As I was going through the lecture I realized a lot of risk management is done before the product hits the market or done on the company side. This made me think of labels and instructions for use. I read somewhere that instructions for use and labels are deemed as the least effective way to solve residual risk, which is the risk left over after a company has done all it can to ensure safety. I have always understood this as a part of risk control and was surprised that it is actually considered the least effective. For something such as painkillers the manufacturers can only do so much to protect the patient and it is ultimately up to the patient to be responsible. Do you think this is fair for companies? What else can a company do to to ensure proper use by the customer for their own saftey. Or what can they do about residual risk?
On the company's end, things they can do for risk management outside of printed warnings include designing out the risk, implementing safeguards, and giving training on the product, service, or device. Assuming the company has done the aforementioned, I believe that on top if it being fair, the company has done what it reasonably could to ensure that the customer is educated on proper use.
Risk management is forecasting and evaluation of financial risks together with the identification of procedures to avoid or minimize impact. Describe the history of risk management. labeling is the cornerstone of risk management and the foundation for the risk management of products. Labeling, instructions and warnings are required for medical devices.
I believe at this point labels are a formality for companies to avoid litigation. The example of a coffee cup with a WARNING HOT label is always one that comes to mind. Everyone knows coffee is hot, but one person ignored the unwritten warning and forced future companies to provide a warning to all future consumers. This goes to show that while it may not be an effective way of preventing risk, it allows companies to shift the risk from the company to the end user without paying a second price.
I believe on the bottle that the drugs come with there are instructions on how to take the drugs. If someone has an adverse effect with the drug, they would go to the hospital and get examined and through a blood test you can tell how much of the drug the person took in a certain period of time. If that does not comply with the directions on the back of the bottle, I do not think the company is liable for anything that happens to that person because they usually have some kind of disclosure that taking the drugs outside of the guidelines provided can cause some adverse effects.
I believe what the company can maximum do is to warn them by labeling, the ultimate result will be how the user deals with it. Coming to medical devices it is very apparent that there will always be some kind of risk associated with the device, so it is upto the user how they handle the device. For example, a hearing aid, you can not set the volume level to maximum for a person who has only little difficulty in hearing, then it will cause damage to the user. Whereas for a person who has lost most of his hearing senses, they might always have to keep volume on the higher range. So here we can not blame the medical device company for the former user if he damages this ear by setting the volume to maximum, as it was written in the manual to set the volume accordingly. So I believe it is up to the user how they handle the device.
In terms of the magnitude of company liabilities for risks associated with misuse of a product by a user, I believe is dependent on the situation at hand. For starters, I believe it is important that the company take the initiative to ensure that all labeling and instructions for use are presented in language that is easy to comprehend without confusion. Other things a company can do to ensure consumer safety is regulate purchases and quantities according to risk. An example of this is how some medications can be purchased over the counter while others require a prescription with instructions from one’s health care provider. In terms of fairness to companies, I believe it is important that evidence be available to show that such risks were identified by the companies and that efforts were made to mitigate them to the best of their ability. Overall, though I believe it may not be completely possible to control how the product is used by the user, so it may not be fair to place all the liability on a company if the use of the product was contrary to what was specified in the labeling and directions.
The first option is to design it out, which is ideal as the product is not in the market yet and if there are any design changes that can be done to reduce the risk then they should be adopted.
The second option being "enact safeguard measures" so as to suppress the activity causing the risk, which the companies try before they move on to the last measure which is nothing but to put a safety label/information/training, and also have a warning as they have tried all the measures to reduce the risk to minimal but still were not able to achieve that.
So I think its fair for companies as they try all the measures to mitigate the risk and I see nothing wrong in that.
I agree that labeling should be the last resort as people don't generally read label. If your product is designed the way that you have mitigated most of the risk that can be mitigated to ensure product works the way it intended to then you have to use labels to worn user, however you can ensure that user reads the label by making a label that catches users eye.
In case of the surgeons and nurses who will be along side surgeons, they are going to have training prior to surgery to ensure that they use device properly or they will already know what the risks are and know how to use the device. If you are making a device that is similar to the device that surgeon uses then you have to make sure that the device is used the way similar devices used in which case surgeons don't have to worry about reading labels and they know what the risks are for that device.
Since it is impossible for the company to predict what every person using their product will do, the team should always reduce or completely eliminate the possibility and level of harm before they place their product on the market. The product's demographic could range from medical professionals to patients using the device for the first time. Adding a warning label to the product should only serve as additional precaution, since the user could easily overlook it depending on the situation or have trouble understanding the severity of harm. While the user is responsible for heeding the instructions and warnings on the label, the company is also responsible for releasing a product that is reasonably safe to use. For example, if the user had to go above and beyond to harm himself/herself during product usage, the company should not be held accountable after practicing proper risk management.
This is tough because the important word you used was "residual". These companies do all they can in the risk management to avoid having these risks out there. Unfortunately, there is only so much a company can do to a product before the "risks" become necessary for the products function. You used the example of painkillers. For these products, the companies do their job, in risk management, in not having the people using these drugs OD after a single pill. This is done by having each pill only contain a certain dosage of the drug (i.e. Advil: 200mg Ibuprofen/pill). Now it would be ridiculous to only sell a single pill per package so thats why there are different amounts depending on the package you buy. It's the responsibility of the individual not to take 15 pills for a headache and thats where labels and instructions come in and are important.
Like many people in this thread I also agree that heathcare professionals should be properly educated in the use of medications and devices so that they may accurately convey the message to their patients during prescription. After all, it is part of their role and job. However unfortunately not all patients feel the same sense of duty to themselves. In order to mitigate the risk of patients not following directions, I think it would require an infrastructure change where over the counter medications are only provided after explaining to patients how to properly take them. But even then, the same issue arises that there is no clear way to ensure directions are being followed properly. The best one can do is ensure a product is safe to the best of their ability and provide patients with the information to use it correctly should they choose to read instructions.
I feel that labels and instructions are used as a last resort to explain the risks to the consumer. If you have ever been on medication on used common medical devices found in a drug store, chances are you have seen the paper insert, folded numerous times, covered in small print. How many people do you think actually read that? It’s likely only a small percentage do. If the consumer is not willing to read for their own benefit, I cannot think of an additional way to make them aware of the risks. I believe in these instances, the consumer is responsible, not the company. In order for the product to be available to the public, it would have to at least included the minimum requirements for risk management.
This brings up a fair point. There is only so much a company can do to reduce the risk to their consumers. At the end of the day, there is not going to be a representative of every company in the household of the customer giving them detailed instructions of use/ and or administering the product to them. Some methods of reducing risk for your example of painkillers is implementing child safety caps to reduce the risks for a child. However, there is only so much they can do for an adult. That being said, they customer must be responsible and read the labels as intended.
One of the aspects of my current job is Installing medical equipment for hospitals and typically we keep labels and instructions for certain devices once it is ready for use by the healthcare provider. However, I have never seen anyone ever actually go through those labels and instructions. Instead, my company sends people to train the nurses or whoever will be operating the machine so that they know what they're doing once the machine is ready to "go live". Actually, even for us we never really went through all the labels or instructions, instead, we're sent out for training to become experts on the machine and ensure we're delivering the service correctly for the sake of the patient's safety, and in consequence the company's liability. So as an employee these labels are useless to me but in the case of a patient taking medications, of course, there's no training for it so it is the accepted form of risk management.
From what I've learned from the Human Factors team at my job, not many customers tend to read the instructions for use (IFU) and may even discard them which can lead to potentially dangerous situations. There's only so much risk in a product that a company can mitigate such as the example that Dr. Simon shared about the scalpel during lecture. Companies do all they can to ensure that the product is safe through risk management but also to cover their bases in case someone wants to sue. The risk management process extends into the post-market phase as marketing keeps track of how users interact with and view the product which can be useful to analyze and potentially mitigate residual risk. However, it is more difficult when a product hits the market to then perform design changes and verifying/validating these changes, so the fastest and possibly least effective way to handle these post-market risks is an IFU and/or caution labels.
