:00:12. > :00:17.The tools of a surgeon's trade are of vital importance, and can mean
:00:17. > :00:22.the difference between life and death. Every single thing that is
:00:22. > :00:30.handed to you need to work. what if it doesn't? I just cannot
:00:30. > :00:34.tell you how bad this is. We reveal the truth about where our surgical
:00:34. > :00:42.tools are made, and expose the weaknesses in the systems in place
:00:42. > :00:52.to protect patients. I cannot believe that anybody in the NHS
:00:52. > :00:58.
:00:58. > :01:03.Every year, more than 30 million operations are carried out in
:01:03. > :01:07.Britain's hospitals. You have someone with a serious life-
:01:07. > :01:14.threatening condition, you're fighting to save their limb or
:01:15. > :01:18.their life... As a surgeon with more than 20 years' experience,
:01:18. > :01:21.this doctor understands the need better than most for surgical
:01:21. > :01:24.instruments to be perfect. They have to be just right, it is no
:01:25. > :01:29.good discovering that something does not work as it should do, and
:01:29. > :01:35.having to hand it back and get another one. Any little bit of that
:01:35. > :01:40.process blurs the boundaries towards delaying recovery, or even
:01:40. > :01:43.resulting in terrible consequences of loss of limb or death. We all
:01:43. > :01:47.assume that surgical instruments are made to the highest of
:01:47. > :01:56.standards. But over the last year, I have been investigating, and the
:01:56. > :02:02.evidence I have uncovered suggests all is not well in this industry.
:02:02. > :02:08.Two years ago, Dorothy underwent heart surgery at Nottingham City
:02:08. > :02:14.Hospital. The operation was a success until she can ratcheted --
:02:15. > :02:20.contracted a super bug. I knew I was dying, I just knew I was dying.
:02:20. > :02:26.I could not go through all that and not know, nobody could. I just
:02:26. > :02:32.remember thinking, just let me go, I had just had enough. 10 others
:02:32. > :02:35.operated on by the same surgeon also became seriously ill. In total,
:02:35. > :02:39.five of the 11 heart patients who became infected died. I have
:02:39. > :02:46.obtained a copy of the confidential report into what happened in
:02:46. > :02:54.Nottingham. The trust's investigation found two of the most
:02:54. > :02:58.likely causes of the spread of infection to be airborne
:02:58. > :03:06.transmission. Micro-punctures in the search and's gloves. The trust
:03:06. > :03:10.now insists that surgeons must wear thick gloves or two sets. There are
:03:10. > :03:14.no official figures regarding poorly made instruments in the UK,
:03:14. > :03:20.but we have come across three cases where sub-standard instruments have
:03:20. > :03:24.been definitively linked to causing death or serious harm. In the US,
:03:24. > :03:29.the Federal Drug Administration records almost 1,000 adverse
:03:29. > :03:33.incidents involving poor quality surgical instruments every year. I
:03:34. > :03:39.have contacted NHS surgeons who say sub-standard instruments have
:03:39. > :03:43.become all too common. Worried about possible repercussions, they
:03:43. > :03:46.refused interviews on camera, but three agreed to us using doubt as
:03:46. > :03:50.to me. There is not a week goes by when
:03:50. > :03:56.something does not go wrong. Rough edges on the instruments will slice
:03:57. > :03:59.through my hands. You struggle with an arterial clamp and you know the
:03:59. > :04:04.patient is pleading longer than they should because you know the
:04:04. > :04:14.instrument is not working. You look at the rough edge of the instrument
:04:14. > :04:15.
:04:15. > :04:22.and you think, have I just bowel with this? One NHS worker is so
:04:22. > :04:31.concerned, he has agreed to speak out. Hello. I'm from the BBC, nice
:04:31. > :04:35.to meet you. Tom Brophy checks the instruments coming in to the Barts
:04:35. > :04:40.and the London Trust. He is its last line of defence. Because so
:04:40. > :04:46.many of the surgical tools he sees are failing his tests, he has begun
:04:46. > :04:51.documenting the faults. For me, I do not know how they made this one
:04:51. > :04:54.that bad. This is an eye instrument. For it to have a trench, that is
:04:54. > :05:02.not supposed to be there. It is supposed to be flat. That is a
:05:03. > :05:10.trench. There's a tunnel. And this is used for the eye? This is just
:05:10. > :05:16.so bad, I just cannot tell you how bad it is. Used to to grip the soft
:05:16. > :05:20.tissue of the eye during surgery, precision is crucial. Most of the
:05:20. > :05:25.defects identified by Tom Brophy are invisible without magnification.
:05:25. > :05:30.In surgery, there can be devastating. He eventually finds
:05:30. > :05:38.faults on instruments, which can trap body tissue and blood - a
:05:38. > :05:43.serious infection risk. Other problems include Sharp, protruding
:05:43. > :05:47.guide pins. These could puncture a surgeon's glove. He also finds
:05:47. > :05:56.metal fragments which could break off inside the body. One example he
:05:56. > :06:02.shows me is a heart retractor, designed to be used on infants.
:06:02. > :06:06.This was the blade of the retractor. It is like a needle. If we had not
:06:06. > :06:12.stopped that, it could have been potentially used on a very young
:06:12. > :06:17.baby. Companies making instruments for the UK must be registered with
:06:17. > :06:23.an EU body. In Britain, that is the Medicine and Healthcare Products
:06:23. > :06:28.Regulatory Agency, the MHRA. After an increase in complaints, the MHRA
:06:28. > :06:33.issued a warning last December, that care should be taken to ensure
:06:33. > :06:41.new instruments are fit for purpose. However, responsibility for quality
:06:41. > :06:44.currently rests with the suppliers and manufacturers. Tom Brophy
:06:44. > :06:49.rejects almost one in five of all surgical instruments supplied to
:06:49. > :06:56.his trust. He says he has even been sent used equipment, passed off as
:06:56. > :07:02.new. In one instance, there was blood still on the actual
:07:02. > :07:06.instruments. There was dry blood on about 11% of the order. Whatever
:07:06. > :07:12.happened, they have re-routed themselves back into the sales
:07:13. > :07:17.market as brand new. I don't know on how that happens, but it has.
:07:17. > :07:25.There are more than 180 health trusts and boards in the UK. The
:07:25. > :07:29.same companies which supply Barts can also supply other hospitals.
:07:29. > :07:33.While most trusts and boards carry out some visual checks of
:07:33. > :07:39.instruments, Barts is the only one to employ a specialist to inspect
:07:39. > :07:44.them to British standards. On more than one occasion, a supplier has
:07:44. > :07:48.rang me up and said, I have passed it on to another hospital, and they
:07:48. > :07:54.accepted it. My answer was, of course they did, because they did
:07:54. > :08:02.not check it. More worryingly, it was a cardiac instrument, and it
:08:02. > :08:07.was actually corroding. Suppliers can be manufacturers or middlemen -
:08:07. > :08:10.major companies or one-man bands. There are more than 900
:08:10. > :08:14.manufacturers registered with the MHRA to sell surgical instruments.
:08:14. > :08:24.The vast majority of those instruments are not made here, but
:08:24. > :08:31.
:08:31. > :08:38.Remarkably, to thirds of the world's surgical instruments are
:08:38. > :08:48.made in one city in Pakistan. 70% of the 916 manufacturers registered
:08:48. > :08:50.
:08:50. > :08:54.with the MHRA are based here. That city is Sialkot. According to their
:08:55. > :08:59.Manufacturers' Association, Sialkot produces 100 million surgical
:08:59. > :09:02.instruments each year. Pakistan has experienced an upsurge in terrorist
:09:02. > :09:08.violence, and Sialkot is in the troubled area close to the border
:09:08. > :09:14.with India. The city's Chamber of Commerce has arranged for me to
:09:14. > :09:21.visit factories which make surgical instruments for British companies.
:09:21. > :09:29.The first factory I visit is a company called Hilbro. Its chief
:09:29. > :09:35.executive, Muhammad Ashraf, is waiting for me. Nice to meet you.
:09:35. > :09:45.What are we about to see? It is so noisy! This is a manufacturing
:09:45. > :09:51.
:09:51. > :09:56.process? Wow! My goodness. Inside, dozens of machines. The sound of
:09:56. > :10:02.the lathes and the drills are deafening. These are surgical
:10:02. > :10:11.instruments. These will be for the UK... Do you do many contracts with
:10:11. > :10:18.the UK hospitals? The instruments made here can pass through several
:10:18. > :10:25.suppliers before reaching UK hospitals. Over three levels, and
:10:25. > :10:29.sitting in 26 acres of land, this factory is one of the biggest in
:10:29. > :10:32.Sialkot. I'm taken upstairs to the quality control room, where every
:10:32. > :10:38.instrument is checked and inspected with a magnifying glass. What is
:10:38. > :10:48.this man stamping? Can I see? Some of the instruments are stamped with
:10:48. > :10:48.
:10:48. > :10:52.the names of British companies. What is this for? The company
:10:52. > :10:57.Seward Thackray describes itself as a leading supplier to hospitals in
:10:57. > :11:04.the UK, including the NHS. Can I have one of those to take, because
:11:04. > :11:10.it is British? As his staff get me a sample, he has a surprising
:11:10. > :11:14.request. You don't want people to know this is from Pakistan? We
:11:14. > :11:20.would have to say they're from England? It is a request I would
:11:20. > :11:30.hear more than once in Sialkot. I will find out why later. Thank you
:11:30. > :11:34.
:11:34. > :11:43.The Chamber of Commerce also arranged for me to see another
:11:43. > :11:47.factory in Sialkot. Again, it was claimed, busy and well-organised. I
:11:47. > :11:51.think that was the public face that the Chamber of Commerce wanted us
:11:51. > :12:01.to see. Professional, spotless, a good advert for the surgical
:12:01. > :12:06.
:12:06. > :12:16.instrument industry. Whether it is Overnight, I have had a call about
:12:16. > :12:18.
:12:18. > :12:21.one of Sialkot's smaller factories. A local translator comes with me to
:12:21. > :12:28.Regal Medical Instruments, which does business with two small UK-
:12:28. > :12:38.based suppliers. Inside, the conditions are a far cry from the
:12:38. > :12:48.
:12:48. > :12:52.Poor alighting makes it difficult to see, and the dust makes it
:12:52. > :13:02.difficult to breed. Yet here in the darkness, surgical instruments are
:13:02. > :13:15.
:13:15. > :13:21.Upstairs is where instruments are checked before being stamped and
:13:21. > :13:27.packed for shipping. This is where it is decided if the surgical
:13:27. > :13:33.instrument is safe to be used by the surgeon somewhere in the world.
:13:33. > :13:37.If it passes inspection, it is given the quality stamp, the CE
:13:37. > :13:42.mark, at which the MHRA say provides the necessary reassurance
:13:42. > :13:46.that the device is safe and fit for purpose. Unlike the other factories
:13:46. > :13:54.but I have seen, there appeared to be no magnifying glasses. What
:13:54. > :14:03.checks we see being carried out on made with the naked eye. This is
:14:03. > :14:09.the quality control stamp? Yes. I have a go? What do I do? You have
:14:09. > :14:12.checked that one? Do I have to check it for quality? I am allowed
:14:13. > :14:21.to stand the guarantee on to forceps used to grasp body tissue
:14:21. > :14:27.during an operation. I could get a job as a quality controller cesser.
:14:27. > :14:33.-- assessor. My first quality control. The checks had seemed far
:14:33. > :14:37.from rigorous. Why will be taking some samples from my trip back for
:14:37. > :14:43.Tom Brophy to test. We contacted the two UK-based companies that
:14:43. > :14:47.Regal Medical trades with. One said that they had never bought products
:14:47. > :14:57.from Regal but occasionally cell component parts to them. The Asian
:14:57. > :14:58.
:14:58. > :15:06.instruments in Bedford confirmed that they do purchase instruments
:15:06. > :15:10.from Regal. Vision agree that they buy some clamps from Regal to sell
:15:10. > :15:15.on to the UK after Vision have made adjustments, checked and cleaned
:15:15. > :15:20.them. We all medical say that they always focus on quality and provide
:15:20. > :15:30.to their customers according to their demand. In Sialkot way
:15:30. > :15:37.
:15:37. > :15:47.stumble upon a more ramshackle Workshop after workshop, involved
:15:47. > :15:50.
:15:50. > :15:55.And I speak to an industry contact who tells me that the larger
:15:55. > :16:00.factories farm out work to these makeshift units to meet orders. It
:16:00. > :16:06.is called outsourcing. One in 10 of the 100 million instruments made in
:16:06. > :16:12.Sialkot each year it sold to the UK, with only Germany and the USA
:16:12. > :16:18.buying more. Workers here earn around �2 per day. Each tool that
:16:18. > :16:22.they make can be sold on to UK hospitals for 10 times that amount.
:16:22. > :16:32.Travelling deeper into the narrow streets, the conditions only get
:16:32. > :16:52.
:16:52. > :17:02.Open sewers at the doorway is often It is packed with workers making
:17:02. > :17:04.
:17:04. > :17:08.arterial clamps and surgical There are more than 3000
:17:09. > :17:16.outsourcing units in Sialkot. Many of them larger companies don't like
:17:16. > :17:21.to admit to outsourcing, but two of the units tell me that Hilbro and
:17:21. > :17:26.Regal, both factories that we filmed earlier, used them. When you
:17:26. > :17:32.ask Hilbro if they outsource, they are quite cagey about it. We will
:17:32. > :17:40.ask these people what they do. This is one of the outsourcing units for
:17:40. > :17:46.Hilbro? Is this the only outsourcing unit for Hilbro? There
:17:46. > :17:51.are many. Hilbro confirmed that they do used outsourcing units but
:17:51. > :17:56.did not specify which ones. All around me, different kinds of
:17:56. > :18:02.surgical forceps are being made. The instruments produced here could
:18:02. > :18:09.find their way to an operating theatre near you. If they did, what
:18:09. > :18:19.the NHS have any idea where or how they are made? Do you know which
:18:19. > :18:27.country these are going to? That is for Russia. That is for Japan.
:18:27. > :18:30.Germany. Have you got any for the UK? That one is for England? They
:18:30. > :18:37.are dissecting forceps, used for grasping soft body tissue during
:18:38. > :18:44.surgery. Made in Pakistan, and I am told bound for the UK. The maker's
:18:44. > :18:53.mark, however, tells a different story. Made in Germany. It will be
:18:53. > :18:58.stamped with made in Germany? Here in Pakistan? Made in Germany. Andy
:18:58. > :19:02.EU laws, the instruments made in these back streets can be stamped
:19:02. > :19:06.with another country's name, so long as that country helped
:19:07. > :19:10.substantially transform the product. As the forged steel they are
:19:10. > :19:15.working with here comes from Germany, the whole thing can be
:19:15. > :19:21.stamped made in Germany. As German instruments sell for much more than
:19:21. > :19:24.those stamped with made in Pakistan. That earlier request from the boss
:19:24. > :19:34.at the Hilbro factory not to tell anyone that his instruments are
:19:34. > :19:35.
:19:35. > :19:38.made here now makes sense. Neither the NHS nor the MHRA requires
:19:38. > :19:42.suppliers to inspect manufacturers. None of the individuals that we
:19:42. > :19:47.spoke to in Pakistan but remember the last time that any British
:19:47. > :19:57.supplier of made an inspection visit. Suet Thackeray by from
:19:57. > :19:58.
:19:58. > :20:08.Hilbro and so pilasters bedded them in 2006. -- Seward Thackray last
:20:08. > :20:13.
:20:13. > :20:17.inspected them in 2006. They told There is no doubt that making
:20:17. > :20:23.inspection trips here is difficult. We have already changed hotels
:20:23. > :20:32.after a bomb threat. Working here is dangerous. Without inspections,
:20:33. > :20:38.can patients' safety be properly Over the last two weeks, we have
:20:38. > :20:43.seen more than 100 workshops. Under Pakistani law, children aged
:20:43. > :20:46.between 8 and 14 can work up to five hours per day. The local
:20:46. > :20:51.chamber of commerce assured me that illegal child labour does not exist
:20:52. > :20:58.in this industry. However, we have seen a few children working. One in
:20:58. > :21:01.particular was clearly very young indeed. We could not verify his age
:21:01. > :21:07.all of his powers. A British Medical Association report
:21:07. > :21:11.estimates that up to 5000 children here are employed making surgical
:21:11. > :21:16.instruments. I want to question the trade body regarding what I have
:21:16. > :21:20.seen. I start by asking about child labour. Do you accept that you have
:21:20. > :21:28.problems with in this industry that I have described? To loud Labour,
:21:28. > :21:32.yes. -- child labour, yes. We have a child labour programme and we are
:21:32. > :21:36.trying very hard but I will not deny the fact. If he has to choose
:21:37. > :21:41.between sleeping hungry and working, a child worker, perhaps he works a
:21:41. > :21:45.little bit. And what about the instruments? I show him a
:21:45. > :21:51.photograph of dissecting forceps made in Pakistan which Tom Brophy
:21:51. > :21:55.had failed. Are you happy with that? That is made in Sialkot. It
:21:55. > :22:04.is very common. I don't know what it is. This is a guide pin that
:22:04. > :22:08.should be flat. It has punctured the surgeon's gloves. Well, this is
:22:08. > :22:14.wrong. I agree with you. If you operated on somebody with that and
:22:14. > :22:18.it was left behind, it could kill them. We do not export such
:22:18. > :22:27.instruments. That was sent from Sialkot into a hospital trust in
:22:27. > :22:32.the UK. That might have been done by some unscrupulous manufacturer.
:22:32. > :22:37.The people here are doing the best that they can. Often in difficult
:22:38. > :22:42.conditions. With only one NHS Trust checking new tools to British
:22:42. > :22:52.standards, it seems highly likely that poor quality instruments are
:22:52. > :22:56.
:22:56. > :23:01.Back in the UK, I wanted to interview the industry regulator,
:23:01. > :23:11.the MHRA, about what we had seen. Nobody was available. In a
:23:11. > :23:15.
:23:15. > :23:19.I show my footage to a man that has advised the Government on patients'
:23:19. > :23:25.safety and who investigates serious adverse instruments in hospitals to
:23:25. > :23:28.see how they can be avoided in the future. My God. I find it almost
:23:28. > :23:32.unbelievable. Surgeons are taking instruments which they believe to
:23:32. > :23:35.be of high quality and they are using them on their patients,
:23:35. > :23:39.believing they are doing the best that they can, when really they
:23:39. > :23:42.have been made in these conditions. If procurement officers knew this
:23:42. > :23:46.was happening in Pakistan, and those surgical instruments were
:23:46. > :23:50.coming from that room into their hospital, I think they would faint
:23:50. > :23:57.at the thought of it. I cannot believe that anybody in the NHS
:23:57. > :24:03.knows that this is going on. London's Bart's Hospital, Tom
:24:03. > :24:07.Brophy has tested my instruments. I had asked for samples from the
:24:07. > :24:12.factories that we visited and in total was given 19 instruments, 12
:24:12. > :24:17.of which have failed. The Seward Thackray soft tissue retractor that
:24:17. > :24:22.I got from Hilbro passed with flying colours. Of those that
:24:22. > :24:30.failed, problems included faulty screw heads, protruding guide bins,
:24:30. > :24:33.soldering faults, pitted metal, and burrs. Tom Brophy says that
:24:33. > :24:37.rigorous inspections have deterred some suppliers from selling to his
:24:37. > :24:43.trust altogether. Of course they can still sell to the private
:24:43. > :24:48.sector and more than 180 other NHS trusts and boards. I hear a lot of
:24:48. > :24:51.companies talking about quality. They come in and say that patient
:24:51. > :24:58.quality is important to them. When you check the equipment, the mask
:24:58. > :25:04.drops quite quickly and it is not about quality. It is about money.
:25:04. > :25:10.Remember Regal, where I stand surgical forceps with the CE mark?
:25:10. > :25:13.-- stamped. They told me they did not have a company in the UK, but I
:25:13. > :25:19.found the Regal in London which shares the Pakistani fax number and
:25:19. > :25:26.website. Posing as a supplier wanting to buy instruments to sell
:25:26. > :25:30.on to the NHS, I arrange a meeting with Nabeel Amir and his business
:25:30. > :25:40.associate, Shahbaz Hussain, who claims to be the son of the factory
:25:40. > :25:41.
:25:41. > :25:46.owner in Pakistan. These apply to the NHS in the UK? Have you got
:25:46. > :25:56.samples with you? Mr Hussain then tells me there are three different
:25:56. > :25:56.
:25:56. > :26:02.grades of steel that I can buy. Pakistani steel? Yes? French steel?
:26:02. > :26:06.German steel. Presumably that is the best? Yes. Traceability is key
:26:06. > :26:10.things go wrong. If the information about the manufacturer and the
:26:10. > :26:15.country of origin is not accurate, then those responsible for poor
:26:15. > :26:23.tools cannot be held to account. Does it matter which one I buy for
:26:23. > :26:30.me to have the German mark? We can put the stamp on Pakistani steel.
:26:30. > :26:35.Even if it is Pakistani steel? Do I have to admit that it is not
:26:35. > :26:44.German steel? Does anybody know the difference? It is not easy to judge
:26:44. > :26:49.it. Mr Hussain and his associate Nabeel Amir offering a low-quality
:26:49. > :26:58.Pakistani steel for using the NHS, but they will stamp its German.
:26:58. > :27:08.That is not legal. From what they tell me next, that is happening
:27:08. > :27:17.
:27:17. > :27:20.Yes. We wanted to ask Mr Hussain and Nabeel Amir if they had any
:27:20. > :27:27.concern for patients' safety. Our repeated request for an interview
:27:27. > :27:32.went without answer. What the Regal London pair were offering to do was
:27:32. > :27:36.criminal. But outsourcing and the rules around the CE mark that event
:27:36. > :27:42.if made illegally, there are no guarantees that we can trace where
:27:42. > :27:52.these kind of tools are produced anyway. The regulator at the MHRA
:27:52. > :27:57.
:27:57. > :28:00.England's Health Secretary Andrew Lansley said that his department
:28:01. > :28:05.would investigate where evidence comes to light of unsafe equipment
:28:05. > :28:11.being supplied to the NHS core labour standards abuses in the
:28:12. > :28:16.supply chain. The world's surgeons rely on Sialkot for the tools of
:28:16. > :28:20.their trade, but is Britain's health sector asleep on the job?
:28:20. > :28:28.Our surgical instruments must be of the highest quality and fit for
:28:28. > :28:33.purpose. Is it time that we all woke up to the risks?
:28:33. > :28:37.Next week on Panorama, why do we hate junk mail? It might be a
:28:37. > :28:42.menace in our mailboxes, costing millions to dispose of, but without