https://jasonpartin.com/wp-content/uploads/2018/08/7c4f6e_7fc116209f4d44e69600fc4d190b5a61mv2-1.jpeg 390 752 jasonpartin http://jasonpartin.com/wp-content/uploads/2019/03/logo-jp-jason-partin-cropped-50-px-high.png jasonpartin2018-08-30 19:10:012019-04-22 18:39:21Take these steps to comply with European Union Medical Device Requirements
This article gives two steps your company can quickly take to prepare for the most confusing requirement of the new European Union Medical Device Regulation, reducing risk As Far As Possible. I use the Kaizen approach to continuous improvement of applying small steps that are likely to be understood rather than drastically new procedures that cause confusion.
If you’re not familiar with the MDR please see my article on the MDR big picture.
If you’re not familiar with the concept of reducing risk to patients “As Far As Possible” please see How to reduce risk As Far As Possible.
All of those concepts can become daunting, which is why I suggest the Kaizen approach of taking small steps even in learning through each of those articles. Now I assume you’re ready to get two Kaizen steps to start complying with the ED MDR:
Assign a qualified person to be your MDR representative. This is required in the MDR, which states that person’s qualifications should be a combination of education and experience and documented in your quality system.Schedule consultants or trainers. Their schedules may be filled as other companies wait until closer to MDR deadlines. Of course this is optional, but I recommend it and list consultants at the end of this article.Modify existing risk/benefit procedures to gradually incorporate the concept of As Far As Possible for products sold in Europe; this may not involve a complete change of your system and will vary for each company.
The last step is difficult to describe in writing because it will be unique to your company. Kaizen is a concept that you must understand then apply to your unique situation; no one can help you determine a Kaizen step without understanding where you are currently. To give examples, I assume your company has an established risk/benefit table and uses Failure Modes Effects and Analysis for risk analysis.
Example of new Risk/Benefit tables
Most of the western world uses Failure Mode Effects and Analysis (FMEA) to quantify risk. The calculated residual risk, RPN, is often based on the severity of harm if a part fails (S) times the probability of that failure happening compared to the acceptable risk table to determine if further work is needed.
Those companies probably document acceptable risk levels in a Risk/Benefit matrix that uses the concept of “As Far As Reasonably Practicable,” which allows companies to decide not to reduce risk because it’s too costly and also allows them to ignore low risks.
A Kaizen step would be changing your risk/benefit table that does not have multiple risk categories but is binary, either unacceptable or reduced as far as possible, eliminating any category that could be justified as “negligible” risk or deemed an acceptable acceptable risk because of business needs instead of patient needs.
The risk analysis method would not have to be changed at first, nor would many other procedures. After implementing this first step you’d continuously improve your quality system with additional Kaizen steps.
But, the Kaizen step I just showed is just one step, it’s not the final goal. I ask attendees in my workshops to think about the concept of reducing risk as far as possible, discuss their understanding in small groups, and to brainstorm the limitations of what I suggested and what a final policy could look like.
For this blog, think about the limitations of a binary risk table before scrolling down to my answer, which I’ll share after copying the lyrics to Weird Al Yankovic‘s song “Yoda,” which is sang to the rhythm of “Lola” by the Kinks.
I met him in a swamp down in Dagoba Where it bubbles all the time like a giant carbonated soda S-O-D-A, soda
I saw the little runt sitting there on a log I asked him his name and in a raspy voice he said “yoda” Y-O-D-A, Yoda Yo-yo-yo-yo Yoda
Well, I’ve been around, but I ain’t never seen A guy who looks like a muppet, but he’s wrinkled and green Oh, my Yoda Yo-yo-yo-yo Yoda
Well, I’m not dumb, but I can’t understand How he can lift me in the air just by raising his hand Oh, my Yoda Yo-yo-yo-yo Yoda yo-yo-yo-yo Yoda
Well, I left home just a week before And I’ve never ever been a Jedi before But Obi Wan, he set me straight, of course He said, “Go to Yoda and he’ll show you the Force”
The limitation of a binary risk matrix is that it isn’t truly reducing risk as far as possible according to a closed-loop process of continuous improvement. To truly understand the concept there wouldn’t be a matrix, all risk would be lowered as far as possible.
In the context of the European Union Medical Device Regulation, reducing risk as far as possible a continuous process and that even “negligible” risks in former risk management tables must be continuously improved reduced until products are state of the art, additional risk reduction wouldn’t lower risk (severity X probability), products are state of the art, and that benefits outweigh residual risks when compared against competitive products and alternative treatments.
In other words, reducing risk as far as possible can’t be quantified in a table because it’s a continuous process that improves based on evolving real-world comparisons every 1-2 years or “as needed.” Reducing risk as far as possible is a concept that must be emphasized by senior management, the core job of every employee, and part of a company’s daily culture.
“The farther you go along the path the more you realize there’s no path.” – Buddhist wisdom
The FMEA table is commonly used but is not state of the art risk analysis because it focuses on parts and misses unforeseen situations that could lead to hazardous situations. Simply adding this step to existing risk analysis processes would bring your company closer to the international standard for risk management, ISO 14971. I cover ISO 14971 in detail throughout my blog and demonstrate it in How to apply ISO 14971 (it’s easier than you think). by re-analyzing the 1986 space shuttle explosion using state of the art risk management.
Learn more independently by using the 2014 consensus paper for EN ISO 14971:2012and theEuropean Union Medical Device Regulation.
Learn more in my article the MDR: the medical device regulation formerly known as MDD.
Or learn more by hiring consultants to work with your teams or train them.
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.
Please share this article if you think others could benefit.
I share this information because I believe reducing risk As Far As Possible will benefit society. This does not mean healthcare will become more expensive, it means that innovative companies now how an advantage over companies that previously had more risky products locked in contracts through business interests rather than patient safety.
Many government regulations can seem burdensome but are simply trying to make companies function as a process of continuous improvement that reduces risks to patients. I discuss my bigger-picture approach to continuous improvement using religions and philosophies from around the world, including lessons from the Buddha, who was an inspiration for Yoda in 1979’s film Star Wars. The Buddha summarized continuous improvement more in a sentence that is clear, easy to understand, and unambiguous:
Each day do more of what you know to be right and less of what you know to not be right – The Buddha
I wish you happiness.