Philips device defect correction updates
4 August 2021
In response to requests from members, the ASA's Clinical Committee has prepared a plain English information sheet for patients. It explains the situation, what patients should do and shouldn't do, and where to go for further information.
Latest information for clinicians
12 July 2021
Philips has issued supplemental clinical information on the risks to patients posed by the devices affected by the product defect in sound abatement form. You can read it HERE.
Last Friday, the TGA also issued additional information for consumers about how to respond to the defect correction action. It highlights the importance of users not attempting to remove the foam from their own devices and continuing to use them afterwards.
ASA President, Alan Young, responded to a number of requests for information from media outlets last week. You can read and view them via our In the media webpage.
Updated risk assessment information
7 July 2021
The TGA has released additional information on the outcome of their risk assessment activities in relation to the machines affected by the Philips product defect. You can read it HERE (scroll to the heading ‘Risk assessment outcomes’).
Key points include:
- the majority of particles are of a size unable to penetrate into deep lung tissue and are likely to remain in the patient's upper airway
- potential risks associated with the defect include: headache/dizziness, irritation (eyes, nose, respiratory tract, skin), inflammatory responses, asthma, hypersensitivity, nausea / vomiting, adverse effects to other organs (e.g. kidneys and liver) and possible carcinogenic effects
- the complaint rate associated with these issues was 0.03% for the year 2020
- to date, there is no definitive evidence of long-term harm to patients and there have been no reports of death.
The ASA issued a media release on Monday providing advice to patients, and the President Alan Young has completed several interviews over the last few days. You can read and view coverage on our website In the media page.
TGA urgent product defect correction notice for Philips devices
2 July 2021
The TGA has just released an urgent product defect correction notice for Philips CPAP, bi-level and ventilator devices. You can access it HERE.
Key points include:
- The potential risks of particulate exposure include: Irritation (skin, eye, and respiratory tract), inflammatory response, headache, asthma, adverse effects to other organs (e.g. kidneys and liver) and carcinogenic affects.
- The potential risks of chemical exposure due to off-gassing include headache/dizziness, irritation (eyes, nose, respiratory tract, skin), hypersensitivity, nausea/vomiting, toxic and carcinogenic effects.
- To date, there is no definitive evidence of long-term harm and there have been no reported deaths as a result of these issues.
- Philips will be writing to all customers with information and instructions by close of business on Monday.
- If a patient does not receive a letter and believes they have one of the affected devices, they can call Philips Recall Support Hotline on 1800 009 579.
Philips has updated its information page with advice for therapy providers, distributors and medical institutions as well as patients, users and caregivers. The advice states that patients should not stop using devices until they have consulted with their physician. The page also includes details of how to register machines for defect correction.
The TGA will release further information about the hazard to users posed by affected devices this afternoon and we will update members again after that.