It was a routine pacemaker implant yesterday. No big deal, really.
But there's always one point of a surgical procedure that grabs the doctor's gonads, and for device implants, it's usually gaining access to the blood vessel where the leads for a pacemaker or defibrillator are to be implanted. You see, poke too deeply, you might hit the patient's lung. Poke a half a centimeter higher toward the patient's head, you might hit the high-pressure artery rather than the low pressure vein and bleeding will compress the target vein, making it very difficult to cannulate. Don't poke deeply enough, you never get in the vessel. That's the way these procedures go. (I've already mentioned that I cheat and use a vascular ultrasound device to find the vessel. I mean, why stress, right?)
But yesterday, I encountered a "new" challenge: not being able to advance a guidewire into the vessel after I had entered it with a needle.
"What the....?" This was certainly not something I had encountered before. And that's when the rep who was in the lab said: "I wonder if that's one of those recalled SafeSheaths."
"What recalled SafeSheaths?"
"I'm not sure, but I think there was a problem that sometimes the needle hub was not aligned properly and people couldn't pass a guidewire into the vein."
"Seriously? Well that sucks," I said.
So I had to pull out the carefully placed needle and try a new one. Fortunately, the rest of the procedure went fine. But I stopped briefly later to see what existed on the Internet about this problem, and sure enough, I found this little pdf document about the problem posted way back in September, 2008. I was unaware of this problem.
I wonder, how many other advisories am I unaware of? What responsibility to distributors of medical products have to their customers? What responsibility to the manufacturers have? What did I miss?
Because all of the FDA warnings and advisories and recalls don't mean a thing if the information is not received by the end users. Unfortunately, I suspect this will always be a challenge, irrespective of the amount of money we pour into oversight bodies. Maybe, just maybe, placing information like this in the blog-o-sphere will help out another device implanter caught unaware.