This website explains this concept of AFAP and something else called "As Low As Reasonably Practicable” (ALARP). The idea is that the device has as many of its risks either removed or mitigated as much as possible with 2 categories of exception. One is not necessarily reducing risk with additional or redundant alarms or controls. The other is that if there is really only 1 risk control that can fit/ makes sense/ etc. The article explains examples of both of these.

I think the documentation in the FMECA or whatever tool the company uses is what the FDA or governing body uses to determine if genuine thought and consideration for risks was taken. Then the mitigations are recorded and the governing bodies are responsible for reviewing. At the end of the day, the team that creates the risks/ mitigations documentation will be responsible and will have to deal with reprocussions if people end up hurt by the device.

http://medicaldeviceacademy.com/en-iso-149712012-deviation-3-risk-reduction/

Hello,

The term 'As Far As Possible' certainly could pose a difficult situation. However, I believe that there should be no possible risk left unconsidered, even if it is extremely unlikely. The intentions of a medical device is to be safe and effective. With safety being of utmost importance. This is a responsibility that falls on the risk analysis team that would have to do all the appropriate research to ensure that all possible risks have been accounted for. This is an extremely important step in the development of a medical device and requires an experienced team's effort.

-Romany

Hi Fady,

I agree that it is not clear as to what exactly "as far as possible" means and what standard it is being compared to. This statement definitely implies that all risks cannot be reduced completely, but should be significantly reduced nonetheless to ensure that the device is safe to use. As long as the manufacturers can verify that the risks are reduced as far as possible within their risk management plan that is a part of their technical documentation, it should be acceptable. Just as others mentioned above, the end goal of any medical device is to be as safe and effective as possible with no risk left unacknowledged and reduced.

At times it is very unlikely to be able to eliminate all risk in a medical device. The article posted above does a great job explaining what "as far as possible" implies in the IPO. This just ensures that the cost to reduce the risk has absolutely no influence whether the risk is considered acceptable or not. Without this companies would try and get past with mitigating the risks to a point that is only financially beneficial for the company. This ensures the safety of the patient is a high priority than the financial revenue of the product. If you are able to prove that there are no other possible methods to mitigate the risk this would be considered reducing the risk as far as possible.

I agree, essentially it is this, that a company should do what it reasonability can to ensure all risks are assessed and ensure no negligence is done on the part of the company to put the users at risk. And this should be done without the thought for cost as a mandatory step and due process that regulations and companies owe to the public. It is also to show there is no risk relative to the specifications of the products that go untested.

I think what it comes down to is essentially the honor system. It may sound quite counterproductive because, of course if you give companies an inch, they'll take a mile. However, if something during the production of an medical device goes wrong, and the company becomes scrutinized, they are going to be cross examined to see if they truly did go as far as possible. Either the company really did try their best and something went wrong, or they tried to get away with something, and they'll either convict themselves or have to purger themselves. I truly do think "asa far as possible" is a feasible restriction

Reducing risks “as far as possible” is definitely a huge challenge for manufactures. I believe that the statement implies that not all of the risks can be reduced 100%, but it should be reduced as much as possible in order for the device to be used safely. In regards to medical device companies, possible risks should never be overlooked, even if there is a chance that the risk may not occur. A medical device is created for a consumer to use effectively and in a safe manner, and thus, safety is undoubtedly the most important aspect. These possible risks should be taken into account by the company’s risk analysis team. In the end, manufactures should be able to verify that the risks have been reduced as much as possible and the product should be deemed as acceptable.

I think as far as possible, is what is literally should be, because the human life is worth more than anything. We shouldn't worry too much about cost of making product because people will pay more money with higher qualities than pay less for a product that could be harmful for you. It will also end up costing you too much money if you get caught. The best example is ford pinto case, where they had to spend millions because they were too stingy to spent $11 per car, after that they had to spend even more per car.

I think in the context of any other field, As Far As Possible is daunting and almost unattainable. However, in medical devices and anything else regulated by the FDA, it is necessary. The goal of the FDA is to have products that are safe and effective. It is sensible that companies should not even consider economics when reducing or even completely eliminating risk. To prove this, a company would need to show proof that every foreseeable risk was addressed.

The ISO 14971:2012 risk management requirement is not clear because one cannot define” as far as possible.” The risk management team can find ways to mitigate, eliminate, prepare for risks which can have an economic effect on the medical device. Despite the economic toll on reducing the risks of a medical device, it is necessary to keep the safety of the user to the upmost importance. The company’s risk management team should layout a PFMEA which breakdown the risks and severity of each process in creating the medical device. Then they should determine ways to reduce the number of risks so that the product is safe for the user.

As the standard states, the company must, to the best of their ability, reduce the risk to the lowest level possible. I believe that this could be done by being able to address all the issues present in the device. After stating the issues, solutions for these issues must be presented in an orderly manner with the possible outcomes also listed. By doing so, it can be said that the device has been completely evaluated and all possible turnout for the device has been checked. To prove that the device has been completely solved, it is important to have risks that are low-level, meaning that these issues will not cause harm or deleterious effects to the user.

This phrase does pose a difficult situation because gauging "As Far As Possible" is pretty much relative. However, I think that thorough assessment of risks involved ,whether it be severe or minor, and providing solutions to either avoid or mitigate these risks is best. This would also tie into another discussion topic regarding risk management documentation being considered a living document; where constantly updating this document can help eliminate risks involved with the product.

"As Far As Possible" (AFAP) sounds like a very general term that is open to interpretation and so it becomes the work of the company to meet industry standards for risk assessment and minimalization. This would include the use of up-to-date methods of analyzing risk and constantly updating documentation and procedures to ensure that risk is constantly being revisited.

Often times, it is best to determine what the worst case scenario is when making a decision. When making a decision for the safety margins in a medical device, one way to think of what ought to be considered "as far as possible" is to determine what a reasonable investigator (or jury!) would consider being as such when determining whether a medical device company has engaged in malpractice. For example, when a particular risk is defined to be high/low chance or high/low danger, there should be documentation showing why. And if a risk that was not discovered, there must be adequate proof that effort was undertaken to find probable risks, and to show that the specific danger could not reasonably have been found.

There are of course numerous examples and precedents that can be used to further clarify and define what "as far as possible means." However, assuming and preparing for the worst is the best option to avoid future difficulties.