Standards and Regulations

“Sharpsmart is broadly recognised as the market leader. Having worked with them for 8 months I can see why”

Chaz Scholefield, Waste Manager, The Queen Elizabeth Hospital King's Lynn NHS Trust

Sharpsmart aims to meet and exceed all applicable international and UK standards for clinical waste and sharps disposal, and to comply with all regulations relating to its operations in any given regulatory jurisdiction.

Sharps Container Regulations

It Is paramount that sharps containers provide a safe method of disposal, as these objects pose a significant risk to the general public, patients and staff working within healthcare facilities. It is critical for the correct container to be provided, one that meets the minimum requirement to minimise risk of injury and infection, with the appropriate colour of lid to identify the waste stream.

BS EN ISO 23907-1:2019 and BS EN ISO 23907-2: 2019 specifies the requirements for single-use and reusable sharps containers, respectively. It is recommended that sharps containers within your healthcare facility meet the requirements set out by the standards authority to ensure you are doing all that you can to reduce the risk of injury and infection to your staff, patients, and the general public.

Regulations for Sharps Disposal

Sharps containers have distinct colour coded lids, as a minimum requirement to ensure the safe and compliant waste disposals. Imp waste segregation leads to an increase in cost, compliance issues and an increased negative impact on the environment. The Health Technical Memorandum outlines best practices for sharps container colour coding, labelling and disposal.

The Health & Safety Executive also provides links to policies and sharps disposal regulations.

The management of sharps disposal, clinical, pharmaceutical, and cytotoxic waste is highly regulated due to the potentially hazardous nature of the materials involved. Sharpsmart 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 of reducing risk in their workplace. It is important that they understand and trust the products and services they use in their everyday tasks. The following are examples of applicable Standards and Regulations:

Clinical, Pharmaceutical and Sharps Container Standards

British Standard BS EN ISO 23907:2012 Specification for sharps containers 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. <a href="http://publications.gc.ca/collections/collection_2017/ongc-cgsb/P29-043-125-2016-eng.pdf" target="_blank">CAN/CGSB-43.125</a> Packaging of Category A and Category B infectious substances (Class 6.2) and clinical, biomedical or regulated medical waste  CSA Z317.10 Handling of healthcare waste materials  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 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

Clinical Waste Handling & Associated Regulations

2003, The Environmental Protection (Duty of Care) (England) (Amendment) Regulations, HMSO 1991, The Environmental Protection (Duty of Care) Regulations 1991, HMSO. 1990, The Environmental Protection Act, HMSO. 2011, Technical Guidance WM3: Hazardous Waste – Interpretation of the definition and classification of hazardous waste, Environment Agency, SEPA, NIEA 2009, Waste Batteries and Accumulators Regulations, HMSO 2009, The Hazardous Waste (England and Wales) (Amendment) Regulations, HMSO 2005, The Hazardous Waste (England & Wales) Regulations 2005, HMSO. 2005, Hazardous Waste – Interpretation of the definition and classification of hazardous waste, Environment Agency/Scottish Environment Protection Agency/Environment & Heritage Service. 2005, A Guide to the Hazardous Waste Regulations: Records, Registers and Returns, Environment Agency 2005, A Guide to the Hazardous Waste Regulations: Consignment Notes (version 1.8), Environment Agency 2002, The Control of Substances Hazardous to Health Regulations (COSHH), HMSO 1999, Control of Substances Hazardous to Health Regulations, Stationery Office. 1994, Health and Safety at Work etc.  Act 1974, HMSO. 1992, Management of Health and Safety at Work Regulations 1992, HMSO. EPR 5.07 - Clinical Waste Guidance UN 3291, Clinical Waste (Bio Medical Waste or Regulated Medical Waste) 2011, The Waste (England and Wales) Regulations, HMSO 2011, Safe Management of Healthcare Waste England 2013 DOH. 2014, National Guidance for Healthcare Waste Water Discharges, Water UK – UK Water and Sewerage Services 2011, How to comply with your environmental permit. Additional guidance for: Clinical Waste (EPR 5.07), version 1.1, Environment Agency 2010, The Environmental Permitting Regulations (England and Wales), HMSO 2010, Guidelines on the Handling and Disposal of Hospital Pharmacy Wastes (For England and Wales and Information for Scotland and Northern Ireland), NHS Pharmaceutical Quality Assurance Committee 2008, The Health and Social Care Act: Code of practice on the prevention and control of infections and related guidance, Department of Health 2007, HTM 07-06: Disposal of Pharmaceutical Waste in Community Pharmacies, Department of Health. HTM 07-01  2013: Safe Management of Healthcare Waste, Department of Health. 2005, Guidance for Dentists on Waste Dental Amalgam, DEFRA 2000, Healthcare Waste Minimisation – A Compendium of Good Practice, Department of Health ISO 9001 (Quality Management Systems) ISO 14001 (Environmental Management Systems) OHSAS 18001 (Occupational Health and Safety Management) ISO 23907:2012 Sharps injury protection -- Requirements and test methods -- Sharps containers 2009, The Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations, HMSO (ADR) 2005, The Waste Management Licensing (England and Wales) (Amendment and Related Provisions) Regulations, HMSO 2005, The List of Wastes (England) Regulations, HMSO 2005, The List of Wastes (England) (Amendment) Regulations, HSMO 2005, The Landfill (England and Wales) (Amendment) Regulations, HMSO 2004, The Control of Substances Hazardous to Health (Amendment) Regulations, HMSO 1994, The Waste Management Licensing Regulations, HMSO 1992, The Controlled Waste Regulations, HMSO 2007, The Waste Electrical and Electronic Equipment (Amendment) Regulations, HMSO 2007, HTM 07-05: The Treatment, Recovery, Recycling and Safe Disposal of Waste Electrical and Electronic Equipment, Department of Health. 2006, The Waste Electrical and Electronic Equipment Regulations, HMSO