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ISO 18562 White paper

A number of recent high-profile cases concerning the recall of medical devices by the US FDA have highlighted the importance of the evaluation of the biocompatibility of breathing gas pathways in devices such as ventilators, breathing systems, nebulizers and respiratory monitors.

In 2022 the recall of more than 5 million sleep apnoea devices and ventilators is estimated to have cost medical device company Philips at least $1.3 billion. The FDA has received over 105 000 medical device reports linked to potential issues concerning the breakdown of a polymer foam contained within the Philips machines since April 2021. The recall was initiated following concerns that the breakdown products from the foam, which is used to soundproof the devices, may potentially be inhaled by the patient users.

The potential impact on patients of toxic compounds and / or particulate matter deriving from the various components within these types of devices makes the thorough evaluation of biocompatibility a vital stage in the product development process.

The BS ISO 18562 standard, which was first published in 2017, provides a framework to assess the risks associated with the breathing gas pathway in products used for healthcare applications.

As a critical part of the medical device development process the standard provides an outline of methodologies and associated acceptance criteria for the biological evaluation of gas pathways of medical devices through the implementation of a defined risk management process.

ISO 18562 is focussed on the identification of any potential contamination of the gas stream deriving from a medical device which may ultimately impact on patient safety. The assessment process includes an evaluation of any existing data, the identification of gaps and confirms any requirement for additional data and testing.

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