Wednesday, April 08, 2009

The Challenge of Medical Device Advisories

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.



Anonymous said...

i usually come here to find out about the advisories, so if you don't know then i'm in trouble.

thanks for blogging-i really enjoy your blogs!

Chris said...

Sounds like there needs to be a clearinghouse--should be easy to implement, what with the interwebs and whatnot. Someone inform Sharfstein!

Jay said...


Interesting story. I had not heard about the problem with Safe Sheath needles.

Glad to see your support of ultrasound access for vascular access with the Site-Rite device. I've been a huge fan of this technique since we used it as fellows for internal jugular vein access in fellowship.

I've tried to promote this technique as well to others with limited success. Most of the doctors in Cincinnati have become fans of the procedure based on direct dissemination of the experience and availabilty of the scanner. Perhaps you learned it here as well. Everytime a visitor comes to the lab -- industry or doctor -- I make a point of showing it off, and it's always well received.

I've tried to get the Bard people to promote this to electrophysiologists with absolutely no success. I, like you, have no financial interest in the device. I just think we'd have less trouble with device complications and malfunctions if a reliable safe vascular access technique was widely disseminated. I'm sure you would agree that with this technique, you can approach the axillary vein with a very shallow angle, avoiding the costoclavicular ligament and this should avoid some of the common mechanisms of lead failure (i.e. crush, sharp angulation at access point). In addition, with reliable "loose" access, lead manipulation is much easier and I've never found it necessary to use thin leads (so I didn't put in many Fidelis leads). I've had only two pneumothoracies that I can attribute to US guided access in nearly 12 years of practice.

I was able with some effort to get up the food chain at Bard and learned some interesting points. The Site-Rite Ultrasound device is marked by Bard Vascular. They have little to do with cardiologists. The Site-RIte is somewhat of a loss leader to promote the use of Bard vascular catheters such as PICC lines and dialysis catheters. That's why so many more radiologists use this device over cardilogists.

The Bard folks tell me that they did exhibit Site Rite once at HRS (NASPE) years ago and it didn't drum up interest. They told me they did a focus group and the doctors said they didn't have any trouble with access and weren't interested in learning the technique (that is -- in between bites of free food and immediately before they picked up their check).

I hope you continue to evangilize the benefits of this technique. Thanks for putting it up on your blog.


DrWes said...


I did, indeed, learn the technique from you and am very, very glad you introduced me to it years ago. I know interventional radiologists use this technique widely at our institution and are equally supportive of its widespread adoption.

Anonymous said...

Deltopectoral groove. Works every time.

The Happy Hospitalist said...

I put in hundreds of subclavians. I have never used the site rite. I found it too cumbersome. I only do subclavians though. There are quite a few docs in my group however, that do use it.

A few years a go I had a string of guidewires that were actually fracturing as I withdrew them after I had already placed the catheter. One time I got so concerned that a piece of guidewire had fractured IN the patient that I ordered a CXR. I saw a bunch of metal fragments in the heart and started freaking out. Until I read the H&P and realized the patient had had a multivessel CABG and those metal fragments where vascular clips of some sort sitting on the heart.

Scared the crap out of me though.

I frequently run into the problem of not being able to advance the guidewire. Usually, this means the needle is up against the wall of the vessel, or it's going north into the neck. Sometimes you have to turn the bevel a bit or cannulate again.

Zelia said...

Yesterday was the 1st anniversary of my 22year old son's dual-chamber pacemaker; who was a brilliant rugby player! Thanks for posting this very interesting read albeit very scary as well for a mom! Maybe you can do a post on all these different recalls (lead recalls, etc; as well as an alternative to electronic pacemakers which can fail or cause infections; ultrasound replacement, smaller pacemakers; nuclear powered; fracture pacing leads; using of own stem cells to repair a damaged heart??!! Looking for answers so that he can play again in the near future maybe??!!