Philips Pdf

[Billy Cromer]

Therehave been some delays to devices being corrected. This is due to a variety of reasons, some of which are beyond Philips' control. We are working with Philips to minimise these delays where possible.

Some patients who have received replacement BiPAP devices with incorrect script settings have been contacted by Philips and their devices have been fixed. Philips will be writing to all patients and working to ensure that all BiPAP device settings have been correctly installed.

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 has taken regulatory action and fined Philips for the delay in providing important information. Philips are now required to meet weekly with the TGA to ensure that progress with the remediation plan remains on track and any further delays to the repair/replacement program are identified as soon as possible.

Approximately 20% of the affected devices registered with Philips in Australia for correction have now been corrected under the repair/replacement program. Users are reminded that registration at is vital to ensure you receive the repair or replacement of your device.

In addition to the DreamStation CPAP and 50 Series CPAP, the repair/replacement program for DreamStation BiPAP devices has now also commenced. Philips has advised the repair/replacement for the following devices will also commence in December 2021-January 2022:

You can verify that your device no longer has the impacted PE-PUR foam by checking the label for a 'UDI' field which is being included on all repaired devices (as shown in the before / after label pictures below):

In the event you have an upcoming surgical procedure and have not received a repaired or replaced device, please advise your clinician prior to your procedure (as early as possible) that you use an affected device and speak with them about ongoing use following surgery.

Philips are currently working to manufacture enough devices for users affected by the issues with PE-PUR foam. Given this, they are unable to fulfil orders at this time for new patients requiring CPAP or Bi-Level PAP devices.

The US-FDA has recently published an update to their report on inspections of a Philips Respironics Inc manufacturing facility. The report outlines concerns with the risk identification process used to identify models subject to recall actions. There was also a question raised about the silicone-based sound abatement foam being used as a replacement for the PE-PUR foam.

Until further findings become available, the US-FDA have not advised of any change to the replacement program in the USA and Philips are continuing their repair and replacement program in Australia. Patients who have already had the PE-PUR foam replaced should continue use of their device, unless instructed otherwise by their doctor.

The TGA has heard from many people affected by this action. We appreciate your feedback and recognise the seriousness of your concerns. Hearing from you assists us in our discussions with Philips to ensure the effectiveness of their proposed actions.

The estimated start date for remediation activities in Australia was September; Philips has now stated that an initial delivery of DreamStation devices will be sent in late September and replacement work for these devices will start in mid-October. Philips' parent company has announced that the repair/replacement program is expected to be completed within approximately 12 months.

This recall is being coordinated globally and relies heavily on manufacturing capacity and importation of materials from overseas. The TGA will monitor the timelines outlined by Philips in their remediation plan and continue to raise issues that need to be addressed by the company.

A recall action should not commence in Australia until the proposed action and communication are agreed to by the TGA. We give this agreement when we are satisfied that the action effectively mitigates the risks posed by an issue with a therapeutic good.

As part of our assessment, we often seek expert medical or scientific advice. Shortly after this recall action was announced, we convened our Ventilator Expert Working Group, comprising state and territory health officials, external independent clinicians, biomedical engineers and peak health professional bodies such as the Australasian Sleep Association. The Working Group provides feedback on the appropriateness of the actions and communications from both the TGA and Philips.

After a recall commences, we monitor its effectiveness to ensure all affected product is fixed or removed from the market where this is needed. In some instances, further investigations or enforcement actions may also occur.

In reviewing Philips' proposed actions, we have concluded that in many instances total removal (recall) of the affected devices is not possible unless sufficient replacements are available. We are aware there are limited supplies of alternative devices and understand the risks posed by interrupting patient treatment. Recognising that individual needs differ, it is important that each patient seeks advice from their own healthcare professional.

We recognise and understand this places significant pressure on health professionals. The course of action for each patient, i.e. immediate replacement, adjustment, interruption, or continued use until repair/exchange, must be assessed in each case. The decision should be based on the currently available information on risks and individual patient circumstances (type and severity of respiratory disorder, age, comorbidities, symptoms, occupation, duration of therapy, etc.)

A 'product defect correction' may be called a 'recall' in some international markets and identified in this way on the websites of other regulatory agencies. However, the advice for users to contact a health professional before making changes to treatment, and the approach of repair / replacement of the devices, remains consistent across the world. We are working closely with international regulators on this Philips recall action to support a consistent approach.

The TGA has commenced a post-market review of other products in the 'sleep device' category included in the Australian Register of Therapeutic Goods (ARTG). This review will confirm if other devices are also affected by degrading sound-insulating foam. Information on the outcomes of this review will be published on our website.

At present, use of an inline bacterial filter has been recommended for mechanical ventilators only. The filter will provide a barrier to prevent users from inhaling the degraded foam particles, but it will not protect against the gases that may be released by the foam. If the filter becomes wet or clogged with debris it may reduce device performance and should be replaced frequently as referenced in the device's user manual.

Where possible Philips Electronics Australia Pty Ltd has sent letters directly to patients. In some cases, patients are not directly managed by Philips because other companies have taken on the responsibility of supplying the devices to customers. These distributor companies will be responsible for sending the letters to their customers. Who sends you the letter will be based on the information you have provided Philips or the place where you purchased your device.

In addition to direct patient letters, Philips have used a variety of ways to let people know about the recall. These include publication of information on the Philips' website, advertising the recall in print and digital newspapers and notifying relevant healthcare associations and patient support organisations.

The TGA has also notified key stakeholders including state and territory health departments, the Australian Government Primary Health Networks, consumer groups and associations. We have also sent information using our social media channels.

Various television and media outlets have published articles about this recall and users are sharing information across social media support groups. We remind all patients and their caregivers to use the TGA website for accurate information.

"the repair process for existing devices requires regulatory approval in your country, which we are working toward obtaining as quickly as possible. We will begin the repair/replacement process immediately upon that approval."

Philips Australia is waiting for stock of replacement foam to arrive from overseas. This is expected to arrive in September for the DreamStation platform and the repair/replacement plan will start as soon as possible after this happens. The TGA will provide another update when corrective actions have commenced.

If customers have already purchased a replacement CPAP machine, please register your affected device at www.philips.com/src-update and click on "Begin registration process". Philips will provide instructions on how to return your affected device.

Philips is responding to consumer requests for refunds. If you are not satisfied with the refund or reimbursement offered, you should request the offer be reviewed. You can do this via the Philips Electronics Australia Ltd support hotline on 1800 009 579.

In addition, you have rights under the Australian Consumer Law which are entirely separate to any remedy Philips may provide as part of this recall action. You can find more information on the Australian Competition & Consumer Commission (ACCC) website about your consumer guarantee rights.

The TGA does not administer consumer law. You can make a consumer complaint to the ACCC if you experience difficulties asserting your rights regarding the Philips products covered by this recall action.

Some consumers have reported that they are not sure if their registration has been received. When you register you will get a registration number. If you don't receive this number, please re-register your device. To help reduce this confusion, Philips is now sending a confirmation email with each new registration.

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