Anyone for out-of-date PPE?

Friday 22 May 2020

Can you trust PPE that has expired?

Can you trust PPE that has expired?

 

Sometimes, what I see forces me to double take, especially as we Londoners are being reassured that life is inching better. For so long I have heard the sound of ambulances in the background as yet another sad case of Covid-19 is fast-tracked to hospital. Those are fewer now, as the capital’s hospital admissions are steadily declining. Today I saw no ambulance, but I did see a hearse outside a house. The sight brought it home that so much of what my country has been doing, over the past few months, has been to stop folk from dying. Today was evidence of failure, there have been plenty of those in past weeks, as another unfortunate had chosen to die at home. The hearse was my reminder that there is still a way to go.

The situation this morning - 22 May 2020 (courtesy Center for Systems Science and Engineering at Johns Hopkins University)

The situation this morning – 22 May 2020 (courtesy Center for Systems Science and Engineering at Johns Hopkins University)

Each morning, my first act is to check the chart of global Covid-19 put together by the USA’s Johns Hopkins University. Anything in red is infected, anything dark grey remains clean. Over the last three months, I have watched the red blotches slowly expanding worldwide. Once it was China, then that became smaller. Then it was Europe, and next the USA. Now, North America is a massive red splodge while South America is hot on its heels. Africa is slower but that, too, is becoming redder, especially in its west. There are few countries unaffected. Remote Pacific islands have the disease, Greenland has it, Iceland has it, and other countries of which I have never heard. Antarctica looks still to be free of Covid-19, so I have placed it on my list of future destinations, once mankind allows itself to travel. But for each of these infected lands, the hearses will be busy, their peoples both suspicious and sad. Survival does that. If you wish to stay alive, you must be wary. Imagine there is something out to get you at all times. In reality there probably is.

To emphasise my worry, I had a mobile call from a friend only yesterday. He works in healthcare and is at the tip of the frontmost frontline. He is doing his best in a care home, the sector that was so clearly ignored and only now is coming to the fore. His care home, as with so many others, has had its fair share of tragedy.

‘They’re out of date,” he half shouted in a way that made him hard to understand. When he hollered, and I listened, my mobile crackled.

“What’s out of date?” I asked.

“The masks. The bloody masks. The idiots have sent us PPE that expired ages ago.” His once confident tone had changed. I sensed he was frightened and yet he is not someone who scares easily.

His story then burst out, his words so rapid I could barely make sense of what he said. His care home was busy, it had already suffered numerous deaths, and the staff needed maximum protection. As it was, nearly 20% of the staff were isolating, either through disease or because they were worried. Most healthcare workers these days know of colleagues who have perished. However much our government may wish this country to feel bright and happy, behind the scenes there are plenty who must still deal with the virus and will be struggling with its effects for a generation. These healthcare workers remain at risk and still need the protection they have been promised.

It may look good but does it work?

It may look good but does it work?

Expiry dates are a big deal in modern medicine. Most drugs and items will carry a date stamp, just like a bottle of milk from the supermarket. No one, ever, uses time-expired items. At least that was how we were all trained. On very rare occasions, when I have worked in remoter countries and have exhausted my normal supplies, I might resort to using out-of-date items. I feel guilty if I do and know I am not alone with that shame. These days, even the less advantaged countries turn up their noses at out-of-date supplies.

When it comes to medicines, since 1979 the US Food & Drug Administration (FDA) has required an expiration date on everything, whether prescription or over-the-counter. This is on the basis that expired medical products can be less effective, or even more risky. Some drugs can actually change their composition as they age. For example, certain antibiotics, as they decay, can encourage bacterial growth rather than inhibit it.

 Aran Maree, Chief Medical Officer for Janssen Pharmaceuticals was asked, “How bad is it to take medicine that’s past its expiration date?”

He replied, “It’s really not a good idea to take expired medication at all.”

The UK’s NHS supports him by declaring, “You should not take medicines after their expiry date.”

For medicines, it is clear. Only under exceptional circumstances would you consider using time-expired drugs. Mind you, not everyone would agree. Despite requiring all medicines to carry an expiry date, the FDA once undertook a large study at the request of the US military, which had a huge, expensive stockpile of medicines that were way out of date. Surprisingly, the research showed that 90% of the medicines studied were perfectly good to use, even 15 years after the expiry date. It was evident that the cited dates were very conservative.

So much for medicines. How about equipment, facemasks in particular? What is the likely effect on my friend if he uses a mask that is out of date? From a user’s viewpoint, you need to trust your equipment. When at the frontline, you must focus on the patient and not on yourself. Let me start with the mask itself and what is called filtration efficiency. This is the percentage of contaminant, virus, particle, whatever you decide, that can be filtered out by a mask’s material. The aim is for as little contaminant as possible to pass through the mask.

There is also a problem with terminology. There are masks and there are respirators. A mask is one of those blue, green or white things that I see strolling the streets of London, or on good-looking characters during an episode of Holby City. Masks were what I wore for my entire surgical career, are typically donned for a specific procedure and discarded afterwards. They are designed to stop me infecting the patient rather than the patient infecting me. However, a surgical mask does protect me from blood splatter should an artery encounter my knife.

Respirators are different. They must be properly selected, properly put on (donning) and properly removed (doffing). They should be worn all the time when in an infected area. To remove a respirator for only 10% of the time can significantly reduce its protective effect. Most of the white, bell-shaped, mask-like devices shown on video clips of frontline Covid-19 care these days are respirators, not masks.

In brief, masks stop things coming out, while respirators stop things going in, seen from a wearer’s viewpoint.

Filtration efficiency is measured as a percentage. The lower the percentage, the better. Ideally, a mask or respirator should have an efficiency of <5%, which means that only 5% of bad stuff will reach the wearer. That is, a mask should filter out at least 95% of what passes through it. If this happens, a mask or respirator is called N95 in the USA, or FFP2 in UK.

In practice, the UK goes one better and for procedures that may create an aerosol, uses a mask with a FFP3 rating, equivalent to N99 in the USA, and which will filter out 99% of bad stuff. Only 1% gets through.

When it comes to filtering out the virus, Holby City surgical masks are not the best. A filtration efficiency of 50%has been reported. That means half of what hits the outside will pass through and reach the wearer. On a Covid-19 ward, that is the last thing I would seek. For me, I want a respirator, please. This should be at least FFP2 (or N95) but ideally FFP3 (or N99).

You would not want to trust this near Covid-19 (Anna Shvets)

You would not want to trust this near Covid-19 (Anna Shvets)

Enter expiry dates and whether these are important. To say that a mask is ineffective once it gets past its expiry date is wrong, although one cannot be complacent. For example, the Centers for Disease Control and Prevention (CDC) in the USA looked at this, albeit for N95 respirators, and concluded:

“Consideration can be made to use N95 respirators beyond the manufacturer-designated shelf life for care of patients with COVID-19, tuberculosis, measles, and varicella. However, respirators beyond the manufacturer-designated shelf life may not perform to the requirements for which they were certified. Over time, components such as the straps and nose bridge material may degrade, which can affect the quality of the fit and seal. Many models found in U.S. stockpiles and stockpiles of healthcare facilities have been found to continue to perform in accordance with NIOSH performance standards.” 

NIOSH is the US National Institute for Occupational Safety and Health.

The CDC has also stated that an expired respirator may offer more protection than a standard surgical mask, and certainly more than wearing nothing at all.

Dr John Balmes, Professor of Environmental Health Science at Berkeley Public Health stated:

 N95 masks really don’t expire in terms of their functionality. The only part that is subject to damage over time are the elastic bands that attach the mask to the user’s face, which can be damaged by sunlight.”

Most research in this area has involved the N95 designs. Conclusions about other designs are sometimes extrapolations from N95 studies, not necessarily proven fact. It is only a presumption that results for N95 will also apply to, say, N99 (FFP3).

I wanted to know how it was that a friend at the frontline of healthcare was being put through the purgatory of being asked to use a time-expired respirator. Other investigators had been there before me. A news channel in UK, Channel 4, prepared a short documentary about the UK’s PPE stockpile being out of date. Their findings were truly frightening. The country had created a stockpile of PPE after the first SARS epidemic in the early 2000s. The need to do this was emphasised by the H1N1 influenza pandemic in 2009. There was plenty of PPE purchased at the end of that year. Stockpiling, which by its very nature requires prolonged storage, demands massive quantities of equipment.

For example, during the SARS outbreak in Toronto in 2003, in one hospital alone, Sunnybrook Hospital, 18,000 N95 respirators were needed every day. Their filtration performance was not significantly degraded by storage of up to ten years in warehouse conditions. Length of storage seemed to make no difference. This conclusion was not necessarily true for all makes of respirator, or for attachments such as face straps.

Nationwide, for a 42-day influenza pandemic outbreak, the USA calculated it would need 90 million masks, an astonishing number. Imagine how many masks would be required worldwide and it is easy to see how a country can run out.

When the UK was faced with this problem, a shortage of PPE, the stockpile had to be used. Much of it had been bought in 2009 and thus, by 2020, had become time expired. This is where a problem started. Instructions were issued from on high, without explanation to the frontline staff, that it would be fine to use time-expired items. Healthcare is an occupation where those receiving instruction are used to asking questions. It is what medics do for a living. No frontline staff member is likely to believe a bigwig just on say-so, especially if the bigwigs themselves are not exposed to frontline risk.

PPE redated by five years (Daily Mail)

PPE redated by five years (Daily Mail)

3M, the company that made the respirators, recommended that out-of-date items should be tested. This was performed by an independent testing company and it was then decreed by the Department of Health & Social Care (DHSC), that the time-expired respirators could be used, and their life could be extended. The filters these masks use are inert and appear to have a lengthy shelf life. The results to support this decision? I have no idea. I have asked for them, others have made the same request. So far, nothing has been provided.

As the pandemic peaked and cases were pouring into hospital, there was no time to waste. Masks and respirators were sent out to the healthcare facilities quicker than it takes to blink. Some of the expiry dates were adjusted, others were not, no results were made available, and little explanation appears to have reached ground level. No wonder healthcare professionals were upset, remain so, and my friend was ringing in a state.

This was simply poor communication.