The Therapeutic Goods Administration (TGA), the Australian regulating authority responsible for the medical device framework, has published a literature review dedicated to safety and performance issues associated with medical software. In particular, the document covers important aspects related to the actual and potential harm medical software could cause to patients when being used for its intended purpose. 


Australian Medical Software Regulatory Background

The agency states that various software products and mobile applications are being widely used nowadays, providing customers and patients with easier access to medical information and services. For instance, such software-based tools are widely used for self-diagnosing. However, the TGA emphasizes that it is quite difficult for patients using the software to assess its quality, safety, and also the reliability of the information it provides. Software that is intended for medical purposes is also growing increasingly complex. For example, more and more software products are based on artificial intelligence used to process medical data. 

The outbreak of the Coronavirus Disease 2019 (COVID-19) caused by the virus “SARS-CoV-2” or the “novel coronavirus” has also played an important role – the increasing need in remote solution creating the possibility of providing healthcare services without face to face contact resulted in significant efforts made by the medical device manufacturers (developers) creating new software intended for remote consultations in order to ensure the safety of healthcare professionals and patients.  These conditions have also confirmed that any and all apps and software products designed and intended to be used for medical purposes should meet applicable safety and performance requirements since their impact on the public health protection could be significant. 

In order to accumulate, analyze, and summarize scientific information related to the safety aspects of medical software, the TGA searched for all available publications dedicated to the aforementioned matters. The scope of the research conducted by the authority covered both special medical software intended to operate medical equipment and mobile apps that become more and more popular nowadays. The TGA has rigorously analyzed publications related to the Software as a Medical Device (SaMD), the software controlling medical devices, and medical software.

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Annual Charges for Prostheses List Devices

The TGA acknowledges certain difficulties faced by the healthcare industry due to the outbreak of the Coronavirus Disease 2019 (COVID-19) caused by the virus “SARS-CoV-2” or the “novel coronavirus”. In order to assist industry representatives, the Australian Government announced that annual charges apply for certain types of medical devices would be reduced. In particular, a 50 percent reduction would be applied to medical devices listed on the prostheses list, providing that such devices are included in the Australian Register of Therapeutic Goods (ARTG) – the national register of medicines and medical devices. 

According to the information published by the TGA, the following fees should be applied:

  • for Active Implantable Medical Devices (AIMD) – USD 600;
  • for Class IIa medical devices – USD 470;
  • for Class IIb medical devices – USD 470;
  • for Class III medical devices – USD 600.  

At the same time, for other types of medical devices, the annual fees remain unchanged, namely:

  • for non-sterile Class I medical devices without a measuring function – USD 90;
  • for sterile Class I medical devices, or ones having a measuring function – USD 630;
  • for Class IV in-house in vitro diagnostic medical devices – n/a. 
  • for all other in vitro diagnostic medical devices – USD 680.   

When considering the eligibility of the particular device to the aforementioned annual charge reduction, the authority will consider the Prostheses List (PL) dated April 8, 2020. In particular, the ARTG inclusion number would be used to identify the eligible devices. The TGA also recommends all interested parties to check whether the ARTG inclusion number is correct and inform the agency accordingly if any correction needed. 

The annual charge reduction should be also applied for the whole ARTG entry that includes several medical devices providing that at least one of such devices is included in the Prosthesis List. 

All parties involved will receive new invoices in August, and such invoices would already include the amended annual charges. However, it is important to mention that the reduced annual charges are applicable only for the 2020-21 financial year. 

According to the appropriate TGA guidelines, no actions need to be performed by any party intending to apply for charge reduction since it would be implemented automatically by the authority in the way and under the conditions described hereabove. This depends on the ARTG inclusion code assigned to the particular medical device in question.

Medical Software Recalls in Australia

The authority started its research with the information regarding recalls – special actions to be taken by the medical device manufacturer, its authorized representative, or any other party responsible for a medical device if it creates hazards to the patients’ health when being used for the intended purpose. As a result, the TGA identified that malfunctions and incorrect operations of the software quite often create grounds for initiating a recall. In particular, the agency states that more than 20% of medical devices have been recalled due to software-related issues. Sometimes the medical devices subject to recall due to the software defects are intended to be used in high-risk circumstances when correct operations of the medical device and its software are vitally important to ensure the safety of the patient. The authority also provides several examples of the most common issues related to medical software, such as:

  • Electrocardiographs: either loss of data or improper signal analysis, incorrect patient assignment affecting the clinical assessment of ECG arrhythmias;
  • Implanted cardiac device: loss of diagnostic information, unable to communicate remotely leading to battery depletion;
  • Patient monitoring: Loss of data, incorrect display, inaccurate blood pressure readings, SpO2 values freezing, fail alarms not activated, inability to measure high pulse rates, cybersecurity vulnerabilities;
  • Incorrect drug dosage calculations: inaccurate patient height and weight calculations in the bedside monitor. 

The TGA also states that in most cases it is quite difficult to evaluate properly the actual impact of the software defects since the information accompanying the recall in most of the cases is quite brief and does not cover all aspects. Another important point is that in some cases the identification of the actual reasons for failure is incorrect since the defects of the software result in failures of other components of the medical device making it difficult to identify the issue. Due to the complexity of the software products, their patients (end-users) have no special skills and knowledge to provide a correct notification about the issue. 

The scope of the analysis performed by the TGA covers many countries, including the US. In particular, the TGA report contains the following details:

  • In 2019, there were 140 recalls caused by user interface errors,
  • Earlier in 2017, up to 627 software-related medical devices (1,4 million units) were recalled. A significant number of medical devices subject to recalls is associated with the high risk to the patient’s health due to the nature of the device, its intended purpose, and functions. 

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

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