Editor’s note: This article is a reprint. It was originally published on December 31, 2016.
First aired in 2011, the BBC documentary “Surgery’s Dirty Secrets” investigates the source of surgical instruments and highlights the shortcomings of UK safety regulations. Like most people, you may think that your surgical instruments are made to the highest and most stringent standards. But the reality of where and how these instruments are made is truly shocking.
According to BBC journalist Samantha Poling, who has spent a year researching the subject, there are serious problems with the industry, which are causing serious illness and death.
Around 30 million surgical operations are performed in UK hospitals each year. To perform a surgical operation, surgeons need the right tools for the job, and these tools must be manufactured to exacting specifications and of the highest quality.
A surgical instrument that is poorly made or does not work can mean the difference between a successful operation and the loss of a limb or organ, or the death of the patient. For example, for every fraction of a second that a surgical assistant struggles with a poorly functioning arterial clamp, the patient loses blood, compromising the success of the operation.
Deadly infections spread by surgical instruments
In 2009, Dorothy Brown underwent heart surgery at Nottingham City Hospital. The surgery was successful, but she almost died from an antibiotic-resistant infection. Ten other patients operated on by Brown’s surgeon at the same time also developed the same life-threatening infection.
Five of them later died. In the United States, there are at least 1,500 cases of harm caused by poor-quality surgical instruments each year.1
A confidential report obtained by Poling found that the two most likely causes of the mass infection at Nottingham City Hospital were airborne bacteria or microscopic holes in surgeons’ gloves. The internal investigation found that surgeons must now wear thicker gloves or double-up their regular gloves.
But what causes repeated microscopic holes in surgeon gloves? According to experts, the most likely cause is poor quality surgical instruments.
Few medical professionals were willing to go on the record with the BBC, but Tom Brophy, chief technologist at Barts Health NHS Trust, did. He was so concerned by what he was seeing that he began gathering evidence to show just how flawed some of the surgical tools were.
Most of these defects are invisible to the naked eye, but a magnifying glass will reveal jagged edges and poor construction. Common problems reported by Brophy include:
- Breaking and rewelding tools that harbor and spread bacteria
- Sharp, protruding guide pins of the glove-tearing forceps
- Sharp thorns and metal fragments can break, tear the glove, or become lodged inside the patient, posing a risk of infection.
- Metals with corrosion and cavities that pose a risk of infection
- Defective screw head
1 in 5 surgical instruments are defective
According to Brophy, one in five devices he receives, or about 20 percent, is rejected for defects that put the patient’s health at risk. He even reports receiving used equipment that contains blood and dried tissue, which can pose a risk of infection.
These instruments are somehow recycled and sold as new. This should never happen. But it does. Poorly made instruments should never end up in the operating room, but they do so with alarming frequency. How is this possible?
In the UK, surgical instrument manufacturers and suppliers must register with the Medicines and Healthcare products Regulatory Agency (MHRA), and there are over 900 registered manufacturers.
In December 2010, following growing complaints about poor quality, the agency issued a warning to all manufacturers, telling them they must take steps to ensure all instruments are “fit for purpose”.
However, the responsibility for ensuring that quality standards are actually met still lies with the manufacturer, not with the MHRA or a separate quality control body. Suppliers are not even required to test products they receive from the manufacturer before reselling them to hospitals.
There are a total of 215 health trusts and boards in England.2 However, Batz is the only health trust that employs technicians to test every instrument before using it in surgery.
When Brophy sent the rejected device back to the Asian supplier, he was told it had been sent to another British hospital, which had accepted it without any problems. “Of course they would accept it,” Brophy said. “They didn’t test it.”
Where are surgical instruments made?
When you think about how surgical instruments are made, Swiss precision comes to mind, but two-thirds of the world’s surgical instruments are actually manufactured in Sialkot, in northern Punjab, Pakistan. Of the 900 MHRA-registered surgical instrument manufacturers, 70% are based there.
Some of these manufacturers seem to be doing pretty well. This includes Hilbro, one of the largest manufacturers. Each device is inspected visually, at least with a magnifying glass, before being shipped. Others operate under much more questionable circumstances.
Regal Medical Instruments, a small manufacturer in Sialkot that ships to two small suppliers in the UK, offers a completely different perspective on the industry. The facility is so dark that you can barely see, the air is filled with metal dust, and surgical instruments are strewn in piles on the floor.
In the quality assurance department, staff visually inspect each device before putting the required “CE” quality stamp required by the MHRA, but without using a magnifying glass. That means most of the defects Brophy spots using a microscope never get detected.
And then there’s the “seedy side of the industry,” as Poling puts it. The workers in this area toil in tiny, dusty shacks with open sewers running through their doors. According to Poling, bigger, more respected companies often outsource their work to these workers to meet demand.
In total, there are more than 3,000 of these “outsourcing units” in Sialkot, with workers earning less than $2.50 a day. According to some of the workers, both Hillbrow and Regal Medical regularly purchase surgical instruments from them.
It’s not ‘made in Germany’!
Surprisingly, the maker’s mark on these Pakistani-made tools often reads “Made in Germany.” As Pauling explains:
“Under EU law, instruments made in these back alleys can be stamped with the name of another country as long as that country helps to significantly modify the product. So the forged steel they’re working with here comes from Germany, so they can stamp everything ‘Made in Germany’, and a German instrument will sell for a lot more than one that’s stamped ‘Made in Pakistan’.”
What makes matters worse is that British suppliers rarely do quality checks on the facilities of Pakistani manufacturers. One of the problems is that there is a constant risk of terrorist attacks in Pakistan. It is a dangerous place and conducting inspections yourself is dangerous. Polling also found evidence that the Pakistani surgical instrument industry may be using child labor.
The MHRA declined to interview Poling, but did provide her with a statement saying there was “no evidence that non-compliant devices were being supplied to the NHS.” Meanwhile, Brophy tested 19 samples of devices collected by Poling during his visit to Pakistan, where he visited more than 100 different device manufacturing facilities. Twelve of the 19 samples failed his tests.
Polling’s investigation uncovered illegal activity: a legal loophole allows Pakistani manufacturers to label their products “Made in Germany” if they use German steel, but it is illegal to label them as German if they use, for example, Pakistani or French steel.
In the undercover video, she poses as a surgical instrument supplier and two British representatives from Regal Medical Instruments offer to sell her instruments made of Pakistani steel with a “Made in Germany” stamp so she can resell them at an inflated price. According to the Pakistani representatives, they are already selling mid-priced French steel instruments to suppliers with a German stamp at the supplier’s request.
Non-disposable equipment also poses a contamination risk
Download interview transcript
As I discussed in an interview last year with Dr. David Lewis, a retired EPA microbiologist, even single-use instruments like flexible sigmoidoscopes and colonoscopes pose risks to patients.
Since these instruments are meant to be reused, they need to be cleaned and sterilized both inside and out before use. However, tests have shown that this is virtually impossible, and the sterilization processes used in most clinics and hospitals do not adequately clean and sterilize these instruments.
As a result, patients are taking a huge risk when these tools are used, as they spread all sorts of infections from one patient to another. There is a solution: create flexible scopes that can be autoclaved (heat sterilized). But manufacturers have not been pressured to come up with such designs. As Lewis points out, it all comes down to federal agencies not taking the contamination issue seriously enough.
If you are having a procedure that uses a colonoscopy or other flexible endoscope, be sure to ask how the scope is cleaned and what cleaning products are used.
- If peracetic acid is used in a hospital or clinic, the risk of infection from a previous patient is very low.
- If the answer is glutaraldehyde or the brand name Sidex (used by 80% of hospitals), cancel your appointment and go somewhere else.
Asking what they use to clean their scopes is a key question that could save your life. It’s important for all of us to start doing this because the FDA simply has no incentive to do anything about it.
But if enough people refuse to do these procedures with instruments sterilized with glutaraldehyde, hospitals and clinics will change even if the FDA does nothing. It is also important that healthcare professionals reading this article start to address the problem internally. They need to be aware of the problem and know how to prevent patients from being put at risk.
There is little you, as a patient, can do about a defective surgical instrument. Ideally, every hospital would employ someone to carefully inspect every surgical instrument before use. Overall, Polling’s report shows that there is a lot of room for improvement in this industry if we put patient well-being first.
