It is the responsibility of the company to fully and accurately inform the end user of the risks associated with their product. Obviously, there are instances where not everything can be listed on a bottle or box but in that case there should be an adjoining paper with the supplemental information. No matter the occurrence or severity of the risk, I believe it should be adequately mentioned with the purchse of any product. In other words, assume the buyer has never read anything about the product prior to purchasing. The product should contain all necessary information for the end user to confidently use it, which means analyzing the risks associated.

In my perspective, risk management starts with end-user training and education. It is incumbent to a corporation to educate the end-user population to the best of their ability once they have done all possible to provide a safe and effective gadget or product. When it comes to intraoperative surgical equipment, for example, corporate representatives should teach all personnel who will handle and utilize the equipment. The accompanying instructions should be as detailed as possible, but they will never be as instructive as a live demonstration. Pharmaceuticals and prescription medications are in the same boat. Of course, drug salespeople are hired to promote products, but they should also offer enough information to physicians and pharmacists who will be writing prescriptions for patients. Labels are necessary, but they should not be regarded as the greatest way to provide risk minimization, as previously stated.

I personally don’t think it’s fair that the companies have to bear the risk of a person’s own reckless actions and inability to read labels. What companies can do about the residual risk to give very clear warnings that are difficult to ignore on product of the possible negative outcomes. Often times warning labels are small and can be hard to read especially for elderly. While this may reduce sales this could also reduce residual risk.

When it pertains to the use of painkillers, it is up to the consumer to follow the instructions that are on the label. Drug companies do a great job at fully listing the directions of use and possible side effects when taken as directed. They also list the telephone number of the poison hotline in case someone takes more than the suggested amount. I think drug companies thoroughly lay out all possible risks of medications and encourage consumers to consult with their doctor before taking them. 

I think companies complete risk management protocols for the safety of the user, but also as a means to remove liability. If the company does not provide safety instructions are identify the risk , then they are liable for possible injuries due to using the product. I think risk assessments should be routinely carried out on every product. 

After the product has been manufactured and the company has done everything possible, it is up to the consumer to use the product as directed. The manufacturer should have clearly written labeling and directions on how to use the medication, when not to take it, and when to consult a doctor. This is an illustration of risk management. This can help healthcare providers ensure that people understand the drug they are going to take. Also on the other hand a lot of people do not read the labels regardless, but when they are simpler to understand this prevents overuse and when to stop or consult a doctor and or pharmacist about your overall use. 

Minimizing residual risk relies heavily on post-market surveillance and updates to risk management files and marketing materials (claims and copy). It is critical for companies to strongly consider monitoring and taking action on trends from complaints or general inquiries from customers directly after devices are marketed. In my experience there is a "post-launch period" where products are reviewed in a bi-weekly quality review board to assess if there has been any issues identified that would require updates to risk management files, marketing material, and/or labeling to further reduce residual risk. Marketing material and labeling especially the IFU are definitely important to helping minimize risk from the use stand point. 

I have to agree that labeling should not be considered a method of mitigating the risk of medication, devices, etc. I understand the importance of warning labels and I understand why companies decide to utilize them, however, I think a patient, consumer, etc., would be briefed by a doctor, or have some knowledge of the medication or device before using it. I highly doubt medications or even medical devices are utilized or distributed without educating the user or patient and they will be told the risks. Ultimately sometimes risks are unavoidable in a sense of complications.

You raise an interesting point about the role of instructions for use and labels in managing residual risk in the context of product safety. While it is true that instructions for use and labels are important elements of risk control, they are considered to be the least effective risk mitigation measures as they rely on the end-users' compliance and understanding, which may vary.

In the case of pharmaceuticals such as painkillers, manufacturers are indeed limited in their ability to control the actions of individual patients who use their products. However, pharmaceutical companies have several other avenues to ensure proper use and mitigate residual risk:

1. Education and awareness: Companies can invest in robust educational initiatives aimed at informing patients and healthcare providers about the safe and appropriate use of their products. This may include providing clear and concise instructions for use, warnings, and precautions, as well as educational materials such as patient brochures or online resources

2. Regulatory compliance: Companies can ensure strict compliance with relevant regulations and standards governing product labeling, instructions for use, and risk management to minimize the risk of non-compliance-related issues and potential liability.

It's important to note that while companies have a responsibility to develop safe products and provide clear instructions for use, end-users also have a role to play in ensuring their own safety by following the provided instructions and using products as intended. Risk management is a shared responsibility between manufacturers and end-users, and a combination of efforts from both parties is necessary to effectively manage residual risk associated with product use.

When it comes to mitigating risk I understand why labels are the least effective in most cases. When it comes to over the counter medications, people do tend to read the label about appropriate use and dosage, but that cannot be enforced and many people tend to do what they perceive is correct. I saw a video of a doctor discussing a medical case in which a patient consumed an entire bottle of ibuprofen because they believed it to be like prescribed antibiotics in that the full course or in their case full bottle must be ingested for the full therapeutic effects to take place. The bottle of ibuprofen was labelled and yet the patient made their own assumptions and took the medication as they saw fit. When it comes to medications and products like it, companies may not be able to design out the risk and they can put some safe guards like child proof lids and tamper seals but at least they are implementing some level of risk management and like the child-proof lids and tamper seals, they often come after tragic events take place.