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Blood Lancets - Single Patient Use Only Labeling Requirements

This guidance applies to all blood lancet devices (21 CFR 878.4800) and provides labeling recommendations for single patient use only. It addresses concerns about the risk of transmission of hepatitis and other bloodborne pathogens when blood lancets are used on multiple patients.

  1. Review and update all device labeling to include “single patient use only” statements
  2. Develop and validate cleaning/disinfection instructions for multiple use devices
  3. Create clear disposal instructions for both single use lancets and replaceable blades
  4. Update Instructions for Use to explicitly prohibit multiple patient use in healthcare settings
  5. For reusable devices, validate and document cleaning/disinfection procedures
  6. Implement prominent warnings about the risks of sharing devices between patients
  7. Consider transitioning to single-use disposable lancets for healthcare settings
  8. Ensure all accompanying documentation consistently reflects single patient use requirement

Key Considerations

Labeling

  • All blood lancet devices must be labeled for “single patient use only”
  • Statement limiting use to a single patient should appear on device labeling
  • For multiple use-capable devices:
    • Reusable base portion must carry “single patient use only” labeling
    • Include instructions that devices should not be used for assisted blood draws by healthcare providers
    • Include validated cleaning and disinfection instructions for the reusable base
    • Include safe disposal instructions for single use lancet blades
  • For single use devices:
    • Must be clearly labeled as “single use only”
    • Include instructions that these are preferred for healthcare provider use
    • Include safe disposal instructions
    • Include instructions for sharps safety/self-disabling features if present

Safety

  • Devices should never be shared between patients, even among family members
  • Single use disposable lancets are preferred for healthcare settings to minimize bloodborne pathogen transmission risk

Other considerations

  • 21 CFR 878.4800: Manual surgical instruments for general use

Original guidance

  • Blood Lancets - Single Patient Use Only Labeling Requirements
  • HTML / PDF
  • Issue date: 2010-11-28
  • Last changed date: 2020-02-28
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket
  • ReguVirta summary file ID: 84f81a91653be4b19e18fbfbd9f9716c
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