We are now in the era of "Comparative Effectiveness"... but will our push for comparative effectiveness be diametrically opposed to our ongoing efforts to improve patient safety? I don't think the two need to be mutually exclusive as long as we ask the right questions and answer them honestly. So I ask... Do we need a pressure device for placement of every central venous line? To answer this question, we need to know a few things. First, what is the incidence of arterial puncture? Second, what is the cost of this complication?
In 2003, McGee published a review in the New England Journal of Medicine (N Engl J Med 2003;348:1123-33) on preventing complications of central venous catheterization. He notes that over 5 million central venous catheters (CVCs) are placed every year in the United States (It can only be more at this time) and that arterial puncture occurs in 6.3 to 15 percent of placements (depending on site of access). That would mean there are as many as 750,000 arterial punctures every year. Unfortunately, what we don't know is the cost of this complication. From my own experience, the vast majority (well over 98%) experience no clinical adversity from this event. In other words, the puncture does not lead to any need for additional medical treatment. That would leave (by my own estimate), approximately 15,000 patients per year across the country that would require some intervention. Usually that intervention would require a surgical procedure, who's cost is difficult to estimate (includes all the direct costs as well as indirect costs of increased hospital length of stay).
So I ask. Is this device necessary? How can we possibly know if the right studies and questions aren't asked and answered. I would like to know the answer, because my mission is to apply technology to improve patient safety while decreasing the cost of medicine. I believe that is exactly what well applied technologic innovation will do. There are others that believe technology is the root of the increasing cost burden to medicine. They will be proven correct if we continue to make technologies that don't address the needs of modern healthcare. New technologies should be created that decrease cost BY improving patient safety.
From Medgadget:
Mirador Gets FDA OK for Two Needle Pressure Devices: "
Here's an interesting simple technology that might come handy to anesthesiologists and others who tend to do lots of central lines. Making sure that you are not in a carotid (or subclavian or femoral arteries, etc) is not always as simple as many think. Sure, you can do a blood color comparison. You can also connect a vertical column, and see how far the blood will rise. But why to do these maneuvers, if you can have something at the end of a finder needle that does not add steps to your procedure? Meet Mirador Biomedical of Seattle, Washington that has just received FDA's 510(k) clearance for its Compass Vascular Access pressure measurement device, as well as a similarly designed Compass Lumbar Puncture pressure monitor.
From the Compass Vascular Access product page:
Focus on the Procedural SiteView your hands, the patient and the pressure without additional cabling, operators or connections
Integrate Seamlessly with Needles and Syringes
Easily incorporated into the Seldinger technique for inserting catheters
Eliminate “Blind” Guidewire Insertion
The port allows insertion of the guidewire while monitoring the pressure
From Compass Lumbar Puncture product page:
Indication of CSF Entrance:
Entrance into the target space is indicated by a pressure increase.
Seamless Integration with LP Needles:
The CompassTM LP connects to standard Lumbar puncture needles.
Immediate and Continuous Measurement of Opening Pressure:
View the pressure continuously without additional cabling, operators or connections.
Press release: Mirador Biomedical, developing the innovative Compass™ family of disposable medical devices, announced FDA 510(k) clearance of its two leading products... (.pdf)
Product page: Compass pressure measurement devices...
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