New technology is hardly tested
One technical feat after another enters the operating room. But: ‘New technology is not always an improvement’, says gynecologist Frank Willem Jansen, professor of Minimal Invasive Surgery (keyhole surgery). ‘All this new technology is hardly tested. Doctors and patients should not rely on it blindly.’
‘Faster recovery through new knee prosthesis technique’. ‘Robot operation surpasses success keyhole surgery’. ‘New nerve-sparing surgical technique for cervical cancer’. Good news, you think when you read these kinds of newspaper reports. Healthcare is getting better!
However, that is not always the case, according to gynecologist Frank Willem Jansen. “We tend to think that newer is always better. But that has to be proven first.” Jansen was already a professor at the Leiden University Medical Center, but at the beginning of this year he was also appointed to a similar chair at TU Delft. His appointment should initiate cross-fertilization between doctors and technicians. “I bring technicians into the operating room and invite doctors to technical lectures. We are increasingly involved in each other’s fields of expertise, but we still do not work together enough.”
The classic, artisan surgeon who cuts open a patient with his operating knife is rapidly disappearing. Jansen and his colleagues are increasingly seeing what is happening in their patient on a monitor. They use thin, metal arms to insert pliers, scissors and blades through a hole in the abdomen, knee or chest. If they have just mastered the technique of keyhole surgery, the next high-tech option is just around the corner: even more sophisticated keyhole surgery, robotic surgery, remote surgery…
All that technology rolls into the operating room almost silently, eagerly embraced by doctors and patients. Because new technology means more possibilities, less pain, faster recovery. Usually – because sometimes things go seriously wrong. Jansen: “Much more attention should be paid to the safety of new technology for patients.”
Should patients be concerned if the doctor says he wants to use an advanced surgical technique?
“I don’t want to scare patients. New technology offers great advantages. Take keyhole surgery. You recover faster from this, you have less pain and blood loss and only three small cuts instead of an unsightly gasp on your stomach. That is a big improvement compared to the past, when the entire abdominal wall had to open.
But if you have to undergo such an operation, it is good to know that keyhole surgery places different demands on the surgeon than old-fashioned operations. The technique is complex. All moves are reversed: right is left and left is right. It’s like eating with chopsticks, while you’re used to a knife and fork. To do it right, you have to practice. Keyhole surgery also requires more teamwork; the whole team must be able to work with the equipment. To gain sufficient dexterity, you have to do many operations per year. If that is only about five times a year, as a patient I would say: thank you, then I would rather go to someone else.”
So you can’t blindly assume that a doctor who suggests keyhole surgery is skilled enough?
“Certainly in the early days of keyhole surgery there was a proliferation. The results were fantastic, until some patients died due to human and technical errors. Others had unexpected complications. Then it turned out that some surgeons had not received sufficient training or were not reaching their numbers. Most of them have now stopped having keyhole surgery, because they realized that they had too little experience.
More and more medical training is being practiced with operation simulators: just like pilots learning to fly an airplane on dry land. Almost all hospitals have also tightened up their procedures for keyhole surgery. Today we have mastered the technology well, but the next innovation is already just around the corner.”
What innovation is that?
“Nowadays, we can perform abdominal operations through a single incision in the navel. This is already happening, while it has not yet been investigated whether it really gives better results and what complications can arise. Every new technique has its downside. We now know that keyhole surgery on the gallbladder can damage the passageways to the liver. In the worst case, the function of the liver can fail. There is also a widely used technique in which blood vessels are cauterized during surgery. Inattention can cause burns on the bowel that are beyond the surgeon’s field of view.
If you have cut open a abdomen, you will usually see that you have hit an intestine. During keyhole surgery, you only have a view of the area where you are operating. As a result, damage in the area around it can go unnoticed. If such a burn on the intestine is not treated quickly, the intestine can break. The insidious thing is that such a complication is rare, but the consequences can be serious.”
Robotic operations are all the rage right now. They are widely used in urology. Can such a robot run amok?
“Operating robot is actually a misnomer. ‘Telemanipulator’ or ‘remote hands’ are better terms. Every cut, every suture is controlled by the surgeon. Robots can malfunction or go into tilt, so that the arms no longer move. The risk of this seems limited. The danger is more that there is no feeling in robotic arms. For example, if you place a suture, you will not feel the resistance of the tissue. If you have to make a suture, as a surgeon you want to know how hard to tighten the knot. That feeling is not yet present in such a robot system.”
So is there a greater chance that you will break something?
“We do not know that. Doctors mainly focus on the benefits, and they are undeniable. The robot turns right again from right and left again from left. The hands of the robot can rotate 360 degrees. This allows you to get to difficult places better than with normal keyhole surgery. The system accurately converts the commands you give with your hands into the correct movement. And very important: the surgeon sees everything three-dimensionally again. It seems like he can actually see inside the patient. But we don’t know exactly how it will play out yet. That’s what I’m concerned about. We should do a lot more research before we bring a new technique into the operating room.”
Why is new technology being introduced so hastily?
“The medical industry is very pushy. They want to earn money from new technology. They come up with the most wonderful inventions. And doctors want to score: making as many patients as possible better by using modern technology. ‘We are the first’, it says in large letters in the newspaper. Don’t forget the pressure of patients. Often they insist on getting the latest treatment.
I sometimes have patients who insist on laser treatment: ‘I’ve read that you can remove my fibroid with a laser.’ Sometimes I have to talk like Brugman to make it clear that laser treatment for a fibroid is like shopping with a rocket: it is possible, but it could be much simpler. And sometimes tricks are left behind because they are not commercially interesting. For example, a fellow doctor has developed a device to remove polyps from the uterus. Its use is easy to learn and it is safer for patients than the technique we use so far. But it is not widely used because the industry sees little benefit in it.”
Will the doctor become a slave to the medical industry?
“That’s too simplistic. It is a complex interplay between doctors and patients on the one hand and commerce on the other. The technology is developing rapidly. It is difficult for doctors and hospitals to keep pace. Especially if you know that you can help patients for whom you could do little with the old technology. What also plays a role is that the technology is getting a little bit better every time. An innovation is often a variation on something we already knew.
Compare it to the switch from a manual car to an automatic transmission. It’s not like we’re all suddenly getting into a race car. But almost without us realizing it, we eventually end up behind the wheel of that Formula 1 car. And if you make a wrong steering movement, you’ll end up in the ditch sooner than with a family cart. Doctors should be more aware of that. It’s not: hupsakee, I’m adding this novelty. We bring in techniques that do not belong to our field. That requires study, practice and constant evaluation. It sometimes seems that thorough evaluations are only made after accidents have happened.”
Medications are extensively tested before they are prescribed. Why don’t such regulations exist for new medical technology?
“That is indeed very remarkable. Each new drug is reversed three times. There are hardly any rules for the admission of new medical techniques, devices and instruments. Instruments must do what they intend to do and they must meet certain safety requirements. We don’t have to show that a new technique makes the average patient better. So at the time such a technique is introduced, we don’t really know its effectiveness yet. Also the long-term results are often impossible to estimate.”
Should the government set stricter rules?
“Please no more rules. I think that the professional associations of doctors can solve this very well themselves. We need to move towards a system of certification whereby doctors demonstrate to their professional association that they are capable of using a technique. That means attending a course for a number of days per year, performing a minimum number of procedures per year and registration of complications. Many professional associations are already working on this. Doctors should also better inform their patients. It is best to say to a patient: ‘There is a new, promising technique with which we have not yet gained much experience. Would you be okay with being the first we operate in this way?’ Or vice versa: ‘There is a new technique, which we first want to test by comparing the results with an already common method. Do you mind if we don’t use the latest technology at your place?’”
I don’t think it’s a good idea that as a patient you just have to rely on your doctor to inform you sufficiently.
“That is why I am arguing for a public quality mark for new medical technology. In the past you had the stamp ‘Approved by the Dutch Association of Housewives’ for household appliances. This was fought over by producers. We should get something like this in hospitals. That patients can see at a glance: I can go to this hospital for this procedure. Patients can also ask more questions themselves. If you need to have surgery, ask how the doctor wants to operate. Let him explain why it has to be this way and what the alternatives are.
Unfortunately, there are still doctors who do not master a new technique and cover it up by saying that the technique is not much. Check the websites of hospitals to see which specializations they have. And above all, do not forget to ask the doctor how often he has performed the proposed procedure himself. A weird question? Come on, it’s your body.”
Sources):
- Plus Magazine