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Found 147 results
  1. 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.
  2. Content Article
    "In one of the most vivid scenes in the Home Box Office (HBO) miniseries 'Chernobyl' (among many vivid scenes), soldiers dressed in leather smocks ran out into radioactive areas to literally shovel radioactive material out of harm's way. Horrifically under-protected, they suited up anyway. In another scene, soldiers fashioned genital protection from scrap metal out of desperation while being sent to other hazardous areas. Please don't tell me that in the richest country in the world in the 21st century, I'm supposed to work in a fictionalized Soviet-era disaster zone and fashion my own face mask out of cloth because other Americans hoard supplies for personal use and so-called leaders sit around in meetings hearing themselves talk. I ran to a bedside the other day to intubate a crashing, likely COVID, patient. Two respiratory therapists and two nurses were already at the bedside. That's 5 N95s masks, 5 gowns, 5 face shields and 10 gloves for one patient at one time. I saw probably 15-20 patients that shift, if we are going to start rationing supplies, what percentage should I wear precautions for? Make no mistake, the CDC (Centers for Disease Control and Prevention) is loosening these guidelines because our country is not prepared. Loosening guidelines increases healthcare workers' risk but the decision is done to allow us to keep working, not to keep us safe. It is done for the public benefit – so I can continue to work no matter the personal cost to me or my family (and my healthcare family). Sending healthcare workers to the front line asking them to cover their face with a bandana is akin to sending a soldier to the front line in a t-shirt and flip flops. I don't want talk. I don't want assurances. I want action. I want boxes of N95s piling up, donated from the people who hoarded them. I want non-clinical administrators in the hospital lining up in the ER asking if they can stock shelves to make sure that when I need to rush into a room, the drawer of Personal Protective Equipment (PPE) I open isn't empty. I want them showing up in the ER asking 'how can I help' instead of offering shallow 'plans' conceived by someone who has spent far too long in an ivory tower and not long enough in the trenches. Maybe they should actually step foot in the trenches. I want billion-dollar companies like 3M halting all production of any product that isn't PPE to focus on PPE manufacturing. I want a company like Amazon, with its logistics mastery (it can drop a package to your door less than 24 hours after ordering it), halting its 2-day delivery of 12 reams of toilet paper to whoever is willing to pay the most in order to help get the available PPE supply distributed fast and efficiently in a manner that gets the necessary materials to my brothers and sisters in arms who need them. I want Proctor and Gamble, and the makers of other soaps and detergents, stepping up too. We need detergent to clean scrubs, hospital linens and gowns. We need disinfecting wipes to clean desk and computer surfaces. What about plastics manufacturers? Plastic gowns aren't some high-tech device, they are long shirts/smocks... made out of plastic. Get on it. Face shields are just clear plastic. Nitrile gloves? Yeah, they are pretty much just gloves... made from something that isn't apparently Latex. Let's go. Money talks in this country. Executive millionaires, why don't you spend a few bucks to buy back some of these masks from the hoarders, and drop them off at the nearest hospital. I love biotechnology and research but we need to divert viral culture media for COVID testing and research. We need biotechnology manufacturing ready and able to ramp up if and when treatments or vaccines are developed. Our Botox supply isn't critical, but our antibiotic supply is. We need to be able to make more plastic Endotracheal tubes, not more silicon breast implants. Let's see all that. Then we can all talk about how we played our part in this fight. Netflix and chill is not enough while my family, friends and colleagues are out there fighting. Our country won two world wars because the entire country mobilised. We out-produced and we out-manufactured while our soldiers out-fought the enemy. We need to do that again because make no mistake, we are at war, healthcare worker s are your soldiers, and the war has just begun." First published on www.telegram.com/news
  3. News Article
    Several trust procurement leads have expressed frustration with the government’s response to covid-19, with HSJ being told of shortages of crucial personal protective equipment, unpredictable deliveries and a lack of clarity from the centre NHS Supply Chain, which procures common consumables and medical devices for trusts, has been “managing demand” for an increasing number of PPE and infection control products for since the end of February to ensure “continuity of supply”. Some products, like certain polymer aprons, are unavailable altogether because of the increased demand and disrupted supply caused by the covid-19 outbreak. One procurement lead told HSJ: “They aren’t supplying enough, they aren’t fulfilling orders. It’s completely chaotic.” Another said his trust had “just enough to manage for the time being.” Read full story (paywalled) Source: HSJ, 20 March 2020
  4. Content Article
    Key facts The occurrence of adverse events due to unsafe care is likely 1 of the 10 leading causes of death and disability in the world. In high-income countries, it is estimated that one in every 10 patients is harmed while receiving hospital care. The harm can be caused by a range of adverse events, with nearly 50% of them being preventable. Each year, 134 million adverse events occur in hospitals in low- and middle-income countries (LMICs), due to unsafe care, resulting in 2.6 million deaths. Another study has estimated that around two-thirds of all adverse events resulting from unsafe care, and the years lost to disability and death (known as disability adjusted life years, or DALYs) occur in LMICs. Globally, as many as 4 in 10 patients are harmed in primary and outpatient health care. Up to 80% of harm is preventable. The most detrimental errors are related to diagnosis, prescription and the use of medicines. In OECD countries, 15% of total hospital activity and expenditure is a direct result of adverse events. Investments in reducing patient harm can lead to significant financial savings, and more importantly better patient outcomes. An example of prevention is engaging patients, if done well, it can reduce the burden of harm by up to 15%.
  5. Content Article
    Part I illustrates why improving safety is so difficult and complex, and why current approaches need to change. Part II looks at some of the work being done to improve safety and offers examples and insights to support practical improvements in patient safety. Part III explains why the system needs to think differently about safety, giving policymakers an insight into how their actions can create an environment where continuous safety improvement will flourish, as well as how they can help to tackle system-wide problems that hinder local improvement.
  6. Content Article
    From the 5365 operations, 188 adverse events were recorded. Of these, 106 adverse events (56.4%) were due to human error, of which cognitive error accounted for 99 of 192 human performance deficiencies (51.6%). These data provide a framework and impetus for new quality improvement initiatives incorporating cognitive training to mitigate human error in surgery.
  7. Content Article
    The findings of this paper show that safety lapses in primary and ambulatory care are common. About half of the global burden of patient harm originates in primary and ambulatory care, and estimates suggest that nearly four out of ten patients experience safety issue(s) in their interaction with this setting. Safety lapses in primary and ambulatory care most often result in an increased need for care or hospitalisations. Available evidence estimates the direct costs of safety lapses – the additional tests, treatments and health care – in primary and ambulatory care to be around 2.5% of total health expenditure. Safety lapses resulting in hospitalisations each year may count 6% of total hospital bed days and more than 7 million admissions in the OECD.
  8. Content Article
    What will I learn? The process for investigating gross negligence manslaughter Reflective practice of healthcare professionals The regulation of healthcare professionals
  9. News Article
    The NHS 111 helpline for urgent medical care is facing calls for an investigation after poor decision-making was linked to more than 20 deaths. Experts say that inexperienced call handlers and the software used to highlight life-threatening emergencies may not always be safe for young children. At least five have died in potentially avoidable incidents. Professor Carrie MacEwen, Chairwoman of the Academy of Medical Royal Colleges, said: “These distressing reports suggest that existing processes did not safeguard the needs of the children in these instances.” Since 2014 coroners have written 15 reports involving NHS 111 to try to prevent further deaths. There have been five other cases where inquests heard of missed chances to save lives by NHS 111 staff; two other cases are continuing and one was subject to an NHS England investigation. Read full story (paywalled) Source: The Times, 5 January 2020
  10. Content Article
    Building on its successful predecessors, the third edition of The Field Guide to Understanding ‘Human Error’ will help you understand a new way of dealing with a perceived 'human error' problem in your organisation. It will help you trace how your organisation juggles inherent trade-offs between safety and other pressures and expectations, suggesting that you are not the custodian of an already safe system. It will encourage you to start looking more closely at the performance that others may still call 'human error', allowing you to discover how your people create safety through practice, at all levels of your organisation, mostly successfully, under the pressure of resource constraints and multiple conflicting goals. The Field Guide to Understanding 'Human Error' will help you understand: how to move beyond 'human error' how to understand accidents how to do better investigations how to understand and improve your safety work. You will be invited to think creatively and differently about the safety issues you and your organisation face. In each, you will find possibilities for a new language, for different concepts, and for new leverage points to influence your own thinking and practice, as well as that of your colleagues and organisation.
  11. Content Article
    This study highlights that people with complex concerns with a history of placement breakdowns and past institutionalisation can be settled successfully and safely in local communities. However, it is difficult for many of them to achieve a satisfactory quality of life long term. The obligation for this lies with service providers to provide adequate support to overcome that difficulty.
  12. Content Article
    This issue of Hindsight includes articles on: Malicious compliance by Sidney Dekker Can we ever imagine how work is done? by Erik Hollnagel Safety is in the eye of the beholder by Florence-Marie Jegoux, Ludovic Mieusset and Sébastien Follet I wouldn't have done what they did by Martin Bromiley
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