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Surgical Devices: Equipment Malfunction, FDA Reporting, Off-Label Use

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Abstract

Surgery has never been more technology driven. The utilization of minimally invasive techniques across all surgical disciplines has been the result of stepwise collaboration between healthcare providers and the medical device industry. The presence of medical devices in operating rooms worldwide has never been greater or more relevant to patient care and postoperative outcomes.

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Selected Readings

  1. CFR pt. 820 Quality System Regulation

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  2. CFR pt. 803 Medical Device Reporting

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  3. CFR pt. 806 Reports of Corrections and Removals

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  4. ISO 13485: 2003 Medical Device: Quality Management System

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  5. ISO 14971: 2007 Application of Risk Management to Medical Devices

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  6. Federal Food, Drug, and Cosmetic Act, 21 USC Section 301 et seq.

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Author information

Authors and Affiliations

  1. Tufts University School of Medicine, 800 Washington Street, South Building, 4th Floor, Boston, MA, 02111, USA

    Michael Tarnoff MD (Assistant Professor of Surgery)

  2. Covidien, 195 McDermott Road, North Haven, CT, 06473, USA

    Joe Sapiente (Vice President of Global Quality Assurance)

  3. Covidien, 15 Hampshire Street, Mansfield, MA, 02048, USA

    David Olson (Vice President of Regulatory Affairs)

  4. Chief Compliance and Regulatory Counsel, Covidien, 15 Hampshire Street, Mansfield, MA, 02048, USA

    Tracy Palmer Berns JD (Vice President)

Authors
  1. Michael Tarnoff MD
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  2. Joe Sapiente
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  3. David Olson
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  4. Tracy Palmer Berns JD
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Corresponding author

Correspondence to Michael Tarnoff MD .

Editor information

Editors and Affiliations

  1. , Minimally Invasive and Bariatric Surgery, Thomas Jefferson University, 1100 Walnut Street, Philadelphia, 19107, Pennsylvania, USA

    David S. Tichansky, MD, FACS

  2. Minimally Invasive Surgery, Stanford School of Medicine, Pasteur Drive 300, Stanford, 94305, USA

    John Morton, MD, MPH

  3. Beth Israel Deaconess Medical, Center (BIDMC), Harvard Medical School, Brookline Ave. 330, Boston, 02215-5400, Massachusetts, USA

    Daniel B. Jones

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© 2012 Springer Science+Business Media, LLC

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Tarnoff, M., Sapiente, J., Olson, D., Berns, T.P. (2012). Surgical Devices: Equipment Malfunction, FDA Reporting, Off-Label Use. In: Tichansky, MD, FACS, D., Morton, MD, MPH, J., Jones, D. (eds) The SAGES Manual of Quality, Outcomes and Patient Safety. Springer, Boston, MA. https://doi.org/10.1007/978-1-4419-7901-8_55

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  • DOI: https://doi.org/10.1007/978-1-4419-7901-8_55

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  • Publisher Name: Springer, Boston, MA

  • Print ISBN: 978-1-4419-7900-1

  • Online ISBN: 978-1-4419-7901-8

  • eBook Packages: MedicineMedicine (R0)

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