Thousands of ventilators removed as power outages put UK patients’ lives at risk | Hospitals
Two thousand ventilators used in UK hospitals are at risk of sudden shutdown due to power outages which have led to a global security alert.
Hospitals have been ordered to procure replacement ventilators after Philips Respironics said its life support devices could suddenly stop working, in some cases without activating a warning alarm.
The Medicines and Healthcare products Regulatory Agency (MHRA) said the problem was linked to “a number of electrical faults in the devices, which can lead to unexpected shutdown, leading to loss of ventilation”.
He said there had been five cases of closures reported in the UK so far, none of which involved harm to patients. Worldwide, there have been 389 failure reports, including one where the patient died and four where he was seriously injured. In six of the cases in total, the warning alarm did not sound.
Philips Respironics is one of many manufacturers that have ramped up ventilator production during the pandemic. The MHRA has put in place a rapid approval process for ventilators and other medical devices in response to Covid-19.
Affected machines include invasive and non-invasive ventilators used to support patients in intensive care and high dependency units.
The MHRA said the root cause of the problem was not yet known and was being investigated, but Philips Respironics currently had “no permanent solution” to fix it.
The Dutch medical device company said it was not advising customers to remove affected devices due to the “extremely low incidence” of issues, and instead recommending measures to reduce risk, such as connecting ventilators to a remote alarm system if the main alarm fails. .
But the MHRA has ordered hospitals and healthcare providers to procure alternative ventilators and train staff in their use, and said the affected devices should be phased out of use by the end of May. In the meantime, doctors should step up patient monitoring and make sure a back-up ventilator is always available.
The regulator said hospitals would still be able to use the affected ventilators if there was a ‘risk of serious harm to the patient due to lack of availability’ but that a ‘thorough risk assessment should be carried out and additional monitoring should be used”.
“If left unnoticed by healthcare professionals, ventilation failure can have a serious impact on patient health,” he said. “This can include hypoxia, which can lead to long-term cognitive impairment for the patient. There is also a risk of death if a patient is unventilated for an extended period.”
The safety alert comes after a series of other issues involving Philips Respironics ventilators. In January, an issue that could cause the device to shut down unexpectedly was reported in the United States. Philips said it was a “production issue” that involved an expired adhesive and only affected a particular batch.
Stoppages were also reported in September 2020, when a recall was issued by the MHRA, which warned that around 300 Philips fans in the UK were at risk of suddenly stopping working. The company said this issue “specifically affects V60 fans with a certain circuit board assembly” and could be fixed through a maintenance schedule.
In June 2021, a separate alert has been issued due to degradation of the foam used in some ventilators and sleep apnea devices, which could cause users to inhale carcinogenic chemicals. The latest safety alert concerns the Philips V60, V60 Plus and V680 ventilators and affects around 105,000 devices worldwide and 2,000 in the UK, Philips said. The Ministry of Health has made arrangements to provide replacement ventilators to hospitals in need.
Dr Ben Messer, consultant in intensive care medicine at Newcastle Hospitals NHS Foundation Trust and spokesperson for the British Thoracic Society, said the recall was ‘significant’ as the devices were ‘very widely used in intensive care units for people with lung disease and Covid-19, especially those who needed lots of oxygen or were weaned off more intensive support.
“It’s frustrating because they’re exceptional machines,” he said. He added that confidence in Philips would be shaken unless the cause of the problem could be identified and corrected. “If they say, ‘No, we’re not going to fix this,’ it’s hard to imagine that’s going to paint Philips in a very positive light.”
Helen Hughes, chief executive of the charity Patient Safety Learning, said there was a “significant patient safety concern” that some Philips devices could remain in use until replacements are found.
Philips Respironics said safety was its “number one priority” and apologized to “any patient or healthcare provider who may have had concerns” following the safety notice. He has set up a team to deal with the reported fan stoppages.
A spokesperson said: “The V60 ventilator has been in service for almost 10 years now with a high reliability record. Every complaint is one complaint too many, and if an issue is raised, we will take each individual complaint seriously, deal with it transparently and report it to the relevant competent authorities.