PPE creates a barrier to communication. So much is lost through this barrier. Not only verbal communication, but also non-verbal cues, which form the basis of the majority of communication – the ability to lip read for those that rely on it and the human connection behind the mask. As such, there is a significant risk of miscommunication of vital information between the patient and healthcare provider, presenting a considerable patient safety issue.

What started out as a simple thought, “would healthcare staff be able to write down what they need to say on a piece of paper and show it to the patient?”, within 72 hours turned into an A–Z index of digital flashcards covering a wide range of topics, and www.cardmedic.com was launched.

A free online resource for all to use, CARDMEDIC^TM launched on 1 April 2020. Prior to being shared on national news platforms, the site already had over 8000 users in 50 countries across 6 continents in just over 3 weeks, including across Europe, Australia, New Zealand, United States, Canada, Asia and Africa. It was shared by the Defence Medical Services to over 70 senior clinicians across all specialties in multiple Trusts across the UK.

Since being featured in The Guardian and various other media outlets, the site has now had over 10,000 visits and 60,000 page views in less than 8 hours! I have been inundated with support, positive feedback and offers of help ranging from translation to illustrations and more.

CARDMEDIC^TM is simple to use. Healthcare providers can access www.cardmedic.com/flashcards either on their institution’s or their patient’s smart phone, tablet or desktop. Choose the flashcard you would like to talk to the patient about and display it on the screen to the patient. Just ensure the website is displayed in the relevant language, there are 10 to choose from at the moment (thanks to Weglot) – this option is currently at the bottom right hand side of the page. If your patient is too unwell or unable to read, or partially sighted or blind, there is also a read-aloud option (thanks to SiteSpeaker) – choose the blue “play” button at the top right of the screen.   

Devices can be placed in freezer bags that are compatible with gloves and can be disposed of between patients, although we are aware of the environmental impact of this. Alternatively, some places have devices that they disinfect by wiping clean between patients. For those who prefer a paper-based approach, the cards can be printed and laminated; write-on, wipe-off. We are working on making these available as downloadable PDFs.

With the re-deployment of vast numbers of healthcare and allied healthcare professionals, together with those returning to practice, there are a large number working outside their usual realm of clinical practice. This presented a further issue;  staff may feel uncertain of how to talk to patients about certain aspects of their care in simple language if it is an area they are not familiar with working. The flashcards can also act as a reminder or prompt in these circumstances and another layer of maintaining patient safety.

We have also just launched a free app on 25 April, compatible with android and iOS/Apple, improving accessibility for those with difficult internet access and ease of access for all..A huge thanks to Phil at A Million Monkeys for working tirelessly over the last couple of weeks on this. The app should not only improve accessibility for those in areas with little or no internet access, but also provide an immediately available source of flashcards that will be continually updated, without having to repeatedly download new versions from the app store.

Based upon my training in anaesthetics and, as a part of this, experience in critical care, I wrote the majority of the CARDMEDIC^TM content. I have had significant contribution both in terms of content and resources from specialist colleagues in critical care nursing, end of life and palliative care, radiography, DNAR, obstetrics, midwifery, speech and language therapists and learning disability nurses, with more to come. Whilst what we have prepared is not professing to be a “gold standard” in communication, it is based upon a wealth of combined experience, knowledge and an acceptable standard in clinical practice.  

There is much planned in way of development, in part shaped by the feedback we have received. For example, we are collaborating with Signly on integrating British Sign Language videos and also working on integrating illustrations to improve accessibility for users. I am delighted to have Scarlett Brandley, a Leeds University Medical School student, spending her elective with me working on it.    

Some incredible suggestions have also been put forward about using it in refugee camps in Greece, Iran and Afghanistan. 

CARDMEDIC^TM has been developed through a combination of extreme generosity of colleagues, friends, family, contacts, word of mouth and Twitter, as well as very much burning the candle at both ends seven days a week. When I started this, I thought I would share the site with a few friends and colleagues and it would hopefully help make a difference to a few patients. I never envisaged it would have grown so rapidly and at such pace.

I am so overwhelmed by the time, advice, services donated free of charge from so many different people – organisations, colleagues, friends and family. There are too many people to thank here! To mention a few – Patient Safety Learning have been championing it and have been a great source of support. My friends and colleagues at Brighton and Sussex University Hospitals NHS Trust and the University of Brighton have been incredibly supportive and proactive – I am very grateful. The Department for International Trade has been fantastic and introduced me to so many different contacts across a wide range of organisations, including Grow Global and Signly. A Million Monkeys has worked tirelessly on developing the app. The Defence Medical Services have shared it across the UK. The Academic Health Sciences Network (AHSN) have also been a really useful resource, especially with advice on possible funding streams. Dr Andy Tagg at Don’t Forget the Bubbles in Australia has been brilliant and we are looking forward to working together, along with Jane Stokes, to translate it into a further 15–20 languages. Having never been on Twitter before, the networking opportunities have been phenomenal and so many people have come forward too, to offer their time and expertise with various clinical sections of the site. I could go on!

I am humbled to think my idea could have such far reaching purpose and value as this. It has been and continues to be, an enormous team effort to pull this together.    

We have applied for government funding and are yet to hear back. If this doesn’t come through, I am going to take the anaesthetics department at Brighton and Sussex University Hospitals NHS Trust up on their incredible offer of financial start-up support to aid further development, as well as a private donor up on their unbelievably generous offer to pay for the app development. All else has been without funding. It is so important for this to remain free for the end users: the patients and the staff.

We are constantly looking to develop and improve. It is essential this works on the frontline and we are very grateful for your thoughts and feedback.

If you have a moment, please either contact us via the website (www.cardmedic.com/contact) or via Twitter (@cardmedic).

Maternity services are rapidly adapting the way they work in light of the pandemic. Pregnant women are being asked to attend antenatal appointments alone or remotely in order to reduce risk of infection. In some areas, the option to have a midwife-led home birth has been suspended.[2] A recent report from the BBC suggests that as many as one third of Trusts could have removed home birth as an option.[3]

For those who are not considered high-risk and have given birth before, home birth is often a very positive experience and clinical outcomes are good, with transfer rates to hospital and medical intervention very low among this group.[4]

There is some evidence to suggest that more women are requesting to birth at home to reduce the risk of catching COVID-19 while in hospital.[5] This will, of course, require the appropriate level of support midwives being available to enable this. Commenting on the role of midwife-led care during the pandemic, joint guidance from the Royal College of Obstetricians and Gynaecologists (RCOG) and the Royal College of Midwives (RCM) states:

“The positive impact of midwife-led birth settings is well documented, including reductions in the need for a range of medical interventions. These positive impacts remain of significant importance to prevent avoidable harm, and availability of midwife-led care settings for birth should therefore be continued as far as is possible during the pandemic.”[6]

For some women though this option is now being taken off the table. Due to the pressures on services caused by the pandemic, the RCOG/RCM guidance also includes a framework to help maternity teams understand when and how they may need to suspend midwife-led services such as home births. In some areas of the UK, this is already happening and low-risk pregnant women are no longer being offered the full spectrum of birthing choices, as recommended by the National Institute of Health and Care Excellence (NICE).[7] There doesn’t seem to be publicly available information on the extent of this service suspension.

The guidance recommends a staged approach in responding to emerging issues with staff shortages and other service pressures during the pandemic. It states that decisions about when to implement each stage will need to be made at a local level based on current local data including:

• bed occupancy in the maternity unit(s)
• community workload
• sickness rate among midwifery staff (midwives, maternity support workers and senior student midwives) 
• available midwifery staffing (including additional midwives from the NMC emergency register, those previously in non-clinical roles or year-3 student midwives)
• skill mix of available midwifery staffing – including level of seniority and experience in provision of community-based care
• availability of ambulances and trained paramedic staff, to provide emergency transfer.

COVID-19 is therefore having the direct impact of reducing birthing options available to some pregnant women.

Patient Safety Learning is concerned with the safety of mums and babies with this erosion of a woman’s right to choose the birth they want. We are hearing that:

• Some women have serious concerns and anxiety about attending hospital during the pandemic and how they and their babies are being protected from COVID-19.
• Suspension of services could have a major impact on women who are frightened to birth in a hospital setting due to past trauma.
• Low-risk women are not being offered a home birth service in some areas.
• Women are unclear as to why they cannot home birth; is it because there are safety concerns where midwife-led services were critically understaffed when responding to home births?

We think there are risks to patient safety and that there are significant questions that need to be answered:

1. Are Trusts able to evidence that their decision-making around the suspension of home births is appropriate and proportionate, particularly for low-risk women where evidence indicates good clinical outcomes?
2. Are Trusts’ decisions to suspend home births (and the basis behind these decisions) being shared publicly with the women under their care?
3. RCOG/RCM guidance gives advice on reinstating services and recommends suspensions be regularly reviewed. How regularly are these suspensions being reviewed? Is this information publicly available?
4. What steps are being put in place to preserve midwife-led services for women and their babies, whose health outcomes may be adversely affected by these changes? Are the health outcomes of these women and babies being monitored and reported on?
5. How are women being reassured and informed of their safety from COVID-19 in hospital maternity care?

High-risk pregnancies

Some pregnancies are deemed as ‘high-risk’ and these women often fall under the care of a consultant. High-risk women and their babies are more likely to need extra medical support that is unavailable in a midwife-led birth setting. They would usually be advised by to go to a hospital labour ward to have their baby where that clinical support is available if needed.

We are hearing that there is the potential for the number of high-risk women requesting to have their baby at home to rise, due to fears around coronavirus. This has serious safety implications and raises further questions around the number of experienced staff (and home birth equipment) available to support these labours. Where home births have been suspended there is also the frightening potential for high-risk women who choose not to go to hospital, to labour without clinical support. The RCM has highlighted there is anecdotal evidence that more women are choosing to birth at home unassisted due to reduced birth options and midwives are becoming increasingly concerned at the safety implications of this.[8]

Maria Booker, Programmes Director from Birthrights, a charity that protects human rights in childbirth, explained their concerns around restricted services:

"We are concerned that more women will have an unassisted birth that they have not actively chosen to have, due to the withdrawal of home births and midwifery led birth centres in some areas, which may put themselves and their babies at risk. Trusts need to be very clear that they can justify these restrictions on services as a proportionate response to their current situation and to review these decisions frequently as circumstances change."[9]

We think there are risks to patient safety and that there are significant questions need to be answered:

1. Has there been an increase in high-risk women deciding to birth at home against clinical advice?
2. Where home birth has been suspended, and a high-risk woman decides to birth at home against clinical advice, will she give birth without clinical assistance?
3. Where there is an increase in women requesting to have their baby at home, are midwives (including those returning to the profession) receiving the right support? Do they have an adequate supply of home birth kit and PPE?
4. Are there enough staff experienced and confident in supporting both low and high-risk women to labour at home? 

Safe births during the pandemic

Maternity services are faced with the challenge of adapting within unfamiliar and unpredictable territory. However, it is important that pregnant women and their babies continue to access the safest care options. There may not be a one-size-fits-all solution and the safety implications of blanket suspensions of home births, combined with a rising fear of hospitals, need due attention in order to protect mums and babies from suffering avoidable harm. Where Trusts take the decision to reduce birth options, these must be evidenced, proportionate and justifications must be made publicly available. 

References

[1] BBC News, Coronavirus: Social restrictions ‘to remain for rest of year’, 22 April 2020. https://www.bbc.co.uk/news/uk-politics-52389285

[2] The Guardian, NHS trusts begin suspending home births due to coronavirus, 27 March 2020. https://www.theguardian.com/world/2020/mar/27/nhs-trusts-suspending-home-births-coronavirus; NHS Lanarkshire, NHS Lanarkshire restricts neonatal visiting and suspends home births, Friday 27 March 2020. https://www.nhslanarkshire.scot.nhs.uk/restricted-neonatal-visiting-suspended-home-births/; The Hillingdon Hospitals NHS Foundation Trust, Covid-19 virus infection and pregnancy, Last Accessed 24 April 2020. http://thh.nhs.uk/services/women_babies/COVID-19_infection_pregnancy.php

[3] BBC News, Coronavirus: Uncertainty over maternity care causing distress, 24 April 2020. https://www.bbc.co.uk/news/health-52356067

[4] Birthplace in England Collaborative Group, Perinatal and maternal outcomes by planned place of birth for healthy women with low-risk pregnancies: the Birthplace in England national prospective cohort study, BMJ, 2011; 343. https://www.bmj.com/content/343/bmj.d7400; National Institute for Health and Care Excellence, Intrapartum care for healthy women and babies: Clinical guideline [CG190], Last Updated 21 February 2017. https://www.nice.org.uk/guidance/cg190/chapter/Recommendations#place-of-birth

[5] Anonymous, Midwifery during COVID-19: A personal account, Patient Safety Learning the hub, 21 April 2020. https://www.pslhub.org/learn/coronavirus-covid19/273_blogs/midwifery-during-covid-19-a-personal-account-r2095/

[6] The Royal College of Midwifes and Royal College of Obstetricians & Gynaecologists, Guidance for provision of midwife-led settings and home birth in the evolving coronavirus (COVID-19) pandemic, 9 April 2020. https://www.rcm.org.uk/media/3875/midiwfe-led-settings-and-guidance.pdf

[7] National Institute for Health and Care Excellence, Intrapartum care: Quality Standard [QS105], Last Updated 28 February 2017. https://www.nice.org.uk/guidance/qs105/chapter/quality-statement-1-choosing-birth-setting

[8] The Royal College of Midwifes and Royal College of Obstetricians & Gynaecologists, Guidance for provision of midwife-led settings and home birth in the evolving coronavirus (COVID-19) pandemic, 9 April 2020. https://www.rcm.org.uk/media/3875/midiwfe-led-settings-and-guidance.pdf

[9] National Institute for Health and Care Excellence, Intrapartum care: Quality Standard [QS105], Last Updated 28 February 2017. https://www.nice.org.uk/guidance/qs105/chapter/quality-statement-1-choosing-birth-setting

An ‘ad hoc’ team is a team that is made up of various healthcare workers that have never met before. An example of this is the medical emergency team or the cardiac arrest team – doctors, anaesthetists, nurses and other allied health professionals scrambled from around the hospital expected to assess and treat a patient in crisis. Often, we don’t know each other’s names, roles or what skills we each have.

What we did in Brighton is to get to know each other…

We had a MET meeting every morning. We all got together and introduced ourselves, found out what skills we all had and made full use of any learning opportunities that arose. The ad hoc team worked well. We all knew what to expect, even when a complex situation arose – we all knew who to contact and how we could get the best for our patient.

Then in comes a pandemic...

Staff have been redeployed; rotas have been changed; the usual rhythm of the hospital has disappeared. Our regular meeting doesn’t happen. This causes problems:

• Who is who?
• What skills do people have?
• Has everyone been fit tested?
• Where do we get the PPE from during a MET call?
• How do we communicate to each other?
• What is the guidance to take blood, do an ECG, defibrillate, order an X-ray during the pandemic?

All these questions and anxieties could be discussed at this meeting, but due to a change in working patterns, the change in doctors seeing different patients (Green and Red – COVID + or COVID –), its not possible to meet up. Our technical skills are not a problem – the team have great skills in advanced life support, using life saving equipment. What we are finding difficult is the non-technical skills: communicating, tone of voice, body language. It was hard enough to communicate in a high stress situation before all this pandemic… now its even harder and so much more important!

Simulation

Simulation has been a large part of how we train in low volume, high risk scenarios in hospital. Cardiac arrests, medical emergencies, emergency intubation, transfer, pacing… you name it we have probably simulated it here at Brighton.

I have been on the medical emergency team for 9 years now. I like to think I have experience in most emergencies and know what to do and who to call. All of a sudden, I feel a novice. I don’t even know how to go into the room correctly, I don’t know what I should take in to the room, I don’t know what I should wear; every action, every protocol I would normally do can't happen due to current constraints. I am worrying so much that I feel paralysed to do anything for fear I’m doing it wrong.

We have simulations every day at 3 pm at our hospital. These simulations are very low fidelity and include how a medical emergency or cardiac arrest in the COVID-19 patient should run.

Simulation can never replace what a real-life scenario will feel like. What simulation can do is allow you to understand what needs to happen, in what order and lets you make mistakes in order for you to learn. Most adults learn from ‘doing’ and from experiences – I am so glad we had this simulation as I was about to attend my first MET call a few days later.

My experience attending an airway medical emergency

The call went out. "Medical emergency XXX ward – COVID positive". Shortly followed by "Anaesthetic emergency XXX ward- COVID positive".

I ran faster knowing that as a team we all had to get there and put full PPE on before we could attend to the patient. If the patient has an airway problem, they will not be able to breathe properly and be at high risk of stopping breathing.

I remembered at the simulation exercise that one person needs to be the ‘gate keeper’. I decided to take on this role as I wasn’t sure who had attended the simulation before and knew about this role.

My role as gate keeper is to make a note of who is in the room, what role they have and to take messages in and out of the room from the doorway.

The notes are not able to be taken into the room, so it would be the gate keeper's role to get the information across to the team inside. I was opening and closing the door and trying to hear muffled voices; I was equally trying to convey important medical information, but they couldn’t hear me well enough. It didn’t help that for many of the team English is not their first language; this made it even more difficult.

Our anaesthetic team simulate situations on a regular basis as part of normal work. They turned up at the call already kitted up in PPE and wheeling a trolley with everything they needed on it; all their drugs and equipment were there.

One of them – the lead anaesthetist – had a headset on which was connected to a walkie talkie. This made conversing with the team so much easier. We could ask questions from outside the room into the room and vice versa without having to open the door. Clearly, they had rehearsed this scenario before – they too couldn’t hear well so had solved the problem by obtaining walkie talkie devices.

They asked for equipment, called for X-ray or asked for more information and I could either relay information, pass equipment or order tests for them – so much easier and safer.

The patient had a complex airway and needed to be seen by a specialist. A consultant arrived; one I had not met before. He arrived anxious. He was worried about donning the PPE in the correct order and in swift time. I helped him donn and, while I did that, I reassured him on who was in the room, what had happened and what treatment the patient had had. He entered the room knowing he had the right gear on and what he was facing. This enabled him to think clearly and treat the patient.

When it was time to transfer the patient to intensive care, we came across a problem. We had two differing protocols. One was from yesterday, the other was rewritten this morning… which was correct? This was quickly cleared up by calling the author of the protocol, but what would happen at 3 am if this was to happen again?

Reflections

It was my first time as gate keeper. To be honest, I didn’t know what I should be doing… some of the information from the simulation flew from my mind. Looking back, I should have asked for the name and role of who walked into the room and wrote it on their PPE or used stickers. People were in such a rush to get in and save the patient's life that it didn’t feel like a priority at the time.

The walkie talkies were a genius idea from the anaesthetists – this is something that I will take back and see if we can implement the same for all MET calls (anaesthetists do not attend MET calls normally). It reduced the opening and closing of the door, which reduced the amount of aerosoled particles to come out from the room that may increase risk of infection to others.

Flattened hierarchy – the moment I had with the consultant outside that room was something I hadn’t experienced before. I noticed his vulnerability, he looked for me – a nurse – for reassurance and guidance which was given with no judgement. At that moment we knew we were one team.

Protocols keep changing. We are working where national guidance and local policy changes daily. Without robust ways of disseminating this information we run the risk of doing the wrong thing. As clinicians we are not at our desks monitoring for changes in guidance – we need ways of getting this information to us. We use the ‘workplace’ app – we have a ‘microguide’ for all our up to date policies. This is great to use in normal circumstances but when dressed in PPE we are not always able to access our mobile phones.

I wasn’t inside the room. I could see the patient. I could see that he was scared. He couldn’t breathe, he was unable to talk anyway due to his altered airway. How were the team communicating with him? How was he being reassured? Our facial expressions say a thousand words – behind a mask the patient sees nothing. I have heard of the CARDMEDIC flash cards, but can we use them in an emergency? Perhaps we could add them on to the cardiac arrest trolley?

The patient is doing well on intensive care now. It would have been ideal for us to debrief; however, half the team go with the patient the other half of the team need to get back to other sick patients, so this can't happen. So much learning comes from these calls; we haven’t got this bit right yet.

Our pregnant women are still being offered good choices in their birth experience such as homebirth and water birth, so long as they are well. I did two lovely home births this week. We are definitely seeing a rise in people transferring to our homebirth service. I do think there is a concern nationally about high risk women choosing to homebirth unassisted, in areas where maternity services have suspended homebirth as an option. Because women in my area still have the option of a homebirth, it’s not something we’re experiencing.

Birthing partners and limited visits

Partners are allowed at births including cesarean sections. Also, we’ve had lots of very positive feedback from the women to say that not having their partners or visitors on the wards hadn’t been as bad as they thought, as they have talked and bonded more with other new mums and made new friends. It’s difficult for them without the support of family in the postnatal period but with encouragement they can usually see it as a positive, a time for them to bond as a family and get to know their little ones. Dads are actually very positive realising that it means they get to spend much more time with their partners and new baby.

Appointments and new ways of working

My Trust are doing just as many face to face antenatal visits. We do virtual appointments at booking and 16 weeks in the vast majority of cases but GPs locally are refusing to see women at 25 and 31 weeks, so we have changed the schedule to include these in midwifery care. We are using well midwives, who are isolating at home for whatever reason, to do phone clinics for booking and 16 week appointments which lifts the pressure off those of us working clinically. They also ring around all of the women due to be seen to make sure they’re well and understand that they need to attend appointments alone. I’m a case loading midwife so I know my mums to be/new mums well and do feel I’ve been able to support and reassure them effectively. I know that sadly not everyone is in this position though.

Staff levels and wellbeing

Annual leave has been cancelled. Nobody has complained about this though (or at least nobody that I’m aware of). We were expecting it and realise it’s vital. Lots of staff are also picking up extra shifts. If staffing levels drop though the pressure will be enormous.

My trust have been very proactive regarding training and we are all being supported in terms of wellbeing. Accommodation has been provided for staff unable to go home and wellness packages and mental health support is in place. We’ve even been provided with a pop-up supermarket.

Our local community are also amazing. Most staff could access a free hot meal most days if they chose to from various donations, school, restaurants and local sports teams. Hand cream, treats, snacks etc are always coming in. We feel so appreciated and loved

One of our biggest issues is PPE

Even for confirmed COVID-positive women we are given less protection than we are normally given when caring for women with flu. Working in community, this has its own issues. Statistically we know that the chances are that viral loads in homes are likely to be high due to the number of people present in small spaces, more soft furnishings, less stringent cleaning routines etc. The apron and mask we are given are unlikely to offer us any real protection.

When we leave the houses we then have to transport the contaminated personal protective equipment (PPE) in our own vehicles, we’re wearing uniform that is likely to be contaminated and we are stood on pavements trying to clean the equipment we have used because that too will be contaminated. We’re not protected in the same way that hospital staff are. We are walking in to homes where there may be 4 or 5 people in the same room that we need to be in, as everyone is at home.

We keep being told effective hand washing is key but we’re doing that in environments which are often less than clean, and in cases of COVID-confirmed women we can’t wash our hands at all as we’re unable to remove our PPE until we’ve left the house. It all feels very unsafe both in terms of staff contracting COVID-19 and cross contamination to other women, colleagues and our family.

The support we are lacking comes from Public Health England and the Government. PPE guidance and availability is pitiful and dangerous and I believe is based on availability rather than need or any scientific basis.

Do you work in maternity services? Or perhaps you are expecting a baby?

Does this midwife's account reflect the maternity services in your area at the moment, or are you seeing different positives and challenges? We want to hear from patients and staff, so please sign up to comment below or contact us directly (content@pslhub.org) to share your story.

Those involved in social care have been calling for the introduction of long-term reforms to ensure that it is fit for purpose, that care workers are invested in and that appropriate support is in place for unpaid carers. Going into the 2019 General Election, all parties recognised the need to reform the system and the Conservative Party was elected on a pledge to find a long-term solution for social care.[

As the impact of the pandemic now takes hold, the ability of the social care system to respond to these issues is beginning to come into focus. In this blog, we look at the emerging patient safety issues the pandemic is creating in the sector, focusing on four main areas:

1. Staff safety and lack of access to appropriate personal protective equipment (PPE).
2.  The pandemic’s impact on existing social care and provision for non COVID-19 patients.
3.  The impact on carers and families of those receiving social care.
4.  The reporting of COVID-19 deaths outside of hospitals.

In response to these issues, Patient Safety Learning have identified some essential steps that that can be taken at a national and local level to tackle some of the most urgent patient safety concerns:

Staff safety

• PPE distribution to social care should be treated with the same urgency as it is for healthcare.
• Clear guidance should be provided on PPE requirements for specific social care roles.
• Clear guidance should be provided on what steps staff can take to report problems accessing PPE.
• Steps must be taken to ensure that there is enough staffing and volunteer capacity to enable staff to work safely.

Patient safety

• All patients and social care service users should receive the care requirements outlined in their care packages.
• There should be clear guidance on what steps families and staff can take to report problems in service provision or to report safety concerns.

Mitigating the impact on existing care and treatment

• The rollout of testing for COVID-19 in social care needs to increase as soon as possible to identify and isolate outbreaks.
• We need to work with care providers to support the continued provision of services and provide adequate staffing levels during this period.
• We must work with third sector organisations to help provide guidance and support for carers and families.
• We need to ensure that the extra funding committed to the healthcare system is also available to provide to social care.

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

1.  Gov.uk, Call for business to help make NHS ventilators, Last Accessed 15 April 2020. 
2. Medicines & Healthcare products Regulatory Agency, Rapidly Manufactured Ventilator System, 10 April 2020. 
3.  Chartered Institute of Ergonomics & Human Factors, Human Factors in the Design and Operation of Ventilators for Covid-19, Last Accessed 1 April 2020. 
4. The Guardian, UK missed three chances to join EU scheme to bulk-buy PPE, 13 April 2020. 
5. The Guardian, How the UK plans to source 30,000 ventilators for the NHS, 26 March 2020. 
6. The Guardian, How close is the NHS to getting the 18,000 ventilators it needs? 14 April 2020. 
7. Health Service Journal, NHS needs a third fewer ventilators than forecast, says Hancock, 5 April 2020. 
8. Gov.uk, Regulator approves first Ventilator Challenge device, 16 April 2020. 
9. The Guardian, UK scraps plans to buy thousands of ventilators from Formula One group, 14 April 2020. 
10. Financial Times, Ventilator standards set out for UK makers ‘of no use’ to Covid patients, 15 April 2020.
11. Medicines & Healthcare products Regulatory Agency, Rapidly Manufactured Ventilator System, 10 April 2020.
12. Financial Times, Ventilator standards set out for UK makers ‘of no use’ to Covid patients, 15 April 2020. 
13. Ibid.
14. Medicines & Healthcare products Regulatory Agency, Rapidly Manufactured CPAP System (RMCPAPS), 29 March 2020. 

Imagine your loved one is in hospital. They are in intensive care, dying of coronavirus. They are scared and alone. You are not allowed to visit. You are not able to share the last moments with the person you have shared your life with. You are heart broken.

Nurses caring for the dying are also heartbroken. We feel we have let you down, we feel helpless, we feel that this virus has already stolen so much from you.

A phone call to say your loved one has died is not enough. It feels cold and unsympathetic.

I was sent an idea by a colleague who saw a tweet by staff at Huddersfield Royal Infirmary. They had an idea that hearts would be shared by patients and relatives. This was a fantastic idea.

With that seed planted, I did a call out on my Facebook page for crafters in the community to make hearts. They could be knitted, quilted, sewn, crocheted or felted, just as long as they are about 6-7cm in size

.At this point I hadn’t got permission to do this or even thought of the process. Too late… .the first bag of handmade hearts had arrived with in 12 hours of the initial call out!

The process:

• Your patient is identified as dying and is given a handmade heart.
• If they are on the ward, a relative might be present. They will be able to choose a matching heart.
• The heart is placed with the dying patient and the relative keeps the matching one.
• Once the patient has passed away, a card with personalised message from the nurse is sent.
• If the patient sadly dies alone, a heart is placed with the patient and the matching one is sent, along with the card, to the next of kin.

I needed to get others involved but every team in the hospital is busy.  Would they even be interested?

Our palliative care lead, Steve was the first person I spoke to. He was really keen and introduced me to the Patient experience manager, Jane.

Together we came up with a design for the card and finalised the process. We then needed posters and a question and answer sheet for the wards. Emma, one of the critical outreach team is shielding, so we used her expertise in poster design and excel to organise the process sheets and a distribution list.

With money donated to the Brighton and Sussex University Hospitals Charity we bought baskets to place the hearts in  and paid for printing. The whole project came to life a matter of days. The red tape has seemed to have disappeared. Instead of endless meetings and blockers, quality improvement projects are coming to life quickly, its liberating!

People from across Sussex have donated their time, materials and love in making these hearts. One lady in her 80s has said that she has felt helpless during this pandemic, but since hearing of this campaign, she feels that she now has a purpose and can support others.

Deaths are not statistics, they are our mothers, father, sons, daughters, brothers, sisters, uncles, aunts, cousins and friends. Every life matters. As a community we care.

We would love to see all hospitals and care homes take on this initiative. For more information, please contact me: Claire@patientsafetylearning.org

Normally, I probably wouldn’t call in sick, I would have just carried on. Following current guidance, I called in sick and was advised to take the next 7 days off. At this point testing was unavailable for NHS staff. I was sat at home not knowing if I had the virus or not while my colleagues were having to pick up the slack.

If I am completely honest, I was glad I didn’t have to go back. I was anxious that we didn’t have the right personal protective equipment (PPE), systems for donning and doffing were not in place, we didn’t know what to expect over the coming days, training for redeployed nurses and doctors was not happening. I just didn’t want to go back anyway. I felt a coward.

Over the coming days while I was at home, my husband then became ill, then my youngest son, then the eldest. All with mild symptoms, but still no idea if we had it or not. While I was off, I was contacted by the ‘staff welfare team’. It was just a quick phone call to see how I was, but it made all the difference. I felt like I wasn’t just a ‘worker’ off sick, I was someone that they cared about and were obviously keen to make sure I was coming back! This has never happened before.

Reluctantly, I return to work, but it was like I had stepped into a different Trust.

Wards with infected patients were labelled as RED wards; huge signs were outside the wards with designated places to don and doff PPE. There were clear guidance on which PPE to wear displayed in poster format. There were green footsteps and red footsteps on the floor enabling you to know which area you were in. PPE safety officers had been deployed to reassure and ensure all departments have enough stock.

It felt safer.

Leadership at all levels is being tested at this time. Where I work in Brighton, we are invested in ‘Patient First’. This is headed up by our Kaizen Team. All staff are trained in differing levels of quality improvement (QI). All wards and departments have improvement huddles, where they can raise a mini project and see it through. We all speak the same QI language.

I dread to think what would happen if we didn’t have this in place during this awful time. By having this process, it has empowered ALL staff to speak up and give permission for frontline staff to improve processes where they work.

Our executive leadership team have done an amazing job in such a small amount of time. They have increased ITU capacity, they have reshaped rotas, redeployed staff, re employed staff, transformed patient pathways (red and green pathways), pooled staff, set up systems for donations…

There has been so much achieved in a short amount of time; the top-level organisation has been incredible. All this in seven days.

They have been phenomenal at strategy, planning and overall management and leadership of what I call ‘the big stuff’. What they are not so good at is the ‘small stuff’. We, frontline workers are brilliant at this. The practicalities of work – where can I don and doff, where the bins should be, how do I know this bed has been cleaned? What do we do when someone dies? Can relatives visit? How do we know who is who in PPE? How can we make sure we don’t contaminate clean areas? How do we take blood now? We know what needs to be improved, we know what is missing.

It’s the small details that worries staff, it’s the small details that can save lives.

As I was walking seeing patients from different wards, I heard staff saying – this isn’t right – we could improve that. They can raise a ticket on the huddle board and they could initiate the change. If the change could be replicated else where in the Trust, the Matron or ward manager can then raise it at the Bronze meeting, the bronze would then raise it to Silver and then implemented.

I often hear that we use a top down, bottom up approach but never really thought it works, as there is so much red tape involved in healthcare. Quite often frontline ideas never reach the top level and they fall flat. This time it’s very different.

To test the system, you need to stress the system.

This system of QI and communication is working. We are all learning together. None of us have dealt with a pandemic before. Frontline staff have been given the permission to improve the way real work is done, quickly and safely, while the top-level management are concentrating on strategy, planning, implementation and co-ordination of services.

We are listening to each other, we are rapidly changing and adapting, the whole Trust is in a constant state of PDSA cycles. It feels dynamic, proactive and controlled.

If this pandemic happened 10 years ago in our trust, I am convinced that we would not be in the position we are now. We have enough intensive care beds, we have the capacity to expand further, we are ready.