The new article provides additional details regarding the specific essential principles to be taken into consideration, including the ones related to compatibility and use environment.
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The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the Essential Principles for Safety and Performance of medical devices. The document provides additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered to ensure compliance thereto. At the same time, the guidance is non-binding in its legal nature and is not intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes to the guidance, should it be reasonably necessary to reflect the respective changes to the underlying legislation.
The annex to the guidance describes in detail the most important essential principles and clarifies the way they should be followed.
Chemical, Physical and Biological Properties
According to the Essential Principles, when developing and manufacturing medical devices, the manufacturers should take into consideration such aspects as:
- The nature and specific features of the materials used;
- The way the manufacturing process could impact the properties of the materials;
- The results of biophysical or modeling research;
- Compatibility-related matters, including the ones related to compatibility between the materials, used to manufacture the products;
- The main characteristics the materials should have due to the nature of the device, its intended use, and the principal mode of action;
- Properties of the surface; and
- Compliance with the respective chemical and/or physical specifications.
The authority further states that the manufacturer should take all the steps to ensure the risks associated with contamination are reduced to the lowest extent possible. In this respect, the manufacturer should pay special attention to issues that could be potentially exposed to contaminants.
Apart from this, the manufacturer should also duly consider and mitigate the risks associated with substances leaking from the device.
Sterility, Packaging, and Microbial Contamination
The scope of the guidance also covers the aspects related to ensuring sterility of the devices that are initially intended to be supplied sterile to reduce the risks associated with infections. According to the guidance, the design should:
- Allow easy and safe handling;
- Reduce as far as reasonably practicable and appropriate any microbial leakage from the medical device and/or microbial exposure during use;
- Prevent microbial contamination of the medical device, or it is content (e.g. specimens); and
- Reduce as low as reasonably practicable and appropriate the risks from unintended exposure.
A special approach should be also applied to medical devices that are labeled as having a special microbiological state – such products should be supplied in the respective condition.
Medical devices intended to be supplied sterile should be manufactured and packaged in a way ensuring they remain sterile within the whole period of shelf life or after transportation performed by the instructions communicated by the manufacturer. Furthermore, all operations with such devices should be carried out by the respective procedures and methods. Should the device be intended to be sterilized by the user, this should be also considered by the manufacturer when deciding on the design of the device and its packaging – the packaging system of the device should be based on the sterilization method used. At the same time, it is important to mention that even in case the device in question is not intended to be supplied sterile, the manufacturer is responsible for ensuring the appropriate level of cleanliness to mitigate the risks associated with potential contamination. In case there are two similar products placed on the market, one of which is supplied sterile, and another one – non-sterile, the appropriate details should be duly reflected in its labeling and packaging to avoid confusion. It is also stated that medical devices meant by the product owner to be reusable, must be designed and manufactured in a way to facilitate appropriate processes to allow reuse, including cleaning, disinfection, packaging, and where appropriate, the method of re-sterilization. The manufacturer should also supply the device together with the instructions prescribing the way to identify the situations when the device should no longer be reused.
Environment and Conditions of Use
As further explained by the HSA, the manufacturer should also take into consideration the specific features in which the device is intended to be used, as well as the use conditions, to ensure the safety and effectiveness of the product. These aspects should be considered to reduce to the lowest extent possible the risks associated with the design of the device, its functions, and features, external influence the device could be subject to when used for its intended purpose and in the intended use environment, as well as the risks associated with the materials and interferences with other medical devices that are usually used in the same environment. As the general rule, medical devices should be also designed in a way reducing the risks associated with the negative interaction between the software operating the device and the IT environment.
The Essential Principles also address the aspects related to the adjustment and calibration the device should undergo to ensure it operates as initially intended. Specifically:
- When maintenance is not possible, the risks from aging of materials used, will be eliminated or reduced, as low as reasonably practicable and appropriate;
- When adjustment and calibration are not possible, the risks from the loss of accuracy of any measuring or control mechanism will be eliminated or reduced, as low as reasonably practicable and appropriate.
In case the device is initially intended to be used in combination with another device, such use should be also subject to a rigorous assessment from a risk perspective, while the restrictions and precautions should be duly reflected in the instructions for use and other documentation accompanying the device.
If the device has a scale, it should be designed in a way ensuring its comfortable use in the context of the way the device is expected to be used, including the basic ergonomic principles.
In summary, the present HSA guidance highlights certain important aspects related to the Essential Principles associated with the intended use environment and compatibility-related matters. The document also provides clarifications regarding the approach to be applied concerning medical devices intended to be supplied sterile.
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