Technology and health care : official journal of the European Society for Engineering and Medicine
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Technol Health Care · Jan 2003
Continuous monitoring of tracheal pressure including spot-check of endotracheal tube resistance.
During mechanical ventilation, the resistance of the endotracheal and tracheostomy tube (ETT) highly influences analysis of respiratory system mechanics and imposes additional work of breathing for the spontaneously breathing patient which both can be circumvented by applying the automatic tube compensation (ATC) mode. In the ATC mode, tracheal pressure (ptrach) is continuously calculated on the basis of measured flow and airway pressure using predetermined tube specific coefficients. However, as during long-term ventilation the ETT might become partially obstructed by secretions or tube kinking, the predetermined coefficients are no longer valid rendering calculation of ptrach inaccurate. ⋯ Accuracy of the procedure was determined during artificial ETT obstruction by comparing calculated with measured ptrach. Correspondence between calculated and measured ptrach has been found excellent. We conclude that by adopting this bedside procedure periodically, accurate calculation of ptrach is guaranteed and the advantages of the ATC mode are ensured even in long-term ventilatory support.
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The quality of the notifications issued within the European Medical Device Vigilance system were retrospectively reviewed and the adequacy of the recommended guidelines evaluated. The study material comprised all 589 vigilance notifications the Finnish competent authority received from manufacturers and other national competent authorities during 1997, 1999, and 2001. The number of vigilance reports, particularly the reports issued by national competent authorities, has increased from 82 in 1997 up 166 in 2001 while the proportion of reports with demonstrated bearing on health risk has decreased from about 40% down to 20% during the last five years. ⋯ It is obvious that the present vigilance guidelines provide adequate guidance for both the manufacturers and competent authorities to manage vigilance cases efficiently and appropriately. It is crucial that all pertinent parties should adopt the recommended procedures and act accordingly. The vigilance system underpinned with high quality notifications only assures the continuous enhancement of patient safety, the bottom line.