RugloopII, TCI &  CE


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... how to benefit from using Rugloop in your all-day practice as a medical professional ....

For those who are interested: some background on European / CE regulations with respect to TCI ...

Since we strongly believe in the capabilities of RugloopII, capable of driving multiple intravenous drugs simultaneously, we can support your work with the following Rugloop versions: 

* for countries that are not under CE regulations or for studies that are compliant to the regulations as mentioned above, we will provide you Rugloop with full TCI capability. More information

* for all other cases and for all-day clinical practice by medical professionals, we have decided to derive the RugloopII tracker version. This program will track your manual actions on the connected infusion pumps and calculate the resulting TCI concentrations from it. More information.

See some References to TCI

Your benefits in using Rugloop: 
* TCI/tracking of drug concentrations on MULTIPLE drugs at the same time provides a better drug dosage
* select from a wide variety of drug models for drug infusion / tracking
* Rugloop has been tested extensively in earlier studies. 
* little additional hardware investments: use your personal laptop and standard infusion devices as new Rugloop versions will be developed for existing infusion devices
* direct installation: run the Rugloop installer, setup your hardware, and start using Rugloop (installation support and hardware packages at all levels can be provided)
* ease of use & little additional learning: if you can operate Microsoft Word, you can operate Rugloop. Self-installer, extensive user-manual and help functionality are provided.

General remarks
* the TCI/tracker versions will, on request, provide the functionality of Rugloop monitor-only as well. For more information, and for information on Rugloop in general, see here.

* we envision a target price for Rugloop TCI or Rugloop Tracker of +/-499,- Euro for an initial subscription, and 99,- Euro per year support fee. All software is node-locked. 

* Rugloop software is plug-and-play, and comes with an extensive user manual. If you have a PC running Windows 98, Windows NT, Windows 2K or XP, installation is straightforward. You will need 1 serial port per pump to control. If you are reluctant modifying your PC, please contact us for installation support. We can arrange hardware packages with serial ports, or even a full installation on your (or a new) PC.  

* Pump manufacturers: if you are interested to allow TCI/Tracking on your devices as well, please contact us. 

* we are still working on all this. If you would like to be kept up-to-date with news about Rugloop / Rugloop TCI / Rugloop Tracker, please fill in the form below to be added to the Rugloop mailing list. REMARKS: the Rugloop mailing list is only used by Demed to inform you about news related to Rugloop & the companion program Labgrab. 














The European community, CE regulations & TCI

Some years ago, the Belgian Pharmaceutical inspection asked us to withdraw RugloopI (at that time including TCI algorithms for realtime control of intravenous infusion) from our website. Under the regulations of the European Community 93/42/EEC (the Medical device directory), RUGLOOP has been classified as a medical device. After some research, here is our interpretation of CE regulations: 

Within all countries applying CE, it is ILLEGAL to use non-CE-marked software for realtime control of infusion devices. ( this includes ALL programs like Rugloop, Stanpump, ... !!! )

The exceptions to this are very restrictive: 

* you can use a program that you've written yourselve, or in joint studies with the software developers. 
* to use third-party software with active TCI (e.g. RUGLOOP) for a study:

- you need a formal Ethics Committee approval on this study

- AND  you need a patientsí informed consent

- AND you have to inform the authorities from the Country where the study is performed that you use RUGLOOP for a clinical study, following regulations of notification as described in the law of the different member states of the European Community.












RugloopII including TCI

For countries that are not under CE regulations or for studies that are compliant to the regulations as mentioned in The European community, CE regulations & TCI, we will provide Rugloop with full TCI capability. We will send you a contract where you confirm that it is allowed to use Rugloop-like software in the circumstances you intend to. For Europe, we will also ask for the notification to your national authorities. (we can be held responsible for abuse of the program, so we have to take our precautions, unfortunately). Please contact us.  


















RugloopII tracker

For all other cases, also for all-day clinical practice by medical professionals, our logical decision was to derive the RugloopII tracker version. This program will track your manual actions on the connected infusion pumps, and calculate an estimated plasma concentration for the set drug & infusate concentration. In addition, it will provide a trajectory presentation of the expected concentration in time at the currently set infusion rate. 
We are currently still working on the tracker version; we expect to release an initial version connecting to the Alaris Asena infusion devices somewhere end of november.    

We would like to stress that Rugloop will NOT control the pump: YOU ARE. YOU take all decisions concerning infusion rate and administered volumes. Rugloop is only monitoring. The calculated concentrations are given to you for information. YOU decide. 

What are the advantages for you: 
* Rugloop will give you an idea of what you are doing infusion-wise. With little effort, you could adjust the infusion rate manually in order to reach your target concentration 
* Rugloop will log all infused volumes, and you get a logging of infused volumes afterwards, without additional effort 
* you will be able to monitor multiple pumps with different drugs with RugloopII. 













Some literature references on TCI

... to be used as a starting point... 

Intravenous anesthetics
Current Opinion in Anaesthesiology 2001;14:393-397
John Petrie; Peter Glass

Comparison of Plasma Compartment versus Two Methods for Effect Compartment-controlled Target-controlled Infusion for Propofol
Anesthesiology 2000;92:399-406
Michel M. R. F. Struys, M.D., Ph.D.; Tom De Smet, M.Sc.; Birgit Depoorter, M.D.; Linda F. M. Versichelen, M.D.; Eric P. Mortier, M.D., D.Sc.; Frank J. E. Dumortier, M.D.; Steven L. Shafer, M.D.; Georges Rolly, M.D., Ph.D.

Influence of Age and Gender on the Pharmacokinetics and Pharmacodynamics of Remifentanil I. Model Development
Anesthesiology 1997;86:10-23
Charles F. Minto, MB, ChB; Thomas W. Schnider, MD; Talmage D. Egan, MD; Elizabeth Youngs, MD; Harry J. M. Lemmens, MD; Pedro L. Gambus, MD; Valerie Billard, MD; John F. Hoke, PhD; Katherine H. P. Moore, PharmD; David J. Hermann, PharmD; Keith T. Muir, PhD; Jaap W. Mandema, PhD; Steven L. Shafer, MD

Nomenclature for Computer-assisted Infusion Devices
Anesthesiology 1997;86:1430-1431
P. S. A. Glass, MD; J. B. Glen, PhD; G. N. C. Kenny, MD; J. Schuttler, MD; S. L. Shafer, MD