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Journal de Pharmacie Clinique

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Computerized traceability of sterile medical devices Volume 20, issue 2, Juin 2001

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Service de pharmacie clinique et des biomatériaux, groupe hospitalier Bichat-Claude-Bernard, 46, rue Henri-Huchard, 75018 Paris.

Traceability of sterile medical devices is not clearly regulated in French hospitals although vigilance on devices requires its organisation, especially for sterile implants. Up to now, at Bichat-Claude-Bernard hospital, departments using those implants realise a hand-written traceability as soon as a device is implanted in a patient, reporting important data on specific registers to follow up the device (name, surname and birth date of the patient, surgery date, doctor's name, designation, batch number and device reference). Taking into account the numerous disadvantages of the hand-written procedures, the pharmacy department decided to cooperate with the computer department to switch to a computerized system. The application has been created on Lotus Notes, functioning from a data base and networking via the Internet. The data base has been implemented from the list of sterile implants used in our hospital. After a 6 months test period, we have written a utilisation procedure and trained users to it. Then the software has been installed in several departments : surgical rooms, radiology and interventional cardiology. After 6 months of utilisation, an evaluation is performed : seven departments are equipped, the data base includes, 1.203 devices references, the system efficiency has been tested through a real device vigilance event (batch number research and withdrawal). Registering a sterile device implanted in a patient is as easy as exploring the data base to research an information. The system performance should now be increased by creating connection with other softwares already existing at Bichat-Claude-Bernard hospital as computerized identification patient system, computerized system of commands and receptions of sterile medical devices.