Classification: Official
Publication reference: PRN01460

To:

• paediatric critical care operational delivery networks (ODNs)
• neonatal ODNs
• adult critical care ODNs
• children’s surgery ODNs
• trust directors of nursing
• trust medical directors
• trust heads of procurement
• trust heads of emergency preparedness, resilience and response (EPRR)
• trust allied health professional directors
• trust medical device safety officers
• integrated care board (ICB) directors of nursing
• ICB medical directors
• ICB procurement leads

cc.

• regional deputy directors of EPRR
• regional directors of nursing
• regional medical directors
• regional allied health profession (AHP) leads

Dear colleagues,

Philips Respironics BiPAP machines – urgent field safety notices

We are writing to inform you of a safety issue regarding Philips Respironics A30 and A40 BiPAP machines used with patients receiving oxygen.

Defects have been discovered in multiple batches of the products listed and Philips have issued two field safety notices (FSN) to UK customers advising of next steps:

FSN 039 (Ventilator Inoperable Alarm and machine shutdown issue): BiPAP A30, BiPAP A30 EFL, BiPAP A30 Hybrid, BiPAP A40, BiPAP A40 EFL, BiPAP A40 Pro devices

FSN 042 (Alarm Malfunction linked to Oxygen Sensor Inside the Ventilator): BiPAP A40 Pro Ventilators, BiPAP A40 EFL Ventilators, and BiPAP A30 EFL Ventilators

Risks

The FSN issued by Philips in the UK states that there have been around 888 reports of malfunctions, with 10 instances of serious harm reported, and 7 deaths from 100,000,000 uses of the device worldwide, relating to interruptions and/or loss of therapy due to a Ventilation Inoperative Alarm (FSN039).

Whilst the likelihood of the device failing is very low, the impact of such an event on ventilator dependent patients in certain situations could lead to severe harm or death.

Philips is recommending that physicians/healthcare professionals assess whether the patients under their care are able to tolerate interruptions of therapy to help ensure that they continue to receive the most appropriate therapy. The safety alert advises that an alternative ventilator should be considered for patients who cannot tolerate brief interruptions of therapy.

The Philips FSN has not requested an immediate recall of the devices, at this point in time. However, Philips continue to investigate the issue and are liaising with the Medicines and Healthcare products
Regulatory Agency (MHRA).

To note, there have been 1828 reports incorrectly generated “High Internal Oxygen” alarms (FSN042) with no instances of patient harm or injury reported to Philip Respironics.

Action 1: Trusts and integrated care boards (ICBs) are asked to ensure the FSNs, and this letter are shared with relevant clinicians. This will likely include, (but is not limited to) any team caring for patients receiving home mechanical ventilation for 24 hours of the day, patients meeting the criteria for complex commissioning of home mechanical ventilation, any patient receiving home mechanical ventilation who does not meet the criteria for complex commissioning of home mechanical ventilation, patients receiving continuous positive airway pressure (CPAP).

NHS England assessment and local identification of ventilator dependent patients

An expert clinical reference group has been established to guide national decision-making, including patient and public representatives, as well as input from the British Thoracic Society.

The clinical reference group assess that individuals who are ventilator dependent outside of hospital (often characterised by those using machines for 14 or more hours a day) should be moved to alternative devices as soon as they become available, subject to review of each patient’s individual circumstances.

It is considered that the risk to patients who use these machines but are not ventilator dependent is very low, and that no action is currently required for these individuals while Philips consider their mitigation and repair options.

Action 2: Identify ventilator dependent patients using affected machines. At this stage, we recommend that Trusts identify patients who are dependent on ventilation 24/7 or 14+ hours per day and explore reallocation of machines across existing stock/patients to ensure backup life support capable machines are available for the highest risk category of patients.

An indicative patient categorisation to support local clinical decision making has been developed and is available in Annex A to this letter.

Stocktake

We are exploring if and how NHSE could support a medium-term programme to help coordinate allocation of replacement or alternative devices for ventilator dependent patients.

In order to inform these exploratory discussions, we wish Trusts who have purchased or leased an affected machine to complete a stocktake. The stocktake template seeks to capture key information including:

• services provided in each unit and to each cohort of patients (as per categorisation at Annex A)
• numbers of ventilator dependent patients
• number of affected ventilators; in use and not in use
• number of patients using affected devices

Action 3 – trusts with affected stock to complete stock take.

Trusts with the affected ventilators (only) are requested to complete the stocktake enclosed with this letter (excel document), returning it to their Regional Operations Centres by 02/08/2024 at 11:00am unless your region gives you a different deadline.

Local procurement and moving to alternative products

The Department of Health and Social Care (DHSC) and NHS Supply Chain are leading engagement with Philips and also alternative suppliers to establish and then maintain the availability of alternative products.

NHS England and DHSC will monitor demand for alternative devices through liaison with equipment suppliers and NHS Supply Chain – and will work to put in place stock control mechanisms to prevent disproportionate orders if necessary. Our aim is to ensure access to replacement machines for those patients in the highest risk categories.

Any move of patients to alternative products will need to be pragmatic (as there are a finite number of alternative devices) and focused on clinical assessment of the risks for individual patients.

Key factors to consider when deciding upon a switch to an alternative product are set out at Annex B along with a list of potentially suitable products.

Informing patients

The choice to inform patients of the field safety notice and implications should be clinically led.

Patient and public representatives as well as clinicians in our clinical reference group did not think that proactive communication to all patients using these machines is appropriate at this juncture (see Annex A for patient categorisation).

Care should be taken to avoid unnecessary anxiety and distress, and to manage the risk of patients inappropriately stopping using their existing devices, where they remain functional.

Contacting patients immediately is deemed to be most likely to be appropriate for those patients who are using the affected ventilators as life support machines (ventilator dependent), for whom the field safety notice recommends alternative machines are provided e.g. patients in group 1 and 2 (see Annex A for patient categorisation).

A discussion of the issues arising from the safety notice and discussion of a plan of transfer to an alternative machine would seem appropriate for these patient groups.

In the event of machine failure, the key action for patients and carers will be to follow guidance they already have from their local service in relation to how to manage any ventilator failure.

An example of patient communications letter is included as Annex C to this letter.

Ongoing national oversight of the issue

NHS England is working closely with DHSC, NHS Supply Chain and MHRA to ensure the risks to patients are fully understood and necessary corrective action undertaken by Philips.

We hope to be able to provide further detail on availability of alternative devices and on any central programme of device replacement in due course, through clinical and procurement networks.

Your cooperation and engagement are vital to mitigating the risk of this product issue, ensuring we continue to provide safe and effective care across all settings.

Yours sincerely,

Mike Prentice, National Director for Emergency Planning and Incident Response, NHS England
Jonathan Fuld, National Clinical Director, Respiratory, NHS England

Annex A: patient categorisation

Level 1 (highest priority)

Patients receiving home mechanical ventilation for 24 hours of the day.

Level 2 

Patients meeting the criteria for complex commissioning of home mechanical ventilation.

These will include:

• patients who are dependent on HMV for at least 14 hours of a 24-hour period
• patients with neuromuscular disease such as Motor neuron disease and Duchenne muscular dystrophy and other inherited/metabolic muscle disease
• severe respiratory disease in association with a learning disability where ventilatory issues are the main clinical issue
• patients receiving tracheostomy ventilation

Level 3 

Any patient receiving home mechanical ventilation who does not meet the criteria for complex commissioning of home mechanical ventilation.

Level 4 

Patients receiving CPAP.

Contextual factors to consider: 

• does the patient live alone? Is 24/7 care present?
• does the patient have restricted mobility?
• does the patient have relevant comorbidities (notably any neuromuscular needs)?
• is a backup machine already present in the home?

Annex B – potential alternatives to Philips A30 and A40 and considerations when resourcing a change to an alternative device 

Steps to take and anticipated resource per patient to enable swap out:

The approach to swapping out devices will vary based on service structure and staffing in each Trust. For example, some services may have different band HCPs to enable aspects of swap out.

The below steps are indicative only. There may be a small number of patients who require more resource to change the machine e.g. An admission/day case review.

• patient communication- letter to communicate issue and anticipated response (band 2/3 10 mins/ patient)
• consider if a 15 mins phone call from the patients’ consultant to explain the issue and why the change is occurring would be beneficial
• allocation to appointment for device swap (admin band 2/3 appointments 10 min/ patient)
• appointment to issue new device (band 6/7/8, will vary according to team structures- 60-90mins) includes device provision, set up, titration and education
• admin support for set up- database capture, connectivity, and return/ decommission of faulty device. (band 4/6/7, varies to service structure- 60mins)
• remote/ housebound will require home visit- added travel time 30 mins/ patient – based on cohorting areas, (band 6/7/8, varies to service structure)
• arrangements for overnight monitoring after changing machines should be considered and may be appropriate for high-risk patients
• appointment to review new device function, usually within 3 months of initiation. May include sleep study (home or hospital) on the ventilator, as clinically indicated (30 mins hospital appointment or home visit). This would usually be in addition to whatever routine follow-up/review plan was in place previously

Selecting an alternative device:

Choosing the replacement ventilator needs to be individualised to the patient’s requirement and the home ventilation service configuration. Factors to consider may include, but not restricted to;

1. the patient’s level of dependency on ventilatory support
2. prior mode of ventilation on the affected
3. service configuration (e.g. prior usage of remote monitoring function of some ventilators)

Services will need to review the capability of each device against the patient’s level of need and dependency.

Annex C – example patient communication letter

View and download an example patient communication letter.