to ensure the accuracy and reliability of the clinical data collected.
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