News and Updates

7 July 2021

Philips Recall: NSW Government Safety Notice

The following are the recommendations from the NSW government regarding the use of Philips Sleep and Respiratory devices:

  • Clinical recommendations
    • Advise patients to continue use of their sleep and respiratory devices
    • Advise patients to contact their clinician or prescriber prior to changing or ceasing use of their device
    • Consider whether the use of bacterial filters would be appropriate for some patient groups
    • Advise patients to stop use of ozone-related (ultraviolet) cleaning products, and adhere to their device’s instructions for Use for approved cleaning methods
    • Clinicians and prescribers can use the following factors to assess any concerns they have for specific patient prioritisation and management:

    • Clinical risk
    • Mental health risk
    • Occupational and driver safety risk
    • Device related risk

 

Sleep and respiratory care update | Philips

Philips recall action for CPAP, Bi-Level PAP devices and mechanical ventilators | Therapeutic Goods Administration (TGA)

 

Nepean Lung & Sleep

 


 

7 July 2021

Australasian Sleep Association Media Release: Philips Machine Recall

On Friday July 5 2021, the Australasian Sleep Association (ASA) released the following:

 

People using Philips ventilation or positive air pressure machines (also known as BiPAP or CPAP) should consult with their doctor before changing their treatment, advises the Australasian Sleep Association.

“The Therapeutic Goods Administration has announced that a large number of Philips ventilators and positive air pressure machines need to be repaired,” said Associate Professor Alan Young, President of the Australasian Sleep Association.

“Some machines manufactured before 26 April 2021 contain sound-muffling foam that may break down and be breathed in when the machine is being used.

“If your machine is one of the affected models, you should speak with your sleep doctor or GP about whether or not you should keep using your machine,” Associate Professor Young said.

Positive air pressure devices are used to treat sleep apnoea, keeping a patient’s airway open at night and allowing them to function properly during the day. Ventilators are used for people with shallow breathing due to lung disease or muscle weakness.

“Patients really rely on these machines to keep them feeling well and productive and in some cases to keep them alive. It’s very important that you discuss your individual situation with your sleep doctor or GP and continue to use your machine until that time.”

Symptoms that patients might experience from affected machines include: headache, irritation (of eyes, nose, airway or skin), cough, chest pressure, nausea/vomiting and sinus infection.

“This problem is a very rare issue, and there have been no serious health problems that have been reported. But it is important that patients are aware of this issue, register their machine with Philips, and discuss their individual situation with their sleep doctor or GP,” Associate Professor Young concluded.

Affected machines are listed on the Philips website, along with information about how patients can register to have their machines repaired.

 

MEDIA RELEASE – Philips breathing machine product recall (sleep.org.au)

In the media (sleep.org.au)

 

Sleep and respiratory care update | Philips

Philips recall action for CPAP, Bi-Level PAP devices and mechanical ventilators | Therapeutic Goods Administration (TGA)

 

Nepean Lung & Sleep

 


 

2 July 2021

UPDATE -Important Philips recall information

On Friday July 2 2021, Philips has annouced they will be conducting an “Urgent Product Defect Correction in Australia for the specific affected devices”.

In accordance with the Therapeutic Goods Administration (TGA), follow the below link for more information.
Sleep and respiratory care update | Philips

Nepean Lung & Sleep

 


 

16 June 2021

Important Philips recall information

On the 26th of April 2021, Philips provided an important update regarding proactive efforts to address identified issues with a component in many of the CPAP and Bilevel CPAP  machines (BiPAP) that may lead to potential health risks. We have been told that oxygen concentrators, nebulisers and airway clearance products are not affected. At that time Philips advised of potential health risks relating to the sound abatement foam degrading and stopped shipping their affected products from their warehouses. There was no directive, or instruction from Philips at that time to cease usage or recall any of the products. It was stressed that the reactions in April were out of an “abundance of caution” while further investigations were being conducted. It was not until June 14th 2021 that Philips provided an update of the situation.

In the statement on 14th June 2021, Philips issued a global level voluntary recall notification (worldwide recall) for specific affected devices. The recall notification informs customers and users of the potential impacts on patient health and clinical use related to the issues identified in April. They also provided instructions on actions to be taken. We have been informed that Philips Australia and New Zealand (the local Philips entity) have been in contact with the local regulatory bodies in relation to this recall action.

Philips also issued a document “clinical information for physicians” on June 14th, 2021. The document informed of potential hazard and potential harm from foam degradation exposure. The document makes mention to unauthorised cleaning methods such as the use of ozone, high heat and high humidity environments contributing to foam degradation.

Nepean Lung & Sleep only operate and clean equipment with strict adherence to the manufacturers instructions under our NATA and TSANZ accreditation mandate. Unauthorised cleaning methods, including the ones listed as examples by Philips have NOT been used on our CPAP/Bilevel CPAP (BiPAP) machines.

As of June 16th 2021, we have had no further communication from Philips Australia and New Zealand in relation to the recall. We understand that Philips Australia and New Zealand are actively engaged in working out a process to rectify the identified issues with the devices. We are as yet unsure of how the fault in Philips Respironics branded equipment will be rectified. We have not been informed of the time frame in which any rectification process will occur.

Follow this link for further information.

https://www.philips.com.au/healthcare/e/sleep/communications/src-update

While the information noted on June 14th still stands, the Therapeutic Goods Administration (TGA)  has issued the following link in which the advice to patients from a regulators directive is “For devices currently in use in critical or lifesaving situations, patients or caregivers should continue using the devices until an alternative becomes available”.

https://www.tga.gov.au/alert/philips-recall-action-cpap-bi-level-pap-devices-and-mechanical-ventilators

Nepean Lung & Sleep


 

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