Detecting Medical Device Complications: Lessons From an Indwelling Pleural Catheter Clinic

Roberto F. Casal, Lara Bashoura, David Ost, Hsienchang T. Chiu, Saadia A. Faiz, Carlos A. Jimenez, Rodolfo C. Morice, George A. Eapen

Research output: Contribution to journalArticle

6 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)69-75
Number of pages7
JournalAmerican Journal of Medical Quality
Volume28
Issue number1
DOIs
StatePublished - Jan 1 2013

Keywords

  • device monitoring
  • medical device safety
  • pleural effusion
  • quality assurance

ASJC Scopus subject areas

  • Health Policy

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    Casal, R. F., Bashoura, L., Ost, D., Chiu, H. T., Faiz, S. A., Jimenez, C. A., Morice, R. C., & Eapen, G. A. (2013). Detecting Medical Device Complications: Lessons From an Indwelling Pleural Catheter Clinic. American Journal of Medical Quality, 28(1), 69-75. https://doi.org/10.1177/1062860612449475