The Australian Therapeutic Goods Administration (ARTG) and the TGA, an authority responsible for medical device regulations, has updated its guidance on thermometers and other temperature measuring medical devices and products used in the context of Coronavirus Disease 2019 (COVID-19) caused by the virus “SARS-CoV-2” or the “novel coronavirus.” In particular, the document has been supplemented with the recommendations regarding thermal imaging systems and products.
TGA: Regulatory Background
Temperature measuring devices are widely used during the pandemic. Some of them are medical devices and thus should be included into the Australian Register of Therapeutic Goods (ARTG), while others are not medical devices in spite of being used for similar purposes (such devices/products are not being used for temperature measurements, but for screening in public places, providing that such screening does not impose strict requirements regarding the accuracy of the results).
The scope of the present TGA guidance covers the following aspects related to thermometers and other temperature measuring products:
- The determination of whether the particular product is a medical device or not,
- Details regarding the requirements thermometers and other temperature measuring products shall meet,
- Process of applying for inclusion of temperature measuring devices in the ARTG.
Thermometers as Medical Devices
It is important to determine whether the particular temperature measuring product in question is a medical device or not since the regulations and requirements to be applied would depend on such determination.
According to the TGA guidance, any temperature measuring product for use on humans for the intended purpose of screening potentially febrile individuals during a pandemic meets the legal definition of a medical device. Thus, such a product should be included in the ARTG and regulated under the Australian laws on medical devices, namely:
- The Therapeutic Goods Act 1989,
- The Therapeutic Goods (Medical Devices) Regulations 2002, and
- The Therapeutic Goods Regulations 1990.
The TGA states that temperature measuring devices based on infrared radiation measurements that are used for screening in public places are Class IIa medical devices and thus should be treated accordingly. In particular, such devices should be included in ARTG before using and distributing them in Australia.
When making a determination regarding the nature of the device and the regulatory approach to be applied, the authority will consider the following criteria based on the labeling and promotion of the device for use:
- by a healthcare professional,
- in a healthcare facility,
- for the purposes matching the purposes applicable for medical devices.
Australian Regulations on Thermal Imaging Products
The TGA guidance on thermometers also contains recommendations regarding thermal imaging products that are often used in the context of the COVID-19 outbreak. According to the document, if such products are intended by the manufacturer to be used for medical purposes, they should be regulated as medical devices, otherwise, they should not be marketed as products intended for screening purposes. Any attempts to market the products that are not medical devices claiming the possibility to use them for medical purposes are restricted and punished under the applicable legislation. For instance, thermal imaging systems initially intended for security and other purposes could not be advertised as suitable for medical purposes in general and body temperature measuring in particular.
Advertising medical devices for any purposes falling outside of the scope outlined by the manufacturer is also strictly prohibited.
The TGA states that it is entitled to take compliance-related actions against entities violating advertising requirements in the sphere of medical devices. Such actions could include direction notices and infringement notices. In case of severe violations, a court action could be initiated, resulting in significant financial penalties.
Australian Classification of Temperature Measuring Medical Devices
In accordance with the TGA guidance, the initial classification of a temperature measuring device should be made by its manufacturer. In particular, the manufacturer shall use a special classification tool designed by the authority in order to assist in making proper classification in accordance with the Australian risk-based classification of medical devices. The class of the device should be based on its features, including design, duration of use, and intended purpose. The document provides a list of the most important criteria to be considered, namely:
- Not battery-powered thermometers are Class I (measuring) medical devices,
- Battery-powered digital thermometers are Class IIa medical devices,
- Screening devices used in public places are Class IIa medical devices.
The authority also mentions that in the case of incorrect classification, the application will be rejected on the stage of the preliminary assessment.
All medical devices, irrespective of the class, should be subject to a conformity assessment performed to ensure compliance with the Essential Principles that cover the most important aspects related to the design and construction of medical devices in accordance with the safety and performance requirements.
Thus, all medical device manufacturers intended to market their products in Australia should provide:
- confirmation of conformity assessment procedures, and
- documentation demonstrating compliance with the Essential Principles.
According to the recommendations issued by the TGA, the medical device manufacturer could demonstrate compliance with the essential requirements by making references to the applicable standards. However, such references to the standards are not mandatory for medical device manufacturers.
The authority also mentions that in the case of battery-powered thermometers the appropriate measures should be taken by the manufacturer to prevent children from accessing the battery compartment.
Regulatory Approach to Medical Software Safety in Australia
According to the findings made by the TGA, some of the mobile apps used for medical purposes could expose patients to unnecessary risks or even be dangerous when used as intended by the software developer. It is stated that such situations appear due to the fact that many medical app developers have no proper professional background in the sphere of medical devices, while they also do not involve healthcare professionals in the course of the app development process, which creates additional risks for patients. Another reason for concern relates to the low accuracy of the mobile sensors used by medical apps intended for diagnostic purposes. This results in an incorrect interpretation of the information and creates significant risks for patients using such information to make clinical decisions. According to the study, a huge part of mobile apps intended to be used for medical purposes provide inaccurate or inappropriate information – for example, faulty alarms.
The TGA also states that medical software is rarely becoming an object of the clinical validation performed to evaluate and confirm its safety and effectiveness. According to the position expressed in the document, any medical software should be subject to clinical validation carried out in accordance with the common rules and requirements applicable for such type of assessment. The authority found that most of the information related to medical software is descriptive, while only a few studies are based on clinical data collected in the course of clinical trials. The general trends show that most of the software products intended for medical purposes and medical apps have not passed proper evaluation and assessment which is necessary to collect reliable information about their performance and safety when being used as intended by the medical device manufacturer (developer), that results in low overall quality of such products and significant risks associated with their use. In most cases, the only information available is represented by consumer ratings, which are quite a doubtful source of information.
Other important aspects covered by the literature review performed by the TGA include, inter alia, ones related to the types of errors taking place. In particular, the authority outlines the following types:
- functional errors (incorrect performance of the software itself),
- resilience and reliability errors (failures occurring during the operations),
- data errors (incorrect operations with the data).
Summarizing the information provided hereinabove, the TGA review of the literature provides a detailed and exhaustive overview of existing information related to the main safety and performance issues associated with the medical software and mobile apps with the intended medical purpose
Supplying Thermometers and Thermal Imaging Devices to Australia
The TGA guidance on thermometers and temperature measuring medical devices also contains a detailed description of a way such devices should be placed on the Australian market.
According to the document, if the product in question meets the definition of a medical device, it should be included in ARTG in order to be allowed for marketing and use in Australia. The recommendations provided in the guidance are intended to assist medical device manufacturers and other parties intended to market medical devices (collectively – the sponsors) in taking all the steps required to distribute thermometers and other temperature measuring devices in Australia. First of all, a sponsor (medical device manufacturer itself or its authorized representative – in the case of foreign manufacturers) should be a company incorporated in Australia.
The process described in the TGA guidance includes the following consecutive steps:
- Submission of a form containing information about the applicant. As a result, the sponsor will receive login credentials (username and password) to be used to access an online portal for application submissions.
- Preparing the documents and materials including ones related to conformity assessment procedure, compliance with the Essential Principles, post-market monitoring system, and also the audit carried out by the authorized body. In particular, the applicant shall have all evidence necessary to demonstrate compliance with the applicable requirements.
- Filing a Manufacturer’s Evidence application using the special online portal operated by the TGA. This application could be submitted free of charge.
- Upon submission of the initial application regarding the manufacturer itself, the applicant should submit an application for the inclusion of the device in question in the national register – ARTG.
- Paying under the invoice received from the TGA for the registration services. According to the guidance, the application fee for Class I medical devices with measuring function and Class IIa medical devices constitutes USD 1040. It is important to mention that the authority will commence the review of the application only when the fee payment will be duly received.
Summarizing the information provided hereinabove, the TGA guidance on thermometers and other thermal measuring medical devices provides manufacturers, their authorized representatives, and other parties involved in operations with the aforementioned devices with the important recommendations to be considered when placing such devices on the Australian market.
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