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Medical Aids and Appliances

Dáil Éireann Debate, Wednesday - 15 December 2021

Wednesday, 15 December 2021

Questions (199)

Catherine Connolly

Question:

199. Deputy Catherine Connolly asked the Minister for Health the assessment that has been carried out to date into the potential impact on COPD patients in Ireland further to a field safety notice (details supplied), particularly in view of the use of these devices in hospitals and community care settings; the actions taken to date in response to the field safety notice and with regard to ensuring that all affected patients are alerted to the notice; and if he will make a statement on the matter. [62164/21]

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Written answers

The Health Products Regulatory Authority (HPRA) was informed in June 2021 by the manufacturer Philips Respironics that, as part of a global action, they have issued Field Safety Notices (FSNs) in Ireland advising of two issues related to a number of different devices in the area of sleep and respiratory care. The issues involve the release of particles and chemicals from the sound abatement foam used in the devices and the potentially impacted devices may be used by patients either at home or in healthcare institutions such as hospitals or long-term care facilities.

The HPRA has published a Safety Notice and dedicated webpage to raise awareness of this issue. The HSE has also issued a separate press release on this matter.

Since notification of this issue, the HPRA has extensively engaged with both Philips and the relevant distributors / service providers in Ireland to ensure that all potentially impacted users of these devices are identified and informed of the field safety notices.

The HPRA also remains in active dialog with Philips and other European and international regulators in relation to the roll out of an appropriate corrective action plan to address this issue and an assessment of the potential toxicological risks in relation to any potential long-term health impacts.

The HPRA is participating in a National Incident Management Team (NIMT) led by HSE to assess the impact of this issue for patients in Ireland. The NIMT includes representatives from a range of stakeholder groups including clinicians and representatives from the private healthcare sector. It is important to note that the FSNs advise patients not to stop or change their prescribed therapy without first consulting their doctor. The HSE recommends that all patients and device users continue to use their device as prescribed until a replacement device is supplied or the device can be repaired.

Furthermore, arising out of the NIMT, the HSE and HPRA briefed a number of patient advocacy groups on 24th June and 19th July in relation to the issue, proposed communications and further investigative steps to be taken.

The HSE, under the Office of the Chief Clinical Officer, is progressing the development of appropriate clinical guidance for patients. The HSE is funding the development of a specific paediatric clinical team to prioritise the replacement of devices for children. This includes relevant training for families on the use of the replacement machines.

As set out above, the HSE has undertaken two briefing meetings with patient representative organisations to ensure openness and transparency with all relevant aspects of their approach. A patient representative organisation is also part of the CCO clinical guidance development process.

The HSE has also been engaging with Philips and the three contracted providers since June 2021.All affected HSE patients have been contacted by the three contracted providers.521 replacements of the affected devices have been exchanged so far. The exchange replacements will continue into 2022 as products are provided by Philips.

The HSE is working in collaboration with the HPRA and other EU competent authorities to ensure alignment of their approach and guidance.

The HSE has made relevant and up to date information available on its website at www.hse.ie/eng/services/news/media/pressrel/statement-philips-field-safety-notice.html

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