(Ventilators, Sleep and Respiratory Care Devices)
Context:
Philips Respironics released a global field safety notice for a number of devices – used for treatment of sleep apnoea and respiratory failure – due to the following two issues related to the polyester- based polyurethane (PE-PUR) sound abatement foam used:
1) The PE-PUR foam may degrade into particulates, which may enter the device’s air pathway and be ingested or inhaled by the user.
2) The PE-PUR foam may emit certain volatile organic chemicals (VOCs).
Philips Respironics has received several global complaints regarding the presence of black debris/particles within the air pathway circuit (extending from the device outlet, humidifier, tubing, and mask).
Potential side effects:
Philips Respironics has received reports of headache, upper airway irritation, cough, chest tightness and sinus infection. In animal trials, some of the volatile chemicals have been shown to be a possible carcinogenic risk. The degradation may be accelerated by unapproved cleaning methods (e.g. ozone). Philips Respironics is conducting testing to better assess the potential short and long-term patient health risks related to these issues.
Links to affected devices:
Please click on the link(s) below for a list of devices involved, Philips Respironics most up to date statement & relevant HSE & HPRA information.
Philips Respironics: https://www..ie/healthcare/e/sleep/communications/src-update#section_2
HSE: https://www.hse.ie/eng/services/news/newsfeatures/advice-philips-respironics-devices/
HPRA: http://www.hpra.ie/homepage/medical-devices/special-topics/philips-sleep-and-respiratory-care-devices
HSE National Incident Management Team :
The HSE National Incident Management Team (NIMT) is responsible for assessing the impact of this issue for patients in Ireland. This team includes representatives from a range of stakeholder groups including the Health Products Regulatory Authority (HPRA), clinicians, representatives from the private healthcare sector and patient advocacy groups. Since notification of the FSN, the NIMT has extensively engaged with both Philips Respironics 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 NIMT, via the HPRA, remains in active dialogue with Philips Respironics 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. This clinical guidance will help inform the appropriate corrective action for adult patients.
Who is this Clinical Guidance for:
This Clinical Guidance has been devised to support clinicians with patients using an affected device. It is based on the limited information received to date and is subject to change as more information becomes available. The Guidance provides information for Adult patients. Separate guidance for the management of Paediatric Patients is available on the HSE website (link above).
Clinical Guidance Summary :
- All affected patients will be informed that they have a device that is affected by this Field Safety Notice (FSN). The supplier of the affected device, either Philips Respironics or a relevant Irish distributor/service provider, is undertaking this communication.
- Based on the current information supplied by Philips Respironics, the Health Service Executive (HSE) recommends that all affected patients should stay on their current device until it is repaired or replaced by the relevant distributor/service provider.
- The HSE NIMT have liaised with Philips & relevant suppliers/distributors to assess and prioritise patient groups for the replacement/repair programme.
- This prioritisation of patients considers the different patient groups’ specific clinical needs and other relevant factors e.g. device dependency.
- Patients should be directed to the following websites to guide them on how they can register their device and get it repaired or replaced. https://www.philips.ie/healthcare/e/sleep/communications/src-update#section_2
https://www.hse.ie/eng/services/news/newsfeatures/advice-philips-respironics-devices/ - If a patient complains of any of the potential side effects listed above they should seek medical advice through normal routes to out rule other unrelated illness.