Ventilator Expert Working Group

On 21 April 2023, the TGA met with the VEWG and Philips. Philips provided an update on the progress with the recall and remediation strategy. As of 20 April 2023, over 93% of the registered devices in Australia have now been remediated. This includes devices that have been repaired, replaced, and refunded.

Philips advised that all Trilogy 100 remediated devices within Australia will be replaced with Trilogy EVO devices and that the 2-year warranty period would be transferred from the Trilogy 100 devices to Trilogy EVO devices.

The TGA also highlighted two issues that affect the Trilogy EVO devices which have been previously supplied; this issue does not affect the Trilogy EVO devices that have been used to replace the remediated Trilogy 100 devices. The first issue relates to a deviation in accuracy of delivered oxygen (fraction of inspired oxygen – FiO2). The second issue relates to air path contamination. The accumulation of environmental debris on the internal machine flow sensor causes partial occlusion, which may impact the accurate delivery of pressure, volume, or flow.

In response to these issues, Philips has worked with the TGA to release two recall market notifications, these are covered under notices: RC-2023-RN-00209-1 and RC-2023-RN-00318-1 (for more information see System for Australian Recall Actions (SARA).

The TGA continues to work with Philips for timely resolution on different issues. More information will be published on the TGA website as it becomes available.

On 3 February 2023, the TGA met with the VEWG and Philips as part of the TGA’s ongoing effort to support patients and healthcare professionals and to track the progress of Philips’ repair and replacement program. As of 30 January 2023, approximately 92% of devices have been remediated. This includes devices that have been repaired, replaced, and refunded.

The group discussed issues relating to low oxygen with Trilogy 202 devices and foam delamination in the remediated Trilogy 100 devices.

Philips advised that all remediated Trilogy 100 devices would be replaced by Trilogy EVO devices and the provision of clinician education and training sessions for the new devices.

The TGA is working with Philips on further risk mitigation options and on a permanent solution for the problems of foam delamination. Any new updates in relation to this corrective action for Philips recalled devices will be published on the TGA’s website.

On 25 November 2022, the TGA met with the VEWG and Philips as part of the TGA’s ongoing effort to support patients and healthcare professionals and to track the progress of Philips’ repair and replacement program. As of 24 November 2022, 84% of devices have been remediated. This includes devices that have been repaired, replaced, and refunded.

The TGA issued a product defect alert and published information on its website to alert patients and healthcare professionals about the issues affecting the remediated Trilogy 100 devices. These issues relate to the foam blocking the airway and debris in the airways of these devices. The information on the interim options to address the issues is available on the TGA website. The TGA is working with Philips on further risk mitigation options and on a permanent solution for the problems.

Further information on the corrective actions for recalled Philips’ devices will be published on TGA’s website as it becomes available.

At the meeting with VEWG, on 28 October 2022, Philips’ representatives provided an update on the progress of the repair and replacement program, stating that 82% of the registered devices had been remediated. This includes devices that have been repaired, replaced and refunded.

The VEWG members raised concerns about the correction of the Trilogy 100 devices for which remediation has been put on hold by Philips due to a ship hold of the repair kits required to fix these devices.  The TGA is working closely with Philips to obtain the necessary information and intends to publish a product defect alert in the coming week to provide information to states and territories about the issue.  The members also raised concerns about the supply of Dreamstation Go devices. Philips advised that they are awaiting inventory to arrive in Australia to start the remediation process for this device.

Any new updates in relation to this matter will be published on TGA’s website.

On 30 September 2022, the TGA met with the VEWG and Philips as part of the TGA’s ongoing effort to support patients and healthcare professionals and to track the progress of Philips’ repair and replacement program. As of 30 September 2022, 77% of devices have been remediated. This includes devices that have been repaired, replaced and refunded.

On 23 September 2022, Philips rolled out the communication for all CPAP and APAP devise, to all registered patients whose devices have not yet been remediated and where the patient’s script is still pending. This communication provided patients with three (3) options: send the SD card from the device to Philips, send the device settings to Philips as downloaded data, or Philips to send the devices with default settings to the patients. Philips’ has advised that patients are preferring the option of receiving the devices with default settings. Furthermore, Philips discussed the issues and concerns around the rectification and completion of corrective action for Trilogy 100 devices

The TGA will continue to work with Philips and VEWG members over any concerns relating to Philips corrective action and will publish any further updates on its website.

The VEWG and Philips met again on 2 September 2022 for an update on Philips’ progress with the recall and remediation strategy. As of 25 August 2022, 73.1% of devices have been remediated. This includes devices that have been repaired, replaced and refunded.

Some of the states and territories shared concerns over the completion deadline of corrective action for the devices that are due to be completed by September end.  The TGA updated the members on the proposed action for all CPAP and APAP devices where patients’ scripts are still pending. To accelerate the supply of replacement devices, Philips has proposed an additional option of sending devices with default settings to all registered patients whose devices have not yet been remediated. The plan includes having patients contact the local seller/pharmacy to have their prescription settings transferred from the old device to the new device. The TGA has agreed to this proposal after discussions with internal and external clinicians and emphasised the need for clear messaging to the patients.

The TGA will continue to work with Philips on any issues raised by VEWG members and will publish any updates on its website as new information becomes available.

On 29 July 2022, the TGA met with the VEWG and Philips. Philips provided an update on the progress with the recall and remediation strategy. As of 26 July 2022, over 71% of the registered devices in Australia have now been remediated. This includes devices that have been repaired, replaced, and refunded.

With respect to the patients receiving replacement devices, the VEWG members again shared information on patient’s receiving wrong devices and devices with incorrect settings. The TGA advised the members that it is in discussion with Philips on how to best manage this issue. Philips has conducted a review of all the BiPAP devices to confirm which devices have been supplied incorrectly. An update has been published on the TGA website. Philips is also in the process of checking all the CPAP devices that have been delivered to patients to confirm the accuracy of the device settings. Where setting discrepancies are found, Philips will be in contact the patients.

The TGA is meeting with Philips every week to discuss the issues raised by VEWG members and consumers. To keep the healthcare professionals and users informed, the TGA will publish updates on its website as new information becomes available.

On 23 June 2022, the TGA met with the VEWG and Philips as part of the TGA’s ongoing effort to support patients and healthcare professionals and to track the progress of Philips’ repair and replacement program. Over 60% of the registered affected devices have now been corrected under the repair/replacement program in Australia. There have been some delays in correcting the devices, and, in order to expedite the correction speed, Philips has proposed to send patients with CPAP devices, updated devices set to default settings. This relates to CPAP patients where Philips has been unsuccessful in obtaining patient scripts. In response to Philips’ proposal, the members expressed their concerns over patients using devices configured to default settings and also raised concerns on clinical impact the delays in the corrective actions might have on patients already using these devices.

The TGA is closely monitoring progress with the recall and is meeting with Philips weekly to ensure any concerns raised by VEWG members are effectively addressed in a timely manner.

The VEWG and Philips met again on 27 May 2022 for an update on Philips’ progress with the recall and remediation strategy. Philips confirmed receipt of Trilogy 100 devices and advised commencement of the repair on 17 May 2022. Philips indicated completion of correction has occurred for 59% of the registered devices in Australia.

Some members expressed concern about slow progress of corrective actions. The group noted overseas actions and the importance of having health care provider involvement where appropriate.

The TGA continues to support consumers and health care professionals in this process and will publish any updates on its website as new information becomes available.

On 29 April 2022, the TGA met with the VEWG and Philips to discuss progress with the repair and replacement program, noting that 52% of the devices registered for correction have been remediated. For Trilogy 100 devices, Philips confirmed shipment to Australia in coming weeks and advised that it is working on final approval required for commencement of the rectification. No update was available on the correction date for the A-series devices.

The members shared information on incidents involving scripting and raised concerns about Philips processes for verification of patient scripts and procedures followed for correction of recalled devices. Philips undertook to investigate issues identified by the members.

The TGA is working closely with Philips, states and territories, and health experts to ensure any concerns around Philips’ recall process and progress are appropriately addressed.

Another meeting with the VEWG was convened on 11 Mar 2022. The members raised concerns in relation to Philips’ current rectification processes and delays in the commencement of corrections for Trilogy 100 and A-series devices. In addition to answering questions raised by the VEWG members, Philips’ representatives provided an update on their progress with the repair and replacement program. As of 9 March, 2022, 48% of the registered devices for correction have been remediated.

The TGA is closely monitoring progress with the recall and is working with Philips to ensure any concerns raised by VEWG members are effectively addressed in a timely manner.

In continuation of the TGA’s effort to support patients and healthcare professionals, the TGA met again with VEWG on 11 Feb 2022. Philips representatives provided an update on Philips progress with the repair and replacement program for impacted devices in Australia, stating that 85% of the active devices had been registered with Philips and that 38% of these registered devices had been remediated. In addition to the DreamStation CPAP and 50 Series CPAP, the repair and replacement program has commenced for DreamStation ASV, DreamStation ST/AVAPS, System One ASV (50 and 60 series), C series S/T and AVAPS (50 and 60 series) and 50 Series base in Australia. Philips also advised that additional VOCs emission testing was conducted on the degraded PE-PUR foam for two recalled devices, Dreamstation CPAP and BiPAP devices. This information has been published on the Philips Australia website to inform physicians and medical care providers.

Furthermore, Philips also answered questions from the VEWG members in relation to the patient communication and processes set for patient engagement and support.

To continue providing support to consumers and healthcare professionals, the TGA met again with the VEWG and Philips on 03 December 2021. Philips representatives provided an update on their progress with the repair and replacement program for impacted devices in Australia. In addition to the Dreamstation CPAP and 50 series CPAP devices that are currently being replaced, Philips advised of receiving a shipment of two more models that will become available for remedial action.

Further information on these models will be published on the TGA website once the correction commences. Furthermore, Philips answered various questions from VEWG members regarding patient communication and support, clinical concerns, patient escalation, and questions in relation to the remediation plan.

In continuation to the discussions about the Philips recall plan, the TGA met with the VEWG and Philips on 12 November 2021. Philips representatives provided an update on the commencement of the repair and replacement program for impacted devices in Australia.

The corrective action commenced on 3 November 2021 for two models, with replacement devices initially sent to the clinically escalated patients. Philips anticipates increasing the capacity of replacements as more devices become available for distribution to the registered users. In addition, Philips gave an update on the processes set for patient engagement and support and answered various questions from VEWG members about the remediation plan.

The TGA continues to work with Philips to monitor the progress of the repair and replacement program of impacted devices in Australia. The TGA will publish further updates on its website as more information become available.

On 22 October 2021, the VEWG was further expanded to include a number of observers, including the ACCC and met to discuss the remediation plan provided by Philips for affected devices. Representatives from Philips also attended the meeting to provide an update on the status of the recall process in Australia and answered questions from the VEWG members about clinical escalation of patients, timeframes, and rectification procedures.

The TGA will continue to meet regularly with the VEWG and Philips to ensure any concerns about the Philips recall process are addressed appropriately and that the repair and replacement process of impacted devices proceeds in a timely manner, supporting patients who rely on these machines for their ongoing care.

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.

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.