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Published 2 July 2021
On 23 June 2021 Philips issued two Field Safety Notices (FSNs), warning of the potential for patient harm due to inhalation of particles and volatile organic compounds caused by affected models of their ventilators, CPAP and BiPAP devices. The notices apply to all devices manufactured before 26 April 2021. Following the notices, alarm was raised by some healthcare providers in the UK as to the implications for future patient care, in addition to what the legal consequences might be for continued use of affected devices.
In response to these FSNs, the MHRA has issued its own Patient Safety Alert which requires action by all Hospital Trusts and Health Boards providing NHS and private healthcare, including community care.
The current clinical advice, corroborated by the MHRA in its Patient Safety Alert, is: ‘Do not advise patients to stop using the devices unless a risk assessment has concluded that the risks outweigh the benefits.’
The MHRA Patient Safety Alert outlines a course of action to be undertaken which includes an obligation on healthcare providers to document and implement a risk assessment process within 1 month. In addition, clinicians are required to read and follow the manufacturer’s FSNs and ensure that conversations with affected patients are carried out to discuss the risks and benefits of continued use of Philips devices.
In this briefing, we look more closely at what is required of healthcare providers and clinicians under the MHRA guidance and what the legal ramifications might be.
Outside of the UK, there have been a small number of reports of degradation of sound abatement foam in Philips ventilator, CPAP and BiPAP devices. Reports indicate that this degraded foam can cause particles of the polyester-based polyurethane (PE-PUR) foam to be blown into the patient’s airway. The known side effects appear to be minor and short-term. They include: irritation to the skin, eyes, and respiratory tract, an inflammatory response, headaches and asthma. However, Philips have stressed that inappropriate use and unapproved cleaning methods, such as use of ozone cleaners, can exacerbate foam degradation and its associated effects. As ozone cleaners are not used in the UK, this should allay some of the concerns.
The FSNs also concern the release of volatile organic compounds (VOCs) including Dimethyl Diazene and Phenol. The current evidence indicates that these gases dissipate after 24 hours from first ‘out of box’ use. The potential short-term side effects of inhaling these gases include: headache/dizziness, irritation of the eyes, nose, respiratory tract and skin, hypersensitivity, nausea and vomiting. Consequently, the MHRA has advised that patients with known allergies or sensitivities to these VOCs should be prioritised for an alternative device if available. At present, there is no definitive data to rely on concerning the long-term harm to patients. Indeed, available laboratory testing data indicates that there is only very limited evidence for degraded foam by-products being classified as carcinogenic and that the particulate’s tendency to stick to nearby surfaces as well as itself reduces the likelihood of respirable particles entering the breathing circuit in any event. However, it is worth noting that possible longer-term side-effects associated with VOCs and foam degradation include: genotoxicity, mutagenic and carcinogenic effects, hepatotoxicity, nephrotoxicity and neurotoxicity.
The current clinical advice, corroborated by the MHRA is: ‘Do not advise patients to stop using the devices unless a risk assessment has concluded that the risks outweigh the benefits’.
The affected devices, predominantly used for patients with obstructive sleep apnoea and type 2 respiratory failure, have been recalled by Philips in the USA. However, it should be stressed that, at present, no incidents of harm have been reported in the UK and that incidents of this kind are in themselves rare. However, it remains a possibility that, as awareness grows of this issue, related incidents of patient harm may surface.
Given the clinical context in which Philips ventilators, CPAP and BiPAP devices are used, the MHRA Patient Safety Alert highlights that no longer using them would have an immediate and detrimental impact on patient health. In the case of BiPAP devices, withholding their use would result in those with established type II respiratory failure deteriorating and possibly requiring hospitalisation. For those on CPAP devices, withholding their use could increase their risk of stroke, heart disease and high blood pressure. In addition to disrupting the ability to perform daily living activities, withdrawing CPAP use could result in hospitalisation, in addition to requiring more invasive forms of treatment with longer-term health side effects.
At present, the MHRA recommends a risk assessment process be undertaken to determine the suitability of the continued use of Philips devices within 1 month. The short timescale stipulated creates a burdensome obligation on healthcare providers, particularly large acute hospitals who may have large patient numbers with the devices and are already stretched by the Covid-19 pandemic, to demonstrate the necessary compliance with its guidance. More immediately, the MHRA has set out a very narrow timeframe for clinicians to read and follow the manufacturer’s FSNs for each device within 2 days. Within the MHRA Patient Safety Alert, there are additional obligations outlined that fall on clinicians to conduct a risk assessment for individual patients or patient groups and contact affected patients to conduct a risk-benefit conversation about continued use. All actions need to be completed by 17 December 2021.
Out of this advice, two important issues arise. The first, is that carrying out individual risk assessments would not seem reasonably practicable within the 1 month timescale articulated. Given that clinicians are already overstretched, a risk assessment by patient group would seem a more viable way forward subject always to individual clinicians being able to nominate specific patients, who may be at a higher risk, for earlier action. The second issue to highlight is that, as awareness of this issue grows amongst the wider public, there will be an even greater need to ensure that clinicians have a robust set of criteria to apply when informing high-risk patients at an individual level of the possible risk in using a Philips device. A sensible strategy for the longer term may also be to start replacing the oldest devices, which are more likely to be susceptible to foam degradation, as a priority.
A careful balance will need to be struck, that considers patient safety and informed consent without causing unnecessary alarm or a scramble on alternative makes of devices that may compromise the wider provision of healthcare.
As regards to new patients assessed as requiring a device, it seems likely that most hospitals and health boards will endeavour to give this group of patients an alternative model wherever possible, at least until a ‘work around’ has been identified and implemented by Philips for their devices.
The MHRA Patient Safety Alert states that, for ventilators only (not CPAP or BiPAP devices), the risk of inhaling foam particulates is greatly reduced by inserting an inline filter into the breathing system of a ventilator. The size of the particulates and consequently the potential harm caused can be significantly reduced. Inserting filters is an approved practice in the Philips ventilator instructions for use. The same cannot be said for Philips CPAP/BiPAP devices because inserting a filter into those devices is considered an ‘off-label use’ and their effect is at this stage unknown.
Fitting filters is a relatively inexpensive solution for affected ventilators. However, it is the labour required to make the fittings at the speed and scale necessary, which will cause healthcare providers the most concern, in the absence of finding an alternative make of ventilator. In any case, the available evidence suggests that most degraded foam particles are too big to be inhaled.
It is important to stress that, if any future litigation were to arise out of the affected devices, Philips would not be absolved of its obligations merely by issuing two safety notices.
Healthcare providers should closely follow the advice and recommended timescales of the MHRA in order to demonstrate they are responding responsibly and reasonably.
Of concern at present is the lack of any clear statement from Philips regarding timescales and arrangements for any recall or workaround to fix existing devices still in use. Further information is anticipated in the near future.
Our health team has extensive experience in advising on all legal matters relating to the sector, including product regulatory compliance, procurement, and commercial contracts. Should you require any assistance in relation to this matter, please contact: Diane Hallatt, Sean Doherty or Alison McAdams.
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