Standards and Regulations

“…safety, environmental impact, and cost… Daniels has exceeded our expectations in all three areas.”

James Herrera, Northern Michigan Supply Alliance, USA, Project Coordinator

 

Daniels’ aim is to meet or exceed all applicable international and U.S. standards and to comply with all regulations relating to its operations in any given regulatory jurisdiction.

 

The management of sharps, pharmaceutical and medical waste is highly regulated due to the potentially hazardous nature of the materials involved. Daniels continuously monitors all relevant laws and regulations locally and internationally and works hard to ensure its products and services are fully compliant. Healthcare professionals understand the importance reducing risk in their workplace. It is important that they understand and trust the products and servivces they use in their everyday tasks. The following are examples of applicable Standards and Regulations:

 

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”.