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Risk management and Labels

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Posts: 15
Active Member

Working with pharmaceutical risk and instructions are a major concern. When people take a medication there are usually instructions on how to take it, however the user may not understand why things need to be done a certain way. Even if the reason is stated people do understand the extent that deviating from these instruction will effect the drug. It is up to the pharmaceutical company and the doctor to be as clear possible with the information, however sometimes there is a lot information and instructions and the patient must also be vigilant.

Posted : 20/11/2016 6:12 pm
Posts: 76
Trusted Member

This is an interesting topic for discussion! I agree with Dr. Simon that labeling or putting a warning on the package is not a direct way of mitigating risk. There are Instructions for use, also known as IFUs, which surgeons use as a guide for the surgery. In the real world, I don’t think this happens as the surgeon must be already trained to the procedure. In my current company, I am working on a project for obsoleting the paper IFUs and updating the labels to have the online (link) IFU reference. In my opinion, there should be tighter controls at final inspection of the product before shipping to the customer. Also, in the OR, the surgeon and the team must be trained to the procedure and the appropriate risk associated with the device prior to the operation. Not to mention, there are some important symbols on the labels that are critical for surgeon to know, such as the if the pack is sterile or not. However, identifying precautions on the labels to mitigate the risk should not be the first resort.

Posted : 19/11/2017 1:38 pm
Posts: 71
Trusted Member

I agree with this post that labels should only be used as a last resort of precaution use. Product should go through immense testing and make sure there are no risk involved in using the product in its intended use. There should be a risk analysis on aspects of what would occur if the product was used incorrectly in various degrees. Obviously if the product is used incorrectly at a high degree, there is not much a company can do. However, by doing so may increase the margins of using the product and therefore mild miss use of a product does not lead to major harm. But in parallel with this, there should be proper training involved in using products that have a learning curve in using them. Having all this in place can be very effective and a label can be added to continue to ensure safe use.

Posted : 19/11/2017 4:27 pm
Posts: 82
Trusted Member

A lot of companies and regulators such as BSI, put a lot of time and effort to ensure that the IFUs and graphic labels on the product match. I can see both sides why this is important and why this could potentially be unnecessary. I've run into issues with labels in which we couldn't sell product because the legal entity was mismatched and the location of the manufacturing site was mismatched. It was a somewhat easy but long undertaking to change. Is it completely necessary? Depends who you ask. Does a company stop from making the change? No.

Posted : 19/11/2017 5:02 pm
Posts: 43
Eminent Member

As the professor says, plainly putting something on the label does not help manage risk for the user. He describes that the instructions on the packages of equipment never get read, which is true for the most part. A lot of companies can help by maybe holding seminars about the equipment and teach surgeons and technicians how to use the equipment to minimize risk and allow them to know when the equipment truly is not working. This not only educates the user, but also can keep others safe, such as the patient that the surgeon is working on. I think this is the most effective way of getting the details medical products across to the users.

Posted : 19/11/2017 5:08 pm
Posts: 61
Trusted Member

Risk mitigation begins with end user training and education, in my opinion. After a company has done all it can to make a safe and efficacious device or product, it is up to them to educate the end user population to the best of their ability. So when it comes to things like intraoperative surgical equipment, reps from the company should train all personal that would handle and use the equipment. The instructions that come should be as comprehensive as possible, but they will never be as illustrative as a live demo. The same can be said of pharmaceuticals and prescription drugs. Drug reps are used to sell the product of course, but they should also provide more than enough information to physicians and pharmacist who would be prescribing the medication to patients. As has been mentioned before, labels are important, but should not be considered the best measure to ensure risk mitigation.

Posted : 19/11/2017 5:23 pm
Posts: 24
Eminent Member

Depending on the situation or the environment in which a medical device or drug is used, its cautionary labels may not always work effectively. As Dr. Simon mentioned, in highly dynamic environments, such as an operation theatre or in an ambulance, its highly unlikely that the user will stop and read the instructions or labels. After putting it through vigorous testing and providing the proper labels, there is little a company can do to ensure the product is used safely. Companies should not be held accountable for the irresponsibility of its customers. One line of defense to increase safety is to make less products available over the counter or without prescription. Before distributing a product, companies can also require its consumers to provide certain documentation or records than reinforce their accountability with their product.

Posted : 19/11/2017 5:25 pm
Posts: 40
Eminent Member

Labelling and istructions are very important for a medical device. Its the way to tell users to how to use device. Companies while advertising the product can actually show how to use the product and also along with that its good to tell the associated risks if not used in the way it should be used. Like this it can create little awareness in the customers/users.

Posted : 19/11/2017 7:33 pm
Posts: 29
Eminent Member

Instructions, labelling a medical device try to tell the users how to use or operate the product. So it is important that users read them carefully. To make sure that users follow the instructions, companies can do some training sessions where in they tell about how to use the product and also explain the risks associated with them when not used in a right way. Also they can put up in social media explaining how to use, risks associated etc.

Posted : 19/11/2017 7:50 pm
Posts: 43
Eminent Member

Labeling, instructions and warnings are required for medical devices. But least effective at preventing hazardous situations and foreseeable misuse. Another way to ensure proper use by the customer for their own safety is that the company should make sure the benefits of the medical device outweigh the residual risks, then the device can be commercially released.

Posted : 19/11/2017 7:59 pm
Posts: 82
Trusted Member

Labels are an essential part of risk management, but I agree that they are the least useful. This is because (from my experience) people do not normally read the warning labels. Think about things that you use on a daily basis, how many of the labels do you actually read before you use the product? The bulk of the risk management has to go into making the product "fool proof" so that you put as little risk as possible in the hands of the user. Is it an inconvenience to go through the trouble of making a label that is barely read? Yes. Yet if you don't have that label, a user that is harmed would just state that there was not a label on the product to say I was not supposed to use it in a way that was probably supposed to be "common sense."

Posted : 16/11/2018 10:51 am
Posts: 79
Trusted Member

I'm going to use a non-BME example to help clarify my thoughts. Whenever you get a coffee, the cup will usually have a label that warns that it is in fact, hot. Seems silly right? Well it's a result of Liebeck v. McDonald's Restaurants. A woman sued and won because she burned herself due to spilling hot coffee on herself. These labels aren't necessarily warnings because people don't know about it, it's more to protect the company from lawsuits. Yeah, a lot of labels actually impart necessary info, such as whether or not its a carcinogen, how to handle a product safely, etc. Do most people actually read these labels? No. The best alternative to labels would be training sessions and exams for BME products should be in place. It really is up to the user to make sure that they safely use the products they've bought.

Posted : 16/11/2018 5:10 pm
Posts: 31
Eminent Member

Somehow this topic interests me. Especially when participant nk229, posting coded 1461 seeks to express the dilemma of attempting to assess pharmaceutical drug risks as a major concern. That it is a concern, is actually an understatement. It is possible to work with risks associated with a medical device; but not with pharmaceutical items put out for human consumption. It is simply impossible to assess the risks of taking pharmaceutical drugs.

It is true the FDA puts pharmaceutical drug items through some sort scrutiny after which they are pronounced fit for marketing.

This is probably the worst job the FDA ever does and until pharmaceutical drug sales is prohibited, the FDA should be held responsible for the danger of letting very dangerous, often deadly, chemical fabrications put out for human consumption in the name of medicinal drugs. To say the least, one's health is in jeopardy each time one of those drugs in ingested.

Yes a great deal of chemical engineering is involved in the design of these drugs, but the last thing these chemical engineers understand is how the body really functions and this includes the so-called physicians who assist in their distribution (sales).

The body only works with something natural; i.e., one whose presence in the body is not questioned by the immune system; one the immune system does not fight to expel from the body [triggering such phenomena as reaction against drugs].

Not a single drug will help a patient get healed; i.e., freed from a disease. If in doubt study the healing practices of a physician - Dr. Gonzalez of New York City killed by mainstream medical practice. He was able to cure, yes! "cure" cancer using pancreatic hormones.

See the use of Frequency Specific Modulation to correct tissue problems by Dr. McMakin of Portland Oregon. These are only simple examples of people using nature to effect disease cure in the human body.

Briefly, the risk of taking pharmaceutical drugs is immeasurable; let alone the attempt to mitigate then.

Posted : 16/11/2018 8:49 pm
Posts: 78
Trusted Member

I understand the point Dr. Simon, but I would hope the surgeon and the techs know the risks of each item they use. They do not have to read it in the middle of the surgery but they should prior to surgery. I agree that it should not be the first resort for companies but as jnm22 said for example with medicine the companies explain on the label how many pills an adult or child should take but that is the only way I think the company can convey how many pills the adult or child should take. After that it is up to the adult or child to listen and not take more than advised. Another example would be labels that say do not do while pregnant. This might be extreme but not every pregnant women listens to those labels. Also if a medicine bottle says that this medicine should not be taken on an empty stomach the company cannot prevent a user from taking it on an empty stomach. Some risks are hard for the company to control because the user can only control them.

Posted : 17/11/2018 9:38 am
Posts: 83
Trusted Member

In medical device industry, labelling is important as it helps the manufacturer to meet the requirement of the device also helps customer in clinical setting to how to identify the devices. It is important that doctors to have training in operating the medical device. Doctors prescribing the medicines to the patient would intake the medicines without really reading the risk mentioned. There are medicines which are used to fever and if intake is for long time it is injurious the liver. So, it is important that the patients intakes the medicines with normal dosage.

Posted : 17/11/2018 3:49 pm
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