Post-market review of ventilators, CPAP and BiPAP devices

The Therapeutic Goods Administration (TGA) is undertaking 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 included in the ARTG provide information to the TGA 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.

Post-market review: Outcomes and actions

The TGA will provide updates and outcomes of the review as they become available. The information about each model will be published on the following pages as reviews are completed. If the model you are interested in is not included in this list , it is still in the process of being reviewed. The table will be updated regularly as the post-market review progresses.

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

Regulatory actions

Infringement notices issued to Philips

The TGA has issued ten infringement notices to Philips Electronics Australia Ltd for failing to provide information about the deterioration in the performance of certain Philips’ ventilators, 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 recall

The TGA has imposed Conditions of Inclusion (COI) on the ARTG entries for the devices affected by this recall. The conditions imposed are regarding the completion dates for the correction of these devices. These conditions will ensure that the recall and remediation program is completed on time. The COI are published on the ARTG certificates.

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

The TGA is working with all sponsors of ventilator and sleep apnoea devices that contain PE-PUR foam material in the breathing gas pathway. The TGA is committed to ensuring that all sponsors have sufficient evidence to support the long-term safety of their devices. Sponsors of these devices have submitted information to the TGA, which is currently under review.

You can find the list of other devices that contain PE-PUR foam in the breathing gas pathway and the current updates on the following page. The table will be updated regularly as the post-market review progresses and is finalised.

• List of Ventilators, 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

The TGA is currently reviewing information from all sponsors of ventilator and sleep apnoea devices that contain other kinds of foam material (not PE-PUR foam) in the breathing gas pathway. This is to ensure that all sponsors have sufficient evidence to support the long-term safety of their devices.

You can find the list of other devices that contain different foam in the breathing gas pathway and the current updates on the following page. The table will be updated regularly 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.

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

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

For meeting updates visit Ventilator Expert Working Group.

Information for consumers and healthcare professionals

People with Philips ventilator, CPAP or BiPAP devices should consult the TGA's Philips recall webpage and register their device on the Philips webpage.

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

Reporting problems

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

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.