It was mentioned above that in the operating room, the surgeons and the technicians are not reading IFU's and packaging labels. Those are meant to be read before the surgery takes place. And while surgeons are experts in their respective surgeries, the margins for mistakes are small. So when accidents, failures, and fatalities happen, the medical device companies need to make sure that they are completely covered for all scenarios by having their IFU's and labels immaculately written.
I do agree that labeling is important but not very effective in informing the risk of the medical product being sold. The reason is that some people just read the instruction only, not the warning, which is not good. For example cough/cold medicines, some causes drowsiness while others don't, if someone just takes the one that causes drowsiness without knowing and has to drive all night, an accident can happen. There could be many to blame but if someone buys anything that has any risk, the seller must inform the customer. Surgeons can't use anything for surgeries, there tools must be specific to the type of surgery and they must be trained in using them, surgeons must also be informed of the risk in using, and as well inform the patient.
I do understand what you and Dr. Simon are saying but I get confused when it comes to situations the company cannot control. For example, medicines such as Tylenol or Advil are sold to the "normal" public which are not usually a group of pregnant women. So it should not be the top priority of a company to make Tylenol safe for pregnant women to use. So the way the company addresses this risk is that they use a label and say that pregnant women should not use this medicine. Now if a pregnant lady does take the medicine how is that the company's fault. They put the warning label and it should not be their top priority to make sure Tylenol is safe enough for pregnant women.
I agree with the idea of showing the buyers how to use the device while selling it to them. Companies cannot rely on the techs or even the surgeons to sit there and read how to use a device so the best way would be for the companies to actually teach the techs or surgeons how to use a device. Doing this can now take some risk away since the companies can say they sat there and taught the surgeons or techs the do's and dont's of the the device.
I think the companies put the effort to research and prepare the labels for patients, So I think it is the personal responsibility to read it and understand what is the risk of it. Some of this medication is over the counter and there is no way for the seller to inform each patient. Also, I believe it is the same way for a surgeon, It is there responsibly to know the risk behind using a tool or drug. It is part of his/Her expertise. I think the companies should not take a blame unless the product is defective or the root cause of the incident happened. I think one of the solutions mentioned above is to focus on graphical labeling. People tend to catch it easier rather than reading. But it is your choice either to read the warning or not.
I absolutely agree, at first I, I too felt surprised how ineffective labels and warning are the least effective in preventing residual risk in our products. In our case at work, there are currently a couple of "exploits" in our software that allows the customer to either produce a part for much cheaper or request a part that is simply unproducible on our end. Although we attempt to enforce guidelines for our customers to follow and warnings to avoid these exploits, it is almost inevitable to receive such cases. Some measures we've taken in addition to the instructions for use is incorporate simple and minor "roadblocks" in the exploited workflows to prevent our customers from being able to follow through. This however adds a step to other normal workflows which makes it slightly more inconvenient for other customers. From my perspective, it seems like incorporating instructions of use, labels, or even slight modifications to prevent residual risk either fails to do so or presents some risk in another way. Perhaps larger modifications are needed to completely eliminate the targeted residual risk without creating some risk elsewhere.
Risk management once the product is in the hands of the end user is as you say, the largest part of risk management. Either through the use case, timing, or general negligence. As Dr. Simon pointed out, a surgeon in the operating room is not going to take the time to read the instructions when they remove the device form it's packaging. Where changes can be made is for something like pharmaceuticals, which the end user has the time to read the instructions. In this case it is up to the company to make sure that the instructions are clearly written and are easy to find. But at the end of the day they cannot truly account for the risk that the end user will improperly use the product, because they are humans, and humans make mistakes.
At the end of the day, it seems that there will always be residual risk that a medical device company will have to deal with. The measures that companies take will not be guaranteed to completely eliminate risk. In fact, even if companies provide warning labels, seminars, trainings, what have you, there will always be the possibility that a user will use a product in the incorrect way, causing harm. An article I found explains a bit of this in terms of how residual risk is managed.
Residual risk is dealt in the following ways (according to the article:
avoid it
reduce it
accept it
transfer it
One example that stuck out to me in terms of managing residual risk is transferring it to another entity. For health companies risk is often deffered to insurance companies.
search what is residual risk? Definition and meaning in google to find article by MBN
Once the product is out in the market, and the company has done everything possible it is up to the user to use the product as indicated. The company should have written clear labels and directions as to how to use the medication, when not to take it or ask a doctor. It has happened to me that on some occasions I was prescribed some strong painkillers and when I went to pick it up at the pharmacy I was told to wait to speak to the Pharmacist. She explained to me how to take the medication, and when to stop. I thought this was another good example of risk management that companies can take. It can help ensure healthcare providers that patients are aware of the medication they're about to ingest. But as many of you have said, ultimately it is up to the user to use the product with diligence. As to what Dr. Simon said, I would think that during surgery, doctors, nurses, and techs are aware of how to use the medical devices, and if it's not the case, they could rely on common practices that will not need the device.
I think that it is fair. I do not think there is anything more a company can do to prevent an overdose for example after all the risks have en avoided or mitigated. On many pain killer bottles, there are multiple warnings on the amount that can be ingested before it can become hazardous to one's health. Once it is on the market, the consumer has full control over the product. God forbid anything happen, unless there was a defect in the product, all risks taken are taken by the consumer as the company has taken all the risks prior to development and evaluated them carefully before releasing it.
The reason labels are the least effective tool for risk management is that they are quite obviously not read. People often use common sense when opening up a product and more often than not figure out the way to use it after a few minutes of trial and error, if not right away. However, companies can not bank on everyone having enough common sense to do so, and as such put warnings and such on labels to protect them from a legal standpoint because is the the off chance that someone doesn't have the common sense to figure out how to use a product or something happens to them while using the product, they can get sued for not having the information there as an earlier post mentioned. There's only so much a company can do in order to inform their patients on how to use their product correctly, but when the market chooses not to read, the companies can do nothing else but protect themselves from taking the bullet for someone else's stupidity.
As mem42 mentioned pharmacy in his example, I have been on the other side of such encounters during my shifts at CVS. Having written directions on the prescription labels only does so much to help, but when it is a patient's first time picking up a medication they have never taken before we make sure that the pharmacist is able to properly instruct the patient on how to take the medicine not only because we want them to be healthy as soon as possible, but so that in the off chance they do not use it correctly and suffer from some harmful results, we cannot be held liable for it. It is common practice to always prepare for the patients that do not have the common sense to use a product without directions, hence the reason labels are common practice but not very effective.
When it comes to Off-The-Shelf (OTS) products, I think the quality department knows that consumers don't really read the labels and instructions that warn them about risks, and try their best to make them as safe as possible. OTS products can't be prescribed to a specific group of consumers, it can be used by young and old, readers and non-readers, etc. So risks written on the labels must be very very low and highly infrequent. When it comes to surgical devices on the other hand, some of the risks written on the label can occur if instructions are not followed precisely. This is why surgeons prefer using the instruments they are skilled and well-versed at, they hate trying new products. So when they get into the surgery room, they use instruments they have practiced with for years, they don't use new ones for which they need to read the label at the time of surgery.
So my point is that (as per my experience and knowledge) labels do well in informing their users about the risks. OTS products don't really carry much risks and it is needed that are so, because of their broad range of users. Surgical instruments can carry major risks if not used properly, this is why the surgeons practice and get skilled in using it correctly before they use it on real patients.
I am surprised to hear as well that instructions for use (IFU) and labels are deemed as the least effective way to solve residual risk since the amount of effort that is taken to ensure the content on the packaging and labeling meets regulatory requirements. Regulatory and quality are heavily involved in the artwork approval process for packaging and labeling content- which can go into several rounds of review and approval to meet all market regulatory and quality requirements. Aside from the IFU, another method for resolving residual risk can be done through reviewing the risk assessment and setting up sufficient customer service and preventative actions for anticipated customer complaints such as customer misuse. For example with the IFU, certain labeling on the product can help identify the market, product type, and product model to help customer service properly address any customer complaints and prevent or resolve risk associated situations. There will also be customer service training in place for the customer service representatives and there will be customer service bulletins created for any anticipated customer complaints to ensure they are handled effectively and with the most care. Unfortunately, as mentioned by sin3, some of the residual risk is indirectly associated with the company and directly with the misuse of the user, even if all preventions are taken to ensure proper use.
Think about a medical device being used during a surgery. The surgeon is scrubbed in and working on the patient. The techs in the OR are following the surgeon's instructions to hand things over, rinse things off, etc. At what point do you think anyone is going to open up the device out of a package and start reading the instructions or warning labels? Not to say it does not happen, but to say that this is not common and now you might see why putting something on the label as a manner of mitigating risk should not be the first resort.
This example would be a great way to show why printing warnings/labels would be the least effective way to mitigate risk. As you're reading, time is passing by and you may not have much time during surgery to be reading labels and learning what tool to use next. This is also why training should be completed beforehand.
