Sharps Container Standards
- FDA (510K Notification) which is required for all disposable and reusable sharps containers. Sharps containers are classified by the FDA as a CLass II medical device.
- United States ASTM F2132-01 Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps
- United States ECRI Guidelines for Sharps Containers
- United States NIOSH Selecting, Evaluating, and Using Sharps Disposal Containers
- Canadian Standard Z316.6-07 Evaluation of Single-Use and Reusable Medical Sharps Containers for Biohazardous and Cytotoxic Waste
- British Standard BS 7320 Specification for sharps containers
- French Standard NFX 30-500
- Australia/New Zealand Standard AS/NZS 4261 Reusable Containers for the Collection of Sharp Items in Human and Animal Medical Applications
- Australia/New Zealand Standard AS/NZS 4478 Guide to the Reprocessing of Reusable Containers for the Collection of Sharp Items used in Animal Clinical/Medical Applications
- Australian Standard AS 4031 Non-reusable Containers for the Collection of Sharp Medical Items used in Healthcare Areas
- South African Standard SANS 452 Non-reusable and reusable sharps containers
- Department of Transportation (DOT) Hazardous Materials Regulations
Medical Waste & Associated Regulations
- OSHA Bloodborne Pathogen Standard: 1910.1030
- UN Guidelines for the Transport of Dangerous Goods
- United Kingdom HTM 07-01 Safe Management of Healthcare Waste
Types of waste regulated by OSHA
- Most state governments require that all medical waste providers properly track waste created in the state up to its proper destruction.
- The majority of the states in the U.S. have a Medical Waste Management Act (“MWMA”), which governs the management of medical waste in all jurisdictions of that state.
- The MWMA imposes stringent guidelines for the treatment of medical waste.
US State and County Regulations
- Counties cannot supersede State environmental agencies or State Department of Health agencies. They can create additional rules but the vast majority of Counties are not involved in promulgating any additional rules or regulations.
- The burden of compliance is on the shipper (i.e. waste generator), and as such, fines for non-compliance are generally imposed on the waste generator. Fines by the various organizations regulating the proper treatment and transportation of medical waste vary by scenario, and examples of fines imposed are:
- $205,000 – Concord Hospital Inc. (NH) agreed to a fine for hazardous waste violations for failure to properly identify certain pharmaceutical waste as hazardous material (2012).
- $400,000 – Scripps Health and Sharp Memorial improperly handled, transported, and stored medical waste at their facility and at a local landfill (2011).
Historical Development of Regulatory Environment
- 1988 – The EPA instituted the Medical Waste Tracking Act (“MWTA”), which defined medical waste and established guidelines for its segregation, containment, labeling and transport. The MWTA shifted the responsibility of proper disposal onto the generators of medical waste.
- 1991 – The MWTA expired in 1991, but served as a model for states as they implemented local waste management programs and regulatory guidelines.
- 1994 – The U.S. DOT implemented the Hazardous Materials Transportation Authorization Act, requiring RMW to be packaged and labeled with designated standards, including the use of “biohazard” markings on the outer packaging and the use of collectors that are “rigid, strong, puncture-resistant, leak-resistant, properly sealed and impervious to moisture”.