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 think as far as possible is as safe and as efficient as possible without creating any hardship. Many have looked to the ISO 14971 norm as a method for dealing with the dangers related to the production and handling of their medical devices. This standard references and recommends the utilization of ALARP. Accordingly, ALARP has become broadly applied and is the reason for the acknowledgment by numerous makers of the low to direct degrees of leftover dangers which might be related to the turn of events, preparing, and utilization of their medical devices.
“As Far As Possible” allows medical devices that vary in use, class, and risk to be considered safe under the manufactures’ own definition. As an example, the risks for a wheelchair and insulin pump are different, however both need to be considered safe to some degree. I would hope that when companies are reducing the risk of their product, they reach the point where the risk is acceptable but continue to move forward with reducing the risk until they cannot go further. Additionally, I believe this broad term was used within ISO 14971:2012 to account for future medical devices that will use new technologies that we do not understand yet.
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?
When designing a risk matrix you can categorize the severity of risk and, thus take appropriate preventative action against each case. If you follow an AFAP approach, then mitigative or designing around each risk should absolutely be done for risks which pose a higher threat. Some companies have been able to put a price on a human's life, should you following AFAP, this practice should be neglected. Financial considerations should not have the greater influence over people's lives. Although not a medical device, well known case study many know about is the Ford Pinto.
Well, I think the regulation being labeled "As Far as Possible" was meant to be kept as a discrepancy because the limit would vary based on the device and its severity threshold. For example in the company I work at we have different levels/classifications for the medical device we're working on based on its risk to the patient. For example, something like an EKG machine would be a class 3 where if something went wrong with it during use wouldn't necessarily harm the patient. On the other hand, an anesthesia machine would be a class 1 where if something functionally goes wrong during use it would be detrimental and the patient's life would be at risk. These precautionary classifications are set forth when servicing those medical devices so I can only imagine the company's approach during the actual design phase. Also, if you recall there are 4 ways to deal with risks: avoidance, mitigation, acceptance, and transferable. These are meant to be general buffers for the risk management process and again would vary on both the device and stage of the production process. So these are the different options a team might have when trying to go "as far as possible"
This is definitely a predicament with establishing standards for anything. If any standard is set it maybe seen as too strict or not strict enough down the line. "As far as possible" should mean within a reasonable expectation of due diligence. That means fully attempting to create a complete picture surrounding the risks of your device. There are standard tests such as sterility and mechanical testing completed on most implants but with each implant there is usually something added or changed. These changes should be accurately assessed to their affect on the device as a whole. Additionally, there should be significant effort in understanding risks that may only happen every so often. For example, thought out hypotheticals of common diseases for the patient using your product and its interaction with the body. This would mean testing on more than just healthy individuals.
Apparently it changed from "as low as reasonably practicable" to "as far as possible" Basically the first one, ALARP; allows a manufacturer to include economic impacts into considerations as to what are acceptable and unacceptable risks. AFAP; does not allow economic impacts to form part of the risk decision making process. I read a blog on this exact topic, I found it pretty insightful:
https://www.presentationeze.com/blog/afap-as-far-as-possible-risk-reduction/
