PAP device safety FAQs

What should you know about the safety of your PAP machine? Discover the answers to your most frequently asked questions about device safety here.

Q. Is bisphenol A used in the manufacture of ResMed devices and other equipment? Is it safe?

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 the United States, Canada and the European Union.

ResMed has been very closely monitoring scientific studies and regulatory assessments around the world concerning the safety of bisphenol A (BPA). 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.

Recently, some countries have introduced new legislation affecting the use of BPA in baby bottles. In March 2010, Health Canada introduced a ban on polycarbonate baby bottles, and this has been followed by the European Commission which will no longer permit sale of SPA-based polycarbonate baby bottles from 1st June 2011. These decisions are not a consequence of any proven adverse effects from BPA, but rather a highly precautionary approach.

Regulators and scientists globally continue to state that BPA does not pose a risk to adults, teenagers and children. The Canadian Minister for Health stated that consumers can continue to use polycarbonate products as the level of exposure from these products is very low. In 2010, the European Food Safety Authority (EFSA) 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. The US Food and Drug Administration (FDA) maintain their position on BPA that there is no evidence of harm to children or adults from the current levels of SPA-exposure.

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 ResMed customer support at 1 (800) 424-0737, or click here to submit an online inquiry.

 

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