Michael Weickert wants to bring the reality of IV error out in the open and eliminate it.
He has heard too many stories of parents losing their children because of IV error, of care providers like nurses taking their lives because they couldn’t live with the error they made and people put behind bars.
“IV error is a huge problem that doesn’t get much attention,” Weickert, president, chairman and CEO of S.E.A Medical Systems in San Jose, said in a recent interview. “The estimate is that IV error causes hundreds of thousands of injuries a year in hospitals and thousands of deaths in U.S. hospitals.”
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The Institute of Medicine estimated in 2006 that there are at least 1.5 million cases of preventable adverse drug events in the U.S. annually, adding that the “true number may be much higher.”
Weickert believes the problem has its roots in the fact that there is no real reporting requirement for IV errors and sometimes many patients are too sick for these errors to be noticed. It does not help that there are no robust tools to help catch these mistakes before they happen either.
“There’s no tools or equipment for anyone to know what’s actually in the bag,” Weickert declared. “Every bag is full of clear liquid. How do you tell what’s what?”
He hopes S.E.A Medical’s IV Check will change all that.
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IV Check is based on proprietary technology that uses sensors to measure the drug, concentration and diluent of aqueous solutions. The product may be used in a hospital or pharmacy — basically anywhere a drug is prepared — and can rapidly deliver results.
“It measures the arrangement of the molecules on the surface of the electrode and the arrangement is dependent on the molecules in the solutions and their concentration. The pattern that is created is unique for all the different molecules concentrations that you encounter in IV medicine,” Weickert explained. “We simply train the system to recognize drugs and when it is presented with a new solution … it can rapidly match that pattern with the library of patterns that there is in the memory of the [device].”
Weickert said he thinks the device will not need a regulatory approval because there is absolutely no contact with a patient, but he has not heard definitively from the U.S. Food and Drug Administration.
In January, the company raised $3 million from Chicago-based venture capital firm JK&B Capital. It also has other funding mechanisms, which Weickert declined to discuss. S.E.A. Medical is also developing three other products, all related to IVs. Recently, the company expanded to a new headquarters after it hired more people to help build all four products in parallel, Weickert said. That has taken the head count from six last October to 22 full-time employees and nine contractors.
But S.E.A Medical is not the only company in this market. Tucson, Arizona-based CDEX that decided to file for Chapter 11 bankruptcy in February also has a device. It’s called ValiMed G4 and it launched last year.
The company’s success will likely be judged on the basis of whether hospitals adopt the technology to help lower the cost of treating preventable adverse drug events. The 2006 IOM report concluded that accurate cost estimates are hard to come by. One study looking at the cost of treating preventable adverse drug events in Medicare patients is $887 million, the report said.
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