http://jasonpartin.com/wp-content/uploads/2019/03/logo-jp-jason-partin-cropped-50-px-high.png 0 0 jasonpartin http://jasonpartin.com/wp-content/uploads/2019/03/logo-jp-jason-partin-cropped-50-px-high.png jasonpartin2018-08-14 04:01:192019-04-22 18:39:22How to reduce risk As Far As Possible
In 1987 Chuck D, frontman of the hip-hop group Public Enemy, asked: “How low can you go?”
In 2017 Europe responded: “As Far As Possible.”
The new European Union Medical Device Regulation entered into effect in 2017 and will require devices to reduce risk As Far As Possible by 2020. Noncomplying devices will be removed from the market 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 14971:2007, to include AFAP in the European version, EN ISO 17971:2012. Unfortunately, this introduced the term but did not explain the concepts, adding to confusion. In 2014 officials tried to clarify the concept in a consensus paper for the interpretation and application of EN ISO 14971:2012, where they state that they’ve clarified AFAP in a way that’s “clear, easy to understand, and unambiguous.”
I offer possible explanations of why we’re confused in Why reducing risk as far as possible seems confusing; I believe it has to do with psychological concepts of anchor bias and a modern corporate culture that doesn’t allow employees to see the big picture of their work.
Regardless of the reasons, it’s important to understand reducing risk to patients As Far As Possible. Here’s my attempt to describe the concept in a way that’s clear, easy to understand, and unambiguous.
A company must demonstrate for each product or family of products, depending on the device classification that:
All risks were reduced as far as possible compared to the “state of the art,” including risks deemed negligible under the practice of As Far As Reasonably Practicable. 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 won’t lower risk levels.Benefits of the medical device outweigh all remaining 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” means 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 you should too.
Risk Controls & Risk/Benefit Analysis
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.
That’s 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.
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.
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.
You can learn independently using the 2014 consensus paper for EN ISO 14971:2012and theEuropean Union Medical Device Regulation.
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.
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.
Please share this article if you think others could benefit.
For what it’s worth
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 billions, and innovation will depend on diversity in boardrooms that begins as equitable education in classrooms.
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.