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Found 36 results
  1. News Article
    Some disabled people in the UK have been struggling to obtain essentials such as medication and breathing equipment during the Covid pandemic, research for the BBC suggests. Some 60% of those who rely on social care told a YouGov survey they were finding it hard to obtain at least one of their necessities. Charity WellChild said people felt more "forgotten than they ever have been". But ministers say the needs of disabled people were being considered. The Department of Health and Social Care says it has sufficient stocks and patients should contact their local care provider. Like one in 20 of those survey respondents who receive social care, Fi Anderson, a mother of two with muscular dystrophy from Bolton in Greater Manchester, said she has faced problems obtaining breathing apparatus. Her local hospital told her to re-use the filter for her portable ventilator, recommending she boil it, because supplies were so short. Disabled people who rely on social care - which funds equipment and other support to allow them to live independent lives - also said they had struggled to obtain personal protective equipment (PPE) such as face masks. Many of them receive funding directly to employ carers in their home, so they also need to provide them with PPE during the coronavirus crisis. The survey, which the BBC commissioned to mark the 25th anniversary of the Disability Discrimination Act, asked more than 1,000 people about life in the UK with a disability and how it has changed in the shadow of a pandemic. More than 65% felt their rights had regressed, and 71% said disabled people's needs had been overlooked. The Coronavirus Act, which granted the government emergency powers, gave local councils the ability to reduce care, education and mental health provision for disabled people if it became necessary during the pandemic. According to the latest figures from the Office for National Statistics, nearly six out of 10 deaths from COVID-19 were of disabled people. Read full story Source: BBC News,
  2. News Article
    The most comprehensive picture so far of how covid’s second wave has hit the NHS in the north of England is revealed in new figures obtained by HSJ. The latest data confirms that parts of the North West region now have more coronavirus patients in hospital beds than they did in the spring. It comes amid intense public debate about the best way to fight covid, and whether or not it is close to swamping the NHS. Collected from local NHS sources in a joint HSJ and Independent investigation, the information shows for example that: Lancashire and South Cumbria had 544 confirmed covid hospital patients yesterday (around 15-18% of the bed base), about 20 more than during the April peak. Liverpool University Hospitals – which remains the most severely affected trust – had 408 confirmed covid patients yesterday (20-25% of bed base), whereas it never topped 400 in the spring. The data is sent routinely by trusts to NHS England but most of it is not published – something some politicians are now calling for. As of yesterday, there were nearly 6,100 confirmed-covid patients across England, about 650 of whom were in critical care, and 560 receiving mechanical ventilation, according to information shared with HSJ. The number of “unoccupied” hospital beds is much lower now than in the spring, when they were cleared out in anticipation of a major hit. In the North West, up to 5,500 acute beds were reported as “unoccupied” in the spring, whereas the figure now is about 2,500 (around 14-18% of the bed base). However, critical care is the major pinch point in the most affected areas, with nearly half of the mechanical ventilation beds open at Liverpool’s hospitals (29 of 62) occupied by confirmed covid patients; and a third of those across the North West (178 of 556). However, hospitals in the area have opened very few extra critical care “surge” beds so far. The total numbers of mechanical ventilation (a subset of critical care) beds open in LUH and the rest of the region has not increased much in recent weeks, and falls well short of what they have declared they could open as potential surge capacity, if they cancelled large amounts of non-urgent care and reorganised staffing and wards. Read full story Source: HSJ, 23 October 2020
  3. Content Article
    Some key findings from the audit: Inpatient mortality was 26%. It has reduced from 34% in 2013 and represents the first time that mortality has improved since the first BTS audit in 2010. Compared to the last audit, an increased proportion of patients treated with acute non-invasive ventilation (NIV) had COPD, the indication with the strongest evidence. We saw a decreased proportion of patients who were treated with NIV despite no clearly documented indication. This suggests improved patient selection in line with the evidence base for NIV. 50% of patients treated with NIV started NIV treatment within 60 minutes of the blood gas that defined the need for NIV. Clinician responses indicate a reduced perception of treatment delay in comparison to prior audits. Acute NIV was successful in resolving respiratory acidaemia for 76% of patients treated, in comparison to 69% in the last audit (2013). Only 74% of organisations reported that they have sufficient capacity to deliver the routine acute NIV service. Only 52% of organisations had a nursing lead and 34% had a physiotherapy lead for their acute NIV service.
  4. News Article
    Covid survivor Tam McCue is one of the lucky ones. Earlier in the year he was in intensive care in the Royal Alexandra Hospital in Paisley where he had been on a ventilator for nearly two weeks. At one point Mr McCue, who could barely speak, didn't think he would live. Fast forward five months and Mr McCue, of Barrhead, East Renfrewshire, is back from the brink. He became desperately ill but, thankfully, it only went as far as his lungs. With coronavirus some patients have have suffered multiple organ failure which also affected their heart, kidneys, brain and gut. Mr McCue describes his recovery as a "rollercoaster". He added: "It's a slow process. You think you can do things then the tiredness and fatigue sets in." He said: "It lies in the back of your mind. As years go on, how are you going to be? Is it going to get you again? It does play on you. It definitely does." As part of his recovery Mr McCue is attending the Ins:pire clinic online. It is normally a face-to-face rehabilitation clinic which involves multiple specialties, including pharmacists, physiotherapists and psychologists. Mr McCue is one of the first Covid survivors to take part in the five-week programme, which started earlier this month. Read full story Source: BBC Scotland News, 29 September 2020
  5. News Article
    Hospitals have been warned hundreds of ventilators used to keep sedated patients alive are at risk of suddenly shutting down because of a fault, in some cases without warning. The Medicines and Healthcare products Regulatory Agency, which said there were approximately 303 Philips Respironics V60 ventilators used in the UK, has warned hospitals over a delay in replacement parts arriving in the UK to fix the problem. It has issued a safety alert to hospitals to make them aware of the increased risk. The regulator said it had received one report of a ventilator suddenly shutting down but said there was no report of any injury to patients. Read full story Source: The Independent, 23 September 2020
  6. Content Article
    Actions required Primary actions to be completed by 7 October 2020: Identify and locate affected devices in your organisation. Identify alternative ventilators available on site. If no suitable alternative available, and capacity is an issue currently or expected imminently, follow protocol for resource shortage escalation set out by your local governance. Train all relevant staff on alternative ventilators and ensure training records are up to date. When actions 1–4 are complete, remove affected V60s from use and quarantine until repaired by the manufacturer. Place the alternative devices into service in place of the affected V60s. You may continue to use affected V60s if there is a risk of severe patient harm due to lack of ventilator availability. A thorough risk assessment must be completed, and additional monitoring must be used. A backup form of ventilation must be available at all times. Secondary action to be completed by 23 December 2020: 8. Review procurement and stock policies to ensure you are not reliant on one manufacturer or model of ventilator.
  7. News Article
    The lungs and hearts of patients damaged by the coronavirus improve over time, a study has shown. Researchers in Austria recruited coronavirus patients who had been admitted to hospital. The patients were scheduled to return for evaluation 6, 12 and 24 weeks after being discharged, in what is said to be the first prospective follow-up of people infected with COVID-19, which will be presented at today's European Respiratory Society International Congress. Clinical examinations, laboratory tests, analysis of the amounts of oxygen and carbon dioxide in arterial blood, and lung function tests were carried out during these visits. At the time of their first visit, more than half of the patients had at least one persistent symptom, predominantly breathlessness and coughing, and CT scans still showed lung damage in 88% of patients. But by the time of their next visit, 12 weeks after discharge, the symptoms had improved, and lung damage was reduced to 56%. Dr Sabina Sahanic, a clinical PhD student at the University Clinic in Innsbruck and part of the team that carried out the study, said: "The bad news is that people show lung impairment from COVID-19 weeks after discharge; the good news is that the impairment tends to ameliorate over time, which suggests the lungs have a mechanism for repairing themselves." A separate presentation to the congress said that the sooner COVID-19 patients started a pulmonary rehabilitation programme after coming off ventilators, the better and faster their recovery. Yara Al Chikhanie, a PhD student at the Dieulefit Sante clinic for pulmonary rehabilitation and the Hp2 Lab at the Grenoble Alps University in France, used a walking test to evaluate the weekly progress of 19 patients who had spent an average of three weeks in intensive care and two weeks in a pulmonary ward before being transferred to a clinic for pulmonary rehabilitation. She said: "The most important finding was that patients who were admitted to pulmonary rehabilitation shortly after leaving intensive care progressed faster than those who spent a longer period in the pulmonary ward where they remained inactive. The sooner rehabilitation started and the longer it lasted, the faster and better was the improvement in patients' walking and breathing capacities and muscle gain." Read full story Source: The Independent, 7 September 2020
  8. News Article
    Death rates among seriously ill COVID-19 patients dropped sharply as doctors rejected the use of mechanical ventilators, analysis has found. The chances of dying in an intensive care unit (ICU) went from 43% before the pandemic peaked to 34% in the period after. In a report, the Intensive Care National Audit & Research Centre said that no new drugs nor changes to clinical guidelines were introduced in that period that could account for the improvement. However, the use of mechanical ventilators fell dramatically. Before the peak in admissions on 1 April, 75.9% of COVID-19 patients were intubated within 24 hours of getting to an ICU, a proportion which fell to 44.1% after the peak. Meanwhile, the proportion of ICU patients put on a ventilator at any point dropped 22 percentage points to 61% either side of the peak. Researchers suggested this could have been a result of “informal learning” among networks of doctors that patients on ventilators were faring worse than expected. Read full story Source: The Telegraph, 3 September 2020
  9. News Article
    NASA scientists as well as other innovators are busy developing alternatives to the traditional ventilator being used worldwide to treat severe cases of COVID-19. The movement is in response to growing evidence that in some cases ventilators can cause more harm than good in some patients with low oxygen levels. Statistics tell the story: 80% of patients with the coronavirus die on such machines. Its VITAL machine is tailored for COVID-19 patients and is focused on providing air delicately to stiff lungs — a hallmark symptom of the virus. Eight U.S. manufacturers have been selected to make the ventilator that was made in 37 days by engineers at NASA’s Jet Propulsion Laboratory. Read full story Source: CNBC, 30 May 2020 Read f
  10. News Article
    National and regional NHS chiefs will seek to share out scarce ventilators to ”areas with the most immediate need, on a fair share basis relative to patient ventilation need," they have told hospital chiefs, who are increasingly concerned about what they will receive and when. Many are expecting demand for ventilated beds to outstrip what they have as the number of patients seriously ill with covid-19 ramps up. Trust leaders yesterday told HSJ they were growing increasingly worried about the lack of information over when the machines would be sent to their trusts. Some are worried London, and other regions which see their demand spike first, will get more supply. A letter from NHS England and Improvement to trust chiefs late on Wednesday told them that as “extra ventilators become available we will coordinate distribution via regional teams who will work with local health systems”. Read full story (paywalled) Source: HSJ, 27 March 2020
  11. News Article
    None of the new life-saving mechanical ventilators ordered last month to cope with the increase in coronavirus patients has so far been awarded safety approval. Models by manufacturers such as Dyson have yet to get the green light from the Medicines and Healthcare products Regulatory Agency, the Financial Times reported. It comes a month after the Government issued a rallying cry to put non-medical manufacturers such as Dyson on a "war footing" to make additional machines. The lag is thought to be due in part to changing clinical understanding of how best to manage the virus. Read full story (paywalled) Source: The Times, 14 April 2020
  12. News Article
    Hundreds of ventilators the UK government bought from China to relieve a major shortage are the wrong type and could kill patients, senior doctors have warned in a newly uncovered letter. The medical staff behind the letter say the devices were designed for use in ambulances rather than hospitals, had an "unreliable" oxygen supply and were of "basic" quality. Seen by Sky News' partner organisation NBC, the document also claims the ventilators cannot be cleaned properly, are an unfamiliar design and come with a confusing instruction manual. Cabinet Office minister Michael Gove triumphantly announced the arrival of "300 ventilators from China" to help treat COVID-19 patients on 4 April. But the letter of warning from doctors was issued just nine days later. "We believe that if used, significant patient harm, including death, is likely," it says. Read full story Source: Sky News, 30 April 2020
  13. Content Article
    Patient Safety Learning works with experts on guidance around ventilator safety As part of the Government’s fast track approach to the development of ventilators, the Medicines & Healthcare products Regulatory Agency (MHRA) issued guidance for clinical requirements based on ‘minimally acceptable’ performance. [2] Patient Safety Learning approached a range of human factors/ergonomics experts, asking for their input on the procurement of these new ventilators due to the involvement of new manufacturers, flexing of established guidelines and ‘safety in use’ issues. We asked them what they believed the key issues were in ensuring that these ventilators are safe in use. Experts did express concerns, identifying several risks: By moving at speed and developing non-standard ventilators (with some manufacturers with no prior experience in this area), we may unintentionally be designing a system than has numerous points of failure, increasing risk for patients. How ventilators can be used safely, particularly for staff redeployed in the pandemic who may be inexperienced or untrained in using them. How safe will ventilators be to operate for staff wearing full Personal Protective Equipment (PPE)? Should patients die as a result of safety problems with ventilators, their deaths may not be identified as such, instead being attributed to Covid-19. There are already known safety issues relating to the use of ventilators. For example, there are currently multiple designs of machines used by the NHS, with different training requirements for different devices. We worked with this expert group, who provided detailed advice and guidance to address these risks. Patient Safety Learning then immediately developed proposals for urgent action to ensure that ventilators are safe for use with patients. We called for the healthcare system to work at a pace, together with manufacturers and experts in human factors/ergonomics, in order to minimise the usability safety risks. With our proposals, we provided details of what is required to ensure ventilator safety in use. Experts called for the MPV (Minimum Viable Product) specification to be revised to reflect ‘safety in use’ requirements with an immediate design, development and test sprint approach with human engineering user trials, task analysis and hazard analysis. NHS and Chartered Institute of Ergonomics and Human Factors (CIEHF) work quickly to design new guidance So, what happened next? Initially there was a swift response. NHS England and NHS Improvement asked the CIEHF to provide designers and manufacturers with guidance aiding the rapid production of new ventilators. CIEHF subsequently designed guidance, sending it to NHS England within 48 hours. The guide, Human Factors in the Design and Operation of Ventilators for Covid-19, was then to be sent to manufacturers of ventilators in the UK.[3] Soon after CIEHF also developed a ‘rapid and easy to use’ testing protocol to assist manufacturers with testing. CIEHF have developed overarching advice and guidance and testing protocol. To support this, a detailed set of user requirements has been developed by Dr Sue Whalley Lloyd and Karen Priestly. They have worked with, and adapted, Yorkshire Water’s general human factors guidance and have produced a detailed Engineering Specification: Ventilator HF Design guidance. We need to address the risk to patient safety We’ve seen an enormous amount of activity these past few weeks towards the design and production of new ventilators; something that would usually take months or even years. However, there are still serious concerns about the process to date and outstanding safety issues. It’s vital that we meet the urgent need for additional ventilators in the UK, however it cannot be at the cost of patient safety. Concerns about the Government’s response The Government has come under increasing pressure in recent weeks over its handling of this issue. This has been, in part, because it decided not to order ventilators through the EU’s procurement scheme. This has resulted in a more urgent need for scaling up production within the UK.[4] There have also been questions raised around the number of ventilators required. Initial estimates of 30,000 have since been cut down by more than a third to 18,000. [5] [6] [7] Efforts to engage more UK manufacturers in the production of new ventilators have also proved to be complicated, with only one new model to date, Penlon’s ESO2 device, receiving approval from the MHRA.[8] While this covers a provisional order for 5,000 ventilators, there are a significant number of other applications still waiting the regulatory clearance that will be needed to meet the revised 18,000 target. Meanwhile, another provisional order has been forced to withdraw, as a model from the Renault and Red Bull Formula 1 teams was found to not be suitable for treating patients with Covid-19. [9] “Don’t bother, you’re wasting your time” There has been increasing clinical concern about the Government’s decision to move away from standard specification and known manufacturers. Some of these concerns have related to the minimum specification for the ventilator programme set out by the MHRA, suggesting that it will not lead to the production of machines that are suitable for treating Covid-19 patients. Dr Alison Pittard, Dean of the Faculty of Intensive Care Medicine, has raised concerns about the minimum specifications.[10] The MHRA guidance states that “it is proposed these ventilators would be for short-term stabilisation for a few hours”.[11] Dr Pittard has said that the group of medical professionals that advised the Government on this in March suggested that these machines should be capable of working for the a patient’s full time in intensive care.[12] She noted that: “If we had been told that that was the case, that the ventilators were only to treat a patient for a few hours, we’d have said: “don’t bother, you’re wasting your time. That’s of no use whatsoever.”[13] Compounding this issue, the standards that currently exist in this area are not formal regulatory requirements. The MHRA state that: “They are not formal regulatory requirements, but many are harmonised against regulatory requirements. Consider them as helpful advisory standards for now. MHRA will lead an exercise to define which can be ‘safely’ relaxed for this emergency situation.”[14] This is not simply a technical issue. If we can’t ensure ventilators are being produced to the right standards, to deliver the right care and to be used safely, then it will inevitably result in errors and could ultimately cost lives. Critical safety questions for the Government Considering these concerns, Patient Safety Learning believes that it is vital that the Government responds to the following critical ventilator safety questions: Safety standards Are the standards for ventilators issued to manufacturers fit for purpose? Are MHRA ensuring that these standards are being applied? These standards are not currently formal regulatory requirements. Should they be? Utilising expertise Has the expert guidance on ventilator safety in use, developed by CIEHF and others, been issued to manufacturers by NHS England and NHS Improvement or the MHRA? If yes, are manufacturers required to apply this guidance? Is it advisory or is it mandatory? Are manufacturers who comply with the guidance and usability protocols given an advantage in the procurement process? Are regulators signing off new ventilators against this guidance? Delivery, communication and timescales Currently only one of the manufacturers of new ventilators has received approval. What is the timescale for delivery of the new ventilators and how does this match estimated demand? How are the NHS and MHRA communicating with patients, staff and the public to assure them that the new ventilators will be safe in use? Monitoring performance How will ventilator ‘safety in use’ be monitored and reported on? Are NHS providers and clinicians being asked to strengthen their incident reporting, particularly where manufacturers have developed novel approaches? References Gov.uk, Call for business to help make NHS ventilators, Last Accessed 15 April 2020. Medicines & Healthcare products Regulatory Agency, Rapidly Manufactured Ventilator System, 10 April 2020. Chartered Institute of Ergonomics & Human Factors, Human Factors in the Design and Operation of Ventilators for Covid-19, Last Accessed 1 April 2020. The Guardian, UK missed three chances to join EU scheme to bulk-buy PPE, 13 April 2020. The Guardian, How the UK plans to source 30,000 ventilators for the NHS, 26 March 2020. The Guardian, How close is the NHS to getting the 18,000 ventilators it needs? 14 April 2020. Health Service Journal, NHS needs a third fewer ventilators than forecast, says Hancock, 5 April 2020. Gov.uk, Regulator approves first Ventilator Challenge device, 16 April 2020. The Guardian, UK scraps plans to buy thousands of ventilators from Formula One group, 14 April 2020. Financial Times, Ventilator standards set out for UK makers ‘of no use’ to Covid patients, 15 April 2020. Medicines & Healthcare products Regulatory Agency, Rapidly Manufactured Ventilator System, 10 April 2020. Financial Times, Ventilator standards set out for UK makers ‘of no use’ to Covid patients, 15 April 2020. Ibid. Medicines & Healthcare products Regulatory Agency, Rapidly Manufactured CPAP System (RMCPAPS), 29 March 2020.
  14. News Article
    Doctors seeing patients with blood oxygen levels so low they are surprised they are conscious – yet they are sitting up and talking. British and American intensive care doctors at the front line of the coronavirus crisis are starting to question the aggressive use of ventilators for the treatment of patients. In many cases, they say the machines – which are highly invasive and require the patient to be rendered unconscious – are being used too early and may cause more harm than good. Instead they are finding that less invasive forms of oxygen treatment through face masks or nasal cannulas work better for patients, even those with very low blood oxygen readings. Dr Ron Daniels, a consultant in critical care at University Hospitals Birmingham NHS Foundation Trust, on Thursday confirmed reports from US medics that he and other NHS doctors were revising their view of when ventilators should be used. Read full story Source: The Telegraph, 9 April 2020
  15. News Article
    Eight in ten coronavirus patients placed on ventilators in New York City have died, according to officials. New York state has recorded more cases than any country other than America itself. The tally rose by 10,000 in 24 hours to 159,937, ahead of Spain and Italy, which at different times have reported the most infections in the world. The US, which now holds the position, had 463,433 confirmed cases yesterday and the national death toll was 16,504. Read full story Source: The Times. 10 April 2020
  16. News Article
    Having access to a ventilator can mean the difference between life and death for patients who are seriously ill with COVID-19, but sometimes even these breathing machines cannot save someone's life. Juanita Nittla is a chief nurse in the intensive care unit (ICU) at London's Royal Free Hospital, and has been working for the NHS as an intensive care specialist nurse for the past 16 years. Switching off ventilators is part of Juanita's job. The work is traumatic and painful, the 42-year-old says. "Sometimes I feel like I am somewhat responsible for someone's death." Medical teams face tough decisions about when to stop treatment for patients who aren't getting better. The decision is made after careful consideration, analysing factors such as the age of the patient, underlying health conditions, their response to the virus and likelihood of recovery. Read full story Source: BBC News, 20 April 2020
  17. News Article
    More than a quarter of patients with COVID-19 on ventilators also need renal support in the form of dialysis, raising concerns that there could be significant supply problems as countries attempt to stock up on the required fluid and plastic consumables. Nephrology consultant Graham Lipkin told The BMJ, “This is an under-recognised challenge. While the original focus has been on whether we have enough ventilators and intensive care beds, it has become apparent that there is a high incidence of acute kidney injury (AKI) requiring some form of renal replacement therapy (RRT) through dialysis. With the volume of people coming into intensive care, there are increasing challenges to capacity across the system.” Lipkin, who is president of the Renal Association, has been working with NHS England to develop new clinical guidelines for the prevention and optimal management of AKI in hospital. The guidance aims to reduce the incidence of AKI and therefore the demand for dialysis. Read full story Source: BMJ, 21 April 2020
  18. Content Article
    This document outlines seven key topics that designers and manufacturers of ventilators should address. Suggestions for how to address these issues and the link to the COVID-19 crisis are identified: User interface Users of ventilators Environment of use Task The risks Instructions for use Training.
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