I agree that the phrase "as far as possible" is broad and difficult to quantify. Because there is no way of knowing how many risks that may exist but haven't been identified. Because of this it isn't possible to reduce risky 100% or by any percentage. Without being able to quantify the reduction in risk I think that the phrase as far as possible is actually a good guideline to follow for risk analysis. This phrase means that a company should ethically devote resources to exhaustively identify any and every risk possible and properly designate and address each risk. In this situation I believe the highest majority of risks can be reduced.
I believe the concept of as far as possible is meant to be vague. It isn't defined as a certain level of safety or risk mitigation. Because by defining the point at which risk is "adequately" mitigated would lead to the requirement being met, but just barely. I believe the concept of as far as possible is meant to be a challenge and a charge to any company to do everything they can within their power to create a device with as low a possibility of risk or harm to its users as possible.
AFAP means that the device no longer can be identified with threats towards humans, operational, reputational, procedural, project, financial, technical, natural, political, or/and structural. These risks most likely have gone through a solution planned to handle the risk which may have been managed with mitigation, acceptance, or transference. There is no real way to prove that the risk has bee completely removed without additional testing or you can also calculate the risk value; Risk value = Probability of Event x Cost of Event. Ideally, this is the companies responsibility and the complete documents (like the mitigation document) that would put them at fault if something harmful was to happen to a patient due to their device.
The best place to start is the traditional risk matrix. The underlying concept of ISO 14971:2007 is to estimate risk (the output of Risk Analysis in Clause 4), evaluate the estimate against the acceptability criteria (in Clause 5), and determine the need for risk reduction (by applying Clause 6). In addition, after risk reduction, evaluate the residual risk estimate (in Clause 6.4) against the acceptability criteria to determine the need for additional risk reduction measures.
"As far as possible" to me would be to the point of common sense. Meaning, depending on the target product audience, there should be a level of intelligence that you expect the user to have. Take a tongue depressor for example. AFAP would be you assuming the user won't try to swallow it. So the labeling on the package will say, "Do Not Swallow" or something to that extent. This is because you expect the average person to have the "common sense" to not try to swallow the depressor.
On the other hand, the average person has no idea what an electrical surgical unit is. So the target audience would surgeons. So you would come up with labelings that say, " Do not use unless professionally trained" to cover the average person that decides to use it. On top of that, you would make other labels for the surgeons who are "trained" to use the device.
The way that I interpret this regulation is that companies have to prove that their manufacturing processes are performing at the most optimal level possible. It's impossible to have a 100% efficient system, many of the things that happen in nature (e.g. chemical reactions, space phenomenon) generate waste and increase the entropy of the universe. Companies have to prove that they are at the point in which they cannot afford to expend more resources to reducing defects or that such an attempt can disrupt and ruin whatever progress that they have made already. "As far as possible" has to take into account that it may be possible to improve quality of your products but the company may be not have the resources to carry out the necessary projects that would results in higher product quality. you would have to rely on statistical analysis and results from the customers themselves(e.g. compliants) that quality has improved. Another way to think about AFAP is that companies have to show that they are improving overall in quality; they cannot and should not trying to do something risky or expensive to get great results fast. If quality is improving slowly, I think that this would still count as abiding by AFAP because it shows that businesses are making an effort to improving their products and reduce risks. AFAP means essentially doing the best you can with what you have.
My interpretation of AFAP is twofold: Businesses are doing just enough to be competitive or Businesses are going above and beyond to be the best. In the medical device realm to be the best is to have the require ISO, CDR , FDA etc regulations that allow them to be certified to sale and produce medical devices. Practical it is impossible to be perfect in every area of the business. When working at my internship I realized that it is a challenge to have good quality. Their was load of ammunition that passed quality and went on to be painted only to realize after the parts were rusted. Therefore, my company had to tell their customer what happened and the possible fix. The quality is also, affected by external factors such as heat in the summer causes the parts to have a less coated surface due to humidity. These factors are impossible to regulate since we cannot control the Sun. There are measure that can be taken like having an air condition plant but, that might cost way to much to run and it better off not doing it. Therefore to reach the possible it will be a challenge given the environment the business is in.
Nowadays, people are willing to sue over anything and anyone. Therefore, companies must take all measures in avoiding, mitigating, transferring, and accepting risks without having any legal issues arise. However, there is a limit for how far a company can go to prevent risk, depending on the product and audience it targets. A company should only need to examine and assess risks that are within common sense, not anything below. Like one of my classmates has said, if given a device with an electrical component to it used by surgeons, the company does not need to caution the surgeons to prevent submersion of the device in water. The limit companies must go for manufacturers to reduce risks must fall within common sense and recognition of who the end-user's are.
The ISO 14971:2012 "Risk management for medical devices" requires manufacturers to reduce risk As Far As Possible without any economical consideration. I consider this a huge Conundrum for all medical device manufacturers. It is a gray area where lots of questions float around. The regulation is clear. it states As Far As Possible(AFAP). What is considered AFAP? and how far do you have to go to prove AFAP? and how do you prove that you were able to reduce risk AFAP? Any thoughts?
I agree that AFAP represents a gray area, though that may perhaps be by design. Many of the standards are intentionally vague to allow flexibility to account for regional or industrial variability. Similarly, I think AFAP varies, by region, as well as by industry. Given that AFAP is not clearly defined, I don't think it can be easily quantified, therefore I don't believe that there is a simple way to objectively prove whether or not a manufacturer reduced risk as far as possible.
I agree with your assertion that there needs to be a line that sets the amount of risk associated with the device that can be managed. However, "as far as possible" may not be thought of as where the line is initially, but a progression over time of where it will eventually end up. Think of an exponential curve depreciating over time. In the design stages of a device, most of the risk is mitigated or removed as it first hits the market and hopefully as the device's market grows. Once the device has made its share and has gone through several iterations, one would expect the device's risk to reach a point where it can't get lower without removing essential functions of the device associated with that risk.
The ISO 14971:2012 "Risk management for medical devices" requires manufacturers to reduce risk As Far As Possible without any economical consideration. I consider this a huge Conundrum for all medical device manufacturers. It is a gray area where lots of questions float around. The regulation is clear. it states As Far As Possible(AFAP). What is considered AFAP? and how far do you have to go to prove AFAP? and how do you prove that you were able to reduce risk AFAP? Any thoughts?
I completely agree, "As Far As Possible" is a pretty ambiguous term, which is why it is up to the medical device company to determine how far their risk management process needs to go. At the end of the day, the medical device company is liable for any harm their product could potentially cause to the user, so it is in their best interest to take all necessary precautions to mitigate risks. As Dr. Simon mentioned in the lecture, the best way to prevent risk is to design it out of the device (i.e. making the blades of a fan plastic), but sometimes you need to accept that certain risks are inherently present in a product (as they are in a scalpel). If a company were to try and design out the risks associated with a scalpel by making it less sharp and pointed, then it wouldn't perform as intended. In those instances, the company would incorporate those foreseeable risks into their risk documents, and add instructions for how to use the device in their IFUs.
Yes, I do believe it's a gray area. But I get the point, the risk management will vary to a great degree from one device to another, so the ISO can not give a generalised list of guidelines or limits to the product. For some devices the risks can be as low as a minor cut or a bruise, whereas it can be lite threatening for other devices like a bone drilling tool.
For starters, I believe the inclusion of the non-descriptive statement of “As Far As Possible” is due to the fact that risks can vary greatly depending on the product. For example, any medical product used to make incisions will still pose many risks. Therefore, I believe the statement is trying to proclaim that depending on the product, the project team should work to mitigate such risks to the best of their ability. As a result, the uncertainty does remain as to what can be classified as reaching the standards of reducing risk “As Far As Possible.” Since this is a gray area, I believe one can attempt to prove that they were able to reduce risk “AFAP” is by having evidence that all such risks were identified by the team and that attempts were made to try to mitigate them to the best of their ability. Since it may not be possible to remove all risks without affecting the intended functionality of the product, the project team should use warnings or labeling to accommodate for such scenarios.
The term as far as possible is a very general statement stating that the risk of medical devices must be minimised as much as the company can to ensure the device is safe for use.In order to do so an experienced team is required to analyse all the possible risk that could arise and try to minimise them and document those risks in their report. The company cannot minimise all the risks but must try to cover all the possible risks they could think of.
The ISO 14971:2012 "Risk management for medical devices" requires manufacturers to reduce risk As Far As Possible without any economical consideration. I consider this a huge Conundrum for all medical device manufacturers. It is a gray area where lots of questions float around. The regulation is clear. it states As Far As Possible(AFAP). What is considered AFAP? and how far do you have to go to prove AFAP? and how do you prove that you were able to reduce risk AFAP? Any thoughts?
This document specifies a process through which the manufacturer of a medical device can identify hazards associated with the medical device, estimate and evaluate the risks associated with these hazards control these risks, and monitor the effectiveness of the controls throughout the life cycle of the medical device. To make the document more clear, less confusing, and more understandable, I feel that it should have a small set amount of requirements that needs to be met. If a medical device does not meet these requirements then the instrument should be exempt. For example, the main goal of any device is to prevent harm. Whether device fulfills it's purpose, safety comes first. If devices in progress cannot meet safety requirements then it should be an automatic exempt.
