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Post-market review of ventilators, CPAP and BiPAP devices
The Therapeutic Goods Administration (TGA) has commenced a post-market review of all devices in the Australian Register of Therapeutic Goods (ARTG) of the following kinds:
- continuous and non-continuous ventilators;
- acute care ventilators;
- ambulatory ventilators including continuous positive airway pressure (CPAP) devices; and
- bi-level positive airway pressure (BiPAP) devices.
This post-market review follows the identification of risks posed by a polyester-based polyurethane (PE-PUR) foam used as soundproofing material in ventilator, CPAP and BiPAP devices supplied by Philips Electronics Australia Ltd. The review has two purposes:
- to ensure devices included in the ARTG continue to meet the essential principles set out in the Therapeutic Goods (Medical Devices) Regulations 2002; and to confirm these devices remain safe for use, by checking if they are made using PE-PUR foam or any other potentially harmful soundproofing material.
The TGA has requested sponsors of ventilator, CPAP, and BiPAP devices in the ARTG provide information about their product, including:
- the type of soundproofing material used;
- the manufacturer risk assessment and risk mitigation strategies; and
- whether the devices pose any unnecessary risk to the health of the user during normal use.
Ventilator Expert Working Group
The TGA established a Ventilator Expert Working Group (VEWG) in September 2018 to provide expertise in a product safety review of intensive care ventilators. The working group is made up of clinicians, scientists, and biomedical engineers, including from state and territory health departments.
Subsequent to the recent Philip recall action for CPAP, BiPAP devices and mechanical ventilators , the VEWG has been reconvened to discuss information received from Philips, and to provide input on the appropriateness of the actions taken. The VEWG will also be asked to consider information about other devices included in this post-market review.
27 August 2021: Ventilator Expert Working Group meeting
On 27 August 2021, the Ventilator Expert Working Group (VEWG) met to discuss Philips' remediation plan for affected devices in relation to rectification procedures, clinical prioritisation of patients, and implementation timeframes. The TGA also provided an update on the post-market review of similar devices.
In consideration of the discussions with VEWG, the TGA continues to work with Philips to expedite the repair and replacement of these impacted devices, and enhance communication with affected consumers.
23 July 2021: Ventilator Expert Working Group meeting
A meeting of the Ventilator Expert Working Group (VEWG) was held on 23 July 2021 to discuss the global recall of the Philips CPAP and BiPAP machines, potential safety risks and mitigation strategies, support to users of the machines and the post-market review of similar devices.
The VEWG provided feedback on a range of matters, including the communication and messaging about the Philips' recall, and the role of the Australian Competition and Consumer Commission (ACCC). There was strong feedback about the TGA continuing to work with stakeholders, including consumer representatives, to ensure consistent and clear messaging on the Philips recall.
Information for consumers and healthcare professionals
Currently, there have not been any safety issues identified for ventilator, CPAP or BiPAP devices made by brands other than Philips. People with non-Philips devices of these kinds do not need to do anything; they can continue using their device and should not stop or alter their prescribed therapy.
Consumers should consult their treating health practitioner if they have any concerns regarding the safety or performance of their ventilator, CPAP, or BiPAP device.
The TGA will publish further information if we become aware of health risks relating to other brands and/or models.
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.