S.E.A. Medical Developing Next Generation Prototype for IV Error Prevention

What killed more than 2,500 people and cost the U.S. economy an estimated $19.5 billion in 2008? A recent study commissioned by the Society of Actuaries and completed by Milliman, Inc., highlighted both the high personal and financial costs exacted by measurable medical errors. In addition to the statistics above, the study found that 1.5 million medical injuries related to medical error occurred in 2008. Medical error accounted for $1.1 billion in lost productivity due to short-term disability claims, $1.4 billion lost due to increased death rates among victims of medical errors, $17 billion in providing pharmaceutical services to individuals who were affected by medical errors; and 10 million excess missed work days due to short-term disability.  The average total cost per error was $13,000.

Medication mistakes are one of the most common types of medical error, causing 7,000 deaths in the U.S. per year and costing the U.S. medical industry $3.5 billion annually. Intravenous drugs, in particular, leave a high margin for error. Patients may receive an incorrect dosage, the drug may be delivered too quickly, it may have been formulated incorrectly, or it may be the wrong drug entirely. IV mistakes cause an estimated 4,000 deaths per year in the U.S.

One company seeking to reduce the incidence of IV-related errors is SEA Medical Systems of Santa Clara, Calif. The medical device company is developing real-time advanced fluid-sensing products for the safe preparation and delivery of IV medications. SEA Medical’s IV Check product utilizes a sensor and a drug formulation database to test the contents of IV formulations before they leave the hospital pharmacy.  The product does not require FDA approval, thus providing a shorter path to the market.

The company’s other product, the Smart IV system, is a low-cost disposable sensor attached to the patient’s IV line. The system is designed to provide continuous reports on the drug and dose, and to alert caregivers when a dose error occurs. The IV administration equipment market is a $4.5 billion industry and is expected to grow to $5.4 billion by 2012. The Smart IV is expected to complement IV pumps and sets, worth over $2.6 billion for just the top 3 manufacturers in 2007.

S.E.A. Medical has been conducting proof-of-concept studies in medical institutions around the U.S., including Brigham and Women’s Hospital in Boston and the Cleveland Clinic. Feedback has been positive thus far, and the company is currently developing a next-generation prototype designed for faster analysis of IV contents. According to Michael Weickert, CEO of S.E.A. Medical, the original prototype used off-the-shelf electronic circuits that were not designed specifically for the purpose of IV analysis. While the prototype proved successful at analyzing IV contents, it could take several minutes before a full analysis was completed. Once the company obtained hospital data on IV drugs, they were able to revise the design of both the sensor and the electronics. The new custom-designed electronics are expected to produce a measurement in a matter of seconds. “The first prototype was to prove the concept,” says Mr. Weickert. “Now with that data we have designed a prototype that specifically creates the sensing and electronic capabilities necessary to do that job really well and really fast.”

The company plans to roll out data from various tests conducted at U.S. medical centers, as well as from the company’s own laboratory testing, at S.E.A. Medical’s scheduled presentation at the OneMedForum San Francisco in January 2011. To learn more about the OneMedForum San Francisco 2011 conference, please visit http://www.onemedplace.com/forum.

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