Project: Technologies for Infusion Pump Improvement and CALibration

INFUSION PUMPS AND BAGS_x000D_Infusion pumps are used to infuse necessary fluids to a patient's circulatory system. Infusion bags contain medications or nutrients. They are often used in situations where continuous monitoring and treatment by a nurse or other health staff would be expensive, impractical, or unreliable. They are used for everything from very simple requirements such as rehydration to more complex requirements such as those needed for chemotherapy and pain management. Accuracy and consistency when delivering medications and other fluids are essential due to the possibility of severe consequences._x000D__x000D_IMPACT OF INFUSION PUMP AND BAG FAILURE_x000D_Infusion pumps have been a source of multiple patient safety concerns, and problems with such pumps have been linked to more than 56,000 adverse event reports from 2005 to 2009, including at least 500 deaths (Pharmacy Practice News, May 2010) and 87 infusion pump recalls. In order to stress the importance and urgency of the problem, the FDA has launched the Infusion Pump Improvement Initiative in 2010. Furthermore, the Institute for Safe Medication Practices (ISMP) has required special safeguards to reduce the risk of patient harm caused by human mistakes: about 40% of a hospital nurse's time is spent giving drugs, for instance via infusion bags. Nurses intercept about 85% of all potential medication errors, which still leaves 15% undiscovered (American Nurse Today, November 2006)._x000D__x000D_PROBLEM DESCRIPTION_x000D_Infusion pump problems have been observed across multiple manufacturers and pump types. Through analysis of pump-related adverse event reports and device recalls, it has been concluded that many of these problems appear to be related to deficiencies in device design and engineering. It is therefore necessary to implement methods, facilities and diagnostic devices to (continuously) monitor the behaviour of the pump. It is also required to do the same for infusion bag and nurse's performance, so that faulty behaviour and human mistakes can either be prevented or quickly detected and fixed._x000D__x000D_TECHNICAL SOLUTION_x000D_The solution we propose for the problem is quadruple:_x000D_(1) include a flow sensor, for continuous real-time monitoring of the behaviour of the infusion pump._x000D_(2) include a disposable flow or pressure sensor, for non-invasive monitoring of infusion bag performance._x000D_(3) develop a transfer standard, which can travel between the (inter)national calibration laboratories and the points-of-use, e.g. the hospitals._x000D_(4) implement a calibration method, to enable a worldwide unity in measurement standards for ultra-low flows, in order to guarantee a worldwide consistency in the dosed amount of medication and nutrient._x000D_All four of the above mentioned items do not yet exist, they will be developed in this project._x000D__x000D_OUTPUT OF THE PROJECT / PRODUCTS_x000D_We envision the following outcome of the project:_x000D_(1) products: (disposable) flow sensor and transfer standard for high-precision ultra low flow measurement_x000D_(2) services: calibration facility in which custom specific calibrations can be performed very accurately_x000D_(3) method: first step towards an international metrological standard for the calibration of infusion pumps_x000D__x000D_SOCIETAL AND SUSTAINABLE IMPACT_x000D_Less injured and casualties, less cost in the health system, less spoiling of drugs and scarce resources._x000D__x000D_OTHER MARKETS AND APPLICATIONS_x000D_Other markets and applications for the developed products, services and technologies are:_x000D_(1) energy market: analysis of shale oil, shale gas and "ice" gas from methane hydrates_x000D_(2) food market: fractionation and encapsulation of nutrients from cow milk for baby nutrition_x000D_(3) pharmaceutical market: synthesis of specialty drugs in micro reaction systems by flow chemistry_x000D__x000D_ECONOMICAL IMPACT_x000D_The world market for infusion pumps was $6.7 billion in 2012, with an annual growth rate of 4%. The energy market for LNG was $135 billion in 2011, with an annual growth rate of 8%. The food market for baby nutrition was $41.5 billion in 2012, with an annual growth rate of 9%. The pharmaceutical market for specialty drugs was $46.9 billion in 2011, with an annual growth rate of 20%._x000D__x000D_With the products and services as developed in this project and as mentioned above, we expect to be able to accomplish an extra turnover of circa € 5 million per year in the above mentioned markets within 5 years after the end of this project, accompanied by extra employment for circa 50 people._x000D__x000D_CONSORTIUM_x000D_The consortium consists of renowned players and worldwide leaders in their field._x000D_Bronkhorst High-Tech BV: flow sensors, flow controllers, calibration systems, facilities and services._x000D_Biofluidix: droplet dispensers, droplet sensors, gravimetrical low volume calibration, custom made lab automation._x000D_University of Twente: MEMS technology, MEMS flow sensors, modelling & simulation._x000D_HSG-IMIT: thermal flow sensors, system integration & testing, MEMS production facilities and services._x000D__x000D_

Acronym TIPICAL (Reference Number: 8264)
Duration 01/08/2013 - 31/07/2016
Project Topic We want to enhance the benefits of infusion systems such as pumps and bags, by developing flow sensors for real-time diagnostic purposes, a calibration method to accurately calibrate the infusion pumps, and a transfer standard to travel between the calibration laboratories and the point-of-use.
Network Eurostars
Call Eurostars Cut-Off 10

Project partner

Number Name Role Country
4 BioFluidix GmbH Partner Germany
4 Bronkhorst High-Tech BV Coordinator Netherlands
4 Hahn-Schickard-Gesellschaft fuer angewandte Forschung e.V. - Institut für Mikro-und Informationstechnik Observer Germany
4 University of Twente Partner Netherlands