Regulation on the Control of Medical Waste

What does the Medical Waste Control Regulation cover?

The Medical Waste Control Regulation was published in the Official Gazette dated 25 January 2017, No. 29959. It governs the separate collection of medical waste generated by healthcare facilities at source, its transport within the facility, temporary storage, transport to the treatment facility and disposal (Articles 1 and 2). It was amended by a text published in the Official Gazette dated 18 August 2022, No. 31927, and is administered by the Ministry of Environment, Urbanisation and Climate Change.

The Regulation defines medical waste as infectious waste, pathological waste and sharps (Article 4).

Who has obligations in medical waste management?

Healthcare facilities must collect waste separately at source, prepare a medical waste management plan and update it every year, and sign a protocol with the relevant municipality for collection, transport and disposal (Articles 9 and 22). The waste declaration form is completed online each year between January and the end of March at the latest, and one copy is kept for five years (Article 9).

Municipalities prepare the medical waste management plan, collect the waste from temporary stores and carry it to the treatment facility, or have it carried, and obtain or have obtained the environmental licence of the facilities (Article 8). Healthcare facilities cannot set up or operate stand-alone medical waste treatment facilities, and medical waste cannot be sent to intermediate storage facilities (Article 5).

How is medical waste separated and temporarily stored?

Medical waste is collected separately at source without being mixed with other waste (Article 10). The basic rules are:

• Infectious waste is collected in red medical waste bags; bags are filled to no more than three quarters, cannot be compacted and cannot be recovered.
• Sharps are collected in puncture-resistant containers that cannot be reopened.
• Pathological waste is collected separately from other medical waste in special puncture-resistant, leak-proof containers.
• Temporary storage cannot exceed 48 hours; if the store is kept at +4 °C and has suitable capacity, this may be extended to one week (Article 12).

Facilities generating more than 50 kilograms of medical waste per day set up a temporary store; those generating up to 50 kilograms keep a temporary container; those generating up to 1 kilogram per day hand the waste to a medical waste collection vehicle (Article 9).

How is medical waste transported and treated?

Medical waste is handed over to licensed transport vehicles using the Ministry's online system. Facilities generating up to 1 kilogram per day use a medical waste receipt instead, and these documents are kept for at least three years (Articles 5, 15 and 28). Transfer stations are not used during transport, and vehicles pass through a radiation panel when entering the treatment facility (Articles 15 and 16).

Treatment is carried out by two methods: sterilisation or incineration. Infectious waste and sharps may be rendered harmless by sterilisation, using a chemical indicator in every load and a biological indicator at least once a week (Articles 17 and 18). Pathological waste that has been treated with any chemical must be disposed of by incineration (Article 20). Anyone wishing to operate a medical waste treatment facility must obtain an environmental licence from the Ministry (Article 21).

What does it mean for destruction and recycling?

Medical waste is a matter of controlled destruction rather than recycling: medical waste bags and sharps containers can in no case be recovered or reused (Article 10). Sterilisation or incineration may only take place at a licensed facility, so an organisation buying destruction services needs to verify the licence, transport and documentation chain together.

All personnel assigned to medical waste management must hold an MYK (Vocational Qualifications Authority) Vocational Qualification Certificate in the relevant field (Article 5). The healthcare facility bears the costs of collection, transport, sterilisation and disposal, and the fee is set by the local environment board of the province where the waste arises (Articles 5 and 24).

What sanctions apply to non-compliance?

Those who act in breach of the Regulation face the sanctions provided for in the Law (Article 29). In addition, those engaged in the collection, transport, temporary storage and disposal of medical waste are jointly and severally liable for environmental damage caused by the waste, and this does not affect liability for compensation under the general provisions (Article 5).