The new article provides an overview of the Essential Principles for specific types of medical devices, such as active medical devices, the ones with measuring functions, as well as software-based products.
The Health Sciences Authority (HSA), a country’s regulatory agency, has published a guidance document dedicated to the Essential Principles for the safety and effectiveness of medical devices. The document describes in detail the principles to be followed by medical device manufacturers to ensure the proper performance of the products they are responsible for, and also the public health protection. The guidance provides clarifications regarding the device-specific principles and explains the way they should be applied.
Active Medical Devices
The scope of the guidance covers, inter alia, the principles to be applied concerning active medical devices connected to or equipped with an energy source. According to the document, such a device should have the function of ensuring continuous monitoring of the power supply. The device should also provide a warning in case of any issues related to the power supply that could impact the operations of the device. Apart from that, the device should also have an alarm notifying about the power failure. The authority additionally emphasizes that medical devices intend to monitor one or more clinical parameters of a patient should be equipped with appropriate alarm systems to alert the user of situations that could lead to severe deterioration of the patient’s state of health. The principles of reducing the risks associated with the potential electromagnetic interference should be followed by the medical device manufacturer starting from the early design and development stage. Moreover, the device should employ the solutions necessary to ensure the proper level of intrinsic immunity to electromagnetic performance.
Medical Devices Incorporating Software
The scope of the guidance also covers medical devices that incorporate software, as well as standalone software or mobile applications. According to the guidance, such products should be developed in a way ensuring their proper performance and the safety of patients using them. All the failure cases should be properly investigated by the manufacturer to ensure that all the necessary measures are taken to prevent the occurrence of such failures in the future. The software products used for medical purposes should incorporate state-of-the-art solutions. The authority also mentions that software that is intended to be used in combination with generic computing platforms should be designed and developed taking into account the platform itself (e.g., size and contrast ratio of the screen, connectivity, memory, etc.) and the external factors related to their use (varying environment as regards the level of light or noise). The party responsible for the product should develop a set of minimum requirements describing the elements necessary to operate the software, including the hardware and IT infrastructure.
Medical Devices With Diagnostic or Measuring Functions
The authority further describes the approach to be applied concerning medical devices with a diagnostic or measuring function. In the case of such devices, it is vitally important to ensure the accuracy of the information the device provides, as such information could be used in the clinical decision-making process and, consequently, impact the treatment options applied. Thus, a party responsible for the device should ensure its proper operations in terms of accuracy, precision, and stability. The HSA additionally emphasizes the following aspects:
- The manufacturer should outline the limits of accuracy for its product;
- The values should use commonly accepted units to ensure their proper interpretation;
- The information regarding the intended use of the device should be provided clearly and understandably.
Labeling and Instructions for Use
The scope of Essential Principles also covers the aspects related to the way the information related to the device should be communicated by the manufacturer to its potential users. The document outlines the key principles to be followed and also refers to the appropriate guidance issued by the HSA.
First of all, the product should be supplied together with the information necessary to identify the device itself, and also the entity responsible for it. Furthermore, it is necessary to provide information the user will need to be able to operate the device safely and efficiently when using it for its intended purpose. As further explained by the HSA, such information may appear on the medical device itself, on the packaging, or in the instructions for use, and should be easily understood. The particular way the information is provided should be chosen by the manufacturer depending on the specific features of the device itself, the way it is intended to be used, and also on the scope of information to be provided. Should the instructions be insufficient to ensure all the information necessary is communicated to end-users, the appropriate training should be carried out. When deciding on the way to provide information, the manufacturer should take into consideration the end-users and their level of qualification and knowledge – the information addressed to laypersons should be provided differently in comparison to the similar information addressed to healthcare professionals.
Another specific aspect addressed by the Essential Principles relates to the protection against electrical, mechanical, and thermal risks. According to the document, all the products should be designed in a way reducing the aforementioned risks, and potential consequences of the incidents associated thereto. The software-related products should have efficient cybersecurity measures ensuring a sufficient level of protection against unauthorized access. Under the general rule, all the identified risks should be duly assessed and evaluated by the manufacturer, resulting in the appropriate risk mitigation measures applies. Depending on the technical feasibility, the risks should be eliminated or reduced to an acceptable level, while such a level should be duly justified by the manufacturer concerning the intended use of the device. Such an approach should be applied to all the types of risks associated with the device in question.
In summary, the present HSA guidance describes in detail some of the device-specific Essential Principles for the safety and performance of medical devices and also highlights the key points to be considered about the risk mitigation approach. The authority outlines the main considerations for various types of medical devices and provides recommendations to be followed by medical device manufacturers to ensure compliance with the applicable regulatory requirements.
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