Philips Respiratory Devices – information for prescribers

TGA Product Defect Correction on some Philips respiratory devices

Information current as at 14 July 2021

On 2 July 2021 the Therapeutic Goods Administration (TGA) issued two Product Defect Corrections on a range of Philips respiratory devices, including some CPAP machines, nocturnal Bi-level ventilators (BiPAP machines) and a continuous life-support ventilator.

You can read more about this on the TGA website as well as the Philips website. The Clinical Excellence Commission (CEC) has issued a Safety Notice.

The information contained on this page is intended only for clinicians who have prescribed a Philips respiratory device through the EnableNSW Home Respiratory Program (HRP) for people in the community.

If this situation impacts you, we encourage you to review this page often. As this situations changes and new information is available, we will update this page regularly.

Philips Rectification Plan update

Where can I find a list of the affected Philips devices?

The Philips website has a list of the affected Philips respiratory devices.

What are the potential health risks for people currently using an affected Philips respiratory device?

The Product defect Correction is due to potential health risks related to the sound abatement foam component in some Philips sleep and respiratory care devices, including:

  • The foam may degrade into particles which may enter the devices’ air pathway and be ingested or inhaled by the user. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone
  • The foam may off-gas certain chemicals. Product testing has demonstrated that off-gassing mostly occurs during initial operation and may possibly continue throughout the device’s useful life.

To date, there is no definitive evidence of long-term harm to patients caused by either issue. There have been no reports of death, due to exposure to the particulate matter or gas.

What advice has been given to people in the community currently using an affected Philips respiratory device?

The advice from the TGA, the CEC and Philips is the health risk to people already using these devices is low.

People already using a Philips respiratory device are advised not to cease use of their device without speaking to their clinician first.

Our team are ensuring all of our internal processes and external communication complies with advice from the TGA and the CEC.

We have recently written to all people who have been provided a Philips respiratory device through the EnableNSW Home Respiratory Program (HRP) to let them know about the situation and ensure all decisions around their device are made in consultation with their respiratory clinician.

The key message in all of our external communication is that people should not stop using their Philips respiratory device unless their respiratory clinician or care provider has told them to do so.

When will existing Philips respiratory devices be corrected or replaced?

As of October 2021 this work has now commenced and is expected to continue into 2022.

If my patient has been provided a Philips respiratory device through the HRP, will they need to register their device?

If a person in your clinical care was provided a Philips respiratory device through the EnableNSW Home respiratory program (HRP), our team has already registered this device with Philips and provided their contact details.

The Philips team will make contact with them to discuss next steps.

How will the person know if they qualify for a correction or replacement?

We are still waiting for further clarification from Philips about the correction/replacement plan.

Some Philips respiratory devices will only need to have an internal part replaced – this is called a correction. The Philips team will make contact with the person directly and let them know how this will happen.

For some devices, a replacement device may be the best option.

We are encouraging people with an affected Philips device to write down their questions and talk to the Philips representative when they are contacted. Please encourage your patients to do this also.

I have many patients in my clinical care who have asked to move to a new device – can you support all these requests?

Given the large number of affected devices in NSW and globally, together with limited supply of alternative devices from other suppliers, alternative devices will need to be prioritised for urgent repairs and new requests in the first instance.

Based on the advice from the TGA, CEC and Philips, we are asking clinicians to work with each person on a case by case basis. The risk of rapidly changing clinical therapy or transitioning to unfamiliar devices must be balanced against the low risk of continued use of affected devices.

I have a high risk patient in my clinical care and I am concerned about the wait time for a correction or replacement device – what are my options?

Please email or call our team (1800 362 253 – option 3) and we will try and work with you towards a long term solution.

Where necessary, we will work with Philips to try and prioritise your patient’s device for correction (of the defect) or replacement or discuss the possibility of moving your patient to an alternative device where available.

As part of this process, you will be asked to complete a series of questions which we will send to you following an initial phone conversation. Please be prepared to send us as much clinical information as you can, to help us prioritise the request accordingly.

What will happen to requests I submitted to EnableNSW prior to the announcement of the TGA Product Defect Correction?

Presently we are unable to fulfil requests for Philips respiratory devices.

Our team is in the process of contacting clinicians to let them know their options and that they may need to move their patient to a suitable device with an alternative supplier. We may require confirmation of settings for an alternative supplier’s device.

My patient is currently using a Philips respiratory device and needs a repair – what is the process?

The current Philips situation means that usual repairs to Philips respiratory devices cannot happen at this time.

If the persons machine is not working as expected, please ask them to call our repairs team on 1800 362 253 (option 2) and one of our customer service officers will talk the person through their options. Alternatively an email can be sent to enable@health.nsw.gov.au.

My patient is currently using a Philips respiratory device and is reporting black particles in their device – what should I do?

Please contact our team immediately to discuss alternative options for your patient.

What information can you tell me about the shipment hold affecting the Trilogy Evo life-support ventilator?

At present we are unable to fulfil any new requests for Trilogy Evo devices due to global supply constraints. We have received confirmation from Philips that all affected devices in the community have been corrected.

In the meantime, it is important to know the software issue impacting Trilogy EVO devices is a separate issue to the current Product Defect Correction and the device is safe for continued use.

How can I contact the Philips customer service team?

Philips have established a dedicated line for clinicians only on 1800 830 517 (option 2). Alternatively you may wish to send an email to srcanz.support@Philips.com.

Please note these contact details are for clinicians only and patients affected by this situation are encouraged to call 1800 009 579 or email sleepservicepatients@philips.com.

Philips Rectification Plan update

What devices will be replaced with a new base unit?

Philips will be replacing the following devices with a new base unit:

  • DreamStation CPAP, BiPAP AVAPS, ASV

The base unit will be set according to the prescribed settings (where applicable) and includes the device only without a humidifier or modem. The device will be shipped to the patient’s home where the patient will be instructed to set up their new device and ship their affected device back to Philips.

What devices will be replaced with a substitute device?

Philips will be replacing the following devices with an equivalent substitute device from the DreamStation Family:

  • 50 Series CPAP, ASV
  • 60 Series ASV, BiPAP AVAPS/ST

Substitute devices will be set according to the prescribed settings (where applicable) and includes a device complete with humidifier. The device will be shipped to the patient’s home where the patient will be instructed to set up their new device and ship their affected device back to Philips.

How will Philips obtain script data for patients?

Philips will contact prescribers to obtain up-to-date settings for their patient’s devices, using the details prescribers have provided to EnableNSW. Philips will also try to obtain permission to access prescribers’ Care Orchestrator (CO) data, allowing Philips to obtain scripting data remotely, as well as update CO with new device details automatically, where available.

If settings cannot be obtained from the prescriber or from Care Orchestrator, Philips will work with the patient to obtain settings directly from their machine at a SleepEasy Centre, or via download of the SD card in the device.

How will Philips contact patients?

Philips will contact patients by phone to confirm device usage (active/inactive), contact, and shipping details. The estimated call time is 5-10 minutes.

Who will collect the person’s old device?

Philips will be responsible for the collection of the old device through Australia Post at no cost to the patient.

What happens to devices that are no longer in use?

If a patient indicates during their call with Philips they are no longer using their device, Philips will pass this information on to EnableNSW for further instruction.

EnableNSW may contact the persons prescriber to confirm the device is no longer required.

How will the repair to my patients Trilogy 100 life support ventilator be done?

Philips biomedical engineering team will perform in-home repair of affected Trilogy 100 devices. A Philips representative will contact the person/carer beforehand to discuss the arrangement and will also let them know of their COVID safe plans.

Treating prescribers will be required to provide a script with settings prior to the repair.

What are the warranty periods for replacement or repaired devices?

Replacement devices (New or Substitute devices) will come with a 2 year warranty or the unexpired warranty period of the affected device, whichever is longer.

Repaired devices will have a 1 year warranty on the parts repaired or the unexpired warranty period of the affected device, whichever is longer.

What are my options for alternative devices?

Philips are currently unable to supply EnableNSW with CPAP and BiPAP devices for new patients. There are also supply limits on unaffected BiPAP A40 Pro and Trilogy Evo devices. Therefore, at this time clinicians are advised to request equipment from an alternate supplier where possible. For information about which devices or suppliers are available on the NSW Health contract, please contact us and ask to speak with a Respiratory Clinical Advisor.