New Regulations for Medical Waste Management: What Changed in 2025

Managing medical waste under the new requirements goes beyond compliance with sanitary and epidemiological standards: it is a fundamental safeguard for medical staff, patients, and the environment. For many years, healthcare facilities followed Ministry of Health of Ukraine (MOH) Order No. 325 of June 8, 2015, which established medical waste regulations.

However, significant changes to Ukrainian legislation took effect on April 1, 2025, when the new State Sanitary Norms and Rules (DSNP), approved by MOH Order No. 1827 of October 31, 2024, entered into force (the New Procedure). These changes reshape the approach to safe waste collection, storage, and disposal and raise several important questions:

• What exactly has changed in the legislation?

• What are the new waste management rules?

• Who should organize medical waste management at healthcare facilities?

• How should medical waste be disposed of?

Since the New Procedure was approved, we have heard these and many other questions almost every day. In this article, we explain the changes and provide practical recommendations for implementing them effectively.

Read also: Documentation for Medical Centers: Forms, Completion, and Standardization of Forms and Logbooks

Medical Waste: Key Definitions

Medical waste includes much more than syringes, masks, and gloves. It encompasses a complex range of materials generated during medical care, diagnostic procedures, laboratory testing, and other activities.

The New Procedure defines medical waste as waste generated during newborn care, diagnostic procedures, treatment, or disease prevention in humans. So how should medical waste be managed in 2025?

Organizing Medical Waste Management at Healthcare Facilities: New Waste Management Requirements

1. Prompt Collection and Storage of Infectious Hazardous Waste

Waste must be collected at its points of generation during the work shift, but the collection period must not exceed 24 hours.

2. Integrating Waste Treatment into Healthcare Facilities (Including Steam Disinfection)

Current standards allow infectious hazardous waste treatment to be integrated directly into a medical facility's operations, particularly pressurized steam disinfection. This is permitted subject to the safe operating requirements set out in DSTU EN 285.

3. Waste Management Premises

The floor area allocated to waste management now depends directly on the medical facility's capacity, with minimum dimensions specified in detail in Annex 3 to the DSNP (Table 1). A clear separation of the premises into "dirty" and "clean" zones is an integral part of this process.

Where a waste generator produces small quantities of waste (less than 200 liters per day), the legislation allows waste storage and processing to take place in a single room within the dirty zone.

Waste intended for further recovery, along with disinfected and cleaned transport equipment—trolley racks, containers, and associated waste transportation equipment—may be kept in a shared room within the clean zone.

4. Equipment and Room Specifications

The height of waste management rooms is determined by the dimensions of the processing equipment to be installed.

The interior finishing, furniture, and processing equipment of waste management premises require smooth wall, floor, and ceiling surfaces that are resistant to moisture and to the aggressive chemicals used for cleaning and disinfection.

5. Internal Transportation of Medical Waste

Infectious hazardous waste must not be transported beyond its points of generation in primary packaging.

Infectious hazardous waste, except for the waste specified in item 3 of Table 2, must undergo thermal destruction (incineration) at specialized waste incineration facilities or co-incineration facilities.

6. Collection and Subsequent Management of Different Types of Waste

Medical devices and supplies contaminated with immunobiological products, blood, and/or bodily fluids (including respirator masks, disposable syringes without an attached needle, and personal protective equipment used by the waste generator's staff) must be collected separately in designated containers:

• Infectious hazardous waste with potential for reuse (which can be regenerated or recycled) by waste management businesses holding the appropriate permit, following treatment with saturated steam under pressure using specialized equipment—autoclave sterilizers—in accordance with the method established in paragraph 12 of Section III of the DSNP;

• Infectious hazardous waste that cannot be regenerated (such as disposable latex gloves) must undergo thermal destruction at waste incineration facilities or co-incineration facilities.

7. Required Documentation and Internal Rules

Every healthcare facility must have an updated Regulation on Medical Waste Management, medical waste management SOPs with detailed instructions specifying who does what with the waste, when, and how, as well as orders appointing responsible persons and logbooks.

8. Supplies and Infrastructure

Compliance with the Procedure requires designated containers and bags, appropriate storage space, and ventilated premises. Mixing hazardous and ordinary (non-hazardous) waste is prohibited. All processes, from disinfection to preparation for disposal, must take place in specially equipped areas.

9. Appointing a Responsible Person for the Waste Management System

Who can be responsible for compliance with waste management requirements? You may appoint an employee of the medical facility, including its head (except for the deputy general director (director) / head (manager) of the healthcare facility whose responsibilities include administrative and facilities management matters).

10. Staff Training

All healthcare facility employees must regularly attend safety training briefings covering medical waste collection rules, the correct choice of containers for waste accumulation, and emergency response procedures.

11. Waste Management Contracts

And, of course, facilities must enter into contracts with licensed specialized companies for medical waste transportation and disposal.

Prohibited Practices in Medical Waste Management

The following practices are prohibited when collecting infectious hazardous waste:

1. Disassembling, breaking, or cutting infectious hazardous waste. This also applies to used intravenous infusion sets.

2. Removing the needle from a syringe after use is strictly prohibited. Sharps must be placed immediately in designated containers without unnecessary handling.

3. Transferring or pouring infectious hazardous waste from one container into another. There is only one exception to this rule: situations expressly covered by your standard operating procedures (SOPs) for emergency response.

4. Compacting infectious hazardous waste in containers/bags. This can cause bags to tear, contents to leak, and hazardous substances to be released. Waste must fit loosely inside containers.

Important! Disposable or reusable containers for collecting infectious hazardous waste must not be placed closer than one meter to any heating appliance. Heat can accelerate the growth of microorganisms or, even more dangerously, cause the release of volatile harmful substances and potentially start a fire.

Read also: Updating Medical Staff Documents During Wartime: Successful Experience and Legal Support

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Liability for Noncompliance with Waste Management Requirements

The primary authority overseeing sanitary and epidemiological welfare in Ukraine is the State Service of Ukraine on Food Safety and Consumer Protection (State Food and Consumer Service). Violations most often have the following consequences:

• Administrative Penalties

Article 82-5 of the Code of Ukraine on Administrative Offenses establishes liability for violations of waste management requirements during collection, transportation, storage, treatment, disposal, neutralization, or burial (landfilling). Fine amounts depend on the nature and extent of the violation. Repeat violations lead to higher penalties.

• Internal Disciplinary Liability

In addition to administrative liability, healthcare facility employees may face disciplinary liability. This may apply to employees whose failure to follow internal medical waste management rules and instructions results in violations of legal requirements. For example, if a nurse or support staff member disregards instructions by failing to disinfect containers, use designated bags, or follow labeling requirements, management may impose disciplinary measures: a reprimand or dismissal.

• Civil Liability

If improper medical waste management causes harm to a person's health or property, those affected may seek compensation through civil proceedings. This means the healthcare facility may have to compensate for the resulting losses. For example, if someone contracts an infection or suffers poisoning because of inadequate waste disposal, the medical facility must compensate for both pecuniary and non-pecuniary (moral) damage.

Read also: New Medical Practice Licensing Requirements: Standard Operating Procedures (SOPs) and Other Important Changes

How Can Healthcare Facilities Adapt to the New Waste Management Requirements?

We understand that the head of a healthcare facility must balance patient care with safety and legal compliance. Medical waste management is one of the most challenging parts of that balance. Without the right specialist, it is difficult to manage.

The legal team at Pravova Dopomoga has ten years of experience supporting such projects at both private medical offices and large clinics. We have already completed dozens of audits and helped healthcare facilities adapt to the new requirements. Here is what we offer our clients:

• An audit of your current system and regulatory compliance. Our medical law attorney examines in detail how you organize waste collection, storage, and disposal. We check that all required documents are in place: regulations, orders, logbooks, and instructions.

• Preparation of all required documents and SOPs. We create clear, easy-to-follow instructions for every waste category, from infectious to chemically hazardous waste. We prepare regulations, orders, and logbooks, including documents identifying responsible persons and their duties at every stage, from accumulation to disposal.

• Advice on contracts and internal orders. We help draft or update orders appointing persons responsible for waste management. We prepare contract templates for service providers (transportation and disposal companies), taking all legal requirements into account.

We are more than attorneys. We are partners committed to helping every medical facility operate safely, legally, and smoothly. By working with us, you can be confident that the new medical waste requirements will become a clear procedure that protects you from risks and fines rather than a burden.

Contact us today. We will help you adapt your waste management system to the new medical waste requirements for 2025 and keep your facility operating safely.

You can learn more about legal services for medical facilities here.