Interested by this TCI system, both researchers started looking for other systems capable of administering drugs using this technology. Hereby, they found STANPUMP ©, a PC-based TCI program capable of administering multiple drugs using three-compartmental pharmacokinetic models. STANPUMP is written by Prof. Dr. Steven L. Shafer from the Stanford University, California, USA. A fruitful collaboration between the group in Gent, Belgium and Prof. Shafer resulted in the addition of monitoring data to the pharmacokinetic data generated by the TCI program. The combination from both program was called RUGLOOP I. Various studies were performed using this program, still operating in DOS.

One year later, RUGLOOP I was again enlarged with the closed-loop algorithms and with a connection to the Datex-Ohmeda ABM-II brain monitor. This work resulted in the development of the first closed-loop system for automated administration of propofol (read more about closed-loop infusion).

Thanks to the development of new and faster computers, Windows (Microsoft, Redmond, USA) became a popular operating system for PC. Therefore, it was decided to re-program RUGLOOP I for a Windows environment. This program was still called RUGLOOP I. For some years, RUGLOOP I (open-loop TCI and data management version) was freely downloadable from the internet and served as drug administration and data-management system for many research projects around the world. Unfortunately, the Belgian Government (General Pharmaceutical Inspection, Brussels) found that RUGLOOP I was a medical device and required a CE label, following the rules developed by the European Community on Medical Devices. As RUGLOOP I was never intended to meet the CE criteria, we were not able to obtain this CE Label (also, we had no money to do so…).

However, you are not losing the war by losing one battle…and therefore in 1999, a “bigger” approach was taken. Ir. Tom De Smet started his own company, DEMED (De Smet Medical Engineering, Temse, Belgium) and a partnership agreement was obtained between DEMED and The Department of Anesthesia, Ghent University, Gent, Belgium (Prof. Michel Struys and Prof. Eric Mortier). With some external funding from several industrial partners, the RUGLOOP II and LABGRAB software platforms were developed.

RUGLOOP II is now a modular software program for professional medical research. It contains data-management facilities and drug administration steering and controlling systems. All data entry are time locked and stored on hard disk. All these data can be managed, time-synchronized throughout the study and re-structured for statistical analysis by a second software program, called LABGRAB.

As RUGLOOP II is a modular system, some modules that require a CE label for Medical Devices can be disabled when a particular research group works inside the European Community. Special notification procedures has to be followed before drug administration can be steered by a RUGLOOP module. (read more about the CE guidelines)