Sharps disposal containers are made from rigid puncture-resistant plastic or metal with leak-resistant sides and bottom, and a tight-fitting, puncture-resistant lid with an opening to accommodate depositing a sharp but not large enough for a hand to enter. “Sharps” is a term for objects with sharp points or edges that can puncture or cut skin, such as needles, syringes, lancets, auto injectors, infusion sets, and connection needles. Generally, sharps disposal containers are regulated by the FDA as class II devices subject to premarket notification (510(k)) requirements (21 CFR 880.5570; product code MKK and FMI).
Sharps Disposal During COVID-19 Mass Vaccination Campaign
The FDA recommends health care facilities use FDA-cleared sharps disposal containers for disposal of used needles and other sharps. The Centers for Disease Control and Prevention (CDC) provides information on Safe and Proper Sharps Disposal During the COVID-19 Mass Vaccination Campaign.
Vaccine administration sites should adopt measures to protect empty COVID-19 vaccine vials and packaging from potential counterfeiting, including treating empty vials and packaging similarly to medical waste by placing in an FDA-cleared sharps disposal container or defacing all, or safely crushing, materials so they cannot be reintroduced or reproduced.
If FDA-cleared sharps disposal containers are scarce or not available during the COVID-19 mass vaccination campaign, refer to CDC’s Strategies for Sharps Disposal Container Use During Supply Shortages for conservation strategies and alternative sharps disposal containers.
Information on bloodborne pathogens and needlestick prevention is available from the Occupational Safety and Health Administration (OSHA).
Syringe being placed into red sharps disposal container with biohazard label.
Yellow sharps disposal container with red label, tight fitting puncture proof lid, heavy-duty leak-proof plastic, clear labels, and stable upright design.
Disposal of Sharps Disposal Containers
Sharps disposal containers are marked with a line to indicate when the container is about three-fourths (3/4) full. Following the manufacturer’s instructions, close and seal sharps disposal containers when about three-fourths (3/4) full. Follow the health care facility’s policy and procedures, medical waste disposal vendor instructions, and local medical waste disposal guidelines. To prevent injury to health care personnel, do not open, empty, or manually clean full sharps disposal containers.
Reporting Issues with Sharps Disposal Containers
The FDA encourages health care providers to report any adverse events or suspected adverse events experienced with sharps disposal containers.
- Voluntary reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
- Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations.
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.
The FDA is interested in hearing from health care facilities and providers experiencing difficulty obtaining medical devices, including sharps disposal containers, as well as from other stakeholders who may be able to help mitigate potential shortages. Contact the FDA about a medical device supply chain issue.
In addition, under Section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act), manufacturers of certain devices must notify the FDA of an interruption or permanent discontinuance in manufacturing of a device that is likely to lead to a meaningful disruption in the supply of that device. Note that sharps disposal containers (product code MMK) are included on the table of device types and corresponding product codes that identifies devices that the FDA believes are critical to the public health during the COVID-19 pandemic under section 506J(a)(1) of the FD&C Act.
The FDA is monitoring the medical product supply chain and working closely with manufacturers and other stakeholders to evaluate the risk of disruptions and to prevent or reduce their impact on patients, health care providers, and the health of the public at large.
- CDC Safe and Proper Sharps Disposal During the COVID-19 Mass Vaccination Campaign
- CDC Strategies for Sharps Disposal Container Use During Supply Shortages
- National Occupational Research Agenda (NORA) Stop Sticks Campaign
- National Occupational Research Agenda (NORA) Sharps Injuries: Sharps Disposal
- CDC/NIOSH Sharps Safety for Healthcare Settings
- Occupational Safety and Health Administration (OSHA) Bloodborne pathogen standard
- Joint Commission requirements for the deployment of sharps containers