device (medical device)

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[1][2][3][4][5][6][7]

Introduction

A medical device is defined as any instrument, apparatus, contrivance, implant or accessory that is used in diagnosis or treatment of disease or other medical conditions.

Notes

  • FDA will require most medical devices to carry a unique code that will allow easier identification & tracking of devices[1] in a system called unique device identification system (UDI)
    • UDI system consists of two core items
      • a unique number that identifies the device
      • publicly searchable database administered by the FDA, called the Global Unique Device Identification Database (GUDID) (No identifying patient information)
  • medical devices 1st approved in the European Union associated with more safety alerts & recalls than those 1st approved in the U.S.[5]

More specific terms

References

  1. ↑ 1.0 1.1 FDA News Release: Sept. 20, 2013 FDA finalizes new system to identify medical devices. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm369276.htm
  2. ↑ FDA: Medical Devices http://www.fda.gov/MedicalDevices/
  3. ↑ FDA News Release. March 12, 2015 FDA releases final guidance on reprocessing of reusable medical devices. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm437804.htm
  4. ↑ CDC Health Advisory. Sept 11, 2015 Immediate Need for Healthcare Facilities to Review Procedures for Cleaning, Disinfecting, and Sterilizing Reusable Medical Devices. http://emergency.cdc.gov/han/han00382.asp
    Centers for Disease Control and Prevention (CDC) Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008. http://www.cdc.gov/hicpac/pdf/guidelines/Disinfection_Nov_2008.pdf
  5. ↑ 5.0 5.1 Hwang TJ, Sokolov E, Franklin JM, Kesselheim AS. Comparison of rates of safety issues and reporting of trial outcomes for medical devices approved in the European Union and United States: cohort study. BMJ 2016;353:i3323 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/27352914 <Internet> http://www.bmj.com/content/353/bmj.i3323
  6. ↑ Shuren J FDA is working with hospitals to modernize data collection about medical devices. FDA Voice. Posted Oct24, 2016 http://blogs.fda.gov/fdavoice/index.php/2016/10/fda-is-working-with-hospitals-to-modernize-data-collection-about-medical-devices/
  7. ↑ Resnic FS, Matheny ME Perspectives: Medical Devices in the Real World. N Engl J Med 2018; 378:595-597 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/29443668 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMp1712001
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