Reducing risk As Far As Possible (AFAP) has been one of the most confusing parts of the European Union Medical Device Regulation (EUMDR). Officials have tried to offer guidance. First, they modified the international standard for risk management, ISO 14971, to include AFAP in the European version, EN ISO 14971.
Unfortunately, the European version of risk management introduced the term “as far as possible” but did not explain the concept. In 2014, officials tried again to clarify the concept in a consensus paper for the interpretation of EN ISO 14971, where they state that they’ve clarified the standard in a way that’s “clear, easy to understand, and unambiguous.”
- All risks were reduced as far as possible compared to the “state of the art,” including risks deemed negligible under ISO 14971. This does not mean the latest, unproven technology; in European law, “state of the art” means “generally accepted state of the art,” which implies general acceptance of best-practices based on current medical knowledge and competitive products.
- Cost wasn’t a factor in reducing risk. In other words, you can not justify stoping at a level of risk control because the next level is state of the art is more expensive.
- Additional risk control wouldn’t lower risk levels.
- Benefits outweigh residual risks.
State of the Art
Cost can not be a factor
Risk Control and Risk / Benefit
There will always be remaining risks in medical devices. For example, hospital workers were at risk of being stuck by used needles that carried viruses such as HIV and hepatitis until state of the art risk controls included caps for needles and designated disposal containers. But, there’s still a needle that must be able to penetrate skin, so there’s still risk. Risk/benefit analysis documents that you followed state of the risk controls and that benefits to patients outweigh your remaining risks.
To help, I share a few steps you could take starting today that will help you comply with the MDR and reduce risk As Far As Possible. Taking small, measurable steps is the basis of Kaizen approach to management. See Take these steps to comply with the EU MDR, with an application to reducing risk As Far As Possible.
It’ll take an industry of millions to provide healthcare for a planet of billions.
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Now, let’s have fun with the 1987 hit “Bring the Noise” that was ranked #160 in Rolling Stone magazine’s 500 best songs of all time. It begins with the phrase “Bass! How low can you go?”