Hi,

I do agree with the above issue in risk management.Risk assessment includes the estimation and evaluation of a risk. FDA's premarketing risk assessment is intended to identify and quantify risks detected during clinical development and to evaluate how carefully any potential risks were assessed by the manufacturer. In addition, an evaluation of the risk of drug interactions as well as the potential for misadministration is performed. The known risks, along with any deficiencies in safety testing, are then weighed in the approval decision and described in the labeling of approved products.
FDA regulates the advertising and promotion of marketed products. Promotional materials must not be false, and they must not be misleading. In great part, this means that benefits should not be exaggerated and that risks should be presented clearly. Regulation of labeling, promotion, and advertising is intended to ensure that healthcare providers and consumers are adequately informed of the potential risks and benefits of the product, so that they can make decisions appropriate for each patient.
Irene Lloyd

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.

Personally, I would hope the techs and surgeon's are aware of what is in the label (such as the risks) prior to using the product. Perhaps through training taken in advance. I agree , that in the surgery example, it is hard to mitigate risk.

I would agree with Dr. Simon that it makes sense why labeling would not be considered a strong way to mitigate risk. While warning and instruction labels are important, it is also up to the company to ensure that the product's risk is outweighed by the benefits. Ultimately, this topic falls under the ways in which risk is managed. I believe that if a risk cannot be removed, it does need to be labeled, but it should be done as a later resort.

-Andrew Nashed

With respect to medical devices that are used during surgery, lab technicians should be properly trained in aseptic technique, and both surgeons and lab technicians should be aware of how there devices function. I know for one product in the company that I worked in, there were complaints on how to use a particular surgical staple device… surgeons did not know how to use the stapler and as a result delayed surgical completion. A cheat sheet was created and attached to the surgical staple giving surgeons a step by step method to using the device. This cheat sheet was pretty much a small sticker like diagram attached to the device that showed what knobs to press and release on the device.

Chris

While yes, everyone should obviously be trained properly ahead of time, this doesn't mean that mistakes don't happen. For instance, if for some reason someone grabbed a drug eluting stent that elutes a concentration much too high for the patient on the table, that could be problematic. All of the staff know how to implement the stent, but if that packaging doesn't have the dosage information on the outside, this risk grows. If all of the information is written on the packaging, then the staff are able to do a final check that every piece is appropriate for the situation and reduce any further human error that is possible to occur.

Kaitlin Connell

Labeling of medical devices is important, both to enable the manufacturers of the devices to meet
the requirements for device tracking using serial numbers and to enable customers in the clinical setting to
identify and properly employ the devices.

Our company offers several videos and training sessions that come with our product. The Training courses are, in my opinion, the best way to properly relay the information required so that the intended user applies the device in its intended use. Now of course you can’t train physically everyone but that is why the videos are available. The videos offer a medium to the indented users that allows them to grasp how the product should be used. It also warrants a prevention of misuse or abuse of the device. The disc is provided with all devices, as well as a service manual and a 24/7 hotline that can connect you to a representative if any issue is to arise. The device also has several alarms and preventive measures to mitigate improper use of the device.

I agreed with above discussions. I think it is very important for doctors, surgeons or who else is involve in using that device to have a training or at least instructions have been read before using any new medical device to avoid complications or delay.

I do not think it is fair for companies do that to patients because they put them into so many health risk that are not safe especially if we look beyond painkillers. I think they should create seminars or tutorials to inform patience the proper way to take the painkiller or product, so that way it could reduce the risk. Think about it for a second if someone gave you a tutorial/ talk on a product and said if you drink such and such will occur because this this and this. That would make people be more aware of the risks that come with that product. Sometimes the label don’t do justice, because some people don’t even read the labels of the product a new technique or method of how to make people pay more attention to that would be great. Or come up with a new label! To piggy back off of the last statement I think everyone should have knowledge, but sometimes the complications come from the person using that product.

I can understand where many of you in this discussion are coming from, however I am going to have to respectably disagree. Although it is the responsibility of the company to ensure that they have minimized the residual risk of their product as far as possible, it is the patient's responsibility to understand the residual risk of the product they are using. As Irene stated as long as the residual risk of the product has been assessed by the FDA and given approval the product will go on market with the risks described in the labels. At this point it is the sole responsibility of the patient to understand this risk and decide if the benefits obtained by this product outweigh this risk.

But if the patient can not understand the residual risk that means FDA is allowing products to go on the market with risks not described clearly in the labels. What if the risk is high, but thats the only medication that works for a person then who is at risk now?

I definitely agree with this. For most people, if a doctor prescribes you a medicine, and tells you how to take it, the patient is highly likely to take the medicine. Even if the patient was to read a warning label later, they are still much more likely to trust the doctor's judgement than what the label says. If the medicine was bought over-the-counter, without a professional's instruction, then the label is much more valuable to the user.

I agree - There comes a point where the company has done their part by putting warnings on labels and the customer who is using the device is responsible for following those instructions. For that to happen, it is expected that the user is trained to the proper handling and use prior to using it during surgery, for example. As many have said, mistakes do happen, but a lot of mistakes can be attributed to negligence by not reading these labels or IFUs.