Surgery's Dirty Secrets Panorama

Surgery's Dirty Secrets

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The tools of a surgeon's trade are of vital importance, and can mean


the difference between life and death. Every single thing that is


handed to you need to work. what if it doesn't? I just cannot


tell you how bad this is. We reveal the truth about where our surgical


tools are made, and expose the weaknesses in the systems in place


to protect patients. I cannot believe that anybody in the NHS


Every year, more than 30 million operations are carried out in


Britain's hospitals. You have someone with a serious life-


threatening condition, you're fighting to save their limb or


their life... As a surgeon with more than 20 years' experience,


this doctor understands the need better than most for surgical


instruments to be perfect. They have to be just right, it is no


good discovering that something does not work as it should do, and


having to hand it back and get another one. Any little bit of that


process blurs the boundaries towards delaying recovery, or even


resulting in terrible consequences of loss of limb or death. We all


assume that surgical instruments are made to the highest of


standards. But over the last year, I have been investigating, and the


evidence I have uncovered suggests all is not well in this industry.


Two years ago, Dorothy underwent heart surgery at Nottingham City


Hospital. The operation was a success until she can ratcheted --


contracted a super bug. I knew I was dying, I just knew I was dying.


I could not go through all that and not know, nobody could. I just


remember thinking, just let me go, I had just had enough. 10 others


operated on by the same surgeon also became seriously ill. In total,


five of the 11 heart patients who became infected died. I have


obtained a copy of the confidential report into what happened in


Nottingham. The trust's investigation found two of the most


likely causes of the spread of infection to be airborne


transmission. Micro-punctures in the search and's gloves. The trust


now insists that surgeons must wear thick gloves or two sets. There are


no official figures regarding poorly made instruments in the UK,


but we have come across three cases where sub-standard instruments have


been definitively linked to causing death or serious harm. In the US,


the Federal Drug Administration records almost 1,000 adverse


incidents involving poor quality surgical instruments every year. I


have contacted NHS surgeons who say sub-standard instruments have


become all too common. Worried about possible repercussions, they


refused interviews on camera, but three agreed to us using doubt as


to me. There is not a week goes by when


something does not go wrong. Rough edges on the instruments will slice


through my hands. You struggle with an arterial clamp and you know the


patient is pleading longer than they should because you know the


instrument is not working. You look at the rough edge of the instrument


and you think, have I just bowel with this? One NHS worker is so


concerned, he has agreed to speak out. Hello. I'm from the BBC, nice


to meet you. Tom Brophy checks the instruments coming in to the Barts


and the London Trust. He is its last line of defence. Because so


many of the surgical tools he sees are failing his tests, he has begun


documenting the faults. For me, I do not know how they made this one


that bad. This is an eye instrument. For it to have a trench, that is


not supposed to be there. It is supposed to be flat. That is a


trench. There's a tunnel. And this is used for the eye? This is just


so bad, I just cannot tell you how bad it is. Used to to grip the soft


tissue of the eye during surgery, precision is crucial. Most of the


defects identified by Tom Brophy are invisible without magnification.


In surgery, there can be devastating. He eventually finds


faults on instruments, which can trap body tissue and blood - a


serious infection risk. Other problems include Sharp, protruding


guide pins. These could puncture a surgeon's glove. He also finds


metal fragments which could break off inside the body. One example he


shows me is a heart retractor, designed to be used on infants.


This was the blade of the retractor. It is like a needle. If we had not


stopped that, it could have been potentially used on a very young


baby. Companies making instruments for the UK must be registered with


an EU body. In Britain, that is the Medicine and Healthcare Products


Regulatory Agency, the MHRA. After an increase in complaints, the MHRA


issued a warning last December, that care should be taken to ensure


new instruments are fit for purpose. However, responsibility for quality


currently rests with the suppliers and manufacturers. Tom Brophy


rejects almost one in five of all surgical instruments supplied to


his trust. He says he has even been sent used equipment, passed off as


new. In one instance, there was blood still on the actual


instruments. There was dry blood on about 11% of the order. Whatever


happened, they have re-routed themselves back into the sales


market as brand new. I don't know on how that happens, but it has.


There are more than 180 health trusts and boards in the UK. The


same companies which supply Barts can also supply other hospitals.


While most trusts and boards carry out some visual checks of


instruments, Barts is the only one to employ a specialist to inspect


them to British standards. On more than one occasion, a supplier has


rang me up and said, I have passed it on to another hospital, and they


accepted it. My answer was, of course they did, because they did


not check it. More worryingly, it was a cardiac instrument, and it


was actually corroding. Suppliers can be manufacturers or middlemen -


major companies or one-man bands. There are more than 900


manufacturers registered with the MHRA to sell surgical instruments.


The vast majority of those instruments are not made here, but


Remarkably, to thirds of the world's surgical instruments are


made in one city in Pakistan. 70% of the 916 manufacturers registered


with the MHRA are based here. That city is Sialkot. According to their


Manufacturers' Association, Sialkot produces 100 million surgical


instruments each year. Pakistan has experienced an upsurge in terrorist


violence, and Sialkot is in the troubled area close to the border


with India. The city's Chamber of Commerce has arranged for me to


visit factories which make surgical instruments for British companies.


The first factory I visit is a company called Hilbro. Its chief


executive, Muhammad Ashraf, is waiting for me. Nice to meet you.


What are we about to see? It is so noisy! This is a manufacturing


process? Wow! My goodness. Inside, dozens of machines. The sound of


the lathes and the drills are deafening. These are surgical


instruments. These will be for the UK... Do you do many contracts with


the UK hospitals? The instruments made here can pass through several


suppliers before reaching UK hospitals. Over three levels, and


sitting in 26 acres of land, this factory is one of the biggest in


Sialkot. I'm taken upstairs to the quality control room, where every


instrument is checked and inspected with a magnifying glass. What is


this man stamping? Can I see? Some of the instruments are stamped with


the names of British companies. What is this for? The company


Seward Thackray describes itself as a leading supplier to hospitals in


the UK, including the NHS. Can I have one of those to take, because


it is British? As his staff get me a sample, he has a surprising


request. You don't want people to know this is from Pakistan? We


would have to say they're from England? It is a request I would


hear more than once in Sialkot. I will find out why later. Thank you


The Chamber of Commerce also arranged for me to see another


factory in Sialkot. Again, it was claimed, busy and well-organised. I


think that was the public face that the Chamber of Commerce wanted us


to see. Professional, spotless, a good advert for the surgical


instrument industry. Whether it is Overnight, I have had a call about


one of Sialkot's smaller factories. A local translator comes with me to


Regal Medical Instruments, which does business with two small UK-


based suppliers. Inside, the conditions are a far cry from the


Poor alighting makes it difficult to see, and the dust makes it


difficult to breed. Yet here in the darkness, surgical instruments are


Upstairs is where instruments are checked before being stamped and


packed for shipping. This is where it is decided if the surgical


instrument is safe to be used by the surgeon somewhere in the world.


If it passes inspection, it is given the quality stamp, the CE


mark, at which the MHRA say provides the necessary reassurance


that the device is safe and fit for purpose. Unlike the other factories


but I have seen, there appeared to be no magnifying glasses. What


checks we see being carried out on made with the naked eye. This is


the quality control stamp? Yes. I have a go? What do I do? You have


checked that one? Do I have to check it for quality? I am allowed


to stand the guarantee on to forceps used to grasp body tissue


during an operation. I could get a job as a quality controller cesser.


-- assessor. My first quality control. The checks had seemed far


from rigorous. Why will be taking some samples from my trip back for


Tom Brophy to test. We contacted the two UK-based companies that


Regal Medical trades with. One said that they had never bought products


from Regal but occasionally cell component parts to them. The Asian


instruments in Bedford confirmed that they do purchase instruments


from Regal. Vision agree that they buy some clamps from Regal to sell


on to the UK after Vision have made adjustments, checked and cleaned


them. We all medical say that they always focus on quality and provide


to their customers according to their demand. In Sialkot way


stumble upon a more ramshackle Workshop after workshop, involved


And I speak to an industry contact who tells me that the larger


factories farm out work to these makeshift units to meet orders. It


is called outsourcing. One in 10 of the 100 million instruments made in


Sialkot each year it sold to the UK, with only Germany and the USA


buying more. Workers here earn around �2 per day. Each tool that


they make can be sold on to UK hospitals for 10 times that amount.


Travelling deeper into the narrow streets, the conditions only get


Open sewers at the doorway is often It is packed with workers making


arterial clamps and surgical There are more than 3000


outsourcing units in Sialkot. Many of them larger companies don't like


to admit to outsourcing, but two of the units tell me that Hilbro and


Regal, both factories that we filmed earlier, used them. When you


ask Hilbro if they outsource, they are quite cagey about it. We will


ask these people what they do. This is one of the outsourcing units for


Hilbro? Is this the only outsourcing unit for Hilbro? There


are many. Hilbro confirmed that they do used outsourcing units but


did not specify which ones. All around me, different kinds of


surgical forceps are being made. The instruments produced here could


find their way to an operating theatre near you. If they did, what


the NHS have any idea where or how they are made? Do you know which


country these are going to? That is for Russia. That is for Japan.


Germany. Have you got any for the UK? That one is for England? They


are dissecting forceps, used for grasping soft body tissue during


surgery. Made in Pakistan, and I am told bound for the UK. The maker's


mark, however, tells a different story. Made in Germany. It will be


stamped with made in Germany? Here in Pakistan? Made in Germany. Andy


EU laws, the instruments made in these back streets can be stamped


with another country's name, so long as that country helped


substantially transform the product. As the forged steel they are


working with here comes from Germany, the whole thing can be


stamped made in Germany. As German instruments sell for much more than


those stamped with made in Pakistan. That earlier request from the boss


at the Hilbro factory not to tell anyone that his instruments are


made here now makes sense. Neither the NHS nor the MHRA requires


suppliers to inspect manufacturers. None of the individuals that we


spoke to in Pakistan but remember the last time that any British


supplier of made an inspection visit. Suet Thackeray by from


Hilbro and so pilasters bedded them in 2006. -- Seward Thackray last


inspected them in 2006. They told There is no doubt that making


inspection trips here is difficult. We have already changed hotels


after a bomb threat. Working here is dangerous. Without inspections,


can patients' safety be properly Over the last two weeks, we have


seen more than 100 workshops. Under Pakistani law, children aged


between 8 and 14 can work up to five hours per day. The local


chamber of commerce assured me that illegal child labour does not exist


in this industry. However, we have seen a few children working. One in


particular was clearly very young indeed. We could not verify his age


all of his powers. A British Medical Association report


estimates that up to 5000 children here are employed making surgical


instruments. I want to question the trade body regarding what I have


seen. I start by asking about child labour. Do you accept that you have


problems with in this industry that I have described? To loud Labour,


yes. -- child labour, yes. We have a child labour programme and we are


trying very hard but I will not deny the fact. If he has to choose


between sleeping hungry and working, a child worker, perhaps he works a


little bit. And what about the instruments? I show him a


photograph of dissecting forceps made in Pakistan which Tom Brophy


had failed. Are you happy with that? That is made in Sialkot. It


is very common. I don't know what it is. This is a guide pin that


should be flat. It has punctured the surgeon's gloves. Well, this is


wrong. I agree with you. If you operated on somebody with that and


it was left behind, it could kill them. We do not export such


instruments. That was sent from Sialkot into a hospital trust in


the UK. That might have been done by some unscrupulous manufacturer.


The people here are doing the best that they can. Often in difficult


conditions. With only one NHS Trust checking new tools to British


standards, it seems highly likely that poor quality instruments are


Back in the UK, I wanted to interview the industry regulator,


the MHRA, about what we had seen. Nobody was available. In a


I show my footage to a man that has advised the Government on patients'


safety and who investigates serious adverse instruments in hospitals to


see how they can be avoided in the future. My God. I find it almost


unbelievable. Surgeons are taking instruments which they believe to


be of high quality and they are using them on their patients,


believing they are doing the best that they can, when really they


have been made in these conditions. If procurement officers knew this


was happening in Pakistan, and those surgical instruments were


coming from that room into their hospital, I think they would faint


at the thought of it. I cannot believe that anybody in the NHS


knows that this is going on. London's Bart's Hospital, Tom


Brophy has tested my instruments. I had asked for samples from the


factories that we visited and in total was given 19 instruments, 12


of which have failed. The Seward Thackray soft tissue retractor that


I got from Hilbro passed with flying colours. Of those that


failed, problems included faulty screw heads, protruding guide bins,


soldering faults, pitted metal, and burrs. Tom Brophy says that


rigorous inspections have deterred some suppliers from selling to his


trust altogether. Of course they can still sell to the private


sector and more than 180 other NHS trusts and boards. I hear a lot of


companies talking about quality. They come in and say that patient


quality is important to them. When you check the equipment, the mask


drops quite quickly and it is not about quality. It is about money.


Remember Regal, where I stand surgical forceps with the CE mark?


-- stamped. They told me they did not have a company in the UK, but I


found the Regal in London which shares the Pakistani fax number and


website. Posing as a supplier wanting to buy instruments to sell


on to the NHS, I arrange a meeting with Nabeel Amir and his business


associate, Shahbaz Hussain, who claims to be the son of the factory


owner in Pakistan. These apply to the NHS in the UK? Have you got


samples with you? Mr Hussain then tells me there are three different


grades of steel that I can buy. Pakistani steel? Yes? French steel?


German steel. Presumably that is the best? Yes. Traceability is key


things go wrong. If the information about the manufacturer and the


country of origin is not accurate, then those responsible for poor


tools cannot be held to account. Does it matter which one I buy for


me to have the German mark? We can put the stamp on Pakistani steel.


Even if it is Pakistani steel? Do I have to admit that it is not


German steel? Does anybody know the difference? It is not easy to judge


it. Mr Hussain and his associate Nabeel Amir offering a low-quality


Pakistani steel for using the NHS, but they will stamp its German.


That is not legal. From what they tell me next, that is happening


Yes. We wanted to ask Mr Hussain and Nabeel Amir if they had any


concern for patients' safety. Our repeated request for an interview


went without answer. What the Regal London pair were offering to do was


criminal. But outsourcing and the rules around the CE mark that event


if made illegally, there are no guarantees that we can trace where


these kind of tools are produced anyway. The regulator at the MHRA


England's Health Secretary Andrew Lansley said that his department


would investigate where evidence comes to light of unsafe equipment


being supplied to the NHS core labour standards abuses in the


supply chain. The world's surgeons rely on Sialkot for the tools of


their trade, but is Britain's health sector asleep on the job?


Our surgical instruments must be of the highest quality and fit for


purpose. Is it time that we all woke up to the risks?


Next week on Panorama, why do we hate junk mail? It might be a


menace in our mailboxes, costing millions to dispose of, but without


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