Editor’s note: This article has been republished. It was originally published on December 31, 2016.
The BBC documentary ‘Surgery’s Dirty Secrets’, first aired in 2011, investigates the sources of surgical instruments and highlights flaws in UK safety regulations. Like most people, you probably assume that surgical instruments are made to the highest and most exacting standards. However, the reality of where and how these instruments are made is truly shocking.
BBC journalist Samantha Pauling, who spent a year investigating the issue, said there were serious problems with the industry and that it could and did cause serious illness and death.
An estimated 30 million surgeries are performed in UK hospitals every year. To carry out these operations, surgeons need the right instruments and these instruments must be made to precise specifications and of the highest quality.
Poor or non-functioning surgical tools can mean the difference between a successful surgery and the loss of a limb or organ, or even the death of a patient. For example, every split second that a surgical assistant struggles with a malfunctioning artery clamp means the patient loses blood and the success of the surgery is jeopardized.
Surgical instruments spread deadly infections
In 2009, Dorothy Brown underwent heart surgery at Nottingham City Hospital. The operation was successful, but she contracted an antibiotic-resistant infection that nearly killed her. Ten other patients operated on by Brown’s surgeons around the same time also contracted the same deadly infection.
Five of those patients subsequently died. At least 1,500 incidents of injuries caused by poor quality surgical instruments occur in the United States each year.1
A confidential report seen by Polling said the most likely cause of the Nottingham City Hospital outbreak was either airborne bacteria or a tiny hole in a surgeon’s glove, and an internal investigation has led to surgeons having to wear thicker gloves or an extra pair of regular gloves in the future.
But what causes surgeons’ gloves to repeatedly develop microscopic holes in the first place? Experts say the most likely culprit is poor quality surgical instruments.
Few medical experts were willing to go on the record with the BBC, but Tom Brophy, chief engineer at Barts Health NHS Trust, was. Deeply concerned by what he was seeing, he began to collect evidence showing just how flawed some of the surgical tools were.
Most of these defects are invisible to the naked eye, but under magnification jagged edges and poor construction are quickly apparent. Common issues reported by Brophy include:
- Broken and rewelded instruments can harbor bacteria
- The sharp guide pin of the forceps cuts through the glove
- Sharp burrs or metal pieces could break off and tear gloves, posing a risk of infection if they become lodged inside the patient.
- Corroded or pitted metal poses infection risks
- Bad screw head
One in five surgical instruments are defective
Brophy said one in five of the instruments he receives — about 20 percent of all instruments — are rejected because they have defects that put patients’ health at risk. He also receives second-hand instruments that may contain blood or dried tissue that poses an infection risk.
These instruments somehow end up recycled and passed off as new. This should never happen, but it does. Poor quality instruments should never even be in the operating room, but they are used with frightening frequency. How does this happen?
In the UK, manufacturers and suppliers of surgical instruments must register with the Medicines and Healthcare products Regulatory Agency (MHRA) and there are over 900 registered manufacturers.
In December 2010, following a rise in complaints about poor quality, the agency warned all manufacturers that they needed to take steps to ensure all equipment was “fit for purpose”.
But the responsibility for ensuring that quality standards are actually being met still rests with the manufacturer, rather than the MHRA or another quality control body: suppliers do not even have to test the products they receive from manufacturers before reselling them to hospitals.
There are a total of 215 health trusts and boards in the UK.2 However, Bart’s is the only medical institution that actually employs technicians who test all of the instruments before they are used in surgery.
Disturbingly, when Brophy sent the rejected devices back to the Asian supplier, he was told they had been sent to another UK hospital which accepted them without issue. “Well, of course they would, because they didn’t test them,” says Brophy.
Where are surgical instruments made?
When we think of how surgical instruments are manufactured, we think of Swiss precision, but two-thirds of the world’s surgical instruments are actually made in Sialkot, in the northern Punjab province of Pakistan, where 70% of the 900 surgical instrument manufacturers registered with the MHRA are based.
Some of these manufacturers, including one of the major ones, Hilbro, do a good job: Each piece of equipment is at least visually inspected with a magnifying glass before it leaves the factory. Others operate under much more questionable conditions.
Regal Medical Instruments, a small manufacturer in Sialkot that ships to two small suppliers in Britain, has a very different view of the industry: The factory is dark and barely visible, metal dust fills the air, and surgical tools lie strewn in piles on the floor.
In the company’s quality assurance department, workers visually inspect each instrument and stamp it with the MHRA-mandated “CE” quality stamp, but they don’t use magnifying glasses, meaning most of the defects spotted by Brophy, who uses a microscope, would never be discovered.
Then there’s what Poling calls “the rough side of the industry.” In this part of town, workers toil at millstones in dusty little huts with sewage running outside their doors. Larger, more reputable companies often outsource work to these workers to meet demand, Poling says.
In total, there are more than 3,000 such “outsourcing units” in Sialkot, where workers earn less than $2.50 a day. Some workers say that both Hillbro and Regal Medical regularly purchase surgical instruments from them.
“Made in Germany” — Not quite!
Surprisingly, Pakistani tools often have the maker’s mark “Made in Germany.” Poling explains:
“Under EU law, these back-street instruments can be stamped with the name of a country, as long as that country has helped significantly improve the product. So the forged steel used here comes from Germany, so the whole thing can be stamped ‘Made in Germany’, and a German-made instrument sells for a lot more than one stamped ‘Made in Pakistan.'”
To make matters worse, British suppliers do little to inspect the quality of their manufacturing facilities in Pakistan. Part of the problem is that there is a constant risk of terrorist attacks in Pakistan; it’s a dangerous area and in-person inspections are risky. Poling also found evidence to suggest that the Pakistani surgical equipment industry may be using child labor.
The MHRA refused to meet with Mr Pauling but said in a statement that it had “no evidence of non-compliant devices being supplied to the NHS”. Meanwhile, Mr Brophy tested 19 samples of devices collected by Mr Pauling during a trip to Pakistan, where he visited more than 100 device manufacturing facilities. Twelve of the 19 failed testing.
Poling even uncovered illegal activity during his investigation: A loophole in the law allowed Pakistani manufacturers to label their products as “Made in Germany” if they used steel from Germany, but it was illegal to use steel from, say, Pakistan or France and label it as German.
In an undercover video in which she poses as a surgical instrument supplier, two British representatives from Regal Medical Instruments are seen offering to sell instruments made from Pakistani steel, stamping them “Made in Germany,” for resale at a higher price. The Pakistani representatives say they are already selling mid-priced French steel instruments to suppliers with German marks, at the request of their suppliers.
Non-disposable devices also pose a contamination risk
As I noted in an interview last year with Dr. David Lewis, a former microbiologist at the Environmental Protection Agency (EPA), non-disposable instruments such as flexible sigmoidoscopes and colonoscopies also pose a risk to patients.
Because these instruments need to be reused, they must be cleaned and sterilized both inside and out before use. However, testing has shown that this is virtually impossible, and the disinfection processes used in most clinics and hospitals are not capable of properly cleaning and sterilizing these instruments.
As a result, when these devices are used on patients, they pose a risk of spreading all kinds of infections from patient to patient. The solution is to make flexible scopes that can be autoclaved. But manufacturers aren’t being pressured to come up with such designs. As Lewis points out, it’s ultimately because federal agencies aren’t taking the contamination problem seriously enough.
If you are having a colonoscopy or other procedure using a flexible endoscope, be sure to learn how to clean the endoscope and what cleaning products to use.
- If a hospital or clinic uses peracetic acid, the chances of contracting an infection from a previous patient are very low.
- If the answer is glutaraldehyde, or the brand name Cidex (what 80% of clinics use), cancel your appointment and go elsewhere.
Asking what you use to clean your scope is an important question that may save your life, and it’s important that we all start doing this because the FDA has zero incentive to take action on this.
But if enough people refuse to be treated with equipment sterilized with glutaraldehyde, clinics and hospitals will change without the FDA doing anything. It’s also important that any healthcare professionals reading this start addressing this issue from the inside out. There needs to be real awareness of this issue and how it’s putting patients at risk.
When it comes to faulty surgical tools, there’s very little you, the patient, can do. Ideally, every hospital would hire someone to carefully inspect every surgical tool before use. Overall, Polling’s report makes clear that there is a lot of room for improvement in the industry if patient welfare is to be a top priority.
