#COVIDaction: Ventilators and Oxygen Package update
Since Monday 16th March, DFID’s Frontier Technologies Hub has been leading #COVIDaction — a collaboration with Global Disability Innovation Hub and UCL’s Institute of Healthcare Engineering.
As a first priority, the initiative set out to find proven, frugal innovation in ventilators designed for emerging markets, to be used globally in the fight against COVID-19. At the time we launched the scan, ventilators (along with PPE and testing), were seen as the most urgent resource requirement in the emergency response to the COVID health crisis around the world.
Now, one month on, #COVIDaction partnership will soon be launching a platform housing COVID-19 related IP for download and use the world over, yet this platform doesn’t feature a single ventilator. What’s changed?
This post is a summary of how the situation has evolved as global understanding of the disease improves, why we won’t be showcasing ventilators when our initial platform goes live this week and what we’ll be doing next.
First, we always adhered to the guidelines set by Medicines and Healthcare products Regulatory Agency (MHRA) for ventilators. This past week, those regulations changed significantly, making a number of ventilators that were being considered for approval largely redundant for use in the UK. We have taken this change — and the enriched understanding of the disease behind the change — seriously.
We have worked closely with clinical colleagues from the beginning. Today those colleagues tell us that COVID patients in intensive care require suctioning due to copious secretions. They tell us that in order to limit long-term adverse outcomes, it is vital that clinicians are able to limit the time patients are ventilated, meaning ventilators need to be responsive enough to support patient breathing as sedation is weaned. Finally, ventilators need to provide effective pressures even when lungs become stiff as the disease progresses. Taken together, the emerging clinical complexity of how the disease evolves, means that COVID patients require ventilators with sophisticated software and a highly agile interface making it possible for the intensivist to adjust all the parameters to meet the individual needs of the patient.
In addition to this change in understanding of the disease and the resulting evolution of regulation around ventilators, we also know there are important and encouraging results emerging from the early use of non-invasive oxygen therapy through devices like CPAP (continuous positive airway pressure, a non-invasive air source). Data is showing that administering CPAP prevents a significant number of patients from needing invasive mechanical ventilation.
An open-sourced design for the CPAP Ventura by UCL has been approved by MHRA and is currently being used across the NHS. Given these devices are less complicated and easier to use by staff on the ground, we believe CPAP devices will feature more prominently in treatment packages for a range of countries.
Of course, with all that said, countries will decide for themselves how best to implement the optimal strategy for ‘net patient benefit’ relevant to local context. The increased pace of approval that has been crucial to the development of solutions, must be balanced with ‘advance market surveillance’ to monitor and evaluate a medical device’s performance on the other side of its implementation.
The quicker a device moves through the regulatory process, the more work needs to be done on the other side of its implementation to monitor and evaluate it. This post market surveillance (PMS) is a complicated process — and many Lower and Middle Income Countries (LMIC) may not have the infrastructure to support vigilant PMS.
Instead, our best current understanding suggests quite simply: devices being brought into LMIC healthcare systems must be proven, or meet the most recent WHO specification. These devices must be implemented with a whole system approach that considers whether intensive care is the best use of limited resources for a local population, and whether there is the necessary broader infrastructure to support the maintenance, appropriate use and risk management of a ventilator if things go wrong.
The Frontier Technologies Hub exists to explore the application of technologies to the biggest challenges in development, COVID-19 is one of the biggest challenges yet. With much global focus on the direct response, #COVIDaction will, as a next priority, turn its attention and resources to support the ‘indirect response’ technology innovations that are and will continue to be critical to families and communities battling the pandemic.
The Hub will continue to do what it does best: scanning for good ideas, evaluating and making sense of what we find, teaming up with experts and those with deep sector expertise to inform our work and give the most promising ideas the best possible chance of success. We will also continue to share what we learn as we go, warts and all.
Next we will turn our attention to a range of areas we are hearing are most needed: Local Solutions and Local Production, Digital Health Services, Data, Digital Distribution, and Digital Financial Support.
We will be launching new themes this week and we’ll also be inviting you to inform what we do after that.
I would like to thank The Hub’s many esteemed clinical and regulatory colleagues who have advised us along the way, including Dr Sara Hamilton who co-authored this post. Sara is an academic clinician who has spent the last decade implementing innovation within frontline NHS systems. Since March 2020, Sara has been an independent advisor to MHRA on Rapid Manufacture of Ventilators in the ‘Clinical and Technical advisory group’.
