Hospitals have been ordered to supply replacement respirators after Philips Respironics said its breathing apparatus could suddenly stop working, in some cases without sounding the alarm. The Drugs and Health Products Regulatory Authority (MHRA) said the problem was related to “a series of electrical failures in the devices, which can lead to unexpected shutdowns, leading to loss of ventilation”. He said five outages had been reported in the UK so far, none of which involved patient harm. Globally, there have been 389 reports of failures, including one where the patient died and four where he was seriously injured. In six of the total cases, the warning alarm did not sound. Philips Respironics is one of the many manufacturers that increased the production of respirators during the pandemic. The MHRA introduced a rapid approval process for respirators and other medical devices in response to Covid-19. Infected machines include invasive and non-invasive respirators used to support patients in intensive care units and high-dependency units. The MHRA said the root cause of the problem was not yet known and remained under investigation, but that Philips Respironics currently had “no permanent solution” to fix it. Respirators were used “very widely in intensive care units” for people with lung disease and Covid-19, said an intensive care consultant. Photo: imageBROKER / Alamy The Dutch medical equipment company said it did not advise customers to remove affected devices due to “extremely low frequency” problems and instead recommended measures to reduce risks, such as connecting ventilators to a remote alarm system in case the device fails. main alarm. However, the MHRA ordered hospitals and healthcare providers to procure alternative respirators and train staff to use them, and said affected devices should be removed from use by the end of May. In the meantime, physicians need to increase patient follow-up and ensure that a spare 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 completed and additional monitoring used”. “If not perceived by health professionals, ventilation failure can have a serious impact on patients’ health,” he said. “This can include hypoxia, which can lead to long-term cognitive impairment of the patient. “There is also a risk of death if a patient is without ventilation for an extended period of time.” The safety alert comes after a number of other problems with Philips Respironics respirators. In January, an issue was reported in the US that could lead to an unexpected shutdown of the device. Philips said it was related to a “production problem” involving an expired adhesive that only affected one specific batch. Shutdowns were also reported in September 2020, when a recall was issued by the MHRA, which warned that around 300 Philips respirators in the UK were in danger of suddenly shutting down. The company said the issue was “specifically with V60 ventilators with a specific printed circuit board assembly” and could be remedied through a maintenance program. In June 2021, a separate alert was issued due to the degradation of the foam used in some respirators and sleep apnea machines, which could lead to inhalation of cancer-causing chemicals to users. The latest safety alert concerns the Philips V60, V60 Plus and V680 respirators and affects around 105,000 devices worldwide and 2,000 in the UK, Philips said. The Ministry of Health has made arrangements for the supply of replacement respirators to the hospitals that need them. Dr Ben Messer, an intensive care consultant at the Newcastle Hospitals NHS Foundation Trust and a spokesman for the British Thoracic Society, said the recall was “significant” because the devices were used “very widely in intensive care units” for people with lung disease and Covid-19. , especially those who needed a lot of oxygen or were weaned from more intensive support. “It’s frustrating because they are great machines,” he said. He added that confidence in Philips would decline unless the cause of the problem was identified and corrected. “If they say, ‘No, we’re not going to solve this problem,’ it’s hard to imagine bringing Philips in with so much positive light.” Helen Hughes, chief executive of the Patient Safety Learning charity, said there was a “significant concern for patient safety” that some Philips devices could remain in use until replacements could be found. Philips Respironics said safety was its “number one priority” and apologized to “any patient or healthcare provider who may have had any concerns” as a result of the safety alert. He has set up a team to deal with the reported ventilator outages. A spokesman said: “The V60 ventilator has been in operation for almost 10 years now with a high reliability record. “Every complaint is a complaint too much, and if there is a reported issue, then we will take each individual complaint seriously, deal with it transparently and report it to the competent authorities.”
