Reduce Risk As Far As Possible

In 1987, the hip-hop group Public Enemy asked: “How low can you go?” In 2017, Europe responded, “As Far As Possible.” This article discusses how to reduce medical device risks as low as possible.

The new European Union Medical Device Regulation require that all medical devices reduce risk to patients As Far As Possible. If a company can’t comply, they can’t sell their products in the European Union by 2024. The penalty is strong because improving risk management is critical for global healthcare: 85,000 to 250,000 people die each year due to healthcare errors in America, and recently 400,000 Europeans received toxic medical implants. Learn more in my article about the MDR Big Picture.

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.”

Companies still struggle to understand and apply the concept of reducing risk As Far As Possible. I offer possible explanations of why we’re confused in an article on human bias in understanding risk. For now, here’s my attempt to describe the concept in a way that’s clear, easy to understand, and unambiguous.

Reducing Risk

A company must demonstrate for each product or family of products, depending on the device classification that:

  1. 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.
  2. 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.
  3. Additional risk control wouldn’t lower risk levels.
  4. Benefits outweigh residual risks.
These are concepts, not simple definitions, that I’ll try to illuminate below.

State of the Art

Think of “state of the art” in terms of an automobile: you wouldn’t buy a car without state of the art safety such as seatbelts, anti-lock brakes, or child-safety seat attachments. Conversely, there’s not enough evidence to make self-driving cars the “generally accepted state of the art.” Learn how to make state of the art medical devices in my article that demonstrates the concept using David Hasselhoff’s 1982 self-driving car.

Cost can not be a factor

You can’t choose not to make state of the art medical devices because your management thinks it costs too much or would reduce profits. Sate of the art means other companies have figured out how to control risks, therefore your company should too. Society benefits from safer products, and the economy benefits by rewarding innovative and efficient companies.

Risk Control and Risk / Benefit

You will still have some risks even after you’ve applied state of the art risk controls, which is why reducing risk As Far As Possible requires a risk/benefit analysis for all remaining risks.

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.

Risk Control and Risk / Benefit the “point” of my article on risk controls and risk-benefit analysis by applying the method to Harry Anderson’s magic trick of apparently sticking a needle through his arm.
Harry Anderson reduced risk using risk controls, but in the end there had to be a sharp needle therefore there was residual risk. The EU MDR simply wants your company to justify that you applied all risk control methods possible, and that the residual risks are justified because of benefits to patients.
At this “point” you will have a risk/benefit analysis documenting that you reduced risk as far as possible by applying risk controls that are state of the art, and that any remaining risk is outweighed by benefits to the patient population on your marketing literature. This risk/benefit analysis will be linked to other MDR requirements such as clinical data and post-market surveillance.

Continuous learning

To reduce risk as far as possible for MDR regulations requires linking to other processes in your quality system, especially clinical data and post-market surveillance. That’s beyond the scope of this article but you can learn more.
I provide more information on the transition to the new regulations in MDR: the medical device regulation formerly known as MDD.

You can hire consultants to help you prepare or train your teams.
  • Oriel STAT-A-MATRIX, an international management consulting organization (I consult with Oriel)
  • Qunique, a Swiss boutique consulting firm
  • Jason (me)
I encourage all companies to discuss original phrasing in the MDR and consensus paper as a team until concepts are clear, easy to understand, and unambiguous. That’s why my workshops focus on teamwork, learning-by-doing, and the bigger picture of how our work impacts the lives of other people.

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.

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Parting Thoughts

I first heard Public Enemy’s album “It’ll take a nation of millions to hold us back” in the 1980’s when they collaborated with diverse styles of music to bridge gaps in our society, such as the heavy metal band Anthrax, and the folk singer Stephen Stills from the band Buffalo Springfield while collaborating with filmmaker Spike Lee to remake their classic 1967 song “For What it’s Worth.”Though not everyone appreciates all of Public Enemy’s political messages, I respect that they collaborated with seemingly different people. I hope the medical device community can do this too:

It’ll take an industry of millions to provide healthcare for a planet of billions.

To do my part, I waive consulting fees for companies that contribute to programs supporting equitable education. Contact me to discuss more.

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?”

And the original 1967 “For What it’s Worth,” a message that’s still relevant today and emphasizes that seemingly different people share common beliefs.
And with their grammy-nominated collaboration with Heavy Metal band Anthrax.