Post-market review of ventilator, CPAP and BiPAP devices

This post-market review covers all devices in the Australian Register of Therapeutic Goods (ARTG) of the following kinds:

• continuous and non-continuous ventilators;
• acute care ventilators;
• ambulatory ventilators;
• CPAP devices; and
• BiPAP devices.

This post-market review has been initiated following 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 purpose of this post-market review is:

• to ensure that ventilator, CPAP and BiPAP devices included in the ARTG continue to meet the Essential Principles set out in the Therapeutic Goods (Medical Devices) Regulations 2002; and
• to confirm that these devices have been designed and produced with safe soundproofing materials and remain safe for use over service life.

As part of the review, we requested all sponsors of ventilator, CPAP, and BiPAP devices included in the ARTG to provide information about their product, including but not limited to:

• the type of soundproofing material used;
• the manufacturer’s risk assessment and risk mitigation strategies; whether the devices pose any unnecessary risk to the health of the user during normal use; and
• evidence supporting the long-term safety of their device.

All regulatory actions taken during the review are made based on the merit of each individual device, taking into account the evidence submitted by the sponsors.

The post-market review is nearly complete. We have reviewed the information provided by the sponsors. For devices containing foam, we have reviewed the specific material grade used and assessed the risk of material degradation and long-term safety for each individual device. 

The review of devices containing PE-PUR foam in the breathing gas pathway, is now complete. A small number of devices that use other types of foam (not PE-PUR foam) in the breathing gas pathway remain under review. These reviews are expected to be finalised in the coming months. 

The following pages include information relating to each device, including current regulatory actions and status of the review.

• List of ventilator, CPAP and BiPAP devices unaffected by foam material
• List of ventilator, CPAP and BiPAP devices containing PE-PUR foam in the breathing gas pathway¹
• List of ventilator, CPAP and BiPAP devices containing other kinds of foam material (not PE-PUR foam) in the breathing gas pathway

¹This page contains the list of other devices from sponsors (i.e. not supplied by Philips Electronics Australia Ltd) which contain any type of PE-PUR foam in the breathing gas pathway irrespective of material

Regulatory actions on other devices that contain PE-PUR foam material in the breathing gas pathway

We worked with all sponsors of ventilator, CPAP and BiPAP devices that contain PE-PUR foam material in the breathing gas pathway to ensure that all sponsors have sufficient evidence to support the long-term safety of their devices. 

The review of the information submitted by the sponsors has been completed, and final decisions have been made for each device, including cancelling the ARTG entries and various market actions. 

The following page outlines the final outcomes for the list of other devices (i.e. not supplied by Philips Electronics Australia Ltd) that contain any type of PE-PUR foam in the breathing gas pathway.

• List of ventilator, CPAP, and BiPAP devices containing PE-PUR foam material in the breathing gas pathway.

Regulatory actions on devices that contain other kinds of foam material (not PE-PUR foam) in the breathing gas pathway

We continue to review information of ventilator, CPAP and BiPAP devices that contain other kinds of foam material (not PE-PUR foam) in the breathing gas pathway. 

When insufficient information was available, additional conditions of inclusion (COI) were imposed on the ARTG entries. This ensures that all sponsors provide sufficient evidence to support the long-term safety of their devices. 

All COI that are currently imposed on any device can be viewed on the ARTG certificate for the device.

The following page outlines the current review status for the list of other devices that contain different foam (not PE-PUR) in the breathing gas pathway. The table will be updated as the post-market review progresses and is finalised.

• List of ventilator, CPAP and BiPAP devices containing other foam material (not PE-PUR foam) in the breathing gas pathway.

Regulatory actions against Philips Electronics Australia Limited

Court proceedings initiated against Philips Electronics Australia Limited

We have commenced proceedings in the Federal Court of Australia against Philips Electronics Australia Limited for the alleged unlawful supply of medical devices that did not meet Australian safety and performance requirements.

Infringement notices issued to Philips

We issued ten infringement notices to Philips Electronics Australia Ltd for failing to provide information about the deterioration in the performance of certain Philips’ ventilator, CPAP, and BiPAP devices within the legislative timeframe. The infringement notices have been issued for products included in Philips global recall.

Conditions of inclusion imposed on Philips' devices affected by the recall

We imposed COI on the ARTG entries for the devices affected by the recall to ensure that the recall and remediation program was completed on time.

Philips Electronics Australia Ltd have fulfilled the COI imposed on the devices affected by the recall and have provided information to us in relation to their corrected devices. With corrections completed for these devices, we have removed the imposed COI. 

All COI that are currently imposed on any device can be viewed on the ARTG certificate for the device.

We established a time-limited Ventilator Expert Working Group (VEWG) in September 2018 to provide expertise in a product safety review of intensive care ventilators. 

The VEWG is made up of clinicians, scientists, and biomedical engineers from state and territory health departments.

Subsequent to the recall action by Philips for their CPAP, BiPAP devices and mechanical ventilators, the VEWG was reconvened to consider information from, and actions by Philips. The VEWG also considered information about other devices included in this post-market review.

For all the meetings that were held between 23 July 2021 to 21 April 2023, visit Ventilator Expert Working Group for the meeting outcomes. The VEWG concluded following the last meeting in April 2023.

Consumers should consult their treating health practitioner if they have any concerns regarding the safety or performance of their ventilator, CPAP, or BiPAP device.

See Philips recall action for CPAP, Bi-Level PAP devices and mechanical ventilators collection.

Patient safety is a priority for the TGA. Patients are encouraged to report all adverse events to us.

Consumers and health professionals are encouraged to Report an adverse event or safety problem. 

Your report will contribute to our monitoring of these products. For more information see the Medical device Incident Reporting and Investigation Scheme (IRIS).

We 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.