Surgery's Dirty Secrets Panorama

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