Cardinal Health would like to highlight two important aspects for the benefit of a proper implementation of the models.
Firstly, products like the original model for prefilled Diprivan, or the one from other pump manufacturers or Alaris (R) PK from Cardinal Health are basically running a similar 3 compartments algorithm mathematical model that is also similar to those used by PC based software existing solutions. If the user interface vary from one device to the other, only due to difference of technology and mechanical interface, the same basic principle apply to every one. The fact is that delivery profile depends only on the selected Model (e.g. Marsh) with its set of parameters, applied to this 3 compartments algorithm. Therefore as manufacturer, Cardinal Health, with its mathematical calculation algorithm, does not need necessarily an open source code for improvement. However from a model implementation code point of view, this can contribute to reach a better consensus in models selection and application of better defined limitations in models parameters.
Secondly, from a regulatory standpoint, integration of Prescribing Information for TCI for a given drug, into the Medical Devices, is the natural way of implementing TCI technology but unfortunately it does not exist for all drugs or for all countries. The trick for medical device companies is to select and extend the offer to models not in drugs PI but those that have demonstrated their superiority based on the existing publications. In that case, the responsibility of the Anaesthesiologist for giving the right prescription by the selection of delivery profile (the drug/model selected/parameters) is paramount and company role here is to help reducing foreseeable misuse and use errors. Therefore, Cardinal Health Product, which already informs users on the display when a chosen profile is not mentioned in the drug prescribing information, believe that safety would benefit from an agreed definition of parameters limitations and a limitation consensus of the key models to be used.
The main contribution of companies providing TCI solutions was to integrate all in one Medical Device, compliant to regulations, and capable to deliver accurately the prescription by selection of the infusion profile based on models and parameter selection. This compliance is achieved by an extensive hardware and software validation required for such devices (including is operating system and its mathematical library). This is not reasonably possible to achieve this with Personal computers using Windows or Linux operating systems with serial connection to pumps.
Cardinal Health would then agree in supporting an open source PC software initiative in order to develop robust and flexible training and simulation tools, knowing that this code, if similar to those implemented in medical devices, can never match exactly the code required for Medical Device integration.
Stefano Zanetti, Marketing Director
Norbert Niedworok, Medical Director
Matt Richardson, R&D Director
Pierre Rebours, Regulatory Manager
Cardinal Health International
A-One Business Centre