Detecting medical device complications: lessons from an indwelling pleural catheter clinic.

Safety monitoring after implantation of medical devices is essential throughout a product's life cycle. A suspected increase in complications related to indwelling pleural catheters led to a 2-part cohort study. Part 1 investigated and corroborated the increase in rate of complications thought to be related to defective catheters. The inability of the standard clinical follow-up to detect such a rise in complication rates for more than 3 months and a 3-fold increase prompted the authors to develop a simple tool to monitor catheter complication rates. This tool, which combined quality control statistics (p-chart) and the existing billing software, was shown to be effective in part 2 of this study. Care center-level active safety assurance monitoring can be of great value because, unfortunately, an independent and impartial safety monitoring organization, which is essential for postmarketing surveillance of any medical device, is still not available.