Health Hygiene Standards: International Regulations

The Universal Importance of Hygiene

Hygiene in healthcare services forms the basis of patient safety and infection control. Every year, millions of patients worldwide are affected by healthcare-associated infections. For this reason, hygiene standards in healthcare are strictly regulated and monitored not only at the national level but also internationally.
This article will address the hygiene standards applied in healthcare institutions worldwide, international regulations, and the compliance processes in Turkey.

1. The Fundamental Purpose of Hygiene Standards in Healthcare

Hygiene standards aim to protect both patients and healthcare workers. Thanks to these standards:

• Infection risk is reduced,
• Confidence in healthcare services is increased,
• Combating antimicrobial resistance is supported,
• The safety of medical interventions is ensured.

Hygiene standards are not limited to hand washing or surface cleaning; disinfectant selection, sterilisation processes, waste management and environmental cleaning protocols are also part of this whole.

2. World Health Organisation (WHO) and Global Guidelines

The World Health Organisation (WHO) has emphasised the global importance of hygiene in healthcare with its “Clean Care is Safer Care” campaign.
The following topics are particularly highlighted in the guidelines updated by the WHO in 2020:

• Hand hygiene practices and the use of antiseptics,
• Disinfection of medical devices,
• Operating theatre sterilisation,
• Separation of cleaning equipment,
• Hygiene management in high-risk areas (intensive care, isolation rooms).

These guidelines provide a basic framework for countries to adapt to their own health protocols.

3. European Union Regulations: BPR and EN Standards

The European Union evaluates hygiene products and disinfectants under the Biocidal Products Regulation (BPR, Regulation (EU) No 528/2012).
This regulation:

• The safety and efficacy of products,
• The toxicological profile of active substances,
• Microbiological efficacy tests,
• Effects on human and environmental health.

Furthermore, EN standardisation tests determining the efficacy of hygiene products in Europe are of great importance:

• EN 1500: Hygienic hand washing efficacy for hand antiseptics
• EN 13624, EN 1650: Fungicidal efficacy
• EN 14476: Virucidal efficacy
• EN 13727, EN 1276: Bactericidal efficacy
• Products that pass these tests are considered to have proven efficacy and to comply with regulations.

4. US Standards: CDC and FDA Guidelines

In the United States, the Centers for Disease Control and Prevention (CDC) publishes comprehensive guidelines for hygiene practices in healthcare.
The CDC’s “Guidelines for Infection Control in Health Care Facilities” document;

• Hand antisepsis,
• Surface disinfection,
• Ventilation and air filtration,
• Waste management,
• Staff training
  establish standard procedures.

In addition, the FDA (Food and Drug Administration) regulates the active ingredient approval and safety testing of medical disinfectants and antiseptics. This ensures that the products are safe for both patients and users.

5. Hygiene Regulations and Compliance Process in Turkey

In Turkey, hygiene products and disinfectants are supervised by the Turkish Ministry of Health, the Turkish Medicines and Medical Devices Agency (TİTCK) and the General Directorate of Public Health (HSGM).
All disinfectants must obtain a biocidal licence under the Biocidal Products Regulation. This licence:

• Confirms that the product has passed microbiological tests,
• The active ingredient is safe,
• The usage instructions are based on scientific evidence.

Additionally, Hygiene and Infection Control Committees in healthcare institutions monitor each hospital’s hygiene protocols and ensure compliance with international standards.

6. Corporate Benefits of Compliance with Hygiene Standards

Compliance with hygiene regulations is not only a legal requirement; it also provides significant benefits in terms of corporate reputation and patient safety:

• A decrease in infection rates,
• Increased patient satisfaction,
• Simplified audit processes,
• Eligibility for international accreditation (JCI, ISO 13485, etc.).

Therefore, healthcare institutions must ensure that everyone, from cleaning staff to management, is aware of these standards.

Global Standard, Local Application

Hygiene in healthcare is a responsibility that knows no boundaries. When international guidelines, national regulations and local practices come together, the safest healthcare environment can be created.
Every healthcare worker, every disinfectant used, every handwashing, and every sterilisation process is a link in this chain.
Compliance with hygiene standards is not just a requirement, but a life-saving habit.