Hitting Home

One of the more personal aspects of why I work in regulatory and quality is because of my dad. As a youth, he experienced a hip injury. Combine that with a condition (don't ask - I never remember its fancy medical name) that causes weak capillaries, and that resulted in a "busted hip". Specifically, one that had become so painful in his late 30's he needed a hip replacement.

Enter the ball-and-socket hip replacement, complete with the raving reviews that its model would never result in flaking of the material. Of course, about 10 years later, he began experiencing pain in his leg on the side his hip was replaced. Initially, the doctors believed that he might have had a hamstring injury, but the pain lingered after treatment. Further investigation revealed that the implant did flake material off, resulting in an immune system response that attacked both the material particulate and his bone. Surgery again, and this time a bit more complex.

Sparing the gory details of that fine winter morning, he emerged healthy from surgery a mere 6 hours later and, thankfully, has not experienced any major setbacks since.

So the news last week (shared in a previous post of mine) that the New England Journal of Medicine pointed at hip replacement devices as one type of device that was intended to gradually make its way to Class III status (including a more dubious regulatory pathway), I took it to heart. Add to that, the FDA recently released a safety communication on metal-on-metal hip implants. It all serves as quite a poignant reminder that the patients are why medical device companies exist, and the important role of quality and regulatory in device development to ensure patients receive the best treatment from the technology.

-RTK