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Medical Device Reporting for Needlestick and Other Sharps Injuries

This guidance provides information for user facilities, manufacturers, and importers regarding their obligations for reporting adverse events related to needlesticks and devices intended to prevent needlesticks. It also includes information for healthcare workers to report adverse events through the voluntary MedWatch reporting system.

  1. Establish clear procedures for identifying reportable needlestick events
  2. Implement a system to track and document all needlestick-related incidents
  3. Create a process for timely reporting to FDA and/or manufacturers as required
  4. Develop investigation procedures for manufacturers to gather required information
  5. Train staff on reporting requirements and differentiation between mandatory and voluntary reporting
  6. Maintain documentation of all follow-up attempts and decision-making rationale
  7. Set up a system for annual reporting (user facilities) and baseline reporting (manufacturers)
  8. Create a process to evaluate if malfunctions are likely to cause death/serious injury if they recur
  9. Establish clear criteria for distinguishing between first aid and medical intervention
  10. Implement a system to track the two-year presumption period for malfunctions

Key Considerations

Safety

  • User facilities must report device-related deaths to FDA and manufacturer
  • User facilities must report serious injuries to manufacturer or FDA if manufacturer unknown
  • Importers must report deaths and serious injuries to both FDA and manufacturer
  • Importers must report malfunctions likely to cause death/serious injury to manufacturer
  • Manufacturers must report deaths and serious injuries to FDA
  • Manufacturers must report malfunctions likely to cause death/serious injury to FDA
  • First aid and diagnostic tests are not considered medical interventions requiring reporting
  • Medical/surgical interventions to prevent permanent impairment require reporting

Other considerations


Original guidance

  • Medical Device Reporting for Needlestick and Other Sharps Injuries
  • HTML / PDF
  • Issue date: 2002-11-11
  • Last changed date: 2020-03-19
  • Status: FINAL
  • Official FDA topics: Medical Devices, Adverse Event Reporting System (FAERS)
  • ReguVirta summary file ID: 27ca5993b4b616b9842d1cc721066664
This post is licensed under CC BY 4.0 by the author.