By: Jaime Ennis (visit Jaime on LinkedIn here.)
For all you physicians, surgeons, and healthcare providers out there: I’m the guy who works to make sure your equipment does all it’s supposed to for the care you give to patients. Stapler misfire? Broken laparoscope with lines on the screen? I’m the guy for that stuff. Let’s talk about how equipment problems are reported so that we can work together to make sure that we don’t have equipment issues that hinder your ability to do the best you can for us–the patients!
The Quality of Medical Device Reporting
Data is everything to a Quality Engineer, and when a Medical Device Report (MDR) is received we must follow a strict procedural approach to reveal the root cause. Often the information received is ambiguous and actually hinders a proper investigation! The Failure Modes Effects Analysis (FMEA) are updated, Statistical Process Control (SPC) is analyzed, and Control Plans are reviewed…but the true value of the report is diminished when a reactive approach is taken and the preventative opportunity lost. Let’s talk about some of the ideas that may diminish the best reporting possible.
Medical device manufacturers are doing it for the money!
True, but remember at the same time device engineers strive to deliver perfect products that meet the customer’s requirements and provide a positive, memorable experience. It’s for the docs, the manufacturers, and the patients. (Don’t worry, I know there’s a patient at the end of the stapler!) In manufacturing medical devices we choose to follow a difficult and costly path riddled with risk. We imagine being the patient who requires perfect quality the first time, every time, but our best efforts are only as good as the data collected from the field. I often wonder what percentage of mandatory reporting is misrepresented or the adverse event occurred during misuse and ultimately a misunderstanding of the devices design capabilities. Please help us understand the problem and we will fix it at any cost!
One MDR can take a year to resolve and is worth every second!
Without being specific, I have worked an entire year to improve a product without a single change to the design. The cost has yet to be realized, but $1,000,000 is a conservative estimate and will absolutely be captured in our cost of quality metric. In this example, different tissue thicknesses were evaluated and countless tests were completed to improve the device’s performance envelope. To validate the smallest process change, several thousand devices were assembled and tested in the predefined manner outlined with the devices approval. Imperceptible to the user, this device will now function in applications never imagined or planned for. This duration could have been reduced, but one MDR with very little information is all it takes to spend a year putting the pieces together. The next time a surgeon reaches for this device the last thing I want is the distraction of failure in their mind.
Surgeons, help us help you!
Here are some simple rules to follow when faced with an MDR:
- Capture every detail: There is no technical detail we can’t unravel, and we will consult your peers to understand any situation. The more relevant detail the better we will serve you and this information may be passed down several times before it reaches the appropriate subject matter experts. Don’t be afraid to use that extra page provided to describe what happened.
- Include technique: When we set out to recreate the failure, your experience must be clear. We want to test devices in an accurate manner and this information is paramount. If a surgeon describes their experience firsthand, we won’t assume anything.
- Query your peers: Before committing to the content, consider every perspective of your surgical team. Perhaps they will add value and reveal something unperceived.
- Pictures speak a thousand MORE words: The most successful investigations I have participated in included reports that were accompanied by pictures. You may be contacted by the device manufacturer and pictures will always be valuable.
So, to all you healthcare providers, I want to say hello and let you know about what we do to make sure all those devices out there do the right thing for the first time they’re used and every time they’re used.
Thoughts, questions, or comments? Let me know beneath!