I have a little problem and would greatly appreciate any help.  Recently I 
began working with Sonotech, a Bellingham Washington based ultrasound gel 
manufacturer.  As we introduce a new sterile product, I was surprised to 
discover our biggest competition: off-label use of gel.

Currently for invasive scanning procedures of any type, our choices are to 
use a sterile saline solution, giving us poor image quality, or use a 
sterile KY or sterile scanning gel off-label.  We are not supposed to use 
any sterile gel on the market inside the body.  Even the manufactures of 
those sterile gels must tell you they are not approved for this use.  Yet 
among practitioners, this off-label use is widely accepted. 

This point was brought home to me when one of Sonotech's Board of Directors 
walked into my office and handed me a jar of Dippity-Doop hair gel, 
pointing at Carbopol on the ingredient list.  He continued, that's the main 
ingredient in most gels.  It goes though a gamma radiation machine to 
complete the transformation to sterile.  We can sterilize just about 
anything, but it does not make it safe for inside the body, and indeed no 
sterile gels currently on the market (save UltraBio) are approved for in 
vivo use.  

We are a small gel manufacturer, and as such, we continually must innovate 
to compete with the big players.  UltraBio Sterile gel represents one of 
these innovations. 
UltraBio sterile is approved by the FDA as both biocompatible and 
Bioeliminating.  We now have an alternative to the off-label use of sterile 
gel.  The gel is a lower viscosity because of its make up of bio-friendly 
polymers; so a little gel goes a lot farther.  The image quality is 
exceptional, and we can feel good about protecting patient health. 
For those off us that want to know at what price, about %10 more than you 
are spending on sterile gel now.

Any feed back around these issues would be greatly appreciated.  Do you use 
sterile gel for ultrasound-guided biopsies?  What product are you using for 
TEE?  PICC lines?  Patients with abraded skin?  Is this an important issue 
to you?  Is it important that we continue to manufacture this alternative? 

Thanks for your help,

Ian Kirouac
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(360) 671-9121 ext 117

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