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What should you know about the safety of your PAP machine? Discover the answers to your most frequently asked questions about device safety here.
A. Many of ResMed's products include polycarbonates in which BPA is a raw material. The use of polycarbonates in these products is approved in every country where these products are sold, including Australia and New Zealand.
ResMed has been closely monitoring scientific studies and regulatory assessments around the world concerning BPA safety. BPA is an industrial chemical used to make hard, clear plastic known as polycarbonate. This plastic is used in many consumer products, including reusable water bottles and baby bottles.
Regulators and scientists globally continue to state that BPA does not pose a risk to adults, teenagers and children. In 2010, the European Food Safety Authority and a WHO-expert panel analysed the currently available scientific data. Both authorities concluded that SPA-based materials can safely be used and any public health measures on BPA would be premature.
As a manufacturer of medical devices, ResMed's products are subject to strict regulation. ResMed must satisfy global regulators that every product is safe and effective for its intended use. One of the requirements in this regard is to demonstrate an appropriate level of biocompatibility for every material to which a patient is exposed. All ResMed devices are thoroughly tested to comply with ISO 10993-1, the international standard for the biological evaluation of medical devices. To this end, the biocompatibility of the polycarbonate in question has been tested and confirmed by ResMed.
ResMed remains confident in the safety of its polycarbonate products for their intended use.
Do you have a question about device safety that isn't addressed here? Contact a customer service representitive.
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