Surgery's Dirty Secrets Panorama


Surgery's Dirty Secrets

Sam Poling investigates claims that surgical instruments with dangerous defects are being used in the NHS, and asks if goods are being sourced ethically to protect patient health.


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

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

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

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

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

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

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

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

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

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

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this doctor understands the need better than most for surgical

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

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

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

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process blurs the boundaries towards delaying recovery, or even

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

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assume that surgical instruments are made to the highest of

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

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

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Two years ago, Dorothy underwent heart surgery at Nottingham City

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

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

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

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

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

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

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obtained a copy of the confidential report into what happened in

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

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likely causes of the spread of infection to be airborne

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

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

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no official figures regarding poorly made instruments in the UK,

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

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

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the Federal Drug Administration records almost 1,000 adverse

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incidents involving poor quality surgical instruments every year. I

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have contacted NHS surgeons who say sub-standard instruments have

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become all too common. Worried about possible repercussions, they

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

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to me. There is not a week goes by when

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

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

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patient is pleading longer than they should because you know the

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

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

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

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

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

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

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

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

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

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

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

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

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defects identified by Tom Brophy are invisible without magnification.

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In surgery, there can be devastating. He eventually finds

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

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serious infection risk. Other problems include Sharp, protruding

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

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

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

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

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

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

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

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

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

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

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currently rests with the suppliers and manufacturers. Tom Brophy

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rejects almost one in five of all surgical instruments supplied to

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

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

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

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

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

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

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same companies which supply Barts can also supply other hospitals.

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While most trusts and boards carry out some visual checks of

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

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

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

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

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

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was actually corroding. Suppliers can be manufacturers or middlemen -

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

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manufacturers registered with the MHRA to sell surgical instruments.

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

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

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

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

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Manufacturers' Association, Sialkot produces 100 million surgical

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instruments each year. Pakistan has experienced an upsurge in terrorist

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

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

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visit factories which make surgical instruments for British companies.

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

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

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

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

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the lathes and the drills are deafening. These are surgical

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

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

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suppliers before reaching UK hospitals. Over three levels, and

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

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

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

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

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

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Seward Thackray describes itself as a leading supplier to hospitals in

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

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

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

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

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

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The Chamber of Commerce also arranged for me to see another

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

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

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

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

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

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

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

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

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

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Upstairs is where instruments are checked before being stamped and

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

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

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

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mark, at which the MHRA say provides the necessary reassurance

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

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

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

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

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

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

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

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

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

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

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

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

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instruments in Bedford confirmed that they do purchase instruments

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

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

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

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to their customers according to their demand. In Sialkot way

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stumble upon a more ramshackle Workshop after workshop, involved

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

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

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

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

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

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

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Travelling deeper into the narrow streets, the conditions only get

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

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arterial clamps and surgical There are more than 3000

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

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

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

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

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

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

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

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

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surgical forceps are being made. The instruments produced here could

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

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

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

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

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are dissecting forceps, used for grasping soft body tissue during

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

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

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

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

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

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substantially transform the product. As the forged steel they are

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

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

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

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

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

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suppliers to inspect manufacturers. None of the individuals that we

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

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supplier of made an inspection visit. Suet Thackeray by from

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

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

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inspection trips here is difficult. We have already changed hotels

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

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

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

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

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

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

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

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all of his powers. A British Medical Association report

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estimates that up to 5000 children here are employed making surgical

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

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

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

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

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

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

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

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photograph of dissecting forceps made in Pakistan which Tom Brophy

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

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

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

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

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

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

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

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

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

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standards, it seems highly likely that poor quality instruments are

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

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

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

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safety and who investigates serious adverse instruments in hospitals to

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

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unbelievable. Surgeons are taking instruments which they believe to

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

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

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

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was happening in Pakistan, and those surgical instruments were

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

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

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

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

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

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

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

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

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

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rigorous inspections have deterred some suppliers from selling to his

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

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

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

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

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

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

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

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

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

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

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

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:25:40.:25:41.

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

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

:25:46.:25:56.
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grades of steel that I can buy. Pakistani steel? Yes? French steel?

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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England's Health Secretary Andrew Lansley said that his department

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would investigate where evidence comes to light of unsafe equipment

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being supplied to the NHS core labour standards abuses in the

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

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

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

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

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

:28:33.:28:37.

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

:28:37.:28:42.

Vigorous investigation of a topical issue. Panorama investigates concerns about the quality of surgical instruments being used on patients in the UK. Reporter Samantha Poling hears from those working inside the NHS who claim that tools with dangerous defects are being supplied to hospitals.

Panorama travels to Pakistan, where the majority of the world's surgical instruments are made, and finds an industry blighted by poor quality control and child labour where workers manufacture tools for £2 a day. Reporter Sam Poling asks whether the NHS is sourcing goods ethically and is doing all it can to protect the health of its patients.


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