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19 min reading time
I’ll be honest: I can’t even imagine what it’s like to learn my implant is being recalled.
But that’s what happened to a group member who prefers anonymity for legal reasons. She writes:
“I was appalled to receive a letter that my two-year-old hip replacements were being recalled. They were supposed to last 25-30 years!
They sold me the ‘the newest and greatest innovation’ when I had both hips replaced at the same time. (I was in excruciating pain, could barely walk, and was bone on bone after too many years of ballet.)
I healed well after physical therapy and, when my letter came, convinced myself my devices would be the exception. It didn’t work out that way.
I started having pain in my left hip and a strange metal-on-metal sound when I moved my leg a certain way after 4.5 years. My MRI showed a pseudo-tumor filled with metal shavings surrounding the implant. If these particles break loose into the blood stream, it can be fatal.
I had my left hip replaced in the fall. The right one is next.”
She concluded with a question for the group: “This is deeply unfair to patients. What can we, as an industry, do to prevent recalls of implanted devices from happening again?”
Related reading: “Are Recalls Preventable?” at http://linkd.in/preventable-recalls
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Mark C Adams, MBA
Dave Sheppard, CMAA
Dave Sheppard, CMAA
Edwin Bills, ASQ Fellow, RAC
Glad you found more information on MEOST> Shainin was a master of simple and uncomplicated techniques that were also powerful. The masters from the early days of quality and reliability still have much to teach us.
I’m currently a medical device reviewer for the FDA, so I can’t comment about the group member’s MoM hips, other than that I truly hope her health improves. And of course, my opinions here don’t represent the FDA’s opinions. But I wanted to share (and/or drone on about) a prior experience with a recalled implant to give anyone that’s unfamiliar a glimpse of the possible complexity of implant failure. Back in the early ’90s, I was a technician working for Pfizer’s Bjork-Shiley Convexo-Concave Heart Valve recall team. The valve was susceptible to a strut fracture over time. This was reported on approximately 500 valves, 2/3 of which caused fatality. (Many failures happened post-recall. Due to the risk of the operation, many weren’t replaced) The FDA removed the device from the market in 1986.
There was a good deal of controversy when it was pulled from the market, involving both Pfizer and the FDA. I can’t offer any insight on that; I wasn’t there yet. But I can say this: By the time I was hired, there was white-hot pressure to fix the problem. Death was still a risk for thousands, which was a sobering motivator in our labs. Also, litigation had reached the “Worried about your heart valve?” infomercial level, putting everything under scrutiny. Pfizer had to do the right thing, and I believe it did. Top people were recruited and worked at high capacity. A wide variety of bench and animal testing was developed and performed on hundreds of carefully reclaimed valves. This effort was above & beyond what would be expected for a new device. (Minus clinical trials – for obvious reasons) Yet even with everyone taking the right steps, the valve failure mechanism wasn’t categorized until 1999.
Testing a device over its life cycle takes time. Also, tracing implant wear failures can be tough due to the number of variables. A device system may come in many shapes and sizes that add different risks. Patient anatomy, age, gender, behavior, etc. could all affect wear. Surgical installation device manufacturing technique could affect performance. The Bjork-Shiley ‘s fracture was originally hypothesized to be caused by a welding defect, but was later disproven. However, even normal manufacturing for a device has potential to create differences .
The testing isn’t always straightforward. Physiology may not be well enough understood to be accurately modeled. Or an unconsidered subclass of patients might turn out to be at higher risk. Or, as is believed for the Bjork-Shiley valve, the concurrence of several variables lead to the failure. For the valve, contributing factors were geometry (larger, wider opening angle) + type (usually mitral) + physiology (higher ventricular contractility potential) + behavior(enough to trigger the ventricular contractions and cause high changes in pulse).
I hope I haven’t droned on too much. The majority of implantable devices aren’t affected by weird nuances that result in premature failure. But as new, innovative devices are introduced, that possibility is still non-zero. But I believe the industry is constantly improving, and that possibility is shrinking. Once again, I agree with the other posters that there are good techniques to improve reliability & quality, that we learn from mistakes (and successes), and that the regulatory process continues to fine-tune the process.
Edwin Bills, ASQ Fellow, RAC
Jeffrey Mumford CTAL-TM
Mark C Adams, MBA
“There is often no sufficient ex-vivo testing that is rigorous enough to completely model what will take place inside the patient.”
With this in mind, however, I think that *some* failure needs to be accepted to keep innovation moving forward. We can’t demand new and less expensive medical devices without accepting the occasional disaster (now, defining “occasional” is another matter).
@Chet Haibel, would you agree, or do you think accelerated life testing (ALT) procedures are good enough now to catch most everything? Are medical device engineers and FDA specialists in need of more training in this area?
There are systems that are designed specifically to capture this information using simple bar code technology that will automatically document with little or no disruption to the procedure.
If anyone is interested, I would be happy to share this info. Just send me your e-mail.
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