Together with our volunteers, we’ve spent the last couple of days intensively diving into the world of repair of critical care medical equipment and ventilators. Our research-from-home raised some really concerning questions.
The starting point — ventilators
In the UK, critical care equipment is a serious issue. Many have observed we have one of the lowest rates of critical care beds per capita.
The ventilated beds situation is not much better. Research from last year revealed:
Ventilated beds per 100,000
Australia – 10.51
NZ – 5.93
UK – 5.64
This is probably why the UK government announced an effort to seek out new manufacturing capacity for ventilator equipment. The media paid this announcement a great deal of attention, and we’ve seen much debate and criticism of this initiative. At the same time, many are working on “open source” designs.
But are we ready to repair what we ventilators already have?
But we’re really worried that not enough attention is being paid to the maintenance of the equipment we already have. This is equipment that NHS staff is already trained on. Even during “normal” times, the equipment needs regular servicing. But we don’t know how well it will do under constant use, for weeks at a time.
We’d love to learn that there is a silent, big effort under way to deal with all of the issues we’ll raise below. We’re just watching from the outside.
In looking at documents from NHS Supply Chain, we rely on 11 companies for intensive care ventilators. Of these, six are also providers of repair services and maintenance contracts.
One of these companies is known to aggressively force well-meaning people sharing their repair manuals to stop. Two more are extremely large multinational companies known for their tight control over supply chains.
When existing arrangements break down
The case of the emergency 3D printing job in Brescia, Italy that saved ten lives when manufacturer supply chains failed gained the world’s attention. Especially because the manufacturer threatened to sue.
It appears in the medical tech space, manufacturers mostly control access to spare parts, there are few to no third-party vendors. What happens when manufacturers fully control supply chains and these are disrupted? Are we prepared for this both technically and in a legal sense? (Dark Matter Labs raised these questions during calmer times.)
Much of NHS equipment is covered by service contracts which probably restrict options in terms of repairs. Then at any given time, equipment goes without a service contract. What in-house or independent “surge capacity” exists for servicing this equipment?
In digging deeper, we learn from NHS Supply Chain that — this appears to be for all equipment
- 80% of maintenance contracts are renewed late / allowed to lapse before renewal.
- 30% of contracts are renewed more than 90 days after the current contract expiry date.
Key skills – testing and component-level repair
Based on initial conversations we’ve had with industry friends, we have reason to be worried that service of medical equipment has become simplified to the point of being very dependent on international supply chains. “Repair” of circuit boards has become swap out the old for a new one. What if the new one is simply not available?
While in other industries, the skills still exist to take a circuit board, test and detect faults, and replace components, does the medical tech industry have these skills? Do engineers have the documentation and test kit they need to do this quickly?
Are complete testing procedures in place for all of the equipment owned by the NHS?
These skills could be borrowed from the armed forces, or other industries, but we hope these skills gaps are being identified urgently.
Investigating “obsolete” ventilators in storage
In the US, a recent study estimated there could be as many as 100,000 extra ventilators held in storage, deemed “obsolete”. Experts are asking whether this could be brought back into service.
An advantage here is that the equipment has been tested, service and training materials already exist for them. Volunteers could even be brought out of retirement to help.
What is the situation in the UK?
There are businesses that help decommission and resell equipment deemed “obsolete” here. They should have a seat at the “war room” table, as should independent service providers and businesses that help them test and conduct component-level repairs.
There’s a great thread currently in development on the UK EBME (Electro BioMedical Engineering) forum , where experts are discussing how best to meet the capacity needs for ventilators, starting with making the most of existing equipment. Here is a great quote from one of the contributors:
Hospital trusts will soon be realizing that EBME departments have a huge role to play in this and we may now be getting some very much overdue airtime. It is our responsibility to email everyone who needs to listen. Put your suggestions forward and dont stop until they listen. Do the same to your local MP too.
Amazing piece, thanks for putting resources and much effort in bringing this important subject under the spotlight. I talked to a leading NHS contractor that said most OEMs charge tens of thousands of pounds for replacements PCBs because they can. And that the lead-time ranges from several days to weeks, time that we don’t have!
Excellent topic to raise. I co-founded Cornwalls first Repair Café and as an electronic engineer have spent most of my life repairing things, I wonder how to offer our services locally?
Need to collect equipment info
https://www.ifixit.com/News/36354/help-us-crowdsource-repair-information-for-hospital-equipment
This is my opinion based on a decade of work in the EBME of a large hospital quite a long time ago. I hope it goes some way to explaining the issue. I can’t comment specifically on ventilators as I only ever worked on neo-natal types.
The problems with component level repair by EBME technicians are: the huge variety of types and models of equipment in use and the sophistication of most devices which makes specialised diagnostic equipment more or less vital for success.
To expand a little: infusion devices (pump fluids into patients blood vessels) are produced by a number of different manufacturers, often producing multiple models (adult and paediatric versions for example) for the same basic function; there were also assorted syringe drivers The same applies to ECG monitors and oxygen saturation monitors , non-invasive and invasive blood pressure monitors and the multi-parameter monitors that became common two decades ago. And this is just a few that you have probably heard of. Just being familiar with how to operate all of them took work. They may all use the same principals but there was a lot of variation. Some improvement to this predicament was the standardisation by the end of the 90s, on the peristaltic method for infusion devices, rather than variations of piston pumps. (I don’t know if that lasted.)
In short, it’s complicated. Fortunately the vast majority of these machines are (or, perhaps I should say, were) extremely reliable.
Thanks, Ian. Didn’t realise you had that experience. This just reinforces what other biomed engineers are saying – prioritise existing and known designs. And training is absolutely essential, not just new equipment.
I have diagnostic & repair skills plus “the basics” (hardware) here at home. I’ve been furloughed and want to use my capability to help in our current crisis – how can I do this?
Hi Tim, Seems like one of the best things we can do from home is contribute to the effort of gathering service manuals on iFixit. More on this webinar and links too https://therestartproject.org/news/repair-covid19/ – if you are an engineer in either Glasgow or Cardiff, keep your eyes open for calls for Auxiliary Engineering Support from RAENG, also mentioned in the webinar.
Thanks Janet, I’m not a Bio-med engineer, just someone from the era of fault-finding to component level on PCBs, twiddling his thumbs… I’ll watch the webinar with interest and check out iFixit.