Search the hub

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.