Post

Medical Waste Sharps Containers and Secondary Sharps Containers - Design, Testing, and Labeling Requirements

This guidance pertains to sharps containers and secondary sharps containers used for medical waste disposal. Secondary containers are specifically designed to hold sharps containers when leakage is possible.

  1. Develop comprehensive test protocols for all design specifications
  2. Prepare detailed documentation of materials and construction methods
  3. Ensure all required labeling elements are included
  4. Conduct comparative analysis with legally marketed devices
  5. Prepare 510(k) submission with all required design validation test results
  6. Include detailed specifications for all safety features
  7. Ensure compliance with OSHA regulations for bloodborne pathogens
  8. Prepare Safety and Effectiveness statement or summary as per 21 CFR 807.92 or 807.93
  9. Submit duplicate copies to FDA Document Mail Center
  10. Verify no claims of FDA approval are made in marketing materials

Key Considerations

Non-clinical testing

  • Impact resistance testing required with specified pass-fail criteria
  • Puncture resistance testing for base, sides, closure, and top
  • Leak resistance testing for sides and bottom
  • Stability testing for maintaining upright position
  • Testing for safe transportation features
  • Capacity validation

Human Factors

  • Must be designed to easily and safely determine if container is full
  • Must not require employees to reach by hand into container for reusable sharps
  • Must maintain stable, upright position
  • One-handed technique required for needle recapping features

Labelling

  • Must include biohazard warning labels
  • Labels must be fluorescent orange or orange-red with contrasting lettering
  • Must include disposal procedures
  • Must include assembly/mounting instructions
  • Must include operating instructions
  • General labeling requirements under 21 CFR 801

Safety

  • Must be closable
  • Must be puncture resistant
  • Must be leakproof on sides and bottom
  • No features to bend, break, or shear needles
  • Must minimize aerosolization

Other considerations

  • BS 7320:1990: Specification for Sharps Containers
  • AS 4031-1992: Non-Reusable Containers for the Collection of Sharps Medical Items Used in Health Care Areas
  • ASTM Task Force F04.65.01: Standard for puncture resistance

Original guidance

  • Medical Waste Sharps Containers and Secondary Sharps Containers - Design, Testing, and Labeling Requirements
  • HTML / PDF
  • Issue date: 1993-10-01
  • Last changed date: 2020-03-17
  • Status: FINAL
  • Official FDA topics: Medical Devices, 510(k), Premarket
  • ReguVirta summary file ID: b4cb9449ca36c5bdbb7bc75fba34581f
This post is licensed under CC BY 4.0 by the author.